Revised: 10/06/2005
CYTOPATHOLOGY
This College of American Pathologists (CAP) Laboratory Accreditation Program (LAP) Checklist is
provided as a Microsoft® Word 2000 electronic file for convenience and for educational purposes. It
represents the fully-approved version for use in the LAP as of the date given in the header.
Newer approved versions of this Checklist may be found via the Internet at the CAP Web site
(http://www.cap.org/apps/docs/laboratory_accreditation/checklists/checklistftp.html) for both viewing
and download to your computer.
If you are currently enrolled in the CAP LAP and are preparing for an inspection, please note:
The Checklists undergo frequent revision, and the contents may have changed after you receive your
inspection packet. If a Checklist has been updated since receiving your packet, you will be inspected
based upon the Checklists that were mailed to you in your application or reapplication packet.
For questions about the use of Checklists in the inspection process, please e-mail the CAP at
accred@cap.org, or call (800) 323-4040, ext. 6065. Suggestions for content improvement should be
sent by e-mail to LAP at accred@cap.org.
All checklists are © 2005 College of American Pathologists. All rights reserved.
College of American Pathologists
Revised: 10/06/2005
OUTLINE
SUMMARY OF CHANGES
INSPECTION TECHNIQUES – KEY POINTS
GENERAL CYTOPATHOLOGY
INTERLABORATORY COMPARISONS
QUALITY MANAGEMENT
QUALITY CONTROL
PROCEDURE MANUAL
SPECIMEN COLLECTION AND RECEIPT
CYTOLOGY STAINS AND SLIDE PREPARATIONS
ON-SITE MICROSCOPIC REVIEW
INSTRUMENTS AND EQUIPMENT
RECORDS AND REPORTS
RETENTION OF SLIDES
STATISTICAL ANALYSIS
GYNECOLOGIC CYTOPATHOLOGY
NON-GYNECOLOGIC CYTOPATHOLOGY
PERSONNEL
PHYSICAL FACILITIES
LABORATORY SAFETY
CYTOPATHOLOGY
Page 2 of 54
College of American Pathologists
Revised: 10/06/2005
SUMMARY OF CHANGES
CYTOPATHOLOGY Checklist
10/6/2005 Edition
The following questions have been added, revised, or deleted in this edition of the checklist, or in the
two editions immediately previous to this one.
If this checklist was created for a reapplication, on-site inspection or self-evaluation it has been
customized based on the laboratory's activity menu. The listing below is comprehensive; therefore
some of the questions included may not appear in the customized checklist. Such questions are not
applicable to the testing performed by the laboratory.
Note: For revised checklist questions, a comparison of the previous and current text may be found on
the CAP website. Click on Laboratory Accreditation, Checklists, and then click the column marked
Changes for the particular checklist of interest.
NEW Checklist Questions
Question
CYP.07432
CYP.05316
CYP.05332
Effective Date
03/30/2005
06/01/2004
06/01/2004
REVISED Checklist Questions
Question
CYP.05257
CYP.05260
CYP.05332
CYP.05350
CYP.07100
CYP.07413
CYP.07426
CYP.08500
CYP.05271
CYP.05300
CYP.07600
CYP.07690
Effective Date
10/06/2005
10/06/2005
10/06/2005
01/27/2005
01/27/2005
01/27/2005
01/27/2005
01/27/2005
06/01/2004
06/01/2004
06/01/2004
06/01/2004
DELETED Checklist Questions
Question
CYP.05271
CYP.10000
CYTOPATHOLOGY
Effective Date
10/06/2005
06/01/2004
Page 3 of 54
College of American Pathologists
Revised: 10/06/2005
The checklists used in connection with the inspection of laboratories by the Commission
on Laboratory Accreditation (“CLA”) of the College of American Pathologists have been
created by the College and are copyrighted works of the College. The College has
authorized copying and use of the checklists by College inspectors in conducting
laboratory inspections for the CLA and by laboratories that are preparing for such
inspections. Except as permitted by section 107 of the Copyright Act, 17 U.S.C. sec.
107, any other use of the checklists constitutes infringement of the College’s copyrights
in the checklists. The College will take appropriate legal action to protect these
copyrights.
IMPORTANT: The contents of the Laboratory General Checklist are applicable to the
Cytopathology section of the laboratory.
****************************************************************
INSPECTION TECHNIQUES – KEY POINTS
****************************************************************
I. READ – OBSERVE – ASK – the three methods of eliciting information during the inspection
process. These three methods may be used throughout the day in no particular order. Plan the
inspection in a way that allows adequate time for all three components.
READ = Review of Records and Documents
Document review verifies that procedures and manuals are complete, current, available to staff,
accurate and reviewed, and describe good laboratory practice. Make notes of any questions you may
have, or processes you would like to observe as you read the documentation. In reviewing records of
quality control, instrument maintenance, documentation of rescreening of gynecological cytology
cases, cytology-histology correlation, and other activities, select records from various times during the
two-year interval since the previous on-site inspection.
OBSERVE – ASK = Direct Observation and Asking Questions
Observing and asking questions accomplish the following:
1. Verifies that the actual practice matches the written policy or procedure
2. Ensures that the laboratory processes are appropriate for the testing performed
3. Ensures that outcomes for any problem areas, such as issues/problems identified through the
quality management process, have been adequately investigated and resolved
4. Ensures that previous deficiencies have been corrected
Use the following techniques:
 Observe laboratory practices – look at what the laboratory is actually doing. Compare the
written policy/procedure to what you actually observe in the laboratory to ensure the written
policy/procedure accurately reflects laboratory practice. Note if practice deviates from the
documented policies/procedures. Observe activities in the specimen preparation area, to determine
whether specimen identity is maintained throughout all the processing steps that result in the
preparation of microscopic slides, and to determine if personnel follow written procedures.
CYTOPATHOLOGY
Page 4 of 54
College of American Pathologists

Revised: 10/06/2005
Ask open ended, probing questions – these are starting points that will allow you to obtain large
amounts of information, and help you clarify your understanding of the documentation you’ve seen
and observations you’ve made. This eliminates the need to ask every single checklist question, as
the dialogue between you and the laboratory may address multiple checklist questions.

Ask open-ended questions that start with phrases such as “show me how…” or “tell me about
…” or “what would you do if…”. By asking questions that are open-ended, or by posing a
hypothetical problem, you will avoid “cookbook” answers. For example, ask “Could you show
me the specimen labeling policy and how it ensures accurate identification of the specimen
throughout processing and reporting?” This will help you to determine how well the technical
staff is trained, whether or not they are adhering to the laboratory’s procedures and policies,
and give you a feel for the general level of performance of the laboratory.

Ask follow-up questions for clarification. Generally, it is best not to ask the checklist questions
verbatim. For example, instead of asking the checklist question “Is there documentation of
corrective action when an unlabeled specimen is received?” ask, “What would you do if an
unlabeled specimen is received?” A follow-up probing question could be, “What would you do
if there were repeated instances of unlabeled specimens from the same source?”
II. PT problem resolution verification: From the inspector’s packet, review the Variant PT
Performance Report that identifies, by analyte, all of the PT scores below 100%. Check to see how
problems were resolved. Check to see whether PT performance was used in the biannual evaluation of
screening personnel. Be thorough when reviewing these representative records, selecting data from the
beginning, middle and end of the period since the last on-site inspection.
III. Review correction of previous deficiencies: Review the list of deficiencies from the previous
on-site inspection provided in the inspector’s packet. Ensure that they have been appropriately
addressed.
##############################################################################
GENERAL CYTOPATHOLOGY
##############################################################################
This Checklist is intended for laboratories that perform on-site preparation and/or interpretation of
cytologic specimens. These include GYNECOLOGIC (cervicovaginal), and/or NON-GYNECOLOGIC
(exfoliated specimens from other sites, fluids, and aspirates) cytopathology. If the laboratory does
NOT perform any on-site examination of cytopathology specimens, but refers all submitted material to
an outside laboratory, do NOT use this Checklist. Do NOT use this Checklist if the laboratory's
involvement in cytopathology is limited to filing of reports and/or slides.
Cytopathology Inspectors should be pathologists or cytotechnologists who are actively involved with
or have extensive experience in the practice of cytology, and are knowledgeable about current CAP
Checklist and CLIA-88 requirements. Inspectors preferably should have attended a recent CAP
CYTOPATHOLOGY
Page 5 of 54
College of American Pathologists
Revised: 10/06/2005
Inspector Training Workshop, and be familiar with the CAP Quality Improvement Manual in Anatomic
Pathology.
Regardless of the size of the laboratory, the Inspector should spend at least several hours inspecting
the cytopathology laboratory. The on-site inspection will require documented review of case (slide)
material, direct observation of technical procedures, and careful review of quality management
monitors.
*****************************************************************
INTERLABORATORY COMPARISONS
*****************************************************************
NOTE: Interlaboratory comparison programs in cytopathology provide valuable educational
opportunities for peer performance comparisons in both technical and diagnostic arenas. While not
an exact emulation of clinical laboratory practice involving the preparation and interpretation of
cytopathology case material, these programs can be useful to benchmark laboratory performance
against national peer-based data. Participation in GYNECOLOGIC interlaboratory programs is
required (Phase II), while participation in NON-GYNECOLOGIC programs is encouraged (Phase I).
CYP.00750
Phase I
N/A YES NO
Do all personnel involved in cytopathologic interpretations participate in an appropriate
interlaboratory comparison program?
NOTE: The exact manner in which this is accomplished is the responsibility of the director, and does
not require reporting of each individual's interpretations to external interlaboratory comparison
programs. As with all aspects of laboratory performance, the director is responsible for documenting
competency of personnel.
COMMENTARY:
All personnel involved in cytopathologic interpretations should participate in an appropriate
interlaboratory comparison program. The exact manner in which this is accomplished is the
responsibility of the director, and does not require reporting of each individual's interpretations to
external interlaboratory comparison programs. As with all aspects of laboratory performance, the
director is responsible for documenting competency of personnel.
*****************************************************************
QUALITY MANAGEMENT
*****************************************************************
CYTOPATHOLOGY
Page 6 of 54
College of American Pathologists
Revised: 10/06/2005
The laboratory must have a clearly defined, documented QM program that includes active surveillance
of laboratory activities. Evaluation of the results of surveillance must be documented. Surveillance
monitors may differ among laboratories. The QM program must ensure quality throughout the preanalytic, analytic and post-analytic (reporting) phases of testing, including specimen identification,
preservation, transportation, and processing; and accurate, timely result reporting. The program must
be capable of detecting problems in the laboratory’s systems, and identifying opportunities for system
improvement. The laboratory must be able to develop plans of corrective/preventive action based on
data from its QM system.
Technical and procedural quality control items are integral components of comprehensive quality
management and should be included within the program.
Quality management in cytopathology should address both negative and abnormal/positive cases. The
program must include both rescreening and hierarchic case review, as well as correlation of
cytological and available histological material. In addition, the laboratory should participate in
interlaboratory comparison, self-assessment and performance improvement programs. There must be
records of intra- and extra-departmental consultation, as appropriate. Results of QM surveillance
should be shared with the responsible pathologist(s) and cytotechnologist(s).
CYP.00800
Phase II
N/A YES NO
Is there a clearly defined and documented quality management program in cytopathology?
NOTE: Laboratories should consistently review activities and monitor their effectiveness in improving
performance. Each laboratory should design a program that meets its needs and conforms to
appropriate regulatory and accreditation standards.
COMMENTARY:
N/A
REFERENCES: 1) Inhorn SL, et al. Quality assurance programs to meet CLIA requirements. Diagn
Cytopathol. 1994;11:195-200; 2) Gatscha RM, et al. Quality assurance: insight into a laboratory's
performance. Lab Med. 1994;25:258; 3) Joste NE, et al. Cytologic/histologic correlation for quality
control in cervicovaginal cytology. Experience with 1,582 paired cases. Am J Clin Pathol.
1995;103:32-34; 4) Abt AB, et al. The effect of interinstitution anatomic pathology consultation on
patient care. Arch Pathol Lab Med. 1995;119:514-517; 5) Jones BA. Rescreening in gynecologic
cytology. Rescreening of 8096 previous cases for current low-grade and indeterminate-grade squamous
intraepithelial lesion diagnoses - a College of American Pathologists Q-Probes study of 323
laboratories. Arch Pathol Lab Med. 1996;120:519-522; 6) Jones BA, Novis DA. Cervical biopsycytology correlation. A College of American Pathologists Q-Probes study of 22439 correlations in 348
laboratories. Arch Pathol Lab Med. 1996;120:523-531; 7) Kline TS. The challenge of quality
improvement with the Papanicolaou smear. Arch Pathol Lab Med. 1997;121:253-255; 8) Receiver
operating characteristic curves for analysis of the results of cervicovaginal smears. A useful quality
improvement tool. Arch Pathol Lab Med. 1997;121:968-975; 9) Renshaw AA, et al. Performance
CYTOPATHOLOGY
Page 7 of 54
College of American Pathologists
Revised: 10/06/2005
characteristics of rapid (30-second) prescreening. Implications for calculating the false-negative rate
and comparison with other quality assurance techniques. Am J Clin Pathol. 1999;111:517-522; 10)
Intersociety Working Group for Cytology Technologies. Proposed method for evaluating secondary
screening (rescreening) instruments for gynecologic cytology. Am J Clin Pathol. 1999;111:590-593;
11) Raab SS, et al. Cost effectiveness of rescreening cervicovaginal smears. Am J Clin Pathol.
1999;111:601-609; 12) Cibas, ES, et al. Quality assurance in gynecologic cytology: the value of
cytotechnologist-cytopathologist discrepancy logs. Am J Clin Pathol. 2001;115:512-516; 13) Triol JL,
Goodell RM. ASCT Cytopathology quality assurance guide. Raleigh, NC: American Society for
Cytotechnology. 2001; 14) American Society of Cytopathology. Cervical cytology practice guidelines.
Acta Cytol. 2001;45:201-226; 15) Clary KM, et al. Cytohistologic discrepancies. A means to improve
pathology practice and patient outcomes. Am J Clin Pathol. 2002;117:567-573; 16) Nakhleh RE,
Fitzgibbons PL, eds. Quality management in anatomic pathology. Promoting patient safety through
systems improvement and error reduction. Northfield, IL: College of American Pathologists, 2005;
17) Persoon TJ, et al. Improving Pap test turnaround time using external benchmark data and
engineering process improvement tools. Am J Clin Pathol. 2002;118:527-533; 18) Department of
Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory
improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3706 [42CFR493.1249];
19) Ibid, 3713[42CFR493.1299].
CYP.00900
Phase II
N/A YES NO
Are records of the results of quality management surveillance maintained?
COMMENTARY:
Documented records of the results of quality management surveillance must be maintained.
CYP.01900
Phase II
N/A YES NO
If significant disparities exist between histological and cytological findings, are these resolved in
a confidential peer-reviewed quality management document, or in an addendum report, as
appropriate?
COMMENTARY:
Disparities between histological and cytological findings must be resolved in a confidential peerreviewed quality management document, or in an addendum report, as appropriate.
CYP.02100
Phase II
N/A YES NO
Are documented records of intra- and extradepartmental consultations maintained?
COMMENTARY:
CYTOPATHOLOGY
Page 8 of 54
College of American Pathologists
Revised: 10/06/2005
Documented records of intra- and extradepartmental consultations must be maintained.
REFERENCE: Abt AB, et al. The effect of interinstitution anatomic pathology consultation on patient
care. Arch Pathol Lab Med. 1995;119:514-517.
CYP.02200
Phase II
N/A YES NO
Is there documented evidence of daily review of the technical quality of cytologic preparations by
the pathologist or supervisory-level cytotechnologist?
COMMENTARY:
The technical quality of cytologic preparations must be reviewed daily by the pathologist or
supervisory-level technologist.
*****************************************************************
QUALITY CONTROL
*****************************************************************
----------------------------------------------------------------PROCEDURE MANUAL
----------------------------------------------------------------The procedure manual should be available to, and used by, personnel at the workbench and should
include, as appropriate: test principle, clinical significance, specimen type, required reagents, test
calibration, quality control, procedural steps, and interpretation of results. The manual should
include pre-analytic, analytic, and post-analytic activities. The specific style and format of procedure
manuals are at the discretion of the laboratory director.
The inspection team should review the procedure manual in detail to understand the laboratory's
standard operating procedures, ensure that all significant information and instructions are included,
and that actual practice matches the contents of the procedure manuals.
CYP.02300
Phase II
N/A YES NO
Is a complete procedure manual available at the workbench or in the work area?
NOTE 1: The use of inserts provided by manufacturers is not acceptable in place of a
procedure manual. However, these inserts may be used as part of a procedure description, if
the insert accurately and precisely describes the procedure as performed in the laboratory.
CYTOPATHOLOGY
Page 9 of 54
College of American Pathologists
Revised: 10/06/2005
Any variation from this printed procedure must be detailed in the procedure manual. In all
cases, appropriate reviews must occur.
NOTE 2: A manufacturer's procedure manual for an instrument reagent system may be
acceptable as a component of departmental procedures. Any modification to or deviation from
the procedure manual must be clearly documented.
NOTE 3: Card files or similar systems that summarize key information are acceptable for use
as quick reference at the workbench provided that:
a.
b.
A complete manual is available for reference
The card file or similar system corresponds to the complete manual and is subject to
document control
NOTE 4: Electronic (computerized) manuals are fully acceptable. There is no requirement for
paper copies to be available for the routine operation of the laboratory, so long as the
electronic versions are readily available to all personnel. Such electronic versions must be
subjected to proper document control (i.e., only authorized persons may make changes,
changes are dated/signed (manual or electronic), and there is documentation of periodic
review). Current paper copies of electronically stored procedures should be available at the
time of the CAP inspection, or rapidly generated at the request of the Inspector.
COMMENTARY:
A documented procedure manual must be developed for the cytopathology section of the laboratory
and be available at the workbench. Its elements should include, as appropriate: test principle, clinical
significance, specimen type(s), required reagents, calibration, quality control, procedural steps,
calculations, and interpretation, as applicable.
NOTE 1: The use of inserts provided by manufacturers is not acceptable in place of a
procedure manual. However, such inserts may be used as part of a procedure description, if the
insert accurately and precisely describes the procedure as performed in the laboratory. Any
variation from this printed procedure must be detailed in the procedure manual. In all cases,
appropriate reviews must occur.
NOTE 2: a manufacturer's procedure manual for an instrument/reagent system may be
acceptable as a component of the overall departmental procedures. Any modification to, or
deviation from the procedure manual must be clearly documented.
NOTE 3: card files or similar systems that summarize key information are acceptable for use
as quick reference at the workbench provided that:
a.
b.
A complete manual is available for reference
The card files or similar systems correspond to the complete manual and is subject to
document control
CYTOPATHOLOGY
Page 10 of 54
College of American Pathologists
Revised: 10/06/2005
NOTE 4: Electronic (computerized) manuals are fully acceptable. There is no requirement for
paper copies to be available for the routine operation of the laboratory, so long as the electronic
versions are readily available to all personnel. Such electronic versions must be subjected to
proper document control (i.e., only authorized persons may make changes, changes are
dated/signed (manual or electronic), and there is documentation of periodic review). Current
paper copies of electronically stored procedures should be available at the time of the CAP
inspection, or rapidly generated at the request of the Inspector.
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7164 [42CFR493.1251]; 2) Van Leeuwen AM. 6 steps to building an efficiency tool.
Advance/Laboratory. 1999:8(6):88-91; 3) NCCLS. Clinical laboratory technical procedure manuals fourth edition; approved guideline GP2-A4. Wayne, PA: NCCLS, 2002.
CYP.02500
Phase II
N/A YES NO
Is there documentation of at least annual review of all policies and procedures in the
cytopathology laboratory section by the current laboratory director or designee?
NOTE: The director must ensure that the collection of policies and technical protocols is complete,
current, and has been thoroughly reviewed by a knowledgeable person. Technical approaches must be
scientifically valid and clinically relevant. To minimize the burden on the laboratory and reviewer(s),
it is suggested that a schedule be developed whereby roughly 1/12 of all procedures are reviewed
monthly. Paper/electronic signature review must be at the level of each procedure, or as multiple
signatures on a listing of named procedures. A single signature on a title page or index of all
procedures is not sufficient documentation that each procedure has been carefully reviewed.
Signature or initials on each page of a procedure is not required.
COMMENTARY:
There must be documentation of at least annual review of all policies and procedures in the
cytopathology laboratory by the current laboratory director or designee. The director is responsible for
ensuring that the collection of technical protocols is complete, current, and has been thoroughly
reviewed by a knowledgeable person. Technical approaches must be scientifically valid and clinically
relevant. To minimize the burden on the laboratory and reviewer(s), it is suggested that a schedule be
developed whereby roughly 1/12 of all procedures are reviewed monthly. Paper/electronic signature
review must be at the level of each procedure, or as multiple signatures on a listing of named
procedures. A single signature on a title page or index of all procedures is not sufficient
documentation that each procedure has been carefully reviewed. Signature or initials on each page of a
procedure is not required.
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb
28):7173 [42CFR493.1407(e)(13)].
CYTOPATHOLOGY
Page 11 of 54
College of American Pathologists
CYP.02550
Phase II
Revised: 10/06/2005
N/A YES NO
Does the director or designee review and approve all new policies and procedures, as well as
substantial changes to existing documents, before implementation?
NOTE: Current practice must match the policy and procedure documents.
COMMENTARY:
The director or designee must review and approve all new policies and procedures, as well as
substantial changes to existing documents before implementation. Current practice must match these
documents.
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7164 [42CFR493.1251(d)].
CYP.02600
Phase II
N/A YES NO
If there is a change in directorship, does the new director ensure (over a reasonable period of
time) that laboratory procedures are well-documented and undergo at least annual review?
COMMENTARY:
If there is a change in directorship of the laboratory, the new director must ensure (over a reasonable
period of time) that all cytopathology laboratory procedures are well-documented and undergo at least
annual review.
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7164 [42CFR493.1251(d)].
CYP.02700
Phase II
N/A YES NO
When a procedure is discontinued, is a paper or electronic copy maintained for at least 2 years,
recording initial date of use, and retirement date?
COMMENTARY:
A paper or electronic copy of a discontinued procedure must be maintained for at least 2 years,
recording initial date of use, and retirement date.
CYTOPATHOLOGY
Page 12 of 54
College of American Pathologists
Revised: 10/06/2005
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7164 [42CFR493. 1105(a)(2); 493.1251(e)].
CYP.02800
Phase II
N/A YES NO
Does the laboratory have a system documenting that all personnel are knowledgeable about the
contents of procedure manuals relevant to the scope of their testing activities?
NOTE: This does not specifically require annual procedure sign-off by testing personnel. The form of
this system is at the discretion of the laboratory director.
COMMENTARY:
The laboratory must have a system documenting that all personnel are knowledgeable about the
contents of procedure manuals relevant to the scope of their testing activities. This does not
specifically require annual procedure sign-off by testing personnel. The form of this system is at the
discretion of the laboratory director.
----------------------------------------------------------------SPECIMEN COLLECTION AND RECEIPT
-----------------------------------------------------------------
CYP.02900
Phase II
N/A YES NO
Are instructions distributed to physicians and paramedical personnel for proper collection,
handling, transportation, and preparation of cytologic specimens?
NOTE: These requirements apply even if the specimens are not accessioned, stained, interpreted,
and/or reported in the institution being inspected. Instructions should be documented for all
applicable cytologic specimens, including Pap tests, sputum, washings, brushings, body fluids, fine
needle aspirations, etc. These instructions must be included in the procedure or user manuals at all
sites where specimens are collected (e.g., nursing stations, clinics, physicians’ offices).
COMMENTARY:
Complete written or electronic instructions must be available for the proper collection, handling, and
transportation of all types of cytologic specimens, as well as preparation of slides for cytologic
examination. Such instructions must be distributed to persons responsible for specimen collection.
REFERENCES: 1) Guidelines of the Papanicolaou Society for Cytopathology for the examination of
fine needle aspiration specimens from thyroid nodules. Diag Cytopathol. 1996;15:84-89; 2) MartinHirsh P, et al. Efficacy of cervical-smear collection devices: a systematic review and meta-analysis.
CYTOPATHOLOGY
Page 13 of 54
College of American Pathologists
Revised: 10/06/2005
Lancet. 1999;354:1763-1770; 3) Diaz-Rosario L, Kabawat SE. Performance of a fluid-based, thinlayer Papanicolaou smear method in the clinical setting of an independent laboratory and an outpatient
screening population in New England. Arch Pathol Lab Med. 1999;123:807-821; 4) NCCLS.
Papanicolaou technique; approved guideline GP15-A2. Wayne, PA: NCCLS, 2001; 5) American
Society of Cytopathology. Cervical cytology practice guidelines. Acta Cytol. 2001;45:201-226; 6)
Guidelines of the Papanicolaou Society of Cytopathology for the examination of cytologic specimens
obtained from the respiratory tract. Modern Pathol.1999;12:427-436.
CYP.03000
Phase II
N/A YES NO
Do the instructions include the preferred method for preparation of slides (proper fixation of
slides and labeling of slides and containers)?
COMMENTARY:
Instructions must include the preferred method of preparation, fixation, and labeling of slides.
CYP.03300
Phase II
N/A YES NO
Are all specimens properly and adequately identified (i.e., patient's name or other unique and
complete identifier on slide or specimen container)?
COMMENTARY:
Specimens must be adequately identified, whether received as slides or in a container of liquid.
Inadequately identified specimens must not be accepted by the laboratory.
CYP.03400
Phase II
N/A YES NO
Does the cytopathology requisition include space for the name of the patient, the date of birth or
age, the sex, the date of specimen collection, the source of the cytologic material, the submitting
physician's name, and pertinent clinical information?
NOTE: For gynecologic specimens, specific clinical information such as date of last menstrual period,
hormone therapy, previous Pap test results, etc. are important data.
COMMENTARY:
The cytopathology requisition form must include space for the following: name of the patient, the date
of birth or age, the sex, the date of specimen collection, the source of the cytologic material, the
submitting physician's name, and pertinent clinical information. For gynecologic specimens, date of
last menstrual period, hormone therapy, previous Pap results, etc. are also important data.
CYTOPATHOLOGY
Page 14 of 54
College of American Pathologists
Revised: 10/06/2005
REFERENCE: NCCLS. Papanicolaou technique; approved guideline GP15-A2. Wayne, PA: NCCLS,
2001.
CYP.03500
Phase II
N/A YES NO
Are specimens recorded in an accession book, computer, or other comparable record and given
an accession number upon receipt?
COMMENTARY:
All specimens must be recorded in an accession book, computer, or other comparable record and be
given an accession number.
CYP.03600
Phase II
N/A YES NO
Does the laboratory have a policy that specimens are accepted only from physicians or other
persons authorized under law?
COMMENTARY:
The laboratory must have a policy specifying that specimens are only accepted from physicians or
other persons authorized under law.
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7162 [42CFR493.1241(c)(1)].
CYP.03700
Phase II
N/A YES NO
Are there documented criteria for rejection of specimens (e.g., inadequate requisition
information, unauthorized source, broken slides)?
COMMENTARY:
Criteria must be developed for unacceptable specimens such as lack of requisition information,
unauthorized source, broken slides, etc.
CYP.03800
Phase II
N/A YES NO
Is there evidence that submitting physicians are notified when unacceptable specimens are
received?
CYTOPATHOLOGY
Page 15 of 54
College of American Pathologists
Revised: 10/06/2005
NOTE: Notification may consist of follow-up correspondence, documented telephone calls, or written
reports.
COMMENTARY:
Because the quality of specimens received and processed by the laboratory greatly affects
interpretation, the laboratory must document that the submitting physician has been notified when
unacceptable specimens are received. Such notification may consist of follow-up correspondence,
documentation of telephone calls, or written reports.
REFERENCES: 1) Nakhleh RE, Fitzgibbons PL, eds. Quality management in anatomic pathology.
Promoting patient safety through systems improvement and error reduction. Northfield, IL: College of
American Pathologists, 2005; 2) Solomon D, et al. The 2001 Bethesda system. Terminology for
reporting results of cervical cytology. JAMA. 2002:287:2114-2119; 3) Solomon D, Nayar, R, eds. The
Bethesda system for reporting cervical/vaginal ctyologic diagnoses: Definitions, criteria, and
explanatory notes for terminology and specimen adequacy. New York, NY: Springer-Verlag; 2nd
edition, 2004.
----------------------------------------------------------------CYTOLOGY STAINS AND SLIDE PREPARATIONS
-----------------------------------------------------------------
CYP.03900
Phase II
N/A YES NO
Are all working solutions and stains properly labeled?
NOTE: Working solutions and stains must be properly labeled with the contents, and, if applicable,
expiration date and/or date changed/filtered.
COMMENTARY:
N/A
CYP.03925
Phase I
N/A YES NO
Are cytology stains assessed at least annually to ensure their proper storage and acceptable
quality?
NOTE: Most stains used in the cytology laboratory are not subject to outdating, so that assignment of
expiration dates may have no meaning. The acceptable performance of such stains should be
periodically confirmed by technical assessment on actual case material, and as part of the evaluation
of cytopathology cases. Where applicable, expiration dates assigned by a manufacturer must be
observed.
CYTOPATHOLOGY
Page 16 of 54
College of American Pathologists
Revised: 10/06/2005
COMMENTARY:
Cytochemical stains should be inventoried at least annually to ensure their proper storage and
acceptable quality.
CYP.04050
Phase II
N/A YES NO
Are all reagents stored as recommended by the manufacturer?
NOTE: Reagents must be stored as recommended by the manufacturer in order to prevent
environmentally-induced alterations that could affect test performance. If ambient storage
temperature is indicated, there must be documentation that the defined ambient temperature is
maintained and corrective action is taken when tolerance limits are exceeded.
COMMENTARY:
N/A
CYP.04070
Phase II
N/A YES NO
Are all reagents used within their indicated expiration date?
COMMENTARY:
Reagents must not be used beyond their stated or assigned expiration date.
CYP.04100
Phase II
N/A YES NO
Are staining solutions filtered or replaced regularly?
COMMENTARY:
All staining solutions must be filtered or replaced regularly.
CYP.04200
Phase I
N/A YES NO
Are staining solutions covered when not in use, and changed periodically?
COMMENTARY:
Solutions should be covered when not in use, and changed periodically.
CYTOPATHOLOGY
Page 17 of 54
College of American Pathologists
CYP.04300
Phase II
Revised: 10/06/2005
N/A YES NO
Are all stains checked for predicted staining characteristics each day of use?
COMMENTARY:
Stains must be checked each day of use to ensure predictable staining characteristics.
CYP.04700
Phase II
N/A YES NO
Are slides adequately labeled?
COMMENTARY:
Slides must be adequately labeled.
----------------------------------------------------------------ON-SITE MICROSCOPIC REVIEW
----------------------------------------------------------------On-site review of actual case (slide) material and corresponding reports is an important element of the
inspection process. This is NOT a comprehensive rescreening of slides or evaluation of competency,
but rather an effort to facilitate the Inspector's evaluation of the laboratory's overall procedures.
Although the case selection method may vary among Inspectors, the following suggestions have been
offered by members of the CAP Cytopathology Resource Committee, and endorsed by the Commission
on Laboratory Accreditation. Cases should be selected from a variety of diagnostic categories. Time
should be allotted to review at least 10-15 cases. The Inspector should choose several randomly
selected negatives as well as cases from unsatisfactory, reactive, low-grade and high-grade
intraepithelial lesions, atypical squamous cells (ASC), and positive for malignancy categories, as well
as cases from non-gynecologic sources. Cases should be selected in advance of the inspection by the
laboratory pathologist and/or cytopathology supervisor in a random manner that may be defined by
the inspecting Team Leader (e.g., the first 1-3 negative and abnormal cases in each specimen category
from a certain date or week). The following are core elements of the on-site review:
1.
2.
3.
4.
Slides should be evaluated for quality of technical preparation as well as specimen
adequacy.
Have significant cells been identified?
Slides should be compared with the diagnostic report for completeness and clarity of
diagnostic terminology.
Is the information provided with the requisition and included in the diagnostic report
complete and appropriate?
CYTOPATHOLOGY
Page 18 of 54
College of American Pathologists
5.
Revised: 10/06/2005
The specimen type and diagnostic categories of the actual cases reviewed (not the case
ID number) should be recorded in the Inspector's Summation Report. Record the
number of cases reviewed (not the pathology numbers) in Part B. If, during the on-site
review, there is believed to be a significant diagnostic discrepancy, this should be
discussed by the pathologist team leader with the laboratory director.
NOTE: Interpretations may be considered discrepant if they are not in the same series
of the Diagnostic Menu of the CAP PAP Program (e.g., "100 series" vs "200 series"),
or comparable major diagnostic classifications in an approved non-CAP program.
Cases considered to be "ASC/AGC" (either by the Inspector or inspectee) should not be
included in the analysis to determine significant discrepancies, because of the current
lack of interlaboratory reproducibility of these interpretations.
CYP.04900
Phase II
N/A YES NO
Is cellular and nuclear detail sufficient for proper interpretation?
COMMENTARY:
Cellular and nuclear material must be properly defined for proper interpretation.
CYP.05000
Phase II
N/A YES NO
Were the findings from the above on-site slide review free of any issues or any significant
diagnostic discrepancies as defined in the above note?
NOTE: If "NO," describe in the Inspector's Summation Report.
COMMENTARY:
The Inspector has identified issues of concern for the cytopathology laboratory's overall performance
during the on-site slide review.
----------------------------------------------------------------INSTRUMENTS AND EQUIPMENT
----------------------------------------------------------------A variety of instruments and equipment are used to support the performance of analytical procedures.
All instruments and equipment should be properly operated, maintained, serviced, and monitored to
ensure that malfunctions of these instruments and equipment do not adversely affect the analytical
results. The inspection team should review the procedures for instrument/equipment operations,
maintenance, and monitoring records to ensure that these devices are properly used. The procedures
CYTOPATHOLOGY
Page 19 of 54
College of American Pathologists
Revised: 10/06/2005
and schedules for instrument maintenance must be as thorough and as frequent as specified by the
manufacturer.
CYP.05100
Phase II
N/A YES NO
Is all equipment used on a routine maintenance schedule?
COMMENTARY:
All instruments and equipment must be on a routine maintenance schedule.
REFERENCE: Department of Health and Human Services, Health Care Financing
Administration. Clinical laboratory improvement amendments of 1988; final rule. Fed Register.
2003(Jan 24):3707 [42 CFR493.1254].
CYP.05200
Phase II
N/A YES NO
Are instrument maintenance, service and repair records (or copies) promptly available to, and
usable by, the technical staff operating the equipment?
NOTE: The effective utilization of instruments by the technical staff depends upon the prompt
availability of maintenance, repair, and service documentation (copies are acceptable). Laboratory
personnel are responsible for the reliability and proper function of their instruments and must have
access to this information. Off-site storage, such as with centralized medical maintenance or computer
files, is not precluded if the inspector is satisfied that the records can be promptly retrieved.
COMMENTARY:
N/A
**REVISED**
CYP.05257
10/06/2005
Phase II
N/A YES NO
Is there documentation of adherence to the manufacturer’s recommended protocol(s) for
implementation and validation of new instruments?
NOTE: Before implementing use of new gynecologic liquid-based methods and instruments,
automated preparations, and automated screening instruments, the laboratory must validate and
document the functioning of the instrument in its own specific laboratory environment, including the
capability of the instrument to replace existing procedure(s), if applicable. If the manufacturer does
not provide validation and instrument monitoring recommendations, the laboratory must document the
specific validation procedure used.
CYTOPATHOLOGY
Page 20 of 54
College of American Pathologists
Revised: 10/06/2005
COMMENTARY:
N/A
REFERENCES: 1) Chang AR, et al. Can technology expedite the cervical cancer screening process? A
Hong Kong experience using the AutoPap Primary Screening System with location-guided screening
capability. Am J Clin Pathol. 2002; 117:399-437-443; 2) Wilbur DC, et al. Location-guided screening
of liquid-based cervical cytology specimens. A potential improvement in accuracy and productivity is
demonstrated in a preclinical feasibility trial. Am J Clin Pathol. 2002; 118:399-407; 3) Department of
Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory
improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3707 [42 CFR493.1253,
493.1255, and 493.1274(g)].
**REVISED**
CYP.05260
10/06/2005
Phase II
N/A YES NO
Is there documentation of ongoing monitoring of instrument maintenance and function for all
devices?
NOTE: There must be documentation of ongoing monitoring of instrument function and maintenance
records on all devices. Monitoring of device operation must be in accordance with manufacturers’
instructions. If the manufacturer does not provide monitoring recommendations, the laboratory must
document the specific monitoring procedures used. Limits of acceptable variation must be defined in
laboratory procedures.
A sample of slides from slide preparation instruments, including those using liquid-based technology
and cytocentrifuge or filtration methods, should be routinely reviewed microscopically for technical
acceptability.
COMMENTARY:
N/A
CYP.05264
Phase II
N/A YES NO
Is there documentation of appropriate technical and interpretive training for each of the
instruments used?
NOTE: Before the implementation of any automated instrument procedure, staff must receive
appropriate training with documented competency. In particular, liquid-based preparation techniques
and high-resolution image analysis techniques require both technical and interpretive training by
CYTOPATHOLOGY
Page 21 of 54
College of American Pathologists
Revised: 10/06/2005
formal external training programs or internal laboratory programs provided by personnel with
documented competence.
COMMENTARY:
There must be documentation of appropriate technical and interpretive training for each of the
instruments used for automated gynecologic liquid-based methods and screening instruments. Before
the implementation of any automated instrument procedure, staff must receive appropriate training
with documented competency. In particular, liquid-based preparation techniques and high-resolution
image analysis techniques require both technical and interpretive training by formal external training
programs or internal laboratory programs provided by personnel with documented competence.
CYP.05278
Phase II
N/A YES NO
If tolerance limits for diagnostic accuracy or determination of specimen adequacy are exceeded,
is there documentation of corrective action?
NOTE: Daily review of all automated slide analysis print summaries by the cytology supervisor or
designee is suggested as a means of conducting ongoing monitoring. Ongoing monitoring must be
frequent enough to minimize adverse reporting. If tolerance limits for correlation of manual review
and automated results are not met, as defined by laboratory policy, corrective action per
manufacturer's recommendations must be documented.
COMMENTARY:
If tolerance limits for diagnostic accuracy or determination of specimen adequacy are exceeded,
records must show evidence of corrective action.
CYP.05285
Phase II
N/A YES NO
Is there a documented procedure for handling workload during instrument failure and/or
downtime?
NOTE: This procedure must address: (a) final processing and resulting of any cases/specimens that
are within the instrument at the time of failure, and (b) alternative procedures to be used during
instrument downtime.
COMMENTARY:
The laboratory must define how it handles workload during instrument failure and/or downtime. This
procedure must address: (a) final processing and resulting of any cases/specimens that are within the
instrument at the time of failure, and (b) alternative procedures to be used during instrument downtime.
CYTOPATHOLOGY
Page 22 of 54
College of American Pathologists
Revised: 10/06/2005
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):3712 [42 CFR493.1282(b)(2)].
CYP.05292
Phase II
N/A YES NO
Is there a defined system to handle slides that are not successfully processed by the instrument?
NOTE: Laboratories must clearly identify slides that fail screening by an automated instrument and
ensure that these slides are completely rescreened by another method. In most instances, manual
rescreening will be used.
COMMENTARY:
A system must be defined to handle slides that are not successfully processed by the instrument.
Laboratories must clearly identify slides that fail screening by an automated instrument for technical or
staining reasons, and ensure that these slides are completely manually rescreened.
----------------------------------------------------------------RECORDS AND REPORTS
-----------------------------------------------------------------
**REVISED**
CYP.05300
06/01/2004
Phase II
N/A YES NO
Does the cytopathology report include all of the following required elements?
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Name of patient and unique identifying number, if available
Age and/or birth date of patient
Accession number
Name of physician and/or clinic
Name of the responsible reviewing pathologist, when applicable
Name and address of the laboratory location where the test was performed
Date of report
Test performed
Anatomic source and/or type of specimen
Basis for correction/amendment (if applicable)
NOTE: Refer to CYP.05316 below for additional details regarding the reviewing pathologist.
COMMENTARY:
CYTOPATHOLOGY
Page 23 of 54
College of American Pathologists
Revised: 10/06/2005
N/A
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):3711 [42CFR493.1274(e)(6); 2) Department of Health and Human Services, Centers for Medicare
and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed
Register. 2003(Jan 24):3713 [42CFR493.1291(c)(1-6) and (k)(1,2)].
**NEW**
CYP.05316
06/01/2004
Phase II
N/A YES NO
Does the cytopathology report clearly indicate the name of the pathologist who has reviewed the
slides, when applicable?
NOTE: The records must indicate those who have reviewed the cytology slides. Cytotechnologists
should be identifiable by name, initials, or other identifier in laboratory records. When a pathologist
has reviewed the slides, the report must indicate his/her name, initials or signature (in written or
electronic form). The reviewing pathologist’s name must be distinct from any other pathologist names
(e.g., the laboratory director) on the report. Electronic signatures must be authorized for each case by
the pathologist who performed the review. No pathologist or cytotechnologist reviewer’s signature or
initials may be present unless the individual personally examined the slides from the case, including
those cases released through automated screening instruments.
COMMENTARY:
N/A
**NEW**
**REVISED**
CYP.05332
06/01/2004
10/06/2005
Phase II
N/A YES NO
Are cytopathology reports reviewed and signed by the pathologist, when applicable?
NOTE: For gynecologic cases reviewed by a pathologist, and for all non-gynecologic cases, the
laboratory must ensure and document that the reviewing pathologist has reviewed and approved the
completed report before release. In the occasional situation when the diagnosing pathologist is not
available for timely review and approval of the completed report, the laboratory may have a policy
and procedure for review and approval of that report by another pathologist. In that circumstance, the
names and responsibilities of both the pathologist who made the diagnosis and the pathologist who
performs final verification must appear on the report.
COMMENTARY:
CYTOPATHOLOGY
Page 24 of 54
College of American Pathologists
Revised: 10/06/2005
N/A
**REVISED**
CYP.05350
01/27/2005
Phase I
N/A YES NO
Does the cytopathology report include all of the following desirable elements?
1.
2.
3.
4.
Date of specimen collection
Date specimen received/accessioned by the laboratory
Description of specimen on receipt (e.g., bloody fluid)
Designation of automated screening device, when applicable
NOTE: The Inspector must provide specific details of any deficiencies in Part B (Deficiency
Summary) of the Inspector's Summation Report. Description of specimens on receipt should document
the type of specimen received. Examples include the number of glass slides submitted and how fixed
(e.g., air-dried or alcohol-fixed); quantity of fluid and fixation (e.g., 10cc bloody fluid in alcohol);
Thin Prep vial; SurePath vial; brush in 10 cc clear yellow fluid, etc.
COMMENTARY:
N/A
CYP.06100
Phase II
N/A YES NO
Does the cytopathology report include an interpretation of the morphologic findings?
COMMENTARY:
The cytopathology report must include an interpretation of the morphologic findings.
CYP.06300
Phase II
N/A YES NO
Are cytologic findings reported using standard descriptive diagnostic terminology?
NOTE: Cytologic diagnoses must be expressed in standard descriptive diagnostic terminology. The
use of diagnostic "classes" does not reflect current understanding of neoplasia, has no comparable
equivalent in diagnostic histopathologic terminology, and does not provide for diagnosis of
non-neoplastic conditions.
COMMENTARY:
CYTOPATHOLOGY
Page 25 of 54
College of American Pathologists
Revised: 10/06/2005
N/A
REFERENCES: 1) Solomon D, et al. The 2001 Bethesda system. Terminology for reporting results of
cervical cytology. JAMA. 2002:287:2114-2119; 2) Solomon D, Nayar, R, eds. The Bethesda System
for Reporting Cervical Cytology; Definitions, Criteria, and Explanatory Notes. 2nd ed., 2004.
CYP.06400
Phase II
N/A YES NO
Is there space for comments or recommendations by the pathologist?
COMMENTARY:
Reports must provide space for comments or recommendations by the pathologist.
CYP.06600
Phase II
N/A YES NO
Are cytopathology records retained for an appropriate period?
NOTE: Minimum requirements for cytopathology, providing these are not less stringent than state and
federal regulations, are:
1.
2.
Accession log records - 2 years
Reports - 10 years
Since a 5-year "look-back" period is required when there is a newly identified abnormality in cervical
cytopathology, non-computerized laboratories may wish to retain these accession records for 5 years.
COMMENTARY:
Cytopathology records must be retained for an appropriate period. The retention period should be
extended in order to provide documentation for adequate quality control and medical care. In
establishing retention requirements, care should be taken to comply with state and federal regulations.
There must be a documented policy for protecting and preserving the integrity and retrieval of
cytopathology materials and records. Suggested retention guidelines for cytopathology, providing
these are not in conflict with state and federal regulations, are:
1.
2.
Accession log records - 2 years
Reports - 10 years
Since a 5-year "look back" period is required when there is a newly identified abnormality in cervical
cytopathology, non-computerized laboratories may wish to retain these accession records for 5 years.
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
CYTOPATHOLOGY
Page 26 of 54
College of American Pathologists
Revised: 10/06/2005
24):7170 [42CFR493.1105(a)(7)(i)(A); 493.1274(f)(2) through (f)(4)]; 2) College of American
Pathologists. Retention of laboratory records and materials. Northfield, IL: CAP, current edition.
CYP.06700
Phase II
N/A YES NO
Is a patient index maintained for easy retrieval of information?
COMMENTARY:
A patient index must be maintained for easy retrieval of information.
CYP.06800
Phase II
N/A YES NO
Is a cross-index with histological material maintained?
COMMENTARY:
A cross-index with histological material must be maintained.
---------------------------------------------------------------RETENTION OF SLIDES
-----------------------------------------------------------------
CYP.06900
Phase II
N/A YES NO
Are all glass slides retained for an appropriate period?
NOTE: Minimum requirements for cytopathology, providing these are not less stringent than state and
federal regulations, are:
1.
2.
Gynecologic and non-gynecologic glass slides - 5 years
Fine needle aspiration glass slides - 10 years
COMMENTARY:
All cytopathology slides must be retained for at least 5 years (gynecologic and non-gynecologic
specimens). Fine needle aspiration slides must be retained for at least 10 years.
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7170 [42CFR493.1105(a)(7)(i)(A); 493.1274(f)(2) through (f)(4)]; 2) College of American
Pathologists. Retention of laboratory records and materials. Northfield, IL: CAP, current edition.
CYTOPATHOLOGY
Page 27 of 54
College of American Pathologists
CYP.07000
Phase I
Revised: 10/06/2005
N/A YES NO
Are slides stored in an orderly manner and readily accessible?
COMMENTARY:
Slides should be stored in an orderly and accessible manner.
**REVISED**
CYP.07100
01/27/2005
Phase II
N/A YES NO
Is there a documented policy for protecting and preserving the integrity and retrieval of original
slides in cytopathology?
NOTE: Cytopathology slides must be stored at room temperature for optimal preservation of their
integrity. Stored slides must be organized to permit timely retrieval when slides are needed for review.
COMMENTARY:
N/A
CYP.07200
Phase II
N/A YES NO
Is there a policy to ensure defined handling and documentation of the use, circulation referral,
transfer and receipt of original slides to ensure availability of materials for consultation and legal
proceedings?
COMMENTARY:
There must be a policy to ensure defined handling and documentation of the use, circulation referral,
transfer and receipt of original slides and blocks to ensure availability of materials for consultation and
legal proceedings.
CYP.07300
Phase II
N/A YES NO
Is there documentation, including acknowledgment of receipt, when material is loaned to special
programs such as the CAP Interlaboratory Comparison Program in Cervicovaginal Cytology
(PAP)?
COMMENTARY:
CYTOPATHOLOGY
Page 28 of 54
College of American Pathologists
Revised: 10/06/2005
The laboratory must maintain documentation, including acknowledgment of receipt, when material is
loaned to special programs such as the CAP interlaboratory comparison program in cervicovaginal
cytology (PAP).
---------------------------------------------------------------STATISTICAL ANALYSIS
-----------------------------------------------------------------
CYP.07400
Phase II
N/A YES NO
Are statistical records maintained, and summarized annually, that include the number of
cytopathologic specimens and type/sources of specimens?
NOTE: At a minimum, the laboratory should divide cytology cases into 2 categories: gynecologic and
non-gynecologic cases.
COMMENTARY:
Numbers of cytopathologic specimens and types/sources of specimens must be recorded and
summarized annually. At a minimum, the laboratory should divide cytology cases into 2 categories:
gynecologic and non-gynecologic cases.
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):3710 [42CFR493.1274(c)(5)].
##############################################################################
GYNECOLOGIC CYTOPATHOLOGY
##############################################################################
NOTE: The following three checklist questions deal with interlaboratory comparison programs. The
first two questions apply only to laboratories subject to CLIA-88 regulations. The third question
applies only to laboratories not subject to CLIA-88.
CYTOPATHOLOGY
Page 29 of 54
College of American Pathologists
**REVISED**
CYP.07413
Revised: 10/06/2005
01/27/2005
Phase I
N/A YES NO
For laboratories subject to CLIA-88 that perform cervicovaginal cytopathology, does the
laboratory participate in the CAP PAP Program or comparable interlaboratory peercomparison program in gynecologic cytopathology?
NOTE: Interlaboratory comparison programs in cytopathology provide valuable educational
opportunities for peer performance comparisons in both technical and diagnostic arenas. While not
completely emulating cervicovaginal cytopathologic preparation and interpretation, participation in
the PAP program enables a laboratory to compare its performance to benchmarks derived from a
database of peer laboratories.
COMMENTARY:
N/A
REFERENCES: 1) Davey DD, et al. Improving accuracy in gynecologic cytology: results of the
College of American Pathologists interlaboratory program in cervicovaginal cytology (PAP). Arch
Pathol Lab Med. 1993;117:1193-1198; 2) Plott E. Cytology proficiency testing research and
development at the Centers for Disease Control, 1967-1992. Lab Med. 1994;25:224-229; 3) Wood D,
Thompson DW. Proficiency testing in gynecologic cytology: the Ontario experience of a voluntary
organization. Lab Med. 1994;25:240-244; 4) Bonfiglio TA, Somark TM. ASCP educational and
proficiency testing programs in cytopathology. Lab Med. 1994;25:245-247; 5) Davey DD, Fidler WJ.
The College of American Pathologists interlaboratory comparison program in cervicovaginal cytology.
Lab Med. 1994;25:248-252; 6) Nielsen ML. Cytopathology laboratory improvement programs of the
College of American Pathologists. Laboratory accreditation program (CAP LAP) and performance
improvement program in cervicovaginal cytology (CAP PAP). Arch Pathol Lab Med.
1997;121:256-259; 7) Woodhouse SL, et al. Interobserver variability in subclassification of squamous
intraepithelial lesions. Results of the College of American Pathologists interlaboratory comparison
program in cervicovaginal cytology. Arch Pathol Lab Med. 1999;123:1079-1084; 8) Keenlyside RA,
et al. Do proficiency test results correlate with the work performance of screeners who screen
Papanicolaou smears? Am J Clin Pathol. 1999;112:769-776; 9) Jones BA, Davey DD. Quality
management in gynecologic cytology using interlaboratory comparison. Arch Pathol Lab Med.
2000;124:672-681; 10) Colgan TJ, et al. Reparative changes and the false-positive/false-negative
Papanicolaou test: A study from the College of American Pathologists interlaboratory comparison
program in cervicovaginal cytology. Arch Pathol Lab Med. 2001;125:123-140; 11) Nakhleh RE,
Fitzgibbons PL, eds. Quality management in anatomic pathology. Promoting patient safety through
systems improvement and error reduction. Northfield, IL: College of American Pathologists, 2005.
CYTOPATHOLOGY
Page 30 of 54
College of American Pathologists
**REVISED**
CYP.07426
Revised: 10/06/2005
01/27/2005
Phase II
N/A YES NO
For laboratories subject to CLIA-88 regulations, is the laboratory and all individuals engaged in
the examination of gynecologic preparations enrolled and participating in a CMS-approved PT
program in gynecologic cytopathology?
NOTE: This checklist question applies only to laboratories subject to CLIA-88 regulations.
Laboratories must maintain documentation of PT performance for at least 2 years. Documentation
must be kept for each individual participating in annual PT, including identification of those who are
retested; documentation of remedial training; records of imposition of limitations on slide
examination; and records of re-examination of slides, as required by CLIA-88.
COMMENTARY:
N/A
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Extension of certain effective dates for clinical laboratory requirements and personnel
requirements for cytologists. Fed Register. 1994(Dec 6):62609 [42CFR493.855].
**NEW**
CYP.07432
03/30/2005
Phase II
N/A YES NO
For laboratories not subject to CLIA-88 regulations, does the laboratory participate in the CAP
PAP Program or another CAP-approved interlaboratory peer-comparison educational program
in gynecologic cytopathology?
NOTE: Interlaboratory comparison programs in cytopathology provide valuable educational
opportunities for peer performance comparisons in both technical and diagnostic arenas. While not
completely emulating cervicovaginal cytopathologic preparation and interpretation, participation in
the PAP program enables a laboratory to compare its performance to benchmarks derived from a
national database of peer laboratories.
COMMENTARY:
N/A
CYP.07439
Phase II
N/A YES NO
Is the Papanicolaou stain used for gynecologic specimens?
CYTOPATHOLOGY
Page 31 of 54
College of American Pathologists
Revised: 10/06/2005
COMMENTARY:
The Papanicolaou stain must be used for gynecologic specimens.
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7169 [42CFR493.1274(b)(1)].
CYP.07452
Phase II
N/A YES NO
Are there documented criteria for categorizing a gynecologic specimen as unsatisfactory?
NOTE: Gynecologic specimens with atypical cells are always "satisfactory", although the report may
include comments on the quality of the preparation.
COMMENTARY:
There must be documented criteria for categorizing a gynecologic specimen as unsatisfactory.
Gynecologic specimens with atypical cells are always "satisfactory", although the report may include
comments on the quality of the preparation.
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7169 [42CFR493.1274(e)(4)]; 2) Davey DD, et al. Terminology and specimen adequacy in
cervicovaginal cytology. Arch Pathol Lab Med. 1992;116:903-907; 3) Ransdell JS, et al.
Clinicopathologic correlation of the unsatisfactory Papanicolaou smear. Cancer Cytopathol.
1997;81:139-143; 4) Renshaw AA, et al. Accuracy and reproducibility of estimating the adequacy of
the squamous component of cervicovaginal smears. Am J Clin Pathol. 1999:11:38-42; 5) Selvaggi
SM. Is it time to revisit the classification system for cervicovaginal cytology? Arch Pathol Lab Med.
1999;123:993-994; 6) Davey DD, et al. Atypical cells and specimen adequacy. Current laboratory
practices of participants in the College of American Pathologists interlaboratory comparison program
in cervicovaginal cytology. Arch Pathol Lab Med. 2000;124:203-211; 7) Nakhleh RE, Fitzgibbons
PL, eds. Quality management in anatomic pathology. Promoting patient safety through systems
improvement and error reduction. Northfield, IL: College of American Pathologists, 2005; 8) Solomon
D, et al. The 2001 Bethesda system. Terminology for reporting results of cervical cytology. JAMA.
2002;287:2114-2119; 9) Solomon D, Nayar, R, eds. The Bethesda system for reporting
cervical/vaginal ctyologic diagnoses: Definitions, criteria, and explanatory notes for terminology and
specimen adequacy. New York, NY: Springer-Verlag; 2nd edition, 2004.
CYP.07465
Phase II
N/A YES NO
Are all gynecologic slides in the following categories interpreted by the pathologist?
CYTOPATHOLOGY
Page 32 of 54
College of American Pathologists
1.
2.
3.
4.
5.
6.
Revised: 10/06/2005
Suspicious or malignant cells
Dysplasia
Cervical intraepithelial neoplasia (CIN)
Low- and high-grade squamous intraepithelial lesions
Atypical cells
Reactive or repair
COMMENTARY:
All abnormal gynecological slides, including those with suspicious or malignant cells, dysplasia,
cervical intraepithelial neoplasia, low- and high-grade squamous intraepithelial lesions, atypical cells,
and reactive or repair must be interpreted by the pathologist.
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7169 [42CFR493. 1274(e)(1)(i) through (e)(1)(v), and (e)(2)]; 2) Raab SS, et al. Interobserver
variability of a Papanicolaou smear diagnosis of atypical glandular cells of undetermined significance.
Am J Clin Pathol. 1998;110:653-659; 3) Selvaggi SM. Is it time to revisit the classification system for
cervicovaginal cytology? Arch Pathol Lab Med. 1999;123:993-994.
CYP.07478
Phase II
N/A YES NO
Are at least 10% of each cytotechnologist's gynecologic cases that have been interpreted to be
negative rescreened?
NOTE: The 10% rescreening is a CLIA-88 requirement, and therefore only applicable to laboratories
subject to those regulations. An individual who qualifies as a cytotechnologist supervisor and who
performs initial screening must also have a minimum of 10% of his or her cases that are initially
interpreted as negative subjected to rescreening. This rescreening must include some cases from
high-risk patients, based upon criteria established by the laboratory director, as well as random
negative cases. Cases screened by MDs or DOs who are certified in Anatomic Pathology by the
American Board of Pathology or the American Osteopathic Board of Pathology, or who possess
qualifications that are equivalent to those required for the above certifications are not subject to this
rescreening requirement. If FDA-approved automated instruments are used for quality control
rescreening case selection, the laboratory must ensure that the methods used meet the requirements of
CLIA-88, and that manufacturer and FDA recommendations for quality control are followed.
Slides must be rescreened in their entirety, including slides processed by imaging instruments that
select a limited number of microscopic fields for examination by the cytotechnologist.
The laboratory must document results of all rescreened cases.
COMMENTARY:
N/A
CYTOPATHOLOGY
Page 33 of 54
College of American Pathologists
Revised: 10/06/2005
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7169 [42CFR493.1274(c)(1)]; 2) Krieger P, et al. Guest editorial: random rescreening of cytology
smears: a practical and effective component of quality assurance programs in both large and small
cytology laboratories. Acta Cytol. 1994;38:291-298; 3) Krieger P, et al. A practical guide to
Papanicolaou smear rescreens. How many slides must be reevaluated to make a statistically valid
assessment of screening performance? Cancer Cytopathol. 1998;84:130-137; 4) Renshaw AA, et al.
Performance characteristics of rapid (30-second) prescreening. Implications for calculating the falsenegative rate and comparison with other quality assurance techniques. Am J Clin Pathol.
1999;111:517-522; 5) Intersociety Working Group for Cytology Technologies. Proposed method for
evaluating secondary screening (rescreening) instruments for gynecologic cytology. Am J Clin Pathol.
1999;111:590-593; 6) Raab SS, et al. Cost effectiveness of rescreening cervicovaginal smears. Am J
Clin Pathol. 1999;111:601-609.
CYP.07491
Phase II
N/A YES NO
Are the results of gynecologic cases selected for rescreening not reported until the rescreen is
complete?
COMMENTARY:
The results of gynecologic cases selected for rescreening must not be reported until the rescreen is
complete.
CYP.07504
Phase II
N/A YES NO
Is the rescreening of negative gynecologic cases performed by an individual qualified as a
cytopathology supervisor under CLIA-88?
COMMENTARY:
N/A
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7169 [42CFR493.1257(c)(1)].
CYP.07517
Phase II
N/A YES NO
Are all available (either on-site or in storage) previously negative slides received within the past
five years and histologic information reviewed whenever a new high-grade squamous
CYTOPATHOLOGY
Page 34 of 54
College of American Pathologists
Revised: 10/06/2005
intraepithelial lesion (moderate or severe dysplasia, carcinoma in situ, CIN II or III) or
malignant gynecologic case is reported?
NOTE: Previously negative slides (manually read or from an automated method) from the index
patient should be rescreened or reviewed by an individual qualified as a cytology supervisor under
CLIA-88. Laboratory policy should specify which cases require pathologist review.
COMMENTARY:
All available (either on-site or in storage) previously negative slides received within the past five years
and histologic information must be reviewed and documented whenever a new high-grade squamous
intraepithelial lesion (moderate or severe dysplasia, carcinoma in situ, CIN II or III) or malignant
gynecologic case) is reported. Previously negative slides from the index patient should be rescreened
or reviewed by an individual qualified as a cytology supervisor under CLIA-88. Laboratory policy
should specify which cases require pathologist review.
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Medicare, Medicaid and CLIA programs; CLIA fee collection; correction and final rule. Fed
Register. 2003(Jan 24):5232 [42CFR493.1274(c)(3)]; 2) Jones BA. Rescreening in gynecologic
cytology. Rescreening of 3762 previous cases for current high-grade squamous intraepithelial lesions
and carcinoma - a College of American Pathologists Q-Probes study of 312 institutions. Arch Pathol
Lab Med. 1995;119:1097-1103; 3) Jones BA. Rescreening in gynecologic cytology. Rescreening of
8096 previous cases for current low-grade and indeterminate-grade squamous intraepithelial lesion
diagnoses - a College of American Pathologists Q-Probes study of 323 laboratories. Arch Pathol Lab
Med. 1996;120:519-522; 4) Davey DD. Papanicolaou smear five year retrospective review: what's
required by the Clinical Laboratory Improvement Amendments of 1988? Arch Pathol Lab Med.
1997;121:296-298; 5) Clary KM, et al. Cytohistologic discrepancies. A means to improve pathology
practice and patient outcomes. Am J Clin Pathol. 2002;117:567-573.
CYP.07530
Phase II
N/A YES NO
If a significant discrepancy, which would affect current patient care, is found during the
retrospective review, is a corrected report issued?
COMMENTARY:
A corrected report must be issued when a significant discrepancy, which would affect current patient
care, is found during the retrospective review.
REFERENCES: 1) Davey DD. Papanicolaou 5-year retrospective review. Arch Pathol Lab Med.
1997;121:296-298; 2) Freedman LF. Implications of mandating amended reports following
retrospective review of Papanicolaou smears. Arch Pathol Lab Med. 1997;121:299-300.
CYTOPATHOLOGY
Page 35 of 54
College of American Pathologists
CYP.07543
Phase II
Revised: 10/06/2005
N/A YES NO
Is a documented effort made to obtain and review follow-up histological reports or material
available within the laboratory when gynecologic cases with high-grade squamous intraepithelial
lesion (HSIL) or malignant cytological findings are reported?
NOTE: The number of cases that have histologic correlation should be documented.
COMMENTARY:
A documented effort must be made to obtain and review follow-up histological reports or material that
is available within the laboratory when high-grade squamous intraepithelial lesion (HSIL) or malignant
gynecologic cytological findings are reported.
REFERENCES: 1) Joste NE, et al. Cytologic/histologic correlation for quality control in
cervicovaginal cytology: experience with 1,582 paired cases. Am J Clin Pathol. 1995:103:32-34; 2)
Tritz DM, et al. Etiologies for non-correlating cervical cytologies and biopsies. Am J Clin Pathol.
1995;103:594-597; 3) Jones BA, et al. Q-Probes - cervical biopsy-cytology correlation: a College of
American Pathologists Q-Probes study of 22439 correlations in 348 laboratories. Arch Pathol Lab
Med. 1996;120:523-531; 4) Nakhleh RE, Fitzgibbons PL, eds. Quality management in anatomic
pathology. Promoting patient safety through systems improvement and error reduction. Northfield, IL:
College of American Pathologists, 2005; 5) Wright, DC, et al. 2001 Consensus guidelines for the
management of women with cervical cytological abnormalities. JAMA. 2002;287:2120-2129; 6) Clary
KM, et al. Cytohistologic discrepancies. A means to improve pathology practice and patient outcomes.
Am J Clin Pathol. 2002;117:567-573; 7) Renshaw A, Granter SR. Appropriate follow-up interval for
biopsy confirmation of squamous intraepithelial lesions diagnosed on cervical smear cytology. Am J
Clin Pathol. 1997;108:275-279.
CYP.07556
Phase II
N/A YES NO
When a follow-up histological report or material is not available within the laboratory, is there a
documented effort to obtain follow-up histological information for correlative review when
gynecologic cases with significantly abnormal (high-grade SIL) or malignant cytological findings
are reported?
NOTE: Documentation may consist of follow-up correspondence, telephone calls, or requests
included in the report.
COMMENTARY:
A documented effort must be made to obtain follow-up histological reports or material for correlative
review when significantly abnormal (high-grade SIL) or malignant gynecologic cytological findings
are reported and follow-up histological material is not available in the laboratory. This documentation
may consist of follow-up correspondence, telephone calls, or requests included in the report.
CYTOPATHOLOGY
Page 36 of 54
College of American Pathologists
Revised: 10/06/2005
REFERENCES: 1) Jones BA, et al. Q-Probes - cervical biopsy-cytology correlation: a College of
American Pathologists Q-Probes study of 22439 correlations in 348 laboratories. Arch Pathol Lab
Med. 1996;120:523-531; 2) Clary KM, et al. Cytohistologic discrepancies. A means to improve
pathology practice and patient outcomes. Am J Clin Pathol. 2002;117:567-573; 3) Wright, DC, et al.
2001 Consensus guidelines for the management of women with cervical cytological abnormalities.
JAMA. 2002;287:2120-2129.
CYP.07569
Phase II
N/A YES NO
Is an effort made to correlate gynecologic cytopathology findings with available clinical
information?
NOTE: Methods of clinical correlation should be documented in the laboratory procedure manual,
and selected reports can be reviewed to confirm practice. Possible mechanisms may include: focused
rescreening of cases based on clinical history, history of bleeding, or previous abnormality;
correlation of glandular cells with hysterectomy status, age of patient, and last menstrual period;
review of previous or current biopsy material. Documentation of clinical correlation may include
policies, problem logs with resolution, or notes in reports.
COMMENTARY:
An effort must be made to correlate gynecologic cytopathology findings with available clinical
information.
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7169 [42CFR493.1274(c)(2)]; 2) Joste NE, et al. Cytologic/histologic correlation for quality
control in cervicovaginal cytology. Experience with 1,582 paired cases. Am J Clin Pathol.
1995;103:32-34; 3) Jones BA, Novis DA. Follow-up of abnormal gynecologic cytology. A College of
American Pathologists Q-Probes study of 16 132 cases from 306 laboratories. Arch Pathol Lab Med.
2000;124:665-671; 4) Wright, DC, et al. 2001 Consensus guidelines for the management of women
with cervical cytological abnormalities. JAMA. 2002;287:2120-2129; 5) Clary KM, et al.
Cytohistologic discrepancies. A means to improve pathology practice and patient outcomes. Am J Clin
Pathol. 2002;117:567-573.
CYP.07582
Phase I
N/A YES NO
Is there a policy to educate providers of cervicovaginal specimens that the Pap test is a screening
test for cervical cancer with inherent false negative results?
NOTE: The preferred mechanism is an educational note on all negative Pap test reports. Other
mechanisms include sending periodic educational information to providers, conference presentations,
etc.
CYTOPATHOLOGY
Page 37 of 54
College of American Pathologists
Revised: 10/06/2005
COMMENTARY:
There should be a policy to educate providers of cervicovaginal specimens that the Pap test is a
screening test for cervical cancer with inherent false negative results. The preferred mechanism is an
educational note on all negative Pap test reports. Other mechanisms include sending periodic
educational information to providers, conference presentations, etc.
REFERENCES: 1) Robb JA. The Pap smear is a cancer screening test: why not put the screening error
rate in the report? Diagn Cytopathol. 1993;9:485-486; 2) Mitchell, H. Report disclaimers and
informed expectations about Papanicolaou smears; an Australian view. Arch Pathol Lab Med.
1997;121:327-330.
**REVISED**
CYP.07600
06/01/2004
Phase I
N/A YES NO
For gynecologic cytopathology cases, are statistical records maintained of the number of cases of
the following cytopathology results?
1.
2.
3.
4.
Diagnostic category (including unsatisfactory cases)
Significant cytologic/histologic discrepancies (as defined by laboratory policy)
Where rescreen resulted in reclassification of a result as premalignant or
malignant
Where histopathology results are available to compare with malignant or highgrade squamous intraepithelial lesion (HSIL) cytopathology results
NOTE: These data should be included in the annual cytopathology statistical report. Inclusion of
AGC data is optional. The following benchmark data have been collected by the CAP's Cytopathology
Resource Committee and may be useful in evaluating the laboratory's statistical data. Separate
statistics for conventional and liquid-based preparations are not required, but may be
useful/educational in individual laboratory settings. These benchmarking data were collected in 2003:
CYTOPATHOLOGY
Page 38 of 54
College of American Pathologists
Revised: 10/06/2005
CONVENTIONAL
Laboratory Percentile-Reporting Rate
CATEGORY
5th
10th
25th
50th
75th
90th
95th
ASC-US (%)
0.5
0.9
1.6
3.1
4.8
7.0
9.7
ASC-H +(%)
0.0
0.0
0.0
0.1
0.3
1.0
2.1
LSIL (%)
0.3
0.5
0.8
1.4
2.1
4.0
5.6
HSIL+ (%)
0.1
0.1
0.2
0.4
0.7
1.5
2.2
ASC/SIL
0.5
0.7
1.0
1.4
2.3
3.3
3.7
AGC (%)
0.0
0.0
0.1
0.2
0.5
1.0
1.3
UNSATISFACTORY (%)
0.0
0.1
0.2
0.5
1.0
2.0
3.1
LIQUID-BASED PREPARATIONS
Laboratory Percentile-Reporting Rate
CATEGORY
5th
10th
25th
50th
75th
90th
95th
ASC-US (%)
0.9
1.4
2.6
4.1
5.9
8.9
11.0
ASC-H+ (%)
0.0
0.0
0.1
0.2
0.4
1.0
1.5
LSIL (%)
0.8
1.1
1.6
2.4
3.6
5.4
6.9
HSIL+ (%)
0.1
0.2
0.4
0.5
0.9
1.6
2.0
ASC/SIL
0.4
0.6
1.0
1.3
1.9
2.5
3.1
AGC (%)
0.0
0.0
0.1
0.2
0.3
0.7
1.0
UNSATISFACTORY (%)
0.0
0.0
0.2
0.4
0.8
1.2
1.6
Patient population should be taken into consideration. Percentile-reporting rates refer to the
distribution of individual laboratory responses from reporting rates in various categories. Responses
are ranked from lowest to highest, and the 50th percentile-reporting rate refers to the median
response. A 25th percentile-reporting rate (which corresponds to 0.8% in the table) for the
conventional LSIL category means that a quarter of laboratories have LSIL rates of 0.8% or less. A
90th percentile-reporting rate (which corresponds to 8.9% in the table) for ASC-US in liquid-based
preparations means that 9 of 10 laboratories have an ASC-US rate of 8.9% or less.
The reporting rates for ASC-US, ASC-H, AGC, LSIL, HSIL, and UNSATISFACTORY are given as
percentages of total case volume. An ASC-US rate of 2.0% means 2/100 cases in the lab are
designated ASC-US. The ASC/SIL figure is a calculated ratio: the percentage or number of a
laboratory's ASC-US and ASC-H cases divided by the percentage or number of LSIL, HSIL, and
CYTOPATHOLOGY
Page 39 of 54
College of American Pathologists
Revised: 10/06/2005
malignant cases. A laboratory with 4% ASC cases and 3% SIL cases has an ASC/SIL ratio of 1.3, as
compared to the median ASC/SIL ratio of 1.4 for conventional Paps and 1.3 for liquid-based
preparations.
COMMENTARY:
N/A
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7169 [42CFR493.1274(c)(5)(i) through (c)(5)(vi)]; 2) Davey DD, et al. Atypical squamous cells
of undetermined significance; current practice in CAP laboratories. Arch Pathol Lab Med.
1996;120:440-444; 3) Genest DR, et al. Qualifying the cytologic diagnosis of "atypical squamous
cells of undetermined significance" affects the predictive value of a squamous intraepithelial lesion on
subsequent biopsy. Arch Pathol Lab Med. 1998;122:338-341; 4) Raab SS, et al. Interobserver
variability of a Papanicolaou smear diagnosis of atypical glandular cells of undetermined significance.
Am J Clin Pathol. 1998;110:653-659; 5) Davey DD, et al. Atypical cells and specimen adequacy.
Current laboratory practices of participants in the College of American Pathologists interlaboratory
comparison program in cervicovaginal cytology. Arch Pathol Lab Med. 2000;124:203-211; 6)
Schiffman M, et al. HPV DNA testing in cervical cancer screening results for women in a high risk
province in Costa Rica. JAMA. 2000;283:87-93; 7) Solomon D, et al. Comparison of three
management strategies for patients with ASCUS. J Natl Cancer Inst. 2000;93:293-299; 8) Juskevicius
R, et al. An analysis of factors that influence the ASCUS/SIL ratio of pathologists. Am J Clin Pathol.
2001;116:331-335.
CYP.07650
Phase I
N/A YES NO
If the laboratory's annual ASC/SIL ratio for gynecologic cases falls outside of the 5th or 95th
percentiles, has the laboratory determined and documented the reason(s)?
NOTE: The ASC/SIL ratio is useful for interlaboratory comparisons, because the number of ASC and
SIL cases varies greatly between laboratories (e.g., a private practice with very few HPV infections, a
sexually transmitted disease clinic, and a dysplasia clinic). This ratio is one good indicator for the
under- or over-interpretation of ASC.
For example, a laboratory with 7% ASC cases might appear to be overdiagnosing ASC, since this is
higher than the 75% percentile-reporting rate. However, if this same laboratory also has a SIL rate of
6.0%, the ASC/SIL ratio of 1.2 is close to the national median, and it can be concluded that this
laboratory serves a high-risk population. A laboratory with 3.0% ASC cases and 0.75% SIL appears
to show average ASC rates, but the ASC/SIL ratio of 4.0 is higher than the average laboratory.
COMMENTARY:
If the laboratory's annual ASC/SIL ratio for gynecologic cases falls outside of the 5th or 95th
percentiles, the laboratory should determine and document the reason(s). The ASC/SIL ratio is useful
CYTOPATHOLOGY
Page 40 of 54
College of American Pathologists
Revised: 10/06/2005
for interlaboratory comparisons, because the number of ASC and SIL cases varies greatly between
laboratories (e.g., a private practice with very few HPV infections, a sexually transmitted disease
clinic, and a dysplasia clinic). This ratio is one good indicator for the under- or over-interpretation of
ASC.
For example, a laboratory with 7% ASC cases might appear to be overdiagnosing ASC, since this is
higher than the 75% percentile-reporting rate. However, if this same laboratory also has a SIL rate of
6.0%, the ASC/SIL ratio of 1.2 is close to the national median, and it can be concluded that this
laboratory serves a high-risk population. A laboratory with 3.0% ASC cases and 0.75% SIL appears to
show average ASC rates, but the ASC/SIL ratio of 4.0 is higher than average laboratory practice.
CYP.07655
Phase II
N/A YES NO
Does the laboratory have a documented system to evaluate and document the ongoing
performance of individuals who do cervicovaginal cytology screening against the overall annual
statistics for the laboratory as a whole?
NOTE: Under CLIA-88 regulations, this applies to both cytotechnologists and pathologists who do
primary cervicovaginal specimen screening. Mechanisms can include evaluation of rescreening and
interpretive discrepancies and detection rates for abnormalities. Pathologists who do primary
cervicovaginal specimen screening are exempted from the 10% rescreen of negative cases.
COMMENTARY:
The laboratory must have a documented system to evaluate and document the ongoing performance of
individuals who perform cytology screening against the overall annual statistics for the laboratory as a
whole. This should be accomplished through the re-examination of normal and negative cases, as well
as feedback on the reactive, reparative, atypical, malignant, or premalignant cases. Under CLIA
regulations, this applies to both cytotechnologists and pathologists who do primary cervicovaginal
specimen screening. Pathologists who do primary cervicovaginal specimen screening are exempted
from the 10% rescreen of negative cases.
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7169 [42CFR493.1274(d)(1)(i)(B)]; 2) Jones BA, Davey DD. Quality management in gynecologic
cytology using interlaboratory comparison. Arch Pathol Lab Med. 2000;124:672-681; 3) Cibas, ES, et
al. Quality assurance in gynecologic cytology: the value of cytotechnologist-cytopathologist
discrepancy logs. Am J Clin Pathol. 2001;115:512-516; 4) Nakhleh RE, Fitzgibbons PL, eds. College
of American Pathologists. Quality improvement manual in anatomic pathology, second edition.
Northfield, IL: CAP, 2002.
CYTOPATHOLOGY
Page 41 of 54
College of American Pathologists
CYP.07660
Phase II
Revised: 10/06/2005
N/A YES NO
Is there documentation of each individual's diagnostic discrepancies, and corrective action
taken?
COMMENTARY:
There must be documentation of each individual's diagnostic discrepancies and corrective action taken
in cervicovaginal cytology.
REFERENCES: 1) Cibas, ES, et al. Quality assurance in gynecologic cytology: the value of
cytotechnologist-cytopathologist discrepancy logs. Am J Clin Pathol. 2001;115:512-516; 2) Nakhleh
RE, Fitzgibbons PL, eds. College of American Pathologists. Quality improvement manual in anatomic
pathology, second edition. Northfield, IL: CAP, 2002.
##############################################################################
NON-GYNECOLOGIC CYTOPATHOLOGY
##############################################################################
CYP.07665
Phase I
N/A YES NO
As applicable, is the laboratory enrolled in a peer educational program in NONGYNECOLOGIC cytopathology (e.g., CAP NONGYN program)?
NOTE: Peer educational programs provide valuable educational opportunities for peer performance
comparisons in both technical and interpretive arenas. While not completely emulating nongynecological cytopathology preparation and interpretation, participation in such programs enables a
laboratory to compare its performance to peer laboratories.
COMMENTARY:
N/A
CYP.07670
Phase II
N/A YES NO
Are all non-gynecologic slides reviewed and the report signed by a pathologist?
COMMENTARY:
N/A
CYTOPATHOLOGY
Page 42 of 54
College of American Pathologists
Revised: 10/06/2005
REFERENCE: Nakhleh RE, Fitzgibbons PL, eds. College of American Pathologists. Quality
improvement manual in anatomic pathology, second edition. Northfield, IL: CAP, 2002.
CYP.07675
Phase II
N/A YES NO
Is an effort made to correlate non-gynecologic cytopathology findings with histological and
clinical findings?
NOTE: Correlation of all, or a subset of, non-gynecologic cytology specimens should be performed.
Methods of correlation should be documented in the laboratory procedure manual and selected
reports can be reviewed to confirm practice. Possible mechanisms for correlation of histology include
correlation of current specimens, focused review of specific specimen/organ types, and/or follow-up of
suspicious/positive specimens. Possible clinical correlation mechanisms include additional review or
testing based on clinical history or physical findings, review of radiologic findings, microbiology, flow
cytometry, or other test results. Clinical correlation may be documented in quality management
records, problem logs, or in patient reports.
COMMENTARY:
N/A
REFERENCE: Nakhleh RE, Fitzgibbons PL, eds. College of American Pathologists. Quality
improvement manual in anatomic pathology, second edition. Northfield, IL: CAP, 2002.
CYP.07680
Phase I
N/A YES NO
Is there a documented policy for ensuring that non-gynecologic specimens with a high potential
for cross-contamination are processed and stained separately from other specimens?
NOTE: Contamination may occur among cases when highly cellular specimens are processed.
Methods to minimize this potential problem may include cytocentrifuge, filter, and monolayer
preparations. Direct smears made from the sediment of highly cellular cases should be stained after
the other cases, and the staining fluids must be changed or filtered between each of the highly cellular
cases. One procedure to detect highly cellular specimens is to use a toluidine blue, or other rapid
stain, on a wet preparation. One procedure to detect possible contamination is to insert a clean blank
slide in each staining run and examine it for contaminating cells.
COMMENTARY:
Non-gynecologic specimens with a high potential for cross-contamination should be processed and
stained separately. Contamination may occur among cases when highly cellular specimens are
processed. Methods to minimize this potential problem may include cytocentrifuge, filter, and
monolayer preparations. Direct smears made from the sediment of highly cellular cases should be
stained after the other cases, and the staining fluids must be changed or filtered between each of the
CYTOPATHOLOGY
Page 43 of 54
College of American Pathologists
Revised: 10/06/2005
highly cellular cases. One procedure to detect highly cellular specimens is to use a toluidine blue, or
other rapid stain, on a wet preparation. One procedure to detect possible contamination is to insert a
clean blank slide in each staining run and examine it for contaminating cells.
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan
24):7169 [42CFR493.1274(b)(2-3)].
CYP.07685
Phase II
N/A YES NO
Is the Papanicolaou stain or another appropriate permanent stain used for non-gynecologic
specimens?
COMMENTARY:
The Papanicolaou stain or other permanent stain must be used for non-gynecologic specimens.
**REVISED**
CYP.07690
06/01/2004
Phase I
N/A YES NO
Are 90% of reports on routine non-gynecologic cytology cases completed within 2 working days
of receipt by the laboratory performing the evaluation?
NOTE: This question is primarily concerned with the majority of routine specimens, and applies to all
laboratories. Longer reporting times may be allowed for specimens requiring special processing or
staining (e.g., immunohistochemistry or other molecular analysis), or for screening (as opposed to
diagnostic) specimens (for example, urines). If the laboratory has certain classes of specimens, patient
types, etc., for which longer turnaround times are clinically acceptable, these must be identified,
together with reasonable target reporting times, for Inspector review. Documentation may consist of
continuous monitoring of data or periodic auditing of reports by the laboratory. In lieu of this
documentation, the Inspector may audit sufficient reports to confirm turn-around time.
COMMENTARY:
N/A
REFERENCE: Jones BA, Novis DA. Nongynecologic cytology turnaround time. A College of
American Pathologists Q-Probes study of 180 laboratories. Arch Pathol Lab Med. 2001;125:12791284.
CYTOPATHOLOGY
Page 44 of 54
College of American Pathologists
Revised: 10/06/2005
##############################################################################
PERSONNEL
##############################################################################
The Inspector must review qualifications of the pathologist director (technical supervisor), general
supervisor, and cytotechnologist(s).
CYP.07700
Phase II
N/A YES NO
Does the cytopathology laboratory have a qualified pathologist as director (technical
supervisor)?
COMMENTARY:
The laboratory must have a qualified pathologist as director (technical supervisor).
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb
28):7179 [42CFR493.1449(k)(1)].
CYP.07800
Phase II
N/A YES NO
For laboratories subject to CLIA-88, do all non-supervisory cytotechnologists meet at least one
of the following qualifications?
1.
2.
3.
4.
5.
Graduated from a Committee on Allied Health Education and Accreditation
(CAHEA) accredited school of cytotechnology or other organization approved by
Health and Human Services (HHS); or
Certified in cytotechnology by a certification agency approved by HHS (e.g.,
American Society of Clinical Pathology)
Before September 1, 1992, have successfully completed 2 years in an accredited
institution (12 semester hours in science, 8 of which are in biology) and have 12
months training in an approved school of cytotechnology; or have received 6
months formal training in an approved school and 6 months full-time experience;
or
Before September 1, 1992, have achieved a satisfactory grade in an HHS
proficiency test for cytotechnologists
Before September 1, 1994, have 2 years full-time experience or equivalent within
the preceding 5 years examining slides under the supervision of a physician
certified in pathology and before January 1, 1969, be a high school graduate with 6
months cytotechnology training in a laboratory directed by a physician and
CYTOPATHOLOGY
Page 45 of 54
College of American Pathologists
6.
Revised: 10/06/2005
completed 2 years full-time supervised experience in cytotechnology before 1/1/69;
or
On or before September 1, 1994, have 2 years full-time experience or equivalent
within preceding 5 years in the US and on or before September 1, 1995, have either
graduated from a CAHEA-approved school or be certified as a cytotechnologist
COMMENTARY:
For laboratories subject to CLIA-88, the cytotechnologists must meet minimal personnel qualifications
as specified in the regulations
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb
28):7182 [42CFR493.1483]; 2) Department of Health and Human Services, Centers for Medicare and
Medicaid Services. Extension of certain effective dates for clinical laboratory requirements and
personnel requirements for cytologists. Fed Register. 1994(Dec 6):62608.
CYP.07900
Phase II
N/A YES NO
For laboratories subject to CLIA-88, do all screening personnel satisfy one or more of the
following three criteria?
1.
2.
3.
Pathologist (or physician), qualified as director
Supervisory level cytotechnologist
Qualified cytotechnologist
NOTE: If not, please include details in the Inspector's Summation Report.
COMMENTARY:
For laboratories subject to CLIA-88, cytologic specimens must be screened by a pathologist (or
physician) qualified as a director, a supervisory level cytotechnologist, or a qualified cytotechnologist.
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb
28):7179 [42 CFR493.1449(k)(1)], 7182 [42CFR493.1469, 1483].
CYP.08000
Phase II
N/A YES NO
Does the cytopathology laboratory have a general supervisor, as defined by CLIA-88?
NOTE: The cytopathologist may serve as the general supervisor.
COMMENTARY:
CYTOPATHOLOGY
Page 46 of 54
College of American Pathologists
Revised: 10/06/2005
The laboratory must have a general supervisor, as required under CLIA-88. The cytopathologist may
serve as the general supervisor.
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb
28):7182 [42CFR493.1467].
CYP.08100
Phase II
N/A YES NO
Does the cytopathology general supervisor meet the qualifications defined by CLIA-88?
NOTE: The qualifications for general supervisor can be the same as that of laboratory director. Less
stringent educational backgrounds are federally recognized.
1.
2.
Qualified as a technical supervisor under 42CFR493.1449(b) or (k), or
Qualified as a cytotechnologist under 42CFR493.1483, with at least 3 years of full-time
experience as a cytotechnologist within the preceding 10 years
COMMENTARY:
The cytopathology laboratory must have a general supervisor who meets the qualifications defined by
CLIA-88 and the CAP. The qualifications for general supervisor can be the same as laboratory
director or technical supervisor. Less stringent educational backgrounds are federally recognized:
1.
2.
Qualified as a technical supervisor under 42CFR493.1449(b) or (k), or
Qualified as a cytotechnologist under 42CFR493.1483, with at least 3 years of full-time
experience as a cytotechnologist within the preceding 10 years
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb
28):7182 [42CFR493.1469].
CYP.08200
Phase II
N/A YES NO
Does the cytopathology general supervisor fulfill the responsibilities defined by CLIA-88?
NOTE: The general supervisor, as designated by the laboratory director, is responsible for day-to-day
supervision or oversight of the laboratory operation and personnel performing testing and reporting
test results. This individual must also:
1.
2.
Be accessible to provide consultation to resolve technical problems
Document the slide interpretation results of each case he or she examined or reviewed
CYTOPATHOLOGY
Page 47 of 54
College of American Pathologists
3.
4.
Revised: 10/06/2005
For each 24-hour period, document the total number of slides he/she examined
(screened/rescreened) or reviewed, as well as ensuring documentation of the total
number of slides evaluated by others
Document the number of hours he/she spent examining slides in each 24-hour period
COMMENTARY:
The cytopathology general supervisor must fulfill the responsibilities defined by CLIA-88. The
general supervisor is responsible for day-to-day supervision or oversight of the laboratory operation
and personnel performing testing and reporting test results. This individual must also:
1.
2.
3.
4.
Be accessible to provide consultation to resolve technical problems
Document the slide interpretation results of each case he or she examined or reviewed
For each 24-hour period, document the total number of slides he/she examined
(screened/rescreened) or reviewed, as well as ensuring documentation of the total
number of slides evaluated by others
Document the number of hours he/she spent examining slides in each 24-hour period
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb
28):7182 [42CFR493.1471].
CYP.08300
Phase II
N/A YES NO
Does the cytotechnologist fulfill the responsibilities defined by CLIA-88?
NOTE: The cytotechnologist is responsible for documenting:
1.
2.
3.
The slide interpretation results of each case examined or reviewed
For each 24-hour period, the total number of slides examined or reviewed in all
laboratories
The number of hours spent examining slides in each 24-hour period
COMMENTARY:
N/A
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb
28):7182 [42CFR493.1485].
CYTOPATHOLOGY
Page 48 of 54
College of American Pathologists
CYP.08400
Phase II
Revised: 10/06/2005
N/A YES NO
Are there sufficient qualified personnel available to handle the volume and variety of
cytopathology cases submitted to the laboratory?
NOTE: While the 100 slide/24-hour limit for laboratories subject to CLIA-88 must never be exceeded,
the CAP does not rely solely upon this specific workload limit because: a) the type of case material
varies among laboratories; b) the number of cases that may be accurately reviewed by individual
screening personnel differs; and c) such personnel may perform other duties. The Inspector should
carefully evaluate these factors together with applicable quality control and quality management data
when judging the adequacy of cytopathology laboratory staffing.
COMMENTARY:
Enough qualified personnel must be available for the volume and variety of cases submitted to the
laboratory. This judgment is based on an evaluation of several factors, including the type of case
material processed in the laboratory, the number of screening personnel available, and their assigned
duties. While the federally mandated 100 slide/24-hour limit for laboratories subject to CLIA-88 must
never be exceeded, the CAP does not rely solely upon this specific workload limit because: a) the type
of case material varies among laboratories; b) the number of cases that may be accurately reviewed by
individual screening personnel differs; and c) such personnel may perform other duties. The Inspector
should carefully evaluate these factors together with applicable quality control and quality
management data when judging the adequacy of cytopathology laboratory staffing.
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Medicare, Medicaid and CLIA programs; CLIA fee collection; correction and final rule. Fed
Register. 2003(Jan 24):5232 [42CFR493.1274(d)]; 2) Kline TS. The challenge of quality
improvement with the Papanicolaou smear. Arch Pathol Lab Med. 1997;121:253-255; 3) Mody DR, et
al. Guest editorial - "workload limits" and CLIA '88 in the 1990's: how much is too much? Or too
little? Diagn Cytopathol. 1997;16:VII-VIII; 4) Cibas, ES, et al. Quality assurance in gynecologic
cytology: the value of cytotechnologist-cytopathologist discrepancy logs. Am J Clin Pathol.
2001;115:512-516.
**REVISED**
CYP.08500
01/27/2005
Phase II
N/A YES NO
Is there a documented workload policy with evidence of data recording?
NOTE: Applicable only to laboratories subject to CLIA-88. The final rule implementing CLIA-88
requires that each individual evaluating cytology preparations by manual microscopic technique must
examine no more than 100 slides (gynecologic and non-gynecologic or both) in 24-hours.
Gynecologic slides include new routine slides, 10% rescreen slides, and 5-year look-back negative
slides. Records must be maintained showing the total number of slides examined by each individual
during each 24-hours.
CYTOPATHOLOGY
Page 49 of 54
College of American Pathologists
Revised: 10/06/2005
The laboratory director must establish the maximum workload (based on capability/documented
performance evaluation) for each individual examining slides and the limit must be reassessed at least
every 6 months. Performance must be evaluated using the following: (1) re-evaluation of 10 percent of
the cases interpreted to be negative by cytotechnologists; and (2) comparing the cytotechnologist’s
interpretation with the final diagnosis on cases of ASC-US, LSIL, HSIL, glandular epithelial cell
abnormalities, or other malignant neoplasms. These are minimal requirements and the laboratory
may use additional methods of evaluating performance such as retrospective reviews, comparison of
individual statistic with overall lab statistics, and competency assessment.
The maximum workload of 100 slides can be completed in no less than an 8-hour workday. This
workload maximum can also be expressed as slides per hour and is 12.5 slides/hour. These total limits
apply regardless of the number of laboratories in which an individual works on a given day.
Part-time employees' workload must be prorated based on screening time and an 8-hour day.
Additional responsibilities must be considered when evaluating workload.
Pathologists who screen previously unscreened gynecologic slides, and/or rescreen 10% of negative
gynecologic slides, or rescreen 5-year lookback slides, must adhere to and document the above
workload limit. Review by the pathologist of previously screened reactive/repair, atypical,
premalignant and malignant gynecologic, and previously screened non-gynecologic slides is not
subject to the workload limit. For primary screening of gynecologic liquid-based preparations, each
slide must be counted as a single slide for the purpose of workload recording.
For primary screening of non-gynecologic liquid-based slide preparations, each slide may be counted
as one-half slide for the purpose of workload recording, provided that cells are dispersed over onehalf or less of the total available slide area.
Workload calculations may vary with the use of automated screening instruments. Laboratories
should follow manufacturer’s instructions for workload calculations and must assure that CLIA-88
requirements are fulfilled.
COMMENTARY:
N/A
REFERENCES: 1) Department of Health and Human Services, Centers for Medicare and Medicaid
Services. Medicare, Medicaid and CLIA programs; CLIA fee collection; correction and final rule. Fed
Register. 2003(Jan 24):5232 [42CFR493.1274(d)]; 2) Kline TS. The challenge of quality
improvement with the Papanicolaou smear. Arch Pathol Lab Med. 1997;121:253-255; 3) Nakhleh RE,
Fitzgibbons PL, eds. College of American Pathologists. Quality improvement manual in anatomic
pathology, second edition. Northfield, IL: CAP, 200.
CYTOPATHOLOGY
Page 50 of 54
College of American Pathologists
CYP.08900
Revised: 10/06/2005
Phase II
N/A YES NO
Is all cytopathology screening performed within the laboratory facility or an approved reference
laboratory?
NOTE: Cytopathology screening must be performed within the laboratory facility or an approved
reference laboratory to provide proper access to technical and professional supervision, pathologist
consultation and a controlled working environment. For laboratories subject to CLIA-88, all
cytopathology screening must be performed within a CLIA-88 certified facility.
COMMENTARY:
N/A
##############################################################################
PHYSICAL FACILITIES
##############################################################################
CYP.09000
Phase I
N/A YES NO
Is sufficient space provided for processing cytologic material?
COMMENTARY:
Additional space should be provided for processing cytologic specimens.
CYP.09100
Phase I
N/A YES NO
Are utilities (water, sink, electrical) sufficient?
COMMENTARY:
Improvement in utilities is needed.
CYP.09200
Phase I
N/A YES NO
Are ambient temperature and ventilation control adequate?
COMMENTARY:
Temperature and ventilation control should be improved for the comfort of personnel.
CYTOPATHOLOGY
Page 51 of 54
College of American Pathologists
CYP.09300
Phase I
Revised: 10/06/2005
N/A YES NO
Is there sufficient space for the microscopes (i.e., an adequate desk or bench area for each
cytotechnologist)?
COMMENTARY:
Additional working bench space should be provided for microscopes and screening activities.
CYP.09400
Phase I
N/A YES NO
Have ergonomic aspects of desks (or benches), chairs, and microscopes been evaluated for good
posture and comfort?
COMMENTARY:
Desks (or benches), chairs, and microscopes should be evaluated for good posture and comfort, using
ergonomic principles.
REFERENCES: 1) Krueger H, et al. Besondere Belastungen am Mikroskoparbeitsplatz [Special
stresses at microscopy work places]. Soz Praventivmed. 1986;31:250-251; 2) Krueger H, Conrady P.
Untersuchung zur Ergonomie der Sehbedingungen bei Mikroskoparbeit [Ergonomic aspects of visual
conditions in microscope work]. Biomed Tech (Berl). 1988;33(9):196-202; 3) James TM. An
ergonomic approach to modifying microscope design for increased comfort: a case study. Proc Human
Factors Ergonom Soc. 1995;39th annual meeting; 4) Kalavar SS, Hunting KL. Musculoskeletal
symptoms among cytotechnologists. Lab Med. 1996;27:765-769; 5) Rorer ML. Safety first - a lesson
in ergonomics. Advance/Laboratory. 1997(March):38-43; 6) Scott FI, Jr. The changing face of clinical
microscopy: meeting new optical and ergonomic challenges. Am Clin Lab. 1998;17(2):8-9; 7) Vratny
M. Considerations in microscope design to avoid cumulative trauma disorder in clinical laboratory
applications. Am Clin Lab. 1999;18(3):8.
CYP.09500
Phase I
N/A YES NO
Is there sufficient space for storage of slides and records?
COMMENTARY:
Additional space should be provided for storage of slides and records.
CYTOPATHOLOGY
Page 52 of 54
College of American Pathologists
CYP.09600
Revised: 10/06/2005
Phase II
N/A YES NO
Is space available so there is no compromise of the quality of work, safety of personnel, or
limitation of quality control activities?
COMMENTARY:
Existing space limitations were so severe as to interfere with the quality of work, the safety of
personnel, and/or the ability of personnel to carry out adequate quality control procedures with
appropriate documentation.
##############################################################################
LABORATORY SAFETY
##############################################################################
The inspector should review relevant questions from the Safety section of the Laboratory General
Checklist to assure that the Cytopathology laboratory is in compliance. Please elaborate upon the
location and the details of each deficiency in the Inspector's Summation Report.
CYP.09700
Phase II
N/A YES NO
Are there procedures for disposal of infectious specimens and contaminated material?
COMMENTARY:
Procedures must be established for the disposal of infectious specimens and contaminated materials.
CYP.09900
Phase II
N/A YES NO
Are formaldehyde and xylene vapor concentrations maintained below the following maxima,
expressed as parts per million?
8 hr Time-Weighted Exposure Limit
Action Level ( 8 hr
Time-Weighted
Exposure)
15 min Short-Term
Exposure Limit (STEL)
Formaldehyde
0.75
0.5
2.0
Xylene
100
150
NOTE: The laboratory must perform an initial formaldehyde monitoring procedure in all areas where
this reagent is used. Further periodic formaldehyde monitoring is mandated if results of the initial
monitoring equal or exceed 0.5 ppm (8 hr time-weighted exposure, the “action level”) or 2.0 ppm
CYTOPATHOLOGY
Page 53 of 54
College of American Pathologists
Revised: 10/06/2005
(STEL). The laboratory may discontinue periodic formaldehyde monitoring if results from 2
consecutive sampling periods taken at least 7 days apart show that employee exposure is below the
action level and the short-term exposure limit, and 1) no change has occurred in production,
equipment, process or personnel or control measures that may result in new or additional exposure to
formaldehyde, and 2) there have been no reports of conditions that may be associated with
formaldehyde exposure.
Formaldehyde monitoring must be repeated any time there is a change in production, equipment,
process, personnel, or control measures which may result in new or additional exposure to
formaldehyde. If any personnel report signs or symptoms of respiratory or dermal conditions
associated with formaldehyde exposure, the laboratory must promptly monitor the affected person’s
exposure.
Xylene must be monitored initially, but there is no requirement for periodic monitoring of xylene.
COMMENTARY:
N/A
REFERENCES: 1) Montanaro A. Formaldehyde in the workplace and in the home. Exploring its
clinical toxicology. Lab Med. 1996;27:752-757; 2) Goris JA. Minimizing the toxic effects of
formaldehyde. Lab Med. 1997;29:39-42; 3) Occupational Safety and Health Administration. US
government printing office, 1999(Jul 1):29CFR1910.1048 and 1450.
CYTOPATHOLOGY
Page 54 of 54