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

2. hkas assessor seminar 20062 HKAS 002 Regulations for HKAS Accreditation Regulations for HKAS Accreditation (Ch.9: Specific Regulations for HOKLAS) HOKLAS 015 Technical Criteria for Laboratory Accreditation (Medical Laboratories) Technical Criteria for Laboratory Accreditation (Medical Laboratories) 2 nd Edition, Feb 2004 2 nd Edition, Aug 2005

3. hkas assessor seminar 20063 God is in the Principle Angels in the Detail

4. hkas assessor seminar 20064 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. 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

5. hkas assessor seminar 20065 HOKLAS: Current Scope for Medical Testing Anatomical Pathology :Hospital Autopsy Anatomical Pathology :Hospital AutopsyCytopathologyHistopathology Chemical Pathology Chemical Pathology Clinical Microbiology & Infection Clinical Microbiology & Infection Haematology Haematology Immunology Immunology

6. hkas assessor seminar 20066 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 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

7. hkas assessor seminar 20067 Role & Responsibility of Technical Assessor (1) Assess findings objectively and collect appropriate data in a well-organized manner during the inspection process 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 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 Document inspection findings in an objective and concise manner that supports the data collected during the inspection

8. hkas assessor seminar 20068 Role & Responsibility of Technical Assessor (2) Confirm methodology, equipment and results are technically valid Confirm methodology, equipment and results are technically valid Question and observe signatories / key personnel / front-line staff’s technical competency Question and observe signatories / key personnel / front-line staff’s technical competency Review manuals, documents and pertinent records Review manuals, documents and pertinent records Inspect physical environments and hardware Inspect physical environments and hardware Gather and record objective evidence to support findings Gather and record objective evidence to support findings

9. hkas assessor seminar 20069 Role & Responsibility of Technical Assessor (3) Maintain contact with the Lead Assessor Maintain contact with the Lead Assessor Report to and assist the Lead Assessor in compiling the inspection report and corrective action requests (CARs) Report to and assist the Lead Assessor in compiling the inspection report and corrective action requests (CARs) Assist in clearance of the CARs Assist in clearance of the CARs No Fear & No Favour!

10. hkas assessor seminar 200610 Document Control All controlled documents shall be reviewed, and revised if necessary, at least annually. 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 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 Retained or archived superseded documents are appropriately identified to prevent their inadvertent use HOKLAS 015:4.3

11. hkas assessor seminar 200611 Technical Requirements The personnel making professional judgements shall have the applicable theoretical and practical background as well as recent experience. 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 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. Personnel should take part in regular professional development or other professional liaison. HOKLAS 015:5.1

12. hkas assessor seminar 200612 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. 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 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

13. hkas assessor seminar 200613 Advisory Services Advice on choice of examinations and use of the services, including repeat frequency and required type of sample 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 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. 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 Professional staff should participate in clinical rounds, enabling advice on effectiveness in general as well as in individual cases HOKLAS 015:4.7

14. hkas assessor seminar 200614 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 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 Unique identification of patient Primary samples shall be traceable to an identified individual Primary samples shall be traceable to an identified individual Date and time of primary sample collection Date and time of primary sample collection Date and time of receipt of samples by the lab Date and time of receipt of samples by the lab HOKLAS 015:5.4

15. hkas assessor seminar 200615 Examination Procedures (1) Performance specifications (e.g., linearity, precision, detection limit, interferences, cross reactions) Performance specifications (e.g., linearity, precision, detection limit, interferences, cross reactions) Principle of procedure for calculating results, including measurement uncertainty (e.g., creatinine clearance) Principle of procedure for calculating results, including measurement uncertainty (e.g., creatinine clearance) Biological reference intervals Biological reference intervals Alert / Critical values where appropriate (e.g., Glucose, K +, Calcium, Amylase, pH, cardiac markers) Alert / Critical values where appropriate (e.g., Glucose, K +, Calcium, Amylase, pH, cardiac markers) HOKLAS 015:5.5

16. hkas assessor seminar 200616 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. 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

17. hkas assessor seminar 200617 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 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!) (Training course organized by HKAS on “Measurement Uncertainty in Laboratory Medicine” by Dr Anders Kallner highly recommended!) HOKLAS 015:3.17

18. hkas assessor seminar 200618 Common Nonconformities (1) Unique identifiers Unique identifiers Sampling time and date Sampling time and date Sample rejection criteria Sample rejection criteria Validation of assay linearity, dynamic range, detection limit, reference intervals and their origins Validation of assay linearity, dynamic range, detection limit, reference intervals and their origins Documented corrective actions on, e.g., EQA failure Documented corrective actions on, e.g., EQA failure Documented inter-instrument correlation Documented inter-instrument correlation

19. hkas assessor seminar 200619 Common Nonconformities (2) Regular drills for handling biological hazards, e.g., chemical spillage Regular drills for handling biological hazards, e.g., chemical spillage SOP for contingency measures for temperature failure of freezers and documentation thereof SOP for contingency measures for temperature failure of freezers and documentation thereof SOP for checking fidelity of manually transcribed lab results SOP for checking fidelity of manually transcribed lab results Documentation of validity of computer generated indices based on calculation Documentation of validity of computer generated indices based on calculation Documentation on authorized changes in assay methodologies and their reference ranges Documentation on authorized changes in assay methodologies and their reference ranges

20. hkas assessor seminar 200620 Thank You!