q.c. histopathology

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    QUALITY ASSURANCEIN

    HISTOPATHOLOGY

    QC should consider thewhole process :starting and finishing with thepatient.

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    This covers the followings:

    Patient benefit from biopsy.Patient consent.

    Proper procedure & excision.

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    Collection of adequate sample.

    Collection of demographicaldata & clinical information.

    Proper sample fixation.

    Rapid transport to laboratory .

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    On specimen receipt, record

    patient identification .Macroscopic description &

    sampling must be acceptable.Tissue processing must be

    acceptable.Sections should be of goodquality

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    Staining must be acceptable.

    Pathologist should be qualified

    Microscopic description is to beacceptable.

    Stains & reagents are to beused properly

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    Final diagnosis must be correct.

    Biopsy must be properly assessed.

    Report should contain patient

    address & identification.Lab. is to store slides, blocks, &copy of the report .

    Clinicians report copy must bedelivered rapidly.

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    Correct report to correct patient.

    Clinician must be able to read &understand the report.

    Subsequent patient care is to becarried out properly.

    Whole process must be rapid.

    Clinician and lab. are to communicateto solve problems .

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    Methods of Quality Assurance

    1.Peer Review :

    Laboratory compares its present

    performance with its own pastperformance( self peer review).

    Review covers strengths &weaknesses in histopathologyprocedures .

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    2.Random Selection Audit

    @ An audit picks randomly 2%of all cases from lab. records.

    @ Audit checks each case for:*time taken for each stage of

    the process,.*typing errors.

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    proper description of specimen.

    accuracy of diagnosis.

    section quality,.

    speed of pathologist's report .

    accuracy of patient identification.

    computer lab.processing & reporting

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    3.Internal Quality Control

    staff check section & stainquality before reporting

    special stains needed should

    be done

    Proper controls are included

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    4. External quality

    assessment (EQA)Organizer sends to lab. samplesof fresh tissue.

    Lab. is to fix & process samples

    same as routine specimensExamined samples are sent to theorganizer .

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    Organizer sends a report

    that compares lab. resultswith those of participating

    labs.

    Sending fixed(not fresh)tissue cannot be identicalto all labs.

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    Organizer prepares

    sections for special stains& sends to participants.

    Specific sections from

    lab. archives are sent toorganizer for assessment .

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    Organizer checks :

    @ fixation , decalcification ,

    processing, embedding ,microtomy ,

    @ haematoxylin stain, eosinstain , artifacts, finishing

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    Organizer report is in the

    form of scores & explanationof why marks were lost.

    Organizer offers educational

    meetings & guidance to allparticipants.

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    5. Benchmarking :

    Falls into two groups :(1) Q-Track program:

    @ similar to the random selectionaudit but in a small scale.

    @ Q-Track covers all disciplines.

    @ Comparison is made with other

    labs of similar type.

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    (2) Q-probe program:

    @ It is a mutual discussionof selected topics in depth

    @ It is run betweendifferent laboratories.

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    @ Topics may include :

    @ staging of breast carcinoma,.

    @ physicians satisfaction with labservices,.

    @ needle biopsies of prostate.

    @ non - gyneacological cytology.

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    6. QC of Histopathologists

    Performance:

    Five methodsare available :

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    a)Total Review Audit : Histopathologist errors aredetected by reviewing report offinal diagnosis .

    This is time-consuming.

    Definition of clinical significanceremains that of a pathologist notthe clinician .

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    b) Single Topic Audit :

    A single topic is submitted

    for audit .Common topics :

    @ frozen section diagnoses,@ paraffin section report,

    @ urine cytology service.

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    c) Internal Q. ControlPoor results are due to:

    @ defect in samples,

    @ defect in techniques

    @ incompetent pathologist

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    Reports of large biopsies

    must contain :

    @ correct diagnosis.

    @for tumors give : stage, grade,resection

    Use checklists in reportingbiopsies.

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    d) Diagnostic EQA:

    @ Tests of diagnostic workare divided into :

    1. tests of diligence, to check :

    *errors of omission or oversight2. tests of competence, to check :

    * experience, qualifications

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    @ Organizer sends specimens to

    participating pathologists.

    @ Specimens are tested same as

    routine samples .@ Diagnoses are returned to

    organizer for analysis.@ Diagnosis is assessed, & areport is sent to pathologist.

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    @Pathologist participate in :

    a slide circulation schemethat allows him to compare his

    report criteria with the group.

    This is needed for cervicalcytology specimens .

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    @ EQA is mainlyeducational leading to :

    self-correction.

    training of pathologists .

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    @Poor EQA :does not mean unsafe

    practice,

    but it reflectsprofessional incompetence

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    e) Statistical Analysis :Many samples are distributed

    by organizer to different

    pathologists .Organizer records :

    @ range & frequency ofdiagnoses given by pathologist,@ rate of detection of

    abnormalities by pathologist.

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    Pathologist detecting:

    @ abnormalities at ahigher or lower rate

    * statistics are used to

    assess significance of anydiscrepancy .

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    f) Clinico-pathological

    Meetings:benefit in :

    Regular case discussions.

    Audit & review of whole process :

    @ from collection of biopsy torelease of report .

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    Laboratory Accreditation

    It is the external inspection

    of quality in the lab.@ Organizations doing that are :

    Clinical Pathology Accreditation

    (UK)College of American Pathologists

    (USA)

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    @ Organization gives

    lab.a list of therequired standards.

    @ Lab. compares its

    tests against thesestandards.

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    @ Standards cover :

    Laboratory organization &administration

    Personnel : numbers, skills,qualifications.

    Buildings, facilities, equipment.Quality & safety aspects.

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    Policies,operating procedures

    Staff: continuous education,conditions of work

    Quality evaluation: audit &assessment procedures.

    Relations of clinical staffwith hospital management.

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    @ On compliance, organization

    subjects lab. for inspection .

    @ Inspectors check :

    compliance with the standards

    if clinicians are happy with lab.

    service .hold meetings with the hospitalmanagement

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    @ Organization feedbacklab.with :

    areas of weakness & how to beremedied.

    @ Re-inspection is repeatedat regular intervals.