Why does QUALITY CONTROL
important in histopathology?
Histopathology is the branch of pathology based on the
examination of tissues obtained from a patient at surgery or
autopsy. Histopathologists provide diagnostic expertise and
advice for clinical colleagues, and work in clinical teams
that care for patients. Histopathologists need to work in
partnership with clinical colleagues, hospital
administrators, laboratory technical officers and support
staff to provide the best possible histopathology standards
and service.
QUALITY CONTROL
Quality Control is defined as a system for verifying and
maintaining a desired level of quality in an individual test
or process. Quality control activities span the testing
process from the moment of specimen collection until the
time the physician receives the report.
Quality control in histopathology involves both external
and internal components for improving the standards of
technical work as well as of reporting.
QUALITY ASSURANCE
Quality Assurance (QA) is defined by the College of
American Pathologists as systematic monitoring of quality
control results and quality practice parameters to assure
that all systems are functioning in a manner appropriate to
excellence in health care delivery. Quality assurance is a
coordinated system designed to detect, control and prevent
the occurrence of errors and, ultimately, to further a
clinician’s ability to appropriately care for his or her
patient.
Quality assurance in pathology and laboratory medicine is
the practice of assessing performance in all steps of the
laboratory testing cycle including pre-analytic, analytic,
and post-analytic phases to promote excellent outcomes in
medical care
OVERVIEW OF QUALITY CONTROL Quality
Control in histopathology laboratory shall be
considered in the following order:
 Pre-analytical requirements
Standard for QUALITY
A standard is that which has been selected as a
model to which objects or actions may be
compared’. It is a document that sets out a
detailed description of requirements,
dimensions, materials and /or procedures
designed to ensure that a product or service
meets its purpose and consistently performs to
its intended use. It aims at achieving
Consistency and Reproducibility.
Talking about quality……
Quality means different things to different
professionals working in the histopathology
laboratory, the patient and the requesting
physician. To the Medical Laboratory Scientist,
quality means the production of high quality
sections or slides. Probing questions considered
include ‘is it well stained?’, ‘is it well
differentiated?’ ‘Is it air bubble free; is it
artifact free; are the required tissue elements
specifically demonstrated?
to the physician..
to the patients…
Therefore for the histopathology laboratory,
quality control must be seen as the policies,
practices and procedures enshrined for the
production of high quality sections with
accurate, timely and complete reports in a cost
effective manner at all times.
 dispatch of reports
 Block archive
 Tissue bank
 Seminars and continuous professional development
 Inventory
 Critical value reporting
QUALITY REQUIREMENTS AND
STANDARDS
Ensuring quality assurance in service delivery
comprises compliance with both quality
requirements and quality standards. Quality
requirements are stated as a description. There
are no targets associated with a requirement as
service providers must fulfil the requirement.
Quality standards are stated as a description of
an activity with a measurable level of
performance, with an associated target for
achievement. The standards are designed to be
measurable i.e. quantitative with criteria that are
valid, reliable and feasible.
OBJECTIVES OF QUALITY CONTROL IN
HISTOPATHOLOGY LABORATORY
1. To ensure quality services that guarantees
patient’s satisfaction
2. To produce high quality sections within and
between laboratories
3. To generate accurate, timely and complete
reports
4. To reduce turn around time
5. To promote ethics and professionalism
6. To enhance improved performance
7. To enahance continuous training and
professional development
QUALITY REQUIREMENT
AUTHORISATION OF RESULTS
Every result will be appropriately authorised
before release. Every report should be checked
for inconsistencies before authorisation
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 Analytical requirements
 Post-analytical requirements.
PRE-ANALYTICAL REQUIREMENTS ·
 Laboratory Design
 Personnel
 Equipment’s
 Sampling
 Request Form
 Fixation
 Transportation
 Registration
 Laboratory Number
 Reagents
 ICT
ANALYTIC REQUIREMENTS
 Grossing
 Tissue processing
 SOP
 Controls
 Equipment
 Screening of slides
 Documentation
POST-ANALYTIC REQUIREMENTS
 Reporting
 Interpretation
 Typing of reports
 Communication
 Auditing
QUALITY ASSURANCE PROGRAM
Quality assurance measures current performance, QUALITY REQUIREMENT RECORDING
compares it with established goals and good OF RESULTS
laboratory practice and is eventually aimed at
improving services. A standard histopathology Results details will include at least:
laboratory must have both internal and external
quality assurance policies.  Patient identification data
The objective of a quality assurance program in
 Name and address of the laboratory
histopathology is to ensure the completeness,  Name of requesting physician
accuracy and timeliness of a histopathology report.  Laboratory ID number
 Date of specimen procurement (specimen date)
LABORATORY INFORMATION SYSTEM  Date of arrival of the specimen in the
laboratory
A laboratory information system stores information
 Sample type
in a relational database, such as Oracle, DB2 or MS
SQL. A link is established between samples, storage  Anatomical site of origin
conditions, test dates, analyst certification,  Relevant clinical details
instrument calibration and testing parameters.
It is aimed at supporting automation in the
laboratory, reducing turnaround time, improving
service quality, and reducing errors. In conclusion,
quality control is essential for effective performance
of the laboratory.
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Suggested Guidelines for Record and Specimen Retention

3 copies of  . Doctor 48 Serum/other body fluids

report
 Patient (original copy) hours
 File 7 days Blood smears (routine)
 Request forms (patient’s Microbiology smears
The Signatories
doctor) BB donor/recipient specimens
 Result forms (pathologist) 1 year Body fluids
 Specimen (tissue) (1 Tissue for toxicology
month to 1 year) 2 years Requisitions
Storage
 Tissue blocks (paraffin)(3 QC
to 10 years) Instrument maintenance
 Slides (indefinite) Clinical pathology lab (reports)
 3 years Wet tissues
Reports

Surgical pathology report
Cytopathology report 5 years BB QC Organization
 10 years BB employee signatures

Autopsy report
Surgical pathology & Surgical pathology (and BM) reports Name/Logo
cytology !24 hrs Pathology/BM slides
 Frozen section Pathology blocks
Turnover of !5-15 mins
results
 Autopsy report 20 years Cytogenetics reports
!1 week (Autopsy Cytogenetics diagnostic images
procedure: !24 hrs) indefini BB donor/recipient records
tely Paraffin blocks
Slides
Reports
Gross photographs/ negatives
Dried blood films
Frozen tissue for DNA