HKAS Assessor Seminar 2006 Technical Assessor Role and Responsibility

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HKAS Assessor Seminar 2006Technical
AssessorRole and Responsibility

• 28 Feb 2006
• Dr Sidney Tam
• Consultant Head
• Division of Clinical Biochemistry
• Queen Mary Hospital

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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)

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God is in the Principle
Angels in the Detail
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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 0153.8
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HOKLAS Current Scopefor Medical Testing

• Anatomical Pathology Hospital Autopsy
• Cytopathology
• Histopathology
• Chemical Pathology
• Clinical Microbiology Infection
• Haematology
• Immunology

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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
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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

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Role Responsibility of Technical Assessor (2)

• Confirm methodology, equipment and results are
  technically valid
• Question and observe signatories / key personnel
  / front-line staffs technical competency
• Review manuals, documents and pertinent records
• Inspect physical environments and hardware
• Gather and record objective evidence to support
  findings

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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!
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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 0154.3
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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 0155.1
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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 0155.3
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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 0154.7
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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 0155.4
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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 0155.5
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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 0155.5.7
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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 0153.17
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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

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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

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Thank You!