Objectives: The primary aim of this study was to determine quantitatively the extent of coverage of the Hong Kong Laboratory Accreditation Scheme (HOKLAS 015) requirements by guidance checklists (HOKLAS 016‑02 and HOKLAS 021). Methods: The level of conformance requirement coverage of HOKLAS 015 by HOKLAS 016‑02 and HOKLAS 021 was calculated by an evaluation checklist based on conformance requirements in HOKLAS 015. A distribution analysis of conformance requirements relating to the International Standard ISO 15189:2012 process‑based quality management system model was also performed to elicit further coverage information. Results: HOKLAS 016‑02 was found to provide coverage of 76% while HOKLAS 021 was found to provide coverage of 11%. HOKLAS 015 was also found to have a distribution coverage of 78% relating to the International Standard ISO 15189:2012 process‑based quality management system model. Conclusion The results of this analysis should be of value to medical laboratories wishing to maintain the internal auditability required by HOKLAS 015 by gaining an awareness of the extent of coverage provided by HOKLAS 016‑02 and HOKLAS 021.
Accreditation ; Management Audit

Background: According to the guidelines of the Department of Health (DOH)’s Health Facilities and Services Regulatory Bureau (HFSRB), accreditation of drug testing laboratories (DTLs) requires annual participation in a proficiency testing (PT) program. Since 2009, the National Reference Laboratory for Environmental and Occupational Health, Toxicology and Micronutrient Assay of the East Avenue Medical Center (NRL-EAMC) has conducted the PT program for DTLs. Objectives: This article aims to provide a general overview of the PT program conducted for screening drug testing laboratories (SDTLs) and to examine data on laboratories’ participation and performance in the PT program. Methodology: Laboratories registered for the PT program were given ten 3-mL synthetic urine specimens which may or may not contain drugs of abuse such as methamphetamine and tetrahydrocannabinol at or above the cut-off level. Laboratories analyzed the PT specimens using immunoassay test kits. The results of the analysis were reported back to NRL-EAMC. The performance of the laboratories in the PT depends on the number of incorrect responses. Results: For ten years (2009-2019), 1102 ± 188 laboratories annually participated in the program. The mean passing rate was 96.6 ± 4.8%. The number of laboratories which initially failed the PT program significantly decreased from 2009 (15.1%) to 2012 (1.5%). From 2013 to 2019, only below 2.5% of the participating laboratories initially failed the PT. On average, 48.4 ± 18.4% of the laboratories achieved an excellent performance, 34.0 ± 13.6% had a highly satisfactory performance, and 14.3 ± 5.4% got an acceptable performance. Conclusion The continued decreasing number of laboratories which failed the PT signifies the improvement of laboratories in urine drug testing. In general, some laboratories participating in the PT for the first time are the ones which initially fail the PT which could be due to a lack of experience in handling PT test items. The PT program highlights the effectiveness of quality control procedures being implemented in a drug testing laboratory.
Laboratories ; Quality Control ; Accreditation ; Methamphetamine

OBJECTIVES: To survey the development status and actual needs of virtual autopsy technology in China and to clarify the applicability of forensic virtual autopsy laboratory accreditation. METHODS: The questionnaire was set up included three aspects：(1) the current status of virtual autopsy technology development; (2) the accreditation elements such as personnel, equipment, entrustment and acceptance, methods, environmental facilities; (3) the needs and suggestions of practicing institutions. A total of 130 forensic pathology institutions were surveyed by online participation through the Questionnaire Star platform. RESULTS: Among the 130 institutions, 43.08% were familiar with the characteristics of virtual autopsy technology, 35.38% conducted or received training in virtual autopsy, and 70.77% have establishment needs (including maintenance). Relevant elements were suitable for laboratory accreditation. CONCLUSIONS Virtual autopsy identification has gained social recognition. There is a demand for accreditation of forensic virtual autopsy laboratory. After the preliminary assessment, considering the characteristics and current situation of this technology, China National Accreditation Service for Conformity Assessment (CNAS) can first carry out the accreditation pilot of virtual autopsy project at large comprehensive forensic institutions with higher identification capability, and then CNAS can popularize the accreditation in a wide range when the conditions are suitable.
Autopsy ; Forensic Medicine ; Forensic Pathology ; Accreditation ; Surveys and Questionnaires

Objectives The implementation of Philippine National Standard PNS ISO 15189:2013 to support the medical laboratory to produce competent results is a recognised challenge. It is apparent that the approach of ensuring the equipment availability can be specifically optimised. No known research has focused on exploring on the conduct of conformity evaluation of Afinion 2 Analyzer maintainability for the PNS ISO 15189:2013 accredited medical laboratory. The aim of the current study was to develop a practical tool for the medical laboratory to support the internal audit process by determining the compliance status of Afinion 2 Analyzer maintainability.
Accreditation

Background: The Universal Health Care (UHC) Act seeks to delineate the roles of key agencies and stakeholders towards equity in access to quality and affordable health care. Under the pillar of health regulation, the Philippine Health Insurance Corporation is mandated to recognize third party accreditation mechanisms as a basis for granting incentives to health facilities that provide better service quality, efficiency, and equity. Methods: A systematic review of literature was conducted to generate a policy brief that outlined the strengths and weaknesses of the current accreditation system, and how to address arising fragmentation issues in implementation based on international and local evidence. To generate recommendations from a multi-stakeholder approach, a roundtable discussion enjoined by all major stakeholders of the policy issue was conducted by the University of the Philippines Manila Health Policy Development Hub in collaboration with the Department of Health. Thematic analysis of the RTD and the literature review were utilized in crafting the position statement with the general aim of producing consensus policy recommendations, as inputs in the Implementing Rules and Regulations of the Act. Results: Policy analysis using results of literature review and policy discussion was crafted, with thematically arranged recommendations in the domains of leadership and governance, financing and sustainability, standards development, program development, and continuing quality improvement that could help the national health system in determining third party accreditation mechanisms set forth by the UHC Act. Significant issues raised was the composition and requirements of the third party accreditor and the risks in transition. Conclusion and Recommendation With the PhilHealth Benchbook setting the standards and with the expressed commitment of stakeholders for third party accreditation, it is an opportune time for the UHC Act to institutionalize the accreditation mechanisms that will address existing challenges of PhilHealth accreditation. The literature review and discussion bring forth the proposed tool for the criteria in selecting third party accreditors.
Universal Health Care ; National Health Programs ; Accreditation

Background: Guaranteeing quality of health care services is part of the objectives of Republic Act No. 11223 or the Universal Health Care (UHC) Act of 2019. In assuring that quality services are delivered by health care providers, they must be accredited to participate in the National Health Insurance Program. The UHC Act mandates the Philippine Health Insurance Corporation (PhilHealth) to recognize third party mechanisms as basis of granting incentives for health facilities that deliver services of higher quality. This review aimed to identify lessons and experiences from literature that can be adopted and contextualized in the Philippine setting, for strategic policies on strengthening the national health facility accreditation system. Methods: A systematic review of literature was conducted to generate evidence-based recommendations from discussions on cross country experiences and local government initiatives towards improved accreditation system. Results: By virtue of the UHC Act, a form of strategic purchasing is further institutionalized through a rating system that incentivizes health facilities that provide better services in terms of quality, efficiency, and equity. It is imperative to consider the country’s previous and current gaps and challenges in accreditation and adopt the best practices of other countries, as appropriate to Philippine's local settings. A tool is proposed in creating a national hospital accreditation system using the domains of leadership and governance, financing and sustainability, standards development, program management, and continuing quality improvement. Conclusion and Recommendations With the legitimacy of third party accreditation body mandated by the UHC Act, operationalization of the prescribed mechanisms and organizational structure must enjoin all pertinent stakeholders and be supported by sustainable funds and technical assistance by the government.
Universal Health Insurance ; Universal Health Care ; Insurance ; Health Policy ; National Health Programs ; Accreditation

Sedation, defined as the depressed level of consciousness, induced by drug administration, is widely used for gastrointestinal endoscopy to relieve a patient’s anxiety and discomfort. In addition, successful procedure is anticipated with control of unintended movements. Endoscopic sedation, however, cannot be free from the risk of serious adverse events, e.g., cardiopulmonary compromise. Therefore, principles on personnel, facility and equipment, as well as performance itself, should be followed to prevent unfavorable incidents. In this article, sedation guidelines for the Accreditation of Qualified Endoscopy Units, issued by the Korean Society of Gastrointestinal Endoscopy, are presented.
Accreditation ; Anxiety ; Consciousness Disorders ; Endoscopy ; Endoscopy, Gastrointestinal ; Oximetry

A thorough disinfection and infection control process associated with gastrointestinal endoscopy is highly important for the health and safety of the examinee and the medical staff involved in the procedure. Endoscopic reprocessing and disinfection are two of the most important steps in quality control of endoscopy. In 2019, the Korean Society of Gastrointestinal Endoscopy updated the Accreditation of Qualified Endoscopy Unit assessment items for these quality indicators. Assessment of disinfection and infection control comprises 28 mandatory items in the categories of disinfection education, pre-cleaning, cleaning, disinfection, rinsing, drying, reprocessing, storage, endoscopic accessories, water bottle and connectors, space/facilities, personal protective equipment, disinfection ledger, and regulations regarding infection control and disinfection. The updated Accreditation of Qualified Endoscopy Unit assessment items are useful for improving the quality of endoscopy by ensuring thorough inspection of endoscopic disinfection and infection control.
Accreditation ; Disinfection ; Education ; Endoscopy ; Endoscopy, Gastrointestinal ; Humans ; Infection Control ; Medical Staff ; Personal Protective Equipment ; Quality Control ; Social Control, Formal ; Water

Endoscopic quality indicators can be classified into three categories, namely facilities and equipment, endoscopic procedures, and outcome measures. In 2019, the Korean Society of Gastrointestinal Endoscopy updated the accreditation of qualified endoscopy unit assessment items for these quality indicators to establish competence and define areas of continuous quality improvement. Here, we presented the updated program guidelines on the facilities, procedures, and performance of the accredited endoscopy unit. Many of these items have not yet been validated. However, the updated program will help in establishing competence and defining areas of continuous quality improvement in Korean endoscopic practice.
Accreditation ; Endoscopy ; Endoscopy, Gastrointestinal ; Mental Competency ; Outcome Assessment (Health Care) ; Quality Improvement

The Korean Society of Gastrointestinal Endoscopy introduced the Accredited Endoscopy Unit Program to enhance endoscopy unit quality through systematic quality management in 2012. It was gradually expanded from training hospitals to institutions with 100+ beds, and the criteria for certification were applied according to the actual conditions of each institution. On the basis of the continuous communication with the institutions and feedback, the Accredited Endoscopy Unit Program certification criteria were revised in 2019 and introduced as follows: (1) the qualification criteria for endoscopy doctors and nurses; (2) facilities and equipment; (3) endoscopic examination process; (4) performance; (5) disinfection and infection control; and (6) endoscopic sedation. The assessment items consist of essential and recommended items. All essential items must be met for accreditation to be awarded. The assessment criteria for each evaluation area were revised as follows: (1) upgrading assessment criteria; (2) qualification of endoscopists and reinforcement of quality control education; (3) detailed standards for safety, disinfection, endoscopic sedation, and management instructions; and (4) presentation of new performance measurement of endoscopy and colonoscopy.
Accreditation ; Awards and Prizes ; Certification ; Colonoscopy ; Disinfection ; Education ; Endoscopy ; Endoscopy, Gastrointestinal ; Infection Control ; Korea ; Quality Control