hkas assessor seminar 2006 technical assessor role and responsibility 28 feb 2006 dr sidney tam...

HKAS Assessor Seminar 2006HKAS Assessor Seminar 2006

Technical AssessorTechnical AssessorRole and ResponsibilityRole and Responsibility

28 Feb 200628 Feb 2006

Dr Sidney TamDr Sidney TamConsultant & HeadConsultant & Head

Division of Clinical BiochemistryDivision of Clinical BiochemistryQueen Mary HospitalQueen Mary Hospital

hkas assessor seminar 2006hkas assessor seminar 2006 22

HKAS 002HKAS 002 Regulations for HKAS AccreditationRegulations for HKAS Accreditation

(Ch.9: Specific Regulations for HOKLAS)(Ch.9: Specific Regulations for HOKLAS)

HOKLAS 015HOKLAS 015

Technical Criteria for Laboratory Technical Criteria for Laboratory Accreditation (Medical Laboratories)Accreditation (Medical Laboratories)

2nd Edition, Feb 2004

2nd Edition, Aug 2005


God is in the PrincipleGod is in the Principle

Angels in the DetailAngels in the Detail


Medical LaboratoryMedical Laboratory A laboratory for the biological, microbiological, A laboratory for the biological, microbiological,

immunological, chemical, immunohaematological, immunological, chemical, immunohaematological, haematological, biophysical, cytological, haematological, biophysical, cytological, pathological or other examination of materials pathological or other examination of materials derived from the human body for the purpose of derived from the human body for the purpose of providing information for the diagnosis, prevention providing information for the diagnosis, prevention and treatment of disease in, or assessment of the and treatment of disease in, or assessment of the health of, human beings, and which may provide a health of, human beings, and which may provide a consultant advisory service covering all aspects of consultant advisory service covering all aspects of laboratory investigation including the interpretation laboratory investigation including the interpretation of results and advice on further appropriate of results and advice on further appropriate investigation.investigation.

HOKLAS 015:3.8


HOKLAS: Current ScopeHOKLAS: Current Scopefor Medical Testingfor Medical Testing

Anatomical PathologyAnatomical Pathology::Hospital AutopsyHospital Autopsy

CytopathologyCytopathology

HistopathologyHistopathology Chemical PathologyChemical Pathology Clinical Microbiology & InfectionClinical Microbiology & Infection HaematologyHaematology ImmunologyImmunology


Technical AssessorTechnical Assessor

A technical expert who has the A technical expert who has the qualifications and experience necessary qualifications and experience necessary for examining, evaluating and judging for examining, evaluating and judging the effectiveness and quality of an the effectiveness and quality of an activity of a laboratory, certification body activity of a laboratory, certification body or inspection body, has undergone or inspection body, has undergone appropriate training for conducting appropriate training for conducting assessment and has been formally assessment and has been formally appointed by HKAS Executiveappointed by HKAS Executive

HKAS 002


Role & Responsibility of Role & Responsibility of Technical Assessor (1)Technical Assessor (1)

Assess findings objectively and collect Assess findings objectively and collect appropriate data in a well-organized appropriate data in a well-organized manner during the inspection processmanner during the inspection process

Make decisions, using professional Make decisions, using professional judgement, regarding compliance / judgement, regarding compliance / non-conformitynon-conformity

Document inspection findings in an Document inspection findings in an objective and concise manner that objective and concise manner that supports the data collected during the supports the data collected during the inspectioninspection



Confirm methodology, equipment and Confirm methodology, equipment and results are technically validresults are technically valid

Question and observe signatories / key Question and observe signatories / key personnel / front-line staff’s technical personnel / front-line staff’s technical competencycompetency

Review manuals, documents and pertinent Review manuals, documents and pertinent recordsrecords

Inspect physical environments and Inspect physical environments and hardwarehardware

Gather and record objective evidence to Gather and record objective evidence to support findingssupport findings



Maintain contact with the Lead Maintain contact with the Lead AssessorAssessor

Report to and assist the Lead Report to and assist the Lead Assessor in compiling the Assessor in compiling the inspection report and corrective inspection report and corrective action requests (CARs)action requests (CARs)

Assist in clearance of the CARsAssist in clearance of the CARsNo Fear & No Favour!No Fear & No Favour!


Document ControlDocument Control All controlled documents shall be All controlled documents shall be

reviewed, and revised if necessary, at reviewed, and revised if necessary, at least annually.least annually.

Only currently authorized versions of Only currently authorized versions of appropriate documents are available for appropriate documents are available for active use at relevant locationsactive use at relevant locations

Retained or archived superseded Retained or archived superseded documents are appropriately identified to documents are appropriately identified to prevent their inadvertent useprevent their inadvertent use

HOKLAS 015:4.3


Technical RequirementsTechnical Requirements The personnel making professional judgements The personnel making professional judgements

shall have the applicable theoretical and practical shall have the applicable theoretical and practical background as well as recent experience.background as well as recent experience.

Professional judgements can be expressed as Professional judgements can be expressed as opinions, interpretations, predictions, simulations, opinions, interpretations, predictions, simulations, and models and values in accordance with local and models and values in accordance with local regulationsregulations

Personnel should take part in regular professional Personnel should take part in regular professional development or other professional liaison. development or other professional liaison.

HOKLAS 015:5.1


Laboratory EquipmentLaboratory Equipment

Where calibrations give rise to a set of Where calibrations give rise to a set of correction factors, the laboratory shall correction factors, the laboratory shall have procedures for ensuring that have procedures for ensuring that copies of prior correction factors are copies of prior correction factors are correctly updated.correctly updated.

A system shall be in operation to alert A system shall be in operation to alert laboratory staff the due dates of laboratory staff the due dates of calibration, verification and calibration, verification and maintenance of all items of equipmentmaintenance of all items of equipment

HOKLAS 015:5.3


Advisory ServicesAdvisory Services Advice on choice of examinations and use of Advice on choice of examinations and use of

the services, including repeat frequency and the services, including repeat frequency and required type of samplerequired type of sample

Interpretation of the results of examination Interpretation of the results of examination where appropriate should be providedwhere appropriate should be provided

Regular documented meetings of professional Regular documented meetings of professional staff with the clinical staff regarding the use staff with the clinical staff regarding the use of the laboratory services and for the purpose of the laboratory services and for the purpose of consultation on scientific matters.of consultation on scientific matters.

Professional staff should participate in clinical Professional staff should participate in clinical rounds, enabling advice on effectiveness in rounds, enabling advice on effectiveness in general as well as in individual casesgeneral as well as in individual cases

HOKLAS 015:4.7


Pre-examination ProceduresPre-examination Procedures Request form (paper or electronic) shall Request form (paper or electronic) shall

contain information sufficient to identify the contain information sufficient to identify the patient and the authorized requester, as patient and the authorized requester, as well as providing pertinent clinical datawell as providing pertinent clinical data

Unique identification of patientUnique identification of patient Primary samples shall be traceable to an Primary samples shall be traceable to an

identified individualidentified individual Date and time of primary sample collectionDate and time of primary sample collection Date and time of receipt of samples by the Date and time of receipt of samples by the

lablabHOKLAS 015:5.4


Examination Procedures (1)Examination Procedures (1) Performance specifications (e.g., Performance specifications (e.g.,

linearity, precision, detection limit, linearity, precision, detection limit, interferences, cross reactions)interferences, cross reactions)

Principle of procedure for calculating Principle of procedure for calculating results, including measurement results, including measurement uncertainty (e.g., creatinine clearance)uncertainty (e.g., creatinine clearance)

Biological reference intervalsBiological reference intervals Alert / Critical values where appropriate Alert / Critical values where appropriate

(e.g., Glucose, K(e.g., Glucose, K++, Calcium, Amylase, , Calcium, Amylase, pH, cardiac markers)pH, cardiac markers)

HOKLAS 015:5.5


Examination Procedures (2)Examination Procedures (2)

If the laboratory intends to change If the laboratory intends to change an examination procedure such that an examination procedure such that results or their interpretation could results or their interpretation could be significantly different, the be significantly different, the implications shall be explained to implications shall be explained to users (i.e., referring clinicians) of the users (i.e., referring clinicians) of the laboratory services in writing, prior to laboratory services in writing, prior to the introduction of the change.the introduction of the change.

HOKLAS 015:5.5.7


Uncertainty of MeasurementUncertainty of Measurement

Parameter, associated with the result of Parameter, associated with the result of a measurement, that characterizes the a measurement, that characterizes the dispersion of the values that could dispersion of the values that could reasonably be attributed to the reasonably be attributed to the measurandmeasurand

(Training course organized by HKAS on (Training course organized by HKAS on “Measurement Uncertainty in Laboratory “Measurement Uncertainty in Laboratory Medicine” by Dr Anders Kallner highly Medicine” by Dr Anders Kallner highly recommended!)recommended!)

HOKLAS 015:3.17


Common Nonconformities Common Nonconformities (1)(1)

Unique identifiersUnique identifiers Sampling time and dateSampling time and date Sample rejection criteriaSample rejection criteria Validation of assay linearity, dynamic Validation of assay linearity, dynamic

range, detection limit, reference intervals range, detection limit, reference intervals and their originsand their origins

Documented corrective actions on, e.g., Documented corrective actions on, e.g., EQA failureEQA failure

Documented inter-instrument correlationDocumented inter-instrument correlation


Common Nonconformities Common Nonconformities (2)(2)

Regular drills for handling biological hazards, Regular drills for handling biological hazards, e.g., chemical spillagee.g., chemical spillage

SOP for contingency measures for temperature SOP for contingency measures for temperature failure of freezers and documentation thereoffailure of freezers and documentation thereof

SOP for checking fidelity of manually SOP for checking fidelity of manually transcribed lab resultstranscribed lab results

Documentation of validity of computer Documentation of validity of computer generated indices based on calculationgenerated indices based on calculation

Documentation on authorized changes in assay Documentation on authorized changes in assay methodologies and their reference ranges methodologies and their reference ranges


Thank You!Thank You!

hkas assessor seminar 2006 technical assessor role and responsibility 28 feb 2006 dr sidney tam...

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