TR 32-04 - Sanas

TR 32-04
TECHNICAL REQUIREMENTS FOR THE ACCREDITATION
OF CYTOLOGY IN MEDICAL LABORATORIES
Approved By: Acting Chief Executive Officer: Ron Josias
Senior Manager:
Christinah Leballo
Date of Approval: 2010-02-05
Date of Implementation: 2010-02-05
©SANAS Page 1 of 5

TR 32-04
CONTENTS:
1. Purpose and Scope
2. Definitions and References
3. List of General Requirements
3.1 Organisation and Management
3.2 Quality and Technical Records
3.3 Pre-Examination Procedures
3.3.1 Sample Collection, Reception & Requisition Form
3.4 Examination Procedures
3.5 Assuring Quality of Examination Procedures
3.6 Reporting of Results
3.7 Laboratory Equipment
3.8 Accommodation & Environmental Conditions and Laboratory Safety
4. Authorship
ADDENDUM 1: Amendment Record
©SANAS Page 2 of 7

TR 32-04
1. Purpose and Scope
This document describes the managerial and technical accreditation requirements of a Cytology
Laboratory. It applies to all Medical Laboratories requiring accreditation to ISO 15189 or ISO/IEC
17025.
2. Definitions and References
SANAS PM
SANAS A01
ISO 15189
ISO/IEC 17025:2005
SANAS Policy Manual
References, Acronyms and Definitions
Medical Laboratories – Particular requirements for quality and competence
General Requirements for the Competence of Testing and Calibration
Laboratories
3. List of General Requirements
All assessments are done in accordance with the relevant ISO or ISO/IEC Standards and SANAS
requirements. SANAS documents are available on the SANAS website at www.sanas.co.za.
3.1 Organisation and Management
3.1.1 All professional staff shall comply fully with the HPCSA Act and regulations applicable
to their professions.
3.1.2 Screening of cytology samples shall only be performed at the following sites:
3.1.2.1 Medical laboratory premises:
a) The above sites shall have fixed premises and an identifiable address;
b) The sites at which cytology samples may be screened shall meet all the
requirements as stated in the SANAS Generic Checklist and any other
statutory requirements.
3.1.2.2 Approved stat service sites, e.g. theatre, clinics
3.2 Quality and Technical Records
3.2.1 The laboratory shall maintain statistics of the number of samples handled in the
laboratory classified under the following headings:
3.2.1.1 Gynaecological;
3.2.1.2 General (non-gynaecological) cytology;
3.2.1.3 Fine needle aspirations.
3.2.2 Cytology slides shall be retained for the periods indicated below:
3.2.2.1 Gynaecological slides: Minimum of 10 years;
3.2.2.2 Non-malignant non-gynaecologic slides: Minimum of 10 years;
3.2.2.3 All abnormal slides: An indefinite period Minimum of 10 years.
3.2.3. Original request forms and final reports shall be retained for a minimum of 10 years.
3.2.4. If any relevant records or slides are removed from a file, this shall be clearly marked
with a rider stating the current location of such records / slides and the person
responsible for their safe custody and return to the file.
©SANAS Page 3 of 7

TR 32-04
3.3 Pre-Examination Procedures
3.3.1. Sample Collection, Reception & Requisition Form
3.3.1.1 The sampling procedures, describing the sampling requirements for each
sample, shall be readily available for all submitting locations (e.g. clinics,
hospitals) and shall contain the following information:
i) Preparation of patient for sampling;
ii) Collection techniques;
iii) Specimen identification and labelling;
iv) Fixation requirements: e.g. fresh, anticoagulants, fixatives and storage
requirements;
v) Transportation instructions;
vi) Safety precautions for all of the above.
3.3.1.2 Where possible, FNAB sampling shall be carried out by a pathologist. In the
absence of a pathologist, a clinician that has been trained or follows the
documented procedure as provided by the laboratory may perform FNAB
sampling.
3.3.1.3 A completed Cytology requisition form must accompany every specimen and
shall include the following information:
3.4 Examination Procedures
i) Full demographic data;
ii) Relevant clinical history;
iii) Current clinical findings;
iv) Anatomical site of specimen and collection method;
v) Requesting clinician’s details;
vi) Date of specimen collection.
In addition, gynaecological cases shall also contain:
vii) Menstrual phase and hormonal status
viii) Details of hormonal therapy
ix) Details of contraception
3.4.1 A procedure manual on slide and specimen reception shall be available and shall
include:
3.4.1.1 Allocation of accession / laboratory numbers;
3.4.1.2 This accession / laboratory number shall appear on all:
a) glass slides (written with a diamond pencil, or on frosted-end slides with a
HB pencil)
b) requisition forms
c) specimen containers
3.4.1.3 Date and time of receipt;
3.4.1.4 Specimen condition i.e. macroscopic appearance, quantity, fixed or not, etc.;
3.4.1.5 Specimen rejection criteria and protocols e.g. improper documentation,
improper specimen etc.;
3.4.1.6 Safety precautions.
3.4.2 A cytopreparatory procedure manual shall be available defining separately the
techniques for Gynaecological and the individual non-gynaecological specimens taking
into account the following:
3.4.2.1 All safety precautions;
3.4.2.2 specimen concentration techniques;
3.4.2.3 slide preparations;
3.4.2.4 fixatives;
3.4.2.5 solutions;
3.4.2.6 staining and mounting;
©SANAS Page 4 of 7

TR 32-04
3.2.4.7 storage of slides.
3.2.5 To prevent cross contamination of material between slides, separate staining sets shall
be used for Gynaecological and non-gynaecological slides. (In laboratories with low
volumes of slides, staining solutions shall be filtered between the Gynaecological slides
and the non-gynaecological slides being stained.) All working solutions should be
changed frequently or filtered daily, solutions should be covered when not in use, etc.
3.5 Assuring Quality of Examination Procedures
3.5.1 The daily laboratory Quality Control policies and procedures shall address the
following additional issues and ensure that QC records can be traced to the source e.g.
documents or slides via accession / laboratory number etc.:
3.5.1.1 Screening current work;
3.5.1.2 Checking / reviewing of routine smears by either “Rapid Review” method or
“10% Re-screen” method;
3.5.1.3 Re-screening previous abnormal slides on receiving a subsequent smear
from the same individual;
3.5.1.4 Re-screening previous normal slides when a subsequent smear received
from the same patient shows any evidence of abnormality;
3.5.1.5 Cytopreparatory procedures, including staining quality and preparation;
3.5.1.6 Administrative procedures involved in the screening process.
3.5.2 Comply with National and/or International QA standards.
3.5.3 Workload volumes for each screener shall be recorded.
3.6 Reporting of Results
3.5.3.1 The laboratory shall enforce workload limits for screeners.
3.5.3.2 Follow up procedures and follow up records shall comply with the following
requirements:
a) Previously reported abnormal smears shall be matched with histological
sections submitted for examination from the patient;
b) For all abnormal smears the laboratory shall seek information regarding
results of Coloscopy, biopsy and details of any treatment;
c) The laboratory shall have procedures in place to follow up discrepancies
identified between the biopsy results and cytological prediction;
d) The laboratory shall implement a system to ensure that a list, of women
notified to the cancer registry of the state as having invasive cervical
cancer, is maintained and updated regularly;
e) The ASCUS : SIL ratio shall comply with the latest Bethesda
Recommendations.
3.6.1 The terminology used in reporting shall be standardised and consistent.
3.6.2 A pathologist or cytotechnologist in compliance with the HPCSA regulations shall report
on all cases with significant abnormalities.
3.6.3 Explanatory notes shall accompany any unsatisfactory or equivocal report.
3.6.4 All routine work should be completed and reported within 5 working days.
3.6.5 All malignancies or suspected malignancies shall be reported immediately in writing. A
telephonic report shall be followed by a written report as soon as possible
3.6.6 All reports with abnormal findings shall make recommendations regarding further
clinical / cytological investigations.
©SANAS Page 5 of 7

TR 32-04
3.7 Laboratory Equipment
3.7.1 All equipment shall have operating manuals, maintenance records, etc.
3.7.2 Microscopes used for screening shall have 10 X and 40 X objectives.
3.7.3 Spare bulbs and fuses shall be available in the laboratory.
3.7.4 All equipment such as centrifuges, homogenizers etc., capable of creating biohazardous
aerosols shall be used in extractor cabinets or rooms fitted with extractor
facilities.
3.8 Accommodation & Environmental Conditions, and Laboratory Safety
4. Authorship
3.8.1 All laboratory staff shall observe and adhered to the Occupational Health and Safety,
and other relevant, Acts and regulations relating to the hazards of chemicals, reagents,
ultraviolet light, electricity etc. as well as the biohazards involved with specimen
handling and preparation.
3.8.1.1 Appropriate protective measures shall be taken for handling, storage and
spills.
3.8.1.2 Material safety data sheets (MSDS) shall be available in the laboratory.
3.8.2 The handling and preparation of wet preparations shall take place in biological safety
cabinets or a room/cabinet with an effective fume extraction system.
3.8.3 Mounting of slides should be performed under fume extraction.
3.8.4 All chemicals and reagents in use or storage shall be labelled as follows:
3.8.4.1 Name and type of chemical/reagent/solution;
3.8.4.2 Expiry date;
3.8.4.3 Date of receipt;
3.8.4.4 Condition on receipt;
3.8.4.5 Date placed in use;
3.8.4.6 Date of preparation (where applicable) and initials of person preparing the
solution.
3.8.5 Appropriate procedures for the disposal of bio-hazardous and chemical waste shall be
documented and followed.
3.8.6 All accidents and incidents, as well as steps taken to prevent the reoccurrence, shall be
documented.
3.8.7 Adequate physical facilities shall be provided to enable all laboratory procedures to be
performed safely and competently.
3.8.8 Cytology screening areas shall be free of distractions and noise that can affect the
concentration of the staff.
This Technical Requirement document has been prepared and revised by the Medical Specialist
Technical Committee members.
SANAS is indebted to the contribution made by the committee members in the preparation of this
document.
©SANAS Page 6 of 7

TR 32-04
ADDENDUM 1.
AMENDMENT RECORD
Proposed By: Section Change
SM All Changed from a technical guidance (TG 32) back to a technical
requirement document (TR 32)
STC Section 1 Deleted: “and shall be used in conjunction with the requirements listed in
the ISO 15189 Standard. For ISO/IEC 17025:2005 clauses, refer to the
equivalent sections in the standard” and “SANAS accredited”
Added: “requiring accreditation to ISO 15189 or ISO/IEC 17025”
Section 3 Deleted: “Additional copies of SANAS documentation may be purchased
from the office.”
Section 3.1 Deleted:
(Clause 4.1)
Should replaced by shall
Section 3.2 Deleted: (Clause 4.13)
Section 3.3 Deleted: (Clause 5.4)
Section 3.4 Deleted: (Clause 5.5)
Section 3.5 Deleted: (Clause 5.6)
Section 3.6 Deleted: (Clause 5.8)
Should replaced by shall
Section 3.7 Deleted: (Clause 5.3)
Section 3.8 Deleted: (Clause 5.2)
©SANAS Page 7 of 7