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PRINCIPLE OF THE TEST.
In order to assure that each diagnosis rendered by Cytopathology is as
accurate as can reasonably be expected, a series of quality control (QC),
quality assurance (QA), and statistical indicators are monitored.
The quality improvement program within the cytopathology laboratory entails
both technical and procedural quality control items.
STEP-BY-STEP DESCRIPTION.
1. Daily monitoring of technical adequacy.
The cytotechnologist and the pathologist review slides
for technical adequacy. Unsatisfactory slides are noted
on the specimen QA sheet. The problem is noted,
and whatever steps are needed to correct it are taken.
The times or solutions are adjusted,
new slides are made and stained, or destained.
2. Daily monitoring of proper handling of cytology specimens.
All cytology screening is performed within the laboratory.
A Standard Tissue Examination Consultation Form (SF-515)
must accompany all non-gynecologic cytology specimens.
Cervical and vaginal smears must be accompanied by a SF-541,
which is specifically designed to insure
an adequate gynecologic history.
The submittal form must be completed appropriately,
and signed by the submitting physician.
The patient's name and hospital number
must appear on the form and on the specimen container.
No specimen is accessioned unless
and until this information is present.
The cytology staff will notify the clinician
when a submission error has occurred.
The cytology staff cannot correct errors
on the form or on the container.
The errors must be corrected
in person by the clinician involved.
The cytology section maintains a logbook
and file of cases that were not accessioned
because of a submission error.
The cytology section maintains
a file of cases that were not accessioned
or rejected for any reason.
Each case has documented the current date,
time, name of person spoken to,
and contents of the discussion.
The technician signs his/her name and date.
3. Specimens are accessioned into the VISTA computer system
by the cytology staff. The time of accessioning appears
on the final cytology report. An effort is made to accession all cases
on the same day they are received in the cytology laboratory,
which is open 8:00 a.m. to 4:30 p.m. Specimens arriving
after those hours or on weekends should be dropped off
to the Stat Laboratory (Room 4D-115),
where they will be refrigerated,
and accessioned when the cytology laboratory opens.
Specimens are prepared and stained
according to current guidelines.
4. Monitoring cytopathology screening activity
and 100 % re-screening policy.
Specimens are screened by a cytotechnologist trained
in all aspects of cytology (See Position Description).
The cytotechnologist renders an evaluation of each specimen.
On certain occasions, a pathologist will screen specimens.
In all instances, specimens are reviewed by a pathologist,
with the final diagnosis rendered by a pathologist.
We have a policy of re-screening 100% of specimens,
with re-screening done by a pathologist.
Re-screening may consist of a simple 30-second
scan of slide at 10x objective, or it may entail
a thorough high-power review of the slide,
depending upon the pathologist.
This technique of 100% re-screening
has been described,
and shown to be more effective than a 10% re-screen
at finding false negative Papanicolaou smears.
5. Cytotechnologist's screening competency is reviewed daily by an attending
pathologist and evaluated annually by the Chief, Anatomic Pathology.
6. Standardization of cytopathology reporting.
Gynecologic cytology specimen with
with filled-out Gynecologic Cytology Form (SF-541).
Non-gynecologic cytology specimen
with a filled-out Tissue Examination Form (SF-515).
Use of The Bethesda System 2001 Classification
(Procedure 129) for all gynecologic case reporting. Use of diagnostic
category and descriptive text for reporting non-gynecologic cases.
In the case of non-gynecologic specimens, all diagnoses must fall into one
of the following 5 categories:
NEGATIVE FOR MALIGNANT CELLS.
INCONCLUSIVE FOR MALIGNANT CELLS.
SUSPICIOUS FOR MALIGNANT CELLS.
POSITIVE FOR MALIGNANT CELLS.
UNSATISFACTORY SPECIMEN.
Except for specimens signed out as
"Negative for malignant cells,"
all diagnoses must be followed by commentary.
Cytopathology attempts to achieve uniformity
in sign-out between Cytotechologist and Pathologists.
Due to a small annual number of cytology cases,
all cervicovaginal and non-gynecologic slides
are reviewed and signed out by a pathologist.
Cytology results are not reported
until the pathologist completes the case
and releases it in the VISTA computer system.
7. Review of prior specimens and clinical-pathological correlation
Prior cytologic and surgical accessions,
and their SNOMED diagnoses, are automatically provided
to the pathologist on the preliminary VISTA accession printout.
The pathologist reviews any and all prior specimens
(cytologic and/or surgical) whose diagnosis may be
of clinical value in the interpretation of the present specimen,
or whose diagnosis is inconsistent with the diagnosis
of the present specimen. In particular,
all previously negative smears received
within the past five years and histological information
are reviewed whenever a new high-grade squamous intraepithelial lesion
(moderate or severe dysplasia, carcinoma in situ, CIN II or III)
or malignant gynecologic smear is reported.
When follow-up histological material is not available within the laboratory,
the Women's health coordinator is notified, and a request is made to obtain
follow-up histological reports for correlative review. The request is
documented as part of the report (under "Comment"). This will occur in the
instance when gynecologic cases with significantly abnormal (high-grade SIL)
or malignant cytological findings are reported. No instance of this
situation has occurred in the laboratory.
An effort is made to correlate gynecologic and non-gynecologic cytopathology
findings with available histological and clinical findings.
When any disparities exist,
which would affect current patient care,
these disparities are reconciled in the report.
When the disparities are significant,
the clinician is notified by the pathologist,
and the notification is also documented
in the issued amended (supplemental) report
and quarterly QA monitor.
8. Monthly cytopathology QA.
Monthly cytopathology QA includes monitoring of cytology
turnaround time and reviewing cytotechnologist - pathologist
screening discrepancies. A monthly report of cytology QA activities
is summarized in the monthly Laboratory QA report,
and is presented verbally at the monthly Pathology & Laboratory Medicine
Service Staff conference. The QA monthly monitors are reviewed,
to compile an annual statistical report for cytology.
9. Quarterly cytopathology QA.
Each quarter, QA conference review includes:
"Inconclusive", "Suspicious", and discrepancy cases
(cases where there was a disagreement
between cytology and surgical, cases where re-screen
resulted in reclassification, and cases where histopathology
results are unavailable to compare with malignant
or high-grade premalignant (high-grade SIL, CIN II-III,
moderate-severe dysplasia) cytopathology results.
At this time, it is determined whether additional material
was received by anatomic pathology (biopsy or cytological specimen).
Where no follow-up material was received,
an email is sent to the responsible physician
(in the case of gynecologic specimens,
an email is sent to the nurse coordinator of the Women's clinic;
in the case of urine specimens,
an email is sent to the Chief, Genitourinary Surgery section),
reminding them that no material was received
since the atypical diagnosis,
and requesting follow-up information or material.
The specimens reviewed are entered in the QA logbook
maintained by the Chief, Cytology Section,
as well as in the VISTA computer system. (QA SNOMED entry, P-030803).
10. Annual statistical reporting.
Annual report that includes the total number
of cytopathological specimens and type/sources of specimens.
Annual statistical compilation for gynecologic cases that includes:
a. Number of cases reported by diagnosis (including unsatisfactories)
(prepared from SNOMED search on M-09010, gynecologic).
b. Number of cases with significant cytological/histological
discrepancies.
c. Number of cases where re-screen resulted in reclassification
of a result as abnormal.
d. Number of cases where histopathology results are unavailable
to compare with malignant or high-grade premalignant (high-grade SIL,
CIN II-III, moderate-severe dysplasia) cytopathology results
(prepared by SNOMED search on P-030803, QA, Cytology).
e.
Number of gynecologic cases with ASCUS or SIL,
and annual ASCUS/SIL ratio.
In 2001, the annual ASCUS/SIL ratio was 2.81=146/52, for 198 cases.
In 2002, the annual ASCUS/SIL ratio was 1.21=85/70, for 155 cases,
which is around the national median.
11. Participation in the national VA Interlaboratory Comparison Program in Cervicovaginal Cytology and Non-Gynecologic Cytopathology.
12. Participation in the American Society of Clinical Pathologist
Cytopathology-VA quality assurance program.
13. Preservation of slide integrity (Procedure #128).
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1.
Baker A, Melcher D, Smith.
Role of re-screening of cervical smears in internal quality control.
J Clin Pathol. 1995; 48:1002-1004.
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Quality assurance in gynecologic cytology. What is practical?
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Accuracy of cytology diagnosis.
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College of American Pathologists.
Quality Improvement Manual in Anatomic Pathology.
Northfield, IL: CAP, 1993:61-96;
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Gatscha RM, et al. Quality Assurance:
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Medical Data Mining and Knowledge Discovery.
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