HKAS Assessor Seminar 2006 Technical Assessor Role and Responsibility

1. HKAS Assessor Seminar 2006Technical AssessorRole and Responsibility 28 Feb 2006 Dr Sidney Tam Consultant & Head Division of Clinical Biochemistry Queen Mary Hospital

2. HKAS 002 2nd Edition, Feb 2004 • Regulations for HKAS Accreditation (Ch.9: Specific Regulations for HOKLAS) HOKLAS 015 2nd Edition, Aug 2005 • Technical Criteria for Laboratory Accreditation (Medical Laboratories) hkas assessor seminar 2006

3. God is in the Principle Angels in the Detail hkas assessor seminar 2006

4. Medical Laboratory • A laboratory for the biological, microbiological, immunological, chemical, immunohaematological, haematological, biophysical, cytological, pathological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention and treatment of disease in, or assessment of the health of, human beings, and which may provide a consultant advisory service covering all aspects of laboratory investigation including the interpretation of results and advice on further appropriate investigation. HOKLAS 015:3.8 hkas assessor seminar 2006

5. HOKLAS: Current Scopefor Medical Testing • Anatomical Pathology: Hospital Autopsy Cytopathology Histopathology • Chemical Pathology • Clinical Microbiology & Infection • Haematology • Immunology hkas assessor seminar 2006

6. Technical Assessor • A technical expert who has the qualifications and experience necessary for examining, evaluating and judging the effectiveness and quality of an activity of a laboratory, certification body or inspection body, has undergone appropriate training for conducting assessment and has been formally appointed by HKAS Executive HKAS 002 hkas assessor seminar 2006

7. Role & Responsibility of Technical Assessor (1) • Assess findings objectively and collect appropriate data in a well-organized manner during the inspection process • Make decisions, using professional judgement, regarding compliance / non-conformity • Document inspection findings in an objective and concise manner that supports the data collected during the inspection hkas assessor seminar 2006

8. Role & Responsibility of Technical Assessor (2) • Confirm methodology, equipment and results are technically valid • Question and observe signatories / key personnel / front-line staff’s technical competency • Review manuals, documents and pertinent records • Inspect physical environments and hardware • Gather and record objective evidence to support findings hkas assessor seminar 2006

9. Role & Responsibility of Technical Assessor (3) • Maintain contact with the Lead Assessor • Report to and assist the Lead Assessor in compiling the inspection report and corrective action requests (CARs) • Assist in clearance of the CARs No Fear & No Favour! hkas assessor seminar 2006

10. Document Control • All controlled documents shall be reviewed, and revised if necessary, at least annually. • Only currently authorized versions of appropriate documents are available for active use at relevant locations • Retained or archived superseded documents are appropriately identified to prevent their inadvertent use HOKLAS 015:4.3 hkas assessor seminar 2006

11. Technical Requirements • The personnel making professional judgements shall have the applicable theoretical and practical background as well as recent experience. • Professional judgements can be expressed as opinions, interpretations, predictions, simulations, and models and values in accordance with local regulations • Personnel should take part in regular professional development or other professional liaison. HOKLAS 015:5.1 hkas assessor seminar 2006

12. Laboratory Equipment • Where calibrations give rise to a set of correction factors, the laboratory shall have procedures for ensuring that copies of prior correction factors are correctly updated. • A system shall be in operation to alert laboratory staff the due dates of calibration, verification and maintenance of all items of equipment HOKLAS 015:5.3 hkas assessor seminar 2006

13. Advisory Services • Advice on choice of examinations and use of the services, including repeat frequency and required type of sample • Interpretation of the results of examination where appropriate should be provided • Regular documented meetings of professional staff with the clinical staff regarding the use of the laboratory services and for the purpose of consultation on scientific matters. • Professional staff should participate in clinical rounds, enabling advice on effectiveness in general as well as in individual cases HOKLAS 015:4.7 hkas assessor seminar 2006

14. Pre-examination Procedures • Request form (paper or electronic) shall contain information sufficient to identify the patient and the authorized requester, as well as providing pertinent clinical data • Unique identification of patient • Primary samples shall be traceable to an identified individual • Date and time of primary sample collection • Date and time of receipt of samples by the lab HOKLAS 015:5.4 hkas assessor seminar 2006

15. Examination Procedures (1) • Performance specifications (e.g., linearity, precision, detection limit, interferences, cross reactions) • Principle of procedure for calculating results, including measurement uncertainty (e.g., creatinine clearance) • Biological reference intervals • Alert / Critical values where appropriate (e.g., Glucose, K+, Calcium, Amylase, pH, cardiac markers) HOKLAS 015:5.5 hkas assessor seminar 2006

16. Examination Procedures (2) • If the laboratory intends to change an examination procedure such that results or their interpretation could be significantly different, the implications shall be explained to users (i.e., referring clinicians) of the laboratory services in writing, prior to the introduction of the change. HOKLAS 015:5.5.7 hkas assessor seminar 2006

17. Uncertainty of Measurement • Parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand • (Training course organized by HKAS on “Measurement Uncertainty in Laboratory Medicine” by Dr Anders Kallner highly recommended!) HOKLAS 015:3.17 hkas assessor seminar 2006

18. Common Nonconformities (1) • Unique identifiers • Sampling time and date • Sample rejection criteria • Validation of assay linearity, dynamic range, detection limit, reference intervals and their origins • Documented corrective actions on, e.g., EQA failure • Documented inter-instrument correlation hkas assessor seminar 2006

19. Common Nonconformities (2) • Regular drills for handling biological hazards, e.g., chemical spillage • SOP for contingency measures for temperature failure of freezers and documentation thereof • SOP for checking fidelity of manually transcribed lab results • Documentation of validity of computer generated indices based on calculation • Documentation on authorized changes in assay methodologies and their reference ranges hkas assessor seminar 2006

20. Thank You! hkas assessor seminar 2006