Statement No. 1425 - Cytology Standards of Accreditation

1. DIRECTOR

In addition to the obligations set forth in Article 6 of By-law 3A of the College, the following requirements apply to the Director of a Cytology Laboratory:

a.	The Director must be a General or an Anatomical Pathologist approved as a Laboratory Physician pursuant to By-Law 3A, and must have professional expertise in cytopathology. (see Statement 500, "Retraining of Inactive Physicians", for the principles applicable to physicians who wish to re-enter a field of practice.)
b.	The Director must appoint a Deputy Director, who will function as the Director in the absence of the Director.
c.	The Director must ensure that only individuals who are General Pathologists or Anatomic Pathologists pursuant to By-Law 3A and who have professional expertise in cytopathology work in the facility as cytopathologists.

2. CYTOTECHNOLOGISTS

Cytotechnologists are required to meet one of the following requirements:

persons with an R.T. (Registered Technologist Cytology) as awarded by the Canadian Society for Medical Laboratory Sciences (CSMLS) or the equivalent of this qualification and currently registered with the CSMLS;
persons who have received six to twelve months training in an approved school of cytotechnology followed by sufficient supervised hospital experience to meet the requirements of the CSMLS, or its equivalent, to become eligible for cytology certification may also be employed; any employee in this category must become certified in cytology by the CSMLS (or its equivalent) within six months of completing training and certification eligibility.

3. PHYSICAL FACILITIES

3.1 Laboratory space

3.1.1	All slides must be stained, screened and reported on the premises of the same institution. (see Article 4 re: exception)
3.1.2	Working conditions in the Cytology Laboratory must be conducive to high quality performance. The microscopy area must be quiet, orderly and of adequate size for the number of individuals employed. Ergonomic assessment of furnishings is strongly recommended.
3.1.3	The work areas must be functionally arranged so as to minimize problems in handling specimens, screening, and reporting.
3.1.4	There must be physical separation of the microscope screening and reporting area from the specimen handling (preparatory) portion of the laboratory. Where both areas are in close proximity, a partial wall of a least three feet in height must separate the two working areas.
3.1.5	The laboratory must be clean, well lit, properly ventilated, and have sufficient appropriate services such as sinks, water, gas, suction and electrical outlets.

3.2 Safety precautions

3.2.1	Precautions to protect employees from physical, chemical and biological hazards must be observed. Safety training for the staff must be provided and documented on an annual basis as per Workplace, Health & Safety Standards. Current Safety Manuals must be available for all cytology staff.
3.2.2	Fume hoods must be used for handling volatile and toxic substances while biological safety cabinets must be used for handling bio-hazardous material.
3.2.3	Volatile and flammable liquids must be properly stored and WHMIS regulations followed.
3.2.4	Fire preventive measures and precautions must be observed, posted, and inspected. Equipment must be tested as per Workplace, Health & Safety Standards.
3.2.5	General laboratory precautions must be observed when handling fresh material and potential biohazardous material.
3.2.6	Hepatitis B vaccination is recommended for Hepatitis B-susceptible health-care workers handling unfixed body fluids.
3.2.7	Eye wash stations must be present in the laboratory and a shower be easily accessible.

3.3 Equipment

3.3.1	It is strongly recommended that all laboratories be computerized to facilitate accessioning, reporting, archiving records and quality assurance practices. A computerized laboratory must have a sufficient number of computer stations for its needs. All personnel must be appropriately trained in their use.
3.3.2	There must be an adequate number of binocular microscopes of high optical and mechanical quality to meet screening and reporting needs.
3.3.3	A multi-headed microscope to facilitate quality control and continuing education is strongly recommended.
3.3.4	All equipment must be of high quality and satisfy Canadian manufacturing standards.
3.3.5	There must be an active program of preventive maintenance with documentation for microscopes and all other equipment.

3.4 Policy and Procedure Manuals

All cytology policy and procedure manuals shall be written in the National Committee for Clinical Laboratory Standards (NCCLS) format. The laboratory shall develop a system of documentation to ensure that all personnel are knowledgeable about the contents of the manuals relevant to the scope of their activities. The manuals shall be reviewed, revised and updated on an annual basis and these processes shall be documented as per the Charge Technologist and the Laboratory Director.

All cytology manuals shall include the following components:

- technical
- clerical
- administrative
- quality management
- safety

All manuals must be available to the staff and all users of the services.

4. SPECIMEN COLLECTION, PREPARATION, SCREENING, CYTODIAGNOSTIC PRACTICES

Preparation, screening, signing out and storing of slides and file copies of reports must be done at the same site (except for cytopathologist-to-cytopathologist requests for consultative opinion on referral of stained slides). When an exception is made, it must be duly noted and approved, in writing, by the Director and kept on file accordingly. The Director must ensure that security concerns have been addressed. There must be appropriate communication and review according to national/international standards. There must be accountability to ensure that slides are not lost.

4.1 Requisition Form

The information required includes the following:

Laboratory accession number
PHIN (if one has been issued) and patient names as required for proper identification
Address and/or hospital record number
Date of birth (including day, month and year)
Name of referring physician or other smear taker and address
Anatomic site of specimen
Appropriate medical history including previous history
Date of specimen collection
Date specimen received in laboratory

4.2 Slide Identification

The slide must be clearly identified with patient’s PHIN (if the patient is a non Manitoba resident, or, for any other reason has not been issued a PHIN, the slide must be identified with the patient’s name).

4.3 Specimen Accessioning

Each specimen received must be accessioned with a PHIN referenced with the patient's name, together with the name of the referring physician, hospital or clinic, and the type of specimen. The specimen(s) must be easily retrievable according to any of the above data.

4.4 Rejection Policy

A. The laboratory will reject a specimen and the slide will be destroyed under the following circumstances:

Specimen slide improperly labelled
Failure to identify the slide with the patient’s name in the situation where the patient is a non-Manitoba resident or, for any other reason, has not been issued a PHIN
Discrepancy of information between specimen and requisition form
Slide broken beyond repair
Slide received without accompanying requisition

B. The slide and requisition will be returned to the health care providers if:
     Requisition lacking pertinent information:
          a)patient’s PHIN (if one has been issued)
          b)patient’s name
          c)date of birth
          d)name/address of referring physician

C. The requisition will be returned to the health care provider if it is received without a slide.

D. When a PAP Smear is rejected by a cytology laboratory, the doctor must be notified within a two week period.

5. TERMINOLOGY FOR CERVICAL CYTOLOGY

5.1 All Cytology laboratories are encouraged to adopt one reporting system. The Bethesda System is the most widely accepted and used by most Cytology Laboratories. In the mean time, diagnostic terminology incorporating both the Bethesda and the Canadian Society of Cytologic Classification System for reporting Cervical-Vaginal diagnosis is adequate. However, the Bethesda System must take precedence. The following terminology is to be used for the reporting of cervical vaginal cytology:

THE CANADIAN SOCIETY OF CYTOLOGY:
CLASSIFICATION SYSTEM FOR REPORTING CERVICAL-VAGINAL DIAGNOSES

CIN/DYSPLASIA SYSTEM
UNSATISFACTORY: state reason
NO ABNORMAL CELLS; metaplasia noted
ABNORMAL CELLS CONSISTENT WITH REACTIVE ATYPIA (Nondysplastic)
   Trichomonas effect
   Yeast effect
   Viral effect (Herpes)
ABNORMAL CELLS CONSISTENT WITH REACTIVE ATYPIA (Nondysplastic)
   Inflammatory effect
   Irradiation effect
   Other (specify)
ABNORMAL CELLS CONSISTENT WITH ATYPIA (possibly dysplasia)
   Atypical metaplasia
   Atypical parakeratosis
   Other (add comment)
ABNORMAL CELLS CONSISTENT WITH CONDYLOMA (HPV) EFFECT
ABNORMAL CELLS CONSISTENT WITH DYSPLASIA
   Mild dysplasia/CIN I
   Moderate dysplasia/CIN2
   Severe dysplasia/CIS/CINIII
ABNORMAL CELLS CONSISTENT WITH MALIGNANT DISEASE
   Consistent with invasive carcinoma
   Squamous carcinoma
   Consistent with adenocarcinoma
   Type unspecified
ABNORMAL CELLS NOT SPECIFICALLY CATEGORIZED
(add comments)

BETHESDA SYSTEM 2001

SPECIMEN TYPE: Indicate conventional smear (Pap smear) vs. liquid based vs. other

SPECIMEN ADEQUACY:

Satisfactory for evaluation (describe presence or absence of endocervical/transformation zone component and any other quality indicators, e.g., partially obscuring blood, inflammation, etc.)
Unsatisfactory for evaluation … (specify reason)
Specimen rejected/not processed (specify reason)
Specimen processed and examined, but unsatisfactory for evaluation of epithelial abnormality because of (specify reason)

INTERPRETATION/RESULT

NEGATIVE FOR INTRAEPITHELIAL LESION OR MALIGNANCY (when there is no cellular evidence of neoplasia, state this in the General Categorization above and/or in the interpretation/Result section of the report, whether or not there are organisms or other non-neoplastic findings)

ORGANISMS:

Trichomonas vaginalis
Fungal organisms morphologically consistent with Candida spp
Shift in flora suggestive of bacterial vaginosis
Bacteria morphologically consistent with Actinomyces spp.
Cellular changes consistent with Herpes simplex virus

OTHER NON NEOPLASTIC FINDINGS (optional to report; list not inclusive):

Reactive cellular changes associated with
- inflammation (includes typical repair)
- radiation
- intrauterine contraceptive device (IUD)
Glandular cells status post hysterectomy
Atrophy

OTHER:

Endometrial cells (in a woman => 40 years of age)
(Specify if ‘negative for squamous intraepithelial lesion’)

EPITHELIAL CELL ABNORMALITIES

SQUAMOUS CELL

Atypical squamous cells
- of undetermined significance (ASC-US)
- cannot exclude HSIL (ASC-H)
Low grade squamous intraepithelial lesion (LSIL)
- encompassing: HPV/mild dysplasia/CIN 1
High grade squamous intraepithelial lesion (HSIL)
- encompassing: moderate and severe dysplasia, CIS/CIN 2 and CIN 3
- with features suspicious for invasion
Squamous cell carcinoma

GLANDULAR CELL

Atypical
- enocervical cells (NOS or specify in comments
- endometrial cells (NOS or specify in comments
- glandular cells (NOS or specify in comments)
Atypical
- endocervical cells, favor neoplastic
- glandular cells, favor neoplastic
Endocervical adenocarcinoma in situ
Adenocarcinoma
- endocervical
- endometrial
- extrauterine
- not otherwise specified (NOS)

OTHER MALIGNANT NEOPLASMS: (specify)

5.2 Reports

The stated reports to the smeartakers shall incorporate:

i.	A clear statement of specimen adequacy: Satisfactory versus Unsatisfactory
ii.	Diagnosis as per the Bethesda System, 2001. The Canadian Society of Cytology Classification. System for reporting cervical-vaginal diagnosis must also be incorporated. However, the Bethesda System must take precedence.
	Qualifiers of atypical squamous cells (ASC) which include: ASC-US ASC-H
	Qualifiers of Atypical Glandular Cells: Atypical endocervical cells (NOS or specify in comments) endometrial cells (NOS or specify in comments) glandular cells (NOS or specify in comments) Atypical endocervical cells, favor neoplastic glandular cells, favor neoplastic
iii.	Recommended follow-up of abnormal smears:
	Unsatisfactory (blood, inflammation, thick, poor fixation, air drying artifact, etc.) First: repeat Second: colposcopy if unsatisfactory because of blood, inflammation (i.e. suspicion of invasion)
	ASC-US and LSIL First: repeat Pap in six months Second: colposcopy/further evaluation
	ASC-H, HSIL, Atypical Glandular Cell, Carcinoma, Endometrial Cells (Out of Cycle in a Woman over 40 with no history given of hormones or IUCD, menstrual history not known, and Post menopausal woman with no history given of HRT) First: colposcopy/further evaluation
iv.	If current smear is abnormal, the results of the targeted review must be stated on the report.

6. STORAGE

All filed reports, slides and blocks must be retained according to the Canadian Association of Pathologists Guidelines:

Cytology	Class	Minimum Retention Period
Slides: A: Within normal limits, unsatisfactory and imflammatory atypia	A	5 years
B: Atypical, suspicious and positive for malignancy	B	20 years
Reports/Records	A	5 years
Reports/Records	B	20 years
Requisitions		6 months beyond the time report was issued and up to 1 year if used as a work sheet or draft report

There must be separate files for normal and abnormal cervical-vaginal gynecological and non gynecological cytology slides.

7. QUALITY STANDARDS

7.1 QUALITY CONTROL

A. RETROSPECTIVE TARGETTED

review last five years of cytology smears on a patient whose current smear is HSIL (high grade squamous intraepithelial lesion) cervical-vaginal cytology smear
review last three years of cytology smears on a patient whose current smear is LSIL (low grade squamous intraepithelial lesion) cervical-vaginal cytology smear

These must be rescreened by a cytotechnologist and evaluated by the cytopathologist responsible for signing out the current abnormal smear.

B. CURRENT TARGETTED REVIEW

retrospective slide review of negative slides in high risk individuals. (e.g. previous abnormal, suspicious history, etc.)
may also include rescreening of previously reported abnormal smears by circulating smears; the report of the initial screen must not be available to persons or persons rescreening the smear.

7.2 Quality Assurance

The facility (both cytopathologists and cytotechnologists) shall participate in the College of American Pathologists (CAP) proficiency testing program (for both gynecologic and non gynecologic cytology) as required by the Manitoba Quality Assurance Program (MANQAP). The results must be copied to MANQAP.

7.3 Follow-up Program

7.3.1	Cyto-histological correlation of gynecological material with a cytology diagnosis of SIL (CIN)/Carcinoma shall be carried out to determine the correlation rates for the combined diagnoses and individual grades of SIL (CIN). This information may be available from the laboratory’s own files or another source, e.g. Provincial Cytology Registry. The data must be used to standardize diagnostic criteria in the laboratory.
7.3.2	A patient follow-up system must be described in writing and included in the laboratory’s Policy Manual.
7.3.3	The rate of follow-ups must be documented. Reasons for difficulties in obtaining a cytohistological correlation shall be documented accordingly.

8. WORKLOAD

8.1	Slide screening workload: Neither economic considerations alone nor expediency may determine the number of cytology slides to be screened by a cytotechnologist in one day (24 hours). It is the responsibility of the Director to ensure that the number and type of cytology slides to be screened does not, through fatigue, affect adversely the cytotechnologist's ability to find, recognize and interpret correctly abnormal cells that may be representative of a disease process.
8.2	Precise workload limitations may be difficult to define because of variations in types of cytology specimens being screened as well as variations in support by screening personnel and of graded responsibility. Some specimen slides may be easier and less fatiguing to screen while other specimen slides may be very difficult and very fatiguing to screen. The relative proportions of these various types of slides shall determine the total number of slides to be screened by a cytotechnologist in a working day. It may be feasible to cytoscreen a larger number of "routine" cancer prevention screening type cervical-vaginal smears than smears in follow-up of a previously detected abnormality. The number of cervical-vaginal smear slides screened by a cytotechnologist exclusively screening full-time without other duties or distractions may vary from sixty to eighty cumulative (including rescreened slides) for that individual in a working day (about six to eight hours of screening).
8.3	A cytotechnologist, whose other duties require that less total time is devoted to slide screening alone, shall have a proportionately reduced workload. For example: a total of four hours exclusively devoted to slide screening must require a prorated workload no greater than 4/8 x (60-80) = 30-40 slides to be screened. The Director shall determine when circumstances for adequate screening by the cytotechnologist require that lesser number of slides be screened in a daily time period.
8.4	A cytotechnologist must not be expected to screen more than ninety slides in a 24 hour time period even if they are “routine” type cervical-vaginal smears (on average about ten slides per hour devoted exclusively to screening).

9. CONTINUING EDUCATION

9.1	Each laboratory must have access to one or more of the cytology journals (e.g. Acta Cytologica and Diagnostic Cytopathology). There shall be a good supply of appropriate, current cytology textbooks. Books and journals must be easily accessible on the laboratory site.
9.2	Each individual (cytotechnologist and cytopathologist) is expected to independently pursue continuing medical education in the specialty. They must participate in scientific meetings, review courses, or specialty conferences, and must update his/her knowledge of cytology practice by reading the current literature. There must be access to a regular schedule of lectures or symposia. The staff shall be relieved of their duties to take advantage of these educational opportunities. The Laboratory Director must make every effort to ensure that this standard is met.
9.3	Performance evaluations must be used to identify those with deficiencies in knowledge and skills who would benefit from a more directed education program.

10. PERFORMANCE INDICATORS

Each laboratory must measure and record the performance indicators listed below. Details of the methodology must be documented.

10.1 Gynecological material: performance indicators

10.1.1

Point System: This will assess the cytotechnologist’s overall diagnostic accuracy rate (%). Using the following chart, points will be assessed to the cytotechnologist diagnosis.

Final DX	UNSAT	NAC	ASCUS	LSIL	HSIL	CANCER
Cytotech Dx
UNSAT	0	-1	-1	-2	-3	-3
NAC	-1	0	-1	-2	-3	-3
ASCUS	-1	-1	0	0	-1	-2
LSIL	-2	-2	0	0	-1	-2
HSIL CANCER	-3 -3	-3 -3	-1 -2	-1 -1	0 0	0 0

Each case will be given three points. The total discrepancy in points will be subtracted from the maximum score to arrive at the points scored.

Points Scored x 100 =% divided by Total Points

The cytotechnologist’s accuracy rate is then compared to Quality Assurance Standard:

QA STANDARD	DIAGNOSTIC
Satisfactory	95-100%
Unsatisfactory	Below 95%

Below 95% initiates the performance enhancement program. After successful completion of the performance enhancement program and within the next quarterly report, the cytotechnologist is evaluated on slide screening workload and diagnostic accuracy. If the cytotechnologist is below standard, remedial action will be a decision of the Director of the laboratory.

10.1.2	The cyto-histological correlation rates for each grade of SIL (i.e. low-grade and high-grade) and for cases of carcinoma on Pap smears shall be measured at least for the laboratory, and if possible, for individual cytotechnologists and individual pathologists.
10.1.3	The rate of within normal limits, satisfactory but limited by... and unsatisfactory smears accessioned by the laboratory shall be measured at least for the laboratory, and if possible, for individual cytotechnologists, individual cytopathologists and health care providers (smear takers).
10.1.4	The total number and rates of abnormal gynecological diagnoses and specific diagnostic categories (using the Bethesda terminology) shall be measured at least for the laboratory, and if possible, for individual cytotechnologists, and individual cytopathologists.
10.1.5	The accuracy of negative cytology in the preceding five years to a histologic confirmed severe or carcinoma in situ or carcinoma shall be measured at least for the laboratory, and if possible, for individual cytotechnologists and individual cytopathologists.
10.1.6	The turnaround time for gynecologic cytology in Manitoba shall be 10 working days with the percent review completed within the 10 working days.

10.2 Non-Gynecological material: performance standards

10.2.1	Correlations of the results of fine needle aspirates (especially those of commonly aspirated sites) with their corresponding surgical material are recommended. When possible, unsatisfactory, sensitivity, and specificity rates shall be calculated.
10.2.2	The turnaround time (the date the specimen is received in the laboratory to the date the finalized report is issued) shall be measured and documentation kept accordingly.

11. AUTOMATED PAP SMEAR SCREENING DEVICES

Automated Pap Smear Screening Devices may be used for secondary screening only (not primary screening) as they are considered to be investigational at this time.

12. ANNUAL REPORT

12.1	The Director must provide an Annual Report to MANQAP. The Annual Report must be for the calendar year (January 1 to, and including, December 31).
12.2	The Annual Report must be received by MANQAP by June 30 in the year following the reporting year

12.3	The Annual Report shall include:
	Facility and address Laboratory Director Executive Director Medical Staff Technical Staff, qualification(s), registration Volume of work

a)	Gynecological specimens: normal, abnormal, unsatisfactory, rejected
b)	Non-gynecological specimens: respiratory, urinary, other
c)	Fine needle aspirations: breast, salivary gland, lymph node, other
d)	Total number of slides screened per cytotechnologist per number of hours devoted to screening activities (double smears taken on a patient should be counted as two smears)

Cytology Laboratory Performance Indicators-Gynecological specimens

a)	i.	Total gynecological specimens: normal, abnormal, unsatisfactory, rejected
a)	ii.	Rejected specimens (4.4)
a)	iii.	Negative for Intraepithelial Lesion or Malignancy (10.1.3) and percentage of total gynecological specimens
a)	iv.	Unsatisfactory (10.1.3) and percentage of total gynecological specimens
b)		Abnormal gynecological diagnose using the Bethesda terminology (10.1.4)
b)	i.	Total Abnormal and percentage of total gynecological specimens
b)	ii.	ASC and percentage of total gynecological specimens
b)	iii.	ASC-US and percentage of ASC
b)	iv.	ASC-H and percentage of ASC
b)	v.	LSIL and percentage of total gynecological specimens
b)	vi.	HSIL and percentage of total gynecological specimens
b)	vii.	Squamous cell carcinoma and percentage gynecological specimens
b)	viii.	Adenocarcinoma and percentage gynecological specimens
b)	ix.	other carcinomas and percentage gynecological specimens
b)	x.	AGC and percentage of total gynecological specimens
b)	xi.	AGC-NOS and percentage of AGC
b)	xii.	AGC-Favour Neoplastic and percentage of AGC

c)		Cyto-histological correlation rates for each grade of SIL (ie LSIL and HSIL) and cases of carcinoma on Pap smear (7.3 and 10.1.2)
c)	i.	LSIL x 100% divided by total abnormal with histology
c)	ii.	HSIL x 100% divided by total abnormal with histology
c)	iii.	Carcinoma x 100% divided by total abnormal with histology
c)	iv.	Under Called x 100% divided by total abnormal with histology
c)	v.	Over Called x 100% divided by total abnormal with histology

d)	False-negative rate defined as a screening miss of an abnormality in a satisfactory smear >/= ASC-H with retrospective targeted review of cytological smears (last five years of smears where current smear is HSIL and in the last three years of smears where current smear is LSIL) (7.1.A)
e)	Accuracy of negative cytology (True negative) in the preceding five years to histology confirmed severe atypia, carcinoma in situ or carcinoma (10.1.5)
f)	Turnaround time-percentage of specimens reported within five working days (the date the smear is received in the laboratory to the date the finalized report is issued) (10.1.6)

Cytology Laboratory Performance Indicators-Non Gynecological specimens

a)	i.	Total Non Gynecological Specimens
	-	Negative
	-	Positive
	-	Unsatsifactory

ii.

Turnaround time - percentage of specimens reported within five working days (the date the smear is received in the laboratory to the date the finalized report is issued) (10.2.2)

Cytology Laboratory Performance Indicators - Fine Needle Aspirates

a)	i.	Total Fine Needle Aspirates
	-	Negative
	-	Positive
	-	Unsatisfactory

ii.

Turnaround time - percentage of specimens reported within five working days (the date the smear is received in the laboratory to the date the finalized report is issued) (10.2.2)

Sample of Pap Smear Reports issued to Smear Takers (blinded to specific patient demographics)
- two (2) of patients with negative
- two (2) of patient with abnormal results
- two (2) of patient with abnormal targetted review

13. REFERENCES

Canadian Society of Cytology Guidelines for Practice and Quality assurance in Cytopathology,
1995-96.

Programmatic Guideline for Screening for Cancer of the Cervix in Canada, 1998.

European Guidelines for Quality Assurance in Cervical Screening. Europe against cancer programme.

Performance Standards for Australian Laboratories Reporting Cervical Cytology.

“Cervical Screening: A Practical Guide for Health Authorities” NHSCSP.

Clinical and Laborataory Standards Institute (CLSI), formerly the National Committee for Clinical Laboratory Standards (NCCLS).

First Print	MANQAP-LAB Med/01-97
Revision	MANQAP-CYTO/06-01
2nd Revision	MANQAP-CYTO/08-02
3rd Revision	MANQAP-CYTO/01-03
4th Revision 5th Revision	MANQAP-CYTO/03-04 MANQAP-CYTO/11-05

A statement is a formal position of the College with which members shall comply.