Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019.

During the training workshop on Inspection of Blood Establishments, which was hosted by the PEI GHPP BloodTrain in Harare from the 20th to the 24th of May 2019, participants from the National Regulatory Authorities from seven Sub-Sahara African countries presented their current experiences related to regulation and inspection of blood establishments in their respective countries. While in all seven countries regulation and inspection of conventional medicinal products manufacturer is performed, the regulatory situation of blood and blood components as well as inspection of blood establishments is still heterogeneous.

INAHTA IMPACT STORY: LEGISLATIVE AND ACCREDITATION REQUIREMENTS FOR OFFICE-BASED SURGERY IN AUSTRALIA.

BACKGROUND: There is growing trend for some surgical procedures previously performed in hospitals to be done in alternative settings, including office-based facilities. There has been some safety concerns reported in the media, which document serious adverse events following procedures performed in an office-based setting. To understand the current regulatory oversight of surgery in this setting ASERNIP-S conducted a review of the legislative and accreditation process governing these facilities in Australia. METHODS: Using rapid review methodology, internet searches targeted government Web sites for relevant publicly-available documents. Use of consolidated versions of legislative instruments ensured currency of information. Standards were sourced directly from the issuing authorities or those that oversee the accreditation process. RESULTS: Within Australia, healthcare facilities for surgery and their licensing are defined by each state and territory, which results in significant jurisdictional variation. These variations relate to the need for anesthesia beyond conscious sedation and listing of procedures in legislative instruments. In 2013, Australia adopted National Safety and Quality Health Service standards (NSQHS standards) for the accreditation of hospitals and day surgery centers; however, there is no NSQHS standard for office-based facilities. The main legislative driver for compliance is access to reimbursement schemes for service delivery. CONCLUSIONS: The legislative and accreditation framework creates a situation whereby healthcare facilities that provide services outside the various legal definitions of surgery and those not covered by a reimbursement scheme, can operate without licensing and accreditation oversight. This situation exposes patients to potential increased risk of harm when receiving treatment in such unregulated facilities.

Hygiene inspections on passenger ships in Europe - an overview.

BACKGROUND: Hygiene inspections on passenger ships are important for the prevention of communicable diseases. The European Union (EU) countries conduct hygiene inspections on passenger ships in order to ensure that appropriate measures have been taken to eliminate potential sources of contamination which could lead to the spread of communicable diseases. This study was implemented within the framework of the EU SHIPSAN project and it investigates the legislation applied and practices of hygiene inspections of passenger ships in the EU Member States (MS) and European Free Trade Association countries. METHODS: Two questionnaires were composed and disseminated to 28 countries. A total of 92 questionnaires were completed by competent authorities responsible for hygiene inspections (n = 48) and the creation of legislation (n = 44); response rates were 96%, and 75.9%, respectively. RESULTS: Out of the 48 responding authorities responsible for hygiene inspections, a routine programme was used by 19 (39.6%) of these to conduct inspections of ships on national voyages and by 26 (54.2%) for ships on international voyages. Standardised inspection forms are used by 59.1% of the authorities. A scoring inspection system is applied by five (11.6%) of the 43 responding authorities. Environmental sampling is conducted by 84.1% of the authorities (37 out of 44). The inspection results are collected and analysed by 54.5% (24 out of 44) of the authorities, while 9 authorities (20.5%) declared that they publish the results. Inspections are conducted during outbreak investigations by 75% and 70.8% of the authorities, on ships on national and international voyages, respectively. A total of 31 (64.6%) and 39 (81.3%) authorities conducted inspections during complaint investigations on ships on international and on national voyages, respectively. Port-to-port communication between the national port authorities was reported by 35.4% (17 out of 48) of the responding authorities and 20.8% (10 out of 48) of the port authorities of other countries. CONCLUSION: This study revealed a diversity of approaches and practices in the conduct of inspections, differences in the qualifications/knowledge/experience of inspectors, the legislation applied during inspections, and the lack of communication and training among many EU countries. An integrated European inspection programme involving competent expert inspectors in each EU Member States and special training for ship hygiene delivered to crew members and inspectors would help to minimize the risk of communicable diseases. Common inspection tools at a European level for hygiene inspection practices and port-to-port communication are needed.

The role of sanctions in Australia's residential aged care quality assurance system.

OBJECTIVE: To assess the role of sanctions as the highest level of enforcement in Australia's residential aged care quality assurance (QA) system. ANALYSIS: of secondary data on accreditation activities and outcomes from 1999-2000 to 2007-08, extracted from the Annual Report on the Aged Care Act 1997. SETTING: A total of 138 sanctioned homes among all aged care homes in Australia (n = 2830 in 2007-08). MAIN OUTCOME MEASURES: Chi-square test of differences between sanctioned and non-sanctioned homes, and z scores to identify variables underlying differences. RESULTS: Sanctions are a rare event as more frequent enforcement actions at lower levels of regulatory action mean that a diminishing number of homes are subject to higher levels of action. Relationships between the risk of sanctions and characteristics of homes (state, size, sector and level of care) were evident. Sanctions provide only limited signals on quality to potential users and do not reflect the full scope of the QA process and the range of quality of care found. CONCLUSIONS: The effectiveness of sanctions in contributing to quality improvement has to be seen within the wider regulatory framework, which in turn has to be set in the context of other factors driving quality of care. Quality improvement in Australia and elsewhere will depend on further development of QA systems but will also require attention to wider contextual factors that contribute to quality outcomes, including quality of the aged care workforce.

Transforming an Academic Radiochemistry Facility for Positron Emission Tomography Drug cGMP Compliance.

In light of the United States Food and Drug Administration (FDA) requirement of 21 CFR 212 current Good Manufacturing Practice (cGMP) for FDA-approved position emission tomography (PET) drugs, the University of California Los Angeles (UCLA) Biomedical Cyclotron (BMC) transformed from a pre-cGMP era academic cyclotron and radiochemistry facility to a current cGMP-compliant PET drug manufacturer. In this article, we share the financial and regulatory compliance aspects of the "transformation" required to develop a sustainable quality system to support the production of two PET drugs under Abbreviated New Drug Applications (ANDAs).

Scores on doors: restaurant hygiene ratings and public health policy.

This paper seeks to contribute to the ongoing policy debate about mandated posting of health department hygiene ratings for establishments that sell food. Posted restaurant hygiene ratings, or 'scores on doors,' exemplify a public health transparency policy in the form of words, letters, numbers, or symbols displayed at entrances to food-serving establishments summarizing their most recent health inspection. After describing the scope of restaurant hygiene inspections and the problem of foodborne illness, this paper critically examines the 'mandation' debate on economic, practical, ethical, and legal aspects. It concludes that mandated posting of hygiene ratings, if done properly, is a potentially effective public policy that fosters transparency, population health, and informed consumer choice.

Experts stress both wellness and amenity aspects of food and nutrition services in assisted living facilities for older adults.

OBJECTIVES: There has been no consensus on best practices in food and nutrition services in assisted living facilities for older adults. We documented experts' views on optimal food and nutrition services emphases in assisted living facilities, and factors affecting their views. METHODS: One hundred thirty-five national experts specializing in health, aging, nutrition and assisted living facilities completed a survey consisting four scenarios (ie, home-style, restaurant/hotel, and health/medical, and a combination of these three) in six food and nutrition services areas: dining room environment, meal services, meal quality, nutrition services, employees' qualifications, and therapeutic nutrition services. RESULTS: Sixty-three percent of experts favored the combination scenario. Dietetics education and experts' beliefs that assisted living facilities should be health promotion and maintenance facilities were significant predictors of emphases, including wellness considerations. Experts' personal views exerted a powerful influence. CONCLUSIONS: Experts chose food and nutrition service quality indicators that emphasized a focus on both wellness and amenities as their ideal scenarios for optimal food and nutrition services in assisted living facilities.

Transitioning dementia residents from assisted living to memory care units: a pilot study.

Our study examined the process of transitioning residents of assisted living facilities (ALFs) who have Alzheimer's disease or a related disorder to memory care units (MCUs). In-depth surveys with 10 ALF administrators in South Carolina were conducted. Grounded theory identified major themes; thematic analysis organized content. Most administrators used a preadmission screening process to assess cognitive status. About half reported that they discussed the possibility of future transfer to another level of care with the family at admission. Most administrators said that their facilities had transfer policies in place; of these, only two-thirds discussed their policies with families on admission. Transfer triggers included leaving the facility without anyone's knowledge, disturbing behaviors, and increased care needs. Challenges included family resistance and greater costs of MCUs. Assisted living facilities that were part of continuing care retirement communities used more multidisciplinary transfer decision-making than free-standing ALFs. Suggested improvements stressed educating families about dementia and MCUs.

Complying with the Occupational Safety and Health Administration: guidelines for the dental office.

This article outlines Occupational Safety and Health Administration (OSHA) guidelines for maintaining a safe dental practice workplace and covers requirements, such as education and protection for dental health care personnel. OSHA regulations aim to reduce exposure to blood-borne pathogens. Environmental infection control in dental offices and operatories is the goal of enforcement of OSHA codes of practice. Universal precautions reduce the risk for infectious disease. OSHA has a mandate to protect workers in the United States from potential workplace injuries. OSHA standards are available through online and print publications and owners of dental practices must meet OSHA standards for the workplace.

[Investigation of the safety of microbial biotechnological products and their hygienic regulation].

Peculiarities of influence of microbial preparations based on microorganisms of different taxonomic groups on the warm-blooded organisms are considered, that is necessary to take into account when developing the strategy of toxico-hygienic studying of these preparations and when substanting hygienic standards in industrial objects and in the environment. The possibility to simplify the methodical scheme of the toxicological estimation and the hygienic regulation of microbial preparations on the basis of soil nitrogen-fixing microorganisms is discussed.

The current status of forensic science laboratory accreditation in Europe.

Forensic science is gaining some solid ground in the area of effective crime prevention, especially in the areas where more sophisticated use of available technology is prevalent. All it takes is high-level cooperation among nations that can help them deal with criminality that adopts a cross-border nature more and more. It is apparent that cooperation will not be enough on its own and this development will require a network of qualified forensic laboratories spread over Europe. It is argued in this paper that forensic science laboratories play an important role in the fight against crime. Another, complimentary argument is that forensic science laboratories need to be better involved in the fight against crime. For this to be achieved, a good level of cooperation should be established and maintained. It is also noted that harmonization is required for such cooperation and seeking accreditation according to an internationally acceptable standard, such as ISO/IEC 17025, will eventually bring harmonization as an end result. Because, ISO/IEC 17025 as an international standard, has been a tool that helps forensic science laboratories in the current trend towards accreditation that can be observed not only in Europe, but also in the rest of the world of forensic science. In the introduction part, ISO/IEC 17025 states that "the acceptance of testing and calibration results between countries should be facilitated if laboratories comply with this international standard and if they obtain accreditation from bodies which have entered into mutual recognition agreements with equivalent bodies in other countries using this international standard." Furthermore, it is emphasized that the use of this international standard will assist in the harmonization of standards and procedures. The background of forensic science cooperation in Europe will be explained by using an existing European forensic science network, i.e. ENFSI, in order to understand the current status of forensic science in Europe better. The Council of Europe and the European Union approaches to forensic science will also be discussed by looking at the legal instruments and documents published by these two European organizations. Data collected from 52 European forensic science laboratories will be examined and findings will be evaluated from a quality assurance and accreditation point of view. The need for harmonization and accreditation in forensic science will be emphasized. The steps that should be taken at the European level for increasing and strengthening the role of European forensic science laboratories in the fight against crime will be given as recommendations in the conclusion.

Amendment to the current good manufacturing practice regulations for finished pharmaceuticals. Direct final rule.

The Food and Drug Administration (FDA) is amending certain regulations as the first phase of an incremental approach to modifying the current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. We are amending the regulations to modernize or clarify some of the CGMP requirements, as well as harmonize some of the CGMP requirements with those of other foreign regulators and other FDA regulations. These amendments are also consistent with current industry practice. We are taking this action as part of our continuing effort to revise outdated regulations without diminishing public health protection. We are issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on these amendments. Elsewhere in this issue of the Federal Register, we are publishing a companion proposed rule, under our usual notice-and-comment rulemaking procedures, to provide a procedural framework to finalize the rule in the event the agency receives any significant adverse comments and withdraws this direct final rule. The companion proposed rule and direct final rule are substantively identical.

The quality of laboratory testing today: an assessment of sigma metrics for analytic quality using performance data from proficiency testing surveys and the CLIA criteria for acceptable performance.

To assess the analytic quality of laboratory testing in the United States, we obtained proficiency testing survey results from several national programs that comply with Clinical Laboratory Improvement Amendments (CLIA) regulations. We studied regulated tests (cholesterol, glucose, calcium, fibrinogen, and prothrombin time) and nonregulated tests (international normalized ratio [INR], glycohemoglobin, and prostate-specific antigen [PSA]). Quality was assessed on the sigma scale with a benchmark for minimum process performance of 3 sigma and a goal for world-class quality of 6 sigma. Based on the CLIA criteria for acceptable performance in proficiency testing (allowable total errors [TEa]), the national quality of cholesterol testing (TEa = 10%) estimated sigma values as 2.9 to 3.0; glucose (TEa = 10%), 2.9 to 3.3; calcium (TEa = 1.0 mg/dL), 2.8 to 3.0; prothrombin time (TEa = 15%), 1.8; INR (TEa = 20%), 2.4 to 3.5; fibrinogen (TEa = 20%), 1.8 to 3.2; glycohemoglobin (TEa = 10%), 1.9 to 2.6; and PSA (TEa = 10%), 1.2 to 1.8. The analytic quality of laboratory tests requires improvement in measurement performance and more intensive quality control monitoring than the CLIA minimum of 2 levels per day.

Diagnostic X-ray facilities as per quality control performances in Tanzania.

Without appropriate quality control (QC) and preventative maintenance (PM) measures for X-ray machines in place, the benefits of reduced dose to the patient and early diagnosis will not be realized. Quality control and PM also make it possible to unify X-ray-imaging practices in the country using international image quality guidelines. The impetus for the present work resulted from the concern that with the recent increase in the numbers of X-ray machines in Tanzania, but with limited technical support to maintain and operate them, can increase radiation risk to patients and lower diagnostic accuracy. The aim of this work is to report on the current status of diagnostic X-ray machines in Tanzania in order to produce the data needed to formulate QC and PM policies and strategies. These policies and strategies are needed to ensure that patients receive the lowest possible radiation risk and maximum health benefits from X-ray examinations. Four QC tests were performed on a total of 196 X-ray units. Accurate beam alignment and collimation were tested on 80 (41%) units, the timer accuracy was tested on 120 (61%) units, and a radiation leakage test was performed on 47(24%) units. Preventative maintenance tests were performed on all 196 X-ray units. The results showed that of the units tested for QC, 59% failed the kilovoltage (kVp) test, 57% failed the timer accuracy test, 60% failed the beam alignment test, and 20% failed the radiation leakage test. Only 13% of the units passed the PM test: 53% of the units were defective, and 34% were out of order. As a result of the PM findings, the government has introduced a rehabilitation project to service X-ray units and replace nonoperational X-ray units. The new units have full support service contracts signed by their suppliers. As a result of the QC findings, X-ray maintenance retraining programs have been introduced.

Demystifying the Occupational Safety and Health Administration inspection process.

Being prepared for an Occupational Safety and Health Administration (OSHA) inspection can save a facility money, as well as potentially protect employees from serious illness or injury. This article explains the OSHA inspection process, types of violations that may be cited and the appeals process for employers and employees. Actual citations given in four recent OSHA health care facility inspections are discussed and general recommendations to prepare for an OSHA site visit are given.

Standard operating procedure: implementation, critical analysis, and validation in the Audiology Department at CESTEH/Fiocruz.

PURPOSE: Evaluate three standard operational procedures (SOPs), regarding the application of the brainstem auditory evoked potential (BAEP) test, implemented by the Audiology Department of the Center for Studies in Occupational Health and Human Ecology (CESTEH) through the application of a questionnaire and to verify whether the SOPs are effective and assess the necessity for improvement. METHODS: The study was conducted in three phases: in the first phase, eight speech-language pathologists and seven physicians, with no experience in BAEP, were instructed to read and perform each SOP, eventually all individuals evaluated the SOPs by responding to a questionnaire; in the second phase, the questionnaires were analyzed and the three SOP texts were reviewed; in the third phase, nine speech-language pathologists and six physicians, also with no experience in BAEP, read and re-evaluated the reviewed SOPs through a questionnaire. RESULTS: In the first phase, difficulties in understanding the texts were found, raising doubts about the procedures; however, every participant was able to perform the procedure as a whole. In the third phase, after the review, all individuals were able to perform the procedures appropriately and continuously without any doubts. CONCLUSION: The assessment of the SOPs by questionnaires showed the need for adaptation in the texts. After the texts were reviewed according to the suggestions of the health professionals, it was possible to observe that the SOPs assisted in the execution of the task, which was conducted without any difficulties or doubts, being regarded effective and ensuring quality to the service offered.

An Assessment Model for Evaluating Outcomes in Federally Qualified Health Centers' Dental Departments: Results of a 5 Year Study.

PURPOSE: The purpose of this report was to establish baseline data on 10 oral health performance indicators over 5 fiscal years (2007 to 2008 through 2011 to 2012) for an Iowa health center. The baseline data provides an assessment model and reports outcomes based on the use of the model. Performance indicators show evidence of provider performance, accountability to stakeholders and provide the benchmarks required for dental management to develop future goals to improve oral health outcomes for atrisk populations. METHODS: Using descriptive statistic, this report extrapolated data from the Iowa Health Center's computer management systems software, HealthPro, and Centricity electronic medical records, and analyzed using IBM® SPSS® 19. This report describes the change in utilization for number and type of visits for uninsured and Medicaid patients over 5 fiscal years (a fiscal year is measured from November 1 through October 31). RESULTS: The number of patients receiving at least 1 dental visit in a measurement year showed n=81,673 procedures with 21% (17,167) being unduplicated patients. Preventive averaged 46%, restorative 18%, urgent care 22% and other procedures 14%. CONCLUSION: Federally qualified health centers (FQHCs) with a dental component serve populations with the greatest health disparities. This population includes ethnic and racial minorities, uninsured, underinsured, rural residents, Medicaid and Medicare. Establishing baseline data for FQHCs provides a foundational tool that will allow dental management to analyze successes as well as deficiencies in the goal to provide increased utilization to oral health care for at-risk populations.