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Internal Auditing Risk Analysis for Medical Laboratories Seeking Accreditation through the Hong Kong Laboratory
Geraldine B Dayrit1,2, Dennis Mok3, Rana Nabulsi4
1The Graduate School, University of Santo Tomas, Manila, Philippines.
Acta Medica Philippina
|July 5, 2024
Summary
This study quantified how well guidance checklists HOKLAS 016-02 and HOKLAS 021 cover Hong Kong Laboratory Accreditation Scheme (HOKLAS 015) requirements. HOKLAS 016-02 covers 76% of HOKLAS 015 requirements, while HOKLAS 021 covers only 11%.
Area of Science:
- Medical Laboratory Science
- Quality Management Systems
- Accreditation Standards
Background:
- The Hong Kong Laboratory Accreditation Scheme (HOKLAS 015) outlines essential requirements for medical laboratory operations.
- Guidance checklists, specifically HOKLAS 016-02 and HOKLAS 021, are utilized to assist laboratories in meeting these accreditation standards.
- Understanding the coverage provided by these checklists is crucial for effective internal audits and maintaining accreditation.
Purpose of the Study:
- To quantitatively assess the extent to which HOKLAS 016-02 and HOKLAS 021 meet the requirements specified in HOKLAS 015.
- To analyze the distribution of conformance requirements within HOKLAS 015 relative to the ISO 15189:2012 quality management system model.
Main Methods:
- An evaluation checklist, based on HOKLAS 015 conformance requirements, was developed to calculate coverage levels.
- Quantitative analysis was performed to determine the percentage of HOKLAS 015 requirements covered by HOKLAS 016-02 and HOKLAS 021.
- A distribution analysis was conducted concerning the ISO 15189:2012 process-based quality management system model.
Main Results:
- HOKLAS 016-02 demonstrated a coverage of 76% for HOKLAS 015 requirements.
- HOKLAS 021 provided a coverage of 11% for HOKLAS 015 requirements.
- The distribution analysis showed 78% coverage of HOKLAS 015 requirements aligned with the ISO 15189:2012 model.
Conclusions:
- HOKLAS 016-02 offers substantial coverage of HOKLAS 015 requirements, making it a valuable tool for laboratories.
- HOKLAS 021 provides limited coverage, suggesting a need for supplementation or revision for comprehensive auditability.
- Awareness of these coverage extents aids medical laboratories in maintaining internal auditability and compliance with HOKLAS 015.
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