QUALITY ASSURANCE

IN
HISTOPATHOLOGY
QC should consider the
whole process :
starting and finishing with the
patient.

This covers the followings:

Patient benefit from biopsy.
Patient consent.
Proper procedure & excision.

Collection of adequate sample.

Collection of demographical
data & clinical information.
Proper sample fixation.
Rapid transport to laboratory .

On specimen receipt, record

patient identification .
Macroscopic description &
sampling must be acceptable.
Tissue processing must be
acceptable.
Sections should be of good
quality

Staining must be acceptable.

Pathologist should be qualified
Microscopic description is to be
acceptable.
Stains & reagents are to be
used properly

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 be
delivered rapidly.

Correct report to correct patient.

Clinician must be able to read &
understand the report.
Subsequent patient care is to be
carried out properly.
Whole process must be rapid.

Clinician and lab. are to communicate

to solve problems .

Methods of Quality Assurance

1.Peer Review :
Laboratory compares its present
performance with its own past
performance( self peer review).

Review covers strengths &

weaknesses in histopathology
procedures .

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.

proper description of specimen.

accuracy of diagnosis.
section quality,.
speed of pathologist's report .

accuracy of patient identification.

computer lab.processing & reporting

3.Internal Quality Control

staff check section & stain
quality before reporting
special stains needed should
be done
Proper controls are included

4. External quality
assessment (EQA)
Organizer sends to lab. samples
of fresh tissue.
Lab. is to fix & process samples
same as routine specimens
Examined samples are sent to the
organizer .

Organizer sends a report

that compares lab. results
with those of participating
labs.

Sending fixed(not fresh)

tissue cannot be identical
to all labs.

Organizer prepares
sections for special stains
& sends to participants.
Specific sections from
lab. archives are sent to
organizer for assessment .

Organizer checks :
@ fixation , decalcification ,
processing, embedding ,
microtomy ,
@ haematoxylin stain, eosin
stain , artifacts, finishing

Organizer report is in the

form of scores & explanation
of why marks were lost.

Organizer offers educational

meetings & guidance to all
participants.

5. Benchmarking :
Falls into two groups :
(1) Q-Track program :
@ similar to the random selection
audit but in a small scale.
@ Q-Track covers all disciplines.
@ Comparison is made with other
labs of similar type.

(2) Q-probe program:

@ It is a mutual discussion
of selected topics in depth
@ It is run between
different laboratories.

@ Topics may include :

@ staging of breast carcinoma,.
@ physicians satisfaction with lab
services,.
@ needle biopsies of prostate.
@ non - gyneacological cytology.

6. QC of Histopathologists
Performance:

Five methods
are available :

a)Total Review Audit :

Histopathologist errors are
detected by reviewing report of
final diagnosis .

This is time-consuming.
Definition of clinical significance
remains that of a pathologist not
the clinician .

b) Single Topic Audit :

A single topic is submitted
for audit .
Common topics :
@ frozen section diagnoses,
@ paraffin section report,
@ urine cytology service.

c) Internal Q. Control
Poor results are due to:
@ defect in samples,
@ defect in techniques
@ incompetent pathologist

Reports of large biopsies

must contain :
@ correct diagnosis.
@for tumors give : stage, grade,
resection

Use checklists in reporting

biopsies.

d) Diagnostic EQA:
@ Tests of diagnostic work
are divided into :

1. tests of diligence, to check :

*errors of omission or oversight

2. tests of competence, to check :
* experience, qualifications

@ Organizer sends specimens to

participating pathologists.
@ Specimens are tested same as
routine samples .
@ Diagnoses are returned to
organizer for analysis.
@ Diagnosis is assessed, & a
report is sent to pathologist.

@Pathologist participate in :
a slide circulation scheme
that allows him to compare his
report criteria with the group.
This is needed for cervical
cytology specimens .

@ EQA is mainly
educational leading to :
self-correction.
training of pathologists .

@Poor EQA :
does not mean unsafe
practice,
but it reflects
professional incompetence

e) Statistical Analysis :

Many samples are distributed

by organizer to different
pathologists .
Organizer records :
@ range & frequency of
diagnoses given by pathologist,
@ rate of detection of
abnormalities by pathologist.

Pathologist detecting:
@ abnormalities at a
higher or lower rate
* statistics are used to
assess significance of any
discrepancy .

f) Clinico-pathological
Meetings:
benefit in :

Regular case discussions.

Audit & review of whole process :
@ from collection of biopsy to
release of report .

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)

@ Organization gives
lab.a list of the
required standards.
@ Lab. compares its
tests against these
standards.

@ Standards cover :
Laboratory organization &
administration
Personnel : numbers, skills,
qualifications.
Buildings, facilities, equipment.
Quality & safety aspects.

Policies,operating procedures
Staff: continuous education,
conditions of work
Quality evaluation: audit &
assessment procedures.
Relations of clinical staff
with hospital management.

@ On compliance, organization
subjects lab. for inspection .
@ Inspectors check :
compliance with the standards
if clinicians are happy with lab.
service .
hold meetings with the hospital
management

@ Organization feedback
lab.with :
areas of weakness & how to be
remedied.

@ Re-inspection is repeated
at regular intervals.