Post on 02-Jun-2018
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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, © 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.