49 CFR 385.715 - Duration of safety monitoring system.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Duration of safety monitoring system. 385.715... SAFETY FITNESS PROCEDURES Safety Monitoring System for Non-North American Carriers § 385.715 Duration of safety monitoring system. (a) Each non-North America-domiciled carrier subject to this subpart will...
49 CFR 385.117 - Duration of safety monitoring system.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Duration of safety monitoring system. 385.117... SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.117 Duration of safety monitoring system. (a) Each Mexico-domiciled carrier subject to this subpart will remain in the...
49 CFR 385.117 - Duration of safety monitoring system.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Duration of safety monitoring system. 385.117... SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.117 Duration of safety monitoring system. (a) Each Mexico-domiciled carrier subject to this subpart will remain in the...
49 CFR 385.715 - Duration of safety monitoring system.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Duration of safety monitoring system. 385.715... SAFETY FITNESS PROCEDURES Safety Monitoring System for Non-North American Carriers § 385.715 Duration of safety monitoring system. (a) Each non-North America-domiciled carrier subject to this subpart will...
49 CFR 385.119 - Applicability of safety fitness and enforcement procedures.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 49 Transportation 5 2012-10-01 2012-10-01 false Applicability of safety fitness and enforcement... REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.119 Applicability of safety fitness and enforcement procedures. At all times during which a Mexico-domiciled motor...
49 CFR 385.119 - Applicability of safety fitness and enforcement procedures.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 49 Transportation 5 2013-10-01 2013-10-01 false Applicability of safety fitness and enforcement... REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.119 Applicability of safety fitness and enforcement procedures. At all times during which a Mexico-domiciled motor...
49 CFR 385.717 - Applicability of safety fitness and enforcement procedures.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 49 Transportation 5 2012-10-01 2012-10-01 false Applicability of safety fitness and enforcement... REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Non-North American Carriers § 385.717 Applicability of safety fitness and enforcement procedures. At all times during which a non-North America...
49 CFR 385.717 - Applicability of safety fitness and enforcement procedures.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 49 Transportation 5 2013-10-01 2013-10-01 false Applicability of safety fitness and enforcement... REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Non-North American Carriers § 385.717 Applicability of safety fitness and enforcement procedures. At all times during which a non-North America...
49 CFR 385.119 - Applicability of safety fitness and enforcement procedures.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 49 Transportation 5 2014-10-01 2014-10-01 false Applicability of safety fitness and enforcement... REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.119 Applicability of safety fitness and enforcement procedures. At all times during which a Mexico-domiciled motor...
49 CFR 385.717 - Applicability of safety fitness and enforcement procedures.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 49 Transportation 5 2014-10-01 2014-10-01 false Applicability of safety fitness and enforcement... REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Non-North American Carriers § 385.717 Applicability of safety fitness and enforcement procedures. At all times during which a non-North America...
49 CFR 385.119 - Applicability of safety fitness and enforcement procedures.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Applicability of safety fitness and enforcement... REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.119 Applicability of safety fitness and enforcement procedures. At all times during which a Mexico-domiciled motor...
49 CFR 385.717 - Applicability of safety fitness and enforcement procedures.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Applicability of safety fitness and enforcement... REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Non-North American Carriers § 385.717 Applicability of safety fitness and enforcement procedures. At all times during which a non-North America...
49 CFR 385.119 - Applicability of safety fitness and enforcement procedures.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Applicability of safety fitness and enforcement... REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.119 Applicability of safety fitness and enforcement procedures. At all times during which a Mexico-domiciled motor...
49 CFR 385.717 - Applicability of safety fitness and enforcement procedures.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Applicability of safety fitness and enforcement... REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Non-North American Carriers § 385.717 Applicability of safety fitness and enforcement procedures. At all times during which a non-North America...
Nuclear Powerplant Safety: Operations.
ERIC Educational Resources Information Center
Department of Energy, Washington, DC. Nuclear Energy Office.
Powerplant systems and procedures that ensure the day-to-day health and safety of people in and around the plant is referred to as operational safety. This safety is the result of careful planning, good engineering and design, strict licensing and regulation, and environmental monitoring. Procedures that assure operational safety at nuclear…
49 CFR 385.333 - What happens at the end of the 18-month safety monitoring period?
Code of Federal Regulations, 2010 CFR
2010-10-01
... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.333 What happens at the end of the 18-month safety monitoring period? (a) If a safety audit has been performed within... the same basis as any other carrier. (d) If a safety audit or compliance review has not been performed...
29 CFR 1956.22 - Procedures for evaluation and monitoring.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 29 Labor 9 2010-07-01 2010-07-01 false Procedures for evaluation and monitoring. 1956.22 Section 1956.22 Labor Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION..., Change, Evaluation and Withdrawal of Approval Procedures § 1956.22 Procedures for evaluation and...
Implementation guide for monitoring work zone safety and mobility impacts
DOT National Transportation Integrated Search
2009-01-01
This implementation guide describes the conceptual framework, data requirements, and computational procedures for determining the safety and mobility impacts of work zones in Texas. Researchers designed the framework and procedures to assist district...
[Safety monitoring of cell-based medicinal products (CBMPs)].
Funk, Markus B; Frech, Marion; Spranger, Robert; Keller-Stanislawski, Brigitte
2015-11-01
Cell-based medicinal products (CBMPs), a category of advanced-therapy medicinal products (ATMPs), are authorised for the European market by the European Commission by means of the centralized marketing authorisation. By conforming to the German Medicinal Products Act (Sec. 4b AMG), national authorisation can be granted by the Paul-Ehrlich-Institut in Germany exclusively for ATMPs not based on a routine manufacturing procedure. In both procedures, quality, efficacy, and safety are evaluated and the risk-benefit balance is assessed. For the centralised procedure, mainly controlled clinical trial data must be submitted, whereas the requirements for national procedures could be modified corresponding to the stage of development of the ATMP. After marketing authorization, the marketing authorization/license holder is obligated to report all serious adverse reactions to the competent authority and to provide periodic safety update reports. If necessary, post-authorization safety studies could be imposed. On the basis of these regulatory measures, the safety of advanced therapies can be monitored and improved.
Analysis of safety reports involving area navigation and required navigation performance procedures.
DOT National Transportation Integrated Search
2010-11-03
In order to achieve potential operational and safety benefits enabled by Area Navigation (RNAV) and Required Navigation Performance (RNP) procedures it is important to monitor emerging issues in their initial implementation. Reports from the Aviation...
Development of safety performance monitoring procedures.
DOT National Transportation Integrated Search
2010-02-01
Highway safety is an ongoing concern to the Texas Department of Transportation (TxDOT). As part of its : proactive commitment to improving highway safety, TxDOT is moving toward including quantitative safety : analyses earlier in the project developm...
Health and Safety in Day Care.
ERIC Educational Resources Information Center
Sells, Clifford J.; Paeth, Susan
1987-01-01
Basic health and day care policies and procedures should be implemented and closely monitored with the help of a health consultant, particularly in terms of respiratory tract, enteric, skin, invasive bacterial, and multiple system infections; Acquired Immune Deficiency Syndrome; vaccine preventable diseases; and general safety procedures.…
49 CFR 385.107 - The safety audit.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false The safety audit. 385.107 Section 385.107 Transportation Other Regulations Relating to Transportation (Continued) FEDERAL MOTOR CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domicile...
10 CFR 34.83 - Records of personnel monitoring procedures.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 1 2012-01-01 2012-01-01 false Records of personnel monitoring procedures. 34.83 Section 34.83 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Recordkeeping Requirements § 34.83 Records of personnel...
10 CFR 34.83 - Records of personnel monitoring procedures.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 1 2013-01-01 2013-01-01 false Records of personnel monitoring procedures. 34.83 Section 34.83 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Recordkeeping Requirements § 34.83 Records of personnel...
10 CFR 34.83 - Records of personnel monitoring procedures.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Records of personnel monitoring procedures. 34.83 Section 34.83 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Recordkeeping Requirements § 34.83 Records of personnel...
10 CFR 34.83 - Records of personnel monitoring procedures.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Records of personnel monitoring procedures. 34.83 Section 34.83 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Recordkeeping Requirements § 34.83 Records of personnel...
10 CFR 34.83 - Records of personnel monitoring procedures.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 1 2014-01-01 2014-01-01 false Records of personnel monitoring procedures. 34.83 Section 34.83 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Recordkeeping Requirements § 34.83 Records of personnel...
Dhakal, Sanjaya; Burwen, Dale R; Polakowski, Laura L; Zinderman, Craig E; Wise, Robert P
2014-03-01
Assess whether Medicare data are useful for monitoring tissue allograft safety and utilization. We used health care claims (billing) data from 2007 for 35 million fee-for-service Medicare beneficiaries, a predominantly elderly population. Using search terms for transplant-related procedures, we generated lists of ICD-9-CM and CPT(®) codes and assessed the frequency of selected allograft procedures. Step 1 used inpatient data and ICD-9-CM procedure codes. Step 2 added non-institutional provider (e.g., physician) claims, outpatient institutional claims, and CPT codes. We assembled preliminary lists of diagnosis codes for infections after selected allograft procedures. Many ICD-9-CM codes were ambiguous as to whether the procedure involved an allograft. Among 1.3 million persons with a procedure ascertained using the list of ICD-9-CM codes, only 1,886 claims clearly involved an allograft. CPT codes enabled better ascertainment of some allograft procedures (over 17,000 persons had corneal transplants and over 2,700 had allograft skin transplants). For spinal fusion procedures, CPT codes improved specificity for allografts; of nearly 100,000 patients with ICD-9-CM codes for spinal fusions, more than 34,000 had CPT codes indicating allograft use. Monitoring infrequent events (infections) after infrequent exposures (tissue allografts) requires large study populations. A strength of the large Medicare databases is the substantial number of certain allograft procedures. Limitations include lack of clinical detail and donor information. Medicare data can potentially augment passive reporting systems and may be useful for monitoring tissue allograft safety and utilization where codes clearly identify allograft use and coding algorithms can effectively screen for infections.
Safety of Induced Sputum Collection in Children Hospitalized With Severe or Very Severe Pneumonia
DeLuca, Andrea N.; Hammitt, Laura L.; Kim, Julia; Higdon, Melissa M.; Baggett, Henry C.; Brooks, W. Abdullah; Howie, Stephen R. C.; Deloria Knoll, Maria; Kotloff, Karen L.; Levine, Orin S.; Madhi, Shabir A.; Murdoch, David R.; Scott, J. Anthony G.; Thea, Donald M.; Amornintapichet, Tussanee; Awori, Juliet O.; Chuananon, Somchai; Driscoll, Amanda J.; Ebruke, Bernard E.; Hossain, Lokman; Jahan, Yasmin; Kagucia, E. Wangeci; Kazungu, Sidi; Moore, David P.; Mudau, Azwifarwi; Mwananyanda, Lawrence; Park, Daniel E.; Prosperi, Christine; Seidenberg, Phil; Sylla, Mamadou; Tapia, Milagritos D.; Zaman, Syed M. A.; O’Brien, Katherine L.; Levine, Orin S.; Knoll, Maria Deloria; Feikin, Daniel R.; DeLuca, Andrea N.; Driscoll, Amanda J.; Fancourt, Nicholas; Fu, Wei; Hammitt, Laura L.; Higdon, Melissa M.; Kagucia, E. Wangeci; Karron, Ruth A.; Li, Mengying; Park, Daniel E.; Prosperi, Christine; Wu, Zhenke; Zeger, Scott L.; Watson, Nora L.; Crawley, Jane; Murdoch, David R.; Brooks, W. Abdullah; Endtz, Hubert P.; Zaman, Khalequ; Goswami, Doli; Hossain, Lokman; Jahan, Yasmin; Ashraf, Hasan; Howie, Stephen R. C.; Ebruke, Bernard E.; Antonio, Martin; McLellan, Jessica; Machuka, Eunice; Shamsul, Arifin; Zaman, Syed M.A.; Mackenzie, Grant; Scott, J. Anthony G.; Awori, Juliet O.; Morpeth, Susan C.; Kamau, Alice; Kazungu, Sidi; Silaba, Micah; Kotloff, Karen L.; Tapia, Milagritos D.; Sow, Samba O.; Sylla, Mamadou; Tamboura, Boubou; Onwuchekwa, Uma; Kourouma, Nana; Toure, Aliou; Madhi, Shabir A.; Moore, David P.; Adrian, Peter V.; Baillie, Vicky L.; Kuwanda, Locadiah; Mudau, Azwifarwi; Groome, Michelle J.; Mahomed, Nasreen; Baggett, Henry C.; Thamthitiwat, Somsak; Maloney, Susan A.; Bunthi, Charatdao; Rhodes, Julia; Sawatwong, Pongpun; Akarasewi, Pasakorn; Thea, Donald M.; Mwananyanda, Lawrence; Chipeta, James; Seidenberg, Phil; Mwansa, James; wa Somwe, Somwe; Kwenda, Geoffrey
2017-01-01
Abstract Background. Induced sputum (IS) may provide diagnostic information about the etiology of pneumonia. The safety of this procedure across a heterogeneous population with severe pneumonia in low- and middle-income countries has not been described. Methods. IS specimens were obtained as part a 7-country study of the etiology of severe and very severe pneumonia in hospitalized children <5 years of age. Rigorous clinical monitoring was done before, during, and after the procedure to record oxygen requirement, oxygen saturation, respiratory rate, consciousness level, and other evidence of clinical deterioration. Criteria for IS contraindications were predefined and serious adverse events (SAEs) were reported to ethics committees and a central safety monitor. Results. A total of 4653 IS procedures were done among 3802 children. Thirteen SAEs were reported in relation to collection of IS, or 0.34% of children with at least 1 IS specimen collected (95% confidence interval, 0.15%–0.53%). A drop in oxygen saturation that required supplemental oxygen was the most common SAE. One child died after feeding was reinitiated 2 hours after undergoing sputum induction; this death was categorized as “possibly related” to the procedure. Conclusions. The overall frequency of SAEs was very low, and the nature of most SAEs was manageable, demonstrating a low-risk safety profile for IS collection even among severely ill children in low-income-country settings. Healthcare providers should monitor oxygen saturation and requirements during and after IS collection, and assess patients prior to reinitiating feeding after the IS procedure, to ensure patient safety. PMID:28575356
Safety of Induced Sputum Collection in Children Hospitalized With Severe or Very Severe Pneumonia.
DeLuca, Andrea N; Hammitt, Laura L; Kim, Julia; Higdon, Melissa M; Baggett, Henry C; Brooks, W Abdullah; Howie, Stephen R C; Deloria Knoll, Maria; Kotloff, Karen L; Levine, Orin S; Madhi, Shabir A; Murdoch, David R; Scott, J Anthony G; Thea, Donald M; Amornintapichet, Tussanee; Awori, Juliet O; Chuananon, Somchai; Driscoll, Amanda J; Ebruke, Bernard E; Hossain, Lokman; Jahan, Yasmin; Kagucia, E Wangeci; Kazungu, Sidi; Moore, David P; Mudau, Azwifarwi; Mwananyanda, Lawrence; Park, Daniel E; Prosperi, Christine; Seidenberg, Phil; Sylla, Mamadou; Tapia, Milagritos D; Zaman, Syed M A; O'Brien, Katherine L
2017-06-15
Induced sputum (IS) may provide diagnostic information about the etiology of pneumonia. The safety of this procedure across a heterogeneous population with severe pneumonia in low- and middle-income countries has not been described. IS specimens were obtained as part a 7-country study of the etiology of severe and very severe pneumonia in hospitalized children <5 years of age. Rigorous clinical monitoring was done before, during, and after the procedure to record oxygen requirement, oxygen saturation, respiratory rate, consciousness level, and other evidence of clinical deterioration. Criteria for IS contraindications were predefined and serious adverse events (SAEs) were reported to ethics committees and a central safety monitor. A total of 4653 IS procedures were done among 3802 children. Thirteen SAEs were reported in relation to collection of IS, or 0.34% of children with at least 1 IS specimen collected (95% confidence interval, 0.15%-0.53%). A drop in oxygen saturation that required supplemental oxygen was the most common SAE. One child died after feeding was reinitiated 2 hours after undergoing sputum induction; this death was categorized as "possibly related" to the procedure. The overall frequency of SAEs was very low, and the nature of most SAEs was manageable, demonstrating a low-risk safety profile for IS collection even among severely ill children in low-income-country settings. Healthcare providers should monitor oxygen saturation and requirements during and after IS collection, and assess patients prior to reinitiating feeding after the IS procedure, to ensure patient safety. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America.
Ahmed, Shihab U; Tonidandel, William; Trella, Jason; Martin, Nicole M; Chang, Yuchiao
2005-04-01
Interventional techniques are now an integral part of chronic pain management. As new procedures are arising at a rapid pace, decisions regarding patient safety and comfort are becoming more challenging. No peri-procedural consensus protocol currently addresses issues such as 1. nulla per os (NPO) status, 2. sedation, 3. monitoring, or 4. recovery. In establishing safety guidelines for interventional pain procedures, the knowledge of current peri-procedural protocols is required. To survey interventional pain practices and to obtain current peri-procedural protocols. We faxed a one-page questionnaire to 105 United States pain practices identified using the directory of the American Pain Society. Fifty-seven academic and private pain practices (54%) responded and were included in the analysis. Monitoring devices such as electrocardiogram (EKG), blood pressure, and pulse oximetry are not universally employed for cervical or lumbar spinal procedures. Even procedures that are often performed by anesthesiologists in operating rooms, such as Bier blocks, are not monitored in a uniform manner when performed in pain clinics. Establishment of intravenous access for procedures also varies among practitioners. Most (72%) practices had treated patients with vasovagal reactions over the past 12 months, but only 42% had simulated cardiac arrests to prepare for these situations. While various trends in peri-procedural care are observable, standards of care are not well established. In order to minimize complications associated with interventional pain management techniques, the pain management community should agree on safety guidelines for all procedures, much as these advocated by the American Society of Anesthesiology for surgical anesthetic care.
Parillo, V L
1994-01-01
To develop a procedure for medical surveillance of healthcare workers who handle cytotoxic drugs. Literature review and guidelines published by the Occupational Safety and Health Administration and the National Institute for Occupational Safety and Health. INFORMATION SELECTION: Studies of possible exposure screening tests, congenital defects in offspring, and case studies. Some degree of risk exists in handling cytotoxic drugs, but no reliable screening test for cytotoxic drug exposure has been developed. Reproductive hazards are possible when protective equipment is not used. Areas to be addressed when devising surveillance procedures include who to cover, what baseline data to gather, what periodic monitoring will be necessary (and at what interval it will be conducted), how to handle exposure incidents, and what documentation system will be used. A procedure using a baseline risk factor form and a yearly monitoring questionnaire was devised and implemented. Forms contain documentation of worker teaching. Most often, nurses are the healthcare workers who handle cytotoxic drugs. A consistent approach to monitoring healthcare workers is facilitated by using a defined procedure and standardized forms.
Eichhorn, Volker; Henzler, Dietrich; Murphy, Michael F
2010-08-01
The purpose of this review is to summarize recommendations for the safe and efficient conductance of sedation and anesthesia at remote locations; and to define safety standards, monitoring techniques, quality of care and procedural eligibility. Anesthesia outside of the operating room is rapidly increasing in numbers, which has seen a growth of older and sicker patients. These circumstances have created a need for guidelines, for both specialist anesthesia providers and nonanesthesia-trained practitioners, that define patient selection, minimum monitoring (hemodynamics and respiration), facility design and equipment, policy framework, recovery facilities and policies. The patient's safety throughout all stages of sedation and/or anesthesia is the most pertinent goal. Recent data emphasize the importance of monitoring pulse oximetry and end-tidal carbon dioxide for any sedating or anesthetic procedure. Substandard monitoring combined with oversedation and subsequent respiratory depression are implicated as the main reasons for catastrophic sedation and anesthetic outcomes at remote locations. Patient selection, procedure appropriateness and location appropriateness are the key elements defining the provision of safe anesthesia care outside the operating room. Titratable, short-acting intravenous drugs are preferred such as propofol and remifentanil.
49 CFR 193.2913 - Security monitoring.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 49 Transportation 3 2012-10-01 2012-10-01 false Security monitoring. 193.2913 Section 193.2913...: FEDERAL SAFETY STANDARDS Security § 193.2913 Security monitoring. Each protective enclosure and the area.... Monitoring must be by visual observation in accordance with the schedule in the security procedures under...
49 CFR 193.2913 - Security monitoring.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 3 2010-10-01 2010-10-01 false Security monitoring. 193.2913 Section 193.2913...: FEDERAL SAFETY STANDARDS Security § 193.2913 Security monitoring. Each protective enclosure and the area.... Monitoring must be by visual observation in accordance with the schedule in the security procedures under...
49 CFR 193.2913 - Security monitoring.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 3 2011-10-01 2011-10-01 false Security monitoring. 193.2913 Section 193.2913...: FEDERAL SAFETY STANDARDS Security § 193.2913 Security monitoring. Each protective enclosure and the area.... Monitoring must be by visual observation in accordance with the schedule in the security procedures under...
Information processing requirements for on-board monitoring of automatic landing
NASA Technical Reports Server (NTRS)
Sorensen, J. A.; Karmarkar, J. S.
1977-01-01
A systematic procedure is presented for determining the information processing requirements for on-board monitoring of automatic landing systems. The monitoring system detects landing anomalies through use of appropriate statistical tests. The time-to-correct aircraft perturbations is determined from covariance analyses using a sequence of suitable aircraft/autoland/pilot models. The covariance results are used to establish landing safety and a fault recovery operating envelope via an event outcome tree. This procedure is demonstrated with examples using the NASA Terminal Configured Vehicle (B-737 aircraft). The procedure can also be used to define decision height, assess monitoring implementation requirements, and evaluate alternate autoland configurations.
49 CFR 385.111 - Suspension and revocation of Mexico-domiciled carrier registration.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Suspension and revocation of Mexico-domiciled... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.111 Suspension and revocation of Mexico-domiciled carrier registration. (a) If a carrier is assigned...
49 CFR 385.111 - Suspension and revocation of Mexico-domiciled carrier registration.
Code of Federal Regulations, 2014 CFR
2014-10-01
... 49 Transportation 5 2014-10-01 2014-10-01 false Suspension and revocation of Mexico-domiciled... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.111 Suspension and revocation of Mexico-domiciled carrier registration. (a) If a carrier is assigned...
49 CFR 385.111 - Suspension and revocation of Mexico-domiciled carrier registration.
Code of Federal Regulations, 2013 CFR
2013-10-01
... 49 Transportation 5 2013-10-01 2013-10-01 false Suspension and revocation of Mexico-domiciled... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.111 Suspension and revocation of Mexico-domiciled carrier registration. (a) If a carrier is assigned...
49 CFR 385.111 - Suspension and revocation of Mexico-domiciled carrier registration.
Code of Federal Regulations, 2012 CFR
2012-10-01
... 49 Transportation 5 2012-10-01 2012-10-01 false Suspension and revocation of Mexico-domiciled... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.111 Suspension and revocation of Mexico-domiciled carrier registration. (a) If a carrier is assigned...
49 CFR 385.111 - Suspension and revocation of Mexico-domiciled carrier registration.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Suspension and revocation of Mexico-domiciled... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES Safety Monitoring System for Mexico-Domiciled Carriers § 385.111 Suspension and revocation of Mexico-domiciled carrier registration. (a) If a carrier is assigned...
ReactorHealth Physics operations at the NIST center for neutron research.
Johnston, Thomas P
2015-02-01
Performing health physics and radiation safety functions under a special nuclear material license and a research and test reactor license at a major government research and development laboratory encompasses many elements not encountered by industrial, general, or broad scope licenses. This article reviews elements of the health physics and radiation safety program at the NIST Center for Neutron Research, including the early history and discovery of the neutron, applications of neutron research, reactor overview, safety and security of radiation sources and radioactive material, and general health physics procedures. These comprise precautions and control of tritium, training program, neutron beam sample processing, laboratory audits, inventory and leak tests, meter calibration, repair and evaluation, radioactive waste management, and emergency response. In addition, the radiation monitoring systems will be reviewed including confinement building monitoring, ventilation filter radiation monitors, secondary coolant monitors, gaseous fission product monitors, gas monitors, ventilation tritium monitor, and the plant effluent monitor systems.
UV disinfection in drinking water supplies.
Hoyer, O
2000-01-01
UV disinfection has become a practical and safely validatable disinfection procedure by specifying the requirements for testing and monitoring in DVGW standard W 294. A standardized biodosimetric testing procedure and monitoring with standardized UV sensors is introduced and successfully applied. On-line monitoring of irradiance can be counterchecked with handheld reference sensors and makes it possible that UV systems can be used for drinking water disinfection with the same level of confidence and safety as is conventional chemical disinfection.
The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study.
Holubkov, Richard; Casper, T Charles; Dean, J Michael; Anand, K J S; Zimmerman, Jerry; Meert, Kathleen L; Newth, Christopher J L; Berger, John; Harrison, Rick; Willson, Douglas F; Nicholson, Carol
2013-05-01
Randomized clinical trials are commonly overseen by a Data and Safety Monitoring Board comprised of experts in medicine, ethics, and biostatistics. Data and Safety Monitoring Board responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. Data and Safety Monitoring Board decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate Data and Safety Monitoring Board oversight into the design, monitoring, and reporting of randomized trials. Case study, narrative review. The Data and Safety Monitoring Board's role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. The National Institutes of Health-appointed CRISIS Data and Safety Monitoring Board was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested Data and Safety Monitoring Board interim review before opening CRISIS to children below 1 yr of age. The first interim analysis found higher 28-day mortality in one treatment arm. The Data and Safety Monitoring Board maintained trial closure to younger children and requested a second interim data review 6 months later. At this second meeting, mortality was no longer of concern, whereas a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the Data and Safety Monitoring Board elected to examine conditional power and unmask treatment arm identities. On finding somewhat greater efficacy in the placebo arm, the Data and Safety Monitoring Board recommended stopping CRISIS due to futility. The design and operating procedures of a multicenter randomized trial must consider a pivotal Data and Safety Monitoring Board role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The Data and Safety Monitoring Board must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups.
46 CFR Appendix A to Subpart C of... - Sample Substance Safety Data Sheet, Benzene
Code of Federal Regulations, 2012 CFR
2012-10-01
.... Observation of Monitoring The employer is required to conduct monitoring that is representative of your exposure to benzene, and you or your designated representative are entitled to observe the monitoring... results obtained. When the monitoring procedure is taking place in an area where respirators or personal...
46 CFR Appendix A to Subpart C of... - Sample Substance Safety Data Sheet, Benzene
Code of Federal Regulations, 2014 CFR
2014-10-01
.... Observation of Monitoring The employer is required to conduct monitoring that is representative of your exposure to benzene, and you or your designated representative are entitled to observe the monitoring... results obtained. When the monitoring procedure is taking place in an area where respirators or personal...
46 CFR Appendix A to Subpart C to... - Sample Substance Safety Data Sheet, Benzene
Code of Federal Regulations, 2011 CFR
2011-10-01
.... Observation of Monitoring The employer is required to conduct monitoring that is representative of your exposure to benzene, and you or your designated representative are entitled to observe the monitoring... results obtained. When the monitoring procedure is taking place in an area where respirators or personal...
46 CFR Appendix A to Subpart C of... - Sample Substance Safety Data Sheet, Benzene
Code of Federal Regulations, 2013 CFR
2013-10-01
.... Observation of Monitoring The employer is required to conduct monitoring that is representative of your exposure to benzene, and you or your designated representative are entitled to observe the monitoring... results obtained. When the monitoring procedure is taking place in an area where respirators or personal...
Conway, Aaron; Sutherland, Joanna
2016-11-01
Processed electroencephalogram-based depth of anaesthesia monitoring devices provide an additional method to monitor level of consciousness during procedural sedation and analgesia. The objective of this systematic review was to determine whether using a depth of anaesthesia monitoring device improves the safety and efficacy of sedation. Systematic review and meta-analysis. Electronic databases (CENTRAL; Medline; CINAHL) were searched up to May 2015. Randomised controlled trials that compared use of a depth of anaesthesia monitoring device to a control group who received standard monitoring during procedural sedation and analgesia were included. Study selection, data extraction and risk of bias assessment (Cochrane risk of bias tool) were performed by two reviewers. Safety outcomes were hypoxaemia, hypotension and adverse events. Efficacy outcomes were amount of sedation used, duration of sedation recovery and rate of incomplete procedures. A total of 16 trials (2138 participants) were included. Evidence ratings were downgraded to either low or moderate quality due to study limitations and imprecision. Meta-analysis of 8 trials (766 participants) found no difference in hypoxaemia (RR 0.87; 95% CI=0.67-1.12). No statistically significant difference in hypotension was observed in meta-analysis of 8 trials (RR 0.96; 95% CI=0.54-1.7; 942 participants). Mean dose of propofol was 51mg lower for participants randomised to depth of anaesthesia monitoring (95% CI=-88.7 to -13.3mg) in meta-analysis of results from four trials conducted with 434 participants who underwent interventional endoscopy procedures with propofol infusions to maintain sedation. The difference in recovery time between depth of anaesthesia and standard monitoring groups was not clinically significant (standardised mean difference -0.41; 95% CI=-0.8 to -0.02; I 2 =86%; 8 trials; 809 participants). Depth of anaesthesia monitoring did impact sedation titration during interventional procedures with propofol infusions. For this reason, it seems reasonable for anaesthetists to utilise a depth of anaesthesia monitoring device for select populations of patients if it is decided that limiting the amount of sedation would be beneficial for the individual patient. However, there is no need to invest in purchasing extra equipment or training staff who are not familiar with this technology (e.g. nurses who do not routinely use a depth of anaesthesia monitoring device during general anaesthesia) because there is no high quality evidence suggestive of clear clinical benefits for patient safety or sedation efficacy. Copyright © 2016 Elsevier Ltd. All rights reserved.
78 FR 21715 - Sexual Assault Prevention and Response (SAPR) Program Procedures
Federal Register 2010, 2011, 2012, 2013, 2014
2013-04-11
... high-risk team to monitor cases where the sexual assault victim's life and safety may be in jeopardy... in Military Rule of Evidence 514. (9) Requires the execution of a high-risk team to monitor cases...
10 CFR 851.21 - Hazard identification and assessment.
Code of Federal Regulations, 2013 CFR
2013-01-01
.... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety workplace hazards through appropriate workplace monitoring; (2) Document assessment for chemical, physical... hazards; (6) Perform routine job activity-level hazard analyses; (7) Review site safety and health...
10 CFR 851.21 - Hazard identification and assessment.
Code of Federal Regulations, 2014 CFR
2014-01-01
.... Procedures must include methods to: (1) Assess worker exposure to chemical, physical, biological, or safety workplace hazards through appropriate workplace monitoring; (2) Document assessment for chemical, physical... hazards; (6) Perform routine job activity-level hazard analyses; (7) Review site safety and health...
Ausserhofer, Dietmar; Rakic, Severin; Novo, Ahmed; Dropic, Emira; Fisekovic, Eldin; Sredic, Ana; Van Malderen, Greet
2016-06-01
We explored how selected 'positive deviant' healthcare facilities in Bosnia and Herzegovina approach the continuous development, adaptation, implementation, monitoring and evaluation of nursing-related standard operating procedures. Standardized nursing care is internationally recognized as a critical element of safe, high-quality health care; yet very little research has examined one of its key instruments: nursing-related standard operating procedures. Despite variability in Bosnia and Herzegovina's healthcare and nursing care quality, we assumed that some healthcare facilities would have developed effective strategies to elevate nursing quality and safety through the use of standard operating procedures. Guided by the 'positive deviance' approach, we used a multiple-case study design to examine a criterion sample of four facilities (two primary healthcare centres and two hospitals), collecting data via focus groups and individual interviews. In each studied facility, certification/accreditation processes were crucial to the initiation of continuous development, adaptation, implementation, monitoring and evaluation of nursing-related SOPs. In one hospital and one primary healthcare centre, nurses working in advanced roles (i.e. quality coordinators) were responsible for developing and implementing nursing-related standard operating procedures. Across the four studied institutions, we identified a consistent approach to standard operating procedures-related processes. The certification/accreditation process is enabling necessary changes in institutions' organizational cultures, empowering nurses to take on advanced roles in improving the safety and quality of nursing care. Standardizing nursing procedures is key to improve the safety and quality of nursing care. Nursing and Health Policy are needed in Bosnia and Herzegovina to establish a functioning institutional framework, including regulatory bodies, educational systems for developing nurses' capacities or the inclusion of nursing-related standard operating procedures in certification/accreditation standards. © 2016 International Council of Nurses.
Donaldson, Mark; Goodchild, Jason H
2009-12-01
Although dental board regulations for the provision of in-office enteral conscious (oral) sedation vary widely with respect to training and pharmacologic strategies, they agree on the use of drugs that are inherently safe, the use of pulse oximetry and the availability of emergency equipment, including pharmacologic antagonists. Patient safety is of greatest concern and is best addressed by appropriate selection of patients, adequate training of personnel and appropriate monitoring of patients. Readings from bispectral index system (BIS) monitors, which use electroencephalographic signals, correlate accurately with depth of sedation during nondissociative general anesthesia of adults and children in the operating room setting. The usefulness of such monitoring as an adjunct to other forms of monitoring of in-office enteral sedation in the dental setting may represent the next important application of this tool, adding a further level of safety for the patient and another level of predictability for the practitioner. This paper reviews the current evidence supporting this new technique, presenting data from 20 procedures in which BIS monitoring during in-office enteral sedation was employed in a community dental practice.
Neuro-oncology update: radiation safety and nursing care during interstitial brachytherapy
DOE Office of Scientific and Technical Information (OSTI.GOV)
Randall, T.M.; Drake, D.K.; Sewchand, W.
Radiation control and safety are major considerations for nursing personnel during the care of patients receiving brachytherapy. Since the theory and practice of radiation applications are not part of the routine curriculum of nursing programs, the education of nurses and other health care professionals in radiation safety procedures is important. Regulatory agencies recommend that an annual safety course be given to all persons frequenting, using, or associated with patients containing radioactive materials. This article presents pertinent aspects of the principles and procedures of radiation safety, the role of personnel dose-monitoring devices, and the value of additional radiation control features, suchmore » as a lead cubicle, during interstitial brain implants. One institution's protocol and procedures for the care of high-intensity iridium-192 brain implants are discussed. Preoperative teaching guidelines and nursing interventions included in the protocol focus on radiation control principles.« less
Code of Federal Regulations, 2012 CFR
2012-07-01
... pollution control equipment and monitoring equipment, in a manner consistent with safety and good air... include, but is not limited to, monitoring results, review of operation and maintenance procedures, review... VOHAP-containing materials to and from containers, tanks, vats, drums, and piping systems is conducted...
Code of Federal Regulations, 2014 CFR
2014-07-01
... pollution control equipment and monitoring equipment, in a manner consistent with safety and good air... include, but is not limited to, monitoring results, review of operation and maintenance procedures, review... VOHAP-containing materials to and from containers, tanks, vats, drums, and piping systems is conducted...
Code of Federal Regulations, 2013 CFR
2013-07-01
... pollution control equipment and monitoring equipment, in a manner consistent with safety and good air... include, but is not limited to, monitoring results, review of operation and maintenance procedures, review... VOHAP-containing materials to and from containers, tanks, vats, drums, and piping systems is conducted...
Registered nurse-administered sedation for gastrointestinal endoscopic procedure
Amornyotin, Somchai
2015-01-01
The rising use of nonanesthesiologist-administered sedation for gastrointestinal endoscopy has clinical significances. Most endoscopic patients require some forms of sedation and/or anesthesia. The goals of this sedation are to guard the patient’s safety, minimize physical discomfort, to control behavior and to diminish psychological responses. Generally, moderate sedation for these procedures has been offered by the non-anesthesiologist by using benzodiazepines and/or opioids. Anesthesiologists and non-anesthesiologist personnel will need to work together for these challenges and for safety of the patients. The sedation training courses including clinical skills and knowledge are necessary for the registered nurses to facilitate the patient safety and the successful procedure. However, appropriate patient selection and preparation, adequate monitoring and regular training will ensure that the use of nurse-administered sedation is a feasible and safe technique for gastrointestinal endoscopic procedures. PMID:26191341
30 CFR 27.4 - Application procedures and requirements.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Application procedures and requirements. 27.4 Section 27.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND APPROVAL OF MINING PRODUCTS METHANE-MONITORING SYSTEMS General Provisions § 27.4 Application...
Sedation and monitoring for gastrointestinal endoscopy
Amornyotin, Somchai
2013-01-01
The safe sedation of patients for diagnostic or therapeutic procedures requires a combination of properly trained physicians and suitable facilities. Additionally, appropriate selection and preparation of patients, suitable sedative technique, application of drugs, adequate monitoring, and proper recovery of patients is essential. The goal of procedural sedation is the safe and effective control of pain and anxiety as well as to provide an appropriate degree of memory loss or decreased awareness. Sedation practices for gastrointestinal endoscopy (GIE) vary widely. The majority of GIE patients are ambulatory cases. Most of this procedure requires a short time. So, short acting, rapid onset drugs with little adverse effects and improved safety profiles are commonly used. The present review focuses on commonly used regimens and monitoring practices in GIE sedation. This article is to discuss the decision making process used to determine appropriate pre-sedation assessment, monitoring, drug selection, dose of sedative agents, sedation endpoint and post-sedation care. It also reviews the current status of sedation and monitoring for GIE procedures in Thailand. PMID:23424050
Honeybourne, D.; Neumann, C. S.
1997-01-01
BACKGROUND: Both patient and staff safety are of major importance during the procedure of fibreoptic bronchoscopy. Patient safety depends partly on adequate disinfection of instruments and accessories used as well as careful monitoring during the procedure. Adequate facilities, manpower and training are also essential. Staff safety depends partly on adequate procedures to minimise any risks of sensitisation to agents such as glutaraldehyde. An audit was carried out of bronchoscopy procedures in hospitals in the UK and the findings were compared with published guidelines on good practice and clinical consensus. METHODS: A postal questionnaire was sent to 218 bronchoscopy units in the UK. Findings were then compared with published evidence of good practice in the areas of disinfection, including the use of glutaraldehyde, patient monitoring, manpower, facilities, and training. RESULTS: A 73% response rate was obtained. Recommended minimum disinfection times before and after routine bronchoscopies were not achieved by 35% of units. No disinfection was carried out in 34% of units before emergency bronchoscopies and in 19% of units after suspected cases of tuberculosis. Adequate rinsing of the bronchoscope with sterile or filtered water was not carried out by 43% of units. Contrary to recommendations, 31% of departments were still using glutaraldehyde in the patient examination room and inadequate room ventilation was common. Protective clothing was often not worn by staff during bronchoscopy. Inadequate intravenous access and use of supplementary oxygen were found in many units. Practice standards were higher in departments where dedicated bronchoscopy/endoscopy units of the hospital were used, and also where staff had been on external training courses. CONCLUSIONS: This audit has shown that many units do not adhere to guidelines on disinfection procedures and patient monitoring. Unnecessary potential risks due to staff exposure to glutaraldehyde were apparent. National guidelines on good practice are not being followed in areas which may potentially affect patient and staff safety. PMID:9337830
ECG Monitoring in Cardiac Rehabilitation: Is It Needed?
ERIC Educational Resources Information Center
Greenland, Philip; Pomilla, Paul V.
1989-01-01
Discusses the controversial use of continuous electrocardiogram (ECG) monitoring as a safety measure in cardiac rehabilitation exercise programs. Little evidence substantiates its value for all patients during exercise. In the absence of empirical evidence documenting the worth of this expensive procedure, it is recommended for use with high-risk…
Yaacoubi, Slah; McKeon, Peter; Ke, Weina; Declercq, Nico F.; Dahmene, Fethi
2017-01-01
This paper presents an overview and description of the approach to be used to investigate the behavior and the defect sensitivity of various ultrasonic guided wave (UGW) modes propagating specifically in composite cylindrical vessels in the framework of the safety of hydrogen energy transportation such as hydrogen-powered aircrafts. These structures which consist of thick and multi-layer composites are envisioned for housing hydrogen gas at high pressures. Due to safety concerns associated with a weakened structure, structural health monitoring techniques are needed. A procedure for optimizing damage detection in these structural types is presented. It is shown that a finite element method can help identify useful experimental parameters including frequency range, excitation type, and receiver placement. PMID:28925961
NASA Technical Reports Server (NTRS)
Maul, William A.; Meyer, Claudia M.
1991-01-01
A rocket engine safety system was designed to initiate control procedures to minimize damage to the engine or vehicle or test stand in the event of an engine failure. The features and the implementation issues associated with rocket engine safety systems are discussed, as well as the specific concerns of safety systems applied to a space-based engine and long duration space missions. Examples of safety system features and architectures are given, based on recent safety monitoring investigations conducted for the Space Shuttle Main Engine and for future liquid rocket engines. Also, the general design and implementation process for rocket engine safety systems is presented.
Novel Use of Google Glass for Procedural Wireless Vital Sign Monitoring.
Liebert, Cara A; Zayed, Mohamed A; Aalami, Oliver; Tran, Jennifer; Lau, James N
2016-08-01
Purpose This study investigates the feasibility and potential utility of head-mounted displays for real-time wireless vital sign monitoring during surgical procedures. Methods In this randomized controlled pilot study, surgery residents (n = 14) performed simulated bedside procedures with traditional vital sign monitors and were randomized to addition of vital sign streaming to Google Glass. Time to recognition of preprogrammed vital sign deterioration and frequency of traditional monitor use was recorded. User feedback was collected by electronic survey. Results The experimental group spent 90% less time looking away from the procedural field to view traditional monitors during bronchoscopy (P = .003), and recognized critical desaturation 8.8 seconds earlier; the experimental group spent 71% (P = .01) less time looking away from the procedural field during thoracostomy, and recognized hypotension 10.5 seconds earlier. Trends toward earlier recognition of deterioration did not reach statistical significance. The majority of participants agreed that Google Glass increases situational awareness (64%), is helpful in monitoring vitals (86%), is easy to use (93%), and has potential to improve patient safety (85%). Conclusion In this early feasibility study, use of streaming to Google Glass significantly decreased time looking away from procedural fields and resulted in a nonsignificant trend toward earlier recognition of vital sign deterioration. Vital sign streaming with Google Glass or similar platforms is feasible and may enhance procedural situational awareness. © The Author(s) 2016.
Microbial ecology laboratory procedures manual NASA/MSFC
NASA Technical Reports Server (NTRS)
Huff, Timothy L.
1990-01-01
An essential part of the efficient operation of any microbiology laboratory involved in sample analysis is a standard procedures manual. The purpose of this manual is to provide concise and well defined instructions on routine technical procedures involving sample analysis and methods for monitoring and maintaining quality control within the laboratory. Of equal importance is the safe operation of the laboratory. This manual outlines detailed procedures to be followed in the microbial ecology laboratory to assure safety, analytical control, and validity of results.
NASA Technical Reports Server (NTRS)
Statler, Irving C. (Editor)
2007-01-01
The Aviation System Monitoring and Modeling (ASMM) Project was one of the projects within NASA s Aviation Safety Program from 1999 through 2005. The objective of the ASMM Project was to develop the technologies to enable the aviation industry to undertake a proactive approach to the management of its system-wide safety risks. The ASMM Project entailed four interdependent elements: (1) Data Analysis Tools Development - develop tools to convert numerical and textual data into information; (2) Intramural Monitoring - test and evaluate the data analysis tools in operational environments; (3) Extramural Monitoring - gain insight into the aviation system performance by surveying its front-line operators; and (4) Modeling and Simulations - provide reliable predictions of the system-wide hazards, their causal factors, and their operational risks that may result from the introduction of new technologies, new procedures, or new operational concepts. This report is a documentation of the history of this highly successful project and of its many accomplishments and contributions to improved safety of the aviation system.
Laser safety programs in general surgery.
Lanzafame, R J
1994-06-01
General surgery represents a speciality where, while any procedure can be performed with lasers, there are no procedures for which the laser is the sine quo non. The general surgeon may perform a variety of procedures with a multitude of laser wavelengths and technologies. Laser safety in general surgery requires a multidisciplinary approach. Effective laser safety requires the oversight of the hospital's "laser usage committee" and "laser safety officer" while providing a workable framework for daily laser use in a variety of clinical scenarios simultaneously. This framework must be user-friendly rather than oppressive. This presentation will describe laser safety at the Rochester General Hospital, a tertiary care, community-based teaching hospital. The safety program incorporates the following components: input to physician credentialing and training, education and in-servicing of nursing and technical personnel, equipment purchase and maintenance, quality assurance, and safety monitoring. The University of Rochester general surgery residency training program mandates laser training during the PGY-2 year. This program stresses the safe use of lasers and provides the basis for graded hands-on experience during the surgical residency. The greatest challenge for laser safety in general surgery centers on the burgeoning field of minimally invasive surgery. Safety assurance must be balanced so as to maintain a safe operating-room environment while ensuring patient safety and the ability to permit the surgery to proceed efficiently. Safety measures for laparoscopic procedures must be sensitive to the needs of the surgical team while not providing confusing signals for the "gallery" observers. This task is critical for the safe operation of lasers in general surgery. Effective laser safety in general surgery requires constant vigilance tempered with sensitivity to the needs of the surgeon and the patient as laser technology and its applications continue to evolve.
Multiparametric methane sensor for environmental monitoring
NASA Astrophysics Data System (ADS)
Borecki, M.; Duk, M.; Kociubiński, A.; Korwin-Pawlowski, M. L.
2016-12-01
Today, methane sensors find applications mostly in safety alarm installations, gas parameters detection and air pollution classification. Such sensors and sensors elements exists for industry and home use. Under development area of methane sensors application is dedicated to ground gases monitoring. Proper monitoring of soil gases requires reliable and maintenance-free semi-constant and longtime examination at relatively low cost of equipment. The sensors for soil monitoring have to work on soil probe. Therefore, sensor is exposed to environment conditions, as a wide range of temperatures and a full scale of humidity changes, as well as rain, snow and wind, that are not specified for classical methane sensors. Development of such sensor is presented in this paper. The presented sensor construction consists of five commercial non dispersive infra-red (NDIR) methane sensing units, a set of temperature and humidity sensing units, a gas chamber equipped with a micro-fan, automated gas valves and also a microcontroller that controls the measuring procedure. The electronics part of sensor was installed into customized 3D printed housing equipped with self-developed gas valves. The main development of proposed sensor is on the side of experimental evaluation of construction reliability and results of data processing included safety procedures and function for hardware error correction. Redundant methane sensor units are used providing measurement error correction as well as improved measurement accuracy. The humidity and temperature sensors are used for internal compensation of methane measurements as well as for cutting-off the sensor from the environment when the conditions exceed allowable parameters. Results obtained during environment sensing prove that the gas concentration readings are not sensitive to gas chamber vertical or horizontal position. It is important as vertical sensor installation on soil probe is simpler that horizontal one. Data acquired during six month of environment monitoring prove that error correction of methane sensing units was essential for maintenance free sensor operation, despite used safety procedures.
Review article: practical current issues in perioperative patient safety.
Eichhorn, John H
2013-02-01
This brief review provides an overview and, importantly, a context perspective of relevant current practical issues in perioperative patient safety. The dramatic improvement in anesthesia patient safety over the last 30 years was not initiated by electronic monitors but, rather, largely by a set of behaviours known as "safety monitoring" that were then made decidedly more effective by extending the human senses through electronic monitoring, for example, capnography and pulse oximetry. In the highly developed world, this current success is threatened by complacency and production pressure. In some areas of the developing/underdeveloped world, the challenge is implementing the components of anesthesia practice that will bring safety improvements to parallel the overall current success, for instance, applying the World Federation of Societies of Anaesthesiologists (WFSA) "International Standards for A Safe Practice of Anaesthesia". Generally, expanding the current success in safety involves many practical issues. System issues involve research, effective reporting mechanisms and analysis/broadcasting of results, perioperative communication (including "speaking up to power"), and checklists. Monitoring issues involve enforcing existing published monitoring standards and also recognizing the risk of danger to the patient from hypoventilation during procedural sedation and from postoperative intravenous pain medications. Issues of clinical care include medication errors in the operating room, cerebral hypoperfusion (especially in the head-up position), dangers of airway management, postoperative residual weakness from muscle relaxants, operating room fires, and risks specific in obstetric anesthesia. Recognition of the issues outlined here and empowerment of all anesthesia professionals, from the most senior professors and administrators to the newest practitioners, should help maintain, solidify, and expand the improvements in anesthesia and perioperative patient safety.
Hamandi, Khalid; Beniczky, Sandor; Diehl, Beate; Kandler, Rosalind H; Pressler, Ronit M; Sen, Arjune; Solomon, Juliet; Walker, Matthew C; Bagary, Manny
2017-08-01
Inpatient video-EEG monitoring (VEM) is an important investigation in patients with seizures or blackouts, and in the pre-surgical workup of patients with epilepsy. There has been an expansion in the number of Epilepsy Monitoring Units (EMU) in the UK offering VEM with a necessary increase in attention on quality and safety. Previous surveys have shown variation across centres on issues including consent and patient monitoring. In an effort to bring together healthcare professionals in the UK managing patients on EMU, we conducted an online survey of current VEM practice and held a one-day workshop convened under the auspices of the British Chapter of the ILAE. The survey and workshop aimed to cover all aspects of VEM, including pre-admission, consent procedures, patient safety, drug reduction and reinstatement, seizure management, staffing levels, ictal testing and good data recording practice. This paper reports on the findings of the survey, the workshop presentations and workshop discussions. 32 centres took part in the survey and there were representatives from 22 centres at the workshop. There was variation in protocols, procedures and consent processes between units, and levels of observation of monitored patients. Nevertheless, the workshop discussion found broad areas of agreement on points. A survey and workshop of UK epilepsy monitoring units found that some variability in practice is inevitable due to different local arrangements and patient groups under investigation. However, there were areas of clear consensus particularly in relation to consent and patient safety that can be applied to most units and form a basis for setting minimum standards. Copyright © 2017 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.
Krause, Ulrich; Backhoff, David; Klehs, Sophia; Schneider, Heike E; Paul, Thomas
2016-08-01
Monitoring of catheter contact force during catheter ablation of atrial fibrillation has been shown to increase efficacy and safety. However, almost no data exists on the use of this technology in catheter ablation of intraatrial reentrant tachycardia in patients with congenital heart disease. The aim of the present study was to evaluate the impact of contact force monitoring during catheter ablation of intraatrial reentrant tachycardia in those patients. Catheter ablation of intraatrial reentrant tachycardia using monitoring of catheter contact force was performed in 28 patients with congenital heart disease (CHD). Thirty-two patients matched according to gender, age, and body weight with congenital heart disease undergoing catheter ablation without contact force monitoring served as control group. Parameters reflecting acute procedural success, long-term efficacy, and safety were compared. Acute procedural success was statistically not different in both groups (contact force 93 % vs. control 84 %, p = 0.3). Likewise the recurrence rate 1 year after ablation as shown by Kaplan-Meier analysis did not differ (contact force 28 % vs. control 37 %, p = 0.63). Major complications were restricted to groin vessel injuries and occurred in 3 out of 60 patients (contact force n = 1; control n = 2). Complications related to excessive catheter contact force were not observed. The present study did not show superiority of catheter contact force monitoring during ablation of intraatrial reentrant tachycardia in patients with CHD in terms of efficacy and safety. Higher contact force compared to pulmonary vein isolation might therefore be required to increase the efficacy of catheter ablation of intraatrial reentrant tachycardia in patients with congenital heart disease.
Long Term Resource Monitoring Program procedures: fish monitoring
Ratcliff, Eric N.; Glittinger, Eric J.; O'Hara, T. Matt; Ickes, Brian S.
2014-01-01
This manual constitutes the second revision of the U.S. Army Corps of Engineers’ Upper Mississippi River Restoration-Environmental Management Program (UMRR-EMP) Long Term Resource Monitoring Program (LTRMP) element Fish Procedures Manual. The original (1988) manual merged and expanded on ideas and recommendations related to Upper Mississippi River fish sampling presented in several early documents. The first revision to the manual was made in 1995 reflecting important protocol changes, such as the adoption of a stratified random sampling design. The 1995 procedures manual has been an important document through the years and has been cited in many reports and scientific manuscripts. The resulting data collected by the LTRMP fish component represent the largest dataset on fish within the Upper Mississippi River System (UMRS) with more than 44,000 collections of approximately 5.7 million fish. The goal of this revision of the procedures manual is to document changes in LTRMP fish sampling procedures since 1995. Refinements to sampling methods become necessary as monitoring programs mature. Possible refinements are identified through field experiences (e.g., sampling techniques and safety protocols), data analysis (e.g., planned and studied gear efficiencies and reallocations of effort), and technological advances (e.g., electronic data entry). Other changes may be required because of financial necessity (i.e., unplanned effort reductions). This version of the LTRMP fish monitoring manual describes the most current (2014) procedures of the LTRMP fish component.
Barcode identification for transfusion safety.
Murphy, M F; Kay, J D S
2004-09-01
Errors related to blood transfusion in hospitals may produce catastrophic consequences. This review addresses potential solutions to prevent patient misidentification including the use of new technology, such as barcoding. A small number of studies using new technology for the transfusion process in hospitals have shown promising results in preventing errors. The studies demonstrated improved transfusion safety and staff preference for new technology such as bedside handheld scanners to carry out pretransfusion bedside checking. They also highlighted the need for considerable efforts in the training of staff in the new procedures before their successful implementation. Improvements in hospital transfusion safety are a top priority for transfusion medicine, and will depend on a combined approach including a better understanding of the causes of errors, a reduction in the complexity of routine procedures taking advantage of new technology, improved staff training, and regular monitoring of practice. The use of new technology to improve the safety of transfusion is very promising. Further development of the systems is needed to enable staff to carry out bedside transfusion procedures quickly and accurately, and to increase their functionality to justify the cost of their wider implementation.
Long term validation of an accelerated polishing test procedure for HMA pavements.
DOT National Transportation Integrated Search
2013-04-01
The Ohio Department of Transportation (ODOT) has set strategic goals to improve driving safety by maintaining : smooth pavement surfaces with high skid resistance. ODOT has taken the initiative to monitor pavement : friction on Ohio roadways and reme...
Placing blood on the target: a challenge for visually impaired persons.
Cleary, M E; Hamilton, J E
1993-01-01
An individualized, blood glucose self-monitoring procedure for those who are visually impaired must be developed, taught, practiced, observed, and reviewed. Effective teaching requires understanding functional vision loss, observing safety precautions, organizing the work area, obtaining an adequate blood sample, ensuring accurate placement of blood on the strip, and cleaning up. Thoroughness and repetition enable the visually impaired person to perform the procedure safely and confidently.
Khan, Nadia A; Herman, Robert J; Quinn, Robert R; Rabkin, Simon W; Ravani, Pietro; Tobe, Sheldon W; Feldman, Ross D; Wijeysundera, Harindra C; Padwal, Raj S
2014-01-01
Renal denervation is a novel catheter-based, percutaneous procedure using radiofrequency energy to ablate nerves within the renal arteries. This procedure might help to significantly lower blood pressure (BP) in patients with resistant hypertension, defined as BP > 140/90 mm Hg (> 130/80 mm Hg for those with diabetes) despite use of ≥ 3 optimally dosed antihypertensive agents, ideally including 1 diuretic agent. The Canadian Hypertension Education Program Recommendations Task Force reviewed the current evidence on safety and efficacy of this procedure. Eleven studies on renal denervation were examined and most of the evidence evaluating renal denervation was derived from the Symplicity studies. In patients with systolic BP ≥ 160 mm Hg (≥ 150 mm Hg for patients with type 2 diabetes) despite use of ≥ 3 antihypertensive agents, bilateral renal denervation was associated with significantly lower BP (-22/11 to -34/13 mm Hg) at 6 months with a low periprocedural complication rate. Few patients underwent 24-hour ambulatory BP monitoring and ambulatory BP monitoring showed more modest BP lowering (0 to -11/7 mm Hg). Although early results on short-term safety and blood pressure-lowering are encouraging, there are no long-term efficacy and safety data, or hard cardiovascular end point data. The discrepancy between office BP reductions and 24-hour ambulatory BP monitor reductions needs to be further investigated. Until more data are available, renal sympathetic denervation should be considered as a treatment option of last resort for patients with resistant hypertension who have exhausted all other available medical management options. Copyright © 2014 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
Microcomputer keeps watch at Emerald Mine
DOE Office of Scientific and Technical Information (OSTI.GOV)
Not Available
1987-04-01
This paper reviews the computerized mine monitoring system set up at the Emerald Mine, SW Pennsylvania, USA. This coal mine has pioneered the automation of many production and safety features and this article covers their work in fire detection and conveyor belt monitoring. A central computer control room can safely watch over the whole underground mining operation using one 25 inch colour monitor. These new data-acquisition systems will lead the way, in the future, to safer move efficient coal mining. Multi-point monitoring of carbon monoxide, heat anomalies, toxic gases and the procedures in conveyor belt operation from start-up to closedown.
Indicators of safety compromise in gastrointestinal endoscopy.
Borgaonkar, Mark Ram; Hookey, Lawrence; Hollingworth, Roger; Kuipers, Ernst J; Forster, Alan; Armstrong, David; Barkun, Alan; Bridges, Ron; Carter, Rose; de Gara, Chris; Dube, Catherine; Enns, Robert; Macintosh, Donald; Forget, Sylviane; Leontiadis, Grigorios; Meddings, Jonathan; Cotton, Peter; Valori, Roland
2012-02-01
The importance of quality indicators has become increasingly recognized in gastrointestinal endoscopy. Patient safety requires the identification and monitoring of occurrences associated with harm or the potential for harm. The identification of relevant indicators of safety compromise is, therefore, a critical element that is key to the effective implementation of endoscopy quality improvement programs. To identify key indicators of safety compromise in gastrointestinal endoscopy. The Canadian Association of Gastroenterology Safety and Quality Indicators in Endoscopy Consensus Group was formed to address issues of quality in endoscopy. A subcommittee was formed to identify key safety indicators. A systematic literature review was undertaken, and articles pertinent to safety in endoscopy were identified and reviewed. All complications and measures used to document safety were recorded. From this, a preliminary list of 16 indicators was compiled and presented to the 35-person consensus group during a three-day meeting. A revised list of 20 items was subsequently put to the consensus group for vote for inclusion on the final list of safety indicators. Items were retained only if the consensus group highly agreed on their importance. A total of 19 indicators of safety compromise were retained and grouped into the three following categories: medication-related - the need for CPR, use of reversal agents, hypoxia, hypotension, hypertension, sedation doses in patients older than 70 years of age, allergic reactions and laryngospasm⁄bronchospasm; procedure-related early - perforation, immediate postpolypectomy bleeding, need for hospital admission or transfer to emergency department from the gastroenterology unit, instrument impaction, severe persistent abdominal pain requiring evaluation proven to not be perforation; and procedure-related delayed - death within 30 days of procedure, 14-day unplanned hospitalization, 14-day unplanned contact with a health provider, gastrointestinal bleeding within 14 days of procedure, infection or symptomatic metabolic complications. The 19 indicators of safety compromise in endoscopy, identified by a rigorous, evidence-based consensus process, provide clear outcomes to be recorded by all facilities as part of their continuing quality improvement programs.
Zegers-Hochschild, F; Adamson, G D; de Mouzon, J; Ishihara, O; Mansour, R; Nygren, K; Sullivan, E; Vanderpoel, S
2009-11-01
Many definitions used in medically assisted reproduction (MAR) vary in different settings, making it difficult to standardize and compare procedures in different countries and regions. With the expansion of infertility interventions worldwide, including lower resource settings, the importance and value of a common nomenclature is critical. The objective is to develop an internationally accepted and continually updated set of definitions, which would be utilized to standardize and harmonize international data collection, and to assist in monitoring the availability, efficacy, and safety of assisted reproductive technology (ART) being practiced worldwide. Seventy-two clinicians, basic scientists, epidemiologists and social scientists gathered together at the World Health Organization headquarters in Geneva, Switzerland, in December 2008. Several months before, three working groups were established as responsible for terminology in three specific areas: clinical conditions and procedures, laboratory procedures, and outcome measures. Each group reviewed the existing International Committee for Monitoring Assisted Reproductive Technology glossary, made recommendations for revisions and introduced new terms to be considered for glossary expansion. A consensus was reached on 87 terms, expanding the original glossary by 34 terms, which included definitions for numerous clinical and laboratory procedures. Special emphasis was placed in describing outcome measures, such as cumulative delivery rates and other markers of safety and efficacy in ART. Standardized terminology should assist in analysis of worldwide trends in MAR interventions and in the comparison of ART outcomes across countries and regions. This glossary will contribute to a more standardized communication among professionals responsible for ART practice, as well as those responsible for national, regional, and international registries.
Sample size allocation for food item radiation monitoring and safety inspection.
Seto, Mayumi; Uriu, Koichiro
2015-03-01
The objective of this study is to identify a procedure for determining sample size allocation for food radiation inspections of more than one food item to minimize the potential risk to consumers of internal radiation exposure. We consider a simplified case of food radiation monitoring and safety inspection in which a risk manager is required to monitor two food items, milk and spinach, in a contaminated area. Three protocols for food radiation monitoring with different sample size allocations were assessed by simulating random sampling and inspections of milk and spinach in a conceptual monitoring site. Distributions of (131)I and radiocesium concentrations were determined in reference to (131)I and radiocesium concentrations detected in Fukushima prefecture, Japan, for March and April 2011. The results of the simulations suggested that a protocol that allocates sample size to milk and spinach based on the estimation of (131)I and radiocesium concentrations using the apparent decay rate constants sequentially calculated from past monitoring data can most effectively minimize the potential risks of internal radiation exposure. © 2014 Society for Risk Analysis.
Acoustic Techniques for Structural Health Monitoring
NASA Astrophysics Data System (ADS)
Frankenstein, B.; Augustin, J.; Hentschel, D.; Schubert, F.; Köhler, B.; Meyendorf, N.
2008-02-01
Future safety and maintenance strategies for industrial components and vehicles are based on combinations of monitoring systems that are permanently attached to or embedded in the structure, and periodic inspections. The latter belongs to conventional nondestructive evaluation (NDE) and can be enhanced or partially replaced by structural health monitoring systems. However, the main benefit of this technology for the future will consist of systems that can be differently designed based on improved safety philosophies, including continuous monitoring. This approach will increase the efficiency of inspection procedures at reduced inspection times. The Fraunhofer IZFP Dresden Branch has developed network nodes, miniaturized transmitter and receiver systems for active and passive acoustical techniques and sensor systems that can be attached to or embedded into components or structures. These systems have been used to demonstrate intelligent sensor networks for the monitoring of aerospace structures, railway systems, wind energy generators, piping system and other components. Material discontinuities and flaws have been detected and monitored during full scale fatigue testing. This paper will discuss opportunities and future trends in nondestructive evaluation and health monitoring based on new sensor principles and advanced microelectronics. It will outline various application examples of monitoring systems based on acoustic techniques and will indicate further needs for research and development.
Assessment of safety culture in isfahan hospitals (2010).
Raeisi, Ahmed Reza; Nazari, Maryam; Bahmanziari, Najme
2013-01-01
Many internal and external risk factors in health care organizations make safety important and it has caused the management to consider safety in their mission statement. One of the most important tools is to establish the appropriate organizational structure and safety culture. The goal of this research is to inform managers and staff about current safety culture status in hospitals in order to improve the efficiency and effectiveness of health services. This is a descriptive-survey research. The research population was selected hospitals of Isfahan, Iran. Research tool was a questionnaire (Cronbach alpha 0.75). The questionnaire including 93 questions (Likert scale) classified in 12 categories: Demographic questions, Individual attitude, management attitude, Safety Training, Induced stress, pressure and emotional conditions during work, Consultation and participation, Communications, Monitoring and control, work environment, Reporting, safety Rules, procedures and work instructions that distributed among 45 technicians, 208 Nurses and 62 Physicians. All data collected from the serve was analysis with statistical package of social science (SPSS). In this survey Friedman test, Spearman correlation, analysis of variance (ANOVA) and factor analysis have been used for data analyzing. The score of safety culture dimensions was 2.90 for Individual attitude, 3.12 for management attitude, 3.32 for Safety Training, 3.14 for Induced stress, pressure and emotional conditions during work, 3.31 for Consultation and participation, 2.93 for Communications, 3.28 for Monitoring and control, 3.19 for work environment, 3.36 for Reporting, 3.59 safety Rules, procedures and work instructions that Communication and individual attitude were in bad condition. Safety culture among different hospitals: governmental and educational, governmental and non-educational and non-governmental and different functional groups (physicians, nurses, diagnostic) of studied hospitals showed no significant differences. There was no relationship between safety culture and demographic data. It was concluded that is no different among governmental and educational, governmental and non-educational and non-governmental in level of safety culture, all of them were on intermediate level so it is essential to attention to the safety culture in hospitals and planning to improve it.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Omar, A; Bujila, R; Nowik, P
2014-06-01
Purpose: To investigate the potential benefits of automatic monitoring of accumulated patient and staff dose indicators, i.e., CAK and KAP, from DICOM Radiation Dose Structured Reports (RDSR) in x-ray angiography (XA). Methods: Recently RDSR has enabled the convenient aggregation of dose indices and technique parameters for XA procedures. The information contained in RDSR objects for three XA systems, dedicated to different types of clinical procedures, has been collected and aggregated in a database for over one year using a system developed with open-source software at the Karolinska University Hospital. Patient weight was complemented to the RDSR data via an interfacemore » with the Hospital Information System (HIS). Results: The linearly approximated trend in KAP over a time period of a year for cerebrovascular, pelvic/peripheral vascular, and cardiovascular procedures showed a decrease of 12%, 20%, and 14%, respectively. The decrease was mainly due to hardware/software upgrades and new low-dose imaging protocols, and partially due to ongoing systematic radiation safety education of the clinical staff. The CAK was in excess of 3 Gy for 15 procedures, and exceeded 5 Gy for 3 procedures. The dose indices have also shown a significant dependence on patient weight for cardiovascular and pelvic/peripheral vascular procedures; a 10 kg shift in mean patient weight can result in a dose index increase of 25%. Conclusion: Automatic monitoring of accumulated dose indices can be utilized to notify the clinical staff and medical physicists when the dose index has exceeded a predetermined action level. This allows for convenient and systematic follow-up of patients in risk of developing deterministic skin injuries. Furthermore, trend analyses of dose indices over time is a valuable resource for the identification of potential positive or negative effects (dose increase/decrease) from changes in hardware, software, and clinical work habits.« less
49 CFR 232.107 - Air source requirements and cold weather operations.
Code of Federal Regulations, 2014 CFR
2014-10-01
... the system. (e) A railroad shall adopt and comply with detailed written operating procedures tailored...) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION BRAKE SYSTEM SAFETY STANDARDS FOR FREIGHT... railroad shall adopt and comply with a written plan to monitor all yard air sources, other than locomotives...
49 CFR 232.107 - Air source requirements and cold weather operations.
Code of Federal Regulations, 2012 CFR
2012-10-01
... the system. (e) A railroad shall adopt and comply with detailed written operating procedures tailored...) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION BRAKE SYSTEM SAFETY STANDARDS FOR FREIGHT... railroad shall adopt and comply with a written plan to monitor all yard air sources, other than locomotives...
49 CFR 232.107 - Air source requirements and cold weather operations.
Code of Federal Regulations, 2013 CFR
2013-10-01
... the system. (e) A railroad shall adopt and comply with detailed written operating procedures tailored...) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION BRAKE SYSTEM SAFETY STANDARDS FOR FREIGHT... railroad shall adopt and comply with a written plan to monitor all yard air sources, other than locomotives...
49 CFR 232.107 - Air source requirements and cold weather operations.
Code of Federal Regulations, 2010 CFR
2010-10-01
... the system. (e) A railroad shall adopt and comply with detailed written operating procedures tailored...) FEDERAL RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION BRAKE SYSTEM SAFETY STANDARDS FOR FREIGHT... railroad shall adopt and comply with a written plan to monitor all yard air sources, other than locomotives...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-29
... purposes in research, industry, and other fields. The subparts cover specific requirements for obtaining a license or license exemption, design and performance criteria for irradiators; and radiation safety... emergency procedures, personnel monitoring, radiation surveys, inspection, and maintenance. Part 36 also...
Fault Injection Validation of a Safety-Critical TMR Sysem
NASA Astrophysics Data System (ADS)
Irrera, Ivano; Madeira, Henrique; Zentai, Andras; Hergovics, Beata
2016-08-01
Digital systems and their software are the core technology for controlling and monitoring industrial systems in practically all activity domains. Functional safety standards such as the European standard EN 50128 for railway applications define the procedures and technical requirements for the development of software for railway control and protection systems. The validation of such systems is a highly demanding task. In this paper we discuss the use of fault injection techniques, which have been used extensively in several domains, particularly in the space domain, to complement the traditional procedures to validate a SIL (Safety Integrity Level) 4 system for railway signalling, implementing a TMR (Triple Modular Redundancy) architecture. The fault injection tool is based on JTAG technology. The results of our injection campaign showed a high degree of tolerance to most of the injected faults, but several cases of unexpected behaviour have also been observed, helping understanding worst-case scenarios.
Sailer, Anna M; Vergoossen, Laura; Paulis, Leonie; van Zwam, Willem H; Das, Marco; Wildberger, Joachim E; Jeukens, Cécile R L P N
2017-11-01
Radiation safety and protection are a key component of fluoroscopy-guided interventions. We hypothesize that providing weekly personal dose feedback will increase radiation awareness and ultimately will lead to optimized behavior. Therefore, we designed and implemented a personalized feedback of procedure and personal doses for medical staff involved in fluoroscopy-guided interventions. Medical staff (physicians and technicians, n = 27) involved in fluoroscopy-guided interventions were equipped with electronic personal dose meters (PDMs). Procedure dose data including the dose area product and effective doses from PDMs were prospectively monitored for each consecutive procedure over an 8-month period (n = 1082). A personalized feedback form was designed displaying for each staff individually the personal dose per procedure, as well as relative and cumulative doses. This study consisted of two phases: (1) 1-5th months: Staff did not receive feedback (n = 701) and (2) 6-8th months: Staff received weekly individual dose feedback (n = 381). An anonymous evaluation was performed on the feedback and occupational dose. Personalized feedback was scored valuable by 76% of the staff and increased radiation dose awareness for 71%. 57 and 52% reported an increased feeling of occupational safety and changing their behavior because of personalized feedback, respectively. For technicians, the normalized dose was significantly lower in the feedback phase compared to the prefeedback phase: [median (IQR) normalized dose (phase 1) 0.12 (0.04-0.50) µSv/Gy cm 2 versus (phase 2) 0.08 (0.02-0.24) µSv/Gy cm 2 , p = 0.002]. Personalized dose feedback increases radiation awareness and safety and can be provided to staff involved in fluoroscopy-guided interventions.
Intelligent monitoring of critical pathological events during anesthesia.
Gohil, Bhupendra; Gholamhhosseini, Hamid; Harrison, Michael J; Lowe, Andrew; Al-Jumaily, Ahmed
2007-01-01
Expert algorithms in the field of intelligent patient monitoring have rapidly revolutionized patient care thereby improving patient safety. Patient monitoring during anesthesia requires cautious attention by anesthetists who are monitoring many modalities, diagnosing clinically critical events and performing patient management tasks simultaneously. The mishaps that occur during day-to-day anesthesia causing disastrous errors in anesthesia administration were classified and studied by Reason [1]. Human errors in anesthesia account for 82% of the preventable mishaps [2]. The aim of this paper is to develop a clinically useful diagnostic alarm system for detecting critical events during anesthesia administration. The development of an expert diagnostic alarm system called ;RT-SAAM' for detecting critical pathological events in the operating theatre is presented. This system provides decision support to the anesthetist by presenting the diagnostic results on an integrative, ergonomic display and thus enhancing patient safety. The performance of the system was validated through a series of offline and real-time testing in the operation theatre. When detecting absolute hypovolaemia (AHV), moderate level of agreement was observed between RT-SAAM and the human expert (anesthetist) during surgical procedures. RT-SAAM is a clinically useful diagnostic tool which can be easily modified for diagnosing additional critical pathological events like relative hypovolaemia, fall in cardiac output, sympathetic response and malignant hyperpyrexia during surgical procedures. RT-SAAM is currently being tested at the Auckland City Hospital with ethical approval from the local ethics committees.
Radiation exposure and safety practices during pediatric central line placement
Saeman, Melody R.; Burkhalter, Lorrie S.; Blackburn, Timothy J.; Murphy, Joseph T.
2015-01-01
Purpose Pediatric surgeons routinely use fluoroscopy for central venous line (CVL) placement. We examined radiation safety practices and patient/surgeon exposure during fluoroscopic CVL. Methods Fluoroscopic CVL procedures performed by 11 pediatric surgeons in 2012 were reviewed. Fluoroscopic time (FT), patient exposure (mGy), and procedural data were collected. Anthropomorphic phantom simulations were used to calculate scatter and dose (mSv). Surgeons were surveyed regarding safety practices. Results 386 procedures were reviewed. Median FT was 12.8 seconds. Median patient estimated effective dose was 0.13 mSv. Median annual FT per surgeon was 15.4 minutes. Simulations showed no significant difference (p = 0.14) between reported exposures (median 3.5 mGy/min) and the modeled regression exposures from the C-arm default mode (median 3.4 mGy/min). Median calculated surgeon exposure was 1.5 mGy/year. Eight of 11 surgeons responded to the survey. Only three reported 100% lead protection and frequent dosimeter use. Conclusion We found non-standard radiation training, safety practices, and dose monitoring for the 11 surgeons. Based on simulations, the C-arm default setting was typically used instead of low dose. While most CVL procedures have low patient/surgeon doses, every effort should be used to minimize patient and occupational exposure, suggesting the need for formal hands-on training for non-radiologist providers using fluoroscopy. PMID:25837269
Anozie, Okechukwu Bonaventure; Lawani, Lucky Osaheni; Eze, Justus Ndulue; Mamah, Emmanuel Johnbosco; Onoh, Robinson Chukwudi; Ogah, Emeka Onwe; Umezurike, Daniel Akuma; Anozie, Rita Onyinyechi
2017-03-01
Awareness of appropriate waste management procedures and occupational safety measures is fundamental to achieving a safe work environment, and ensuring patient and staff safety. This study was conducted to assess the attitude of healthcare managers to medical waste management and occupational safety practices. This was a cross-sectional study conducted among 54 hospital administrators in Ebonyi state. Semi-structured questionnaires were used for qualitative data collection and analyzed with SPSS statistics for windows (2011), version 20.0 statistical software (Armonk, NY: IBM Corp). Two-fifth (40%) of healthcare managers had received training on medical waste management and occupational safety. Standard operating procedure of waste disposal was practiced by only one hospital (1.9%), while 98.1% (53/54) practiced indiscriminate waste disposal. Injection safety boxes were widely available in all health facilities, nevertheless, the use of incinerators and waste treatment was practiced by 1.9% (1/54) facility. However, 40.7% (22/54) and 59.3% (32/54) of respondents trained their staff and organize safety orientation courses respectively. Staff insurance cover was offered by just one hospital (1.9%), while none of the hospitals had compensation package for occupational hazard victims. Over half (55.6%; 30/54) of the respondents provided both personal protective equipment and post exposure prophylaxis for HIV. There was high level of non-compliance to standard medical waste management procedures, and lack of training on occupational safety measures. Relevant regulating agencies should step up efforts at monitoring and regulation of healthcare activities and ensure staff training on safe handling and disposal of hospital waste.
Hung, Yu-Ting; Liu, Chi-Te; Peng, I-Chen; Hsu, Chin; Yu, Roch-Chui; Cheng, Kuan-Chen
2015-09-01
To ensure the safety of the peanut butter ice cream manufacture, a Hazard Analysis and Critical Control Point (HACCP) plan has been designed and applied to the production process. Potential biological, chemical, and physical hazards in each manufacturing procedure were identified. Critical control points for the peanut butter ice cream were then determined as the pasteurization and freezing process. The establishment of a monitoring system, corrective actions, verification procedures, and documentation and record keeping were followed to complete the HACCP program. The results of this study indicate that implementing the HACCP system in food industries can effectively enhance food safety and quality while improving the production management. Copyright © 2015. Published by Elsevier B.V.
Monitoring process hygiene in Serbian retail establishments
NASA Astrophysics Data System (ADS)
Vesković Moračanin, S.; Baltić, T.; Milojević, L.
2017-09-01
The present study was conducted to estimate the effectiveness of sanitary procedures on food contact surfaces and food handlers’ hands in Serbian retail establishments. For that purpose, a total of 970 samples from food contact surfaces and 525 samples from workers’ hands were microbiologically analyzed. Results of total aerobic plate count and total Enterobacteriaceae count showed that the implemented washing and disinfection procedures, as a part of HACCP plans, were not effective enough in most retail facilities. Constant and intensive education of employees on proper implementation of sanitation procedures are needed in order to ensure food safety in the retail market.
The Wettzell System Monitoring Concept and First Realizations
NASA Technical Reports Server (NTRS)
Ettl, Martin; Neidhardt, Alexander; Muehlbauer, Matthias; Ploetz, Christian; Beaudoin, Christopher
2010-01-01
Automated monitoring of operational system parameters for the geodetic space techniques is becoming more important in order to improve the geodetic data and to ensure the safety and stability of automatic and remote-controlled observations. Therefore, the Wettzell group has developed the system monitoring software, SysMon, which is based on a reliable, remotely-controllable hardware/software realization. A multi-layered data logging system based on a fanless, robust industrial PC with an internal database system is used to collect data from several external, serial, bus, or PCI-based sensors. The internal communication is realized with Remote Procedure Calls (RPC) and uses generative programming with the interface software generator idl2rpc.pl developed at Wettzell. Each data monitoring stream can be configured individually via configuration files to define the logging rates or analog-digital-conversion parameters. First realizations are currently installed at the new laser ranging system at Wettzell to address safety issues and at the VLBI station O Higgins as a meteorological data logger. The system monitoring concept should be realized for the Wettzell radio telescope in the near future.
Preliminary development of an intelligent computer assistant for engine monitoring
NASA Technical Reports Server (NTRS)
Disbrow, James D.; Duke, Eugene L.; Ray, Ronald J.
1989-01-01
As part of the F-18 high-angle-of-attack vehicle program, an AI method was developed for the real time monitoring of the propulsion system and for the identification of recovery procedures for the F404 engine. The aim of the development program is to provide enhanced flight safety and to reduce the duties of the propulsion engineers. As telemetry data is received, the results are continually displayed in a number of different color graphical formats. The system makes possible the monitoring of the engine state and the individual parameters. Anomaly information is immediately displayed to the engineer.
HASEGAWA, Mitsuhiro; NOURI, Mohsen; FUJISAWA, Hironori; HAYASHI, Yutaka; INAMASU, Joji; HIROSE, Yuichi; YAMASHITA, Junkoh
2015-01-01
There are many reports on position-related complications in neurosurgical literature but so far, continuous quantification of the patient’s position during the surgery has not been reported. This study aims to explore the utility of a new surgical table system and its software in displaying the patient’s body positions during surgery on real-time basis. More than 200 neurosurgical cases were monitored for their positions intra-operatively. The position was digitally recorded and could be seen by all the members in the operating team. It also displayed the three-dimensional relationship between the head and the heart positions. No position-related complications were observed during the study. The system was able to serve as an excellent indicator for monitoring the patient’s position. The recordings were analyzed and even used to reproduce or improve the position in the subsequent operations. The novel technique of monitoring the position of the head and the heart of the patients and the operating table planes are considered to be useful during delicate neurosurgical procedures thereby, preventing inadvertent procedural errors. This can be used to quantify various surgical positions in the future and define safety measures accordingly. PMID:25797776
Hasegawa, Mitsuhiro; Nouri, Mohsen; Fujisawa, Hironori; Hayashi, Yutaka; Inamasu, Joji; Hirose, Yuichi; Yamashita, Junkoh
2015-01-01
There are many reports on position-related complications in neurosurgical literature but so far, continuous quantification of the patient's position during the surgery has not been reported. This study aims to explore the utility of a new surgical table system and its software in displaying the patient's body positions during surgery on real-time basis. More than 200 neurosurgical cases were monitored for their positions intra-operatively. The position was digitally recorded and could be seen by all the members in the operating team. It also displayed the three-dimensional relationship between the head and the heart positions. No position-related complications were observed during the study. The system was able to serve as an excellent indicator for monitoring the patient's position. The recordings were analyzed and even used to reproduce or improve the position in the subsequent operations. The novel technique of monitoring the position of the head and the heart of the patients and the operating table planes are considered to be useful during delicate neurosurgical procedures thereby, preventing inadvertent procedural errors. This can be used to quantify various surgical positions in the future and define safety measures accordingly.
Rembovskiĭ, V R; Mogilenkova, L A; Savel'eva, E I
2005-01-01
The major unit monitoring chemical weapons destruction objects is a system of chemical analyticcontrol over the technologic process procedures and possibility of environment and workplace pollution withtoxicchemicals and their destruction products. At the same time, physical and chemical control means meet sanitary and hygienic requirements incompletely. To provide efficient control, internationally recognized approaches should be adapted to features of Russian system monitoring pollution of chemical weapons destruction objects with toxic chemicals.
Data Sharing to Improve Close Approach Monitoring and Safety of Flight
NASA Astrophysics Data System (ADS)
Chan, Joseph; DalBello, Richard; Hope, Dean; Wauthier, Pascal; Douglas, Tim; Inghram, Travis
2009-03-01
Individual satellite operators have done a good job of developing the internal protocols and procedures to ensure the safe operation of their fleets. However, data sharing among operators for close approach monitoring is conducted in an ad-hoc manner during relocations, and there is currently no standardized agreement among operators on the content, format, and distribution protocol for data sharing. Crowding in geostationary orbit, participation by new commercial actors, government interest in satellite constellations, and highly maneuverable spacecraft all suggest that satellite operators will need to begin a dialogue on standard communication protocols and procedure to improve situation awareness. We will give an overview of the current best practices among different operators for close approach monitoring and discuss the concept of an active data center to improve data sharing, conjunction monitoring, and avoidance among satellite operators. We will also report on the progress and lessons learned from a Data Center prototype conducted by several operators over a one year period.
Pérez, Cristina Díaz-Agero; Rodela, Ana Robustillo; Monge Jodrá, Vincente
2009-12-01
In 1997, a national standardized surveillance system (designated INCLIMECC [Indicadores Clínicos de Mejora Continua de la Calidad]) was established in Spain for health care-associated infection (HAI) in surgery patients, based on the National Nosocomial Infection Surveillance (NNIS) system. In 2005, in its procedure-associated module, the National Healthcare Safety Network (NHSN) inherited the NNIS program for surveillance of HAI in surgery patients and reorganized all surgical procedures. INCLIMECC actively monitors all patients referred to the surgical ward of each participating hospital. We present a summary of the data collected from January 1997 to December 2006 adapted to the new NHSN procedures. Surgical site infection (SSI) rates are provided by operative procedure and NNIS risk index category. Further quality indicators reported are surgical complications, length of stay, antimicrobial prophylaxis, mortality, readmission because of infection or other complication, and revision surgery. Because the ICD-9-CM surgery procedure code is included in each patient's record, we were able to reorganize our database avoiding the loss of extensive information, as has occurred with other systems.
2016-10-15
The safe sedation of children for procedures requires a systematic approach that includes the following: no administration of sedating medication without the safety net of medical/dental supervision, careful presedation evaluation for underlying medical or surgical conditions that would place the child at increased risk from sedating medications, appropriate fasting for elective procedures and a balance between the depth of sedation and risk for those who are unable to fast because of the urgent nature of the procedure, a focused airway examination for large (kissing) tonsils or anatomic airway abnormalities that might increase thepotential for airway obstruction, a clear understanding of the medication's pharmacokinetic and pharmacodynamic effects and drug interactions, appropriate training and skills in airway management to allow rescue of the patient, age- and size-appropriate equipment for airway management and venous access, appropriate medications and reversal agents, sufficient numbers of staff to both carry out the procedure and monitor the patient, appropriate physiologic monitoring during and after the procedure, a properly equipped and staffed recovery area, recovery to the presedation level of consciousness before discharge from medical/dental supervision, and appropriate discharge instructions. This report was developed through a collaborative effort of the American Academy of Pediatrics and the American Academy of Pediatric Dentistry to offer pediatric providers updated information and guidance in delivering safe sedation to children.
2016-10-01
The safe sedation of children for procedures requires a systematic approach that includes the following: no administration of sedating medication without the safety net of medical/dental supervision, careful presedation evaluation for underlying medical or surgical conditions that would place the child at increased risk from sedating medications, appropriate fasting for elective procedures and a balance between the depth of sedation and risk for those who are unable to fast because of the urgent nature of the procedure, a focused airway examination for large (kissing) tonsils or anatomic airway abnormalities that might increase thepotential for airway obstruction, a clear understanding of the medication's pharmacokinetic and pharmacodynamic effects and drug interactions, appropriate training and skills in airway management to allow rescue of the patient, age- and size-appropriate equipment for airway management and venous access, appropriate medications and reversal agents, sufficient numbers of staff to both carry out the procedure and monitor the patient, appropriate physiologic monitoring during and after the procedure, a properly equipped and staffed recovery area, recovery to the presedation level of consciousness before discharge from medical/dental supervision, and appropriate discharge instructions. This report was developed through a collaborative effort of the American Academy of Pediatrics and the American Academy of Pediatric Dentistry to offer pediatric providers updated information and guidance in delivering safe sedation to children.
Elbasty, Ahmed; Metcalf, James
2017-12-01
Catheter direct thrombolysis (CDT) has been shown to be an effective treatment for deep venous thrombosis. The objective of the review is to improve safety and efficacy of the CDT by using ward based protocol, better able to predict complications and treatment outcome through monitoring of haemostatic parameters and clinical observation during thrombolysis procedure. MEDLINE, EMBASE, CENTRAL and Web of Science were searched for all articles on deep venous thrombosis, thrombolysis and correlations of clinical events (bleeding, successful thrombolysis) during thrombolysis with hemostatic parameters to March 2016. The risk of bias in included studies was assessed by Cochrane Collaboration's tool and Cochrane Risk of Bias Assessment Tool: for Non-Randomized Studies of Interventions. Twenty-four studies were included in the review and we found that improving safety and efficacy of CDT by using ward based protocol depending on eight factors; strict patient selection criteria, types of fibrinolytic drugs, mode of fibrinolytic drug injection, biochemical markers monitoring (fibrinogen, D-dimer, activated partial thromboplastin time, plasminogen activator inhibitor-1), timing of intervention, usage of intermittent pneumatic calf, ward monitoring and thrombolysis imaging assessment (intravascular ultrasound). These factors may help to improve safety and efficacy by reducing total thrombolytic drug dosage and at the same time ensure successful lysis. There is a marked lack of randomized controlled trials discussing the safety and efficacy of catheter direct thrombolysis. CDT can be performed safely and efficiently in clinical ward, providing that careful nursing, biochemical monitoring, proper selection and mode of infusion of fibrinolytic drugs, usage of Intermittent pneumatic calf and adequate thrombolysis imaging assessment are ensured.
Status of chemistry lab safety in Nepal.
Kandel, Krishna Prasad; Neupane, Bhanu Bhakta; Giri, Basant
2017-01-01
Chemistry labs can become a dangerous environment for students as the lab exercises involve hazardous chemicals, glassware, and equipment. Approximately one hundred thousand students take chemistry laboratory classes annually in Nepal. We conducted a survey on chemical lab safety issues across Nepal. In this paper, we assess the safety policy and equipment, protocols and procedures followed, and waste disposal in chemistry teaching labs. Significant population of the respondents believed that there is no monitoring of the lab safety in their lab (p<0.001). Even though many labs do not allow food and beverages inside lab and have first aid kits, they lack some basic safety equipment. There is no institutional mechanism to dispose lab waste and chemical waste is disposed haphazardly. Majority of the respondents believed that the safety training should be a part of educational training (p = 0.001) and they would benefit from short course and/or workshop on lab safety (p<0.001).
Status of chemistry lab safety in Nepal
Kandel, Krishna Prasad; Neupane, Bhanu Bhakta
2017-01-01
Chemistry labs can become a dangerous environment for students as the lab exercises involve hazardous chemicals, glassware, and equipment. Approximately one hundred thousand students take chemistry laboratory classes annually in Nepal. We conducted a survey on chemical lab safety issues across Nepal. In this paper, we assess the safety policy and equipment, protocols and procedures followed, and waste disposal in chemistry teaching labs. Significant population of the respondents believed that there is no monitoring of the lab safety in their lab (p<0.001). Even though many labs do not allow food and beverages inside lab and have first aid kits, they lack some basic safety equipment. There is no institutional mechanism to dispose lab waste and chemical waste is disposed haphazardly. Majority of the respondents believed that the safety training should be a part of educational training (p = 0.001) and they would benefit from short course and/or workshop on lab safety (p<0.001). PMID:28644869
Patrick, Hannah; Sims, Andrew; Burn, Julie; Bousfield, Derek; Colechin, Elaine; Reay, Christopher; Alderson, Neil; Goode, Stephen; Cunningham, David; Campbell, Bruce
2013-03-01
New devices and procedures are often introduced into health services when the evidence base for their efficacy and safety is limited. The authors sought to assess the availability and accuracy of routinely collected Hospital Episodes Statistics (HES) data in the UK and their potential contribution to the monitoring of new procedures. Four years of HES data (April 2006-March 2010) were analysed to identify episodes of hospital care involving a sample of 12 new interventional procedures. HES data were cross checked against other relevant sources including national or local registers and manufacturers' information. HES records were available for all 12 procedures during the entire study period. Comparative data sources were available from national (5), local (2) and manufacturer (2) registers. Factors found to affect comparisons were miscoding, alternative coding and inconsistent use of subsidiary codes. The analysis of provider coverage showed that HES is sensitive at detecting centres which carry out procedures, but specificity is poor in some cases. Routinely collected HES data have the potential to support quality improvements and evidence-based commissioning of devices and procedures in health services but achievement of this potential depends upon the accurate coding of procedures.
Program on immunization and cold chain monitoring: the status in eight health districts in Cameroon.
Ateudjieu, Jérôme; Kenfack, Bruno; Nkontchou, Blaise Wakam; Demanou, Maurice
2013-03-16
Cold chain monitoring is a precondition to ensure immunization quality, efficacy and safety. In Cameroon, the Expanded Program on Immunization (EPI) has National Standard Operating Procedure (SOP) that describes the vaccines, the cold chain system and equipment, its use and recommended procedures to control and monitor the temperatures and the cold chain. This study was conducted to assess the status of cold chain in eight health districts in Cameroon. The study was carried out in eight health districts out of fifty with poor immunization coverage rate. Data were collected using a validated form by observation and consultation of related documents. District Health Services (DHS) and four Integrated. Health Centers (IHC) randomly selected were targeted per health district. Forty health facilities were included. Twenty eight (70.0%) had at least one functional refrigerator for EPI activities. The power supply was reported to be permanent in 7 (20.6%) out of 34. (85.0%) health facilities with access to power supply. The temperature monitoring chart was pasted on 27 (96.4%) of the cold chain equipment. On 16 (59.3%) of these charts, the temperature was recorded twice daily as recommended. Seven (25.9%) of 27 refrigerators assessed had temperature out of the recommended range of 2 to 8°C. Almost 23.30% of health centers did not received any supervision on cold chain monitoring during a vaccination campaign. This study documents failure of the cold chain maintenance and questions the efficacy and safety of vaccines administered during EPI activities in Cameroun. These findings indicate that appropriate actions are needed to ensure monitoring of EPI cold chain in the country.
Program on immunization and cold chain monitoring: the status in eight health districts in Cameroon
2013-01-01
Background Cold chain monitoring is a precondition to ensure immunization quality, efficacy and safety. In Cameroon, the Expanded Program on Immunization (EPI) has National Standard Operating Procedure (SOP) that describes the vaccines, the cold chain system and equipment, its use and recommended procedures to control and monitor the temperatures and the cold chain. This study was conducted to assess the status of cold chain in eight health districts in Cameroon. Findings The study was carried out in eight health districts out of fifty with poor immunization coverage rate. Data were collected using a validated form by observation and consultation of related documents. District Health Services (DHS) and four Integrated. Health Centers (IHC) randomly selected were targeted per health district. Forty health facilities were included. Twenty eight (70.0%) had at least one functional refrigerator for EPI activities. The power supply was reported to be permanent in 7 (20.6%) out of 34. (85.0%) health facilities with access to power supply. The temperature monitoring chart was pasted on 27 (96.4%) of the cold chain equipment. On 16 (59.3%) of these charts, the temperature was recorded twice daily as recommended. Seven (25.9%) of 27 refrigerators assessed had temperature out of the recommended range of 2 to 8°C. Almost 23.30% of health centers did not received any supervision on cold chain monitoring during a vaccination campaign. Conclusion This study documents failure of the cold chain maintenance and questions the efficacy and safety of vaccines administered during EPI activities in Cameroun. These findings indicate that appropriate actions are needed to ensure monitoring of EPI cold chain in the country. PMID:23497720
Launch Commit Criteria Monitoring Agent
NASA Technical Reports Server (NTRS)
Semmel, Glenn S.; Davis, Steven R.; Leucht, Kurt W.; Rowe, Dan A.; Kelly, Andrew O.; Boeloeni, Ladislau
2005-01-01
The Spaceport Processing Systems Branch at NASA Kennedy Space Center has developed and deployed a software agent to monitor the Space Shuttle's ground processing telemetry stream. The application, the Launch Commit Criteria Monitoring Agent, increases situational awareness for system and hardware engineers during Shuttle launch countdown. The agent provides autonomous monitoring of the telemetry stream, automatically alerts system engineers when predefined criteria have been met, identifies limit warnings and violations of launch commit criteria, aids Shuttle engineers through troubleshooting procedures, and provides additional insight to verify appropriate troubleshooting of problems by contractors. The agent has successfully detected launch commit criteria warnings and violations on a simulated playback data stream. Efficiency and safety are improved through increased automation.
NASA's Software Safety Standard
NASA Technical Reports Server (NTRS)
Ramsay, Christopher M.
2007-01-01
NASA relies more and more on software to control, monitor, and verify its safety critical systems, facilities and operations. Since the 1960's there has hardly been a spacecraft launched that does not have a computer on board that will provide command and control services. There have been recent incidents where software has played a role in high-profile mission failures and hazardous incidents. For example, the Mars Orbiter, Mars Polar Lander, the DART (Demonstration of Autonomous Rendezvous Technology), and MER (Mars Exploration Rover) Spirit anomalies were all caused or contributed to by software. The Mission Control Centers for the Shuttle, ISS, and unmanned programs are highly dependant on software for data displays, analysis, and mission planning. Despite this growing dependence on software control and monitoring, there has been little to no consistent application of software safety practices and methodology to NASA's projects with safety critical software. Meanwhile, academia and private industry have been stepping forward with procedures and standards for safety critical systems and software, for example Dr. Nancy Leveson's book Safeware: System Safety and Computers. The NASA Software Safety Standard, originally published in 1997, was widely ignored due to its complexity and poor organization. It also focused on concepts rather than definite procedural requirements organized around a software project lifecycle. Led by NASA Headquarters Office of Safety and Mission Assurance, the NASA Software Safety Standard has recently undergone a significant update. This new standard provides the procedures and guidelines for evaluating a project for safety criticality and then lays out the minimum project lifecycle requirements to assure the software is created, operated, and maintained in the safest possible manner. This update of the standard clearly delineates the minimum set of software safety requirements for a project without detailing the implementation for those requirements. This allows the projects leeway to meet these requirements in many forms that best suit a particular project's needs and safety risk. In other words, it tells the project what to do, not how to do it. This update also incorporated advances in the state of the practice of software safety from academia and private industry. It addresses some of the more common issues now facing software developers in the NASA environment such as the use of Commercial-Off-the-Shelf Software (COTS), Modified OTS (MOTS), Government OTS (GOTS), and reused software. A team from across NASA developed the update and it has had both NASA-wide internal reviews by software engineering, quality, safety, and project management. It has also had expert external review. This presentation and paper will discuss the new NASA Software Safety Standard, its organization, and key features. It will start with a brief discussion of some NASA mission failures and incidents that had software as one of their root causes. It will then give a brief overview of the NASA Software Safety Process. This will include an overview of the key personnel responsibilities and functions that must be performed for safety-critical software.
The implementation of physical safety system in bunker of the electron beam accelerator
NASA Astrophysics Data System (ADS)
Ahmad, M. A.; Hashim, S. A.; Ahmad, A.; Leo, K. W.; Chulan, R. M.; Dalim, Y.; Baijan, A. H.; Zain, M. F.; Ros, R. C.
2017-01-01
This paper describes the implementation of physical safety system for the new low energy electron beam (EB) accelerator installed at Block 43T Nuclear Malaysia. The low energy EB is a locally designed and developed with a target energy of 300 keV. The issues on radiation protection have been addressed by the installation of radiation shielding in the form of a bunker and installation radiation monitors. Additional precaution is needed to ensure that personnel are not exposed to radiation and other physical hazards. Unintentional access to the radiation room can cause serious hazard and hence safety features must be installed to prevent such events. In this work we design and built a control and monitoring system for the shielding door. The system provides signals to the EB control panel to allow or prevent operation. The design includes limit switches, key-activated switches and emergency stop button and surveillance camera. Entry procedure is also developed as written record and for information purposes. As a result, through this safety implementation human error will be prevented, increase alertness during operation and minimizing unnecessary radiation exposure.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Pytel, K.; Mieleszczenko, W.; Lechniak, J.
2010-03-01
The presented paper contains neutronic and thermal-hydraulic (for steady and unsteady states) calculation results prepared to support annex to Safety Analysis Report for MARIA reactor in order to obtain approval for program of testing low-enriched uranium (LEU) lead test fuel assemblies (LTFA) manufactured by CERCA. This includes presentation of the limits and operational constraints to be in effect during the fuel testing investigations. Also, the scope of testing program (which began in August 2009), including additional measurements and monitoring procedures, is described.
Retrofitting Air Conditioning and Duct Systems in Hot, Dry Climates
DOE Office of Scientific and Technical Information (OSTI.GOV)
Shapiro, C.; Aldrich, R.; Arena, L.
2012-07-01
This technical report describes CARB's work with Clark County Community Resources Division in Las Vegas, Nevada, to optimize procedures for upgrading cooling systems on existing homes in the area to implement health, safety, and energy improvements. Detailed monitoring of five AC systems showed that three of the five systems met or exceeded air flow rate goals.
2017-01-01
Most gastrointestinal endoscopic procedures are now performed with sedation. Moderate sedation using benzodiazepines and opioids continue to be widely used, but propofol sedation is becoming more popular because its unique pharmacokinetic properties make endoscopy almost painless, with a very predictable and rapid recovery process. There is controversy as to whether propofol should be administered only by anesthesia professionals (monitored anesthesia care) or whether properly trained non-anesthesia personnel can use propofol safely via the modalities of nurse-administered propofol sedation, computer-assisted propofol sedation or nurse-administered continuous propofol sedation. The deployment of non-anesthesia administered propofol sedation for low-risk procedures allows for optimal allocation of scarce anesthesia resources, which can be more appropriately used for more complex cases. This can address some of the current shortages in anesthesia provider supply, and can potentially reduce overall health care costs without sacrificing sedation quality. This review will discuss efficacy, safety, efficiency, cost and satisfaction issues with various modes of sedation for non-advanced, non-emergent endoscopic procedures, mainly esophagogastroduodenoscopy and colonoscopy. PMID:29142513
Natural Bridges National Monument photovoltaic power plant operations manual
NASA Astrophysics Data System (ADS)
Coleman, S. D.
1982-02-01
After a basic introduction and overview of the photovoltaic system at the Natural Bridges National Monument, a history of the project and a description of the installation, safety procedures essential for all operators and maintenance personnel are discussed. Locations and detailed descriptions of the equipment are provided to permit operators to identify the system controls and equipment. Step by step system operation procedures are described, including diesel generator start up and photovoltaic power system turn on. Information is provided about routine monitoring and maintenance of the system.
Elbasty, Ahmed; Metcalf, James
2017-01-01
Purpose Catheter direct thrombolysis (CDT) has been shown to be an effective treatment for deep venous thrombosis. The objective of the review is to improve safety and efficacy of the CDT by using ward based protocol, better able to predict complications and treatment outcome through monitoring of haemostatic parameters and clinical observation during thrombolysis procedure. Materials and Methods MEDLINE, EMBASE, CENTRAL and Web of Science were searched for all articles on deep venous thrombosis, thrombolysis and correlations of clinical events (bleeding, successful thrombolysis) during thrombolysis with hemostatic parameters to March 2016. The risk of bias in included studies was assessed by Cochrane Collaboration’s tool and Cochrane Risk of Bias Assessment Tool: for Non-Randomized Studies of Interventions. Results Twenty-four studies were included in the review and we found that improving safety and efficacy of CDT by using ward based protocol depending on eight factors; strict patient selection criteria, types of fibrinolytic drugs, mode of fibrinolytic drug injection, biochemical markers monitoring (fibrinogen, D-dimer, activated partial thromboplastin time, plasminogen activator inhibitor-1), timing of intervention, usage of intermittent pneumatic calf, ward monitoring and thrombolysis imaging assessment (intravascular ultrasound). These factors may help to improve safety and efficacy by reducing total thrombolytic drug dosage and at the same time ensure successful lysis. There is a marked lack of randomized controlled trials discussing the safety and efficacy of catheter direct thrombolysis. Conclusion CDT can be performed safely and efficiently in clinical ward, providing that careful nursing, biochemical monitoring, proper selection and mode of infusion of fibrinolytic drugs, usage of Intermittent pneumatic calf and adequate thrombolysis imaging assessment are ensured. PMID:29354622
DOE Office of Scientific and Technical Information (OSTI.GOV)
Physical device safety is typically implemented locally using embedded controllers, while operations safety is primarily performed in control centers. Safe operations can be enhanced by correct design of device-level control algorithms, and protocols, procedures and operator training at the control-room level, but all can fail. Moreover, these elements exchange data and issue commands via vulnerable communication layers. In order to secure these gaps and enhance operational safety, we believe monitoring of command sequences must be combined with an awareness of physical device limitations and automata models that capture safety mechanisms. One way of doing this is by leveraging specification-based intrusionmore » detection to monitor for physical constraint violations. The method can also verify that physical infrastructure state is consistent with monitoring information and control commands exchanged between field devices and control centers. This additional security layer enhances protection from both outsider attacks and insider mistakes. We implemented specification-based SCADA command analyzers using physical constraint algorithms directly in the Bro framework and Broccoli APIs for three separate scenarios: a water heater, an automated distribution system, and an over-current protection scheme. To accomplish this, we added low-level analyzers capable of examining control system-specific protocol packets for both Modbus TCP and DNP3, and also higher-level analyzers able to interpret device command and data streams within the context of each device's physical capabilities and present operational state. Thus the software that we are making available includes the Bro/Broccoli scripts for these three scenarios, as well as simulators, written in C, of those scenarios that generate sample traffic that is monitored by the Bro/Broccoli scripts. In addition, we have also implemented systems to directly pull cyber-physical information from the OSIsoft PI historian system. We have included the Python scripts used to perform that monitoring.« less
Paediatric dental chair sedation: An audit of current practice in Gauteng, South Africa.
Bham, F; Perrie, H; Scribante, J; Lee, C-A
2015-06-01
Procedural sedation and analgesia (PSA) is often required to perform dental procedures in children. Serious adverse outcomes, while rare, are usually preventable. To determine the proportion of dental practitioners making use of paediatric dental chair PSA in Gauteng Province, South Africa, describe their PSA practice, and determine compliance with recommended safety standards. A prospective, contextual, descriptive study design was used, with 222 randomly selected dental practitioners contacted to determine whether they offered paediatric dental chair PSA. Practitioners offering PSA were then asked to complete a web-based questionnaire assessing their practice. Of the 213 dental practitioners contacted, 94 (44.1%; 95% confidence interval 37 - 51) provided PSA to children. Most patients were 1 - 5 years old, although there were practices that offered PSA to infants. While most procedures were performed under minimal to moderate sedation, deep sedation and general anaesthesia were also administered in dental rooms. Midazolam was the most frequently used sedative agent, often in conjunction with inhaled nitrous oxide; 28.1% of PSA providers administered a combination of three or more agents. Presedation patient assessment was documented in 83.0% of cases, and informed consent for sedation was obtained in 75.6%. The survey raised several areas of concern regarding patient safety: 41.3% of dental practices did not use any monitoring equipment during sedation; the operator was responsible for the sedation and monitoring of the patient in 41.3%; 43.2% did not keep any recommended emergency drugs; and 19.6% did not have any emergency or resuscitation equipment available. Most respondents (81.8%) indicated an interest in sedation training. Paediatric dental chair PSA was offered by 44.1% of dental practitioners interviewed in Gauteng. Modalities of PSA provided varied between practices, with a number of safety concerns being raised.
NASA Technical Reports Server (NTRS)
Cassell, Rick; Smith, Alex; Connors, Mary; Wojciech, Jack; Rosekind, Mark R. (Technical Monitor)
1996-01-01
As new technologies and procedures are introduced into the National Airspace System, whether they are intended to improve efficiency, capacity, or safety level, the quantification of potential changes in safety levels is of vital concern. Applications of technology can improve safety levels and allow the reduction of separation standards. An excellent example is the Precision Runway Monitor (PRM). By taking advantage of the surveillance and display advances of PRM, airports can run instrument parallel approaches to runways separated by 3400 feet with the same level of safety as parallel approaches to runways separated by 4300 feet using the standard technology. Despite a wealth of information from flight operations and testing programs, there is no readily quantifiable relationship between numerical safety levels and the separation standards that apply to aircraft on final approach. This paper presents a modeling approach to quantify the risk associated with reducing separation on final approach. Reducing aircraft separation, both laterally and longitudinally, has been the goal of several aviation R&D programs over the past several years. Many of these programs have focused on technological solutions to improve navigation accuracy, surveillance accuracy, aircraft situational awareness, controller situational awareness, and other technical and operational factors that are vital to maintaining flight safety. The risk assessment model relates different types of potential aircraft accidents and incidents and their contribution to overall accident risk. The framework links accident risks to a hierarchy of failsafe mechanisms characterized by procedures and interventions. The model will be used to assess the overall level of safety associated with reducing separation standards and the introduction of new technology and procedures, as envisaged under the Free Flight concept. The model framework can be applied to various aircraft scenarios, including parallel and in-trail approaches. This research was performed under contract to NASA and in cooperation with the FAA's Safety Division (ASY).
Algorithm-based arterial blood sampling recognition increasing safety in point-of-care diagnostics.
Peter, Jörg; Klingert, Wilfried; Klingert, Kathrin; Thiel, Karolin; Wulff, Daniel; Königsrainer, Alfred; Rosenstiel, Wolfgang; Schenk, Martin
2017-08-04
To detect blood withdrawal for patients with arterial blood pressure monitoring to increase patient safety and provide better sample dating. Blood pressure information obtained from a patient monitor was fed as a real-time data stream to an experimental medical framework. This framework was connected to an analytical application which observes changes in systolic, diastolic and mean pressure to determine anomalies in the continuous data stream. Detection was based on an increased mean blood pressure caused by the closing of the withdrawal three-way tap and an absence of systolic and diastolic measurements during this manipulation. For evaluation of the proposed algorithm, measured data from animal studies in healthy pigs were used. Using this novel approach for processing real-time measurement data of arterial pressure monitoring, the exact time of blood withdrawal could be successfully detected retrospectively and in real-time. The algorithm was able to detect 422 of 434 (97%) blood withdrawals for blood gas analysis in the retrospective analysis of 7 study trials. Additionally, 64 sampling events for other procedures like laboratory and activated clotting time analyses were detected. The proposed algorithm achieved a sensitivity of 0.97, a precision of 0.96 and an F1 score of 0.97. Arterial blood pressure monitoring data can be used to perform an accurate identification of individual blood samplings in order to reduce sample mix-ups and thereby increase patient safety.
Zegers-Hochschild, F; Adamson, G D; de Mouzon, J; Ishihara, O; Mansour, R; Nygren, K; Sullivan, E; van der Poel, S
2009-11-01
Many definitions used in medically assisted reproduction (MAR) vary in different settings, making it difficult to standardize and compare procedures in different countries and regions. With the expansion of infertility interventions worldwide, including lower resource settings, the importance and value of a common nomenclature is critical. The objective is to develop an internationally accepted and continually updated set of definitions, which would be utilized to standardize and harmonize international data collection, and to assist in monitoring the availability, efficacy, and safety of assisted reproductive technology (ART) being practiced worldwide. Seventy-two clinicians, basic scientists, epidemiologists and social scientists gathered together at the WHO headquarters in Geneva, Switzerland in December, 2008. Several months in advance, three working groups were established which were responsible for terminology in three specific areas: clinical conditions and procedures, laboratory procedures and outcome measures. Each group reviewed the existing ICMART glossary, made recommendations for revisions and introduced new terms to be considered for glossary expansion. A consensus was reached on 87 terms, expanding the original glossary by 34 terms, which included definitions for numerous clinical and laboratory procedures. Special emphasis was placed in describing outcome measures such as cumulative delivery rates and other markers of safety and efficacy in ART. Standardized terminology should assist in analysis of worldwide trends in MAR interventions and in the comparison of ART outcomes across countries and regions. This glossary will contribute to a more standardized communication among professionals responsible for ART practice, as well as those responsible for national, regional and international registries.
Hand held data collection and monitoring system for nuclear facilities
Brayton, D.D.; Scharold, P.G.; Thornton, M.W.; Marquez, D.L.
1999-01-26
Apparatus and method is disclosed for a data collection and monitoring system that utilizes a pen based hand held computer unit which has contained therein interaction software that allows the user to review maintenance procedures, collect data, compare data with historical trends and safety limits, and input new information at various collection sites. The system has a means to allow automatic transfer of the collected data to a main computer data base for further review, reporting, and distribution purposes and uploading updated collection and maintenance procedures. The hand held computer has a running to-do list so sample collection and other general tasks, such as housekeeping are automatically scheduled for timely completion. A done list helps users to keep track of all completed tasks. The built-in check list assures that work process will meet the applicable processes and procedures. Users can hand write comments or drawings with an electronic pen that allows the users to directly interface information on the screen. 15 figs.
Hand held data collection and monitoring system for nuclear facilities
Brayton, Darryl D.; Scharold, Paul G.; Thornton, Michael W.; Marquez, Diana L.
1999-01-01
Apparatus and method is disclosed for a data collection and monitoring system that utilizes a pen based hand held computer unit which has contained therein interaction software that allows the user to review maintenance procedures, collect data, compare data with historical trends and safety limits, and input new information at various collection sites. The system has a means to allow automatic transfer of the collected data to a main computer data base for further review, reporting, and distribution purposes and uploading updated collection and maintenance procedures. The hand held computer has a running to-do list so sample collection and other general tasks, such as housekeeping are automatically scheduled for timely completion. A done list helps users to keep track of all completed tasks. The built-in check list assures that work process will meet the applicable processes and procedures. Users can hand write comments or drawings with an electronic pen that allows the users to directly interface information on the screen.
NASA Technical Reports Server (NTRS)
2014-01-01
Topics covered include: Innovative Software Tools Measure Behavioral Alertness; Miniaturized, Portable Sensors Monitor Metabolic Health; Patient Simulators Train Emergency Caregivers; Solar Refrigerators Store Life-Saving Vaccines; Monitors Enable Medication Management in Patients' Homes; Handheld Diagnostic Device Delivers Quick Medical Readings; Experiments Result in Safer, Spin-Resistant Aircraft; Interfaces Visualize Data for Airline Safety, Efficiency; Data Mining Tools Make Flights Safer, More Efficient; NASA Standards Inform Comfortable Car Seats; Heat Shield Paves the Way for Commercial Space; Air Systems Provide Life Support to Miners; Coatings Preserve Metal, Stone, Tile, and Concrete; Robots Spur Software That Lends a Hand; Cloud-Based Data Sharing Connects Emergency Managers; Catalytic Converters Maintain Air Quality in Mines; NASA-Enhanced Water Bottles Filter Water on the Go; Brainwave Monitoring Software Improves Distracted Minds; Thermal Materials Protect Priceless, Personal Keepsakes; Home Air Purifiers Eradicate Harmful Pathogens; Thermal Materials Drive Professional Apparel Line; Radiant Barriers Save Energy in Buildings; Open Source Initiative Powers Real-Time Data Streams; Shuttle Engine Designs Revolutionize Solar Power; Procedure-Authoring Tool Improves Safety on Oil Rigs; Satellite Data Aid Monitoring of Nation's Forests; Mars Technologies Spawn Durable Wind Turbines; Programs Visualize Earth and Space for Interactive Education; Processor Units Reduce Satellite Construction Costs; Software Accelerates Computing Time for Complex Math; Simulation Tools Prevent Signal Interference on Spacecraft; Software Simplifies the Sharing of Numerical Models; Virtual Machine Language Controls Remote Devices; Micro-Accelerometers Monitor Equipment Health; Reactors Save Energy, Costs for Hydrogen Production; Cameras Monitor Spacecraft Integrity to Prevent Failures; Testing Devices Garner Data on Insulation Performance; Smart Sensors Gather Information for Machine Diagnostics; Oxygen Sensors Monitor Bioreactors and Ensure Health and Safety; Vision Algorithms Catch Defects in Screen Displays; and Deformable Mirrors Capture Exoplanet Data, Reflect Lasers.
NASA Technical Reports Server (NTRS)
Romero, Raylund; Summers, Harold; Cronkhite, James
1996-01-01
The objective was to evaluate the feasibility of a state-of-the-art health and usage monitoring system (HUMS) to provide monitoring of critical mechanical systems on the helicopter, including motors, drive train, engines, and life-limited components. The implementation of HUMS and cost integration with current maintenance procedures was assessed from the operator's viewpoint in order to achieve expected benefits from these systems, such as enhanced safety, reduced maintenance cost, and increased availability. An operational HUMS that was installed and operated under an independent flight trial program was used as a basis for this study. The HUMS equipment and software were commercially available. Based on the results of the feasibility study, the HUMS used in the flight trial program generally demonstrated a high level of reliability in monitoring the rotor system, engines, drive train, and life-limited components. The system acted as a sentinel to warn of impending failures. A worn tail rotor pitch bearing was detected by HUMS, which had the capability for self testing to diagnose system and sensor faults. Examples of potential payback to the operator with HUMS were identified, including reduced insurance cost through enhanced safety, lower operating costs derived from maintenance credits, increased aircraft availability, and improved operating efficiency. The interfacing of HUMS with current operational procedures was assessed to require only minimal revisions to the operator's maintenance manuals. Finally the success in realizing the potential benefits from HUMS technology was found to depend on the operator, helicopter manufacturer, regulator (FAA), and HUMS supplier working together.
NASA Astrophysics Data System (ADS)
Fahey, Brian J.; Trahey, Gregg E.
2005-04-01
When performing radiofrequency ablation (RFA) procedures, physicians currently have little or no feedback concerning the success of the treatment until follow-up assessments are made days to weeks later. To be successful, RFA must induce a thermal lesion of sufficient volume to completely destroy a target tumor or completely isolate an aberrant cardiac pathway. Although ultrasound, computed tomography (CT), and CT-based fluoroscopy have found use in guiding RFA treatments, they are deficient in giving accurate assessments of lesion size or boundaries during procedures. As induced thermal lesion size can vary considerably from patient to patient, the current lack of real-time feedback during RFA procedures is troublesome. We have developed a technique for real-time monitoring of thermal lesion size during RFA procedures utilizing acoustic radiation force impulse (ARFI) imaging. In both ex vivo and in vivo tissues, ARFI imaging provided better thermal lesion contrast and better overall appreciation for lesion size and boundaries relative to conventional sonography. The thermal safety of ARFI imaging for use at clinically realistic depths was also verified through the use of finite element method models. As ARFI imaging is implemented entirely on a diagnostic ultrasound scanner, it is a convenient, inexpensive, and promising modality for monitoring RFA procedures in vivo.
Reflections on the implementation of governance structures for early-stage clinical innovation.
Cowie, Luke; Sandall, Jane; Ehrich, Kathryn
2013-12-01
This paper seeks to further explore the question of how best to monitor and govern innovative clinical procedures in their earliest phase of development. We examine the potential value of proposed governance frameworks, such as the IDEAL model, and examine the functioning of a novel procedures review committee. The paper draws upon 20 qualitative, semi-structured interviews. Nine interviews were conducted with members of a committee that was established as a means of governing innovative procedures within a large National Health Service Foundation Trust hospital in the UK. Eleven interviews were conducted with health providers involved with the development of a variety of novel clinical procedures. Prominent themes from the data include the potential willingness of clinicians to engage with regulatory frameworks for innovative procedures, existing ways in which clinicians and others attempt to ensure patient's safety and manage uncertainty in the context of novel procedures, views on the potential benefits and drawbacks of engaging with a review committee for novel procedures, and the pragmatic considerations and potential unintended consequences that are entailed in the implementation of regulatory requirements for the monitoring of innovative procedures. The views of committee members and clinical innovators help us to understand the practical issues of implementing governance structures for novel clinical procedures. The data illustrate those factors that must be taken into account if governance is to support innovation rather than act as an inhibiting factor in the development of new clinical procedures. © 2012 John Wiley & Sons Ltd.
Identifying the most significant indicators of the total road safety performance index.
Tešić, Milan; Hermans, Elke; Lipovac, Krsto; Pešić, Dalibor
2018-04-01
The review of the national and international literature dealing with the assessment of the road safety level has shown great efforts of the authors who tried to define the methodology for calculating the composite road safety index on a territory (region, state, etc.). The procedure for obtaining a road safety composite index of an area has been largely harmonized. The question that has not been fully resolved yet concerns the selection of indicators. There is a wide range of road safety indicators used to show a road safety situation on a territory. Road safety performance index (RSPI) obtained on the basis of a larger number of safety performance indicators (SPIs) enable decision makers to more precisely define the earlier goal- oriented actions. However, recording a broader comprehensive set of SPIs helps identify the strengths and weaknesses of a country's road safety system. Providing high quality national and international databases that would include comparable SPIs seems to be difficult since a larger number of countries dispose of a small number of identical indicators available for use. Therefore, there is a need for calculating a road safety performance index with a limited number of indicators (RSPI ln n ) which will provide a comparison of a sufficient quality, of as many countries as possible. The application of the Data Envelopment Analysis (DEA) method and correlative analysis has helped to check if the RSPI ln n is likely to be of sufficient quality. A strong correlation between the RSPI ln n and the RSPI has been identified using the proposed methodology. Based on this, the most contributing indicators and methodologies for gradual monitoring of SPIs, have been defined for each country analyzed. The indicator monitoring phases in the analyzed countries have been defined in the following way: Phase 1- the indicators relating to alcohol, speed and protective systems; Phase 2- the indicators relating to roads and Phase 3- the indicators relating to trauma management. This will help achieve the standardization of indicators including data collection procedures and selection of the key list of indicators that need to be monitored. Based on the results, it has been concluded that the use of the most contributing indicators will make it possible to assess the level of road safety on a territory, with an acceptable quality score by focusing on the low-ranked countries. A smaller set of significant indicators defined in this manner can serve for a fast and simple understanding of a road safety situation and assessment of effects of measures undertaken. Also, this universal index approach is applicable in cases when a broader comprehensive set of indicators is analyzed, which provides a more accurate identification of weaker points and rank the countries in a more meaningful way. Copyright © 2018 Elsevier Ltd. All rights reserved.
Bitar, George; Mullis, William; Jacobs, William; Matthews, David; Beasley, Michael; Smith, Kevin; Watterson, Paul; Getz, Stanley; Capizzi, Peter; Eaves, Felmont
2003-01-01
Office-based surgery has several potential benefits over hospital-based surgery, including cost containment, ease of scheduling, and convenience to both patients and surgeons. Scrutiny of office-based surgery by regulators and state-licensing agencies has increased and must be addressed by improved documentation of safety and efficacy. To evaluate the safety and efficacy of the authors' office-based plastic surgery, a review was undertaken of 3615 consecutive patients undergoing 4778 outpatient plastic surgery procedures under monitored anesthesia care/sedation in a single office. The charts of 3615 consecutive patients who had undergone office-based surgery with monitored anesthesia care/sedation between May of 1995 and May of 2000 were reviewed. In all cases, the anesthesia protocol used included sedation with midazolam, propofol, and a narcotic administered by a board-certified registered nurse anesthetist with local anesthesia provided by the surgeon. Charts were reviewed for patient profile, types of procedures, multiple procedures, duration of anesthesia, American Society of Anesthesiologists class, and complications related to anesthesia. Outcomes measured included death, airway compromise, dyspnea, hypotension, venous thrombosis, pulmonary emboli, protracted nausea and vomiting lasting more than 24 hours, and unplanned hospital admissions. Statistical analyses were performed using the Microsoft Excel program and the SAS package. Results were as follows: 92.3 percent of the patients were female and 7.7 percent were male, with a mean age of 42.7 years (range, 3 to 83 years). Patients underwent aesthetic (95.6 percent) and reconstructive (4.4 percent) plastic surgery procedures. Same-session multiple procedures occurred in 24.8 percent of patients. The vast majority of patients were healthy: 84.3 percent of patients were American Society of Anesthesiologists class I, 15.6 percent were class II, and 0.1 percent were class III. The operations required a mean of 111 minutes. There were no deaths, ventilator requirements, deep venous thromboses, or pulmonary emboli. Complications were as follows: 0.05 percent (n = 2) of patients had dyspnea that resolved, 0.2 percent (n = 6) of patients had protracted nausea and vomiting, and 0.05 percent (n = 2) of patients had unplanned hospital admissions (<24 hours). One patient had an emergent intubation. No prolonged adverse effects were noted. There was a 30-day follow-up minimum. Outpatient surgery is an important aspect of plastic surgery. It was shown that office-based surgery with intravenous sedation, performed by board-certified plastic surgeons and nurse anesthetists, is safe. Appropriate accreditation, safe anesthesia protocols, and proper patient selection constitute the basis for safe and efficacious office-based outpatient plastic surgery.
Comparing the coding of complications in Queensland and Victorian admitted patient data.
Michel, Jude L; Cheng, Diana; Jackson, Terri J
2011-08-01
To examine differences between Queensland and Victorian coding of hospital-acquired conditions and suggest ways to improve the usefulness of these data in the monitoring of patient safety events. Secondary analysis of admitted patient episode data collected in Queensland and Victoria. Comparison of depth of coding, and patterns in the coding of ten commonly coded complications of five elective procedures. Comparison of the mean complication codes assigned per episode revealed Victoria assigns more valid codes than Queensland for all procedures, with the difference between the states being significantly different in all cases. The proportion of the codes flagged as complications was consistently lower for Queensland when comparing 10 common complications for each of the five selected elective procedures. The estimated complication rates for the five procedures showed Victoria to have an apparently higher complication rate than Queensland for 35 of the 50 complications examined. Our findings demonstrate that the coding of complications is more comprehensive in Victoria than in Queensland. It is known that inconsistencies exist between states in routine hospital data quality. Comparative use of patient safety indicators should be viewed with caution until standards are improved across Australia. More exploration of data quality issues is needed to identify areas for improvement.
Coté, Charles J; Wilson, Stephen
2016-07-01
The safe sedation of children for procedures requires a systematic approach that includes the following: no administration of sedating medication without the safety net of medical/dental supervision, careful presedation evaluation for underlying medical or surgical conditions that would place the child at increased risk from sedating medications, appropriate fasting for elective procedures and a balance between the depth of sedation and risk for those who are unable to fast because of the urgent nature of the procedure, a focused airway examination for large (kissing) tonsils or anatomic airway abnormalities that might increase the potential for airway obstruction, a clear understanding of the medication's pharmacokinetic and pharmacodynamic effects and drug interactions, appropriate training and skills in airway management to allow rescue of the patient, age- and size-appropriate equipment for airway management and venous access, appropriate medications and reversal agents, sufficient numbers of staff to both carry out the procedure and monitor the patient, appropriate physiologic monitoring during and after the procedure, a properly equipped and staffed recovery area, recovery to the presedation level of consciousness before discharge from medical/dental supervision, and appropriate discharge instructions. This report was developed through a collaborative effort of the American Academy of Pediatrics and the American Academy of Pediatric Dentistry to offer pediatric providers updated information and guidance in delivering safe sedation to children. Copyright © 2016 American Academy of Pediatric Dentistry and American Academy of Pediatrics. This report is being published concurrently in Pediatric Dentistry July 2016. The articles are identical. Either citation can be used when citing this report.
Wright, Melanie C; Taekman, Jeffrey M; Barber, Linda; Hobbs, Gene; Newman, Mark F; Stafford-Smith, Mark
2005-12-01
Errors in clinical research can be costly, in terms of patient safety, data integrity, and data collection. Data inaccuracy in early subjects of a clinical study may be associated with problems in the design of the protocol, procedures, and data collection tools. High-fidelity patient simulation centers provide an ideal environment to apply human-centered design to clinical trial development. A draft of a complex clinical protocol was designed, evaluated and modified using a high-fidelity human patient simulator in the Duke University Human Simulation and Patient Safety Center. The process included walk-throughs, detailed modifications of the protocol and development of procedural aids. Training of monitors and coordinators provided an opportunity for observation of performance that was used to identify further improvements to the protocol. Evaluative steps were used to design the research protocol and procedures. Iterative modifications were made to the protocol and data collection tools. The success in use of human simulation in the preparation of a complex clinical drug trial suggests the benefits of human patient simulation extend beyond training and medical equipment evaluation. Human patient simulation can provide a context for informal expert evaluation of clinical protocol design and for formal "rehearsal" to evaluate the efficacy of procedures and support tools.
49 CFR 385.703 - Safety monitoring system.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Safety monitoring system. 385.703 Section 385.703... Safety Monitoring System for Non-North American Carriers § 385.703 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...
49 CFR 385.103 - Safety monitoring system.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Safety monitoring system. 385.103 Section 385.103... Safety Monitoring System for Mexico-Domiciled Carriers § 385.103 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...
49 CFR 385.703 - Safety monitoring system.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Safety monitoring system. 385.703 Section 385.703... Safety Monitoring System for Non-North American Carriers § 385.703 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...
49 CFR 385.103 - Safety monitoring system.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Safety monitoring system. 385.103 Section 385.103... Safety Monitoring System for Mexico-Domiciled Carriers § 385.103 Safety monitoring system. (a) General... Vehicle Safety Standards (FMVSSs), and Hazardous Materials Regulations (HMRs). (b) Roadside monitoring...
Electromyographic monitoring and its anatomical implications in minimally invasive spine surgery.
Uribe, Juan S; Vale, Fernando L; Dakwar, Elias
2010-12-15
Literature review. The objective of this article is to examine current intraoperative electromyography (EMG) neurophysiologic monitoring methods and their application in minimally invasive techniques. We will also discuss the recent application of EMG and its anatomic implications to the minimally invasive lateral transpsoas approach to the spine. Minimally invasive techniques require that the same goals of surgery be achieved, with the hope of decreased morbidity to the patient. Unlike standard open procedures, direct visualization of the anatomy is decreased. To increase the safety of minimally invasive spine surgery, neurophysiological monitoring techniques have been developed. Review of the literature was performed using the National Center for Biotechnology Information databases using PUBMED/MEDLINE. All articles in the English language discussing the use of intraoperative EMG monitoring and minimally invasive spine surgery were reviewed. The role of EMG monitoring in special reference to the minimally invasive lateral transpsoas approach is also described. In total, 76 articles were identified that discussed the role of neuromonitoring in spine surgery. The majority of articles on EMG and spine surgery discuss the use of intraoperative neurophysiological monitoring (IOM) for safe and accurate pedicle screw placement. In general, there is a paucity of literature that pertains to intraoperative EMG neuromonitoring and minimally invasive spine surgery. Recently, EMG has been used during minimally invasive lateral transpsoas approach to the lumbar spine for interbody fusion. The addition of EMG to the lateral approach has contributed to decrease the complication rate from 30% to less than 1%. In minimally invasive approaches to the spine, the use of EMG IOM might provide additional safety, such as percutaneous pedicle screw placement, where visualization is limited compared with conventional open procedures. In addition to knowledge of the anatomy and image guidance, directional EMG IOM is crucial for safe passage through the psoas muscle during the minimally invasive lateral retroperitoneal approach.
Clarke, John R
2009-01-01
Surgical errors with minimally invasive surgery differ from those in open surgery. Perforations are typically the result of trocar introduction or electrosurgery. Infections include bioburdens, notably enteric viruses, on complex instruments. Retained foreign objects are primarily unretrieved device fragments and lost gallstones or other specimens. Fires and burns come from illuminated ends of fiber-optic cables and from electrosurgery. Pressure ischemia is more likely with longer endoscopic surgical procedures. Gas emboli can occur. Minimally invasive surgery is more dependent on complex equipment, with high likelihood of failures. Standardization, checklists, and problem reporting are solutions for minimizing failures. The necessity of electrosurgery makes education about best electrosurgical practices important. The recording of minimally invasive surgical procedures is an opportunity to debrief in a way that improves the reliability of future procedures. Safety depends on reliability, designing systems to withstand inevitable human errors. Safe systems are characterized by a commitment to safety, formal protocols for communications, teamwork, standardization around best practice, and reporting of problems for improvement of the system. Teamwork requires shared goals, mental models, and situational awareness in order to facilitate mutual monitoring and backup. An effective team has a flat hierarchy; team members are empowered to speak up if they are concerned about problems. Effective teams plan, rehearse, distribute the workload, and debrief. Surgeons doing minimally invasive surgery have a unique opportunity to incorporate the principles of safety into the development of their discipline.
Federal Radiological Monitoring and Assessment Center Monitoring Manual Volume 1, Operations
DOE Office of Scientific and Technical Information (OSTI.GOV)
NSTec Aerial Measurement Systems
2012-07-31
The Monitoring division is primarily responsible for the coordination and direction of: Aerial measurements to delineate the footprint of radioactive contaminants that have been released into the environment. Monitoring of radiation levels in the environment; Sampling to determine the extent of contaminant deposition in soil, water, air and on vegetation; Preliminary field analyses to quantify soil concentrations or depositions; and Environmental and personal dosimetry for FRMAC field personnel, during a Consequence Management Response Team (CMRT) and Federal Radiological Monitoring and Assessment Center (FRMAC) response. Monitoring and sampling techniques used during CM/FRMAC operations are specifically selected for use during radiological emergenciesmore » where large numbers of measurements and samples must be acquired, analyzed, and interpreted in the shortest amount of time possible. In addition, techniques and procedures are flexible so that they can be used during a variety of different scenarios; e.g., accidents involving releases from nuclear reactors, contamination by nuclear waste, nuclear weapon accidents, space vehicle reentries, or contamination from a radiological dispersal device. The Monitoring division also provides technicians to support specific Health and Safety Division activities including: The operation of the Hotline; FRMAC facility surveys; Assistance with Health and Safety at Check Points; and Assistance at population assembly areas which require support from the FRMAC. This volume covers deployment activities, initial FRMAC activities, development and implementation of the monitoring and assessment plan, the briefing of field teams, and the transfer of FRMAC to the EPA.« less
Safety of pandemic H1N1 vaccines in children and adolescents.
Wijnans, Leonoor; de Bie, Sandra; Dieleman, Jeanne; Bonhoeffer, Jan; Sturkenboom, Miriam
2011-10-06
During the 2009 influenza A (H1N1) pandemic several pandemic H1N1 vaccines were licensed using fast track procedures, with relatively limited data on the safety in children and adolescents. Different extensive safety monitoring efforts were put in place to ensure timely detection of adverse events following immunization. These combined efforts have generated large amounts of data on the safety of the different pandemic H1N1 vaccines, also in children and adolescents. In this overview we shortly summarize the safety experience with seasonal influenza vaccines as a background and focus on the clinical and post marketing safety data of the pandemic H1N1 vaccines in children. We identified 25 different clinical studies including 10,505 children and adolescents, both healthy and with underlying medical conditions, between the ages of 6 months and 23 years. In addition, large monitoring efforts have resulted in large amounts of data, with almost 13,000 individual case reports in children and adolescents to the WHO. However, the diversity in methods and data presentation in clinical study publications and publications of spontaneous reports hampered the analysis of safety of the different vaccines. As a result, relatively little has been learned on the comparative safety of these pandemic H1N1 vaccines - particularly in children. It should be a collective effort to give added value to the enormous work going into the individual studies by adhering to available guidelines for the collection, analysis, and presentation of vaccine safety data in clinical studies and to guidance for the clinical investigation of medicinal products in the pediatric population. Importantly the pandemic has brought us the beginning of an infrastructure for collaborative vaccine safety studies in the EU, USA and globally. Copyright © 2011 Elsevier Ltd. All rights reserved.
Ban, Vin Shen; Madden, Christopher J; Browning, Travis; O'Connell, Ellen; Marple, Bradley F; Moran, Brett
2017-04-01
Monitoring the supervision of residents can be a challenging task. We describe our experience with the implementation of a templated note system for documenting procedures with the aim of enabling automated, discrete, and standardized capture of documentation of supervision of residents performing floor-based procedures, with minimal extra effort from the residents. Procedural note templates were designed using the standard existing template within a commercial electronic health record software. Templates for common procedures were created such that residents could document every procedure performed outside of the formal procedural areas. Automated reports were generated and letters were sent to noncompliers. A total of 27 045 inpatient non-formal procedural area procedures were recorded from August 2012 to June 2014. Compliance with NoteWriter template usage averaged 86% in the first year and increased to 94.6% in the second year ( P = .0055). Initially, only 12.5% of residents documented supervision of any form. By the end of the first year, this was above 80%, with the gains maintained into the second year and beyond. Direct supervision was documented to have occurred where required in 62.8% in the first year and increased to 99.8% in the second year ( P = .0001) after the addition of hard stops. Notification of attendings prior to procedures was documented 100% of the time by September 2013. Letters sent to errant residents decreased from 3.6 to 0.83 per 100 residents per week. The templated procedure note system with hard stops and integrated reporting can successfully be used to improve monitoring of resident supervision. This has potential impact on resident education and patient safety. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com
Transformer partial discharge monitoring based on optical fiber sensing
NASA Astrophysics Data System (ADS)
Wang, Kun; Tong, Xinglin; Zhu, Xiaolong
2014-06-01
The power transformer is the most important equipment of the high voltage power grid, however, some traditional methods of online partial discharge monitoring have some limitations. Based on many advantages of the optical fiber sensing technology, we have done some research on fiber optics Fabry-Perot (FP) sensing which can be useful for the transformer on online partial discharge monitoring. This research aimed at improving the reliability of power system safety monitoring. We have done some work as follows: designing a set for fiber optics FP sensor preparation, according to the fabrication procedure strictly making out the sensors, building a reasonable signal demodulation system for fiber optics FP sensing, doing a preliminary analysis about online partial discharge signal monitoring, including the research on different discharge intensities with the same measuring distance and different measuring distances with the same discharge intensity, and then making a detailed analysis of the experimental results.
U.S. Geological Survey Unmanned Aircraft Systems (UAS) Roadmap 2014
Cress, Jill J.; Hutt, Michael E.; Sloan, Jeff L.; Bauer, Mark A.; Feller, Mark R.; Goplen, Susan E.
2015-01-01
This Roadmap provides operational procedures and lessons learned from completed proof-of-concept UAS missions in areas such as wildlife management, resource monitoring, and public land inspections. This information provides not only an implementation framework but can also help increase the awareness by resource managers, scientists, and others of the ability of UAS technology to advance data quality, improve personnel safety, and reduce data acquisition costs.
Random safety auditing, root cause analysis, failure mode and effects analysis.
Ursprung, Robert; Gray, James
2010-03-01
Improving quality and safety in health care is a major concern for health care providers, the general public, and policy makers. Errors and quality issues are leading causes of morbidity and mortality across the health care industry. There is evidence that patients in the neonatal intensive care unit (NICU) are at high risk for serious medical errors. To facilitate compliance with safe practices, many institutions have established quality-assurance monitoring procedures. Three techniques that have been found useful in the health care setting are failure mode and effects analysis, root cause analysis, and random safety auditing. When used together, these techniques are effective tools for system analysis and redesign focused on providing safe delivery of care in the complex NICU system. Copyright 2010 Elsevier Inc. All rights reserved.
Douglas, Pamela S; Carr, J Jeffery; Cerqueira, Manuel D; Cummings, Jennifer E; Gerber, Thomas C; Mukherjee, Debabrata; Taylor, Allen J
2012-05-01
Technological advances and increased utilization of medical testing and procedures have prompted greater attention to ensuring the patient safety of radiation use in the practice of adult cardiovascular medicine. In response, representatives from cardiovascular imaging societies, private payers, government and nongovernmental agencies, industry, medical physicists, and patient representatives met to develop goals and strategies toward this end; this report provides an overview of the discussions. This expert "think tank" reached consensus on several broad directions including: the need for broad collaboration across a large number of diverse stakeholders; clarification of the relationship between medical radiation and stochastic events; required education of ordering and providing physicians, and creation of a culture of safety; development of infrastructure to support robust dose assessment and longitudinal tracking; continued close attention to patient selection by balancing the benefit of cardiovascular testing and procedures against carefully minimized radiation exposures; collation, dissemination, and implementation of best practices; and robust education, not only across the healthcare community, but also to patients, the public, and media. Finally, because patient radiation safety in cardiovascular imaging is complex, any proposed actions need to be carefully vetted (and monitored) for possible unintended consequences.
Douglas, Pamela S; Carr, J Jeffrey; Cerqueira, Manuel D; Cummings, Jennifer E; Gerber, Thomas C; Mukherjee, Debabrata; Taylor, Allen J
2012-05-15
Technological advances and increased utilization of medical testing and procedures have prompted greater attention to ensuring the patient safety of radiation use in the practice of adult cardiovascular medicine. In response, representatives from cardiovascular imaging societies, private payers, government and nongovernmental agencies, industry, medical physicists, and patient representatives met to develop goals and strategies toward this end; this report provides an overview of the discussions. This expert “think tank” reached consensus on several broad directions including: the need for broad collaboration across a large number of diverse stakeholders; clarification of the relationship between medical radiation and stochastic events; required education of ordering and providing physicians, and creation of a culture of safety; development of infrastructure to support robust dose assessment and longitudinal tracking; continued close attention to patient selection by balancing the benefit of cardiovascular testing and procedures against carefully minimized radiation exposures; collation, dissemination, and implementation of best practices; and robust education, not only across the healthcare community, but also to patients, the public, and media. Finally, because patient radiation safety in cardiovascular imaging is complex, any proposed actions need to be carefully vetted (and monitored) for possible unintended consequences.
Douglas, Pamela S; Carr, J Jeffrey; Cerqueira, Manuel D; Cummings, Jennifer E; Gerber, Thomas C; Mukherjee, Debabrata; Taylor, Allen J
2012-06-01
Technological advances and increased utilization of medical testing and procedures have prompted greater attention to ensuring the patient safety of radiation use in the practice of adult cardiovascular medicine. In response, representatives from cardiovascular imaging societies, private payers, government and nongovernmental agencies, industry, medical physicists, and patient representatives met to develop goals and strategies toward this end; this report provides an overview of the discussions. This expert "think tank" reached consensus on several broad directions including: the need for broad collaboration across a large number of diverse stakeholders; clarification of the relationship between medical radiation and stochastic events; required education of ordering and providing physicians, and creation of a culture of safety; development of infrastructure to support robust dose assessment and longitudinal tracking; continued close attention to patient selection by balancing the benefit of cardiovascular testing and procedures against carefully minimized radiation exposures; collation, dissemination, and implementation of best practices; and robust education, not only across the healthcare community but also to patients, the public, and media. Finally, because patient radiation safety in cardiovascular imaging is complex, any proposed actions need to be carefully vetted (and monitored) for possible unintended consequences.
Setkina, Svetlana; Dotsenko, Marina; Bondar, Sviatlana; Charnysh, Iryna; Kuchko, Alla; Kaznacheeva, Alena; Kozorez, Elena; Dodaleva, Alena; Rossa, Natalia
2015-04-01
Antiretroviral drugs have well-documented evidence-based favorable benefit-risk ratios. Although various studies have investigated and characterized the safety profile of antiretroviral medicines, there are a limited number of studies evaluating the safety of first-line antiretroviral therapy (ART) in patients with a specific co-morbidity. A cohort event monitoring (CEM) study of the safety and effectiveness of antiretroviral medicines in a target population that has a significant level of co-morbidities (chronic infectious diseases, peripheral blood cytopenias) was implemented. The aim was to evaluate the safety profile of the highly active ART (HAART) in the target population and subpopulations with risk factors, to optimize the monitoring and decision-making procedure for subgroups of patients with specific types of co-morbidity, and to implement a more vigilant approach to therapy management in risk groups of patients. Prospective observational CEM was implemented among HAART-naïve HIV-positive patients at four clinical sites from December 2012. Eligible patients were those starting first-line HAART. Close medical supervision of all enrolled patients, with regular clinical and laboratory monitoring, was provided by healthcare professionals within 1 year after commencement of therapy. Standardized forms were used for data collection on initial and subsequent visits. All objective or subjective deviations in condition (events) were assessed for a causal relationship with ART, and for severity, seriousness, reversibility, preventability, and pre-existing risk factors in the case of adverse drug reactions (ADRs). A total of 518 HAART-naïve HIV-positive patients were enrolled in the CEM study. Of these patients, 65% (337) experienced one or several ADRs related to one or more components of HAART. Most of the ADRs reported were non-serious, expected, common (very common), transient (correctable), or reversible. The most common were hematotoxic, hepatotoxic, and neurotoxic adverse reactions. In several cases, some types of toxicities, associated with zidovudine, efavirenz, and nevirapine, had a high level of severity, necessitating hospitalization and drug regimen or single-agent substitution. Severe cases of hematological, hepatobiliary, and psychiatric toxicities were associated with pre-existing risk factors. CEM is an effective tool for safety and effectiveness monitoring and could be successfully implemented for intensive study of important safety issues and for overcoming knowledge gaps regarding safety. In order to achieve a favorable benefit-risk ratio for HAART in the specific sections of the population with pre-existing risk factors for development of ART toxicities, more vigilant consideration and careful assessment before therapy is commenced and further regular monitoring of key laboratory parameters is required.
Automated System Of Monitoring Of The Physical Condition Of The Staff Of The Enterprise
NASA Astrophysics Data System (ADS)
Pilipenko, A.
2017-01-01
In the work the author solves an important applied problem of increasing of safety of engineering procedures and production using technologies of monitoring of a condition of employees. The author offers a work algorithm, structural and basic electric schemes of system of collection of data of employee’s condition of the enterprise and some parameters of the surrounding environment. In the article the author offers an approach to increasing of efficiency of acceptance of management decisions at the enterprise at the expense of the prompt analysis of information about employee’s condition and productivity of his work and also about various parameters influencing these factors.
ATV Engineering Support Team Safety Console Preparation for the Johannes Kepler Mission
NASA Astrophysics Data System (ADS)
Chase, R.; Oliefka, L.
2010-09-01
This paper describes the improvements to be implemented in the Safety console position of the Engineering Support Team(EST) at the Automated Transfer Vehicle(ATV) Control Centre(ATV-CC) for the upcoming ATV Johannes Kepler mission. The ATV missions to the International Space Station are monitored and controlled from the ATV-CC in Toulouse, France. The commanding of ATV is performed by the Vehicle Engineering Team(VET) in the main control room under authority of the Flight Director. The EST performs a monitoring function in a room beside the main control room. One of the EST positions is the Safety console, which is staffed by safety engineers from ESA and the industrial prime contractor, Astrium. The function of the Safety console is to check whether the hazard controls are available throughout the mission as required by the Hazard Reports approved by the ISS Safety Review Panel. Safety console preparation activities were limited prior to the first ATV mission due to schedule constraints, and the safety engineers involved have been working to improve the readiness for ATV 2. The following steps have been taken or are in process, and will be described in this paper: • review of the implementation of Operations Control Agreement Documents(OCADs) that record the way operational hazard controls are performed to meet the needs of the Hazard Reports(typically in Flight Rules and Crew Procedures), • crosscheck of operational control needs and implementations with respect to ATV's first flight observations and post flight evaluations, with a view to identifying additional, obsolete or revised operational hazard controls, • participation in the Flight Rule review and update process carried out between missions, • participation in the assessment of anomalies observed during the first ATV mission, to ensure that any impacts are addressed in the ATV 2 safety documentation, • preparation of a Safety console handbook to provide lists of important safety aspects to be monitored at various stages of the mission, including links to relevant Hazard Reports, Flight Rules, and supporting documentation, • participation to training courses conducted in the frame of the ATV Training Academy(ATAC), and provision of courses related to safety for the other members of the VET and EST, • participation to simulations conducted at ATV-CC, including off-nominal cases. The result of these activities will be an improved level of readiness for the ATV 2 mission.
Laminar-airflow equipment certification: what the pharmacist needs to know.
Bryan, D; Marback, R C
1984-07-01
The basic information pharmacy practitioners need to determine the suitability and applicability of laminar-airflow equipment test standards and procedures is presented. The operative guideline for any laminar-flow clean bench (LFCB) certification is the cleanroom and work station requirements for controlled environments as defined by the federal government under Federal Standard 209b (FS 209b). FS 209b outlines the tests, test procedures, and acceptable performance ranges for all LFCB equipment. National Sanitation Foundation Standard Number 49 (NSF 49) is used in the certification of biological-safety cabinets (BSCs). NSF 49 covers those aspects of safety, maintenance, performance, and testing that are unique BSCs. To monitor certification properly, practitioners should be familiar with these standards and the air-velocity profile, high-efficiency particulate air filter performance, noise output, light, and electrical test procedures. A review of the requisite knowledge, experience, and reputation of certifying agents is presented, along with an outline of all the necessary procedures, equipment, and documentation to be used in the process. A thorough test report should be issued upon unit certification. As pharmacy practitioners are responsible for all other aspects of quality assurance, they should also be capable of auditing these certifications to ensure the aseptic quality of products compounded in the laminar-airflow environment.
Jephcott, C; Grummet, J; Nguyen, N; Spruyt, O
2018-05-01
Methoxyflurane delivered via a hand-held inhaler is a proven analgesic which has been used in Australasia for emergency relief of trauma associated pain since the 1970s. The agent is self-administered by the patient under the supervision of trained personnel. More than 5 million patients have received inhaled methoxyflurane without significant side effects. Methoxyflurane is also licensed in Australasia for the relief of pain in monitored conscious patients requiring analgesia for minor surgical procedures. Recent clinical studies undertaken in a variety of outpatient settings, including colonoscopy, prostate biopsy, dental procedures, bone marrow biopsy, and the management of burns dressings, indicate that inhaled methoxyflurane has significant analgesic activity, without producing deep sedation or respiratory depression. Return to full psychomotor activity is rapid. Thus, methoxyflurane may be a suitable and well-tolerated alternative to traditional i.v. sedative agents for outpatient medical and surgical procedures. There are direct advantages to the patient in terms of rapid recovery and an early return to normal activities, and significant benefits for outpatient departments in terms of cost saving and rate of throughput. Further randomised controlled trials comparing the efficacy, safety, and cost-effectiveness of inhaled methoxyflurane against traditional i.v. sedative techniques are currently in progress. Copyright © 2018 British Journal of Anaesthesia. All rights reserved.
Quality and safety aspects in histopathology laboratory
Adyanthaya, Soniya; Jose, Maji
2013-01-01
Histopathology is an art of analyzing and interpreting the shapes, sizes and architectural patterns of cells and tissues within a given specific clinical background and a science by which the image is placed in the context of knowledge of pathobiology, to arrive at an accurate diagnosis. To function effectively and safely, all the procedures and activities of histopathology laboratory should be evaluated and monitored accurately. In histopathology laboratory, the concept of quality control is applicable to pre-analytical, analytical and post-analytical activities. Ensuring safety of working personnel as well as environment is also highly important. Safety issues that may come up in a histopathology lab are primarily those related to potentially hazardous chemicals, biohazardous materials, accidents linked to the equipment and instrumentation employed and general risks from electrical and fire hazards. This article discusses quality management system which can ensure quality performance in histopathology laboratory. The hazards in pathology laboratories and practical safety measures aimed at controlling the dangers are also discussed with the objective of promoting safety consciousness and the practice of laboratory safety. PMID:24574660
Automatisms in EMIR instrument to improve operation, safety and maintenance
NASA Astrophysics Data System (ADS)
Fernández Izquierdo, Patricia; Núñez Cagigal, Miguel; Barreto Rodríguez, Roberto; Martínez Rey, Noelia; Santana Tschudi, Samuel; Barreto Cabrera, Maria; Patrón Recio, Jesús; Garzón López, Francisco
2014-08-01
EMIR is the NIR imager and multiobject spectrograph being built as a common user instrument for the 10-m class GTC. Big cryogenic instruments demand a reliable design and a specific hardware and software to increase its safety and productivity. EMIR vacuum, cooling and heating systems are monitored and partially controlled by a Programmable Logic Controller (PLC) in industrial format with a touch screen. The PLC aids the instrument operator in the maintenance tasks recovering autonomously vacuum if required or proposing preventive maintenance actions. The PLC and its associated hardware improve EMIR safety having immediate reactions against eventual failure modes in the instrument or in external supplies, including hardware failures during the heating procedure or failure in the PLC itself. EMIR PLC provides detailed information periodically about status and alarms of vacuum and cooling components or external supplies.
Implementing AORN recommended practices for MIS: Part II.
Morton, Paula J
2012-10-01
This article focuses on the equipment and workplace safety aspects of the revised AORN "Recommended practices for minimally invasive surgery." A multidisciplinary team that includes the perioperative nurse should be established to discuss aspects of the development and design of new construction or renovation (eg, room access, ergonomics, low-lighting, OR integration, hybrid OR considerations, design development). Equipment safety considerations during minimally invasive surgical procedures include using active electrode monitoring; verifying the properties of distention media; using smoke evacuation systems; reducing equipment, electrical, thermal, and fire hazards; performing routine safety checks on insufflation accessories; and minimizing the risk of ergonomic injuries to staff members. Additional considerations include using video recording devices, nonmagnetic equipment during magnetic resonance imaging, and fluid containment methods for fluid management. Copyright © 2012 AORN, Inc. Published by Elsevier Inc. All rights reserved.
Sittig, Dean F; Salimi, Mandana; Aiyagari, Ranjit; Banas, Colin; Clay, Brian; Gibson, Kathryn A; Goel, Ashutosh; Hines, Robert; Longhurst, Christopher A; Mishra, Vimal; Sirajuddin, Anwar M; Satterly, Tyler; Singh, Hardeep
2018-04-26
The Safety Assurance Factors for EHR Resilience (SAFER) guides were released in 2014 to help health systems conduct proactive risk assessment of electronic health record (EHR)- safety related policies, processes, procedures, and configurations. The extent to which SAFER recommendations are followed is unknown. We conducted risk assessments of 8 organizations of varying size, complexity, EHR, and EHR adoption maturity. Each organization self-assessed adherence to all 140 unique SAFER recommendations contained within 9 guides (range 10-29 recommendations per guide). In each guide, recommendations were organized into 3 broad domains: "safe health IT" (total 45 recommendations); "using health IT safely" (total 80 recommendations); and "monitoring health IT" (total 15 recommendations). The 8 sites fully implemented 25 of 140 (18%) SAFER recommendations. Mean number of "fully implemented" recommendations per guide ranged from 94% (System Interfaces-18 recommendations) to 63% (Clinical Communication-12 recommendations). Adherence was higher for "safe health IT" domain (82.1%) vs "using health IT safely" (72.5%) and "monitoring health IT" (67.3%). Despite availability of recommendations on how to improve use of EHRs, most recommendations were not fully implemented. New national policy initiatives are needed to stimulate implementation of these best practices.
Equipment Safety, Maintenance and Inspection: What the Oral Surgeon Needs to Know.
Keeley, Katherine A
2017-05-01
Many oral and maxillofacial surgical procedures are done in an office-based setting, with many oral and maxillofacial surgeons involved in oversight of equipment maintenance. Goals in equipment management are to prevent harm to patients and staff, stay compliant with current regulations, and increase equipment longevity. This article covers the safety, maintenance, and inspection related to electrical equipment used in the treatment of patients, autoclaves, radiograph machines, nitrous oxide and oxygen medical gases, and required back-up power and lighting. An office should always follow manufacturer's recommendations regarding maintenance and inspection and document policies and monitoring so compliance can be assured. Copyright © 2017 Elsevier Inc. All rights reserved.
[Blood transfusion and supply chain management safety].
Quaranta, Jean-François; Caldani, Cyril; Cabaud, Jean-Jacques; Chavarin, Patricia; Rochette-Eribon, Sandrine
2015-02-01
The level of safety attained in blood transfusion now makes this a discipline better managed care activities. This was achieved both by scientific advances and policy decisions regulating and supervising the activity, as well as by the quality system, which we recall that affects the entire organizational structure, responsibilities, procedures, processes and resources in place to achieve quality management. So, an effective quality system provides a framework within which activities are established, performed in a quality-focused way and continuously monitored to improve outcomes. This system quality has to irrigate all the actors of the transfusion, just as much the establishments of blood transfusion than the health establishments. Copyright © 2014 Elsevier Masson SAS. All rights reserved.
Kumari, Kamlesh; Samra, Tanvir; Naik, B Naveen; Saini, Vikas
2018-01-01
To ensure patient safety, it is important to regularly assess the knowledge and practical skills of anesthesia trainees. This study was conducted to evaluate the competency of the residents and the impact of various corrective measures in the form of didactic lectures and clinical skill demonstrations on the conduct of various procedural skills by the residents. Ninety-five junior residents were enrolled in this study. Assessment of competency of 1 st , 2 nd , and 3 rd year residents in performing various procedure skills of anesthesia was done in two stages using procedure specific checklist (PSC) and Global Rating Scales (GRSs). Preliminary results of the first assessment (Score 1) were discussed with the residents; deficiencies were identified and corrective measures suggested by didactic lectures and clinical skill demonstrations which were followed by a subsequent assessment after 3 months (Score 2). There was a statistically significant improvement in the PSC and GRS scores after corrective measures for all the procedural interventions studied. Percentage increase in scores was maximum in 1 st year (42.98 ± 6.62) followed by 2 nd year (34.62 ± 5.49) and minimum in 3 rd year residents (18.06 ± 3.69). The percentage increase of scores was almost similar for all subset of procedural skills; low, intermediate, and high skill anesthetic procedures. For assessment of procedural skills of residents, use of PSC and GRS scores should be incorporated and the same should be used to monitor the impact of various corrective measures (didactic lectures and clinical skill demonstrations) on the conduct of various procedural skills by the resident.
Flohr, Luisa; Beaudry, Shaylene; Johnson, K Taneille; West, Nicholas; Burns, Catherine M; Ansermino, J Mark; Dumont, Guy A; Wensley, David; Skippen, Peter
2018-01-01
The pediatric intensive care unit (ICU) is a complex environment, in which a multidisciplinary team of clinicians (registered nurses, respiratory therapists, and physicians) continually observe and evaluate patient information. Data are provided by multiple, and often physically separated sources, cognitive workload is high, and team communication can be challenging. Our aim is to combine information from multiple monitoring and therapeutic devices in a mobile application, the VitalPAD, to improve the efficiency of clinical decision-making, communication, and thereby patient safety. We observed individual ICU clinicians, multidisciplinary rounds, and handover procedures for 54 h to identify data needs, workflow, and existing cognitive aid use and limitations. A prototype was developed using an iterative participatory design approach; usability testing, including general and task-specific feedback, was obtained from 15 clinicians. Features included map overviews of the ICU showing clinician assignment, patient status, and respiratory support; patient vital signs; a photo-documentation option for arterial blood gas results; and team communication and reminder functions. Clinicians reported the prototype to be an intuitive display of vital parameters and relevant alerts and reminders, as well as a user-friendly communication tool. Future work includes implementation of a prototype, which will be evaluated under simulation and real-world conditions, with the aim of providing ICU staff with a monitoring device that will improve their daily work, communication, and decision-making capacity. Mobile monitoring of vital signs and therapy parameters might help improve patient safety in wards with single-patient rooms and likely has applications in many acute and critical care settings. PMID:29552425
Flohr, Luisa; Beaudry, Shaylene; Johnson, K Taneille; West, Nicholas; Burns, Catherine M; Ansermino, J Mark; Dumont, Guy A; Wensley, David; Skippen, Peter; Gorges, Matthias
2018-01-01
The pediatric intensive care unit (ICU) is a complex environment, in which a multidisciplinary team of clinicians (registered nurses, respiratory therapists, and physicians) continually observe and evaluate patient information. Data are provided by multiple, and often physically separated sources, cognitive workload is high, and team communication can be challenging. Our aim is to combine information from multiple monitoring and therapeutic devices in a mobile application, the VitalPAD , to improve the efficiency of clinical decision-making, communication, and thereby patient safety. We observed individual ICU clinicians, multidisciplinary rounds, and handover procedures for 54 h to identify data needs, workflow, and existing cognitive aid use and limitations. A prototype was developed using an iterative participatory design approach; usability testing, including general and task-specific feedback, was obtained from 15 clinicians. Features included map overviews of the ICU showing clinician assignment, patient status, and respiratory support; patient vital signs; a photo-documentation option for arterial blood gas results; and team communication and reminder functions. Clinicians reported the prototype to be an intuitive display of vital parameters and relevant alerts and reminders, as well as a user-friendly communication tool. Future work includes implementation of a prototype, which will be evaluated under simulation and real-world conditions, with the aim of providing ICU staff with a monitoring device that will improve their daily work, communication, and decision-making capacity. Mobile monitoring of vital signs and therapy parameters might help improve patient safety in wards with single-patient rooms and likely has applications in many acute and critical care settings.
Lidocaine use for pain management during paediatric dental rehabilitation under general anaesthesia.
El Batawi, H Y
2013-12-01
Dental rehabilitation under general anaesthesia is gaining more popularity among parents as a result of increasing safety margins of new anaesthetic drugs and the adoption of strict policies and procedures that target patient safety and comfort. Harmony between members of the anaesthesia team and the dental team is a must to produce full dental service with least discomfort to our child patients. To investigate the possible effect of using local analgesia (lidocaine) during general anaesthesia sessions on stabilising heart rate, respiratory rate and tidal CO2 levels during painful dental procedures. Eighty ASA class I children undergoing full dental rehabilitation under general anaesthesia were divided into two groups of 40 each. Group A had the dental procedures carried out without lidocaine local analgesia, and group B had the procedures done with lidocaine local analgesia prior to painful dental procedures. Patient monitor readings were recorded by a group-allocation blinded anaesthesia technician and the two groups were compared statistically. Group A showed a statistically significant increase in heart rates and respiratory rates during dentine cutting, dental extractions and pulpotomies. No significant difference was observed between the two groups for changes in CO2 end-tidal volume during cavity preparations. During dental extractions and pulpotomies, Group A showed significantly lower carbon dioxide end-tidal volume. Use of local analgesia prior to performing pain-provoking dental procedures under general anaesthesia seems to help patient's homeostasis and stabilises vital signs. This may help in providing a safer anaesthesia environment for medically compromised children undergoing the same procedures under general anaesthesia.
Poulos, Roslyn G; Donaldson, Alex
2012-06-01
To investigate the level of translation of the Australian Rugby Union 'Mayday' safety procedure into practice among community rugby union coaches in New South Wales (Australia). All registered coaches of senior community rugby union teams in five zones/associations in the north-eastern region of the state were invited to complete a short online questionnaire at the end of the 2010 rugby season. The questionnaire was designed around the five RE-AIM dimensions and assessed: Reach, perceived Effectiveness, Adoption, Implementation and Maintenance of the Mayday procedure. Seventy (39%) coaches participated. There was a high level of awareness of the Mayday procedure, and most coaches believed it was effective in preventing injuries. The majority reported training their players in the procedure, although training was generally infrequent. Coaches were confident that their own players could implement the procedure appropriately if required to do so, but less confident that other teams or referees could do so. Barriers to providing training included not enough players at training, players not taking training seriously and technical difficulties (eg, verbalisation of instructions for physical tasks). The findings suggest that the translation of the Mayday 'policy' could be improved by building individual coach, and club or zone organisational capacity by ensuring that coaches have the resources and skills in 'how' to train their players to complement their existing knowledge on 'what' to train them; setting expectations that encourage coaches to provide regular training for players; and regular monitoring of player competency to perform the procedure appropriately.
Patient safety in thoracic surgery and European Society of Thoracic Surgeons checklist.
Novoa, Nuria M
2015-04-01
Improving patient safety seems to be a new interesting clinical subject but, in fact, it is no new. It has to do with one of the oldest ethical principles of our profession: curing and not harming. The important research that has been done in a short period of time has brought in new insight to this complex area that is fast developing. The creation of safety managing systems will allow coordinating efforts from very different, although complementary, areas to create real safety culture and safety climate in every organization. In the surgical settings, teamwork is basic to provide good quality of care. Safety leaders in every team have an important role in establishing priorities, summarizing proposals, coordinating efforts, launching new initiatives and transmitting that safety efforts are worth taken. Preparedness and anticipation are key points for avoiding most of the diverse types of patient harm that can occur. As has been published, a great number of errors can be avoided simply using crosscheck based on specialized checklist that reviews every important detail of the procedure. This strategy has been demonstrated very useful at other high risk industries such as aviation, nuclear or food management. The Safe Surgery Saves Lives program launched in 2002 by the WHO has taught us that improvement is possible using a simple checklist. More complex and detail checklist can be more adequate for more complex procedures and settings. The proposed ESTS checklist reviews different areas of possible error in deeper detail allowing the finest adjustment of the patient before the skin incision. It has been recently released to the general thoracic community and monitors its use and usefulness has to be warrantied.
1988-10-01
sample these ducts. This judgement was based on the following factors : 1. The ducts were open to the atmosphere. 2. RMA records of building area samples...selected based on several factors including piping arrangements, volume to be sampled, sampling equipment flow rates, and the flow rate necessary for...effective sampling. Therefore, each sampling point strategy and procedure was customized based on these factors . The individual specific sampling
Osimani, Andrea; Aquilanti, Lucia; Tavoletti, Stefano; Clementi, Francesca
2013-01-01
Food safety is essential in mass catering. In Europe, Regulation (EC) No. 852/2004 requires food business operators to put in place, implement and maintain permanent procedures based on Hazard Analysis and Critical Control Point (HACCP) principles. Each HACCP plan is specifically implemented for the processing plant and processing methods and requires a systematic collection of data on the incidence, elimination, prevention, and reduction of risks. In this five-year-study, the effectiveness of the HACCP plan of a University canteen was verified through periodic internal auditing and microbiological monitoring of meals, small equipment, cooking tools, working surfaces, as well as hands and white coats of the canteen staff. The data obtained revealed no safety risks for the consumers, since Escherichia coli, Salmonella spp. and Listeria monocytogenes were never detected; however, a quite discontinuous microbiological quality of meals was revealed. The fluctuations in the microbial loads of mesophilic aerobes, coliforms, Staphylococcus aureus, Bacillus cereus, and sulphite-reducing clostridia were mainly ascribed to inadequate handling or processing procedures, thus suggesting the need for an enhancement of staff training activities and for a reorganization of tasks. Due to the wide variety of the fields covered by internal auditing, the full conformance to all the requirements was never achieved, though high scores, determined by assigning one point to each answer which matched with the requirements, were achieved in all the years. PMID:23594937
Osimani, Andrea; Aquilanti, Lucia; Tavoletti, Stefano; Clementi, Francesca
2013-04-17
Food safety is essential in mass catering. In Europe, Regulation (EC) No. 852/2004 requires food business operators to put in place, implement and maintain permanent procedures based on Hazard Analysis and Critical Control Point (HACCP) principles. Each HACCP plan is specifically implemented for the processing plant and processing methods and requires a systematic collection of data on the incidence, elimination, prevention, and reduction of risks. In this five-year-study, the effectiveness of the HACCP plan of a University canteen was verified through periodic internal auditing and microbiological monitoring of meals, small equipment, cooking tools, working surfaces, as well as hands and white coats of the canteen staff. The data obtained revealed no safety risks for the consumers, since Escherichia coli, Salmonella spp. and Listeria monocytogenes were never detected; however, a quite discontinuous microbiological quality of meals was revealed. The fluctuations in the microbial loads of mesophilic aerobes, coliforms, Staphylococcus aureus, Bacillus cereus, and sulphite-reducing clostridia were mainly ascribed to inadequate handling or processing procedures, thus suggesting the need for an enhancement of staff training activities and for a reorganization of tasks. Due to the wide variety of the fields covered by internal auditing, the full conformance to all the requirements was never achieved, though high scores, determined by assigning one point to each answer which matched with the requirements, were achieved in all the years.
Vicentini, Federico; Pedrocchi, Nicola; Malosio, Matteo; Molinari Tosatti, Lorenzo
2014-09-01
Robot-assisted neurorehabilitation often involves networked systems of sensors ("sensory rooms") and powerful devices in physical interaction with weak users. Safety is unquestionably a primary concern. Some lightweight robot platforms and devices designed on purpose include safety properties using redundant sensors or intrinsic safety design (e.g. compliance and backdrivability, limited exchange of energy). Nonetheless, the entire "sensory room" shall be required to be fail-safe and safely monitored as a system at large. Yet, sensor capabilities and control algorithms used in functional therapies require, in general, frequent updates or re-configurations, making a safety-grade release of such devices hardly sustainable in cost-effectiveness and development time. As such, promising integrated platforms for human-in-the-loop therapies could not find clinical application and manufacturing support because of lacking in the maintenance of global fail-safe properties. Under the general context of cross-machinery safety standards, the paper presents a methodology called SafeNet for helping in extending the safety rate of Human Robot Interaction (HRI) systems using unsafe components, including sensors and controllers. SafeNet considers, in fact, the robotic system as a device at large and applies the principles of functional safety (as in ISO 13489-1) through a set of architectural procedures and implementation rules. The enabled capability of monitoring a network of unsafe devices through redundant computational nodes, allows the usage of any custom sensors and algorithms, usually planned and assembled at therapy planning-time rather than at platform design-time. A case study is presented with an actual implementation of the proposed methodology. A specific architectural solution is applied to an example of robot-assisted upper-limb rehabilitation with online motion tracking. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
Hunt, G J; Tabachnick, W J
1996-05-01
Equipment and procedures are described for biosafety level 3 (BL-3) containment work with small, zoophilic arthropods. BL-3 classified pathogens always must be manipulated in biological safety cabinets. Procedures, including physical barriers and handling methods, that prevent the escape of potentially virus-infected insects are discussed, and the use of a monitoring system for insect security is explained. The inability to recover escaped minute, flying insects poses a major difference from similar work with larger insects, such as mosquitoes. Methods were developed for the safe and secure handling of Culicoides variipennis sonorensis Wirth & Jones infected with exotic bluetongue viruses during BL-3 containment.
NASA Technical Reports Server (NTRS)
Ray, Ronald J.; Hicks, John W.; Wichman, Keith D.
1991-01-01
Procedures for real time evaluation of the inflight health and performance of gas turbine engines and related systems were developed to enhance flight test safety and productivity. These techniques include the monitoring of the engine, the engine control system, thrust vectoring control system health, and the detection of engine stalls. Real time performance techniques were developed for the determination and display of inflight thrust and for aeroperformance drag polars. These new methods were successfully shown on various research aircraft at NASA-Dryden. The capability of NASA's Western Aeronautical Test Range and the advanced data acquisition systems were key factors for implementation and real time display of these methods.
Schlaich, Markus P; Schmieder, Roland E; Bakris, George; Blankestijn, Peter J; Böhm, Michael; Campese, Vito M; Francis, Darrel P; Grassi, Guido; Hering, Dagmara; Katholi, Richard; Kjeldsen, Sverre; Krum, Henry; Mahfoud, Felix; Mancia, Giuseppe; Messerli, Franz H; Narkiewicz, Krzysztof; Parati, Gianfranco; Rocha-Singh, Krishna J; Ruilope, Luis M; Rump, Lars C; Sica, Domenic A; Sobotka, Paul A; Tsioufis, Costas; Vonend, Oliver; Weber, Michael A; Williams, Bryan; Zeller, Thomas; Esler, Murray D
2013-12-03
Catheter-based radiofrequency ablation technology to disrupt both efferent and afferent renal nerves has recently been introduced to clinical medicine after the demonstration of significant systolic and diastolic blood pressure reductions. Clinical trial data available thus far have been obtained primarily in patients with resistant hypertension, defined as standardized systolic clinic blood pressure ≥ 160 mm Hg (or ≥ 150 mm Hg in patients with type 2 diabetes) despite appropriate pharmacologic treatment with at least 3 antihypertensive drugs, including a diuretic agent. Accordingly, these criteria and blood pressure thresholds should be borne in mind when selecting patients for renal nerve ablation. Secondary forms of hypertension and pseudoresistance, such as nonadherence to medication, intolerance of medication, and white coat hypertension, should have been ruled out, and 24-h ambulatory blood pressure monitoring is mandatory in this context. Because there are theoretical concerns with regard to renal safety, selected patients should have preserved renal function, with an estimated glomerular filtration rate ≥ 45 ml/min/1.73 m(2). Optimal periprocedural management of volume status and medication regimens at specialized and experienced centers equipped with adequate infrastructure to cope with potential procedural complications will minimize potential patient risks. Long-term safety and efficacy data are limited to 3 years of follow-up in small patient cohorts, so efforts to monitor treated patients are crucial to define the long-term performance of the procedure. Although renal nerve ablation could have beneficial effects in other conditions characterized by elevated renal sympathetic nerve activity, its potential use for such indications should currently be limited to formal research studies of its safety and efficacy. Copyright © 2013 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
van Det, M J; Meijerink, W J H J; Hoff, C; Totté, E R; Pierie, J P E N
2009-06-01
With minimally invasive surgery (MIS), a man-machine environment was brought into the operating room, which created mental and physical challenges for the operating team. The science of ergonomics analyzes these challenges and formulates guidelines for creating a work environment that is safe and comfortable for its operators while effectiveness and efficiency of the process are maintained. This review aimed to formulate the ergonomic challenges related to monitor positioning in MIS. Background and guidelines are formulated for optimal ergonomic monitor positioning within the possibilities of the modern MIS suite, using multiple monitors suspended from the ceiling. All evidence-based experimental ergonomic studies conducted in the fields of laparoscopic surgery and applied ergonomics for other professions working with a display were identified by PubMed searches and selected for quality and applicability. Data from ergonomic studies were evaluated in terms of effectiveness and efficiency as well as comfort and safety aspects. Recommendations for individual monitor positioning are formulated to create a personal balance between these two ergonomic aspects. Misalignment in the eye-hand-target axis because of limited freedom in monitor positioning is recognized as an important ergonomic drawback during MIS. Realignment of the eye-hand-target axis improves personal values of comfort and safety as well as procedural values of effectiveness and efficiency. Monitor position is an important ergonomic factor during MIS. In the horizontal plain, the monitor should be straight in front of each person and aligned with the forearm-instrument motor axis to avoid axial rotation of the spine. In the sagittal plain, the monitor should be positioned lower than eye level to avoid neck extension.
Kapur, Ajay; Goode, Gina; Riehl, Catherine; Zuvic, Petrina; Joseph, Sherin; Adair, Nilda; Interrante, Michael; Bloom, Beatrice; Lee, Lucille; Sharma, Rajiv; Sharma, Anurag; Antone, Jeffrey; Riegel, Adam; Vijeh, Lili; Zhang, Honglai; Cao, Yijian; Morgenstern, Carol; Montchal, Elaine; Cox, Brett; Potters, Louis
2013-01-01
By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice. PMID:24380074
Post-marketing safety monitoring of a new group B meningococcal vaccine in New Zealand, 2004-2006.
McNicholas, Anne; Galloway, Yvonne; Stehr-Green, Paul; Reid, Stewart; Radke, Sarah; Sexton, Kerry; Kieft, Charlotte; Macdonald, Claire; Neutze, Jocelyn; Drake, Ross; Isaac, Dorothy; O'Donnell, Mary; Tatley, Michael; Oster, Philipp; O'Hallahan, Jane
2007-01-01
New Zealand introduced a new outer membrane vesicle vaccine in 2004 to combat an epidemic of group B meningococcal disease. An Independent Safety Monitoring Board oversaw intensive safety monitoring, which included hospital surveillance, health professional reporting (passive and active) and mortality monitoring. With over three million doses administered to individuals aged under 20 years, the monitoring results provide consistent evidence supporting the vaccine's safety.
The role of the Data and Safety Monitoring Board in a clinical trial: The CRISIS Study
Holubkov, Richard; Casper, T. Charles; Dean, J. Michael; Anand, K. J. S.; Zimmerman, Jerry; Meert, Kathleen L.; Newth, Christopher J. L.; Berger, John; Harrison, Rick; Willson, Douglas F.; Nicholson, Carol
2012-01-01
Objective Randomized clinical trials are commonly overseen by a data and safety monitoring board (DSMB) comprised of experts in medicine, ethics, and biostatistics. DSMB responsibilities include protocol approval, interim review of study enrollment, protocol compliance, safety, and efficacy data. DSMB decisions can affect study design and conduct, as well as reported findings. Researchers must incorporate DSMB oversight into the design, monitoring, and reporting of randomized trials. Design Case study, narrative review. Methods The DSMB’s role during the comparative pediatric Critical Illness Stress-Induced Immune Suppression (CRISIS) Prevention Trial is described. Findings The NIH-appointed CRISIS DSMB was charged with monitoring sample size adequacy and feasibility, safety with respect to adverse events and 28-day mortality, and efficacy with respect to the primary nosocomial infection/sepsis outcome. The Federal Drug Administration also requested DSMB interim review before opening CRISIS to children below one year of age. The first interim analysis found higher 28-day mortality in one treatment arm. The DSMB maintained trial closure to younger children, and requested a second interim data review six months later. At this second meeting, mortality was no longer of concern, while a weak efficacy trend of lower infection/sepsis rates in one study arm emerged. As over 40% of total patients had been enrolled, the DSMB elected to examine conditional power, and unmask treatment arm identities. Upon finding somewhat greater efficacy in the placebo arm, the DSMB recommended stopping CRISIS due to futility. Conclusions The design and operating procedures of a multicenter randomized trial must consider a pivotal DSMB role. Maximum study design flexibility must be allowed, and investigators must be prepared for protocol modifications due to interim findings. The DSMB must have sufficient clinical and statistical expertise to assess potential importance of interim treatment differences in the setting of multiple looks at accumulating data with numerous outcomes and subgroups. PMID:23392377
Reid, Daniel Brooks; Parsons, Shaun R; Gill, Stephen D; Hughes, Andrew J
2015-04-01
To audit written medical discharge summary procedure and practice against Standard Six (clinical handover) of the Australian National Safety and Quality Health Service Standards at a major regional Victorian health service. Department heads were invited to complete a questionnaire about departmental discharge summary practices. Twenty-seven (82%) department heads completed the questionnaire. Seven (26%) departments had a documented discharge summary procedure. Fourteen (52%) departments monitored discharge summary completion and 13 (48%) departments monitored the timeliness of completion. Seven (26%) departments informed the patient of the content of the discharge summary and six (22%) departments provided the patient with a copy. Seven (26%) departments provided training for staff members on how to complete discharge summaries. Completing discharge summaries was usually delegated to the medical intern. The introduction of the National Service Standards prompted an organisation-wide audit of discharge summary practices against the external criterion. There was substantial variation in the organisation's practices. The Standards and the current audit results highlight an opportunity for the organisation to enhance and standardise discharge summary practices and improve communication with general practice.
Final safety analysis report for the Ground Test Accelerator (GTA), Phase 2
DOE Office of Scientific and Technical Information (OSTI.GOV)
NONE
1994-10-01
This document is the second volume of a 3 volume safety analysis report on the Ground Test Accelerator (GTA). The GTA program at the Los Alamos National Laboratory (LANL) is the major element of the national Neutral Particle Beam (NPB) program, which is supported by the Strategic Defense Initiative Office (SDIO). A principal goal of the national NPB program is to assess the feasibility of using hydrogen and deuterium neutral particle beams outside the Earth`s atmosphere. The main effort of the NPB program at Los Alamos concentrates on developing the GTA. The GTA is classified as a low-hazard facility, exceptmore » for the cryogenic-cooling system, which is classified as a moderate-hazard facility. This volume consists of failure modes and effects analysis; accident analysis; operational safety requirements; quality assurance program; ES&H management program; environmental, safety, and health systems critical to safety; summary of waste-management program; environmental monitoring program; facility expansion, decontamination, and decommissioning; summary of emergency response plan; summary plan for employee training; summary plan for operating procedures; glossary; and appendices A and B.« less
A Model Lightning Safety Policy for Athletics
Bennett, Brian L.
1997-01-01
Objective: The purpose of this paper is to present a model policy on lightning safety for athletic trainers. Background: Among college athletic programs in the United States there is a serious lack of written policy on lightning safety. Available evidence shows that most National Collegiate Athletic Association (NCAA) Division I institutions, even though they are located in high lightning activity areas of the country, do not have formal, written lightning safety policies. Clinical Advantages/ Recommendations: The policy presented herein, which is at the forefront of such policies, is the lightning safety policy written as part of a policies and procedures manual for the division of sports medicine at a public NCAA Division I university. This is a policy based on practicality that utilizes the “flash-to- bang” method for determining the distance of lightning activity from the observer. The policy begins with the importance of prevention, including the daily monitoring of weather reports. The policy defines a “safe shelter” and specifies the chain of command for determining who removes a team or individuals from an athletic site in the event of dangerous lightning activity. PMID:16558459
Chu, Bae P.; Horan, Christopher; Basu, Ellen; Dauer, Lawrence; Williamson, Matthew; Carrasquillo, Jorge A.; Pandit-Taskar, Neeta; Modak, Shakeel
2015-01-01
Background Although 131I-metaiodobenzylguanidine therapy (131I-MIBG) is increasingly used for children with high-risk neuroblastoma, a paucity of lead-lined rooms limits its wider use. We implemented radiation safety procedures to comply with New York City Department of Health and Mental Hygiene regulations for therapeutic radioisotopes and administered 131I-MIBG using rolling lead shields. Procedure Patients received 0.67GBq (18mCi)/kg/dose 131I-MIBG on an IRB-approved protocol (NCT00107289). Radiation safety procedures included private room with installation of rolling lead shields to maintain area dose rates ≤0.02mSv/h outside the room, patient isolation until dose rate <0.07mSv/h at 1m and retention of a urinary catheter with collection of urine in lead boxes. Parents were permitted in the patient’s room behind lead shields, trained in radiation safety principles and given real-time radiation monitors. Results Records on 16 131I-MIBG infusions among 10 patients (age 2–11 years) were reviewed. Mean ± standard deviation 131I-MIBG administered was 17.67±11.14 (range: 6.11–40.59) GBq. Mean maximum dose rates outside treatment rooms were 0.013±0.008 mSv/hr. Median time-to-discharge was 3 days post-131I-MIBG. Exposure of medical staff and parents was below regulatory limits. Cumulative whole-body dose received by the physician, nurse and radiation safety officer during treatment was 0.098±0.058, 0.056±0.045, 0.055±0.050 mSv respectively. Cumulative exposure to parents was 0.978±0.579mSv. Estimated annual radiation exposure for inpatient nurses was 0.096±0.034mSv/nurse. Thyroid bioassay scans on all medical personnel were
DOE Office of Scientific and Technical Information (OSTI.GOV)
Muzrakchi, Ahmed Al; Szmigielski, W., E-mail: wojszmi@qatar.net.qa; Omar, Ahmed J.S.
2004-09-15
The aim of this study was to determine the rate of complications in percutaneous nephrostomy (PCN) and nephrolithotomy (PCNL) performed through the 11th and 10th intercostal spaces using our monitoring technique and to discuss the safety of the procedure. Out of 398 PCNs and PCNLs carried out during a 3-year period, 56 patients had 57 such procedures performed using an intercostal approach. The 11th intercostal route was used in 42 and the 10th in 15 cases. One patient had two separate nephrostomies performed through the 10th and 11th intercostal spaces. The technique utilizes bi-planar fluoroscopy with a combination of amore » conventional angiographic machine to provide anterior-posterior fluoroscopy and a C-arm mobile fluoroscopy machine to give a lateral view, displayed on two separate monitors. None of the patients had clinically significant thoracic or abdominal complications. Two patients had minor chest complications. Only one developed changes (plate atelectasis, elevation of the hemi-diaphragm) directly related to the nephrostomy (2%). The second patient had bilateral plate atelectasis and unilateral congestive lung changes after PCNL. These changes were not necessarily related to the procedure but rather to general anesthesia during nephrolithotomy. The authors consider PCN or PCNL through the intercostal approach a safe procedure with a negligible complication rate, provided that it is performed under bi-planar fluoroscopy, which allows determination of the skin entry point just below the level of pleural reflection and provides three-dimensional monitoring of advancement of the puncturing needle toward the target entry point.« less
Monitoring of mass measles campaign in AILA-affected areas of West Bengal.
Dasgupta, Samir; Bagchi, Saumendra Nath; Ghosh, Pramit; Sardar, Jadab Chandra; Roy, Amal Sinha; Sau, Manabendra
2010-01-01
A mass measles campaign was organized in AILA-affected areas of West Bengal in July-August 2009. The present cross-sectional study was conducted with the objectives to monitor and assess the cold chain maintenance, safe injection practices, IEC methods adopted, and to observe the conduction of the sessions in the campaign. All the cold chain points at the block level had adequate vaccines and equipments, twice monitoring of temperature which was in optimal range. 82% sessions had team according to microplan, AWW was present and team members were actively mobilizing the children in 83% sessions, puncture proof container was used and vaccines were given in correct sites in more than 95% sessions. The study observed satisfactory conduction of the whole campaign, still the injection safety procedures should be strengthened considering the potential harm to the health care providers.
Evaluation of the SEDline to improve the safety and efficiency of conscious sedation
Caputo, Thomas D.; Rossmann, Jeffrey A.; Beach, M. Miles; Griffiths, Garth R.; Meyrat, Benjamin; Barnes, James B.; Kerns, David G.; Crump, Brad; Bookatz, Barnett; Ezzo, Paul
2011-01-01
Brain function monitors have improved safety and efficiency in general anesthesia; however, they have not been adequately tested for guiding conscious sedation for periodontal surgical procedures. This study evaluated the patient state index (PSI) obtained from the SEDline monitor (Sedline Inc., San Diego, CA) to determine its capacity to improve the safety and efficiency of intravenous conscious sedation during outpatient periodontal surgery. Twenty-one patients at the periodontics clinic of Baylor College of Dentistry were admitted to the study in 2009 and sedated to a moderate level using midazolam and fentanyl during periodontal surgery. The PSI monitoring was blinded from the clinician, and the following data were collected: vital signs, Ramsay sedation scale (RSS), medications administered, adverse events, PSI, electroencephalography, and the patients' perspective through visual analogue scales. The data were correlated to evaluate the PSI's ability to assess the level of sedation. Results showed that the RSS and PSI did not correlate (r = −0.25) unless high values associated with electromyographical (EMG) activity were corrected (r = −0.47). Oxygen desaturation did not correlate with the PSI (r = −0.08). Satisfaction (r = −0.57) and amnesia (r = −0.55) both increased as the average PSI decreased. In conclusion, within the limits of this study, PSI appears to correlate with amnesia, allowing a practitioner to titrate medications to that effect. It did not provide advance warning of adverse events and had inherent inaccuracies due to EMG activity during oral surgery. The PSI has the potential to increase safety and efficiency in conscious sedation but requires further development to eliminate EMG activity from confounding the score. PMID:21738291
NASA Astrophysics Data System (ADS)
Wang, Wanshun; Chen, Zhuo; Li, Xiuwen
2018-03-01
The safety monitoring is very important in the operation and management of water resources and hydropower projects. It is the important means to understand the dam running status, to ensure the dam safety, to safeguard people’s life and property security, and to make full use of engineering benefits. This paper introduces the arrangement of engineering safety monitoring system based on the example of a water resource control project. The monitoring results of each monitoring project are analyzed intensively to show the operating status of the monitoring system and to provide useful reference for similar projects.
Verwer, Cynthia M; van der Ark, Arno; van Amerongen, Geert; van den Bos, Ruud; Hendriksen, Coenraad F M
2009-04-01
This paper describes the results of a study of the effects of modified housing conditions, conditioning and habituation on humans using a rabbit model for monitoring whole-cell pertussis vaccine (pWCV)-induced adverse effects. The study has been performed with reference to previous vaccine safety studies of pWCV in rabbits in which results were difficult to interpret due to the large variation in experimental outcome, especially in the key parameter deep-body temperature (T(b)). Certain stressful laboratory conditions, as well as procedures involving humans, e.g. blood sampling, inoculation and cage-cleaning, were hypothesized to cause this large variation. The results of this study show that under modified housing conditions rabbits have normal circadian body temperatures. This allowed discrimination of pWCV-induced adverse effects in which handled rabbits tended to show a dose-related increase in temperature after inoculation with little variance, whereas non-handled rabbits did not. Effects of experimental and routine procedures on body temperature were significantly reduced under modified conditions and were within the normal T(b) range. Handled animals reacted less strongly and with less variance to experimental procedures, such as blood sampling, injection and cage-cleaning, than non-handled rabbits. Overall, handling had a positive effect on the behaviour of the animals. Data show that the housing modifications have provided a more robust model for monitoring pWCV adverse effects. Furthermore, conditioning and habituation of rabbits to humans reduce the variation in experimental outcome, which might allow for a reduction in the number of animals used. In addition, this also reduces distress and thus contributes to refining this animal model.
Safety concerns for first entry operations of orbiting spacecraft
NASA Technical Reports Server (NTRS)
Wilson, Steven H.; Limero, Thomas F.; James, John T.
1994-01-01
The Space Station Freedom crew will face operational problems unique to the spacecraft environment due to the absence of convection currents and the confined atmosphere within the habitable modules. Airborne contaminants from the materials offgassing or contingency incidents like thermodegradation may accumulate until they reach hazardous concentrations. Flow modeling and experiences from previous space flight missions confirm that caution must be exercised during first-entry operations. A review of the first-entry procedures performed during the Skylab Program will be presented to highlight the necessity for carefully planned operations. Many of the environmental conditions that can be expected on the Space Station are analogous to those which exist in confined storage or work spaces in the industrial setting. Experience with closed-loop environmental operations (e.g., atmospheric control of submarines) have also demonstrated that the buildup of trace contaminant gases could result in conditions that lead to mission termination or loss of crew. Consequently, some first-entry issues for the Station can be addressed by comparing them to familiar techniques developed on Earth. The instruments of the Environmental Health System (EHS) will provide the necessary monitoring capability to protect crew health and safety during the planned first-entry procedures of the MTC phase of the SSF Program. The authors of this paper will describe those procedures and will cite an example of the consequences when proper first-entry procedures are not followed.
Kobulashvili, Teia; Höfler, Julia; Dobesberger, Judith; Ernst, Florian; Ryvlin, Philippe; Cross, J Helen; Braun, Kees; Dimova, Petia; Francione, Stefano; Hecimovic, Hrvoje; Helmstaedter, Christoph; Kimiskidis, Vasilios K; Lossius, Morten Ingvar; Malmgren, Kristina; Marusic, Petr; Steinhoff, Bernhard J; Boon, Paul; Craiu, Dana; Delanty, Norman; Fabo, Daniel; Gil-Nagel, Antonio; Guekht, Alla; Hirsch, Edouard; Kalviainen, Reetta; Mameniskiené, Ruta; Özkara, Çiğdem; Seeck, Margitta; Rubboli, Guido; Krsek, Pavel; Rheims, Sylvain; Trinka, Eugen
2016-05-01
The European Union-funded E-PILEPSY network aims to improve awareness of, and accessibility to, epilepsy surgery across Europe. In this study we assessed current clinical practices in epilepsy monitoring units (EMUs) in the participating centers. A 60-item web-based survey was distributed to 25 centers (27 EMUs) of the E-PILEPSY network across 22 European countries. The questionnaire was designed to evaluate the characteristics of EMUs, including organizational aspects, admission, and observation of patients, procedures performed, safety issues, cost, and reimbursement. Complete responses were received from all (100%) EMUs surveyed. Continuous observation of patients was performed in 22 (81%) EMUs during regular working hours, and in 17 EMUs (63%) outside of regular working hours. Fifteen (56%) EMUs requested a signed informed consent before admission. All EMUs performed tapering/withdrawal of antiepileptic drugs, 14 (52%) prior to admission to an EMU. Specific protocols on antiepileptic drugs (AED) tapering were available in four (15%) EMUs. Standardized Operating Procedures (SOP) for the treatment of seizure clusters and status epilepticus were available in 16 (59%). Safety measures implemented by EMUs were: alarm seizure buttons in 21 (78%), restricted patient's ambulation in 19 (70%), guard rails in 16 (59%), and specially designated bathrooms in 7 (26%). Average costs for one inpatient day in EMU ranged between 100 and 2200 Euros. This study shows a considerable diversity in the organization and practice patterns across European epilepsy monitoring units. The collected data may contribute to the development and implementation of evidence-based recommended practices in LTM services across Europe. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.
Reijnen, Michel M P J; Zeebregts, Clark J; Meijerink, Wilhelmus J H J
2005-01-01
Operating-room design has not changed significantly since the modern era of surgery began. Minimal invasive, endoscopic, procedures, and evolution of technology will affect operating-room design in the near future. Poor ergonomics has always been one of the major drawbacks of endoscopic surgery. Use of retractable arms and monitors will improve ergonomics of the operating team. Developments in telecommunication will allow surgeons to communicate with colleagues and experts during the procedure in virtually any location around the world, which increases teaching possibilities and procedural safety. Introduction and further development of intraoperative imaging, including real-time, three-dimensional (3-D) reconstructions of patient, and computer-aided surgery offer surgeons the opportunity to train the planned surgical procedure. Moreover, they will improve control and supervision of the procedure in learning situations. The last decade's robotics have made their introduction into the operating rooms. They improve control over the operating-room environment and will facilitate the performance of more complex procedures. However, high costs and lack of force feedback remain its major drawbacks. Improvements of robotic techniques and its implementation into the operating rooms will further guide their design into highly specialized operating units.
Assessment of potential exposure to friable insulation materials containing asbestos
NASA Technical Reports Server (NTRS)
Kim, W. S.; Kuivinen, D. E.
1980-01-01
Asbestos and the procedures for assessing potential exposure hazards are discussed. Assessment includes testing a bulk sample of the suspected material for the presence of asbestos, and monitoring the air, if necessary. Based on field inspections and laboratory analyses, the health hazard is evaluated, and abatement measures are taken if a potential hazard exists. Throughout the assessment and abatement program, all applicable regulations are administered as specified by the Environmental Protection Agency and the Occupational Safety and Health Administration.
How to monitor patient safety in primary care? Healthcare professionals' views
Samra, R; Car, J; Majeed, A; Vincent, C
2016-01-01
Summary Objective To identify patient safety monitoring strategies in primary care. Design Open-ended questionnaire survey. Participants A total of 113 healthcare professionals returned the survey from a group of 500 who were invited to participate achieving a response rate of 22.6%. Setting North-West London, United Kingdom. Method A paper-based and equivalent online survey was developed and subjected to multiple stages of piloting. Respondents were asked to suggest strategies for monitoring patient safety in primary care. These monitoring suggestions were then subjected to a content frequency analysis which was conducted by two researchers. Main Outcome measures Respondent-derived monitoring strategies. Results In total, respondents offered 188 suggestions for monitoring patient safety in primary care. The content analysis revealed that these could be condensed into 24 different future monitoring strategies with varying levels of support. Most commonly, respondents supported the suggestion that patient safety can only be monitored effectively in primary care with greater levels of staffing or with additional resources. Conclusion Approximately one-third of all responses were recommendations for strategies which addressed monitoring of the individual in the clinical practice environment (e.g. GP, practice nurse) to improve safety. There was a clear need for more staff and resource set aside to allow and encourage safety monitoring. Respondents recommended the dissemination of specific information for monitoring patient safety such as distributing the lessons of significant event audits amongst GP practices to enable shared learning. PMID:27540488
Research on public participant urban infrastructure safety monitoring system using smartphone
NASA Astrophysics Data System (ADS)
Zhao, Xuefeng; Wang, Niannian; Ou, Jinping; Yu, Yan; Li, Mingchu
2017-04-01
Currently more and more people concerned about the safety of major public security. Public participant urban infrastructure safety monitoring and investigation has become a trend in the era of big data. In this paper, public participant urban infrastructure safety protection system based on smart phones is proposed. The system makes it possible to public participant disaster data collection, monitoring and emergency evaluation in the field of disaster prevention and mitigation. Function of the system is to monitor the structural acceleration, angle and other vibration information, and extract structural deformation and implement disaster emergency communications based on smartphone without network. The monitoring data is uploaded to the website to create urban safety information database. Then the system supports big data analysis processing, the structure safety assessment and city safety early warning.
Cortical spreading depression occurs during elective neurosurgical procedures.
Carlson, Andrew P; William Shuttleworth, C; Mead, Brittany; Burlbaw, Brittany; Krasberg, Mark; Yonas, Howard
2017-01-01
OBJECTIVE Cortical spreading depression (CSD) has been observed with relatively high frequency in the period following human brain injury, including traumatic brain injury and ischemic/hemorrhagic stroke. These events are characterized by loss of ionic gradients through massive cellular depolarization, neuronal dysfunction (depression of electrocorticographic [ECoG] activity) and slow spread (2-5 mm/min) across the cortical surface. Previous data obtained in animals have suggested that even in the absence of underlying injury, neurosurgical manipulation can induce CSD and could potentially be a modifiable factor in neurosurgical injury. The authors report their initial experience with direct intraoperative ECoG monitoring for CSD. METHODS The authors prospectively enrolled patients undergoing elective craniotomy for supratentorial lesions in cases in which the surgical procedure was expected to last > 2 hours. These patients were monitored for CSD from the time of dural opening through the time of dural closure, using a standard 1 × 6 platinum electrode coupled with an AC or full-spectrum DC amplifier. The data were processed using standard techniques to evaluate for slow potential changes coupled with suppression of high-frequency ECoG propagating across the electrodes. Data were compared with CSD validated in previous intensive care unit (ICU) studies, to evaluate recording conditions most likely to permit CSD detection, and identify likely events during the course of neurosurgical procedures using standard criteria. RESULTS Eleven patients underwent ECoG monitoring during elective neurosurgical procedures. During the periods of monitoring, 2 definite CSDs were observed to occur in 1 patient and 8 suspicious events were detected in 4 patients. In other patients, either no events were observed or artifact limited interpretation of the data. The DC-coupled amplifier system represented an improvement in stability of data compared with AC-coupled systems. Compared with more widely used postoperative ICU monitoring, there were additional challenges with artifact from saturation during bipolar cautery as well as additional noise peaks detected. CONCLUSIONS CSD can occur during elective neurosurgical procedures even in brain regions distant from the immediate operative site. ECoG monitoring with a DC-coupled full-spectrum amplifier seemed to provide the most stable signal despite significant challenges to the operating room environment. CSD may be responsible for some cases of secondary surgical injury. Though further studies on outcome related to the occurrence of these events is needed, efforts to decrease the occurrence of CSD by modification of anesthetic regimen may represent a novel target for study to increase the safety of neurosurgical procedures.
Baum, Rachel; Amjad, Urooj; Luh, Jeanne; Bartram, Jamie
2015-11-01
National and sub-national governments develop and enforce regulations to ensure the delivery of safe drinking water in the United States (US) and countries worldwide. However, periodic contamination events, waterborne endemic illness and outbreaks of waterborne disease still occur, illustrating that delivery of safe drinking water is not guaranteed. In this study, we examined the potential added value of a preventive risk management approach, specifically, water safety plans (WSPs), in the US in order to improve drinking water quality. We undertook a comparative analysis between US drinking water regulations and WSP steps to analyze the similarities and differences between them, and identify how WSPs might complement drinking water regulations in the US. Findings show that US drinking water regulations and WSP steps were aligned in the areas of describing the water supply system and defining monitoring and controls. However, gaps exist between US drinking water regulations and WSPs in the areas of team procedures and training, internal risk assessment and prioritization, and management procedures and plans. The study contributes to understanding both required and voluntary drinking water management practices in the US and how implementing water safety plans could benefit water systems to improve drinking water quality and human health. Copyright © 2015 Elsevier GmbH. All rights reserved.
Bilateral effects of hospital patient-safety procedures on nurses' job satisfaction.
Inoue, T; Karima, R; Harada, K
2017-09-01
The aim of this study was to examine how hospital patient-safety procedures affect the job satisfaction of hospital nurses. Additionally, we investigated the association between perceived autonomy and hospital patient-safety procedures and job satisfaction. Recently, measures for patient safety have been recognized as an essential requirement in hospitals. Hospital patient-safety procedures may enhance the job satisfaction of nurses by improving the quality of their work. However, such procedures may also decrease their job satisfaction by imposing excessive stress on nurses because they cannot make mistakes. The participants included 537 nurses at 10 private hospitals in Japan (The surveys were collected from March to July 2012). Factors related to hospital patient-safety procedures were demonstrated using factor analysis, and the associations between these factors and nurses' self-perceived autonomy and job satisfaction were examined using structural equation modelling. Five factors regarding hospital patient-safety procedures were extracted. Additionally, structural equation modelling revealed statistically significant associations between these factors and the nurses' self-perceived autonomy and job satisfaction. The findings showed that nurses' perceived autonomy of the workplace enhanced their job satisfaction and that their perceptions of hospital patient-safety procedures promoted their job satisfaction. However, some styles of chief nurses' leadership regarding patient safety restrict nurses' independent and autonomous decision-making and actions, resulting in a lowering of job satisfaction. This study demonstrated that hospital patient-safety procedures have ambiguous effects on nurses' job satisfaction. In particular, chief nurses' leadership relating to patient safety can have a positive or negative effect on nurses' job satisfaction. The findings indicated that hospital managers should demonstrate positive attitudes to improve patient safety for nurses' job satisfaction. In addition, policymakers in the hospitals should consider that chief nurses' leadership styles may reduce autonomy and suppress nurses' job satisfaction. © 2017 The Authors International Nursing Review published by John Wiley & Sons Ltd on behalf of International Council of Nurses.
23 CFR 630.1106 - Policy and procedures for work zone safety management.
Code of Federal Regulations, 2011 CFR
2011-04-01
... 23 Highways 1 2011-04-01 2011-04-01 false Policy and procedures for work zone safety management... Policy and procedures for work zone safety management. (a) Each agency's policy and processes, procedures... established in accordance with 23 CFR 630.1006, shall include the consideration and management of road user...
2016-02-12
The Food and Drug Administration (FDA, the Agency, or we) is removing two regulations that prescribe procedures for FDA's review and classification of biological products licensed before July 1, 1972. FDA is taking this action because the two regulations are obsolete and no longer necessary in light of other statutory and regulatory authorities established since 1972, which allow FDA to evaluate and monitor the safety and effectiveness of all biological products. In addition, other statutory and regulatory authorities authorize FDA to revoke a license for biological products because they are not safe and effective, or are misbranded. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation.
Implant Evaluation of an Insertable Cardiac Monitor Outside the Electrophysiology Lab Setting
Pachulski, Roman; Cockrell, James; Solomon, Hemant; Yang, Fang; Rogers, John
2013-01-01
Background To date, insertable cardiac monitors (ICM) have been implanted in the hospital without critical evaluation of other potential settings. Providing alternatives to in-hospital insertion may increase access to ICM, decrease waiting times for patients awaiting diagnosis, and reduce hospital resources. Methods This was a prospective, non-randomized, clinical trial involving nine clinical sites throughout the United States designed to assess the feasibility of ICM implants in a non-hospital setting. Other than the Reveal® ICM, implant supplies and techniques were left to physician discretion in patients who met indications. Patients were followed up to 90 days post-implant. The primary objective was to characterize the number of procedure-related adverse events that required surgical intervention within 90 days. Results Sixty-five patients were implanted at nine out-of-hospital sites. The insertion procedure was well tolerated by all patients. There were no deaths, systemic infections or endocarditis. There were two (3%) procedure-related adverse events requiring device explant and four (6%) adverse events not requiring explant. ICM use led to 16 diagnoses (24.6%) with 9 patients proceeding to alternate cardiac device implants during the course of the 90-day follow up. Conclusion Out-of-hospital ICM insertion can be accomplished with comparable procedural safety and represents a reasonable alternative to the in-hospital setting. Clinicaltrials.gov registration number: NCT01168427 PMID:23977071
Valeriani, Federica; Protano, Carmela; Gianfranceschi, Gianluca; Cozza, Paola; Campanella, Vincenzo; Liguori, Giorgio; Vitali, Matteo; Divizia, Maurizio; Romano Spica, Vincenzo
2016-08-09
Appropriate sanitation procedures and monitoring of their actual efficacy represent critical points for improving hygiene and reducing the risk of healthcare-associated infections. Presently, surveillance is based on traditional protocols and classical microbiology. Innovation in monitoring is required not only to enhance safety or speed up controls but also to prevent cross infections due to novel or uncultivable pathogens. In order to improve surveillance monitoring, we propose that biological fluid microflora (mf) on reprocessed devices is a potential indicator of sanitation failure, when tested by an mfDNA-based approach. The survey focused on oral microflora traces in dental care settings. Experimental tests (n = 48) and an "in field" trial (n = 83) were performed on dental instruments. Conventional microbiology and amplification of bacterial genes by multiple real-time PCR were applied to detect traces of salivary microflora. Six different sanitation protocols were considered. A monitoring protocol was developed and performance of the mfDNA assay was evaluated by sensitivity and specificity. Contaminated samples resulted positive for saliva traces by the proposed approach (CT < 35). In accordance with guidelines, only fully sanitized samples were considered negative (100 %). Culture-based tests confirmed disinfectant efficacy, but failed in detecting incomplete sanitation. The method provided sensitivity and specificity over 95 %. The principle of detecting biological fluids by mfDNA analysis seems promising for monitoring the effectiveness of instrument reprocessing. The molecular approach is simple, fast and can provide a valid support for surveillance in dental care or other hospital settings.
Kapur, Ajay; Potters, Louis
2012-01-01
The purpose of this work was to develop and implement six sigma practices toward the enhancement of patient safety in an electronic, quality checklist-driven, multicenter, paperless radiation medicine department. A quality checklist process map (QPM), stratified into consultation through treatment-completion stages was incorporated into an oncology information systems platform. A cross-functional quality management team conducted quality-function-deployment and define-measure-analyze-improve-control (DMAIC) six sigma exercises with a focus on patient safety. QPM procedures were Pareto-sorted in order of decreasing patient safety risk with failure mode and effects analysis (FMEA). Quantitative metrics for a grouped set of highest risk procedures were established. These included procedural delays, associated standard deviations and six sigma Z scores. Baseline performance of the QPM was established over the previous year of usage. Data-driven analysis led to simplification, standardization, and refinement of the QPM with standard deviation, slip-day reduction, and Z-score enhancement goals. A no-fly policy (NFP) for patient safety was introduced at the improve-control DMAIC phase, with a process map interlock imposed on treatment initiation in the event of FMEA-identified high-risk tasks being delayed or not completed. The NFP was introduced in a pilot phase with specific stopping rules and the same metrics used for performance assessments. A custom root-cause analysis database was deployed to monitor patient safety events. Relative to the baseline period, average slip days and standard deviations for the risk-enhanced QPM procedures improved by over threefold factors in the NFP period. The Z scores improved by approximately 20%. A trend for proactive delays instead of reactive hard stops was observed with no adverse effects of the NFP. The number of computed potential no-fly delays per month dropped from 60 to 20 over a total of 520 cases. The fraction of computed potential no-fly cases that were delayed in NFP compliance rose from 28% to 45%. Proactive delays rose to 80% of all delayed cases. For potential no-fly cases, event reporting rose from 18% to 50%, while for actually delayed cases, event reporting rose from 65% to 100%. With complex technologies, resource-compromised staff, and pressures to hasten treatment initiation, the use of the six sigma driven process interlocks may mitigate potential patient safety risks as demonstrated in this study. Copyright © 2012 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.
77 FR 51943 - Procedures for Safety Investigations
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-28
... DEFENSE NUCLEAR FACILITIES SAFETY BOARD 10 CFR Part 1708 Procedures for Safety Investigations AGENCY: Defense Nuclear Facilities Safety Board. ACTION: Proposed rule; extension of comment period. SUMMARY: The Defense Nuclear Facilities Safety Board is extending the time for comments on its proposed...
Modeling, Monitoring and Fault Diagnosis of Spacecraft Air Contaminants
NASA Technical Reports Server (NTRS)
Ramirez, W. Fred; Skliar, Mikhail; Narayan, Anand; Morgenthaler, George W.; Smith, Gerald J.
1998-01-01
Control of air contaminants is a crucial factor in the safety considerations of crewed space flight. Indoor air quality needs to be closely monitored during long range missions such as a Mars mission, and also on large complex space structures such as the International Space Station. This work mainly pertains to the detection and simulation of air contaminants in the space station, though much of the work is easily extended to buildings, and issues of ventilation systems. Here we propose a method with which to track the presence of contaminants using an accurate physical model, and also develop a robust procedure that would raise alarms when certain tolerance levels are exceeded. A part of this research concerns the modeling of air flow inside a spacecraft, and the consequent dispersal pattern of contaminants. Our objective is to also monitor the contaminants on-line, so we develop a state estimation procedure that makes use of the measurements from a sensor system and determines an optimal estimate of the contamination in the system as a function of time and space. The real-time optimal estimates in turn are used to detect faults in the system and also offer diagnoses as to their sources. This work is concerned with the monitoring of air contaminants aboard future generation spacecraft and seeks to satisfy NASA's requirements as outlined in their Strategic Plan document (Technology Development Requirements, 1996).
Establishment of Groundwater Arsenic Potential Distribution and Discrimination in Taiwan
NASA Astrophysics Data System (ADS)
Tsai, Kuo Sheng; Chen, Yu Ying; Chung Liu, Chih; Lin, Chien Wen
2016-04-01
According to the last 10 years groundwater monitoring data in Taiwan, Arsenic concentration increase rapidly in some areas, similar to Bengal and India, the main source of Arsenic-polluted groundwater is geological sediments, through reducing reactions. There are many researches indicate that high concentration of Arsenic in groundwater poses the risk to water safety, for example, the farm lands irrigation water contains Arsenic cause the concentration of Arsenic increase in soil and crops. Based on the management of water usage instead of remediation in the situation of insufficient water. Taiwan EPA has been developed the procedures of Arsenic contamination potential area establishment and source discriminated process. Taiwan EPA use the procedures to determine the management of using groundwater, and the proposing usage of Arsenic groundwater accordance with different objects. Agencies could cooperate with the water quality standard or water needs, studying appropriate water purification methods and the groundwater depth, water consumption, thus achieve the goal of water safety and environmental protection, as a reference of policy to control total Arsenic concentration in groundwater. Keywords: Arsenic; Distribution; Discrimination; Pollution potential area of Arsenic; Origin evaluation of groundwater Arsenic
The Wake Vortex Prediction and Monitoring System WSVBS
NASA Astrophysics Data System (ADS)
Gerz, T.; Holzäpfel, F.
2009-09-01
Design and performance of the Wake Vortex Prediction and Monitoring System WSVBS are described. The WSVBS has been developed to tactically increase airport capacity for approach and landing on closely-spaced parallel runways. It is thought to dynamically adjust aircraft separations dependent on weather conditions and the resulting wake vortex behaviour without compromising safety. The WSVBS consists of components that consider meteorological conditions, aircraft glide path adherence, aircraft parameter combinations representing aircraft weight categories, the resulting wake-vortex behaviour, the surrounding safety areas, wake vortex monitoring, and the integration of the predictions into the arrival manager. The WSVBS has been designed and applied to Frankfurt Airport. However, its components are generic and can well be adjusted to any runway system and or airport location. The prediction horizon is larger than 45 min (as required by air traffic control) and updated every 10 minutes. It predicts the concepts of operations and procedures established by DFS and it further predicts additional temporal separations for in-trail traffic. A specific feature of the WSVBS is the usage of both measured and predicted meteorological quantities as input to wake vortex prediction. In ground proximity where the probability to encounter wake vortices is highest, the wake predictor employs measured environmental parameters that yield superior prediction results. For the less critical part aloft, which can not be monitored completely by instrumentation, the meteorological parameters are taken from dedicated numerical terminal weather predictions. The wake vortex model predicts envelopes for vortex position and strength which implicitly consider the quality of the meteorological input data. This feature is achieved by a training procedure which employs statistics of measured and predicted meteorological parameters and the resulting wake vortex behaviour. The WSVBS combines various conservative elements that presumably lead to a very high overall safety level of the WSVBS. The combination of these conservative measures certainly leads to a very high but currently unknown overall safety. Once the methodology of a comprehensive risk analysis will be established, it is planned to adjust all components to appropriate and consistent confidence levels. The WSVBS has demonstrated its functionality at Frankfurt airport during 66 days in the period from 18/12/06 until 28/02/07. The performance test indicates that (i) the system ran stable - no forecast breakdowns occurred, (ii) aircraft separations could have been reduced in 75% of the time compared to ICAO standards, (iii) reduced separation procedures could have been continuously applied for at least several tens of minutes and up to several hours occasionally, (iv) the predictions were correct as for about 1100 landings observed during 16 days no warnings occurred from the LIDAR. Fast-time simulations reveal that adapted concepts of operation yield significant reductions in delay and/or an increase in capacity to 3% taking into account the real traffic mix and operational constraints in the period of one month. Before the WSVBS can be handed over for final adaptations to become a customized fully operational system some further steps are planned. A risk analysis needs to be pursued to convince all stakeholders of the usefulness and capabilities of the system.
Safety syringes and anti-needlestick devices in orthopaedic surgery.
Sibbitt, Wilmer L; Band, Philip A; Kettwich, Lawrence G; Sibbitt, Cristina R; Sibbitt, Lori J; Bankhurst, Arthur D
2011-09-07
The American Academy of Orthopaedic Surgery (AAOS), The Joint Commission, the Occupational Safety and Health Administration (OSHA), and the Needlestick Safety and Prevention Act encourage the integration of safety-engineered devices to prevent needlestick injuries to health-care workers and patients. We hypothesized that safety syringes and needles could be used in outpatient orthopaedic injection and aspiration procedures. The study investigated the orthopaedic uses and procedural idiosyncrasies of safety-engineered devices, including (1) four safety needles (Eclipse, SafetyGlide, SurGuard, and Magellan), (2) a mechanical safety syringe (RPD), (3) two automatic retractable syringes (Integra, VanishPoint), (4) three manual retractable syringes (Procedur-SF, Baksnap, Invirosnap), and (5) three shielded syringes (Safety-Lok, Monoject, and Digitally Activated Shielded [DAS] Syringe). The devices were first tested ex vivo, and then 1300 devices were used for 425 subjects undergoing outpatient arthrocentesis, intra-articular injections, local anesthesia, aspiration biopsy, and ultrasound-guided procedures. During the clinical observation, there were no accidental needlesticks (0 needlesticks per 1300 devices). Safety needles could be successfully used on a Luer syringe but were limited to ≤1.5 in (≤3.81 cm) in length and the shield could interfere with sonography. The mechanical safety syringes functioned well in all orthopaedic procedures. Automatic retractable syringes were too small for arthrocentesis of the knee, and the plunger blew out and prematurely collapsed with high-pressure injections. The manual retractable syringes and shielded syringes could be used with conventional needles for most orthopaedic procedures. The most effective and reliable safety devices for orthopaedic syringe procedures are shielded safety needles, mechanical syringes, manual retractable syringes, and shielded syringes, but not automatic retractable syringes. Even when adopting safety-engineered devices for an orthopaedic clinic, conventional syringes larger than 20 mL and conventional needles longer than 1.5 in (3.8 cm) are necessary.
Caron, Alexandre; Chazard, Emmanuel; Muller, Joris; Perichon, Renaud; Ferret, Laurie; Koutkias, Vassilis; Beuscart, Régis; Beuscart, Jean-Baptiste; Ficheur, Grégoire
2017-03-01
The significant risk of adverse events following medical procedures supports a clinical epidemiological approach based on the analyses of collections of electronic medical records. Data analytical tools might help clinical epidemiologists develop more appropriate case-crossover designs for monitoring patient safety. To develop and assess the methodological quality of an interactive tool for use by clinical epidemiologists to systematically design case-crossover analyses of large electronic medical records databases. We developed IT-CARES, an analytical tool implementing case-crossover design, to explore the association between exposures and outcomes. The exposures and outcomes are defined by clinical epidemiologists via lists of codes entered via a user interface screen. We tested IT-CARES on data from the French national inpatient stay database, which documents diagnoses and medical procedures for 170 million inpatient stays between 2007 and 2013. We compared the results of our analysis with reference data from the literature on thromboembolic risk after delivery and bleeding risk after total hip replacement. IT-CARES provides a user interface with 3 columns: (i) the outcome criteria in the left-hand column, (ii) the exposure criteria in the right-hand column, and (iii) the estimated risk (odds ratios, presented in both graphical and tabular formats) in the middle column. The estimated odds ratios were consistent with the reference literature data. IT-CARES may enhance patient safety by facilitating clinical epidemiological studies of adverse events following medical procedures. The tool's usability must be evaluated and improved in further research. © The Author 2016. Published by Oxford University Press on behalf of the American Medical Informatics Association.
Di Renzo, Laura; Colica, Carmen; Carraro, Alberto; Cenci Goga, Beniamino; Marsella, Luigi Tonino; Botta, Roberto; Colombo, Maria Laura; Gratteri, Santo; Chang, Ting Fa Margherita; Droli, Maurizio; Sarlo, Francesca; De Lorenzo, Antonino
2015-04-23
The important role of food and nutrition in public health is being increasingly recognized as crucial for its potential impact on health-related quality of life and the economy, both at the societal and individual levels. The prevalence of non-communicable diseases calls for a reformulation of our view of food. The Hazard Analysis and Critical Control Point (HACCP) system, first implemented in the EU with the Directive 43/93/CEE, later replaced by Regulation CE 178/2002 and Regulation CE 852/2004, is the internationally agreed approach for food safety control. Our aim is to develop a new procedure for the assessment of the Nutrient, hazard Analysis and Critical Control Point (NACCP) process, for total quality management (TMQ), and optimize nutritional levels. NACCP was based on four general principles: i) guarantee of health maintenance; ii) evaluate and assure the nutritional quality of food and TMQ; iii) give correct information to the consumers; iv) ensure an ethical profit. There are three stages for the application of the NACCP process: 1) application of NACCP for quality principles; 2) application of NACCP for health principals; 3) implementation of the NACCP process. The actions are: 1) identification of nutritional markers, which must remain intact throughout the food supply chain; 2) identification of critical control points which must monitored in order to minimize the likelihood of a reduction in quality; 3) establishment of critical limits to maintain adequate levels of nutrient; 4) establishment, and implementation of effective monitoring procedures of critical control points; 5) establishment of corrective actions; 6) identification of metabolic biomarkers; 7) evaluation of the effects of food intake, through the application of specific clinical trials; 8) establishment of procedures for consumer information; 9) implementation of the Health claim Regulation EU 1924/2006; 10) starting a training program. We calculate the risk assessment as follows: Risk (R) = probability (P) × damage (D). The NACCP process considers the entire food supply chain "from farm to consumer"; in each point of the chain it is necessary implement a tight monitoring in order to guarantee optimal nutritional quality.
Science Safety Procedure Handbook.
ERIC Educational Resources Information Center
Lynch, Mervyn A.; Offet, Lorna
This booklet outlines general safety procedures in the areas of: (1) student supervision; (2) storage safety regulations, including lists of incompatible chemicals, techniques of disposal and storage; (3) fire; and (4) first aid. Specific sections exist for elementary, junior high school, senior high school, in which special procedures are…
Dijkstra, Boukje A G; Kamal, Rama; van Noorden, Martijn S; de Haan, Hein; Loonen, Anton J M; De Jong, Cor A J
2017-01-01
Gamma-hydroxybutyrate (GHB) detoxification procedures have been insufficiently studied for effectiveness and safety. Based on case reports, benzodiazepines are generally regarded as first-choice agents in GHB detoxification. Detoxification by titration and tapering (DeTiTap) with pharmaceutical GHB in an open-label consecutive case series of 23 GHB-dependent patients showed to be feasible, effective and safe. This study further explored the feasibility, effectiveness and safety of this detoxification procedure in a large group of patients. A large observational multicenter study was carried out in six addiction treatment centers in the Netherlands. GHB-dependent inpatients (229 unique patients, 274 admissions) were titrated on and tapered off with pharmaceutical GHB. Successful detoxification was achieved in 85% of cases. Detoxification was carried out in 12.5days in most patients. The DeTiTap procedure proved to be feasible and significantly reduced the experienced withdrawal symptoms and craving (p≤0.001). Several symptoms were found to influence the course of subjective withdrawal symptoms. During detoxification, psychological symptoms such as depression, anxiety, and stress decreased (p≤0.05). The main complications were hypertension and anxiety. Six patients were sent to the general hospital for observation, but all six were able to continue detoxification in the addiction treatment centers. Most patients (69%) relapsed within three months after detoxification. The DeTiTap procedure using pharmaceutical GHB seems a safe alternative to benzodiazepines as a GHB detoxification procedure. However, the high relapse rates warrant further investigation. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
Visually guided male urinary catheterization: a feasibility study.
Willette, Paul A; Banks, Kevin; Shaffer, Lynn
2013-01-01
Ten percent to 15% of urinary catheterizations involve complications. New techniques to reduce risks and pain are indicated. This study examines the feasibility and safety of male urinary catheterization by nursing personnel using a visually guided device in a clinical setting. The device, a 0.6-mm fiber-optic bundle inside a 14F triple-lumen flexible urinary catheter with a lubricious coating, irrigation port, and angled tip, connects to a camera, allowing real-time viewing of progress on a color monitor. Two emergency nurses were trained to use the device. Male patients 18 years or older presenting to the emergency department with an indication for urinary catheterization using a standard Foley or Coudé catheter were eligible to participate in the study. Exclusion criteria were a current suprapubic tube or gross hematuria prior to the procedure. Twenty-five patients were enrolled. Data collected included success of placement, total procedure time, pre-procedure pain and maximum pain during the procedure, gross hematuria, abnormalities or injuries identified if catheterization failed, occurrence of and reason for equipment failures, and number of passes required for placement. All catheters were successfully placed. The median number of passes required was 1. For all but one patient, procedure time was ≤ 17 minutes. A median increase in pain scores of 1 point from baseline to the maximum was reported. Gross hematuria was observed in 2 patients. The success rate for placement of a Foley catheter with the visually guided device was 100%, indicating its safety, accuracy, and feasibility in a clinical setting. Minimal pain was associated with the procedure. Copyright © 2013 Emergency Nurses Association. Published by Mosby, Inc. All rights reserved.
Developments in seismic monitoring for risk reduction
Celebi, M.
2007-01-01
This paper presents recent state-of-the-art developments to obtain displacements and drift ratios for seismic monitoring and damage assessment of buildings. In most cases, decisions on safety of buildings following seismic events are based on visual inspections of the structures. Real-time instrumental measurements using GPS or double integration of accelerations, however, offer a viable alternative. Relevant parameters, such as the type of connections and structural characteristics (including storey geometry), can be estimated to compute drifts corresponding to several pre-selected threshold stages of damage. Drift ratios determined from real-time monitoring can then be compared to these thresholds in order to estimate damage conditions drift ratios. This approach is demonstrated in three steel frame buildings in San Francisco, California. Recently recorded data of strong shaking from these buildings indicate that the monitoring system can be a useful tool in rapid assessment of buildings and other structures following an earthquake. Such systems can also be used for risk monitoring, as a method to assess performance-based design and analysis procedures, for long-term assessment of structural characteristics of a building, and as a possible long-term damage detection tool.
Hazards of Electromagnetic Radiation to Ordnance (HERO) Safety Test
2013-01-10
Ordnance Test Procedure (JOTP)-061 Hazards of Electromagnetic Radiation to...DEPARTMENT OF DEFENSE JOINT ORDNANCE TEST PROCEDURE (JOTP)-061 HAZARDS OF ELECTROMAGNETIC RADIATION TO ORDNANCE (HERO) SAFETY...TEST Joint Services Munition Safety Test Working Group Joint Ordnance Test Procedure (JOTP)-061 Hazards of Electromagnetic Radiation
Sustaining Vaccine Confidence in the 21st Century
Hardt, Karin; Schmidt-Ott, Ruprecht; Glismann, Steffen; Adegbola, Richard A.; Meurice, François P.
2013-01-01
Vaccination provides many health and economic benefits to individuals and society, and public support for immunization programs is generally high. However, the benefits of vaccines are often not fully valued when public discussions on vaccine safety, quality or efficacy arise, and the spread of misinformation via the internet and other media has the potential to undermine immunization programs. Factors associated with improved public confidence in vaccines include evidence-based decision-making procedures and recommendations, controlled processes for licensing and monitoring vaccine safety and effectiveness and disease surveillance. Community engagement with appropriate communication approaches for each audience is a key factor in building trust in vaccines. Vaccine safety/quality issues should be handled rapidly and transparently by informing and involving those most affected and those concerned with public health in effective ways. Openness and transparency in the exchange of information between industry and other stakeholders is also important. To maximize the safety of vaccines, and thus sustain trust in vaccines, partnerships are needed between public health sector stakeholders. Vaccine confidence can be improved through collaborations that ensure high vaccine uptake rates and that inform the public and other stakeholders of the benefits of vaccines and how vaccine safety is constantly assessed, assured and communicated. PMID:26344109
[Perioperative mortality. Risk factors associated with anaesthesia].
Zajac, Krzysztof; Zajac, Małgorzata
2005-01-01
Perioperative mortality associated with anaesthesia has been closely monitored throughout half of the century. The breakthrough in anaesthesia safety occurred in the 80-ties and 90-ties of the last century, when we could witness 5-folded reduction in mortality associated with anaesthesia, i.e. from 1 death:2680 operations/anaesthetic procedures (the 50-ties of the 20 h century) to 1:10,000 (and even 20-folded reduction within the ASA 1 and 2 groups of the patients--1 death:185,000 procedures). However, the more detailed analysis showed that the perioperative mortality is significantly higher, namely 1 death: approximately 500 procedures, and in the ASA 5 group of patients 1:4.5 procedures; what is more meaningful, the numbers have not been changed since 50 years. This phenomenon supports the thesis of anaesthesia safety, however, it indicates the drawbacks within the models and scoring systems evaluating operative risk. Several available scoring scales which can predict death rate, at the same time are not able to assess the extent of the other than biological risk factors. The "extra-biological risk" (i.e. process of therapy) may in some cases increase the operative risk as a whole. The value of the operative risk, as the fraction given by predicted death rate, is located between the numbers 0 and 1 (or between survival and death in the binary model of the probability theory). Recognition of the "extrabiological risk" value depends however on the high sensitivity of the scales evaluating prediction of death rate.
23 CFR 1200.26 - Non-compliance.
Code of Federal Regulations, 2010 CFR
2010-04-01
... TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS Implementation and Management of the Highway Safety Program § 1200.26 Non-compliance. Where a State is found to... special conditions for high-risk grantees and the enforcement procedures of 49 CFR part 18, or the...
NASA Technical Reports Server (NTRS)
1981-01-01
General information and administrative instructions are provided for individuals gathering ground truth data to support research and development techniques for estimating crop acreage and production by remote sensing by satellite. Procedures are given for personal safety with regards to organophosphorus insecticides, for conducting interviews for periodic observations, for coding the crops identified and their growth stages, and for selecting sites for placing rain gages. Forms are included for those citizens agreeing to monitor the gages and record the rainfall. Segment selection is also considered.
12 CFR 21.21 - Procedures for monitoring Bank Secrecy Act (BSA) compliance.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 12 Banks and Banking 1 2012-01-01 2012-01-01 false Procedures for monitoring Bank Secrecy Act (BSA... MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Procedures for Monitoring Bank Secrecy Act Compliance § 21.21 Procedures for monitoring Bank...
12 CFR 21.21 - Procedures for monitoring Bank Secrecy Act (BSA) compliance.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 12 Banks and Banking 1 2013-01-01 2013-01-01 false Procedures for monitoring Bank Secrecy Act (BSA... MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Procedures for Monitoring Bank Secrecy Act Compliance § 21.21 Procedures for monitoring Bank...
12 CFR 21.21 - Procedures for monitoring Bank Secrecy Act (BSA) compliance.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 12 Banks and Banking 1 2014-01-01 2014-01-01 false Procedures for monitoring Bank Secrecy Act (BSA... MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Procedures for Monitoring Bank Secrecy Act Compliance § 21.21 Procedures for monitoring Bank...
12 CFR 21.21 - Procedures for monitoring Bank Secrecy Act (BSA) compliance.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 12 Banks and Banking 1 2011-01-01 2011-01-01 false Procedures for monitoring Bank Secrecy Act (BSA... MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Procedures for Monitoring Bank Secrecy Act Compliance § 21.21 Procedures for monitoring Bank...
12 CFR 21.21 - Procedures for monitoring Bank Secrecy Act (BSA) compliance.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 12 Banks and Banking 1 2010-01-01 2010-01-01 false Procedures for monitoring Bank Secrecy Act (BSA... MINIMUM SECURITY DEVICES AND PROCEDURES, REPORTS OF SUSPICIOUS ACTIVITIES, AND BANK SECRECY ACT COMPLIANCE PROGRAM Procedures for Monitoring Bank Secrecy Act Compliance § 21.21 Procedures for monitoring Bank...
Code of Federal Regulations, 2012 CFR
2012-10-01
... TRANSPORTATION REGULATIONS ON SAFETY INTEGRATION PLANS GOVERNING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL Safety Integration Plans § 244.17 Procedures. (a) Each applicant shall file one original of a proposed Safety Integration Plan with the Associate Administrator for Safety, FRA, 1200 New...
Code of Federal Regulations, 2011 CFR
2011-10-01
... TRANSPORTATION REGULATIONS ON SAFETY INTEGRATION PLANS GOVERNING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL Safety Integration Plans § 244.17 Procedures. (a) Each applicant shall file one original of a proposed Safety Integration Plan with the Associate Administrator for Safety, FRA, 1200 New...
Code of Federal Regulations, 2010 CFR
2010-10-01
... TRANSPORTATION REGULATIONS ON SAFETY INTEGRATION PLANS GOVERNING RAILROAD CONSOLIDATIONS, MERGERS, AND ACQUISITIONS OF CONTROL Safety Integration Plans § 244.17 Procedures. (a) Each applicant shall file one original of a proposed Safety Integration Plan with the Associate Administrator for Safety, FRA, 1200 New...
Federal Register 2010, 2011, 2012, 2013, 2014
2011-03-25
....fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/default.htm , http://www.fda.gov/AnimalVeterinary/SafetyHealth/AntimicrobialResistance/NationalAntimicrobialResistanceMonitoringSystem/ucm062630.htm , http://www.fda.gov/AnimalVeterinary/Safety...
Moorjani, Gautam R; Bedrick, Edward J; Michael, Adrian A; Peisajovich, Andres; Sibbitt, Wilmer L; Bankhurst, Arthur D
2008-07-01
To identify and integrate new safety technologies into outpatient musculoskeletal procedures and measure the effect on outcome, including pain. Using national resources for patient safety and literature review, the following safety technologies were identified: a safety needle to reduce inadvertent needlesticks to heath care workers, and the reciprocating procedure device (RPD) to improve patient safety and reduce pain. Five hundred sixty-six musculoskeletal procedures involving syringes and needles were randomized to either an RPD group or a conventional syringe group, and pain, quality, safety, and physician acceptance were measured. During 566 procedures, no accidental needlesticks occurred with safety needles. Use of the RPD resulted in a 35.4% reduction (95% confidence interval [95% CI] 24-46%) in patient-assessed pain (mean +/- SD scores on a visual analog pain scale [VAPS] 3.12 +/- 2.23 for the RPD and 4.83 +/- 3.22 for the conventional syringe; P < 0.001) and a 49.5% reduction (95% CI 34-64%) in patient-assessed significant pain (VAPS score > or =5) (P < 0.001). Physician acceptance of the RPD combined with a safety needle was excellent. As mandated by the Joint Commission and the Occupational Safety and Health Administration, safety technologies and the use of pain scales can be successfully integrated into rheumatologic and orthopedic procedures. The combination of a safety needle to reduce needlestick injuries to health care workers and the RPD to improve safety and outcome of patients is effective and well accepted by physicians.
Collier, Sue; Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P; McCrae, John; McCorkindale, Sheila; Leather, David
2017-03-01
The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once-daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in-depth exploration of the safety results will be the subject of future publications. The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd.
An Operational Safety and Health Program.
ERIC Educational Resources Information Center
Uhorchak, Robert E.
1983-01-01
Describes safety/health program activities at Research Triangle Institute (North Carolina). These include: radioisotope/radiation and hazardous chemical/carcinogen use, training, monitoring, disposal; chemical waste management; air monitoring and analysis; medical program; fire safety/training, including emergency planning; Occupational Safety and…
[MR-guided focused ultrasound. Current and future applications].
Trumm, C G; Napoli, A; Peller, M; Clevert, D-A; Stahl, R; Reiser, M; Matzko, M
2013-03-01
High-intensity focused ultrasound (synonyms FUS and HIFU) under magnetic resonance imaging (MRI) guidance (synonyms MRgFUS and MR-HIFU) is a completely non-invasive technology for accurate thermal ablation of a target tissue while neighboring tissues and organs are preserved. The combination of FUS with MRI for planning, (near) real-time monitoring and outcome assessment of treatment markedly enhances the safety of the procedure. The MRgFUS procedure is clinically established in particular for the treatment of symptomatic uterine fibroids, followed by palliative ablation of painful bone metastases. Furthermore, promising results have been shown for the treatment of adenomyosis, malignant tumors of the prostate, breast and liver and for various intracranial applications, such as thermal ablation of brain tumors, functional neurosurgery and transient disruption of the blood-brain barrier.
Post-earthquake building safety assessments for the Canterbury Earthquakes
Marshall, J.; Barnes, J.; Gould, N.; Jaiswal, K.; Lizundia, B.; Swanson, David A.; Turner, F.
2012-01-01
This paper explores the post-earthquake building assessment program that was utilized in Christchurch, New Zealand following the Canterbury Sequence of earthquakes beginning with the Magnitude (Mw.) 7.1 Darfield event in September 2010. The aftershocks or triggered events, two of which exceeded Mw 6.0, continued with events in February and June 2011 causing the greatest amount of damage. More than 70,000 building safety assessments were completed following the February event. The timeline and assessment procedures will be discussed including the use of rapid response teams, selection of indicator buildings to monitor damage following aftershocks, risk assessments for demolition of red-tagged buildings, the use of task forces to address management of the heavily damaged downtown area and the process of demolition. Through the post-event safety assessment program that occurred throughout the Canterbury Sequence of earthquakes, many important lessons can be learned that will benefit future response to natural hazards that have potential to damage structures.
Safety in the Chemical Laboratory: Developing Departmental Safety Procedures.
ERIC Educational Resources Information Center
Renfrew, Malcolm M., Ed.; Palladino, George F.
1980-01-01
Presents rationale and guidelines for development of Safety Standard Operating Procedures (Safety SOP) specific for local conditions. Includes an outline of a Safety SOP developed for a department primarily focused on undergraduate education with a wide variety of expertise from common laborer to PhD with 20 years experience. (Author/JN)
Code of Federal Regulations, 2013 CFR
2013-10-01
... industry safety appliance standard for new construction of railroad cars, locomotives, tenders, or other... 49 Transportation 4 2013-10-01 2013-10-01 false Procedure for modification of an approved industry... TRANSPORTATION RAILROAD SAFETY APPLIANCE STANDARDS § 231.35 Procedure for modification of an approved industry...
Code of Federal Regulations, 2014 CFR
2014-10-01
... industry safety appliance standard for new construction of railroad cars, locomotives, tenders, or other... 49 Transportation 4 2014-10-01 2014-10-01 false Procedure for modification of an approved industry... TRANSPORTATION RAILROAD SAFETY APPLIANCE STANDARDS § 231.35 Procedure for modification of an approved industry...
Code of Federal Regulations, 2012 CFR
2012-10-01
... industry safety appliance standard for new construction of railroad cars, locomotives, tenders, or other... 49 Transportation 4 2012-10-01 2012-10-01 false Procedure for modification of an approved industry... TRANSPORTATION RAILROAD SAFETY APPLIANCE STANDARDS § 231.35 Procedure for modification of an approved industry...
Code of Federal Regulations, 2011 CFR
2011-10-01
... industry safety appliance standard for new construction of railroad cars, locomotives, tenders, or other... 49 Transportation 4 2011-10-01 2011-10-01 false Procedure for modification of an approved industry... TRANSPORTATION RAILROAD SAFETY APPLIANCE STANDARDS § 231.35 Procedure for modification of an approved industry...
Understanding procedural violations using Safety-I and Safety-II: The case of community pharmacies.
Jones, Christian E L; Phipps, Denham L; Ashcroft, Darren M
2018-06-01
Procedural violations are known to occur in a range of work settings, and are an important topic of interest with regard to safety management. A Safety-I perspective sees violations as undesirable digressions from standardised procedures, while a Safety-II perspective sees violations as adaptations to a complex work system. This study aimed to apply both perspectives to the examination of violations in community pharmacies. Twenty-four participants (13 pharmacists and 11 pharmacy support staff) were purposively sampled to participate in semi-structured interviews using the critical incident technique. Participants described violations they made during the course of their work. Interviews were digitally recorded, transcribed verbatim and analysed using template analysis. Community pharmacies located in England and Wales. 31 procedural violations were described during the interviews revealing multiple reasons for violations in this setting. Our findings suggest that from a Safety-II perspective, staff violated to adapt to situations and to manage safety. However, participants also violated procedures in order to maintain productivity which was found to increase risk in some, but not all situations. Procedural violations often relied on the context in which staff were working, resulting in the violation being deemed rational to the individual making the violation, yet the behaviour may be difficult to justify from an outside perspective. Combining Safety-I and Safety-II perspectives provided a detailed understanding of the underlying reasons for procedural violations. Our findings identify aspects of practice that could benefit from targeted interventions to help support staff in providing safe patient care.
Monitoring product safety in the postmarketing environment.
Sharrar, Robert G; Dieck, Gretchen S
2013-10-01
The safety profile of a medicinal product may change in the postmarketing environment. Safety issues not identified in clinical development may be seen and need to be evaluated. Methods of evaluating spontaneous adverse experience reports and identifying new safety risks include a review of individual reports, a review of a frequency distribution of a list of the adverse experiences, the development and analysis of a case series, and various ways of examining the database for signals of disproportionality, which may suggest a possible association. Regulatory agencies monitor product safety through a variety of mechanisms including signal detection of the adverse experience safety reports in databases and by requiring and monitoring risk management plans, periodic safety update reports and postauthorization safety studies. The United States Food and Drug Administration is working with public, academic and private entities to develop methods for using large electronic databases to actively monitor product safety. Important identified risks will have to be evaluated through observational studies and registries.
Harvey, Catherine; Brewster, Jill; Bakerly, Nawar Diar; Elkhenini, Hanaa F.; Stanciu, Roxana; Williams, Claire; Brereton, Jacqui; New, John P.; McCrae, John; McCorkindale, Sheila; Leather, David
2016-01-01
Abstract Background The Salford Lung Study (SLS) programme, encompassing two phase III pragmatic randomised controlled trials, was designed to generate evidence on the effectiveness of a once‐daily treatment for asthma and chronic obstructive pulmonary disease in routine primary care using electronic health records. Objective The objective of this study was to describe and discuss the safety monitoring methodology and the challenges associated with ensuring patient safety in the SLS. Refinements to safety monitoring processes and infrastructure are also discussed. The study results are outside the remit of this paper. The results of the COPD study were published recently and a more in‐depth exploration of the safety results will be the subject of future publications. Achievements The SLS used a linked database system to capture relevant data from primary care practices in Salford and South Manchester, two university hospitals and other national databases. Patient data were collated and analysed to create daily summaries that were used to alert a specialist safety team to potential safety events. Clinical research teams at participating general practitioner sites and pharmacies also captured safety events during routine consultations. Confidence in the safety monitoring processes over time allowed the methodology to be refined and streamlined without compromising patient safety or the timely collection of data. The information technology infrastructure also allowed additional details of safety information to be collected. Conclusion Integration of multiple data sources in the SLS may provide more comprehensive safety information than usually collected in standard randomised controlled trials. Application of the principles of safety monitoring methodology from the SLS could facilitate safety monitoring processes for future pragmatic randomised controlled trials and yield important complementary safety and effectiveness data. © 2016 The Authors Pharmacoepidemiology and Drug Safety Published by John Wiley & Sons Ltd. PMID:27804174
Jiaxi, Qiang; Lin, Yang; Jianhui, He; Qisheng, Zhou
2013-01-01
Batteries, as the main or assistant power source of EV (Electric Vehicle), are usually connected in series with high voltage to improve the drivability and energy efficiency. Today, more and more batteries are connected in series with high voltage, if there is any fault in high voltage system (HVS), the consequence is serious and dangerous. Therefore, it is necessary to monitor the electric parameters of HVS to ensure the high voltage safety and protect personal safety. In this study, a high voltage safety monitor system is developed to solve this critical issue. Four key electric parameters including precharge, contact resistance, insulation resistance, and remaining capacity are monitored and analyzed based on the equivalent models presented in this study. The high voltage safety controller which integrates the equivalent models and control strategy is developed. By the help of hardware-in-loop system, the equivalent models integrated in the high voltage safety controller are validated, and the online electric parameters monitor strategy is analyzed and discussed. The test results indicate that the high voltage safety monitor system designed in this paper is suitable for EV application. PMID:24194677
Jiaxi, Qiang; Lin, Yang; Jianhui, He; Qisheng, Zhou
2013-01-01
Batteries, as the main or assistant power source of EV (Electric Vehicle), are usually connected in series with high voltage to improve the drivability and energy efficiency. Today, more and more batteries are connected in series with high voltage, if there is any fault in high voltage system (HVS), the consequence is serious and dangerous. Therefore, it is necessary to monitor the electric parameters of HVS to ensure the high voltage safety and protect personal safety. In this study, a high voltage safety monitor system is developed to solve this critical issue. Four key electric parameters including precharge, contact resistance, insulation resistance, and remaining capacity are monitored and analyzed based on the equivalent models presented in this study. The high voltage safety controller which integrates the equivalent models and control strategy is developed. By the help of hardware-in-loop system, the equivalent models integrated in the high voltage safety controller are validated, and the online electric parameters monitor strategy is analyzed and discussed. The test results indicate that the high voltage safety monitor system designed in this paper is suitable for EV application.
Expanding the scope of practice for radiology managers: radiation safety duties.
Orders, Amy B; Wright, Donna
2003-01-01
In addition to financial responsibilities and patient care duties, many medical facilities also expect radiology department managers to wear "safety" hats and complete fundamental quality control/quality assurance, conduct routine safety surveillance in the department, and to meet regulatory demands in the workplace. All managers influence continuous quality improvement initiatives, from effective utilization of resource and staffing allocations, to efficacy of patient scheduling tactics. It is critically important to understand continuous quality improvement (CQI) and its relationship with the radiology manager, specifically quality assurance/quality control in routine work, as these are the fundamentals of institutional safety, including radiation safety. When an institution applies for a registration for radiation-producing devices or a license for the use of radioactive materials, the permit granting body has specific requirements, policies and procedures that must be satisfied in order to be granted a permit and to maintain it continuously. In the 32 U.S. Agreement states, which are states that have radiation safety programs equivalent to the Nuclear Regulatory Commission programs, individual facilities apply for permits through the local governing body of radiation protection. Other states are directly licensed by the Nuclear Regulatory Commission and associated regulatory entities. These regulatory agencies grant permits, set conditions for use in accordance with state and federal laws, monitor and enforce radiation safety activities, and audit facilities for compliance with their regulations. Every radiology department and associated areas of radiation use are subject to inspection and enforcement policies in order to ensure safety of equipment and personnel. In today's business practice, department managers or chief technologists may actively participate in the duties associated with institutional radiation safety, especially in smaller institutions, while other facilities may assign the duties and title of "radiation safety officer" to a radiologist or other management, per the requirements of regulatory agencies in that state. Radiation safety in a medical setting can be delineated into two main categories--equipment and personnel requirements--each having very specific guidelines. The literature fails to adequately address the blatant link between radiology department managers and radiation safety duties. The breadth and depth of this relationship is of utmost concern and warrants deeper insight as the demands of the regulatory agencies increase with the new advances in technology, procedures and treatments associated with radiation-producing devices and radioactive materials.
In-Office Endoscopic Laryngeal Laser Procedures: A Patient Safety Initiative.
Anderson, Jennifer; Bensoussan, Yael; Townsley, Richard; Kell, Erika
2018-05-01
Objective To review complications of in-office endoscopic laryngeal laser procedures after implementation of standardized safety protocol. Methods A retrospective review was conducted of the first 2 years of in-office laser procedures at St Michaels Hospital after the introduction of a standardized safety protocol. The protocol included patient screening, procedure checklist with standardized reporting of processes, medications, and complications. Primary outcomes measured were complication rates of in-office laryngeal laser procedures. Secondary outcomes included hemodynamic changes, local anesthetic dose, laser settings, total laser/procedure time, and incidence of sedation. Results A total of 145 in-office KTP procedures performed on 65 patients were reviewed. In 98% of cases, the safety protocol was fully implemented. The overall complication rate was 4.8%. No major complications were encountered. Minor complications included vasovagal episodes and patient intolerance. The rate of patient intolerance resulting early termination of anticipated procedure was 13.1%. Total local anesthetic dose averaged 172.9 mg lidocaine per procedure. The mean amount of laser energy dispersed was 261.2 J, with mean total procedure time of 48.3 minutes. Sixteen percent of patients had preprocedure sedation. Vital signs were found to vary modestly. Systolic blood pressure was lower postprocedure in 13.8% and symptomatic in 4.1%. Discussion The review of our standardized safety protocol has revealed that in-office laser treatment for laryngeal pathology has extremely low complication rates with safe patient outcomes. Implications for Practice The trend of shifting procedures out of the operating room into the office/clinic setting requires new processes designed to promote patient safety.
Safety validation test equipment operation
NASA Astrophysics Data System (ADS)
Kurosaki, Tadaaki; Watanabe, Takashi
1992-08-01
An overview of the activities conducted on safety validation test equipment operation for materials used for NASA manned missions is presented. Safety validation tests, such as flammability, odor, offgassing, and so forth were conducted in accordance with NASA-NHB-8060.1C using test subjects common with those used by NASA, and the equipment used were qualified for their functions and performances in accordance with NASDA-CR-99124 'Safety Validation Test Qualification Procedures.' Test procedure systems were established by preparing 'Common Procedures for Safety Validation Test' as well as test procedures for flammability, offgassing, and odor tests. The test operation organization chaired by the General Manager of the Parts and Material Laboratory of NASDA (National Space Development Agency of Japan) was established, and the test leaders and operators in the organization were qualified in accordance with the specified procedures. One-hundred-one tests had been conducted so far by the Parts and Material Laboratory according to the request submitted by the manufacturers through the Space Station Group and the Safety and Product Assurance for Manned Systems Office.
ERIC Educational Resources Information Center
Haering, Franklin C.
A wide variety of school safety guidelines are included in this handbook. The introduction provides guidelines for delegating responsibility to school personnel. Procedures for developing safety policies and for establishing school safety councils and committees are outlined. A chapter on traffic control specifies procedures for pavement marking…
Rogers, John D; Sanders, Prashanthan; Piorkowski, Christopher; Sohail, M Rizwan; Anand, Rishi; Crossen, Karl; Khairallah, Farhat S; Kaplon, Rachelle E; Stromberg, Kurt; Kowal, Robert C
2017-02-01
Recent miniaturization of an insertable cardiac monitor (ICM) may make it possible to move device insertion from a hospital to office setting. However, the safety of this strategy is unknown. The primary objective was to compare the safety of inserting the Reveal LINQ ICM in an office vs a hospital environment. Ancillary objectives included summarizing device- and procedure-related adverse events and responses to a physician questionnaire. Five hundred twenty-one patients indicated for an ICM were randomized (1:1 ratio) to undergo ICM insertion in a hospital or office environment at 26 centers in the United States in the Reveal LINQ In-Office 2 study (ClinicalTrials.gov identifier NCT02395536). Patients were followed for 90 days. ICM insertion was successful in all 482 attempted patients (office: 251; hospital: 231). The untoward event rate (composite of unsuccessful insertion and ICM- or insertion-related complications) was 0.8% (2 of 244) in the office and 0.9% (2 of 227) in the hospital (95% confidence interval, -3.0% to 2.9%; 5% noninferiority: P < .001). In addition, adverse events occurred during 2.5% (6 of 244) of office and 4.4% (10 of 227) of hospital insertions (95% confidence interval [office minus inhospital rates], -5.8% to 1.9%; 5% noninferiority: P < .001). Physicians indicated that for procedures performed in an office vs a hospital, there were fewer delays >15 minutes (16% vs 35%; P < .001) and patient response was more often "very positive." Physicians considered the office location "very convenient" more frequently than the hospital location (85% vs 27%; P < .001). The safety profile for the insertion of the Reveal LINQ ICM is excellent irrespective of insertion environment. These results may expand site of service options for LINQ insertion. Copyright © 2016 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.
Generic oncology drugs: are they all safe?
Yang, Y Tony; Nagai, Sumimasa; Chen, Brian K; Qureshi, Zaina P; Lebby, Akida A; Kessler, Samuel; Georgantopoulos, Peter; Raisch, Dennis W; Sartor, Oliver; Hermanson, Terhi; Kane, Robert C; Hrushesky, William J; Riente, Joshua J; Norris, LeAnn B; Bobolts, Laura R; Armitage, James O; Bennett, Charles L
2016-11-01
Although the availability of generic oncology drugs allows access to contemporary care and reduces costs, there is international variability in the safety of this class of drugs. In this Series paper, we review clinical, policy, safety, and regulatory considerations for generic oncology drugs focusing on the USA, Canada, the European Union (EU), Japan, China, and India. Safety information about generic formulations is reviewed from one agent in each class, for heavy metal drugs (cisplatin), targeted agents (imatinib), and cytotoxic agents (docetaxel). We also review regulatory reports from Japan and the USA, countries with the largest pharmaceutical expenditures. Empirical studies did not identify safety concerns in the USA, Canada, the EU, and Japan, where regulations and enforcement are strong. Although manufacturing problems for generic pharmaceuticals exist in India, where 40% of all generic pharmaceuticals used in the USA are manufactured, increased inspections and communication by the US Food and Drug Administration are occurring, facilitating oversight and enforcement. No safety outbreaks among generic oncology drugs were reported in developed countries. For developing countries, oversight is less intensive, and concerns around drug safety still exist. Regulatory agencies should collaboratively develop procedures to monitor the production, shipment, storage, and post-marketing safety of generic oncology drugs. Regulatory agencies for each country should also aim towards identical definitions of bioequivalence, the cornerstone of regulatory approval. Copyright © 2016 Elsevier Ltd. All rights reserved.
78 FR 39587 - Uniform Procedures for State Highway Safety Grant Programs
Federal Register 2010, 2011, 2012, 2013, 2014
2013-07-02
... DEPARTMENT OF TRANSPORTATION National Highway Traffic Safety Administration 23 CFR Parts 1200... 2127-AL29 Uniform Procedures for State Highway Safety Grant Programs AGENCY: National Highway Traffic... governing the implementation of State highway safety grant programs as amended by the Moving Ahead for...
23 CFR 1200.40 - Expiration of the Highway Safety Plan.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 23 Highways 1 2013-04-01 2013-04-01 false Expiration of the Highway Safety Plan. 1200.40 Section 1200.40 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE...
23 CFR 1200.40 - Expiration of the Highway Safety Plan.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 23 Highways 1 2014-04-01 2014-04-01 false Expiration of the Highway Safety Plan. 1200.40 Section 1200.40 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE...
DOE Office of Scientific and Technical Information (OSTI.GOV)
Todd Potts, T.; Hylko, J.M.
2008-07-01
A Regulated Metals Plan (RMP) was implemented for outdoor work activities involving the removal and disposition of approximately 4,000 deteriorated waste drums containing 236 metric tonnes (260 tons) of lead turnings from various, unspecified machine shop facilities at the Paducah Gaseous Diffusion Plant. Until exposure monitoring could prove otherwise, the work area established for processing the drums was conservatively defined as a Lead Regulated Area (LRA) subject to the Occupational Safety and Health Administration's Lead Standard found in Title 29 of the Code of Federal Regulations, Part 1910.1025. The vast majority of the analytical results for the industrial hygiene breathingmore » zone samples collected and tested for arsenic, beryllium, cadmium, chromium, lead, nickel, selenium, silver, and thallium using the National Institute for Occupational Safety and Health's analytical method 7300 were equivalent to the laboratory detection limits for each analyte. All results were less than 6% of their respective Permissible Exposure Limits (PEL), except for one nickel result that was approximately 17% of its PEL. The results provided justification to eventually down-post the LRA to existing employee protection requirements. In addition to removing the deteriorated drums and accompanying debris, the success of this project was quantified in terms of zero recordable injuries. The primary contributor in achieving this success was the sharing and communication of information between management, safety, and the field teams. Specifically, this was what the employees needed (and wanted) to hear when justifying the suspension of the RMP for the processing of drums containing metal turnings. Daily briefings on the status of the project and field monitoring results were just as important as maintaining budget and schedule milestones. Also, the Environmental, Safety and Health organization maintained its presence by continuing to monitor evolving field conditions to ensure the effectiveness of its plans and procedures. (authors)« less
Sedation/anaesthesia in paediatric radiology
Arlachov, Y; Ganatra, R H
2012-01-01
Objectives In this article we will give a comprehensive literature review on sedation/general anaesthesia (S/GA) and discuss the international variations in practice and options available for S/GA for imaging children. Methods The key articles were obtained primarily from PubMed, MEDLINE, ERIC, NHS Evidence and The Cochrane Library. Results Recently, paediatric radiology has seen a surge of diagnostic and therapeutic procedures, some of which require children to be still and compliant for up to 1 h. It is difficult and sometimes even impossible to obtain quick and high-quality images without employing sedating techniques in certain children. As with any medical procedure, S/GA in radiological practice is not without risks and can have potentially disastrous consequences if mismanaged. In order to reduce any complications and practice safety in radiological units, it is imperative to carry out pre-sedation assessments of children, obtain parental/guardian consent, monitor them closely before, during and after the procedure and have adequate equipment, a safe environment and a well-trained personnel. Conclusion Although the S/GA techniques, sedative drugs and personnel involved vary from country to country, the ultimate goal of S/GA in radiology remains the same; namely, to provide safety and comfort for the patients. Advances in knowledge Imaging children under general anaesthesia is becoming routine and preferred by operators because it ensures patient conformity and provides a more controlled environment. PMID:22898157
Investigative bronchoprovocation and bronchoscopy in airway diseases.
Busse, William W; Wanner, Adam; Adams, Kenneth; Reynolds, Herbert Y; Castro, Mario; Chowdhury, Badrul; Kraft, Monica; Levine, Robert J; Peters, Stephen P; Sullivan, Eugene J
2005-10-01
Basic and clinical research strategies used for many lung diseases have depended on volunteer subjects undergoing bronchoscopy to establish access to the airways to collect biological specimens and tissue, perhaps with added bronchoprovocation in asthma syndromes. These procedures have yielded a wealth of important scientific information. Since the last critical review more than a decade ago, some of the techniques and applications have changed, and untoward events have occurred, raising safety concerns and increasing institutional review scrutiny. To reappraise these investigational methods in the context of current knowledge, the National Heart, Lung, and Blood Institute and the National Institute of Allergy and Infectious Diseases of the National Institutes of Health convened a working group to review these procedures used for airway disease research, emphasizing asthma and chronic obstructive pulmonary disease. The group reaffirmed the scientific importance of investigative bronchoscopy and bronchoprovocation, even as less invasive technologies evolve. The group also considered the safety of bronchoscopy and bronchoprovocation with methacholine and antigen to be acceptable for volunteer subjects and patients, but stressed the need to monitor this closely and to emphasize proper training of participating medical research personnel. Issues were raised about vulnerable volunteers, especially children who need surrogates for informed consent. This review of investigative bronchoscopy and bronchoprovocation could serve as the basis for future guidelines for the use of these procedures in the United States.
Ward, Denham S; Williams, Mark R; Berkenbosch, John W; Bhatt, Maala; Carlson, Douglas; Chappell, Phillip; Clark, Randall M; Constant, Isabelle; Conway, Aaron; Cravero, Joseph; Dahan, Albert; Dexter, Franklin; Dionne, Raymond; Dworkin, Robert H; Gan, Tong J; Gozal, David; Green, Steven; Irwin, Michael G; Karan, Suzanne; Kochman, Michael; Lerman, Jerrold; Lightdale, Jenifer R; Litman, Ronald S; Mason, Keira P; Miner, James; O'Connor, Robert E; Pandharipande, Pratik; Riker, Richard R; Roback, Mark G; Sessler, Daniel I; Sexton, Anne; Tobin, Joseph R; Turk, Dennis C; Twersky, Rebecca S; Urman, Richard D; Weiss, Mark; Wunsch, Hannah; Zhao-Wong, Anna
2018-05-17
The Sedation Consortium on Endpoints and Procedures for Treatment, Education, and Research, established by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks, a public-private partnership with the US Food and Drug Administration, convened a second meeting of sedation experts from a variety of clinical specialties and research backgrounds to develop recommendations for procedural sedation research. The previous meeting addressed efficacy and patient- and/or family-centered outcomes. This meeting addressed issues of safety, which was defined as "the avoidance of physical or psychological harm." A literature review identified 133 articles addressing safety measures in procedural sedation clinical trials. After basic reporting of vital signs, the most commonly measured safety parameter was oxygen saturation. Adverse events were inconsistently defined throughout the studies. Only 6 of the 133 studies used a previously validated measure of safety. The meeting identified methodological problems associated with measuring infrequent adverse events. With a consensus discussion, a set of core and supplemental measures were recommended to code for safety in future procedural clinical trials. When adopted, these measures should improve the integration of safety data across studies and facilitate comparisons in systematic reviews and meta-analyses.
CSHM: Web-based safety and health monitoring system for construction management.
Cheung, Sai On; Cheung, Kevin K W; Suen, Henry C H
2004-01-01
This paper describes a web-based system for monitoring and assessing construction safety and health performance, entitled the Construction Safety and Health Monitoring (CSHM) system. The design and development of CSHM is an integration of internet and database systems, with the intent to create a total automated safety and health management tool. A list of safety and health performance parameters was devised for the management of safety and health in construction. A conceptual framework of the four key components of CSHM is presented: (a) Web-based Interface (templates); (b) Knowledge Base; (c) Output Data; and (d) Benchmark Group. The combined effect of these components results in a system that enables speedy performance assessment of safety and health activities on construction sites. With the CSHM's built-in functions, important management decisions can theoretically be made and corrective actions can be taken before potential hazards turn into fatal or injurious occupational accidents. As such, the CSHM system will accelerate the monitoring and assessing of performance safety and health management tasks.
A Smartphone-Based Driver Safety Monitoring System Using Data Fusion
Lee, Boon-Giin; Chung, Wan-Young
2012-01-01
This paper proposes a method for monitoring driver safety levels using a data fusion approach based on several discrete data types: eye features, bio-signal variation, in-vehicle temperature, and vehicle speed. The driver safety monitoring system was developed in practice in the form of an application for an Android-based smartphone device, where measuring safety-related data requires no extra monetary expenditure or equipment. Moreover, the system provides high resolution and flexibility. The safety monitoring process involves the fusion of attributes gathered from different sensors, including video, electrocardiography, photoplethysmography, temperature, and a three-axis accelerometer, that are assigned as input variables to an inference analysis framework. A Fuzzy Bayesian framework is designed to indicate the driver’s capability level and is updated continuously in real-time. The sensory data are transmitted via Bluetooth communication to the smartphone device. A fake incoming call warning service alerts the driver if his or her safety level is suspiciously compromised. Realistic testing of the system demonstrates the practical benefits of multiple features and their fusion in providing a more authentic and effective driver safety monitoring. PMID:23247416
Chang, Beverly; Kaye, Alan D; Diaz, James H; Westlake, Benjamin; Dutton, Richard P; Urman, Richard D
2015-04-07
This study examines the impact of procedural locations and types of anesthetics on patient outcomes in non-operating room anesthesia (NORA) locations. The National Anesthesia Clinical Outcomes Registry database was examined to compare OR to NORA anesthetic complications and patient demographics. The National Anesthesia Clinical Outcomes Registry database was examined for all patient procedures from 2010 to 2013. A total of 12,252,846 cases were analyzed, with 205 practices contributing information, representing 1494 facilities and 7767 physician providers. Cases were separated on the basis of procedure location, OR, or NORA. Subgroup analysis examined outcomes from specific subspecialties. Non-OR anesthesia procedures were performed on a higher percentage of patients older than 50 years (61.92% versus 55.56%, P < 0.0001). Monitored anesthesia care (MAC) (20.15%) and sedation (2.05%) were more common in NORA locations. The most common minor complications were postoperative nausea and vomiting (1.06%), inadequate pain control (1.01%), and hemodynamic instability (0.62%). The most common major complications were serious hemodynamic instability (0.10%) and upgrade of care (0.10%). There was a greater incidence of complications in cardiology and radiology locations. Overall mortality was higher in OR versus NORA (0.04% versus 0.02%, P < 0.0001). Subcategory analysis showed increased incidence of death in cardiology and radiology locations (0.05%). Non-OR anesthesia procedures have lower morbidity and mortality rates than OR procedures, contrary to some previously published studies. However, the increased complication rates in both the cardiology and radiology locations may need to be the target of future safety investigations. Providers must ensure proper monitoring of patients, and NORA locations need to be held to the same standard of care as the main operating room. Further studies need to identify at-risk patients and procedures that may predispose patients to complications.
Chang, Beverly; Kaye, Alan D; Diaz, James H; Westlake, Benjamin; Dutton, Richard P; Urman, Richard D
2018-03-01
This study examines the impact of procedural locations and types of anesthetics on patient outcomes in non-operating room anesthesia (NORA) locations. The National Anesthesia Clinical Outcomes Registry database was examined to compare OR to NORA anesthetic complications and patient demographics. The National Anesthesia Clinical Outcomes Registry database was examined for all patient procedures from 2010 to 2013. A total of 12,252,846 cases were analyzed, with 205 practices contributing information, representing 1494 facilities and 7767 physician providers. Cases were separated on the basis of procedure location, OR, or NORA. Subgroup analysis examined outcomes from specific subspecialties. NORA procedures were performed on a higher percentage of patients older than 50 years (61.92% versus 55.56%, P < 0.0001). Monitored anesthesia care (MAC) (20.15%) and sedation (2.05%) were more common in NORA locations. The most common minor complications were postoperative nausea and vomiting (1.06%), inadequate pain control (1.01%), and hemodynamic instability (0.62%). The most common major complications were serious hemodynamic instability (0.10%) and upgrade of care (0.10%). There was a greater incidence of complications in cardiology and radiology locations. Overall mortality was higher in OR versus NORA (0.04% versus 0.02%, P < 0.0001). Subcategory analysis showed increased incidence of death in cardiology and radiology locations (0.05%). NORA procedures have lower morbidity and mortality rates than OR procedures, contrary to some previously published studies. However, the increased complication rates in both the cardiology and radiology locations may need to be the target of future safety investigations. Providers must ensure proper monitoring of patients, and NORA locations need to be held to the same standard of care as the main operating room. Further studies need to identify at-risk patients and procedures that may predispose patients to complications.
Tukey, Melissa H; Wiener, Renda Soylemez
2014-03-01
At some academic hospitals, medical procedure services are being developed to provide supervision for residents performing bedside procedures in hopes of improving patient safety and resident education. There is limited knowledge of the impact of such services on procedural complication rates and resident procedural training opportunities. To determine the impact of a medical procedure service (MPS) on patient safety and resident procedural training opportunities. Retrospective cohort analysis comparing characteristics and outcomes of procedures performed by the MPS versus the primary medical service. Consecutive adults admitted to internal medicine services at a large academic hospital who underwent a bedside medical procedure (central venous catheterization, thoracentesis, paracentesis, lumbar puncture) between 1 July 2010 and 31 December 2011. The primary outcome was a composite rate of major complications. Secondary outcomes included resident participation in bedside procedures and use of "best practice" safety process measures. We evaluated 1,707 bedside procedures (548 by the MPS, 1,159 by the primary services). There were no differences in the composite rate of major complications (1.6 % vs. 1.9 %, p = 0.71) or resident participation in bedside procedures (57.0 % vs. 54.3 %, p = 0.31) between the MPS and the primary services. Procedures performed by the MPS were more likely to be successfully completed (95.8 % vs. 92.8 %, p = 0.02) and to use best practice safety process measures, including use of ultrasound guidance when appropriate (96.8 % vs. 90.0 %, p = 0.0004), avoidance of femoral venous catheterization (89.5 vs. 82.7 %, p = 0.02) and involvement of attending physicians (99.3 % vs. 57.0 %, p < 0.0001). Although use of a MPS did not significantly affect the rate of major complications or resident opportunities for training in bedside procedures, it was associated with increased use of best practice safety process measures.
Comella, Kristin; Silbert, Robert; Parlo, Michelle
2017-01-13
Stromal vascular fraction (SVF) can easily be obtained from a mini-lipoaspirate procedure of fat tissue and platelet rich plasma (PRP) can be obtained from peripheral blood. The SVF contains a mixture of cells including ADSCs and growth factors and has been depleted of the adipocyte (fat cell) population. We evaluated the safety and efficacy of administering SVF and PRP intra-discally into patients with degenerative disc disease. A total of 15 patients underwent a local tumescent liposuction procedure to remove approximately 60 ml of fat tissue. The fat was separated to isolate the SVF and the cells were delivered into the disc nucleus of patients with degenerative disc disease. The subjects were then monitored for adverse events, range of motion, visual analog scale (VAS), present pain intensity (PPI), Oswestry Disability Index (ODI), Beck Depression Inventory (BDI), Dallas Pain Questionnaire and Short Form (SF)-12 scores over a period of 6 months. Safety events were followed for 12 months. No severe adverse events (SAEs) were reported during a 12 month follow up period with no incidences of infection. Patients demonstrated statistically significant improvements in several parameters including flexion, pain ratings, VAS, PPI, and short form questionnaires. In addition, both ODI and BDI data was trending positive and a majority of patients reported improvements in their Dallas Pain Questionnaire scores. Overall, patients were pleased with the treatment results. More importantly, the procedure demonstrated a strong safety profile with no severe adverse events or complications linked to the therapy. Trial registration NCT02097862. Name of registry: www.clinicaltrials.gov . https://clinicaltrials.gov/ct2/show/NCT02097862?term=bioheart&rank=6 . Date of registration: March 25, 2014; Date of enrollment: March 2014.
23 CFR Appendix B to Part 1200 - HIGHWAY SAFETY PROGRAM COST SUMMARY (HS-217)
Code of Federal Regulations, 2013 CFR
2013-04-01
... 23 Highways 1 2013-04-01 2013-04-01 false HIGHWAY SAFETY PROGRAM COST SUMMARY (HS-217) B APPENDIX B TO PART 1200 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR...
23 CFR Appendix B to Part 1200 - Highway Safety Program Cost Summary (HS-217)
Code of Federal Regulations, 2014 CFR
2014-04-01
... 23 Highways 1 2014-04-01 2014-04-01 false Highway Safety Program Cost Summary (HS-217) B Appendix B to Part 1200 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR...
49 CFR 193.2605 - Maintenance procedures.
Code of Federal Regulations, 2013 CFR
2013-10-01
... Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS FACILITIES: FEDERAL SAFETY STANDARDS Maintenance § 193.2605 Maintenance procedures. (a) Each operator shall determine...
49 CFR 193.2605 - Maintenance procedures.
Code of Federal Regulations, 2011 CFR
2011-10-01
... Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS FACILITIES: FEDERAL SAFETY STANDARDS Maintenance § 193.2605 Maintenance procedures. (a) Each operator shall determine...
Lama, Javier R; Karuna, Shelly T; Grant, Shannon P; Swann, Edith M; Ganoza, Carmela; Segura, Patricia; Montano, Silvia M; Lacherre, Martin; De Rosa, Stephen C; Buchbinder, Susan; Sanchez, Jorge; McElrath, M Juliana; Lemos, Maria P
2016-01-01
Rectal and genital sampling in HIV prevention trials permits assessments at the site of HIV entry. Yet the safety and acceptability of circumcision and sigmoidoscopy (and associated abstinence recommendations) are unknown in uncircumcised men who have sex with men (MSM) at high risk of HIV infection. Twenty-nine HIV-seronegative high-risk Peruvian MSM agreed to elective sigmoidoscopy biopsy collections (weeks 2 and 27) and circumcision (week 4) in a 28-week cohort study designed to mimic an HIV vaccine study mucosal collection protocol. We monitored adherence to abstinence recommendations, procedure-related complications, HIV infections, peripheral immune activation, and retention. Twenty-three (79.3%) underwent a first sigmoidoscopy, 21 (72.4%) were circumcised, and 16 (55.2%) completed a second sigmoidoscopy during the study period. All who underwent procedures completed the associated follow-up safety visits. Those completing the procedures reported they were well tolerated, and complication rates were similar to those reported in the literature. Immune activation was detected during the healing period (1 week post-sigmoidoscopy, 6 weeks post-circumcision), including increases in CCR5+CD4+T cells and α4β7+CD4+T cells. Most participants adhered to post-circumcision abstinence recommendations whereas reduced adherence occurred post-sigmoidoscopy. Rectosigmoid mucosal and genital tissue collections were safe in high-risk MSM. Although the clinical implications of the post-procedure increase in peripheral immune activation markers are unknown, they reinforce the need to provide ongoing risk reduction counseling and support for post-procedure abstinence recommendations. Future HIV vaccine studies should also consider the effects of mucosal and tissue collections on peripheral blood endpoints in trial design and analysis. ClinicalTrials.gov NCT02630082.
Monitoring circuit for reactor safety systems
Keefe, Donald J.
1976-01-01
The ratio between the output signals of a pair of reactor safety channels is monitored. When ratio falls outside of a predetermined range, it indicates that one or more of the safety channels has malfunctioned.
49 CFR 193.2635 - Monitoring corrosion control.
Code of Federal Regulations, 2010 CFR
2010-10-01
....2635 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS FACILITIES: FEDERAL SAFETY STANDARDS Maintenance § 193.2635 Monitoring corrosion control...
Systems safety monitoring using the National Full-Scale Aerodynamic Complex Bar Chart Monitor
NASA Technical Reports Server (NTRS)
Jung, Oscar
1990-01-01
Attention is given to the Bar Chart Monitor system designed for safety monitoring of all model and facility test-related articles in wind tunnels. The system's salient features and its integration into the data acquisition system are discussed.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 21 Food and Drugs 2 2014-04-01 2014-04-01 false Monier-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition, Food and Drug Administration (November 1985...-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 21 Food and Drugs 2 2010-04-01 2010-04-01 false Monier-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition, Food and Drug Administration (November 1985...-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition...
Code of Federal Regulations, 2012 CFR
2012-04-01
... 21 Food and Drugs 2 2012-04-01 2012-04-01 false Monier-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition, Food and Drug Administration (November 1985...-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition...
Code of Federal Regulations, 2013 CFR
2013-04-01
... 21 Food and Drugs 2 2013-04-01 2013-04-01 false Monier-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition, Food and Drug Administration (November 1985...-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition...
Code of Federal Regulations, 2011 CFR
2011-04-01
... 21 Food and Drugs 2 2011-04-01 2011-04-01 false Monier-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition, Food and Drug Administration (November 1985...-Williams Procedure (With Modifications) for Sulfites in Food, Center for Food Safety and Applied Nutrition...
49 CFR 193.2503 - Operating procedures.
Code of Federal Regulations, 2013 CFR
2013-10-01
...: FEDERAL SAFETY STANDARDS Operations § 193.2503 Operating procedures. Each operator shall follow one or more manuals of written procedures to provide safety in normal operation and in responding to an... 49 Transportation 3 2013-10-01 2013-10-01 false Operating procedures. 193.2503 Section 193.2503...
49 CFR 193.2503 - Operating procedures.
Code of Federal Regulations, 2011 CFR
2011-10-01
...: FEDERAL SAFETY STANDARDS Operations § 193.2503 Operating procedures. Each operator shall follow one or more manuals of written procedures to provide safety in normal operation and in responding to an... 49 Transportation 3 2011-10-01 2011-10-01 false Operating procedures. 193.2503 Section 193.2503...
49 CFR 193.2503 - Operating procedures.
Code of Federal Regulations, 2014 CFR
2014-10-01
...: FEDERAL SAFETY STANDARDS Operations § 193.2503 Operating procedures. Each operator shall follow one or more manuals of written procedures to provide safety in normal operation and in responding to an... 49 Transportation 3 2014-10-01 2014-10-01 false Operating procedures. 193.2503 Section 193.2503...
49 CFR 193.2503 - Operating procedures.
Code of Federal Regulations, 2012 CFR
2012-10-01
...: FEDERAL SAFETY STANDARDS Operations § 193.2503 Operating procedures. Each operator shall follow one or more manuals of written procedures to provide safety in normal operation and in responding to an... 49 Transportation 3 2012-10-01 2012-10-01 false Operating procedures. 193.2503 Section 193.2503...
Vaccine safety monitoring systems in developing countries: an example of the Vietnam model.
Ali, Mohammad; Rath, Barbara; Thiem, Vu Dinh
2015-01-01
Only few health intervention programs have been as successful as vaccination programs with respect to preventing morbidity and mortality in developing countries. However, the success of a vaccination program is threatened by rumors and misunderstanding about the risks of vaccines. It is short-sighted to plan the introduction of vaccines into developing countries unless effective vaccine safety monitoring systems are in place. Such systems that track adverse events following immunization (AEFI) is currently lacking in most developing countries. Therefore, any rumor may affect the entire vaccination program. Public health authorities should implement the safety monitoring system of vaccines, and disseminate safety issues in a proactive mode. Effective safety surveillance systems should allow for the conduct of both traditional and alternative epidemiologic studies through the use of prospective data sets. The vaccine safety data link implemented in Vietnam in mid-2002 indicates that it is feasible to establish a vaccine safety monitoring system for the communication of vaccine safety in developing countries. The data link provided the investigators an opportunity to evaluate AEFI related to measles vaccine. Implementing such vaccine safety monitoring system is useful in all developing countries. The system should be able to make objective and clear communication regarding safety issues of vaccines, and the data should be reported to the public on a regular basis for maintaining their confidence in vaccination programs.
DOE Office of Scientific and Technical Information (OSTI.GOV)
Lattin, F.G.; Paul, D.G.; Jakubowski, E.M.
1994-12-31
The Real Time Analytical Platform (RTAP) is designed to provide mobile, real-time monitoring support to ensure protection of worker safety in areas where military unique compounds are used and stored, and at disposal sites. Quantitative analysis of low-level vapor concentrations in air is accomplished through sorbent-based collection with subsequent thermal desorption into a gas chromatograph (GC) equipped with a variety of detectors. The monitoring system is characterized by its sensitivity (ability to measure at low concentrations), selectivity (ability to filter out interferences), dynamic range and linearity, real time mode (versus methods requiring extensive sample preparation procedures), and ability to interfacemore » with complimentary GC detectors. This presentation describes an RTAP analytical method for analyzing lewisite, an arsenical compound, that consists of a GC screening technique with an Electron Capture Detector (ECD), and a confirmation technique using an Atomic Emission Detector (AED). Included in the presentation is a description of quality assurance objectives in the monitoring system, and an assessment of method accuracy, precision and detection levels.« less
Trial of a novel endoscopic tattooing biopsy forceps on animal model
Si, Jian-Min; Sun, Lei-Min; Fan, Yu-Jing; Wang, Liang-Jing
2005-01-01
AIM: To tattoo gastric mucosa with a novel medical device which could be used to monitor and follow-up gastric mucosal lesions. METHODS: Combining endoscopic biopsy with sclerotherapy injection, we designed a new device that could perform biopsy and injection simultaneously. We performed endoscopies on a pig by using a novel endoscope tattoo biopsy forceps for 15 mo. At the same time, we used two-step method combining sclerotherapy injection needle with endoscopic biopsy. The acuity, inflammation and duration of endoscopy were compared between two methods. RESULTS: Compared with the old two-step method, although the inflammation induced by our new device was similar, the duration of procedure was markedly decreased and the acuity of tattooing was better than the old two-step method. All characteristics of the novel device complied with national safety guidelines. Follow-up gastroscopy after 15 mo showed the stained site with injection of 1:100 0.5 mL of India ink was still markedly visible with little inflammatory reaction. CONCLUSION: Endoscopic tattooing biopsy forceps can be widely used in monitoring precancerous lesions. Its safety and effectiveness has been established in animals. PMID:15793881
Training and outcome monitoring in robotic urologic surgery.
Liberman, Daniel; Trinh, Quoc-Dien; Jeldres, Claudio; Valiquette, Luc; Zorn, Kevin C
2011-11-08
The use of robot-assisted laparoscopic technology is rapidly expanding, with applicability in numerous disciplines of surgery. Training to perform robot-assisted laparoscopic urological procedures requires a motivated learner, a motivated teacher or proctor, a curriculum with stepwise learning objectives, and regular access to a training robot. In light of the many constraints that limit surgical training, animal models should be utilized to quantifiably improve the surgical skills of residents and surgical fellows, before these skills are put into practice on patients. A system based on appropriate supervision, graduated responsibility, real-time feedback, and objective measure of progress has proven to be safe and effective. Surgical team education directed towards cohesion is perhaps the most important aspect of training. At present, there are very few published guidelines for the safe introduction of robotic urologic surgery at an institution. Increasing evidence demonstrates the effects of learning curve and surgical volume on oncological and functional outcomes in robotic surgery (RS). This necessitates the introduction of mechanisms and guidelines by which trainee surgeons can attain a sufficient level of skill, without compromising the safety of patients. Guidelines for outcome monitoring following RS should be developed, to ensure patient safety and sufficient baseline surgeon skill.
Clerici, P; Guercio, A
2010-01-01
The proposed model is aimed at assessing work-related stress and consists of a preliminary phase during which the Organization is monitored, Indexes and stressors are defined, characterized and then weighted; existing symptoms (if any) are also identified. A 'Probability vs. Severity' Matrix is then built up as a result: these tasks can profitably be performed by a technical professional, typically the Responsible of the Safety and Health Committee. According to found evidences, a second phase, strictly based upon the application of psychosocial research tools, might be needed to investigate group of workers that resulted troublesome during the preliminary phase. The preliminary phase of investigation on organizational stressors and indexes can be easily and successfully integrated with the 'Safety Assessment' steps provided for the B-BS protocol, also aimed at monitoring the organizational wellbeing and consequently acting on the workers' behavior. The model has been specifically designed for Small and Medium Enterprises, with the global objective of preventing accidents at work due to misbehavior and distraction, by correctly and safely applying operational procedures and mutual relationships.
Howell, Ann-Marie; Burns, Elaine M; Hull, Louise; Mayer, Erik; Sevdalis, Nick; Darzi, Ara
2017-02-01
Patient safety incident reporting systems (PSRS) have been established for over a decade, but uncertainty remains regarding the role that they can and ought to play in quantifying healthcare-related harm and improving care. To establish international, expert consensus on the purpose of PSRS regarding monitoring and learning from incidents and developing recommendations for their future role. After a scoping review of the literature, semi-structured interviews with experts in PSRS were conducted. Based on these findings, a survey-based questionnaire was developed and subsequently completed by a larger expert panel. Using a Delphi approach, consensus was reached regarding the ideal role of PSRSs. Recommendations for best practice were devised. Forty recommendations emerged from the Delphi procedure on the role and use of PSRS. Experts agreed reporting system should not be used as an epidemiological tool to monitor the rate of harm over time or to appraise the relative safety of hospitals. They agreed reporting is a valuable mechanism for identifying organisational safety needs. The benefit of a national system was clear with respect to medication error, device failures, hospital-acquired infections and never events as these problems often require solutions at a national level. Experts recommended training for senior healthcare professionals in incident investigation. Consensus recommendation was for hospitals to take responsibility for creating safety solutions locally that could be shared nationally. We obtained reasonable consensus among experts on aims and specifications of PSRS. This information can be used to reflect on existing and future PSRS, and their role within the wider patient safety landscape. The role of PSRS as instruments for learning needs to be elaborated and developed further internationally. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.
Anesthesia and sedation in pediatric gastrointestinal endoscopic procedures: A review
Dar, Abdul Q; Shah, Zahoor A
2010-01-01
Gastrointestinal (GI) endoscopic procedure has become an essential modality for evaluation and treatment of GI diseases. Intravenous (IV) sedation and General Anesthesia (GA) have both been employed to minimize discomfort and provide amnesia. Both these procedures require, at the very least, monitoring of the level of consciousness, pulmonary ventilation, oxygenation and hemodynamics. Although GI endoscopy is considered safe, the procedure has a potential for complications. Increased awareness of the complications associated with sedation during GI endoscopy in children, and involving the anesthesiologists in caring for these children, may be optimal for safety. Belonging to a younger age group, having a higher ASA class and undergoing IV sedation were identified as risk factors for developing complications. Reported adverse events included inadequate sedation, low oxygen saturation, airway obstruction, apnea needing bag mask ventilation, excitement and agitation, hemorrhage and perforation. A complication rate of 1.2% was associated with procedures performed under GA, as compared to 3.7% of complications associated with IV sedation. IV sedation was seen to be independently associated with a cardiopulmonary complication rate 5.3% times higher when compared to GA. GA can therefore be considered safer and more effective in providing comfort and amnesia. PMID:21160616
Strengthening safety compliance in nuclear power operations: a role-based approach.
Martínez-Córcoles, Mario; Gracia, Francisco J; Tomás, Inés; Peiró, José M
2014-07-01
Safety compliance is of paramount importance in guaranteeing the safe running of nuclear power plants. However, it depends mostly on procedures that do not always involve the safest outcomes. This article introduces an empirical model based on the organizational role theory to analyze the influence of legitimate sources of expectations (procedures formalization and leadership) on workers' compliance behaviors. The sample was composed of 495 employees from two Spanish nuclear power plants. Structural equation analysis showed that, in spite of some problematic effects of proceduralization (such as role conflict and role ambiguity), procedure formalization along with an empowering leadership style lead to safety compliance by clarifying a worker's role in safety. Implications of these findings for safety research are outlined, as well as their practical implications. © 2014 Society for Risk Analysis.
Student manual, Book 2: Orientation to occupational safety compliance in DOE
DOE Office of Scientific and Technical Information (OSTI.GOV)
Colley, D.L.
1993-10-01
This is a student hand-book an Occupational Safety Compliance in DOE. Topics include the following: Electrical; materials handling & storage; inspection responsibilities & procedures; general environmental controls; confined space entry; lockout/tagout; office safety, ergonomics & human factors; medical & first aid, access to records; construction safety; injury/illness reporting system; and accident investigation procedures.
Image-Directed Fine-needle Aspiration Biopsy of the Thyroid with Safety-engineered Devices
DOE Office of Scientific and Technical Information (OSTI.GOV)
Sibbitt, Randy R., E-mail: THESIBB2@aol.com; Palmer, Dennis J., E-mail: lyonscreek@aol.com; Sibbitt, Wilmer L., E-mail: wsibbitt@salud.unm.edu
2011-10-15
Purpose: The purpose of the present study was to integrate safety-engineered devices into outpatient fine-needle aspiration (FNA) biopsy of the thyroid in an interventional radiology practice. Materials and Methods: The practice center is a tertiary referral center for image-directed FNA thyroid biopsies in difficult patients referred by the primary care physician, endocrinologist, or otolaryngologist. As a departmental quality of care and safety improvement program, we instituted integration of safety devices into our thyroid biopsy procedures and determined the effect on outcome (procedural pain, diagnostic biopsies, inadequate samples, complications, needlesticks to operator, and physician satisfaction) before institution of safety devices (54more » patients) and after institution of safety device implementation (56 patients). Safety devices included a patient safety technology-the mechanical aspirating syringe (reciprocating procedure device), and a health care worker safety technology (antineedlestick safety needle). Results: FNA of thyroid could be readily performed with the safety devices. Safety-engineered devices resulted in a 49% reduction in procedural pain scores (P < 0.0001), a 56% reduction in significant pain (P < 0.002), a 21% increase in operator satisfaction (P < 0.0001), and a 5% increase in diagnostic specimens (P = 0.5). No needlesticks to health care workers or patient injuries occurred during the study. Conclusions: Safety-engineered devices to improve both patient and health care worker safety can be successfully integrated into diagnostic FNA of the thyroid while maintaining outcomes and improving safety.« less
Monitoring of Thermal Protection Systems Using Robust Self-Organizing Optical Fiber Sensing Networks
NASA Technical Reports Server (NTRS)
Richards, Lance
2013-01-01
The general aim of this work is to develop and demonstrate a prototype structural health monitoring system for thermal protection systems that incorporates piezoelectric acoustic emission (AE) sensors to detect the occurrence and location of damaging impacts, and an optical fiber Bragg grating (FBG) sensor network to evaluate the effect of detected damage on the thermal conductivity of the TPS material. Following detection of an impact, the TPS would be exposed to a heat source, possibly the sun, and the temperature distribution on the inner surface in the vicinity of the impact measured by the FBG network. A similar procedure could also be carried out as a screening test immediately prior to re-entry. The implications of any detected anomalies in the measured temperature distribution will be evaluated for their significance in relation to the performance of the TPS during re-entry. Such a robust TPS health monitoring system would ensure overall crew safety throughout the mission, especially during reentry
Independent data monitoring committees: Preparing a path for the future
Hess, Connie N.; Roe, Matthew T.; Gibson, C. Michael; Temple, Robert J.; Pencina, Michael J.; Zarin, Deborah A.; Anstrom, Kevin J.; Alexander, John H.; Sherman, Rachel E.; Fiedorek, Fred T.; Mahaffey, Kenneth W.; Lee, Kerry L.; Chow, Shein-Chung; Armstrong, Paul W.; Califf, Robert M.
2014-01-01
Independent data monitoring committees (IDMCs) were introduced to monitor patient safety and study conduct in randomized clinical trials (RCTs), but certain challenges regarding the utilization of IDMCs have developed. First, the roles and responsibilities of IDMCs are expanding, perhaps due to increasing trial complexity and heterogeneity regarding medical, ethical, legal, regulatory, and financial issues. Second, no standard for IDMC operating procedures exists, and there is uncertainty about who should determine standards and whether standards should vary with trial size and design. Third, considerable variability in communication pathways exist across IDMC interfaces with regulatory agencies, academic coordinating centers, and sponsors. Finally, there has been a substantial increase in the number of RCTs using IDMCs, yet there is no set of qualifications to help guide the training and development of the next generation of IDMC members. Recently, an expert panel of representatives from government, industry, and academia assembled at the Duke Clinical Research Institute to address these challenges and to develop recommendations for the future utilization of IDMCs in RCTs. PMID:25066551
Wang, Hai-Nan; Chen, Wen; Fu, Zheng; Du, Wen-min; He, Jia
2008-03-01
Traditional Chinese medicine (TCM) injection has become one of the hotspots in the new TCM research and development. The serious adverse drug reactions happened in clinical have arosed attention widely in the whole society. It's very urgent to monitor the post-marketing safety of TCM injections. This paper elucidated the pharmacovigilance's necessity in the post-marketing safety monitoring of TCM injections, basing on the reason of safety problem of TCM injections and the future developing trend of adverse drug reaction monitoring. Also, this paper introduced the rapid signal detection method of spontaneous reporting system database by data mining technology.
Detection of errant laser beams
NASA Astrophysics Data System (ADS)
Taylor, Arthur F. D. S.; Edwards, Stanley A.; Barrett, J. A.; Bandle, Anthony M.
1990-10-01
The new generation of automated laser machine tools poses problems for those responsible for setting safety standards. While traditional safeguarding will frustrate full exploitation of this hybrid technology, wholesale abandonment of effective containment in favour of safety monitoring and control systems is unlikely to be acceptable. Long term, quantitative risk assessment will resolve this dilemma. Short term, guide lines will have to be derived from practical considerations of the laser facility design, materials, primary safety devices and procedures. Earlier risk assessments are reviewed relative to the emerging perspective of high average power laser installations. Aspects of extended beam delivery systems and equipment utilization and maintenance are examined to assess possible interaction with operational safety and in particular the potential to adversely influence errant laser beam occurrances (ELBO). To satisfy international safety standards for a laser enclosure which offers flexibility and is cost effective a detection system is described which continuously surveys the inside of the enclosure. Extensive trials have been carried out with high average power lasers (up to 10kW) where a range of engineering materials has been exposed to a laser beam. It is shown that the ratio of detection and shut down time to the burn through time can be an acceptable risk and thus indicate which materials will prove adequate.
Use of computer-assisted drug therapy outside the operating room.
Singh, Preet Mohinder; Borle, Anuradha; Goudra, Basavana G
2016-08-01
The number of procedures performed in the out-of-operating room setting under sedation has increased many fold in recent years. Sedation techniques aim to achieve rapid patient turnover through the use of short-acting drugs with minimal residual side-effects (mainly propofol and opioids). Even for common procedures, the practice of sedation delivery varies widely among providers. Computer-based sedation models have the potential to assist sedation providers and offer a more consistent and safer sedation experience for patients. Target-controlled infusions using propofol and other short-acting opioids for sedation have shown promising results in terms of increasing patient safety and allowing for more rapid wake-up times. Target-controlled infusion systems with real-time patient monitoring can titrate drug doses automatically to maintain optimal depth of sedation. The best recent example of this is the propofol-based Sedasys sedation system. Sedasys redefined individualized sedation by the addition of an automated clinical parameter that monitors depth of sedation. However, because of poor adoption and cost issues, it has been recently withdrawn by the manufacturer. Present automated drug delivery systems can assist in the provision of sedation for out-of-operating room procedures but cannot substitute for anesthesia providers. Use of the available technology has the potential to improve patient outcomes, decrease provider workload, and have a long-term economic impact on anesthesia care delivery outside of the operating room.
Monitoring Java Programs with Java PathExplorer
NASA Technical Reports Server (NTRS)
Havelund, Klaus; Rosu, Grigore; Clancy, Daniel (Technical Monitor)
2001-01-01
We present recent work on the development Java PathExplorer (JPAX), a tool for monitoring the execution of Java programs. JPAX can be used during program testing to gain increased information about program executions, and can potentially furthermore be applied during operation to survey safety critical systems. The tool facilitates automated instrumentation of a program's late code which will then omit events to an observer during its execution. The observer checks the events against user provided high level requirement specifications, for example temporal logic formulae, and against lower level error detection procedures, for example concurrency related such as deadlock and data race algorithms. High level requirement specifications together with their underlying logics are defined in the Maude rewriting logic, and then can either be directly checked using the Maude rewriting engine, or be first translated to efficient data structures and then checked in Java.
Pahl, Christina; Ebelt, Henning; Sayahkarajy, Mostafa; Supriyanto, Eko; Soesanto, Amiliana
2017-08-15
This paper proposes a robotic Transesophageal Echocardiography (TOE) system concept for Catheterization Laboratories. Cardiovascular disease causes one third of all global mortality. TOE is utilized to assess cardiovascular structures and monitor cardiac function during diagnostic procedures and catheter-based structural interventions. However, the operation of TOE underlies various conditions that may cause a negative impact on performance, the health of the cardiac sonographer and patient safety. These factors have been conflated and evince the potential of robot-assisted TOE. Hence, a careful integration of clinical experience and Systems Engineering methods was used to develop a concept and physical model for TOE manipulation. The motion of different actuators of the fabricated motorized system has been tested. It is concluded that the developed medical system, counteracting conflated disadvantages, represents a progressive approach for cardiac healthcare.
Maia, Mélanie R; Simões, Alexandra; Lapão, Luís V
2018-01-01
HAITooL information system design and implementation was based on Design Science Research Methodology, ensuring full participation, in close collaboration, of researchers and a multidisciplinary team of healthcare professionals. HAITooL enables effective monitoring of antibiotic resistance, antibiotic use and provides an antibiotic prescription decision-supporting system by clinicians, strengthening the patient safety procedures. The design, development and implementation process reveals benefits in organizational and behavior change with significant success. Leadership commitment multidisciplinary team and mainly informaticians engagement was crucial to the implementation process. Participants' motivation and the final product delivery and evolution depends on that.
NASA Astrophysics Data System (ADS)
Mihlan, G. J.; Ungers, L. J.; Smith, R. K.; Mitchell, R. I.; Jones, J. H.
1983-05-01
A preliminary control technology assessment survey was conducted at the facility which manufactures N-channel metal oxide semiconductor (NMOS) integrated circuits. The facility has industrial hygiene review procedures for evaluating all new and existing process equipment. Employees are trained in safety, use of personal protective equipment, and emergency response. Workers potentially exposed to arsenic are monitored for urinary arsenic levels. The facility should be considered a candidate for detailed study based on the diversity of process operations encountered and the use of state-of-the-art technology and process equipment.
Code of Federal Regulations, 2012 CFR
2012-10-01
... TRANSPORTATION RULES OF PRACTICE PROCEDURES FOR SURFACE TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION.... This part is designed to ensure adequate and coordinated consideration of safety integration issues, by... subject to the Board's jurisdiction. It establishes the procedures by which the Board will consider safety...
Code of Federal Regulations, 2013 CFR
2013-10-01
... TRANSPORTATION RULES OF PRACTICE PROCEDURES FOR SURFACE TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION.... This part is designed to ensure adequate and coordinated consideration of safety integration issues, by... subject to the Board's jurisdiction. It establishes the procedures by which the Board will consider safety...
Code of Federal Regulations, 2011 CFR
2011-10-01
... TRANSPORTATION RULES OF PRACTICE PROCEDURES FOR SURFACE TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION.... This part is designed to ensure adequate and coordinated consideration of safety integration issues, by... subject to the Board's jurisdiction. It establishes the procedures by which the Board will consider safety...
Code of Federal Regulations, 2014 CFR
2014-10-01
... TRANSPORTATION RULES OF PRACTICE PROCEDURES FOR SURFACE TRANSPORTATION BOARD CONSIDERATION OF SAFETY INTEGRATION.... This part is designed to ensure adequate and coordinated consideration of safety integration issues, by... subject to the Board's jurisdiction. It establishes the procedures by which the Board will consider safety...
77 FR 62224 - Hanford Tank Farms Flammable Gas Safety Strategy
Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-12
... believes that actions are necessary to install real time monitoring to measure tank ventilation flowrates... monitoring. In its August letter, the Board noted that DOE's SAC for flammable gas monitoring exhibited a... flammable gas monitoring, it remained inadequate as a credited safety control. The SAC is less reliable than...
Safety compliance and safety climate: A repeated cross-sectional study in the oil and gas industry.
Kvalheim, Sverre A; Dahl, Øyvind
2016-12-01
Violations of safety rules and procedures are commonly identified as a causal factor in accidents in the oil and gas industry. Extensive knowledge on effective management practices related to improved compliance with safety procedures is therefore needed. Previous studies of the causal relationship between safety climate and safety compliance demonstrate that the propensity to act in accordance with prevailing rules and procedures is influenced to a large degree by workers' safety climate. Commonly, the climate measures employed differ from one study to another and identical measures of safety climate are seldom tested repeatedly over extended periods of time. This research gap is addressed in the present study. The study is based on a survey conducted four times among sharp-end workers of the Norwegian oil and gas industry (N=31,350). This is done by performing multiple tests (regression analysis) over a period of 7years of the causal relationship between safety climate and safety compliance. The safety climate measure employed is identical across the 7-year period. Taking all periods together, the employed safety climate model explained roughly 27% of the variance in safety compliance. The causal relationship was found to be stable across the period, thereby increasing the reliability and the predictive validity of the factor structure. The safety climate factor that had the most powerful effect on safety compliance was work pressure. The factor structure employed shows high predictive validity and should therefore be relevant to organizations seeking to improve safety in the petroleum sector. The findings should also be relevant to other high-hazard industries where safety rules and procedures constitute a central part of the approach to managing safety. Copyright © 2016 Elsevier Ltd and National Safety Council. All rights reserved.
Kern-Goldberger, Andrew S; Hessels, Amanda J; Saiman, Lisa; Quittell, Lynne M
2018-03-14
Recruiting both pediatric and adult participants for clinical trials in CF is currently of paramount importance as numerous new therapies are being developed. However, recruitment is challenging as parents of children with CF and adults with CF cite safety concerns as a principal barrier to enrollment. In conjunction with the CF Foundation (CFF) Data Safety Monitoring Board (DSMB), a pilot brochure was developed to inform patients and parents of the multiple levels of safety monitoring; the CFF simultaneously created an infographic representing the safety monitoring process. This study explores the attitudes and beliefs of CF patients and families regarding safety monitoring and clinical trial participation, and elicits feedback regarding the educational materials. Semi-structured interviews were conducted using a pre-tested interview guide and audio-recorded during routine CF clinic visits. Participants included 5 parents of children with CF <16years old; 5 adolescents and young adults with CF 16-21years old; and 5 adults with CF ≥22years old from pediatric and adult CF centers. The study team performed systematic text condensation analysis of the recorded interviews using an iterative process. Four major thematic categories with subthemes emerged as supported by exemplar quotations: attitudes toward clinical trials, safety values, conceptualizing the safety monitoring process, and priorities for delivery of patient education. Participant feedback was used to revise the pilot brochure; text was shortened, unfamiliar words clarified (e.g., "pipeline"), abbreviations eliminated, and redundancy avoided. Qualitative analysis of CF patient and family interviews provided insights into barriers to participation in clinical trials, safety concerns, perspectives on safety monitoring and educational priorities. We plan a multicenter study to determine if the revised brochure reduces knowledge, attitude and practice barriers regarding participation in CF clinical trials. Copyright © 2018 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.
Federal Register 2010, 2011, 2012, 2013, 2014
2011-08-31
... DEPARTMENT OF TRANSPORTATION Federal Motor Carrier Safety Administration Notice of Procedural... Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice; extension of effective date. SUMMARY..., Transportation Specialist, Office of Enforcement and Compliance, Federal Motor Carrier Safety Administration...
29 CFR 1926.1081 - Pre-dive procedures.
Code of Federal Regulations, 2010 CFR
2010-07-01
... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Diving General Operations Procedures § 1926.1081 Pre-dive procedures. Note: The requirements applicable to construction work under this section are...
29 CFR 1926.1083 - Post-dive procedures.
Code of Federal Regulations, 2010 CFR
2010-07-01
... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Diving General Operations Procedures § 1926.1083 Post-dive procedures. Note: The requirements applicable to construction work under this section are...
29 CFR 1926.1082 - Procedures during dive.
Code of Federal Regulations, 2010 CFR
2010-07-01
... Regulations Relating to Labor (Continued) OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR (CONTINUED) SAFETY AND HEALTH REGULATIONS FOR CONSTRUCTION Diving General Operations Procedures § 1926.1082 Procedures during dive. Note: The requirements applicable to construction work under this section are...
Radiation Safety in Nuclear Medicine Procedures.
Cho, Sang-Geon; Kim, Jahae; Song, Ho-Chun
2017-03-01
Since the nuclear disaster at the Fukushima Daiichi Nuclear Power Plant in 2011, radiation safety has become an important issue in nuclear medicine. Many structured guidelines or recommendations of various academic societies or international campaigns demonstrate important issues of radiation safety in nuclear medicine procedures. There are ongoing efforts to fulfill the basic principles of radiation protection in daily nuclear medicine practice. This article reviews important principles of radiation protection in nuclear medicine procedures. Useful references, important issues, future perspectives of the optimization of nuclear medicine procedures, and diagnostic reference level are also discussed.
Electrical safety during transplantation.
Amicucci, G L; Di Lollo, L; Fiamingo, F; Mazzocchi, V; Platania, G; Ranieri, D; Razzano, R; Camin, G; Sebastiani, G; Gentile, P
2010-01-01
Technologic innovations enable management of medical equipment and power supply systems, with improvements that can affect the technical aspects, economics, and quality of medical service. Herein are outlined some technical guidelines, proposed by Istituto Superiore per la Prevenzione e la Sicurezza del Lavoro, for increasing the effectiveness of the power supply system and the safety of patients and surgeons in the operating room, with particular focus on transplantation. The dependence of diagnoses and therapies on operation of the electrical equipment can potentially cause great risk to patients. Moreover, it is possible that faulty electrical equipment could produce current that may flow through the patient. Because patients are particularly vulnerable when their natural protection is considerably decreased, as during transplantation or other surgery, power supply systems must operate with a high degree of reliability and quality to prevent risk, and must be designed to reduce hazards from direct and indirect contact. Reliability of the power supply system is closely related to the quality of the project, choice of materials, and management of the system (eg, quality and frequency of servicing). Among the proposed guidelines, other than normal referencing, are (1) adoption of a monitoring system to improve the quality of the electrical parameters in the operating room, (2) institution of emergency procedures for management of electrical faults, (3) a procedure for management of fires in the operating room, (4) and maintenance interventions and inspections of medical devices to maintain minimal requirements of safety and performance. Copyright 2010 Elsevier Inc. All rights reserved.
40 CFR 75.32 - Determination of monitor data availability for standard missing data procedures.
Code of Federal Regulations, 2011 CFR
2011-07-01
... availability for standard missing data procedures. 75.32 Section 75.32 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.32 Determination of monitor data availability for standard missing data procedures...
40 CFR 75.32 - Determination of monitor data availability for standard missing data procedures.
Code of Federal Regulations, 2014 CFR
2014-07-01
... availability for standard missing data procedures. 75.32 Section 75.32 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.32 Determination of monitor data availability for standard missing data procedures...
40 CFR 75.32 - Determination of monitor data availability for standard missing data procedures.
Code of Federal Regulations, 2013 CFR
2013-07-01
... availability for standard missing data procedures. 75.32 Section 75.32 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.32 Determination of monitor data availability for standard missing data procedures...
40 CFR 75.32 - Determination of monitor data availability for standard missing data procedures.
Code of Federal Regulations, 2010 CFR
2010-07-01
... availability for standard missing data procedures. 75.32 Section 75.32 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.32 Determination of monitor data availability for standard missing data procedures...
40 CFR 75.32 - Determination of monitor data availability for standard missing data procedures.
Code of Federal Regulations, 2012 CFR
2012-07-01
... availability for standard missing data procedures. 75.32 Section 75.32 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY (CONTINUED) AIR PROGRAMS (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.32 Determination of monitor data availability for standard missing data procedures...
49 CFR 214.337 - On-track safety procedures for lone workers.
Code of Federal Regulations, 2013 CFR
2013-10-01
... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection... performing routine inspection or minor correction may use individual train detection to establish on-track... worker retains an absolute right to use on-track safety procedures other than individual train detection...
49 CFR 214.337 - On-track safety procedures for lone workers.
Code of Federal Regulations, 2012 CFR
2012-10-01
... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection... performing routine inspection or minor correction may use individual train detection to establish on-track... worker retains an absolute right to use on-track safety procedures other than individual train detection...
49 CFR 214.337 - On-track safety procedures for lone workers.
Code of Federal Regulations, 2014 CFR
2014-10-01
... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection... performing routine inspection or minor correction may use individual train detection to establish on-track... worker retains an absolute right to use on-track safety procedures other than individual train detection...
49 CFR 214.337 - On-track safety procedures for lone workers.
Code of Federal Regulations, 2011 CFR
2011-10-01
... RAILROAD ADMINISTRATION, DEPARTMENT OF TRANSPORTATION RAILROAD WORKPLACE SAFETY Roadway Worker Protection... performing routine inspection or minor correction may use individual train detection to establish on-track... worker retains an absolute right to use on-track safety procedures other than individual train detection...
A "Fine" Relationship: OSHA and Schools.
ERIC Educational Resources Information Center
O'Neill, Steve
2001-01-01
To avoid California schools' experience with Occupational Safety and Health Administration fines, principals should comply with safety regulations, establish quick-response procedures, take care of chemicals, prepare site personnel for state OSHA visits, inform safety personnel about procedures for appealing citations, keep good records, and work…
49 CFR 397.201 - Purpose and scope of the procedures.
Code of Federal Regulations, 2010 CFR
2010-10-01
... CARRIER SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS TRANSPORTATION OF HAZARDOUS MATERIALS; DRIVING AND PARKING RULES Preemption Procedures § 397.201 Purpose and... Administrator, who is the chief executive of the Federal Motor Carrier Safety Administration, an agency of the...
23 CFR 630.1008 - State-level processes and procedures.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 630.1008 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1008 State-level processes and... sustain their respective work zone safety and mobility policies. State-level processes and procedures...
23 CFR 630.1008 - State-level processes and procedures.
Code of Federal Regulations, 2012 CFR
2012-04-01
... 630.1008 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1008 State-level processes and... sustain their respective work zone safety and mobility policies. State-level processes and procedures...
23 CFR 630.1008 - State-level processes and procedures.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 630.1008 Highways FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1008 State-level processes and... sustain their respective work zone safety and mobility policies. State-level processes and procedures...
The natural lifespan of a safety policy: violations and system migration in anaesthesia.
de Saint Maurice, Guillaume; Auroy, Yves; Vincent, Charles; Amalberti, René
2010-08-01
Safety rules continue growing rapidly, as if constraining human behaviour was the unique avenue for reaching ultimate safety. Safety rules are essential for a safe system, but their multiplication can have counterproductive effects. To monitor, in an anaesthesia ward, compliance with a process-oriented safety rule, and understand barriers and facilitators which help and hinder physicians from following guidelines. The rule stipulated that the day before surgery anaesthetists had to record in the patient's file the drugs to be used for the anaesthesia (induction, maintenance, airway control). Compliance was assessed before introduction of the rule, immediately after, at 6 months and at 12 months. All medical staff were blinded to the protocol. 717 patient records were included. The results showed an initial compliance with policy, reaching 86% for some items (never 100%). Reduction began within 6 months and returned almost to initial levels within a year. One individual showed poor compliance throughout the study but even initially compliant doctors experienced a reduction. Compliance was higher for complex surgery but lower for unscheduled surgery and when job pressure was greater. Compliance eroded over time. A major trigger of erosion seemed to be lack of continued compliance by a senior member of staff. Rules and procedures constitute fragile safety barriers, and it may be better to forego introducing a new safety rule if it is not considered as a priority by staff and is therefore vulnerable to sacrifice in case of conflict with competitive demands.
Sladakovic, Izidora; Ellis, Angela E; Divers, Stephen J
2017-01-01
OBJECTIVE To evaluate the efficacy and safety of gastroscopy and biopsy of the proventriculus and ventriculus in pigeons (Columba livia). ANIMALS 15 adult pigeons. PROCEDURES Each pigeon was anesthetized, and the upper gastrointestinal tract (from the cervical portion of the esophagus to the ventriculus) was endoscopically evaluated by use of a rigid endoscope inserted orally. Saline (0.9% NaCl) solution was orally infused to achieve lumen dilation and visibility. Two mucosal biopsy specimens were collected from each of the proventriculus and ventriculus, histologically evaluated, and graded for crush artifacts and depth. Pigeons were monitored for adverse effects for 3 to 6 days after the procedure, after which they were euthanized for necropsy. RESULTS Gastroscopy via the oral approach provided excellent visibility of the lumen and mucosal surfaces of the proventriculus and cranial portion of the ventriculus and was safe provided that appropriate precautions were taken. Two intraoperative deaths occurred at the beginning of the study; following procedure refinement, no additional deaths occurred. No major adverse effects of the procedure were detected in the remaining 13 pigeons during the postoperative monitoring period or at necropsy. Diagnostic quality of proventriculus specimens was adequate for 10 of 13 pigeons. Eight of 13 ventriculus specimens were of inadequate quality, and only 3 were of adequate quality. CONCLUSIONS AND CLINICAL RELEVANCE Gastroscopy was useful for evaluating the lumen and mucosal surface of the proventriculus and ventriculus in pigeons, and biopsy of those organs was safely performed with the appropriate technique. Further evaluation of these techniques is needed in birds with clinical disease and birds of other species.
Maddox, Thomas M; Plomondon, Mary E; Petrich, Megan; Tsai, Thomas T; Gethoffer, Hans; Noonan, Gregory; Gillespie, Brian; Box, Tamara; Fihn, Stephen D; Jesse, Robert L; Rumsfeld, John S
2014-12-01
A "learning health care system", as outlined in a recent Institute of Medicine report, harnesses real-time clinical data to continuously measure and improve clinical care. However, most current efforts to understand and improve the quality of care rely on retrospective chart abstractions complied long after the provision of clinical care. To align more closely with the goals of a learning health care system, we present the novel design and initial results of the Veterans Affairs (VA) Clinical Assessment, Reporting, and Tracking (CART) program-a national clinical quality program for VA cardiac catheterization laboratories that harnesses real-time clinical data to support clinical care and quality-monitoring efforts. Integrated within the VA electronic health record, the CART program uses a specialized software platform to collect real-time patient and procedural data for all VA patients undergoing coronary procedures in VA catheterization laboratories. The program began in 2005 and currently contains data on 434,967 catheterization laboratory procedures, including 272,097 coronary angiograms and 86,481 percutaneous coronary interventions, performed by 801 clinicians on 246,967 patients. We present the initial data from the CART program and describe 3 quality-monitoring programs that use its unique characteristics-procedural and complications feedback to individual labs, coronary device surveillance, and major adverse event peer review. The VA CART program is a novel approach to electronic health record design that supports clinical care, quality, and safety in VA catheterization laboratories. Its approach holds promise in achieving the goals of a learning health care system. Published by Elsevier Inc.
New types of time domain reflectometry sensing waveguides for bridge scour monitoring
NASA Astrophysics Data System (ADS)
Lin, Chih-Ping; Wang, Kai; Chung, Chih-Chung; Weng, Yu-Wen
2017-07-01
Scour is a major threat to bridge safety, especially in harsh fluvial environments. Real-time monitoring of bridge scour is still very limited due to the lack of robust and economic scour monitoring device. Time domain reflectometry (TDR) is an emerging waveguide-based technique holding great promise to develop more durable scour monitoring devices. This study presents new types of TDR sensing waveguides in forms of either sensing rod or sensing wire, taking into account of the measurement range, durability, and ease of field installation. The sensing rod is composed of a hollow grooved steel rod paired up with a metal strip on the insulating groove, while the sensing wire consists of two steel strands with one of them coated with an insulating jacket. The measurement sensitivity is inevitably sacrificed when other properties such as the measurement range, field durability, and installation easiness are enhanced. Factors affecting the measurement sensitivity were identified and experimentally evaluated for better arranging the waveguide conductors. A data reduction method for scour-depth estimation without the need for identifying the sediment/water reflection and a two-step calibration procedure for rating propagation velocities were proposed to work with the new types of TDR sensing waveguides. Both the calibration procedure and the data reduction method were experimentally validated. The test results indicated that the new TDR sensing waveguide provides accurate scour depth measurements regardless of the sacrificed sensitivity. The insulating coating of the new TDR sensing waveguide was also demonstrated to be effective in extending the measurement range up to at least 15 m.
40 CFR 75.39 - Missing data procedures for sorbent trap monitoring systems.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 40 Protection of Environment 16 2010-07-01 2010-07-01 false Missing data procedures for sorbent... (CONTINUED) AIR PROGRAMS (CONTINUED) CONTINUOUS EMISSION MONITORING Missing Data Substitution Procedures § 75.39 Missing data procedures for sorbent trap monitoring systems. (a) If a primary sorbent trap...
Burn, Julie; Sims, Andrew J; Keltie, Kim; Patrick, Hannah; Welham, Sally A; Heaney, Liam G; Niven, Robert M
2017-10-01
Bronchial thermoplasty (BT) is a novel treatment for severe asthma. Its mode of action and ideal target patient group remain poorly defined, though clinical trials provided some evidence on efficacy and safety. This study presents procedural and short-term safety evidence from routine UK clinical practice. Patient characteristics and safety outcomes (procedural complications, 30-day readmission and accident and emergency (A&E) attendance, length of stay) were assessed using two independent data sources, the British Thoracic Society UK Difficult Asthma Registry (DAR) and Hospital Episodes Statistics (HES) database. A matched cohort (with records in both) was used to estimate safety outcome event rates and compare them with clinical trials. Between June 2011 and January 2015, 215 procedure records (83 patients; 68 treated in England) were available from DAR and 203 (85 patients) from HES. 152 procedures matched (59 patients; 6 centres), and of these, 11.2% reported a procedural complication, 11.8% resulted in emergency respiratory readmission, 0.7% in respiratory A&E attendance within 30 days (20.4% had at least one event) and 46.1% involved a post-procedure stay. Compared with published clinical trials which found lower hospitalisation rates, BT patients in routine clinical practice were, on average, older, had worse baseline lung function and asthma quality of life. A higher proportion of patients experienced adverse events compared with clinical trials. The greater severity of disease amongst patients treated in clinical practice may explain the observed rate of post-procedural stay and readmission. Study of long-term safety and efficacy requires continuing data collection.
de Merich, D; Pellicci, M; Serignoli, R
2010-01-01
Within the intelligence support and training to small and medium-sized enterprises (SMEs) and promoting a culture of health and safety at work, ISPESL is engaged on two fundamental pillars of activity: Consolidation of the national surveillance system of injuries through the promotion of methods and tools for the reconstruction of the dynamics incidental identification of causal determinants, with the aim of improving the capabilities of risk assessment of systems to prevent corporate. The promotion of good working practices, as Focal Point of the European Health and Safety at Work in Bilbao, the goal is to support prevention activities by providing business application examples of measures for improvement (technical, organizational, procedural) made in the proposing firms and validated by a technical appraisal conducted by ISPESL. Among the methodologies and tools that can be made available to companies in the operational management of health and safety in work activities, the approach to analyze and evaluate the behavior implemented by all persons within the company (managers, employees, workers) is a the most innovative preventive strategies that can be implemented to correct any improper practices behavioral wrongly tolerated in everyday work practice. The experience of Crown Aerosol Italy, the program "STOP TO ACCIDENTS, 2009 Best Practices award in the competition on the theme" Risk Assessment ", aims to demonstrate how the application of a method for monitoring behavior at work, shared in its planning with all those business, has not only reached but would assist the organization has developed at an individual level greater awareness and sense of responsibility also to their colleagues, by promoting good working practices.
A sensor monitoring system for telemedicine, safety and security applications
NASA Astrophysics Data System (ADS)
Vlissidis, Nikolaos; Leonidas, Filippos; Giovanis, Christos; Marinos, Dimitrios; Aidinis, Konstantinos; Vassilopoulos, Christos; Pagiatakis, Gerasimos; Schmitt, Nikolaus; Pistner, Thomas; Klaue, Jirka
2017-02-01
A sensor system capable of medical, safety and security monitoring in avionic and other environments (e.g. homes) is examined. For application inside an aircraft cabin, the system relies on an optical cellular network that connects each seat to a server and uses a set of database applications to process data related to passengers' health, safety and security status. Health monitoring typically encompasses electrocardiogram, pulse oximetry and blood pressure, body temperature and respiration rate while safety and security monitoring is related to the standard flight attendance duties, such as cabin preparation for take-off, landing, flight in regions of turbulence, etc. In contrast to previous related works, this article focuses on the system's modules (medical and safety sensors and associated hardware), the database applications used for the overall control of the monitoring function and the potential use of the system for security applications. Further tests involving medical, safety and security sensing performed in an real A340 mock-up set-up are also described and reference is made to the possible use of the sensing system in alternative environments and applications, such as health monitoring within other means of transport (e.g. trains or small passenger sea vessels) as well as for remotely located home users, over a wired Ethernet network or the Internet.
NASA Technical Reports Server (NTRS)
Pennington, D. F.; Man, T.; Persons, B.
1977-01-01
The DOT classification for transportation, the military classification for quantity distance, and hazard compatibility grouping used to regulate the transportation and storage of explosives are presented along with a discussion of tests used in determining sensitivity of propellants to an impact/shock environment in the absence of a large explosive donor. The safety procedures and requirements of a Scout launch vehicle, Western and Eastern Test Range, and the Minuteman, Delta, and Poseidon programs are reviewed and summarized. Requirements of the space transportation system safety program include safety reviews from the subsystem level to the completed payload. The Scout safety procedures will satisfy a portion of these requirements but additional procedures need to be implemented to comply with the safety requirements for Shuttle operation from the Eastern Test Range.
[Safety in intensive care medicine. Can we learn from aviation?].
Graf, J; Pump, S; Maas, W; Stüben, U
2012-05-01
Safety is of extraordinary value in commercial aviation. Therefore, sophisticated and complex systems have been developed to ensure safe operation. Within this system, the pilots are of specific concern: they form the human-machine interface and have a special responsibility in controlling and monitoring all aircraft systems. In order to prepare pilots for their challenging task, specific selection of suitable candidates is crucial. In addition, for every commercial pilot regulatory requirements demand a certain number of simulator training sessions and check flights to be completed at prespecified intervals. In contrast, career choice for intensive care medicine most likely depends on personal reasons rather than eligibility or aptitude. In intensive care medicine, auditing, licensing, or mandatory training are largely nonexistent. Although knowledge of risk management and safety culture in aviation can be transferred to the intensive care unit, the diversity of corporate culture and tradition of leadership and training will represent a barrier for the direct transfer of standards or procedures. To accomplish this challenging task, the analysis of appropriate fields of action with regard to structural requirements and the process of change are essential.
30 CFR 56.12007 - Junction box connection procedures.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Junction box connection procedures. 56.12007 Section 56.12007 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Electricity...
30 CFR 56.12007 - Junction box connection procedures.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Junction box connection procedures. 56.12007 Section 56.12007 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Electricity...
30 CFR 56.12007 - Junction box connection procedures.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Junction box connection procedures. 56.12007 Section 56.12007 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Electricity...
30 CFR 56.12007 - Junction box connection procedures.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Junction box connection procedures. 56.12007 Section 56.12007 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Electricity...
30 CFR 56.12007 - Junction box connection procedures.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Junction box connection procedures. 56.12007 Section 56.12007 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Electricity...
9 CFR 392.5 - Filing procedures.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 9 Animals and Animal Products 2 2010-01-01 2010-01-01 false Filing procedures. 392.5 Section 392.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOOD SAFETY AND..., Food Safety and Inspection Service, Room 2534 South Building, 1400 Independence Ave., SW., Washington...
Code of Federal Regulations, 2010 CFR
2010-04-01
... 23 Highways 1 2010-04-01 2010-04-01 false Application. 1200.10 Section 1200.10 Highways NATIONAL... PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS Application, Approval, and Funding of the Highway Safety Program § 1200.10 Application. Each fiscal year, a State's...
30 CFR 57.4330 - Surface firefighting, evacuation, and rescue procedures.
Code of Federal Regulations, 2010 CFR
2010-07-01
... LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Fire Prevention and Control Firefighting Procedures/alarms/drills § 57.4330 Surface... coordinated in advance with available firefighting organizations. (b) Fire alarm procedures or systems shall...
EMS providers' perceptions of safety climate and adherence to safe work practices.
Eliseo, Laura J; Murray, Kate A; White, Laura F; Dyer, Sophia; Mitchell, Patricia A; Fernandez, William G
2012-01-01
Occupational injuries are an important source of morbidity for emergency medical services (EMS) providers. Previous work has shown that employee perceptions of an organization's commitment to safety (i.e., safety climate) correlate with adherence to safe practices. To assess the association between perceived safety climate and compliance with safety procedures in an urban EMS system with >100,000 calls/year. EMS providers were issued a self-administered survey that included questions on demographics, years of experience, perceived safety climate, and adherence to safety procedures. Safety climate was assessed with a 20-item validated instrument. Adherence to safety procedures was assessed with a nine-item list of safety behaviors. Strict adherence to safety procedures was defined as endorsing "agree" or "strongly agree" on 80% of items. The effect of safety climate on compliance with safe practices was estimated using multiple logistic regression. One hundred ninety-six of 221 providers (89%) completed surveys; 74% were male; the median age was 36-40 years; and the median amount of experience was 8 years. One hundred twenty-seven of 196 respondents (65%) reported strict adherence to safe work practice. Factor analysis confirmed the original six-factor grouping of questions; frequent safety-related feedback/training was significantly associated with safe practices (odds ratio [OR] = 2.14, 95% confidence interval [CI] = 1.01-4.51). EMS workers perceiving a high degree of perceived safety climate was associated with twofold greater odds of self-reported level of strict adherence to safe work practices. Frequent safety-related feedback/training was the one dimension of safety climate that had the strongest association with adherence to safe workplace behaviors.
Developing and Implementing a Quality Assurance Strategy for Electroconvulsive Therapy.
Hollingsworth, Jessa; Baliko, Beverly; McKinney, Selina; Rosenquist, Peter
2018-04-17
The literature provides scant guidance in effective quality assurance strategies concerning the use of electroconvulsive therapy (ECT) for the treatment of psychiatric conditions. Numerous guidelines are published that provide guidance in the delivery of care; however, little has been done to determine how a program or facility might ensure compliance to best practice for safety, tolerability, and efficacy in performing ECT. The objective of this project was to create a quality assurance strategy specific to ECT. Determining standards for quality care and clarifying facility policy were key outcomes in establishing an effective quality assurance strategy. An audit tool was developed utilizing quality criteria derived from a systematic review of ECT practice guidelines, peer review, and facility policy. All ECT procedures occurring over a 2-month period of May to June 2017 were retrospectively audited and compared against target compliance rates set for the facility's ECT program. Facility policy was adapted to reflect quality standards, and audit findings were used to inform possible practice change initiatives, were used to create benchmarks for continuous quality monitoring, and were integrated into regular hospital quality meetings. Clarification on standards of care and the use of clinical auditing in ECT was an effective starting point in the development of a quality assurance strategy. Audit findings were successfully integrated into the hospital's overall quality program, and recognition of practice compliance informed areas for future quality development and policy revision in this small community-based hospital in the southeastern United States. This project sets the foundation for a quality assurance strategy that can be used to help monitor procedural safety and guide future improvement efforts in delivering ECT. Although it is just the first step in creating meaningful quality improvement, setting clear standards and identifying areas of greatest clinical need were crucial beginning for this hospital's growing program.
Mei, Qiang; Wang, Qiwei; Liu, Suxia; Zhou, Qiaomei; Zhang, Jingjing
2018-06-07
Based on the characteristics of small-scale enterprises, the improvement of occupational health and safety management systems (OHS MS) needs an effective intervention. This study proposed a structural equation model and examined the relationships of perceived organization support for safety (POSS), person-organization safety fit (POSF) and proactivity safety behaviors with safety management, safety procedures and safety hazards identification. Data were collected from 503 employees of 105 Chinese high-risk small-scale enterprises over 6 months. The results showed that both POSS and POSF were positively related to improvement in safety management, safety procedures and safety hazards identification through proactivity safety behaviors. Our findings provide a new perspective on organizational safety for improving OHS MS for small-scale enterprises and extend the application of proactivity safety behaviors.
Safety climate and the distracted driving experiences of truck drivers.
Swedler, David I; Pollack, Keshia M; Agnew, Jacqueline
2015-07-01
For truck drivers, distracted driving is a workplace behavior that increases occupational injury risk. We propose safety climate as an appropriate lens through which researchers can examine occupational distracted driving. Using a mixed methods study design, we surveyed truck drivers using the Safety Climate Questionnaire (SCQ) complemented by semi-structured interviews of experts on distracted driving and truck safety. Safety climate was assessed by using the entire SCQ as an overall climate score, followed by factor analysis that identified the following safety climate factors: Communications and Procedures; Management Commitment; and Work Pressure. In multivariate regression, the overall safety climate scale was associated with having ever experienced a crash and/or distraction-involved swerving. Interview participants described how these SCQ constructs could affect occupational distracted driving. To reduce distraction-related crashes in their organizations, management can adhere to safe policies and procedures, invest in engineering controls, and develop safer communication procedures. © 2015 Wiley Periodicals, Inc.
47 CFR 80.323 - Information furnished by an acknowledging station.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 47 Telecommunication 5 2010-10-01 2010-10-01 false Information furnished by an acknowledging station. 80.323 Section 80.323 Telecommunication FEDERAL COMMUNICATIONS COMMISSION (CONTINUED) SAFETY AND SPECIAL RADIO SERVICES STATIONS IN THE MARITIME SERVICES Safety Watch Requirements and Procedures Distress, Alarm, Urgency and Safety Procedures § 8...
46 CFR 160.016-5 - Procedure for approval.
Code of Federal Regulations, 2010 CFR
2010-10-01
...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Lamps, Safety, Flame, for Merchant Vessels § 160.016-5 Procedure for approval. (a) General. Flame safety lamps are approved for use on merchant vessels only by the... safety lamp for use on merchant vessels, submit one complete sample, together with four copies of an...
46 CFR 160.016-5 - Procedure for approval.
Code of Federal Regulations, 2013 CFR
2013-10-01
...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Lamps, Safety, Flame, for Merchant Vessels § 160.016-5 Procedure for approval. (a) General. Flame safety lamps are approved for use on merchant vessels only by the... safety lamp for use on merchant vessels, submit one complete sample, together with four copies of an...
46 CFR 160.016-5 - Procedure for approval.
Code of Federal Regulations, 2012 CFR
2012-10-01
...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Lamps, Safety, Flame, for Merchant Vessels § 160.016-5 Procedure for approval. (a) General. Flame safety lamps are approved for use on merchant vessels only by the... safety lamp for use on merchant vessels, submit one complete sample, together with four copies of an...
46 CFR 160.016-5 - Procedure for approval.
Code of Federal Regulations, 2014 CFR
2014-10-01
...: SPECIFICATIONS AND APPROVAL LIFESAVING EQUIPMENT Lamps, Safety, Flame, for Merchant Vessels § 160.016-5 Procedure for approval. (a) General. Flame safety lamps are approved for use on merchant vessels only by the... safety lamp for use on merchant vessels, submit one complete sample, together with four copies of an...
23 CFR 1200.62 - Pre-2013 fiscal year grants.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 23 Highways 1 2014-04-01 2014-04-01 false Pre-2013 fiscal year grants. 1200.62 Section 1200.62 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY GRANT PROGRAMS Special Provisions for...
23 CFR 1200.62 - Pre-2013 fiscal year grants.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 23 Highways 1 2013-04-01 2013-04-01 false Pre-2013 fiscal year grants. 1200.62 Section 1200.62 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY GRANT PROGRAMS Special Provisions for...
29 CFR 1987.100 - Purpose and scope.
Code of Federal Regulations, 2014 CFR
2014-07-01
... (CONTINUED) PROCEDURES FOR HANDLING RETALIATION COMPLAINTS UNDER SECTION 402 OF THE FDA FOOD SAFETY...) This part sets forth the procedures for, and interpretations of, section 402 of the FDA Food Safety.... Section 402 of the FDA Food Safety Modernization Act amended the Federal Food, Drug, and Cosmetic Act (FD...
30 CFR 56.4330 - Firefighting, evacuation, and rescue procedures.
Code of Federal Regulations, 2010 CFR
2010-07-01
... METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Fire Prevention and Control Firefighting Procedures/alarms/drills § 56.4330 Firefighting, evacuation... organizations. (b) Fire alarm procedures or systems shall be established to pomptly warn every person who could...
Carpentry and Finishing Procedures. Building Maintenance. Module II. Instructor's Guide.
ERIC Educational Resources Information Center
Hawk, Sam; Brunk, Art
This curriculum guide, keyed to the building maintenance competency profile developed by industry and education professionals, provides three units on carpentry and finishing procedures. The first unit, Exterior Carpentry, contains the following lessons: carpentry safety procedures, ladder and scaffolding safety, door installation/repair,…
[New international initiatives to create systems of effective risk prediction and food safety].
Efimochkinal, N R; Bagryantseva, E C; Dupouy, E C; Khotimchenko, S A; Permyakov, E V; Sheveleva, S A; Arnautov, O V
2016-01-01
Ensuring food safety is one of the most important problems that is directly related to health protection of the population. The problem is particularly relevant on aglobalscale because ofincreasingnumberoffood-borne diseases andimportance of the health consequence early detection. In accordance with the position of the Codex Alimentarius Commission, food safety concept also includes quality. In this case, creation of the national, supranational and international early warning systems related to the food safety, designed with the purpose to prevent or minimize risks on different stages of the food value chain in various countries, regions and climate zones specific to national nutrition and lifestyle in different groups of population, gains particular importance. The article describes the principles and working examples of international, supranational and national food safety early warning systems. Great importance is given to the hazards of microbial origin - emergent pathogens. Example of the rapid reaction to the appearance of cases, related to the melanin presence in infant formula, are presented. Analysis of the current food safety and quality control system in Russian Federation shows that main improvements are mostly related to the development of the efficient monitoring, diagnostics and rapid alert procedures forfood safety on interregional and international levels that will allow to estimate real contamination of food with the most dangerous pathogens, chemical and biological contaminants, and the development of the electronic database and scientifically proved algorithms for food safety and quality management for targeted prevention activities against existing and emerging microbiological and other etiology risks, and public health protection.
42 CFR 483.362 - Monitoring of the resident in and immediately after restraint.
Code of Federal Regulations, 2011 CFR
2011-10-01
... CARE FACILITIES Condition of Participation for the Use of Restraint or Seclusion in Psychiatric... use of emergency safety interventions must be physically present, continually assessing and monitoring... duration of the emergency safety intervention. (b) If the emergency safety situation continues beyond the...
42 CFR 483.362 - Monitoring of the resident in and immediately after restraint.
Code of Federal Regulations, 2010 CFR
2010-10-01
... CARE FACILITIES Condition of Participation for the Use of Restraint or Seclusion in Psychiatric... use of emergency safety interventions must be physically present, continually assessing and monitoring... duration of the emergency safety intervention. (b) If the emergency safety situation continues beyond the...
Vitse, J; Bekara, F; Bertheuil, N; Sinna, R; Chaput, B; Herlin, C
2017-02-01
Current data on upper extremity propeller flaps are poor and do not allow the assessment of the safety of this technique. A systematic literature review was conducted searching PubMed, EMBASE, and the Cochrane Library electronic databases, and the selection process was adapted from the preferred reporting items for systematic reviews and meta-analysis statement. The final analysis included ten relevant articles involving 117 flaps. The majority of flaps were used for the hand, distal wrist, and elbow. The radial artery perforator and ulnar artery perforator were the most frequently used flaps. The were 7% flaps with venous congestion and 3% with complete necrosis. No difference in complications rate was found for different flaps sites. Perforator-based propeller flaps appear to be an interesting procedure for covering soft tissue defects involving the upper extremities, even for large defects, but the procedure requires experience and close monitoring. II.
10 CFR 34.47 - Personnel monitoring.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...
10 CFR 34.47 - Personnel monitoring.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...
10 CFR 34.47 - Personnel monitoring.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 1 2014-01-01 2014-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...
10 CFR 34.47 - Personnel monitoring.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 1 2012-01-01 2012-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...
10 CFR 34.47 - Personnel monitoring.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 1 2013-01-01 2013-01-01 false Personnel monitoring. 34.47 Section 34.47 Energy NUCLEAR REGULATORY COMMISSION LICENSES FOR INDUSTRIAL RADIOGRAPHY AND RADIATION SAFETY REQUIREMENTS FOR INDUSTRIAL RADIOGRAPHIC OPERATIONS Radiation Safety Requirements § 34.47 Personnel monitoring. (a) The licensee may not...
Guo, Xin-E; Zhao, Yu-Bin; Xie, Yan-Ming; Zhao, Li-Cai; Li, Yan-Feng; Hao, Zhe
2013-09-01
To establish a nurse based post-marketing safety surveillance model for traditional Chinese medicine injections (TCMIs). A TCMIs safety monitoring team and a research hospital team engaged in the research, monitoring processes, and quality control processes were established, in order to achieve comprehensive, timely, accurate and real-time access to research data, to eliminate errors in data collection. A triage system involving a study nurse, as the first point of contact, clinicians and clinical pharmacists was set up in a TCM hospital. Following the specified workflow involving labeling of TCM injections and using improved monitoring forms it was found that there were no missing reports at the ratio of error was zero. A research nurse as the first and main point of contact in post-marketing safety monitoring of TCM as part of a triage model, ensures that research data collected has the characteristics of authenticity, accuracy, timeliness, integrity, and eliminate errors during the process of data collection. Hospital based monitoring is a robust and operable process.
Aust, H; Veltum, B; Wächtershäuser, T; Wulf, H; Eberhart, L
2014-02-01
Many anesthesia departments operate a pre-anesthesia assessment clinic (PAAC). Data regarding organization, equipment and structure of such clinics are not yet available. Information about modern anesthesiology techniques and procedures contributes to a reduction in emotional stress of the patients but such modern techniques often require additional technical hardware and costs and are not equally available. This survey examined the current structures of PAAC in the state of Hessen, demonstrated current concepts and associated these with the performance and the portfolio of procedures in these departments. An online survey was carried out. Data on structure, equipment, organization and available methods were compiled. In addition, anesthesia department personnel were asked to give individual subjective attitudes toward the premedication work. Of the anesthesia departments in Hessen 84 % participated in the survey of which 91 % operated a PAAC. A preoperative contact with the anesthesiologist who would perform anesthesia existed in only 19 % of the departments. Multimedia processing concepts for informed consent in a PAAC setting were in general rare. Many modern procedures and anesthesia techniques were broadly established independent of the hospital size. Regarding the individual and subjective attitudes of anesthetists towards the work, the psychological and medical importance of the pre-medication visit was considered to be very high. The PAACs are now well established. This may make economic sense but is accompanied by an anonymization of care in anesthesiology. The high quality, safety and availability of modern anesthesiology procedures and monitoring concepts should be communicated to patients all the more as an expression of trust and high patient safety. These factors can be facilitated in particular by multimedia tools which have as yet only been sparsely implemented in PAACs.
Allogeneic blood stem cell transplantation: considerations for donors.
Anderlini, P; Körbling, M; Dale, D; Gratwohl, A; Schmitz, N; Stroncek, D; Howe, C; Leitman, S; Horowitz, M; Gluckman, E; Rowley, S; Przepiorka, D; Champlin, R
1997-08-01
Allogeneic transplantation of cytokine-mobilized peripheral blood stem cells (PBSCs) is now being increasingly performed, but safety considerations for hematologically normal PBSC donors have not been fully addressed. Progenitors are generally mobilized for collection from normal donors using recombinant human granulocyte colony-stimulating factor (rhG-CSF). Although the short-term safety profile of rhG-CSF seems acceptable, experience remains limited and its optimal dose and schedule have not been defined. Minimal data exist regarding long-term safety of rhG-CSF, primarily derived from experience in patients with chronic neutropenia or cancer. An "ad hoc" workshop was recently convened among a group of investigators actively involved in the field of allogeneic stem cell transplantation to discuss the safety issues pertaining to normal PBSC donors. There was agreement on the following points: (1) On the basis of available data, it appears that rhG-CSF treatment and PBSC collection have an acceptable short-term safety profile in normal donors. However, the need for continued safety monitoring was recognized. (2) rhG-CSF doses up to 10 microg/kg/d show a consistent dose-response relationship with the mobilization (and collection) of CD34+ progenitor cells, and this dose is acceptable for routine clinical use. Whether higher doses are superior (or cost effective) remains to be determined, and they may produce more severe side effects. The potential risks of marked leukocytosis (arbitrarily defined as a leukocyte count of more than 70 x 10(9)/L) have been a concern, and rhG-CSF dose reduction is performed by many centers to maintain leukocyte counts below this level. (3) Transient post donation cytopenias, involving granulocytes, lymphocytes, and platelets, may occur and are at least partly related to the leukapheresis procedure. These are generally asymptomatic and self-limited; follow-up blood counts are not necessarily required. Reinfusion of autologous platelet-rich plasma should be considered for donors with expected postdonation thrombocytopenia (platelet count < 80 to 100 x 10(9)/L). (4) Donors should meet the eligibility criteria which apply to donors of apheresis platelets, with the exception that pediatric donors may also be considered. Any deviation from these criteria should have supporting documentation. There is insufficient information at this time to clearly establish definite contraindications for PBSC collection in a hematologically normal donor. Potential contraindications include the presence of inflammatory, autoimmune, or rheumatologic disorders, as well as atherosclerotic or cerebrovascular disease. (5) The creation of an International PBSC Donor Registry is desirable to facilitate monitoring the long-term effects of the procedure. Individual institutions or donor centers are encouraged to establish their own PBSC donor follow-up system, preferably with a standardized approach to data collection.
16 CFR 1301.7 - Test procedures.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 16 Commercial Practices 2 2012-01-01 2012-01-01 false Test procedures. 1301.7 Section 1301.7 Commercial Practices CONSUMER PRODUCT SAFETY COMMISSION CONSUMER PRODUCT SAFETY ACT REGULATIONS BAN OF UNSTABLE REFUSE BINS § 1301.7 Test procedures. (a) The refuse bin shall be tested by applying forces as...
Sommer, Doron D; Arbab-Tafti, Sadaf; Farrokhyar, Forough; Tewfik, Marc; Vescan, Allan; Witterick, Ian J; Rotenberg, Brian; Chandra, Rakesh; Weitzel, Erik K; Wright, Erin; Ramakrishna, Jayant
2018-02-27
The goal of this study was to develop and evaluate the impact of an aviation-style challenge and response sinus surgery-specific checklist on potential safety and equipment issues during sinus surgery at a tertiary academic health center. The secondary goal was to assess the potential impact of use of the checklist on surgical times during, before, and after surgery. This initiative is designed to be utilized in conjunction with the "standard" World Health Organization (WHO) surgical checklist. Although endoscopic sinus surgery is generally considered a safe procedure, avoidable complications and potential safety concerns continue to occur. The WHO surgical checklist does not directly address certain surgery-specific issues, which may be of particular relevance for endoscopic sinus surgery. This prospective observational pilot study monitored compliance with and compared the occurrence of safety and equipment issues before and after implementation of the checklist. Forty-seven consecutive endoscopic surgeries were audited; the first 8 without the checklist and the following 39 with the checklist. The checklist was compiled by evaluating the patient journey, utilizing the available literature, expert consensus, and finally reevaluation with audit type cases. The final checklist was developed with all relevant stakeholders involved in a Delphi method. Implementing this specific surgical checklist in 39 cases at our institution, allowed us to identify and rectify 35 separate instances of potentially unsafe, improper or inefficient preoperative setup. These incidents included issues with labeling of topical vasoconstrictor or injectable anesthetics (3, 7.7%) and availability, function and/or position of video monitors (2, 5.1%), endoscope (6, 15.4%), microdebrider (6, 15.4%), bipolar cautery (6, 15.4%), and suctions (12, 30.8%). The design and integration of this checklist for endoscopic sinus surgery, has helped improve efficiency and patient safety in the operating room setting. © 2018 ARS-AAOA, LLC.
[Project to enhance bone bank tissue storage and distribution procedures].
Huang, Jui-Chen; Wu, Chiung-Lan; Chen, Chun-Chuan; Chen, Shu-Hua
2011-10-01
Organ and tissue transplantation are now commonly preformed procedures. Improper organ bank handling procedures may increase infection risks. Execution accuracy in terms of tissue storage and distribution at our bone bank was 80%. We thus proposed an execution improvement project to enhance procedures in order to fulfill the intent of donors and ensure recipient safety. This project was designed to raise nurse professionalism, and ensure patient safety through enhanced tissue storage and distribution procedures. Education programs developed for this project focus on teaching standard operating procedures for bone and ligament storage and distribution, bone bank facility maintenance, trouble shooting and solutions, and periodic inspection systems. Cognition of proper storage and distribution procedures rose from 81% to 100%; Execution accuracy also rose from 80% to 100%. The project successfully conveyed concepts essential to the correct execution of organ storage and distribution procedures and proper organ bank facility management. Achieving and maintaining procedural and management standards is crucial to continued organ donations and the recipient safety.
40 CFR 63.2161 - What performance tests and other procedures must I use if I monitor brew ethanol?
Code of Federal Regulations, 2013 CFR
2013-07-01
... procedures must I use if I monitor brew ethanol? 63.2161 Section 63.2161 Protection of Environment... performance tests and other procedures must I use if I monitor brew ethanol? (a) You must conduct each... performance test simultaneously with brew ethanol monitoring to establish a brew-to-exhaust correlation...
40 CFR 63.2161 - What performance tests and other procedures must I use if I monitor brew ethanol?
Code of Federal Regulations, 2012 CFR
2012-07-01
... procedures must I use if I monitor brew ethanol? 63.2161 Section 63.2161 Protection of Environment... performance tests and other procedures must I use if I monitor brew ethanol? (a) You must conduct each... performance test simultaneously with brew ethanol monitoring to establish a brew-to-exhaust correlation...
40 CFR 63.2161 - What performance tests and other procedures must I use if I monitor brew ethanol?
Code of Federal Regulations, 2014 CFR
2014-07-01
... procedures must I use if I monitor brew ethanol? 63.2161 Section 63.2161 Protection of Environment... performance tests and other procedures must I use if I monitor brew ethanol? (a) You must conduct each... performance test simultaneously with brew ethanol monitoring to establish a brew-to-exhaust correlation...
A guide to safe field operations
Yobbi, D.K.; Yorke, T.H.; Mycyk, R.T.
1996-01-01
Most functions of the U.S. Geological Survey (USGS), Water Resources Division (WRD) require employees to participate in numerous field activities ranging from routine meetings with cooperators, other federal and public officials, and private citizens to potentially hazardous assignments, such as making flood measurements and scuba diving to service underwater instruments. It is paramount that each employee be aware of safety procedures and operational policies of the WRD to ensure that (1) their activities avoid or minimize personal injury to the employee, coworkers, or anyone in the vicinity of the field activity, and (2) their conduct does not infringe on the personal or property rights of any individual or organization. The purpose of the guide is to familiarize employees with the operational and safety procedures expected to be followed by each employee as a representative of the WRD. It is also intended as a training tool for all new employees and a document to be reviewed by each employee before undertaking a field assignment. It includes general procedures that are standard and applicable to all field operations, such as communication, vehicle operation, and adequate preparation for anticipated weather conditions. It also includes a discussion of specific procedures and safety considerations for most of the routine field assignments undertaken by hydrologists and hydrologic technicians of the WRD. The guide is not intended to be a technical handbook outlining step-by-step procedures for performing specific tasks or a comprehensive discussion of every possible activity that may be undertaken by a USGS employee. Employees are referred to the Techniques for Water-Resources Investigations (TWRI) series for specific technical procedures and to the U.S. Geological Survey Safety and Environmental Health Handbook 445-1-H (USGS, August 1989), USGS Occupational Hazards and Safety Procedures Handbook 445-2-H (December 1993), the WRD notebook on Safety Policy and Guidance Memoranda, and other references for procedures and safety issues related to nonroutine activities, such as operations on large vessels and aircraft.
Development of CMS monitoring procedures : technical summary.
DOT National Transportation Integrated Search
1998-04-01
This research study is concerned with the development of a set of procedures for monitoring congestion using GPS and GIS. These procedures are meant to be used more as a planning tool than for everyday traffic monitoring. Under this assumption, a ser...
23 CFR 1200.60 - Fiscal year 2013 Section 402 grants.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 23 Highways 1 2013-04-01 2013-04-01 false Fiscal year 2013 Section 402 grants. 1200.60 Section 1200.60 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY GRANT PROGRAMS Special Provisions...
23 CFR 1200.61 - Fiscal year 2013 Section 405 grants.
Code of Federal Regulations, 2013 CFR
2013-04-01
... 23 Highways 1 2013-04-01 2013-04-01 false Fiscal year 2013 Section 405 grants. 1200.61 Section 1200.61 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY GRANT PROGRAMS Special Provisions...
23 CFR 1200.60 - Fiscal year 2013 Section 402 grants.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 23 Highways 1 2014-04-01 2014-04-01 false Fiscal year 2013 Section 402 grants. 1200.60 Section 1200.60 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY GRANT PROGRAMS Special Provisions...
23 CFR 1200.61 - Fiscal year 2013 Section 405 grants.
Code of Federal Regulations, 2014 CFR
2014-04-01
... 23 Highways 1 2014-04-01 2014-04-01 false Fiscal year 2013 Section 405 grants. 1200.61 Section 1200.61 Highways NATIONAL HIGHWAY TRAFFIC SAFETY ADMINISTRATION AND FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION PROCEDURES FOR STATE HIGHWAY SAFETY PROGRAMS UNIFORM PROCEDURES FOR STATE HIGHWAY SAFETY GRANT PROGRAMS Special Provisions...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-05-07
... DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. FSIS-2011-0009] Changes... Availability of Compliance Guidelines AGENCY: Food Safety and Inspection Service, USDA. ACTION: Notice. SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing proposed new procedures that it intends to...
Federal Register 2010, 2011, 2012, 2013, 2014
2010-11-23
... Handling of Retaliation Complaints Under Section 219 of the Consumer Product Safety Improvement Act of 2008... Product Safety Improvement Act of 2008 (CPSIA) (75 FR 53533). In the August 31, 2010 notice, OSHA... Procedures for the Handling of Retaliation Complaints Under Section 219 of the Consumer Product Safety...
Model Development for Risk Assessment of Driving on Freeway under Rainy Weather Conditions
Cai, Xiaonan; Wang, Chen; Chen, Shengdi; Lu, Jian
2016-01-01
Rainy weather conditions could result in significantly negative impacts on driving on freeways. However, due to lack of enough historical data and monitoring facilities, many regions are not able to establish reliable risk assessment models to identify such impacts. Given the situation, this paper provides an alternative solution where the procedure of risk assessment is developed based on drivers’ subjective questionnaire and its performance is validated by using actual crash data. First, an ordered logit model was developed, based on questionnaire data collected from Freeway G15 in China, to estimate the relationship between drivers’ perceived risk and factors, including vehicle type, rain intensity, traffic volume, and location. Then, weighted driving risk for different conditions was obtained by the model, and further divided into four levels of early warning (specified by colors) using a rank order cluster analysis. After that, a risk matrix was established to determine which warning color should be disseminated to drivers, given a specific condition. Finally, to validate the proposed procedure, actual crash data from Freeway G15 were compared with the safety prediction based on the risk matrix. The results show that the risk matrix obtained in the study is able to predict driving risk consistent with actual safety implications, under rainy weather conditions. PMID:26894434
Buttussi, Fabio; Chittaro, Luca
2018-02-01
The increasing availability of head-mounted displays (HMDs) for home use motivates the study of the possible effects that adopting this new hardware might have on users. Moreover, while the impact of display type has been studied for different kinds of tasks, it has been scarcely explored in procedural training. Our study considered three different types of displays used by participants for training in aviation safety procedures with a serious game. The three displays were respectively representative of: (i) desktop VR (a standard desktop monitor), (ii) many setups for immersive VR used in the literature (an HMD with narrow field of view and a 3-DOF tracker), and (iii) new setups for immersive home VR (an HMD with wide field of view and 6-DOF tracker). We assessed effects on knowledge gain, and different self-reported measures (self-efficacy, engagement, presence). Unlike previous studies of display type that measured effects only immediately after the VR experience, we considered also a longer time span (2 weeks). Results indicated that the display type played a significant role in engagement and presence. The training benefits (increased knowledge and self-efficacy) were instead obtained, and maintained at two weeks, regardless of the display used. The paper discusses the implications of these results.
Gazzeri, Roberto; Faiola, Andrea; Neroni, Massimiliano; Fiore, Claudio; Callovini, Giorgio; Pischedda, Mauro; Galarza, Marcelo
2013-09-01
Intraoperative motor evoked potentials (MEP) and electromyography (EMG) monitoring in patients with spinal and cranial lesions is a valuable tool for prevention of postoperative motor deficits. The purpose of this study was to determine whether electrophysiological monitoring during skull base, spinal cord, and spinal surgery might be useful for predicting postoperative motor deterioration. From January 2012 to March 2013, thirty-three consecutive patients were studied using intraoperative monitoring (Nuvasive NV-M5 System) to check the integrity of brainstem, spinal cord, and nerve roots, recording transcranial motor evoked potentials (TcMEPs) and electromyography. Changes in MEPs and EMGs were related to postoperative deficits. Preoperative diagnosis included skull base and brainstem lesions (6 patients), spinal tumors (11 patients), spinal deformity (16 cases). Using TcMEPs and EMG is a practicable and safe method. MEPs are useful in any surgery in which the brainstem and spinal cord are at risk. EMG stimulation helps to identify an optimal trans-psoas entry point for an extreme lateral lumbar interbody fusion (XLIF) approach to protect against potential nerve injury. This neural navigation technique via a surgeon-interpreted interface assists the surgical team in safely removing lesions and accessing the intervertebral disc space for minimally invasive spinal procedures.
de Carvalho, Paulo Victor Rodrigues; Gomes, José Orlando; Huber, Gilbert Jacob; Vidal, Mario Cesar
2009-05-01
A fundamental challenge in improving the safety of complex systems is to understand how accidents emerge in normal working situations, with equipment functioning normally in normally structured organizations. We present a field study of the en route mid-air collision between a commercial carrier and an executive jet, in the clear afternoon Amazon sky in which 154 people lost their lives, that illustrates one response to this challenge. Our focus was on how and why the several safety barriers of a well structured air traffic system melted down enabling the occurrence of this tragedy, without any catastrophic component failure, and in a situation where everything was functioning normally. We identify strong consistencies and feedbacks regarding factors of system day-to-day functioning that made monitoring and awareness difficult, and the cognitive strategies that operators have developed to deal with overall system behavior. These findings emphasize the active problem-solving behavior needed in air traffic control work, and highlight how the day-to-day functioning of the system can jeopardize such behavior. An immediate consequence is that safety managers and engineers should review their traditional safety approach and accident models based on equipment failure probability, linear combinations of failures, rules and procedures, and human errors, to deal with complex patterns of coincidence possibilities, unexpected links, resonance among system functions and activities, and system cognition.
Lin, Jhih-Tsong; Chen, Yan-Cheng; Wu, Shih-Chieh; Hwang, Sheue-Ling
2017-01-01
In an advanced nuclear power plant (NPP), the operators are responsible for monitoring a massive number of alarm parameters. To assist the operators, a monitoring-aid system (MAS), that applies four quality control chart methods, was proposed and evaluated. Two types of MAS, namely, text and graph marks, were proposed and compared with the original display. To validate the proposed MAS, 17 professional engineers and operators were invited to join an experiment. Two different system states, normal and abnormal, were simulated. The operators were asked to manipulate the system, monitor the critical parameters, search for operational procedures, and deal with other secondary tasks. The primary and secondary task performance and heart rate were measured. After each task was conducted, three subjective rating questionnaires, namely, mental workload, situation awareness, and preference ratings, were implemented for the proposed MAS and the original system. With the assistance of the MAS, the alarm detection rate, secondary task performance, and subjective mental workload demonstrate significant improvements. The proposed MAS helps the operators monitor critical parameters. Therefore, the MAS should be considered for implementation with the control panel to increase the safety of NPPs. Furthermore, the MAS could reduce the mental workload might decrease the health hazard of the operators.
Mou, Ling; Xu, Bing; Lan, Zhixun
2015-04-01
To investigate the validity and safety of trans-esophageal echocardiography (TEE) in monitoring of Nuss surgery. A total of 140 patients with pectus excavatum from Sichuan Provincial People's Hospital underwent Nuss surgery from August, 2011 to Aμgust, 2013. Among them, 72 patients received TEE monitoring while 68 patients didn't. The injury of heart and large vessels by the introducer and Nuss steel bar was observed by intraoperative TEE monitoring under middle-esophageal four chamber view and middle-esophageal aortic short axis view. The operation in all patients had been performed successfully without any severe complications. Satisfactory TEE images were obtained in all patients. The procedure of inserting the inducer and Nuss steel bar behind sternum and steel bar overturn could be seen clearly. No injury in heart and large vessels was detected. Local streak-like hemorrhage in 3 patients was observed under intra-operative TEE screen, but no further new bleeding was found in postoperative TEE examination. The blood was absorbed and couldn't see under trans-thoracic echocardiography in 1 month after the operation. The TEE is a non-invasive monitoring method. It is sensitive to detect the status of the heart and large vessels and can prevent the severe complications due to Nuss surgery.
Novel application of simultaneous multi-image display during complex robotic abdominal procedures
2014-01-01
Background The surgical robot offers the potential to integrate multiple views into the surgical console screen, and for the assistant’s monitors to provide real-time views of both fields of operation. This function has the potential to increase patient safety and surgical efficiency during an operation. Herein, we present a novel application of the multi-image display system for simultaneous visualization of endoscopic views during various complex robotic gastrointestinal operations. All operations were performed using the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) with the assistance of Tilepro, multi-input display software, during employment of the intraoperative scopes. Three robotic operations, left hepatectomy with intraoperative common bile duct exploration, low anterior resection, and radical distal subtotal gastrectomy with intracorporeal gastrojejunostomy, were performed by three different surgeons at a tertiary academic medical center. Results The three complex robotic abdominal operations were successfully completed without difficulty or intraoperative complications. The use of the Tilepro to simultaneously visualize the images from the colonoscope, gastroscope, and choledochoscope made it possible to perform additional intraoperative endoscopic procedures without extra monitors or interference with the operations. Conclusion We present a novel use of the multi-input display program on the da Vinci Surgical System to facilitate the performance of intraoperative endoscopies during complex robotic operations. Our study offers another potentially beneficial application of the robotic surgery platform toward integration and simplification of combining additional procedures with complex minimally invasive operations. PMID:24628761
10 CFR 39.65 - Personnel monitoring.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 10 Energy 1 2014-01-01 2014-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...
10 CFR 39.65 - Personnel monitoring.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 10 Energy 1 2011-01-01 2011-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...
10 CFR 39.65 - Personnel monitoring.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 10 Energy 1 2013-01-01 2013-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...
10 CFR 39.65 - Personnel monitoring.
Code of Federal Regulations, 2010 CFR
2010-01-01
... 10 Energy 1 2010-01-01 2010-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...
10 CFR 39.65 - Personnel monitoring.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 10 Energy 1 2012-01-01 2012-01-01 false Personnel monitoring. 39.65 Section 39.65 Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.65 Personnel monitoring. (a) The licensee may not permit an individual to act as a logging...
Buy, Xavier; Tok, Chung-Hong; Szwarc, Daniel; Bierry, Guillaume; Gangi, Afshin
2009-05-01
Percutaneous image-guided thermal ablation of tumor is widely used, and thermal injury to collateral structures is a known complication of this technique. To avoid thermal damage to surrounding structures, several protection techniques have been reported. We report the use of a simple and effective protective technique combining carbon dioxide dissection and thermocouple: CO(2) displaces the nontarget structures, and its low thermal conductivity provides excellent insulation; insertion of a thermocouple in contact with vulnerable structures achieves continuous thermal monitoring. We performed percutaneous thermal ablation of 37 tumors in 35 patients (4 laser, 10 radiofrequency, and 23 cryoablations) with protection of adjacent vulnerable structures by using CO(2) dissection combined with continuous thermal monitoring with thermocouple. Tumor locations were various (19 intra-abdominal tumors including 4 livers and 9 kidneys, 18 musculoskeletal tumors including 11 spinal tumors). CO(2) volume ranged from 10 ml (epidural space) to 1500 ml (abdominal). Repeated insufflations were performed if necessary, depending on the information given by the thermocouple and imaging control. Dissection with optimal thermal protection was achieved in all cases except two patients where adherences (one postoperative, one arachnoiditis) blocked proper gaseous distribution. No complication referred to this technique was noted. This safe, cost-effective, and simple method increases the safety and the success rate of percutaneous thermal ablation procedures. It also offers the potential to increase the number of tumors that can be treated via a percutaneous approach.
Diorio, Caroline; Celis Ekstrand, Amanda; Hesser, Tanya; O'Sullivan, Cathy; Lee, Michelle; Schechter, Tal; Sung, Lillian
2016-09-01
Purpose Fatigue is an important problem in children receiving intensive chemotherapy and hematopoietic stem cell transplantation (HSCT). Exercise may be an effective intervention for fatigue. Individualized yoga represents an ideal intervention because it can be tailored according to an individual child's needs. Little is known about how to structure a standardized yoga program for intensivelytreated children. Therefore, this study describes the development of a yoga program and an approach to monitoring sessions suitable for hospitalized children receiving intensive chemotherapy or HSCT. Methods The yoga program was designed to increase mobility in hospitalized children and to provide children with relaxation techniques that could be used independently in a variety of environments. The program was founded on 4 key tenets: safety, adaptability, environmental flexibility, and appeal to children. We also developed quality and consistency assurance procedures. Results A menu format with a fixed structure was selected for the yoga program. Each yoga session contained up to 6 sections: breathing exercises, warmup exercises, yoga poses, balancing poses, cool-down poses, and final relaxation. Yoga instructors selected specific yoga poses for each session from a predetermined list organized by intensity level (low, moderate, or high). Monitoring procedures were developed using videotaping and multirater adjudication. Conclusion We created a standardized yoga program and an approach to monitoring that are now ready for incorporation in clinical trials. Future work should include the adaptation of the program to different pediatric populations and clinical settings. © The Author(s) 2016.
42 CFR 86.5 - Grant appeals procedure.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 42 Public Health 1 2010-10-01 2010-10-01 false Grant appeals procedure. 86.5 Section 86.5 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES OCCUPATIONAL SAFETY AND HEALTH RESEARCH AND RELATED ACTIVITIES GRANTS FOR EDUCATION PROGRAMS IN OCCUPATIONAL SAFETY AND HEALTH General § 86.5 Grant appeals procedure. The informal...
9 CFR 392.5 - Filing procedures.
Code of Federal Regulations, 2013 CFR
2013-01-01
... 9 Animals and Animal Products 2 2013-01-01 2013-01-01 false Filing procedures. 392.5 Section 392.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS PETITIONS FOR RULEMAKING § 392.5 Filing procedures. (a) Any interested person may file a petition...
9 CFR 392.5 - Filing procedures.
Code of Federal Regulations, 2012 CFR
2012-01-01
... 9 Animals and Animal Products 2 2012-01-01 2012-01-01 false Filing procedures. 392.5 Section 392.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS PETITIONS FOR RULEMAKING § 392.5 Filing procedures. (a) Any interested person may file a petition...
9 CFR 392.5 - Filing procedures.
Code of Federal Regulations, 2011 CFR
2011-01-01
... 9 Animals and Animal Products 2 2011-01-01 2011-01-01 false Filing procedures. 392.5 Section 392.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS PETITIONS FOR RULEMAKING § 392.5 Filing procedures. (a) Any interested person may file a petition...
9 CFR 392.5 - Filing procedures.
Code of Federal Regulations, 2014 CFR
2014-01-01
... 9 Animals and Animal Products 2 2014-01-01 2014-01-01 false Filing procedures. 392.5 Section 392.5 Animals and Animal Products FOOD SAFETY AND INSPECTION SERVICE, DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE ADMINISTRATIVE PROVISIONS PETITIONS FOR RULEMAKING § 392.5 Filing procedures. (a) Any interested person may file a petition...
NASA's post-Challenger safety program - Themes and thrusts
NASA Technical Reports Server (NTRS)
Rodney, G. A.
1988-01-01
The range of managerial, technical, and procedural initiatives implemented by NASA's post-Challenger safety program is reviewed. The recommendations made by the Rogers Commission, the NASA post-Challenger review of Shuttle design, the Congressional investigation of the accident, the National Research Council, the Aerospace Safety Advisory Panel, and NASA internal advisory panels and studies are summarized. NASA safety initiatives regarding improved organizational accountability for safety, upgraded analytical techniques and methodologies for risk assessment and management, procedural initiatives in problem reporting and corrective-action tracking, ground processing, maintenance documentation, and improved technologies are discussed. Safety issues relevant to the planned Space Station are examined.
Wachter, Rolf; Gröschel, Klaus; Gelbrich, Götz; Hamann, Gerhard F; Kermer, Pawel; Liman, Jan; Seegers, Joachim; Wasser, Katrin; Schulte, Anna; Jürries, Falko; Messerschmid, Anna; Behnke, Nico; Gröschel, Sonja; Uphaus, Timo; Grings, Anne; Ibis, Tugba; Klimpe, Sven; Wagner-Heck, Michaela; Arnold, Magdalena; Protsenko, Evgeny; Heuschmann, Peter U; Conen, David; Weber-Krüger, Mark
2017-04-01
Atrial fibrillation is a major risk factor for recurrent ischaemic stroke, but often remains undiagnosed in patients who have had an acute ischaemic stroke. Enhanced and prolonged Holter-electrocardiogram-monitoring might increase detection of atrial fibrillation. We therefore investigated whether enhanced and prolonged rhythm monitoring was better for detection of atrial fibrillation than standard care procedures in patients with acute ischaemic stroke. Find-AF randomised is an open-label randomised study done at four centres in Germany. We recruited patients with acute ischaemic stroke (symptoms for 7 days or less) aged 60 years or older presenting with sinus rhythm and without history of atrial fibrillation. Patients were included irrespective of the suspected cause of stroke, unless they had a severe ipsilateral carotid or intracranial artery stenosis, which were the exclusion criteria. We used a computer-generated allocation sequence to randomly assign patients in a 1:1 ratio with permuted block sizes of 2, 4, 6, and 8, stratified by centre, to enhanced and prolonged monitoring (ie, 10-day Holter-electrocardiogram [ECG]-monitoring at baseline, and at 3 months and 6 months of follow-up) or standard care procedures (ie, at least 24 h of rhythm monitoring). Participants and study physicians were not masked to group assignment, but the expert committees that adjudicated endpoints were. The primary endpoint was the occurrence of atrial fibrillation or atrial flutter (30 sec or longer) within 6 months after randomisation and before stroke recurrence. Because Holter ECG is a widely used procedure and not known to harm patients, we chose not to assess safety in detail. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01855035. Between May 8, 2013, and Aug 31, 2014, we recruited 398 patients. 200 patients were randomly assigned to the enhanced and prolonged monitoring group and 198 to the standard care group. After 6 months, we detected atrial fibrillation in 14% of 200 patients in the enhanced and prolonged monitoring group (27 patients) versus 5% in the control group (nine of 198 patients, absolute difference 9·0%; 95% CI 3·4-14·5, p=0·002; number needed to screen 11). Enhanced and prolonged monitoring initiated early in patients with acute ischaemic stroke aged 60 years or older was better than standard care for the detection of atrial fibrillation. These findings support the consideration of all patients aged 60 years or older with stroke for prolonged monitoring if the detection of atrial fibrillation would result in a change in medical management (eg, initiation of anticoagulation). Boehringer Ingelheim. Copyright © 2017 Elsevier Ltd. All rights reserved.
Outcomes of transcatheter aortic valve replacement using a minimalist approach.
Gurevich, Sergey; Oestreich, Brett; Kelly, Rosemary F; Mbai, Mackenzie; Bertog, Stefan; Ringsred, Karen; Lawton, Annette; Thooft, Brenda; Wagner, Julie; Garcia, Santiago
2018-03-01
Transcatheter Aortic Valve Replacement (TAVR) is increasingly performed using a minimalist approach under monitored anesthesia care (MAC). The safety of this approach remains controversial and adoption has been low in the US. The study cohort was comprised of 130 patients (98% male) who underwent TAVR between 4/2015 and 4/2017 at the Minneapolis VA. We compared the outcomes of 81 patients who underwent TAVR using a standard approach (standard TAVR) and 49 who underwent TAVR using a minimalist approach (minimalist TAVR). Outcome measures included device and procedural success, procedural efficiency, length of intensive care unit (ICU) and hospital stay, procedural complications and hospital readmissions. Mean age was 80 (±9) years and median (IQR) STS score was 5 (4-6). Access included transfemoral (n = 111, 85%) and alternative (n = 19, 15%). Minimalist TAVR was associated with reduced procedural time: median 101 min (IQR: 78-135) versus 127 min (IQR: 97-182, p = 0.03), fluoroscopy time: median 18 min (IQR: 12-26) versus 24 min (IQR: 16-38), p = 0.001), contrast volume 90 ml (IQR: 70-120 ml) versus 140 ml (IQR: 86-213 ml, p < 0.001). A minimalistic approach to TAVR is associated with improved procedural efficiency and reduced length of stay without compromising procedural success or clinical outcomes. Published by Elsevier Inc.
Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre
2015-09-29
International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.
Leadless Pacing: Current State and Future Direction.
Merkel, Matthias; Grotherr, Philipp; Radzewitz, Andrea; Schmitt, Claus
2017-12-01
Leadless pacing is now an established alternative to conventional pacing with subcutaneous pocket and transvenous lead for patients with class I or II single-chamber pacing indication. Available 12-month follow-up data shows a 48% fewer major complication rate in patients with Micra™ compared to a historical control group in a nonrandomized study [1]. There is one system with Food and Drug Administration (FDA) approval and two with the Communauté Européenne (CE) mark. The OPS code for the implantation is 8-83d.3 and the procedure has recently been rated as a "new Examination and Treatment Method (NUB)" in the German DRG system, meaning adequate reimbursement is negotiable with health insurance providers. The systems offer similar generator longevity and programming possibilities as conventional pacemaker systems, including rate response, remote monitoring, and MRI safety. The biggest downsides to date are limitations to single-chamber stimulation, lack of long-time data, and concerns of handling of the system at the end of its life span. However, implant procedure complication rates and procedure times do not exceed conventional pacemaker operations, and proper training and patient selection is provided.
Airway Management During Upper GI Endoscopic Procedures: State of the Art Review.
Goudra, Basavana; Singh, Preet Mohinder
2017-01-01
With the growing popularity of propofol mediated deep sedation for upper gastrointestinal (GI) endoscopic procedures, challenges are being felt and appreciated. Research suggests that management of the airway is anything but routine in this setting. Although many studies and meta-analyses have demonstrated the safety of propofol sedation administered by registered nurses under the supervision of gastroenterologists (likely related to the lighter degrees of sedation than those provided by anesthesia providers and is under medicolegal controversy in the United States), there is no agreement on the optimum airway management for procedures such as endoscopic retrograde cholangiopancreatography. Failure to rescue an airway at an appropriate time has led to disastrous consequences. Inability to evaluate and appreciate the risk factors for aspiration can ruin the day for both the patient and the health care providers. This review apprises the reader of various aspects of airway management relevant to the practice of sedation during upper GI endoscopy. New devices and modification of existing devices are discussed in detail. Recognizing the fact that appropriate monitoring is important for timely recognition and management of potential airway disasters, these issues are explored thoroughly.
Byrum, Russell; Keith, Lauren; Bartos, Christopher; St Claire, Marisa; Lackemeyer, Matthew G; Holbrook, Michael R; Janosko, Krisztina; Barr, Jason; Pusl, Daniela; Bollinger, Laura; Wada, Jiro; Coe, Linda; Hensley, Lisa E; Jahrling, Peter B; Kuhn, Jens H; Lentz, Margaret R
2016-10-03
Medical imaging using animal models for human diseases has been utilized for decades; however, until recently, medical imaging of diseases induced by high-consequence pathogens has not been possible. In 2014, the National Institutes of Health, National Institute of Allergy and Infectious Diseases, Integrated Research Facility at Fort Detrick opened an Animal Biosafety Level 4 (ABSL-4) facility to assess the clinical course and pathology of infectious diseases in experimentally infected animals. Multiple imaging modalities including computed tomography (CT), magnetic resonance imaging, positron emission tomography, and single photon emission computed tomography are available to researchers for these evaluations. The focus of this article is to describe the workflow for safely obtaining a CT image of a live guinea pig in an ABSL-4 facility. These procedures include animal handling, anesthesia, and preparing and monitoring the animal until recovery from sedation. We will also discuss preparing the imaging equipment, performing quality checks, communication methods from "hot side" (containing pathogens) to "cold side," and moving the animal from the holding room to the imaging suite.
30 CFR 57.5037 - Radon daughter exposure monitoring.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Radon daughter exposure monitoring. 57.5037 Section 57.5037 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Air Quality, Radiation, Physical Agents, and Diesel...
30 CFR 57.5037 - Radon daughter exposure monitoring.
Code of Federal Regulations, 2012 CFR
2012-07-01
... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Radon daughter exposure monitoring. 57.5037 Section 57.5037 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Air Quality, Radiation, Physical Agents, and Diesel...
30 CFR 57.5037 - Radon daughter exposure monitoring.
Code of Federal Regulations, 2014 CFR
2014-07-01
... 30 Mineral Resources 1 2014-07-01 2014-07-01 false Radon daughter exposure monitoring. 57.5037 Section 57.5037 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Air Quality, Radiation, Physical Agents, and Diesel...
30 CFR 57.5037 - Radon daughter exposure monitoring.
Code of Federal Regulations, 2013 CFR
2013-07-01
... 30 Mineral Resources 1 2013-07-01 2013-07-01 false Radon daughter exposure monitoring. 57.5037 Section 57.5037 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR METAL AND NONMETAL MINE SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-UNDERGROUND METAL AND NONMETAL MINES Air Quality, Radiation, Physical Agents, and Diesel...
Federal Register 2010, 2011, 2012, 2013, 2014
2012-10-16
... of Practice in Air Safety Proceedings; Rules Implementing the Equal Access to Justice Act of 1980... procedure concerning applications for fees and expenses under the Equal Access to Justice Act of 1980 (EAJA... procedure, Airmen, Aviation safety. 49 CFR Part 826 Claims, Equal access to justice, Lawyers. For the...
Fire Safety Trianing in Health Care Institutions.
ERIC Educational Resources Information Center
American Hospital Association, Chicago, IL.
The manual details the procedures to be followed in developing and implementing a fire safety plan. The three main steps are first, to organize; second, to set up a procedure and put it in writing; and third, to train and drill employees and staff. Step 1 involves organizing a safety committee, appointing a fire marshall, and seeking help from…
NASA Technical Reports Server (NTRS)
Richards, Lance
2014-01-01
The general aim of this work is to develop and demonstrate a prototype structural health monitoring system for thermal protection systems that incorporates piezoelectric acoustic emission (AE) sensors to detect the occurrence and location of damaging impacts, such as those from Micrometeoroid Orbital Debris (MMOD). The approach uses an optical fiber Bragg grating (FBG) sensor network to evaluate the effect of detected damage on the thermal conductivity of the TPS material. Following detection of an impact, the TPS would be exposed to a heat source, possibly the sun, and the temperature distribution on the inner surface in the vicinity of the impact measured by the FBG network. A similar procedure could also be carried out as a screening test immediately prior to re-entry. The implications of any detected anomalies in the measured temperature distribution will be evaluated for their significance in relation to the performance of the TPS during reentry. Such a robust TPS health monitoring system would ensure overall crew safety throughout the mission, especially during reentry.
Post Launch Monitoring of food products: what can be learned from pharmacovigilance.
van Puijenbroek, E P; Hepburn, P A; Herd, T M; van Grootheest, A C
2007-03-01
Post Launch Monitoring (PLM) is one of the new approaches that are used in assessing the safety of novel foods or ingredients. It shares a close resemblance with procedures applied in the field of medicines, where Post Marketing Surveillance (PMS) has been carried out since the beginning of the 1960s. For this reason, Unilever and the Netherlands Pharmacovigilance Centre Lareb, maintaining the national reporting scheme in the Netherlands for adverse drug reactions, have been working together to optimize the Unilever's Post Launch Monitoring service. As a result of this cooperation a practical model for conducting PLM for food products has been developed. This model is also applicable for consumer products in general. The system allows for coding and assessing reports and the early detection of 'signals' of unintended health reactions. The methodological issues surrounding reporting of possible health reactions and practical issues surrounding coding and assessment of the reports that were encountered in the first period of this partnership are discussed. In addition, similarities and differences concerning PMS and PLM are described.
Investigation of Stability of Precise Geodetic Instruments Used in Deformation Monitoring
NASA Astrophysics Data System (ADS)
Woźniak, Marek; Odziemczyk, Waldemar
2017-12-01
Monitoring systems using automated electronic total stations are an important element of safety control of many engineering objects. In order to ensure the appropriate credibility of acquired data, it is necessary that instruments (total stations in most of the cases) used for measurements meet requirements of measurement accuracy, as well as the stability of instrument axis system geometry. With regards to the above, it is expedient to conduct quality control of data acquired using electronic total stations in the context of performed measurement procedures. This paper presents results of research conducted at the Faculty of Geodesy and Cartography at Warsaw University of Technology investigating the stability of "basic" error values (collimation, zero location for V circle, inclination), for two types of automatic total stations: TDA 5005 and TCRP 1201+. Research provided also information concerning the influence of temperature changes upon the stability of investigated instrument's optical parameters. Results are presented in graphical analytic technique. Final conclusions propose methods, which allow avoiding negative results of measuring tool-set geometry changes during conducting precise deformation monitoring measurements.
Cruz, Jennifer L; Brown, Jamie N
2015-06-01
Rigorous practices for safe dispensing of investigational drugs are not standardized. This investigation sought to identify error-prevention processes utilized in the provision of investigational drug services (IDS) and to characterize pharmacists' perceptions about safety risks posed by investigational drugs. An electronic questionnaire was distributed to an audience of IDS pharmacists within the Veteran Affairs Health System. Multiple facets were examined including demographics, perceptions of medication safety, and standard processes used to support investigational drug protocols. Twenty-one respondents (32.8% response rate) from the Northeast, Midwest, South, West, and Non-contiguous United States participated. The mean number of pharmacist full-time equivalents (FTEs) dedicated to the IDS was 0.77 per site with 0.2 technician FTEs. The mean number of active protocols was 22. Seventeen respondents (81%) indicated some level of concern for safety risks. Concerns related to the packaging of medications were expressed, most notably lack of product differentiation, expiration dating, barcodes, and choice of font size or color. Regarding medication safety practices, the majority of sites had specific procedures in place for storing and securing drug supply, temperature monitoring, and prescription labeling. Repackaging bulk items and proactive error-identification strategies were less common. Sixty-seven percent of respondents reported that an independent double check was not routinely performed. Medication safety concerns exist among pharmacists in an investigational drug service; however, a variety of measures have been employed to improve medication safety practices. Best practices for the safe dispensing of investigational medications should be developed in order to standardize these error-prevention strategies.
Brown, Jamie N.
2015-01-01
Objectives: Rigorous practices for safe dispensing of investigational drugs are not standardized. This investigation sought to identify error-prevention processes utilized in the provision of investigational drug services (IDS) and to characterize pharmacists’ perceptions about safety risks posed by investigational drugs. Methods: An electronic questionnaire was distributed to an audience of IDS pharmacists within the Veteran Affairs Health System. Multiple facets were examined including demographics, perceptions of medication safety, and standard processes used to support investigational drug protocols. Results: Twenty-one respondents (32.8% response rate) from the Northeast, Midwest, South, West, and Non-contiguous United States participated. The mean number of pharmacist full-time equivalents (FTEs) dedicated to the IDS was 0.77 per site with 0.2 technician FTEs. The mean number of active protocols was 22. Seventeen respondents (81%) indicated some level of concern for safety risks. Concerns related to the packaging of medications were expressed, most notably lack of product differentiation, expiration dating, barcodes, and choice of font size or color. Regarding medication safety practices, the majority of sites had specific procedures in place for storing and securing drug supply, temperature monitoring, and prescription labeling. Repackaging bulk items and proactive error-identification strategies were less common. Sixty-seven percent of respondents reported that an independent double check was not routinely performed. Conclusions: Medication safety concerns exist among pharmacists in an investigational drug service; however, a variety of measures have been employed to improve medication safety practices. Best practices for the safe dispensing of investigational medications should be developed in order to standardize these error-prevention strategies. PMID:26240744
Moyaert, Hilde; de Jong, Anno; Simjee, Shabbir; Thomas, Valérie
2014-07-16
Resistance monitoring programmes are essential to generate data for inclusion in the scientific risk assessment of the potential for transmission of antimicrobial-resistant bacteria or their resistance determinants from food-producing animals to humans. This review compares the technical specifications on monitoring of antimicrobial resistance in zoonotic Salmonella, Campylobacter and indicator Escherichia coli and Enterococcus as performed by the European Food Safety Authority (EFSA) with veterinary pharmaceutical industry's European Antimicrobial Susceptibility Surveillance in Animals (EASSA) programme. The authors conclude that most of EFSA's recent monitoring recommendations have been covered by EASSA since the start of the latter programme in 1998. The major difference between the two programmes is the classification into 'susceptible' versus 'resistant'. While EFSA categorises all isolates with an MIC value above the epidemiological cut-off value as 'resistant', EASSA differentiates between 'percentage decreased susceptible' and 'percentage clinical resistant' strains by applying both epidemiological cut-off values and clinical breakpoints. Because there is still a need to further improve harmonisation among individual EU Member State activities, Animal Health Industry welcomes EFSA's initiative to further improve the quality of resistance monitoring as it is of utmost importance to apply standardised collection procedures and harmonised susceptibility testing, when monitoring antimicrobial resistance across Europe. Copyright © 2014 Elsevier B.V. All rights reserved.
Detecting GNSS spoofing attacks using INS coupling
NASA Astrophysics Data System (ADS)
Tanil, Cagatay
Vulnerability of Global Navigation Satellite Systems (GNSS) users to signal spoofing is a critical threat to positioning integrity, especially in aviation applications, where the consequences are potentially catastrophic. In response, this research describes and evaluates a new approach to directly detect spoofing using integrated Inertial Navigation Systems (INS) and fault detection concepts based on integrity monitoring. The monitors developed here can be implemented into positioning systems using INS/GNSS integration via 1) tightly-coupled, 2) loosely-coupled, and 3) uncoupled schemes. New evaluation methods enable the statistical computation of integrity risk resulting from a worst-case spoofing attack - without needing to simulate an unmanageably large number of individual aircraft approaches. Integrity risk is an absolute measure of safety and a well-established metric in aircraft navigation. A novel closed-form solution to the worst-case time sequence of GNSS signals is derived to maximize the integrity risk for each monitor and used in the covariance analyses. This methodology tests the performance of the monitors against the most sophisticated spoofers, capable of tracking the aircraft position - for example, by means of remote tracking or onboard sensing. Another contribution is a comprehensive closed-loop model that encapsulates the vehicle and compensator (estimator and controller) dynamics. A sensitivity analysis uses this model to quantify the leveraging impact of the vehicle's dynamic responses (e.g., to wind gusts, or to autopilot's acceleration commands) on the monitor's detection capability. The performance of the monitors is evaluated for two safety-critical terminal area navigation applications: 1) autonomous shipboard landing and 2) Boeing 747 (B747) landing assisted with Ground Based Augmentation Systems (GBAS). It is demonstrated that for both systems, the monitors are capable of meeting the most stringent precision approach and landing integrity requirements of the International Civil Aviation Organization (ICAO). The statistical evaluation methods developed here can be used as a baseline procedure in the Federal Aviation Administration's (FAA) certification of spoof-free navigation systems. The final contribution is an investigation of INS sensor quality on detection performance. This determines the minimum sensor requirements to perform standalone GNSS positioning in general en route applications with guaranteed spoofing detection integrity.
Deep Needle Procedures: Improving Safety With Ultrasound Visualization
Peabody, Christopher R.; Mandavia, Diku
2017-01-01
Abstract Promoting patient safety and increasing health care quality have dominated the health care landscape during the last 15 years. Health care regulators and payers are now tying patient safety outcomes and best practices to hospital reimbursement. Many health care leaders are searching for new technologies that not only make health care for patients safer but also reduce overall health care costs. New advances in ultrasonography have made this technology available to health care providers at the patient’s bedside. Point-of-care ultrasound assistance now aids providers with real-time diagnosis and with visualization for procedural guidance. This is especially true for common deep needle procedures such as central venous catheter insertion, thoracentesis, and paracentesis. There is now mounting evidence that clinician-performed point-of-care ultrasound improves patient safety, enhances health care quality, and reduces health care cost for deep needle procedures. Furthermore, the miniaturization, ease of use, and the evolving affordability of ultrasound have now made this technology widely available. The adoption of point-of-care ultrasonography has reached a tipping point and should be seriously considered the safety standard for all hospital-based deep needle procedures. PMID:24786918
Esposito, G; Rossi, F; Puca, A; Albanese, A; Sabatino, G; Matteini, P; Lofrese, G; Maira, G; Pini, R
2010-01-01
Laser welding has been proposed as an alternative technique to conventional stitching in microvascular anastomosis, with the advantages of improving the vascular healing process and reducing the risk of malfunction of a bypass. Our group recently proposed a laser-assisted end-to-side anastomotic technique, providing the advantages of laser welding and reducing the occlusion time of the recipient vessel, that is important in neurosurgical bypass procedures, in order to reduce the risk of cerebral ischemia. This in vivo study focuses on the control of the temperature dynamics developing in the welded tissue. A jugular vein graft was harvested and implanted on the rabbit carotid artery by means of two end-to-side anastomosis. Laser welding procedure was then carried out to implant the bypass. A real-time monitoring of the temperature during welding was performed with an infrared thermocamera, in order to control the laser-induced heating effect on the external surface of the vessel walls. The temperature analysis highlighted the dynamic of the heating effect in space and time and enabled us to define an optimal temperature range in operative conditions. The temperature control provided safe tissue heating confined within the directly irradiated area, with negligible damage to surrounding tissues, as well as effective sealing and welding of the vessel edges at the anastomotic sites. The average occlusion time of the carotid artery was about 11 minutes. After a follow-up of 30 days, all the bypasses were patent and no signs of thrombosis or leak point pressure were present, thus confirming the safety of this laser-assisted anastomotic procedure.
Implications of electronic health record downtime: an analysis of patient safety event reports.
Larsen, Ethan; Fong, Allan; Wernz, Christian; Ratwani, Raj M
2018-02-01
We sought to understand the types of clinical processes, such as image and medication ordering, that are disrupted during electronic health record (EHR) downtime periods by analyzing the narratives of patient safety event report data. From a database of 80 381 event reports, 76 reports were identified as explicitly describing a safety event associated with an EHR downtime period. These reports were analyzed and categorized based on a developed code book to identify the clinical processes that were impacted by downtime. We also examined whether downtime procedures were in place and followed. The reports were coded into categories related to their reported clinical process: Laboratory, Medication, Imaging, Registration, Patient Handoff, Documentation, History Viewing, Delay of Procedure, and General. A majority of reports (48.7%, n = 37) were associated with lab orders and results, followed by medication ordering and administration (14.5%, n = 11). Incidents commonly involved patient identification and communication of clinical information. A majority of reports (46%, n = 35) indicated that downtime procedures either were not followed or were not in place. Only 27.6% of incidents (n = 21) indicated that downtime procedures were successfully executed. Patient safety report data offer a lens into EHR downtime-related safety hazards. Important areas of risk during EHR downtime periods were patient identification and communication of clinical information; these should be a focus of downtime procedure planning to reduce safety hazards. EHR downtime events pose patient safety hazards, and we highlight critical areas for downtime procedure improvement. © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com
Tazoe, Hirofumi; Obata, Hajime; Yamagata, Takeyasu; Karube, Zin'ichi; Nagai, Hisao; Yamada, Masatoshi
2016-05-15
It is important for public safety to monitor strontium-90 in aquatic environments in the vicinity of nuclear related facilities. Strontium-90 concentrations in seawater exceeding the background level have been observed in accidents of nuclear facilities. However, the analytical procedure for measuring strontium-90 in seawater is highly demanding. Here we show a simple and high throughput analytical technique for the determination of strontium-90 in seawater samples using a direct yttrium-90 separation. The DGA Resin is used to determine the abundance of strontium-90 by detecting yttrium-90 decay (beta-emission) in secular equilibrium. The DGA Resin can selectively collect yttrium-90 and remove naturally occurring radionuclides such as (40)K, (210)Pb, (214)Bi, (238)U, and (232)Th and anthropogenic radionuclides such as (140)Ba, and (140)La. Through a sample separation procedure, a high chemical yield of yttrium-90 was achieved at 95.5±2.3%. The result of IAEA-443 certified seawater analysis (107.7±3.4 mBq kg(-1)) was in good agreement with the certified value (110±5 mBq kg(-1)). By developed method, we can finish analyzing 8 samples per day after achieving secular equilibrium, which is a reasonably fast throughput in actual seawater monitoring. By processing 3 L of seawater sample and applying a counting time of 20 h, minimum detectable activity can be as low as 1.5 mBq kg(-1), which could be applied to monitoring for the contaminated marine environment. Reproducibility was found to be 3.4% according to 10 independent analyses of natural seawater samples from the vicinity of the Fukushima Daiichi Nuclear Power Plant in September 2013. Copyright © 2016 Elsevier B.V. All rights reserved.
Use of diagnostic imaging procedures and fetal monitoring devices in the care of pregnant women.
Moore, R M; Jeng, L L; Kaczmarek, R G; Placek, P J
1990-01-01
Medical devices and diagnostic imaging procedures such as ultrasound, X-rays, and electronic fetal monitoring devices are used in the medical care of many pregnant women today. The responsibility for the safety and effectiveness of these diagnostic technologies is shared by a number of Public Health Service agencies, one of which is the Center for Devices and Radiological Health (CDRH), a unit within the Food and Drug Administration. The CDRH collaborated with the National Center for Health Statistics (NCHS) in conducting a study of recent trends in the uses of diagnostic ultrasound, medical X-rays, and electronic fetal monitoring devices in the medical care of pregnant women. This study used data from the 1980 National Natality and Fetal Mortality Surveys and the 1987 pretest to the National Maternal and Infant Health Survey. Hospitals and prenatal care providers of the pregnant women contributed information regarding the use of these medical devices. Between 1980 and 1987, ultrasound use more than doubled, increasing from 33.5 percent of pregnancies in 1980 to 78.8 percent in 1987 (P less than 0.001). More ultrasound examinations were performed earlier in gestation in 1987 than in 1980, with 10.1 percent being performed during the first trimester in 1987, compared with 6.9 percent in 1980 (P less than 0.001). Use of external electronic fetal monitoring devices during delivery also increased significantly between 1980 and 1987, from 33.5 percent to 74.6 percent (P less than 0.001). Use of medical X-rays among women with live births remained relatively unchanged, 15.0 percent in 1980 and 15.3 percent in 1987 (P = .282). The implications of these trends are discussed.
30 CFR 56.5002 - Exposure monitoring.
Code of Federal Regulations, 2010 CFR
2010-07-01
... SAFETY AND HEALTH SAFETY AND HEALTH STANDARDS-SURFACE METAL AND NONMETAL MINES Air Quality and Physical Agents Air Quality § 56.5002 Exposure monitoring. Dust, gas, mist, and fume surveys shall be conducted as...
Kabanywanyi, Abdunoor M; Mulure, Nathan; Migoha, Christopher; Malila, Aggrey; Lengeler, Christian; Schlienger, Raymond; Genton, Blaise
2010-07-14
To identify and implement strategies that help meet safety monitoring requirements in the context of an observational study for artemether-lumefantrine (AL) administered as first-line treatment for uncomplicated malaria in rural Tanzania. Pharmacovigilance procedures were developed through collaboration between the investigating bodies, the relevant regulatory authority and the manufacturer of AL. Training and refresher sessions on the pharmacovigilance system were provided for healthcare workers from local health facilities and field recorders of the Ifakara Health Demographic Surveillance System (IHDSS). Three distinct channels for identification of adverse events (AEs) and serious adverse events (SAEs) were identified and implemented. Passive reporting took place through IHDSS and health care facilities, starting in October 2007. The third channel was through solicited reporting that was included in the context of a survey on AL as part of the ALIVE (Artemether-Lumefantrine In Vulnerable patients: Exploring health impact) study (conducted only in March-April 2008). Training was provided for 40 healthcare providers (with refresher training 18 months later) and for six field recorders. During the period 1st September 2007 to 31st March 2010, 67 AEs were reported including 52 under AL, five under sulphadoxine-pyrimethamine, one under metakelfin, two after antibiotics; the remaining seven were due to anti-pyretic or anti-parasite medications. Twenty patients experienced SAEs; in 16 cases, a relation to AL was suspected. Six of the 20 cases were reported within 24 hours of occurrence. Safety monitoring and reporting is possible even in settings with weak health infrastructure. Reporting can be enhanced by regular and appropriate training of healthcare providers. SMS text alerts provide a practical solution to communication challenges. Experience gained in this setting could help to improve spontaneous reporting of AEs and SAEs to health authorities or marketing authorization holders.
Pati, Debajyoti; Evans, Jennie; Waggener, Laurie; Harvey, Tom
2008-01-01
Should power, medical gases, and monitoring and communications systems be located in a headwall or a ceiling-mounted boom in intensive care unit (ICU) rooms? Often, only the financial costs could be determined for the options, whereas data regarding its potential influence on teamwork, safety, and efficiency are lacking. Hence, purchase decisions are more arbitrary than evidence based. This study simulated care delivery in settings with a traditional headwall and a ceiling boom. Observed were the way the following elements were managed and the extent either system affected flexibility, ergonomics, and teamwork: tubing for intravenous fluids, medical gases, and suction drainage; monitoring leads and equipment power cords; and the medical equipment itself. Simulation runs involving 6 scenarios were conducted with the voluntary participation of 2 physicians, 2 nurse practitioners, 2 respiratory therapists, and 4 registered nurses at a children's tertiary care center in December 2007. Analysis suggests that booms have an advantage over headwalls in case of high-acuity ICU patients and when procedures are performed inside patient rooms. However, in case of lower-acuity ICU patients, as well as when procedures are not typically conducted in the patient room, booms may not provide a proportionate level of advantage when compared with the additional cost involved in its procurement.
Photodynamic diagnosis and related optical techniques for the management of malignant glioma
NASA Astrophysics Data System (ADS)
Sroka, R.; Stepp, H.; Beyer, W.; Markwardt, N.; Rühm, A.
2017-04-01
Malignant gliomas are a devastating brain tumor disease with very poor prognosis. Stereotactic biopsy sampling is routinely used in larger neurosurgical centers to confirm the diagnosis of a suspected brain tumor. This procedure is associated with risk of blood vessel rupture as well as false-negative results. Recent investigations suggest a potential of light-based techniques to improve both therapy and diagnosis of GBM. Optical guidance can be utilized to improve the biopsy sampling procedure in terms of safety, reliability, and efficacy. Recording of optical signals (transmission, remission, fluorescence) can be potentially integrated into a biopsy needle for providing optical detection of tumor tissue and blood vessel recognition during the biopsy sampling. Optical signals can also be used for monitoring purposes during photodynamic therapy. Here, fluorescence signals recorded before the treatment indicate the presence and accumulation level of photosensitizer, while photobleaching of the photosensitizer fluorescence during the treatment can be used as a measure of the effectiveness of the therapy. Finally, transmitted light can reveal problematic tissue-optical conditions as well as changes of the optical properties of the treated tissue, which may be relevant with regard to treatment prognosis and strategy. Different optical concepts for interstitial PDT monitoring and optical tissue property assessment are presented.
DOT National Transportation Integrated Search
2016-12-01
An independent evaluation of a non-video-based onboard monitoring system (OBMS) was conducted. The objective was to determine if the OBMS system performed reliably, improved driving safety and performance, and improved fuel efficiency in a commercial...
DOT National Transportation Integrated Search
2016-11-01
An independent evaluation of a non-video-based onboard monitoring system (OBMS) was conducted. The objective was to determine if the OBMS system performed reliably, improved driving safety and performance, and improved fuel efficiency in a commercial...
Post-licensure rapid immunization safety monitoring program (PRISM) data characterization.
Baker, Meghan A; Nguyen, Michael; Cole, David V; Lee, Grace M; Lieu, Tracy A
2013-12-30
The Post-Licensure Rapid Immunization Safety Monitoring (PRISM) program is the immunization safety monitoring component of FDA's Mini-Sentinel project, a program to actively monitor the safety of medical products using electronic health information. FDA sought to assess the surveillance capabilities of this large claims-based distributed database for vaccine safety surveillance by characterizing the underlying data. We characterized data available on vaccine exposures in PRISM, estimated how much additional data was gained by matching with select state and local immunization registries, and compared vaccination coverage estimates based on PRISM data with other available data sources. We generated rates of computerized codes representing potential health outcomes relevant to vaccine safety monitoring. Standardized algorithms including ICD-9 codes, number of codes required, exclusion criteria and location of the encounter were used to obtain the background rates. The majority of the vaccines routinely administered to infants, children, adolescents and adults were well captured by claims data. Immunization registry data in up to seven states comprised between 5% and 9% of data for all vaccine categories with the exception of 10% for hepatitis B and 3% and 4% for rotavirus and zoster respectively. Vaccination coverage estimates based on PRISM's computerized data were similar to but lower than coverage estimates from the National Immunization Survey and Healthcare Effectiveness Data and Information Set. For the 25 health outcomes of interest studied, the rates of potential outcomes based on ICD-9 codes were generally higher than rates described in the literature, which are typically clinically confirmed cases. PRISM program's data on vaccine exposures and health outcomes appear complete enough to support robust safety monitoring. Copyright © 2013 Elsevier Ltd. All rights reserved.
Simulation and Flight Test Capability for Testing Prototype Sense and Avoid System Elements
NASA Technical Reports Server (NTRS)
Howell, Charles T.; Stock, Todd M.; Verstynen, Harry A.; Wehner, Paul J.
2012-01-01
NASA Langley Research Center (LaRC) and The MITRE Corporation (MITRE) have developed, and successfully demonstrated, an integrated simulation-to-flight capability for evaluating sense and avoid (SAA) system elements. This integrated capability consists of a MITRE developed fast-time computer simulation for evaluating SAA algorithms, and a NASA LaRC surrogate unmanned aircraft system (UAS) equipped to support hardware and software in-the-loop evaluation of SAA system elements (e.g., algorithms, sensors, architecture, communications, autonomous systems), concepts, and procedures. The fast-time computer simulation subjects algorithms to simulated flight encounters/ conditions and generates a fitness report that records strengths, weaknesses, and overall performance. Reviewed algorithms (and their fitness report) are then transferred to NASA LaRC where additional (joint) airworthiness evaluations are performed on the candidate SAA system-element configurations, concepts, and/or procedures of interest; software and hardware components are integrated into the Surrogate UAS research systems; and flight safety and mission planning activities are completed. Onboard the Surrogate UAS, candidate SAA system element configurations, concepts, and/or procedures are subjected to flight evaluations and in-flight performance is monitored. The Surrogate UAS, which can be controlled remotely via generic Ground Station uplink or automatically via onboard systems, operates with a NASA Safety Pilot/Pilot in Command onboard to permit safe operations in mixed airspace with manned aircraft. An end-to-end demonstration of a typical application of the capability was performed in non-exclusionary airspace in October 2011; additional research, development, flight testing, and evaluation efforts using this integrated capability are planned throughout fiscal year 2012 and 2013.
ERIC Educational Resources Information Center
Shaw, Richard
1999-01-01
Addresses workplace safety needs and tips for helping an organization achieve a high level of safety. Tips include showing administration commitment, establishing retribution-free reporting of safety problems and violations, rewarding excellent safety effort, and allowing no compromises in following safety procedures. (GR)
Assessing patient safety in Canadian ambulatory surgery facilities: A national survey
Ahmad, Jamil; Ho, Olivia A; Carman, Wayne W; Thoma, Achilles; Lalonde, Donald H; Lista, Frank
2014-01-01
BACKGROUND: There has been increased interest regarding patient safety and standards of care in Canadian ambulatory surgery facilities where surgical procedures are performed. The Canadian Association for Accreditation of Ambulatory Surgical Facilities (CAAASF) is a national organization formed to establish and maintain standards to ensure that surgical procedures conducted outside of public hospitals are performed safely. OBJECTIVE: To determine how many procedures are performed annually at CAAASF member sites, and to examine complication rates and several key patient safety practices. METHODS: All 69 facilities accredited by the CAAASF were surveyed. The survey focused on procedural data, complication rates and patient safety interventions. RESULTS: In 2010, 40,240 estimated procedures were performed. A total of 263 (0.007%) complications were reported. Sixteen (0.0004%) patients required reoperations in hospital and 19 (0.0004%) patients required transfer to hospital on the day of surgery. There were only two mortalities within 30 days of surgery reported in the past five years. With regard to patient safety practices, 93% used antimicrobial prophylaxis, 100% used strategies to maintain normothermia and 82% used measures for venous thromboembolism prevention. CONCLUSION: The present study is the first to report on the Canadian experience in ambulatory surgery facilities and provides insight into current practices at these facilities. Appropriate accreditation of ambulatory surgery facilities, well-established patient safety-related standards of care, careful patient selection and procedures performed by qualified health care professionals with appropriate certification practicing within the scope of their practice form the basis for safe and effective ambulatory surgery. PMID:25152645
Monitoring road safety development at regional level: A case study in the ASEAN region.
Chen, Faan; Wang, Jianjun; Wu, Jiaorong; Chen, Xiaohong; Zegras, P Christopher
2017-09-01
Persistent monitoring of progress, evaluating the results of interventions and recalibrating to achieve continuous improvement over time is widely recognized as being crucial towards the successful development of road safety. In the ASEAN (Association of Southeast Asian Nations) region there is a lack of well-resourced teams that contain multidisciplinary safety professionals, and specialists in individual countries, who are able to carry out this work effectively. In this context, not only must the monitoring framework be effective, it must also be easy to use and adapt. This paper provides a case study that can be easily reproduced; based on an updated and refined Road Safety Development Index (RSDI), by means of the RSR (Rank-sum ratio)-based model, for monitoring/reporting road safety development at regional level. The case study was focused on the road safety achievements in eleven Southeast Asian countries; identifying the areas of poor performance, potential problems and delays. These countries are finally grouped into several classes based on an overview of their progress and achievements regarding to road safety. The results allow the policymakers to better understand their own road safety progress toward their desired impact; more importantly, these results enable necessary interventions to be made in a quick and timely manner. Keeping action plans on schedule if things are not progressing as desired. This would avoid 'reinventing the wheel' and trial and error approaches to road safety, making the implementation of action plans more effective. Copyright © 2017 Elsevier Ltd. All rights reserved.
49 CFR 193.2509 - Emergency procedures.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 3 2010-10-01 2010-10-01 false Emergency procedures. 193.2509 Section 193.2509 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS FACILITIES...
49 CFR 193.2605 - Maintenance procedures.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 3 2010-10-01 2010-10-01 false Maintenance procedures. 193.2605 Section 193.2605 Transportation Other Regulations Relating to Transportation (Continued) PIPELINE AND HAZARDOUS MATERIALS SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION (CONTINUED) PIPELINE SAFETY LIQUEFIED NATURAL GAS FACILITIES...
49 CFR 385.19 - Safety fitness information.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final safety ratings, remedial directives, and safety...
49 CFR 385.19 - Safety fitness information.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Safety fitness information. 385.19 Section 385.19... ADMINISTRATION, DEPARTMENT OF TRANSPORTATION FEDERAL MOTOR CARRIER SAFETY REGULATIONS SAFETY FITNESS PROCEDURES General § 385.19 Safety fitness information. (a) Final safety ratings, remedial directives, and safety...
Molecular Tools To Study Preharvest Food Safety Challenges.
Kumar, Deepak; Thakur, Siddhartha
2018-02-01
Preharvest food safety research and activities have advanced over time with the recognition of the importance and complicated nature of the preharvest phase of food production. In developed nations, implementation of preharvest food safety procedures along with strict monitoring and containment at various postharvest stages such as slaughter, processing, storage, and distribution have remarkably reduced the burden of foodborne pathogens in humans. Early detection and adequate surveillance of pathogens at the preharvest stage is of the utmost importance to ensure a safe meat supply. There is an urgent need to develop rapid, cost-effective, and point-of-care diagnostics which could be used at the preharvest stage and would complement postmortem and other quality checks performed at the postharvest stage. With newer methods and technologies, more efforts need to be directed toward developing rapid, sensitive, and specific methods for detection or screening of foodborne pathogens at the preharvest stage. In this review, we will discuss the molecular methods available for detection and molecular typing of bacterial foodborne pathogens at the farm. Such methods include conventional techniques such as endpoint PCR, real-time PCR, DNA microarray, and more advanced techniques such as matrix-assisted layer desorption ionization-time of flight mass spectrometry and whole-genome sequencing.
Point-of-Care Detection Devices for Food Safety Monitoring: Proactive Disease Prevention.
Wu, Marie Yung-Chen; Hsu, Min-Yen; Chen, Shih-Jen; Hwang, De-Kuang; Yen, Tzung-Hai; Cheng, Chao-Min
2017-04-01
Food safety has become an increasingly significant public concern in both developed and under-developed nations around the world; it increases morbidity, mortality, human suffering, and economic burden. This Opinion focuses on (i) examining the influence of pathogens and chemicals (e.g., food additives and pesticide residue) on food-borne illnesses, (ii) summarizing food hazards that are present in Asia, and (iii) summarizing the array of current point-of-care (POC) detection devices that have potential applications in food safety monitoring. In addition, we provide insight into global healthcare issues in both developing and under-developed nations with a focus on bridging the gap between food safety issues in the public sector (associated with relevant clinical cases) and the use of POC detection devices for food safety monitoring. Copyright © 2016 Elsevier Ltd. All rights reserved.
Plavnick, Joshua B; Ferreri, Summer J; Maupin, Angela N
2010-01-01
The effects of self-monitoring on the procedural integrity of token economy implementation by 3 staff in a special education classroom were evaluated. The subsequent changes in academic readiness behaviors of 2 students with low-incidence disabilities were measured. Multiple baselines across staff and students showed that procedural integrity increased when staff used monitoring checklists, and students' academic readiness behavior also increased. Results are discussed with respect to the use of self-monitoring and the importance of procedural integrity in public school settings. PMID:21119907
Radioactive waste management in a hospital.
Khan, Shoukat; Syed, At; Ahmad, Reyaz; Rather, Tanveer A; Ajaz, M; Jan, Fa
2010-01-01
Most of the tertiary care hospitals use radioisotopes for diagnostic and therapeutic applications. Safe disposal of the radioactive waste is a vital component of the overall management of the hospital waste. An important objective in radioactive waste management is to ensure that the radiation exposure to an individual (Public, Radiation worker, Patient) and the environment does not exceed the prescribed safe limits. Disposal of Radioactive waste in public domain is undertaken in accordance with the Atomic Energy (Safe disposal of radioactive waste) rules of 1987 promulgated by the Indian Central Government Atomic Energy Act 1962. Any prospective plan of a hospital that intends using radioisotopes for diagnostic and therapeutic procedures needs to have sufficient infrastructural and manpower resources to keep its ambient radiation levels within specified safe limits. Regular monitoring of hospital area and radiation workers is mandatory to assess the quality of radiation safety. Records should be maintained to identify the quality and quantity of radioactive waste generated and the mode of its disposal. Radiation Safety officer plays a key role in the waste disposal operations.
Radiation exposure to sonographers from nuclear medicine patients: A review.
Earl, Victoria Jean; Badawy, Mohamed Khaldoun
2018-06-01
Following nuclear medicine scans a patient can be a source of radiation exposure to the hospital staff, including sonographers. Sonographers are not routinely monitored for occupational radiation exposure as they do not commonly interact with radioactive patients or other sources of ionizing radiation. This review aims to find evidence relating to the risk and amount of radiation the sonographer is exposed to from nuclear medicine patients. It is established in the literature that the radiation exposure to the sonographer following diagnostic nuclear medicine studies is low and consequently the risk is not significant. Nevertheless, it is paramount that basic radiation safety principles are followed to ensure any exposure to ionizing radiation is kept as low as reasonably achievable. Practical recommendations are given to assist the sonographer in radiation protection. Nuclear medicine therapy procedures may place the sonographer at higher risk and as such consultation with a Radiation Safety Officer or Medical Physicist as to the extent of exposure is recommended. © 2018 The Royal Australian and New Zealand College of Radiologists.
Assessment of Occupational Health and Safety for a Gas Meter Manufacturing Plant
NASA Astrophysics Data System (ADS)
Korkmaz, Ece; Iskender, Gulen; Germirli Babuna, Fatos
2016-10-01
This study investigates the occupational health and safety for a gas meter manufacturing plant. The risk assessment and management study is applied to plastic injection and mounting departments of the factory through quantitative Fine Kinney method and the effect of adopting 5S workplace organization procedure on risk assessment is examined. The risk assessment reveals that there are 17 risks involved; 14 grouped in high risk class (immediate improvement as required action); 2 in significant (measures to be taken as required action) and one in possible risk class (monitoring as required action). Among 14 high risks, 4 can be reduced by 83 % to be grouped under possible class when 5S is applied. One significant risk is observed to be lowered by 78 % and considered as possible risk due to the application of 5S. As a result of either 67 or 50 % reductions in 7 high risks, these risks are converted to be members of significant risk group after 5S implications.
Monitoring calculation of closure change of Extradosed Cable-stayed Bridge
NASA Astrophysics Data System (ADS)
Shi, Jing Xian; Ran, Zhi Hong
2018-06-01
During the construction of extradosed cable-stayed bridge in Yunnan province, China, the construction unit has made certain changes in the construction process of the closure section due to environmental restrictions: remove the hanging basket after the closure, the sling shall not be provided in closure section, the function of the sling is realized by the hanging basket on the 16th beam. In case of this change, the bridge has been constructed to section 15th. In order to ensure the smooth and orderly progress of each stage in the closure phase, this article is arranged according to the construction plan, appropriate adjustment of related procedures, checking the bridge safety at all stages of construction, the stress and force of the main girder are compared to ensure the safety of the construction after closure changes. Adjust the height of the beam of the 16th and 17th to adapt the new construction plan, and the bridge closure smoothly.
2013-09-09
dosimetry records, NDI’s operating procedures/instructions, and radiation safety training. c. Survey Personnel: (1) Health... Dosimetry . (1) Verify unshielded NDI safety procedures meet T.O. 33B-l-l and other occupational safety and health requirements. (2) Verify an...distribution is unlimited. Case Number: 88ABW-2013-3977, 9 Sep 2013 b. The electronic personal dosimeters (EPDs) worn by NDI personnel had
The design of the intelligent monitoring system for dam safety
NASA Astrophysics Data System (ADS)
Yuan, Chun-qiao; Jiang, Chen-guang; Wang, Guo-hui
2008-12-01
Being a vital manmade water-control structure, a dam plays a very important role in the living and production of human being. To make a dam run safely, the best design and the superior construction quality are paramount; moreover, with working periods increasing, various dynamic, alternative and bad loads generate little by little various distortions on the dam structure inevitably, which shall lead to potential safety problems or further a disaster (dam burst). There are many signs before the occurrence of a dam accident, so the timely and effective surveying on the distortion of a dam is important. On the basis of the cause supra, two intelligent (automatic) monitoring systems about the dam's safety based on the RTK-GPS technology and the measuring robot has been developed. The basic principle, monitoring method and monitoring process of these two intelligent (automatic) monitoring systems are introduced. It presents examples of monitor and puts forward the basic rule of dam warning based on data of actual monitor.
Conway, Aaron; Page, Karen; Rolley, John; Fulbrook, Paul
2013-08-01
Side effects of the medications used for procedural sedation and analgesia in the cardiac catheterisation laboratory are known to cause impaired respiratory function. Impaired respiratory function poses considerable risk to patient safety as it can lead to inadequate oxygenation. Having knowledge about the conditions that predict impaired respiratory function prior to the procedure would enable nurses to identify at-risk patients and selectively implement intensive respiratory monitoring. This would reduce the possibility of inadequate oxygenation occurring. To identify pre-procedure risk factors for impaired respiratory function during nurse-administered procedural sedation and analgesia in the cardiac catheterisation laboratory. Retrospective matched case-control. 21 cases of impaired respiratory function were identified and matched to 113 controls from a consecutive cohort of patients over 18 years of age. Conditional logistic regression was used to identify risk factors for impaired respiratory function. With each additional indicator of acute illness, case patients were nearly two times more likely than their controls to experience impaired respiratory function (OR 1.78; 95% CI 1.19-2.67; p = 0.005). Indicators of acute illness included emergency admission, being transferred from a critical care unit for the procedure or requiring respiratory or haemodynamic support in the lead up to the procedure. Several factors that predict the likelihood of impaired respiratory function were identified. The results from this study could be used to inform prospective studies investigating the effectiveness of interventions for impaired respiratory function during nurse-administered procedural sedation and analgesia in the cardiac catheterisation laboratory.
23 CFR 630.1014 - Implementation.
Code of Federal Regulations, 2014 CFR
2014-04-01
... FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1014 Implementation. Each State shall work in partnership with the FHWA in the implementation of its policies and procedures to improve work zone safety and...
23 CFR 630.1014 - Implementation.
Code of Federal Regulations, 2013 CFR
2013-04-01
... FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1014 Implementation. Each State shall work in partnership with the FHWA in the implementation of its policies and procedures to improve work zone safety and...
23 CFR 630.1014 - Implementation.
Code of Federal Regulations, 2012 CFR
2012-04-01
... FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1014 Implementation. Each State shall work in partnership with the FHWA in the implementation of its policies and procedures to improve work zone safety and...
23 CFR 630.1014 - Implementation.
Code of Federal Regulations, 2011 CFR
2011-04-01
... FEDERAL HIGHWAY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION ENGINEERING AND TRAFFIC OPERATIONS PRECONSTRUCTION PROCEDURES Work Zone Safety and Mobility § 630.1014 Implementation. Each State shall work in partnership with the FHWA in the implementation of its policies and procedures to improve work zone safety and...
49 CFR 179.3 - Procedure for securing approval.
Code of Federal Regulations, 2010 CFR
2010-10-01
... Executive Director—Tank Car Safety, AAR, for consideration by its Tank Car Committee and other appropriate... SAFETY ADMINISTRATION, DEPARTMENT OF TRANSPORTATION HAZARDOUS MATERIALS REGULATIONS SPECIFICATIONS FOR TANK CARS Introduction, Approvals and Reports § 179.3 Procedure for securing approval. (a) Application...
30 CFR 28.10 - Application procedures.
Code of Federal Regulations, 2014 CFR
2014-07-01
... Labor, Mine Safety and Health Administration, Approval and Certification Center, 765 Technology Drive... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND... TRAILING CABLES IN COAL MINES Application for Approval § 28.10 Application procedures. (a) Each applicant...
30 CFR 28.10 - Application procedures.
Code of Federal Regulations, 2012 CFR
2012-07-01
... Labor, Mine Safety and Health Administration, Approval and Certification Center, 765 Technology Drive... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND... TRAILING CABLES IN COAL MINES Application for Approval § 28.10 Application procedures. (a) Each applicant...
30 CFR 28.10 - Application procedures.
Code of Federal Regulations, 2011 CFR
2011-07-01
... Labor, Mine Safety and Health Administration, Approval and Certification Center, 765 Technology Drive... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND... TRAILING CABLES IN COAL MINES Application for Approval § 28.10 Application procedures. (a) Each applicant...
30 CFR 28.10 - Application procedures.
Code of Federal Regulations, 2013 CFR
2013-07-01
... Labor, Mine Safety and Health Administration, Approval and Certification Center, 765 Technology Drive... Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING, EVALUATION, AND... TRAILING CABLES IN COAL MINES Application for Approval § 28.10 Application procedures. (a) Each applicant...
Pretest and refinement of items for alcohol highway safety surveys
DOT National Transportation Integrated Search
1984-05-30
This study summarizes the procedures employed in pre-testing a set of alcohol-highway safety questionnaire items. The procedures included conducting a set of focus groups and a series of telephone interviews on several forms of the questionnaires. Th...
Development of procedures for identifying high-crash locations and prioritizing safety improvements
DOT National Transportation Integrated Search
2003-06-01
The objectives of this study were to review and analyze the current procedures for identifying high-crash locations and evaluating and prioritizing roadway safety improvements at high-crash locations, and to recommend improved methods. Several tasks ...
Development of procedures for identifying high-crash locations and prioritizing safety improvements.
DOT National Transportation Integrated Search
2003-06-01
The objectives of this study were to review and analyze the current procedures for identifying high-crash locations and evaluating and prioritizing roadway safety improvements at high-crash locations, and to recommend improved methods. Several tasks ...
Sowan, Azizeh Khaled; Reed, Charles Calhoun; Staggers, Nancy
2016-09-30
Large datasets of the audit log of modern physiologic monitoring devices have rarely been used for predictive modeling, capturing unsafe practices, or guiding initiatives on alarm systems safety. This paper (1) describes a large clinical dataset using the audit log of the physiologic monitors, (2) discusses benefits and challenges of using the audit log in identifying the most important alarm signals and improving the safety of clinical alarm systems, and (3) provides suggestions for presenting alarm data and improving the audit log of the physiologic monitors. At a 20-bed transplant cardiac intensive care unit, alarm data recorded via the audit log of bedside monitors were retrieved from the server of the central station monitor. Benefits of the audit log are many. They include easily retrievable data at no cost, complete alarm records, easy capture of inconsistent and unsafe practices, and easy identification of bedside monitors missed from a unit change of alarm settings adjustments. Challenges in analyzing the audit log are related to the time-consuming processes of data cleaning and analysis, and limited storage and retrieval capabilities of the monitors. The audit log is a function of current capabilities of the physiologic monitoring systems, monitor's configuration, and alarm management practices by clinicians. Despite current challenges in data retrieval and analysis, large digitalized clinical datasets hold great promise in performance, safety, and quality improvement. Vendors, clinicians, researchers, and professional organizations should work closely to identify the most useful format and type of clinical data to expand medical devices' log capacity.
Ultrasound and bronchoscopic controlled percutaneous tracheostomy on trauma ICU.
Kollig, E; Heydenreich, U; Roetman, B; Hopf, F; Muhr, G
2000-11-01
Tracheostomy is a common surgical procedure performed in long-term ventilated patients in intensive care. Since the role of percutaneous dilatational tracheostomy (PDT) on Intensive Care Unit (ICU) has become steadily more important in the last few years, a prospective study was started to evaluate the economic efficiency and to show the minimization of the complication rate of this procedure. In 72 patients we performed PDT as a bedside procedure. Initially the thyroid gland and the subcutaneous vessels were studied by ultrasound in every patient. The puncture of the trachea, the dilatational procedure and the insertion of the tracheal cannula were executed under bronchoscopic monitoring. Finally, a bronchoscopic control view followed via the new cannula to detect intratracheal complications. Mechanical ventilation was maintained during the procedure and controlled by continuous pulse oximetry. According to prior ultrasound findings the place to puncture the trachea was changed in 24% of the patients, in one case tracheostomy was performed as an open conventional procedure. The following complications could be observed: one case involving perforation of a cartilaginous ring, one case with venous bleeding of a small subcutaneous vein and two cases with punctures of the bronchoscope. There were no cases of miscannulation, penetration of the posterior tracheal wall or major bleeding requiring intervention or conversion. The followup study revealed that there was no sign of further complications in any patient. In addition, cost analysis demonstrated that there was a significant economical advantage of PDT in comparison with open standard tracheostomy. Standardized ultrasonographically and bronchoscopically controlled PDT turns out to be a safe, simple and cost effective bedside procedure on ICU. Because of ultrasound examination performed before the procedure, and bronchoscopic surveillance during the procedure, safety of this procedure can be enhanced, thus minimizing the rate of complications.
Promulgated quality assurance Procedure 5 Quality Assurance Requirements For Vapor Phase Mercury Continuous Emissions Monitoring Systems And Sorbent Trap Monitoring Systems Used For Compliance Determination At Stationary Sources
Monitoring work zone safety and mobility impacts in Texas.
DOT National Transportation Integrated Search
2009-05-01
In this report, Texas Transportation Institute researchers identify key work zone safety and mobility : performance measures that the Texas Department of Transportation (TxDOT) should target as part of a work : zone monitoring program within a distri...
Validity of a Sun Safety Diary Using UV Monitors in Middle School Children
ERIC Educational Resources Information Center
Yaroch, Amy L.; Reynolds, Kim D.; Buller, David B.; Maloy, Julie A.; Geno, Cristy R.
2006-01-01
This article describes a validity study conducted among middle school students comparing self-reported sun safety behaviors from a diary with readings from ultraviolet (UV) monitors worn on different body sites. The UV monitors are stickers with panels that turn increasingly darker shades of blue in the presence of increasing amounts of UV light.…
30 CFR 74.11 - Tests of the continuous personal dust monitor.
Code of Federal Regulations, 2010 CFR
2010-07-01
... 30 Mineral Resources 1 2010-07-01 2010-07-01 false Tests of the continuous personal dust monitor. 74.11 Section 74.11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH COAL MINE DUST SAMPLING DEVICES Requirements for Continuous Personal Dust Monitors § 74.11 Tests of the continuous personal...
30 CFR 74.11 - Tests of the continuous personal dust monitor.
Code of Federal Regulations, 2011 CFR
2011-07-01
... 30 Mineral Resources 1 2011-07-01 2011-07-01 false Tests of the continuous personal dust monitor. 74.11 Section 74.11 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR COAL MINE SAFETY AND HEALTH COAL MINE DUST SAMPLING DEVICES Requirements for Continuous Personal Dust Monitors § 74.11 Tests of the continuous personal...
1983-05-01
Firing data cards. PROCEDURES I. Prior to live fire exercises all firers must be oriented on range procedures. 2. Preparatory marksmanship training...Ordnance detail. 2. Range safety officer. 7. Medical personnel. 3. Firing line safety NCOs. 8. Control tower operators. i 4. Scorer (I per firer ). 9. Pit...phones and wire (for PIT commo). PROCEDURES I. Prior to live fire exercises, all firers must be oriented on range procedures. 2. Scorers are responsible
Bond, Aaron E; Shah, Binit B; Huss, Diane S; Dallapiazza, Robert F; Warren, Amy; Harrison, Madaline B; Sperling, Scott A; Wang, Xin-Qun; Gwinn, Ryder; Witt, Jennie; Ro, Susie; Elias, W Jeffrey
2017-12-01
Clinical trials have confirmed the efficacy of focused ultrasound (FUS) thalamotomy in essential tremor, but its effectiveness and safety for managing tremor-dominant Parkinson disease (TDPD) is unknown. To assess safety and efficacy at 12-month follow-up, accounting for placebo response, of unilateral FUS thalamotomy for patients with TDPD. Of the 326 patients identified from an in-house database, 53 patients consented to be screened. Twenty-six were ineligible, and 27 were randomized (2:1) to FUS thalamotomy or a sham procedure at 2 centers from October18, 2012, to January 8, 2015. The most common reasons for disqualification were withdrawal (8 persons [31%]), and not being medication refractory (8 persons [31%]). Data were analyzed using intention-to-treat analysis, and assessments were double-blinded through the primary outcome. Twenty patients were randomized to unilateral FUS thalamotomy, and 7 to sham procedure. The sham group was offered open-label treatment after unblinding. The predefined primary outcomes were safety and difference in improvement between groups at 3 months in the on-medication treated hand tremor subscore from the Clinical Rating Scale for Tremor (CRST). Secondary outcomes included descriptive results of Unified Parkinson's Disease Rating Scale (UPDRS) scores and quality of life measures. Of the 27 patients, 26 (96%) were male and the median age was 67.8 years (interquartile range [IQR], 62.1-73.8 years). On-medication median tremor scores improved 62% (IQR, 22%-79%) from a baseline of 17 points (IQR, 10.5-27.5) following FUS thalamotomy and 22% (IQR, -11% to 29%) from a baseline of 23 points (IQR, 14.0-27.0) after sham procedures; the between-group difference was significant (Wilcoxon P = .04). On-medication median UPDRS motor scores improved 8 points (IQR, 0.5-11.0) from a baseline of 23 points (IQR, 15.5-34.0) following FUS thalamotomy and 1 point (IQR, -5.0 to 9.0) from a baseline of 25 points (IQR, 15.0-33.0) after sham procedures. Early in the study, heating of the internal capsule resulted in 2 cases (8%) of mild hemiparesis, which improved and prompted monitoring of an additional axis during magnetic resonance thermometry. Other persistent adverse events were orofacial paresthesia (4 events [20%]), finger paresthesia (1 event [5%]), and ataxia (1 event [5%]). Focused ultrasound thalamotomy for patients with TDPD demonstrated improvements in medication-refractory tremor by CRST assessments, even in the setting of a placebo response. ClinicalTrials.gov identifier NCT01772693.
Report on UQ and PCMM Analysis of Vacuum Drying for UFD S&T Gaps
DOE Office of Scientific and Technical Information (OSTI.GOV)
M. Fluss
2015-08-31
This report discusses two phenomena that could affect the safety, licensing, transportation, storage, and disposition of the spent fuel storage casks and their contents (radial hydriding during drying and water retention after drying) associated with the drying of canisters for dry spent fuel storage. The report discusses modeling frameworks and evaluations that are, or have been, developed as a means to better understand these phenomena. Where applicable, the report also discusses data needs and procedures for monitoring or evaluating the condition of storage containers during and after drying. A recommendation for the manufacturing of a fully passivated fuel rod, resistantmore » to oxidation and hydriding is outlined.« less
Visceral Blood Flow Modulation: Potential Therapy for Morbid Obesity
DOE Office of Scientific and Technical Information (OSTI.GOV)
Harris, Tyler J., E-mail: tjharris@gmail.com; Murphy, Timothy P.; Jay, Bryan S.
We present this preliminary investigation into the safety and feasibility of endovascular therapy for morbid obesity in a swine model. A flow-limiting, balloon-expandable covered stent was placed in the superior mesenteric artery of three Yorkshire swine after femoral arterial cutdown. The pigs were monitored for between 15 and 51 days after the procedure and then killed, with weights obtained at 2-week increments. In the two pigs in which the stent was flow limiting, a reduced rate of weight gain (0.42 and 0.53 kg/day) was observed relative to the third pig (0.69 kg/day), associated with temporary food aversion and signs ofmore » mesenteric ischemia in one pig.« less
D Textured Modelling of both Exterior and Interior of Korean Styled Architectures
NASA Astrophysics Data System (ADS)
Lee, J.-D.; Bhang, K.-J.; Schuhr, W.
2017-08-01
This paper describes 3D modelling procedure of two Korean styled architectures which were performed through a series of processing from data acquired with the terrestrial laser scanner. These two case projects illustate the use of terrestrial laser scanner as a digital documentation tool for management, conservation and restoration of the cultural assets. We showed an approach to automate reconstruction of both the outside and inside models of a building from laser scanning data. Laser scanning technology is much more efficient than existing photogrammetry in measuring shape and constructing spatial database for preservation and restoration of cultural assets as well as for deformation monitoring and safety diagnosis of structures.
Myths, fallacies and practical pearls in GI lab
Kumar, Pradeep
2014-01-01
Many prevalent practices and guidelines related to Gastrointestinal endoscopy and procedural sedation are at odds with the widely available scientific-physiological and clinical outcome data. In many institutions, strict policy of pre-procedural extended fasting is still rigorously enforced, despite no evidence of increased incidence of aspiration after recent oral intake prior to sedation. Supplemental oxygen administration in the setting of GI procedural sedation has been increasingly adopted as reported in the medical journals, despite clear evidence that supplemental oxygen blunts the usefulness of pulse oximetry in timely detection of sedation induced hypoventilation, leading to increased number of adverse cardiopulmonary outcomes. Use of Propofol by Gastroenterologist-Nurse team is erroneously considered dangerous and often prohibited in various institutions, at the same time worldwide reports of remarkable safety and patient satisfaction continue to be published, dating back more than a decade. Of patient monitoring practices that have been advocated to be standard, many merely add cost, not value. Advances in the technology often are not incorporated in a timely manner in guidelines or clinical practices, e.g., Capsule endoscopy or electrocautery during GI procedures do not interfere with proper functioning of the current pacemakers or defibrillators. Orthopedic surgeons have continued to recommend prophylactic antibiotics for joint replacement patients prior to GI procedures, without any evidence of need. These myths are explored for a succint review to prompt a change in clinical practices and institutional policies. PMID:25512767
[Design of an HACCP program for a cocoa processing facility].
López D'Sola, Patrizia; Sandia, María Gabriela; Bou Rached, Lizet; Hernández Serrano, Pilar
2012-12-01
The HACCP plan is a food safety management tool used to control physical, chemical and biological hazards associated to food processing through all the processing chain. The aim of this work is to design a HACCP Plan for a Venezuelan cocoa processing facility.The production of safe food products requires that the HACCP system be built upon a solid foundation of prerequisite programs such as Good Manufacturing Practices (GMP) and Sanitation Standard Operating Procedures (SSOP). The existence and effectiveness of these prerequisite programs were previously assessed.Good Agriculture Practices (GAP) audit to cocoa nibs suppliers were performed. To develop the HACCP plan, the five preliminary tasks and the seven HACCP principles were accomplished according to Codex Alimentarius procedures. Three Critical Control Points (CCP) were identified using a decision tree: winnowing (control of ochratoxin A), roasting (Salmonella control) and metallic particles detection. For each CCP, Critical limits were established, the Monitoring procedures, Corrective actions, Procedures for Verification and Documentation concerning all procedures and records appropriate to these principles and their application was established. To implement and maintain a HACCP plan for this processing plant is suggested. Recently OchratoxinA (OTA) has been related to cocoa beans. Although the shell separation from the nib has been reported as an effective measure to control this chemical hazard, ochratoxin prevalence study in cocoa beans produced in the country is recommended, and validate the winnowing step as well
49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?
Code of Federal Regulations, 2013 CFR
2013-10-01
... 49 Transportation 5 2013-10-01 2013-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...
49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?
Code of Federal Regulations, 2012 CFR
2012-10-01
... 49 Transportation 5 2012-10-01 2012-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...
49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?
Code of Federal Regulations, 2014 CFR
2014-10-01
... 49 Transportation 5 2014-10-01 2014-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...
49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...
49 CFR 385.317 - Will a safety audit result in a safety fitness determination by the FMCSA?
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Will a safety audit result in a safety fitness... SAFETY REGULATIONS SAFETY FITNESS PROCEDURES New Entrant Safety Assurance Program § 385.317 Will a safety audit result in a safety fitness determination by the FMCSA? A safety audit will not result in a safety...
... over-the-counter drug. The FDA evaluates the safety of a drug by looking at Side effects ... clinical trials The FDA also monitors a drug's safety after approval. For you, drug safety means buying ...
77 FR 52219 - Amendment of Class E Airspace; Lewistown, MT
Federal Register 2010, 2011, 2012, 2013, 2014
2012-08-29
... Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Lewistown Municipal Airport. This improves the safety and management of Instrument Flight Rules (IFR...) standard instrument approach procedures at the airport. This action is necessary for the safety and...
76 FR 59502 - Establishment of Class E Airspace; Gordonsville, VA
Federal Register 2010, 2011, 2012, 2013, 2014
2011-09-27
... at Gordonsville, VA, to accommodate the new Standard Instrument Approach Procedures serving Gordonsville Municipal Airport. This action enhances the safety and airspace management of Instrument Flight... approach procedures developed for Gordonsville Municipal Airport. This action is necessary for the safety...
30 CFR 15.4 - Application procedures and requirements.
Code of Federal Regulations, 2012 CFR
2012-07-01
..., Mine Safety and Health Administration, Approval and Certification Center, 765 Technology Drive... 30 Mineral Resources 1 2012-07-01 2012-07-01 false Application procedures and requirements. 15.4 Section 15.4 Mineral Resources MINE SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR TESTING...
10 CFR 39.63 - Operating and emergency procedures.
Code of Federal Regulations, 2012 CFR
2012-01-01
... Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.63 Operating and emergency procedures. Each licensee shall develop and... radiation surveys, including surveys for detecting contamination, as required by § 39.67(c)-(e); (d...
10 CFR 39.63 - Operating and emergency procedures.
Code of Federal Regulations, 2014 CFR
2014-01-01
... Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.63 Operating and emergency procedures. Each licensee shall develop and... radiation surveys, including surveys for detecting contamination, as required by § 39.67(c)-(e); (d...
10 CFR 39.63 - Operating and emergency procedures.
Code of Federal Regulations, 2013 CFR
2013-01-01
... Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.63 Operating and emergency procedures. Each licensee shall develop and... radiation surveys, including surveys for detecting contamination, as required by § 39.67(c)-(e); (d...
10 CFR 39.63 - Operating and emergency procedures.
Code of Federal Regulations, 2010 CFR
2010-01-01
... Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.63 Operating and emergency procedures. Each licensee shall develop and... radiation surveys, including surveys for detecting contamination, as required by § 39.67(c)-(e); (d...
10 CFR 39.63 - Operating and emergency procedures.
Code of Federal Regulations, 2011 CFR
2011-01-01
... Energy NUCLEAR REGULATORY COMMISSION LICENSES AND RADIATION SAFETY REQUIREMENTS FOR WELL LOGGING Radiation Safety Requirements § 39.63 Operating and emergency procedures. Each licensee shall develop and... radiation surveys, including surveys for detecting contamination, as required by § 39.67(c)-(e); (d...
Development, implementation and evaluation of a pedestrian safety zone for elderly pedestrians
DOT National Transportation Integrated Search
1998-02-01
The objectives of this study were to develop and apply procedures for defining pedestrian safety zones for the older (age 65+) adult and to develop, implement and evaluate a countermeasure program in the defined zones. Zone definition procedures were...
49 CFR 385.11 - Notification of safety rating and safety fitness determination.
Code of Federal Regulations, 2011 CFR
2011-10-01
... 49 Transportation 5 2011-10-01 2011-10-01 false Notification of safety rating and safety fitness... REGULATIONS SAFETY FITNESS PROCEDURES General § 385.11 Notification of safety rating and safety fitness... notice of remedial directive will constitute the notice of safety fitness determination. If FMCSA has not...
49 CFR 385.11 - Notification of safety rating and safety fitness determination.
Code of Federal Regulations, 2010 CFR
2010-10-01
... 49 Transportation 5 2010-10-01 2010-10-01 false Notification of safety rating and safety fitness... REGULATIONS SAFETY FITNESS PROCEDURES General § 385.11 Notification of safety rating and safety fitness... notice of remedial directive will constitute the notice of safety fitness determination. If FMCSA has not...
Using Cell Phone Technology for Self-Monitoring Procedures in Inclusive Settings
ERIC Educational Resources Information Center
Bedesem, Pena L.
2012-01-01
The purpose of this study was to determine the effects and social validity of an innovative method of self-monitoring for middle school students with high-incidence disabilities in inclusive settings. An updated self-monitoring procedure, called CellF-Monitoring, utilized a cell phone as an all-inclusive self-monitoring device. The study took…
Benhamou, Pierre Yves; Huneker, Erik; Franc, Sylvia; Doron, Maeva; Charpentier, Guillaume
2018-06-01
Improvement in closed-loop insulin delivery systems could result from customization of settings to individual needs and remote monitoring. This pilot home study evaluated the efficacy and relevance of this approach. A bicentric clinical trial was conducted for 3 weeks, using an MPC-based algorithm (Diabeloop Artificial Pancreas system) featuring five settings designed to modulate the reactivity of regulation. Remote monitoring was ensured by expert nurses with a web platform generating automatic Secured Information Messages (SIMs) and with a structured procedure. Endpoints were glucose metrics and description of impact of monitoring on regulation parameters. Eight patients with type 1 diabetes (six men, age 41.8 ± 11.4 years, HbA1c 7.7 ± 1.0%) were included. Time spent in the 70-180 mg/dl range was 70.2% [67.5; 76.9]. Time in hypoglycemia < 70 mg/dl was 2.9% [2.1; 3.4]. Eleven SIMs led to phone intervention. Original default settings were modified in all patients by the intervention of the nurses. This pilot trial suggests that the Diabeloop closed-loop system could be efficient regarding metabolic outcomes, whereas its telemedical monitoring feature could contribute to enhanced efficacy and safety. This study is registered at ClinicalTrials.gov with trial registration number NCT02987556.
Aviation Safety Reporting System: Process and Procedures
NASA Technical Reports Server (NTRS)
Connell, Linda J.
1997-01-01
The Aviation Safety Reporting System (ASRS) was established in 1976 under an agreement between the Federal Aviation Administration (FAA) and the National Aeronautics and Space Administration (NASA). This cooperative safety program invites pilots, air traffic controllers, flight attendants, maintenance personnel, and others to voluntarily report to NASA any aviation incident or safety hazard. The FAA provides most of the program funding. NASA administers the program, sets its policies in consultation with the FAA and aviation community, and receives the reports submitted to the program. The FAA offers those who use the ASRS program two important reporting guarantees: confidentiality and limited immunity. Reports sent to ASRS are held in strict confidence. More than 350,000 reports have been submitted since the program's beginning without a single reporter's identity being revealed. ASRS removes all personal names and other potentially identifying information before entering reports into its database. This system is a very successful, proof-of-concept for gathering safety data in order to provide timely information about safety issues. The ASRS information is crucial to aviation safety efforts both nationally and internationally. It can be utilized as the first step in safety by providing the direction and content to informed policies, procedures, and research, especially human factors. The ASRS process and procedures will be presented as one model of safety reporting feedback systems.
29 CFR 1956.22 - Procedures for evaluation and monitoring.
Code of Federal Regulations, 2011 CFR
2011-07-01
..., Change, Evaluation and Withdrawal of Approval Procedures § 1956.22 Procedures for evaluation and... enforcement authority under section 18(e) of the Act is not relevant to Phase II and III monitoring under...