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

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

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

Abdominal ultrasound examinations are performed by many gastroenterologists in clinical practice, but abdominal ultrasound education has not been included in internal medicine resident or gastroenterology fellowship training courses. Abdominal ultrasound education was established as an essential part of the resident training program in 2017, and since then interest in ultrasound has increased. An educational accreditation system for trainers of ultrasonography in the internal medicine field was developed in 2018, but accredited ultrasound trainers and equipment and space for ultrasound education are lacking. This article describes how to revitalize ultrasound education program for resident and fellowship training.
Accreditation ; Education ; Fellowships and Scholarships ; Gastroenterology ; Internal Medicine ; Ultrasonography

Since the residency training program in internal medicine changed from a four-year to a three-year program in 2017 in Korea, issues of an optimal training program for the gastrointestinal (GI) fellowship has arisen. Currently, the evaluation criteria for a GI fellowship in Korea include the following; 1) the total number of assigned patients during the training period, 2) the number of GI endoscopy procedures, 3) attendance at academic conferences, and 4) research presentations. However, competency-based training should be introduced in the GI fellowship training program. The current issues of GI fellowship training in Korea include the following; 1) reorganization of the GI fellowship education system and consideration of an optimal training period following the introduction of the three-year internal medicine residency training program, 2) development of a standardized, competency-based GI fellowship training program, 3) provision of a support program for instructors in GI fellowship education, 4) introduction of a mentor-mentee system, 5) introduction of an accreditation system for GI fellowship, 6) supplementation of a GI sub-specialty qualification system, and 7) provision of benefits to GI sub-specialists.
Accreditation ; Congresses as Topic ; Education* ; Endoscopy ; Fellowships and Scholarships* ; Gastroenterology ; Humans ; Internal Medicine ; Internship and Residency ; Korea*

Accreditation ; Education ; Genetics ; United States

BACKGROUND: In Korea, the Korean Laboratory Accreditation Program (KLAP) has set minimum standards for verification of clinical test performance. This verification process is time-consuming and labor-intensive when performed manually. We developed a free, statistical software program for KLAP, using the R language (R Foundation for Statistical Computing, Vienna, Austria). METHODS: We used CLSI guidelines for the algorithm. We built graphic user interfaces, including data input, with Embarcadero Delphi EX4 (Embarcadero Technologies, Inc., Texas, USA). The R Base Package and MCR Package for Method Comparison Regression were used to implement statistical and graphical procedures. RESULTS: Our program LaboStats has six modules: parallel test, linearity, method comparison, precision, reference interval, and cutoff. Data can be entered into the field either manually or by copying and pasting from an MS Excel worksheet. Users can print out precise reports. CONCLUSIONS: LaboStats can be useful for evaluating clinical test performance characteristics and preparing documents requested by KLAP.
Accreditation ; Korea ; Mathematical Computing ; Methods ; Texas