ANP10062005

Revised: 10/06/2005
ANATOMIC PATHOLOGY
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
GENERAL ANATOMIC PATHOLOGY..................................................................................................................................6

SURGICAL PATHOLOGY.....................................................................................................................................................12
HISTOLOGY LABORATORY...............................................................................................................................................33
AUTOPSY PATHOLOGY......................................................................................................................................................59
ELECTRON MICROSCOPY..................................................................................................................................................77
ANATOMIC PATHOLOGY Page 2 of 86

SUMMARY OF CHANGES
ANATOMIC PATHOLOGY 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 Effective Date

ANP.11475 10/06/2005
ANP.22615 10/06/2005
ANP.23500 10/06/2005
ANP.27720 10/06/2005
ANP.28290 10/06/2005
ANP.28860 10/06/2005
ANP.29430 10/06/2005
ANP.11610 04/28/2005
ANP.11713 04/28/2005
ANP.11756 04/28/2005
ANP.21850 04/28/2005
ANP.22366 09/30/2004
ANP.22432 09/30/2004
ANP.22925 09/30/2004
REVISED Checklist Questions

ANP.12200 10/06/2005
ANP.23700 10/06/2005
ANP.32350 10/06/2005
ANP.33200 10/06/2005
ANP.12100 04/28/2005
ANP.21400 04/28/2005
ANP.10250 09/30/2004
ANP.12087 09/30/2004

ANP.21150 09/30/2004
ANP.21250 09/30/2004
ANP.22550 09/30/2004
ANP.22570 09/30/2004
ANP.22660 09/30/2004
ANP.32450 09/30/2004
ANP.34150 09/30/2004
ANP.57070 09/30/2004
DELETED Checklist Questions

ANP.22400 09/30/2004
ANP.22450 09/30/2004
ANP.22470 09/30/2004
ANP.22600 09/30/2004
ANP.22650 09/30/2004
ANP.24000 09/30/2004

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
Anatomic Pathology section of the laboratory.
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INSPECTION TECHNIQUES – KEY POINTS
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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, cases sent for consultation, and other activities, select records
from various times during the two-year interval since the previous on-site inspection. A sufficient
sample of surgical pathology reports (and other records, as appropriate) should be reviewed to assure
that consultations, special notification of unexpected diagnoses (e.g., by phone), and corrections are
well documented.
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 gross dissection and histology areas, 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.
 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. 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.
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GENERAL ANATOMIC PATHOLOGY
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Do NOT use this Checklist if:
1. The laboratory does NOT perform any on-site preparation or examination of anatomic
pathology specimens, but refers all submitted material to an outside laboratory
2. The laboratory's involvement in anatomic pathology is limited to filing of reports and/or slides
This Checklist covers several areas of anatomic pathology services, and is divided into the following
sections: Surgical Pathology, Histology Laboratory, Autopsy Pathology, and Electron Microscopy.
Cytopathology (both gynecologic and non-gynecologic) is covered in a separate Checklist. The
sequence for inspection of the anatomic pathology service is at the discretion of the inspection team.
The sequence herein is consistent with that used for all other sections of the laboratory, but is not
restrictive.

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INTERLABORATORY COMPARISONS
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ANP.02000 Phase I N/A YES NO
As applicable, does the laboratory participate in a peer educational program in anatomic

pathology (e.g., CAP Educational Anatomic Pathology Programs)?
NOTE: The laboratory should consider participation in programs appropriate to its scope of service.
Such programs provide valuable educational opportunities for peer performance comparisons in both
technical and diagnostic arenas. While none of these completely emulates the precise clinical setting
involving anatomic pathology preparations and rendering of anatomic or clinical diagnoses, they can
be a useful benchmark of peer-based performance in a national database.
COMMENTARY:
N/A
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PROCEDURE MANUAL
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The anatomic pathology laboratory must have a procedure manual that addresses pre-analytic,
analytic, and post-analytic processes. The manual should include procedures for accessioning and
maintaining the identity of specimens; reporting diagnostic results; safety issues relevant to anatomic
pathology; and procedures for tests performed in the histology, immunohistochemistry, and electron
microscopy laboratories. Procedures must include, as applicable, principle, clinical significance,
specimen type, required reagents, calibration, quality control, procedural steps, calculations,
reference intervals, and interpretation. 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.
ANP.02888 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, 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. A complete manual is available for reference

b. 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:
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):7164 [42CFR493.1251]; 2) Check W. Immunostains making the difference. Northfield, IL:
College of American Pathologists CAP Today. 1997;11(10):1; 3) van Leeuwen AM. 6 Steps to
building an efficiency tool. Advance/Lab. 1999:8(6):88-91; 4) Werner M, et al. Effect of formalin
tissue fixation and processing on immunohistochemistry. Am J Surg Pathol. 2000;24:1016-1019; 5)
Borkowski A, et al. Intranet-based quality improvement documentation at the Veterans Affairs
Maryland health care system. Mod. Pathol. 2001;14:1-5; 6) NCCLS. Clinical laboratory technical
procedure manuals - fourth edition; approved guideline GP2-A4. Wayne, PA: NCCLS, 2002.
Is there documentation of at least annual review of all policies and procedures in the anatomic
pathology section by the current laboratory director or designee?

NOTE: The director must ensure that the collection of policies and procedures 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:
N/A
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb
28):7173 [42CFR493.1407(e)(13)]; 2) Borkowski A, et al. Intranet-based quality improvement
documentation at the Veterans Affairs Maryland health care system. Mod. Pathol. 2001;14:1-5.
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:
N/A
REFERENCE: Department of Health and Human Services, Centers for Medicare and Medicaid
24):7164 [42CFR493.1251(d)].
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:
N/A
24):7164 [42CFR493. 1105(a)(2); 493.1251(e)].

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:
N/A
Is there a policy defining the handling of original slides/blocks for consultation and legal
proceedings?
NOTE: This must include appropriate handling and documentation of the use, circulation, referral,
transfer, and receipt of original slides and blocks. The laboratory must have a record of the location of
original slides and blocks that have been referred for consultation or legal proceedings.
COMMENTARY:
N/A
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SAFETY
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Are formaldehyde and xylene vapor concentrations maintained below the following maxima,
expressed as parts per million, in all areas of the Anatomic Pathology Department where
formaldehyde or xylene are used?
8 hr Time-Weighted Exposure Limit Action Level ( 8 hr 15 min Short-Term

Time-Weighted Average Exposure Limit
Exposure) (STEL)
Formaldehyde 0.75 0.5 2.0
Xylene 100 150

NOTE: Formaldehyde and xylene vapor concentrations must be monitored in all areas where these
reagents are used: e.g., surgical pathology gross dissection room, histology laboratory, autopsy
room, etc. After the initial formaldehyde monitoring procedure, 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 (STEL). Initial 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. Periodic formaldehyde monitoring is mandated only if the
initial monitoring is at or exceeds 0.75 ppm (8-hr TWA) or 2.0 ppm (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) Wenk PA. Disposal of histology stains. Lab Med.
1998;29:337-338; 4) Occupational Safety and Health Administration. 29CFR1910.1048 and 1450,
revised July 1, 1998.
Is adequate space available so that there is no compromise of the quality of work or safety of
personnel in any section of the Anatomic Pathology Department?
COMMENTARY:
N/A

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SURGICAL PATHOLOGY
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QUALITY MANAGEMENT
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Many technical and procedural quality control items are covered elsewhere in this Checklist. They
are integral components of comprehensive quality management and should be included within the
defined program. This section determines if there is an active program of surveillance of the quality of
surgical pathology activities, particularly the diagnostic reports. How this is accomplished depends
upon the number of departmental staff, as well as the volume and type of diagnostic material. Such a
program must include appropriate combinations of activities such as the use of intra- and
extra-departmental consultations, circulation of diagnostic material (random or by case type),
periodic review of completed surgical pathology reports, and participation in self-assessment and
performance improvement programs.
Is the quality management program defined and documented for surgical pathology?
NOTE: The type of program may vary depending upon factors such as number of staff and workload.
COMMENTARY:
N/A
REFERENCES: 1) Kempson RL. The time is now. Checklists for surgical pathology reports. Arch
Pathol Lab Med. 1992;116:1107-1108; 2) Zarbo RJ. Interinstitutional assessment of colorectal
carcinoma surgical pathology report adequacy. A College of American Pathologists Q-Probes study of
practice patterns from 532 laboratories and 15 940 reports. Arch Pathol Lab Med.
1992;116:1113-1119; 3) Shaw PA. Launching quality improvement in histology. Med Lab Observ.
1993(Mar):45-49; 4) Abt AB, et al. The effect of interinstitution anatomic pathology consultation on
patient care. Arch Pathol Lab Med. 1995;119:514-517; 5) Scully RE, et al. Practice protocol for the
examination of specimens removed from patients with ovarian tumors. A basis for checklists. Arch
Pathol Lab Med. 1995;119:1012-1022; 6) Gephardt GN, Zarbo RJ. Interinstitutional comparison of
frozen section consultations. A College of American Pathologists Q-Probes study of 90538 cases in
461 institutions. Arch Pathol Lab Med. 1996;120:804-809; 7) Zarbo RJ. Quality assessment in
anatomic pathology in the cost-conscious era. Am J Clin Pathol. 1996;106(Suppl 1):s3-s10; 8) Novis
DA, et al. Interinstitutional comparison of frozen section consultation in small hospitals. A College of

American Pathologists Q-Probes study of 18 532 frozen section consultation diagnoses in 233 small
hospitals. Arch Pathol Lab Med. 1996;120:1087-1093; 9) Hammond EH, et al. Practice protocol for
the examination of specimens removed from patients with carcinoma of the urinary bladder, ureter,
renal pelvis, and urethra. Arch Pathol Lab Med. 1996;120:1103-1110; 10) Novis DA, Zarbo RJ.
Interinstitutional comparison of frozen section turnaround time. A College of American Pathologists
Q-Probes of 32 868 frozen sections in 700 hospitals. Arch Pathol Lab Med. 1997;121:559-567; 11)
Lee RG, et al. Protocol for the examination of specimens removed from patients with esophageal
carcinoma. A basis for checklists. Arch Pathol Lab Med. 1997;121:925-929; 12) Novis DA, et al.
Interinstitutional comparison of surgical biopsy diagnosis turnaround time. A College of American
Pathologists Q-Probes study of 5384 surgical biopsies in 157 small hospitals. Arch Pathol Lab Med.
1998;122:951-956; 13) Compton CC, et al. Updated protocol for the examination of specimens from
patients with carcinomas of the colon and rectum, excluding carcinoid tumors, lymphomas, sarcomas,
and tumors of the vermiform appendix: a basis for checklists. Arch Pathol Lab Med. 2000;124:1016-
1025; 14) Cruz DC, et al. Digital image documentation for quality assessment. Arch Pathol Lab Med.
2001;125:1430-1435; 15) Cooper K, et al. Institutional consultations in surgical pathology. How
should diagnostic disagreements be handled? Arch Pathol Lab Med. 2002;126:650-651; 16) Nakhleh
RE, Fitzgibbons PL, editors. College of American Pathologists. Quality improvement manual in
anatomic pathology, second edition. Northfield, IL: CAP, 2002; 17) Renshaw AA, et al. Blinded
review as a method of quality improvement in surgical pathology. Arch Pathol Lab Med.
2002;126:961-963; 18) Rüdiger T, et al. Quality assurance in immunohistochemistry: results of an
interlaboratory trial involving 172 pathologists. Am J Surg Pathol. 2002;26:873-882.
Is there a policy that lists types of specimens (if any) that an institution may choose to exclude
from routine submission to the pathology department for examination, and for recording their
disposition?
NOTE: Specimens removed during surgery are ordinarily sent to a pathologist for evaluation, but
there may be policy exceptions. Such a policy is neither mandatory nor a requirement for CAP
accreditation. If all specimens are sent to the pathologist, this question is "N/A". If there is a policy, it
should be made in conjunction with the hospital administration and appropriate medical staff
departments. The laboratory director must have participated in or been consulted by the medical staff
in deciding which surgical specimens are to be sent to the laboratory for examination. If certain types
of specimens (e.g., dental appliances, pacemakers, bone donated to the bone bank, neonatal foreskins)
are not routinely submitted for pathologist examination, there must be an alternative procedure for
documenting the removal and disposition of such specimens.
COMMENTARY:
N/A
REFERENCES: 1) Kassan MA, et al. Value of routine pathology in herniorrhaphy performed upon
adults. Surg Gynecol Obstet. 1986;163:518-522; 2) Netser JC, et al. Value-based pathology: a cost-
benefit analysis of the examination of routine and non-routine tonsil and adenoid specimens. Am J Clin

Pathol. 1997;108:158-165; 3) Zarbo RJ, Nakleh RE. Surgical pathology specimens for gross
examination only and exempt from submission. A College of American Pathologists Q-Probes study of
current policies in 413 institutions. Arch Pathol Lab Med. 1999;123:133-139; 4) College of American
Pathologists. Policies and guidelines manual. Surgical specimens to be submitted to pathology for
examination. Northfield, IL: CAP, 1999:Appendix M; 5) Nakhleh RE, Fitzgibbons PL, editors.
College of American Pathologists. Quality improvement manual in anatomic pathology, second
edition. Northfield, IL: CAP, 2002.
Is there a policy regarding what types of surgical specimens (if any) may be exempt from
microscopic examination?
NOTE: Such a policy is recommended as good laboratory practice but is not a requirement for CAP
accreditation. Irrespective of any exemptions, microscopic examination should be performed
whenever there is a request by the attending physician, or at the discretion of the pathologist when
indicated by the clinical history or gross findings. If there is such a policy, it should be approved by
the medical staff or appropriate committee. Typical exempt specimens include foreskins in children,
prosthetic cardiac valves without attached tissue, torn meniscus, varicose veins, tonsils in children
below a certain age, etc.
COMMENTARY:
N/A
REFERENCES: 1) Weibel E. Pathological findings of clinical value in tonsils and adenoids. Acta
Otolaryngol. 1965;60:331-338; 2) Wolkomir AF, et al. Selective microscopic examination of
gallbladders, hernia sacs and appendices. Am Surg. 1991:57:289-292; 3) Boutin P, Hogshead H.
Surgical pathology of the intervertebral disc: is routine examination necessary? Spine. 1992;17:1236-
1238; 4) Cornell WB, Levin HS. The inguinal hernia sac: trash or treasure? Anatomic pathology II
check sample, APII-9. Chicago, IL: American Society of Clinical Pathology, 1993:17(4); 5) Delong
WH, Grignon DJ. Pathologic findings in ribs removed at the time of radical nephrectomy for renal cell
carcinoma. Int J Surg Pathol. 1994;1:177-180; 6) Raab SS. The cost-effectiveness of routine
histologic examination. Am J Clin Pathol. 1998;110:391-396; 7) Zarbo RJ, Nakleh RE. Surgical
pathology specimens for gross examination only and exempt from submission. A College of American
Pathologists Q-Probes study of current policies in 413 institutions. Arch Pathol Lab Med.
1999;123:133-139; 8) College of American Pathologists. Policies and guidelines manual. Surgical
specimens to be submitted to pathology for examination. Northfield, IL: CAP, 1999:Appendix M.
Whenever possible, is pertinent previous cytologic and/or histologic material from the patient
reviewed with current material being examined?

NOTE: Because sequential analysis of cytologic and histologic specimens may be critical in patient
management and follow- up, efforts must be made to routinely review pertinent previous material.
COMMENTARY:
N/A
REFERENCE: Bozzo P. Implementing quality assurance. Chicago, IL: American Society of Clinical
Pathology, 1991:72-74.
When significant disparities exist between initial intraoperative consultation (e.g., frozen section,
cytology, gross evaluation) and final pathology diagnosis, are these reconciled and documented
either in the surgical pathology report or in the departmental quality management file?
COMMENTARY:
N/A
REFERENCES: 1) Gephardt GN, Zarbo RJ. Interinstitutional comparison of frozen section

consultations. A College of American Pathologists Q-Probes study of 90 538 cases in 461 institutions.
Arch Pathol Lab Med. 1996;120:804-809; 2) Nakhleh RE, Zarbo RJ. Amended reports in surgical
pathology and implications for diagnostic error detection and avoidance. A College of American
Pathologists Q-Probes study of 1 667 547 accessioned cases in 359 laboratories. Arch Pathol Lab Med.
1998;122:303-309; 3) Firlik KS, et al. Use of cytological preparations for the intraoperative diagnosis
of stereotactically obtained brain biopsies: a 19-year experience and survey of neuropathologists. J
Neurosurg. 1999;91:454-458.
Does the laboratory have a policy for inclusion of INTRA-departmental consultations in the
patient's final report?
NOTE: Intradepartmental consultations may be included in the patient’s final report, or filed
separately. The pathologist in charge of the surgical pathology case must decide whether the results
of intra-departmental consultations provide relevant information for inclusion in some manner in the
patient's report.
COMMENTARY:
N/A

REFERENCES: 1) Leslie KO, et al. Second opinions in surgical pathology. Am J Clin Pathol.
1996;106(suppl 1):S58-S64; 2) Tomaszewski JE, et al. Consensus conference on second opinions in
diagnostic anatomic pathology. Who, what, and when. Am J Clin Pathol. 2000;114:329-335; 3) Hahm
GK, et al. Quality assurance of second opinion in gastrointestinal and liver pathology. Am J Clin
Pathol. 2000;114:631; 4) Renshaw AA, et al. Blinded review as a method of quality improvement in
surgical pathology. Arch Pathol Lab Med. 2002;126:961-963.
Are EXTRA-departmental consultations documented, and are records of these consultations

maintained in a systematic manner within the pathology department?
NOTE: Documentation of extra-departmental consultations must be readily accessible within the

pathology department. The method used to satisfy this requirement is at the discretion of the
laboratory director, and can be expected to vary according to the organization of the department.
These consultations can be maintained with the official surgical pathology reports or kept separately,
so long as they can be readily linked.
COMMENTARY:
N/A
REFERENCES: 1) Leslie KO, et al. Second opinions in surgical pathology. Am J Clin Pathol.
1996;106(suppl 1):S58-S64; 2) Tomaszewski JE, et al. Consensus conference on second opinions in
diagnostic anatomic pathology. Who, what, and when. Am J Clin Pathol. 2000;114:329-335; 3) Hahm
GK, et al. Quality assurance of second opinion in gastrointestinal and liver pathology. Am J Clin
Pathol. 2000;114:631; 4) Azam M, Nakhleh RE. Surgical pathology extradepartmental consultation
practices. A College of American Pathologists Q-probes study of 2746 consultations from 180
laboratories. Arch Pathol Lab Med. 2002;126:405-412; 5) Cooper K, et al. Institutional consultations
in surgical pathology. How should diagnostic disagreements be handled? Arch Pathol Lab Med.
2002;126:650-651.
**REVISED** 09/30/2004
When extra-departmental cases are submitted to the laboratory for consultation, are they
accessioned according to the standard practices of the laboratory, and is a documented report
prepared, with a copy sent to the original pathologist?
NOTE: Extra-departmental cases submitted for consultation should be accessioned according to the
standard practices of the laboratory, and a report issued. A copy of this report should be sent to the
original pathologist. In most cases, original materials including slides and blocks should be promptly
returned to the original institution. However, in some situations (for example, when the patient is

receiving ongoing care at the referral institution pending tumor resection, etc.) it may be appropriate
for the referral laboratory to retain slides/blocks for a period of time. In such situations, a letter
should be sent to the original pathologist along with the consultation report, requesting permission to
retain the slides/blocks and accepting transfer of stewardship of the patient materials from the original
laboratory to the referral institution.
COMMENTARY:
N/A
REFERENCE: Stewardship of Pathologic Specimens. Policy Statement. College of American

Pathologists, Waukegan, IL. Adopted February 1997. Reaffirmed May 2000.
http://www.cap.org/apps/docs/policies/policy_appF.htm.
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QUALITY CONTROL
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SURGICAL SPECIMEN EXAMINATION
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Inspectors and laboratories are reminded that questions relating to collection and accessioning of
specimens are covered in the Laboratory General Checklist. During the on-site inspection, the
handling of surgical specimens must be evaluated.
Is there sufficient space and are utilities (water, drainage, electrical power) adequate for
collection, gross examination, and storage of specimens?
COMMENTARY:
N/A
Is refrigerated storage available for large or unfixed specimens?
COMMENTARY:

N/A
Are there specific policies and procedures for the safe handling of tissues that may contain
radioactive material (e.g., sentinel lymph nodes, breast biopsies, prostate "seeds", etc.)?
NOTE: These procedures should be developed in conjunction with the institutional radiation safety
officer, and must comply with any state regulations for the safe handling of tissues containing
radionuclides. The policy should distinguish between low radioactivity specimens such as sentinel
lymphadenectomy and implant devices with higher radiation levels.
The pathology department may wish to monitor these specimens for radioactivity, with safe storage of
specimens until sufficient decaying has occurred, before proceeding with processing in the histology
laboratory.
COMMENTARY:
N/A
REFERENCES: 1) Glass EC, et al. Editorial: radiation safety considerations for sentinel node
techniques. Ann Surg Oncol. 1999:6:10; 2) Miner TJ, et al. Guideline for the safe use of radioactive
materials during localization and resection of sentinel lymph nodes. Ann Surg Oncol. 1999;6:75-82; 3)
Cibull ML. Handling sentinel lymph node biopsy specimens. A work in progress. Arch Pathol Lab
Med. 1999;123:620-621; 4) Pfeifer JD. Sentinel lymph node biopsy. Am J Clin Pathol. 1999;112:599-
602; 5) Barnes CA. False-negative frozen section results. Am J Clin Pathol. 2000;113:900; 6)
Fitzgibbons PL, et al. Recommendations for handling radioactive specimens obtained by sentinel
lymphadenectomy. Am J Surg Pathol. 2000;24:1549-1551.
Is the lighting satisfactory?
NOTE: Direct sunlight should be avoided because of its extreme variability and the need for low light
levels necessary to observe various computer consoles, etc. Lighting control should be sectionalized
so general levels of illumination can be controlled in areas of the room if desired.
COMMENTARY:
N/A

Are the examination and storage areas adequately ventilated by an exhaust fan or fume hood to
remove noxious fumes and odors?
COMMENTARY:
N/A
Are dictating facilities available and convenient to use?
COMMENTARY:
N/A
Are photographic facilities available and convenient?
NOTE: In addition to providing material for a teaching collection, such photographs can serve as
valuable documentation for the report.
COMMENTARY:
N/A
**NEW** 10/06/2005
Are there documented procedures for handling sub-optimal specimens (e.g., specimens that are
unlabeled, unaccompanied by adequate requisition information, left unfixed or unrefrigerated
for an extended period, received in a container/bag with a contaminated outside surface)?
COMMENTARY:
N/A

Is the identity of every specimen maintained at all times during the processing and examination
steps?
COMMENTARY:
N/A
Are all gross specimens retained until at least 2 weeks after the final reports are signed and
results reported to the referring physician?
COMMENTARY:
N/A
REFERENCES: 1) Travers H. Q&A Section. Northfield, IL: College of American Pathologists CAP
Today, March 1992:63; 2) Travers H. Q&A Section. Savage RA, editor. CAP Today, November
1993:86-87; 3) Tracey ME. Hospital takes closer look at specimen returns. CAP Today, July 1992:81;
4) Lester SC. Manual of surgical pathology. New York, NY: Churchill Livingstone, 2001:18-20; 5)
Nakhleh RE, Fitzgibbons PL. Quality improvement manual in anatomic pathology, second edition.
Northfield, IL: CAP; 2002:14.
Are all specimens examined grossly by a pathologist or pathology resident, or under the
supervision of a qualified pathologist?
COMMENTARY:
N/A
**NEW** 04/28/2005
If specimens are dissected by individuals other than a pathologist or pathology resident, do such
individuals qualify as high complexity testing personnel under CLIA-88 regulations?

NOTE: The laboratory director may delegate the dissection of specimens to non-pathologist
individuals; these individuals must be qualified as high complexity testing personnel under CLIA-88
regulations. The minimum training/experience required of such personnel is:
1. An earned associate degree in a laboratory science or medical laboratory technology,

obtained from an accredited institution, OR
2. Education/training equivalent to the above that includes at least 60 semester hours or
equivalent from an accredited institution. This education must include 24 semester
hours of medical laboratory technology courses, OR 24 semester hours of science
courses that includes 6 semester hours of chemistry, 6 semester hours of biology, and
12 semester hours of chemistry, biology or medical laboratory technology in any
combination. In addition, the individual must have laboratory training including either
completion of a clinical laboratory training program approved or accredited by the
ABHES, the CAHEA, or other organization approved by HHS (note that this training
may be included in the 60 semester hours listed above), OR at least 3 months
documented laboratory training in each specialty in which the individual performs high
complexity testing.
In addition, the CLIA-88 regulations include exceptions for grandfathered individuals; these
regulations (42CFR493.1489 and 1491) may be found at
http://www.phppo.cdc.gov/clia/regs/subpart_m.aspx#493.1487
This checklist question applies only to laboratories subject to CLIA-88.
COMMENTARY:
N/A
Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Oct
1):1070-1071 [42CFR493.1489], 1071-1072 [42CFR493.1491].
Are the types of specimens examined and the extent of the examination performed by a
non-pathologist clearly defined in a documented policy or protocol?
COMMENTARY:
N/A
28):7183 [42CFR493.1489(b)(6)]; 2) Cibull ML. Q&A. Northfield, IL: College of American

Pathologists CAP Today. 1997;11(7):112; 3) Grzybicki DM, et al. National practice characteristics
and utilization of pathologists’ assistants. Arch Pathol Lab Med. 2001;125:905-912.
Is the nature of the pathologist supervision (direct vs. indirect) clearly documented for each type
of specimen grossly examined by a non-pathologist?
COMMENTARY:
N/A
28):7183 [42CFR493.1489(b)(6)]; 2) Cibull ML. Q&A. Northfield, IL: College of American
Pathologists CAP Today. 1997;11(7):112; 3) Grzybicki DM, et al. The usefulness of pathologists'
assistants. Am J Clin Pathol. 1999;112:619-626.
Is the performance of non-pathologist(s) who perform gross tissue examinations evaluated by the
pathologist on a regular, periodic basis?
COMMENTARY:
N/A
REFERENCES: 1) Cibull ML. Q&A. Northfield, IL: College of American Pathologists CAP Today.
1997;11(7):112; 2) Grzybicki DM, et al. The usefulness of pathologists' assistants. Am J Clin Pathol.
1999;112:619-626; 3) Galvis CO, et al. Pathologists’ assistants practice. A measurement of
performance. Am J Clin Pathol. 2001;116:816-822.
Are all surgical tissue diagnoses made by a pathologist?
COMMENTARY:
N/A
REFERENCE: Cibull ML. Q&A. Northfield, IL: College of American Pathologists CAP Today.
1997;11(7):112.

Are documented instructions or guidelines available for the proper dissection, description, and
histologic sampling of various specimen types (e.g., mastectomy, colectomy, hysterectomy, renal
biopsy, etc.)?
NOTE: The guidelines should address large or complicated specimen types and smaller specimens
requiring special handling, such as muscle biopsies, renal biopsies, and rectal suction biopsies for
Hirschsprung's disease. Guidelines serve an important educational function in departments with
postgraduate (residency) programs. However, they also are useful in providing consistency in the
handling of similar specimen types in departments without such training programs.
COMMENTARY:
N/A
**NEW** 04/28/2005
Is there documented evidence of daily review of the technical quality of histologic preparations
by the pathologist?
NOTE: If specimens are referred to an outside laboratory for histologic processing, there must be a
procedure for providing feedback on slide quality to the outside laboratory.
COMMENTARY:
N/A
-----------------------------------------------------------------
INTRAOPERATIVE CONSULTATION (RAPID DIAGNOSIS OR FROZEN SECTION)
-----------------------------------------------------------------
**NEW** 04/28/2005
Are all working solutions and stains properly labeled?
NOTE: Working solutions and stains must be properly labeled with the contents, and, if applicable,
date they are changed/filtered, and expiration date.

COMMENTARY:
N/A
Is each slide labeled with patient's name and/or accession number?
COMMENTARY:
N/A
Are frozen section preparations adequate for intraoperative diagnosis?
NOTE: The inspector should evaluate several cases for quality of histological sectioning and staining.
COMMENTARY:
N/A
Does the laboratory periodically evaluate turnaround time for intraoperative frozen sections?
NOTE: If 90% of frozen sections are not completed within 20 minutes, the laboratory must document
evaluation of the reason(s) for the delay. This turnaround time is intended to apply to the typical
single frozen section. In cases where there are multiple sequential frozen sections required on a single
specimen (e.g., resection margins), or in cases where additional studies such as radiographic
correlation are required, longer turnaround times may be expected.
COMMENTARY:
N/A
REFERENCE: Novis DA, Zarbo RJ. Interinstitutional comparison of frozen section turnaround time.
A College of American Pathologists Q-Probes study of 32 868 frozen sections in 700 hospitals. Arch
Pathol Lab Med. 1997;121:559-567.

Are the results of surgical consultations documented and signed by the pathologist who made the
diagnosis?
NOTE: The intent of this question is for the laboratory to maintain a contemporaneous report of the
surgical consultation. This may be a handwritten, signed report or a computer-generated report with
electronic signature.
COMMENTARY:
N/A
If verbal reports are given, is the pathologist able to speak directly with the surgeon?
COMMENTARY:
N/A
Is the patient's identification checked and confirmed before delivery of any verbal report?
COMMENTARY:
N/A
Are all intraoperative consultation reports made a part of the final surgical pathology report?
COMMENTARY:
N/A
Are all frozen section slides permanently stained, mounted, properly labeled, and retained with
the rest of the slides from the case?

COMMENTARY:
N/A
REFERENCE: Nakhleh RE, Fitzgibbons PL, editors. College of American Pathologists. Quality
improvement manual in anatomic pathology, second edition. Northfield, IL: CAP, 2002.
Following frozen section examination, is the residual frozen tissue routinely processed and a
paraffin section prepared for comparison with the intraoperative interpretation?
NOTE: Correlation of frozen section findings with a permanent section prepared from routinely fixed
and processed residual frozen tissue is an important quality assurance and improvement mechanism.
Evaluation of such permanent sections improves recognition of specific frozen section morphologic
alterations and provides important feedback regarding diagnostic accuracy. For some evaluations
(e.g., margin assessment), the findings on deeper permanent sections from residual frozen material
may not be as clinically relevant as the original frozen section. For this latter situation, the laboratory
should have a policy specifying the types of specimens for which permanent section follow- up may be
unnecessary.
COMMENTARY:
N/A
REFERENCES: 1) Rickert RR. Quality assurance goals in surgical pathology. Arch Pathol Lab Med.
1990;114:1157-1162; 2) Association of Directors of Anatomic and Surgical Pathology.
Recommendations on quality control and quality assurance in anatomic pathology. Am J Surg Pathol.
1991;15:1007-1009; 3) Gephardt GN, et al. Interinstitutional comparison of frozen section
consultations. A College of American Pathologists Q-probes study of 90 538 cases in 461 institutions.
Arch Pathol Lab Med. 1996;120:804-809; 4) Novis DA, et al. Interinstitutional comparison of frozen
section consultation in small hospitals. Arch Pathol Lab Med. 1996;120:1087-1093; 5) Nakhleh RE,
Fitzgibbons PL, editors. College of American Pathologists. Quality improvement manual in anatomic
pathology, second edition. Northfield, IL: CAP, 2002.
**REVISED** 09/30/2004
Is there a documented procedure for the routine decontamination of the cryostat at defined
intervals, and are decontamination records evident?

NOTE: Decontamination of the interior of cryostats may be accomplished with 70% ethanol.
Trimmings and sections of tissue that accumulate inside the cryostat should be removed during
decontamination. In addition to this decontamination process, the cryostat should be defrosted and
decontaminated with a tuberculocidal disinfectant at an interval appropriate for the institution; this
should be weekly for instruments used daily. Although not a requirement, steel mesh gloves should be
worn when changing knife blades.
COMMENTARY:
N/A
REFERENCE: NCCLS. Protection of laboratory workers from instrument biohazards and infectious
disease transmitted by blood, body fluids, and tissue; approved guideline M29-A. Wayne, PA:
NCCLS, 1997.
-----------------------------------------------------------------
SURGICAL PATHOLOGY REPORTS
-----------------------------------------------------------------
**REVISED** 04/28/2005
Are all reports reviewed and signed by the pathologist?
NOTE: The inspector must review 15-20 recent surgical pathology reports. When diagnostic reports
are generated by computer or telecommunications equipment, the actual signature or initials of the
pathologist may not appear on the report. It is nevertheless essential that the laboratory have a
procedure that ensures and documents that the responsible pathologist has reviewed and approved the
completed report before its 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:
N/A
REFERENCE:
http://www.cap.org/apps/docs/laboratory_accreditation/RetentionGuidelines010405.pdf.

Are reports on routine cases completed within 2 working days?
NOTE: Unusual, complex or special specimens may require prolonged fixation before dissecting and
selecting tissue samples, additional time for special stains, etc., and the reporting time may extend
beyond 2 working days of receipt by the laboratory conducting the surgical pathology examination.
This question is primarily concerned with the majority of routine specimens, and applies to all
laboratories.
COMMENTARY:
N/A
REFERENCES: 1) Zarbo RJ, et al. Intralaboratory timeliness of surgical pathology reports. Results of
two College of American Pathologists Q-Probes studies of biopsies and complex specimens. Arch
Pathol Lab Med. 1996;120:234-244; 2) Smith MT, Garvin AJ. Anatomic pathology turnaround times.
Use and abuse. Am J Clin Pathol. 1996;106(suppl 1):S70-S73; 3) Novis DA, et al. Interinstitutional
comparison of surgical biopsy diagnosis turnaround time. A College of American Pathologists Q-
Probes study of 5384 surgical biopsies in 157 small hospitals. Arch Pathol Lab Med. 1998;122:951-
956.
Is there a policy regarding the timely communication, and documentation thereof, of significant
or unexpected surgical pathology findings?
NOTE: Certain surgical pathology diagnoses may be considered particularly significant or

unexpected. Such diagnoses may include: malignancy in an uncommon location or specimen type
(e.g., hernia sac, intervertebral disk material, tonsil, etc.), absence of chorionic villi when clinically
expected (potential ectopic pregnancy), change of a frozen section diagnosis after review of permanent
sections, and/or mycobacterial, fungal or other significant infectious organisms identified on special
stains. Diagnoses to be defined as “significant” or “unexpected,” if any, should be determined by the
pathology department, in cooperation with local clinical medical staff. Consideration should be given
to assuring, with reasonable effort, prompt communication of such results, by telephone, pager, or
other system. There should be documentation of date and time of such special notification (which may
be included in the pathology report or in laboratory files).
COMMENTARY:
N/A
REFERENCES: 1) Rosai J, Bonfiglio TA, Corson JM, et al. Standardization of the surgical pathology
report. Mod Pathol.1992 Mar;5(2):197-9; 2) Zarbo RJ, Nakhleh RE, Walsh M; Quality Practices
Committee, College of American Pathologists. Customer satisfaction in anatomic pathology. A

College of American Pathologists Q-Probes study of 3065 physician surveys from 94 laboratories.
Arch Pathol Lab Med. 2003 Jan;127(1):23-9.
**REVISED** 10/06/2005
Do all surgical pathology reports include gross descriptions that contain adequate information
regarding type, number, dimensions and/or weight of specimens, measurements and extent of
gross lesions, and other information essential to the diagnosis and patient care?
NOTE: Annotated drawings and photographs are valuable tools for documenting gross findings, but
are not adequate replacements for a text description.
COMMENTARY:
N/A
REFERENCES: 1) Association of Directors of Anatomic and Surgical Pathology. Recommendations

for the reporting of resected large intestinal carcinomas. Am J Clin Pathol. 1996;106:12-15; 2)
Imperato PJ, et al. Radical prostatectomy specimens among Medicare patients in New York State. A
review of pathologists' reports. Arch Pathol Lab Med. 1998;122:966-971; 3) Cochran AJ, et al.
Recommendations for the reporting of tissues removed as part of the surgical treatment of cutaneous
melanoma. Am J Clin Pathol. 1998;110:719-722; 4) Ruby SG. Clinician interpretation of pathology
reports. Confusion or comprehension? Arch Pathol Lab Med. 2000;124:943-944; 5) Powsner SM, et
al. Clinicians are from Mars and pathologists are from Venus. Clinician interpretation of pathology
reports. Arch Pathol Lab Med. 2000;124:104-1046.
When appropriate, do gross descriptions include a key or summary noting block and slide
designations for special sections (e.g., margins of resection, deepest penetration of tumor, breast
quadrants, lymph node levels, etc.)?
COMMENTARY:
N/A
REFERENCE: Imperato PJ, et al. Radical prostatectomy specimens among Medicare patients in New
York State. A review of pathologists' reports. Arch Pathol Lab Med. 1998;122:966-971.

Do gross descriptions and microscopic findings (if included) support the pathologic diagnosis?
COMMENTARY:
N/A
REFERENCE: Rickert RR. Quality Assurance in Surgical Pathology. Arch Pathol Lab Med
1990;114:1157-1162.
In tumor cases, does the final report provide appropriate information for standard systems of
histologic grading and staging, including pathologic parameters such as margin status, vascular
invasion, etc., as applicable for the tumor type?
NOTE: The pathology report must provide data that, within the confines of information available to
the pathologist, is sufficient to allow appropriate grading and staging of neoplasms according to
standard classification schemes. This information should be easily identifiable (e.g., bold type,
distinctive font, or visually set apart from the descriptive text of the report). The use of checklists or
synoptic diagnostic reports is recommended, to ensure that all information relevant to staging and
grading is included, and to facilitate interpretation of pathology reports by clinicians.
COMMENTARY:
N/A
REFERENCE: College of American Pathologists. Practicing Pathology: Cancer Protocols.

http://www.cap.org/cancerprotocols/protocols/intro.html.
Is there a mechanism to correlate the results of specialized studies (e.g., electron microscopy,
immunohistochemistry, nucleic acid probes, cytogenetics) with the morphologic diagnosis?
NOTE: It is not in the best interests of the patient to have potentially conflicting diagnoses or
interpretations rendered by different sections of the laboratory. The pathologist should correlate all of
the special studies, reconcile conflicting data, and render a final interpretation of all correlated
studies.
COMMENTARY:
N/A

REFERENCES: 1) Editorial. Incorporation of immunostaining data in anatomic pathology reports. Am

J Clin Pathol. 1993;99:1; 2) Putti T, et al. Cost-effectiveness of immunohistochemistry in surgical
pathology. Am J Clin Pathol. 1998;110:51; 3) Raab SS. The cost-effectiveness of
immunohistochemistry. Arch Pathol Lab Med. 2000;124:1185-1191.
If patient testing is performed using Class I analyte-specific reagents (ASR’s) obtained or

purchased from an outside vendor, does the patient report include the disclaimer required by
federal regulations?
NOTE: ASR’s are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands,
nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction
with substances in a specimen, are intended for use in a diagnostic application for identification and
quantification of an individual chemical substance or ligand in biological specimens.
By definition, an ASR is the active ingredient of an in-house-developed (“home brew”) test system.
ASR’s may be obtained from outside vendors or synthesized in-house. ASR’s from outside vendors are
supplied individually. They are not bundled with other materials in kit form, and the accompanying
product literature does not include any claims with respect to use or performance of the reagent.
Class I ASR’s in use in the anatomic pathology laboratory include some antibodies for
immunohistochemistry and nucleic acid probes for FISH and ISH.
Class I ASR’s are not subject to preclearance by the U.S. Food and Drug Administration or to special
controls by FDA. Thus, if the laboratory performs patient testing using Class I ASR’s obtained or
purchased from an outside vendor, federal regulations require that the following disclaimer
accompany the test result on the patient report:
"This test was developed and its performance characteristics determined by (laboratory name).
It has not been cleared or approved by the U.S. Food and Drug Administration."
The CAP recommends additional language, such as "The FDA has determined that such clearance or
approval is not necessary. This test is used for clinical purposes. It should not be regarded as
investigational or for research. This laboratory is certified under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA-88) as qualified to perform high complexity clinical
laboratory testing."
The above disclaimer is not required when using reagents that are sold in kit form with other materials
and/or an instrument, and/or with instructions for use, and/or when labeled by the manufacturer as
Class I for in vitro diagnostic use (IVD), Class II IVD, or Class III IVD.
Most antibodies used in immunohistochemistry are labeled “for in vitro diagnostic use” and thus do
NOT require the disclaimer.

Antibodies, nucleic acid sequences, etc., labeled “Research Use Only” (RUO) purchased from
commercial sources may be used in home brew tests only if the laboratory has made a reasonable
effort to search for IVD or ASR class reagents. The results of that failed search should be documented
by the laboratory director.
The laboratory must establish or verify the performance characteristics of tests using Class I ASR’s
and RUO’s in accordance with the Method Performance Specifications section of the Laboratory
General checklist.
The laboratory may put an ASR disclaimer on the pathology report for all immunostains, FISH and
ISH studies collectively used in a particular case. Separately tracking each reagent used for a case
and selectively applying the disclaimer to only the class I ASR’s is unnecessary.
COMMENTARY:
N/A
REFERENCES: 1) Department of Health and Human Services, Food and Drug Administration.
Medical devices; classification/reclassification; restricted devices; analyte specific reagents. Final rule.
Fed Register. 1997(Nov 21);62243-45 [21CFR809, 21CFR864]; 2) Caldwell CW. Analyte-specific
reagents in the flow cytometry laboratory. Arch Pathol Lab Med. 1998;122:861-864; 3) Graziano.
Disclaimer now needed for analyte-specific reagents. Northfield, IL: College of American Pathologists
CAP Today. 1998;12(11):5-11; 4) Analyte Specific Reagents; Small Entity Compliance Guidance.
http://www.fda.gov/cdrh/oivd/guidance/1205.html, February 26, 2003; 5) Shapiro JD and Prebula RJ.
FDA’s Regulation of Analyte-Specific Reagents. Medical Devicelink, February 2003.
http://www.devicelink.com/mddi/archive/03/02/018.html; 6) U.S. Department of Health and Human
Services, Food and Drug Administration. www.fda.gov/cdrh/ode/immuno.html; 7) U.S. Department of
Health and Human Services, Food and Drug Administration. http://www.fda.gov/cdrh/oivd/index.html.
Can surgical pathology report information be retrieved by patient identifier (e.g., name, medical
record number, etc.)?
NOTE: For computerized surgical pathology systems, software tools typically permit text-based
searches for any element of the report, such as name and diagnosis. Or, these data elements may
already be stored in an electronic database. For paper-based manual systems, it is acceptable to store
reports by name.
COMMENTARY:
N/A

Are surgical pathology records and materials retained for an appropriate period?
NOTE: Minimum requirements for surgical pathology, providing these are not less stringent than
state and federal regulations, are:
1. Accession log records - 2 years

2. Wet tissue (stock bottle) - 2 weeks after final report
3. Paraffin blocks - 10 years
4. Glass slides and reports - 10 years
The retention period should be extended, when appropriate, to provide documentation for adequate
quality control and medical care.
There must be a documented policy for protecting and preserving the integrity and retrieval of
surgical pathology materials and records.
COMMENTARY:
N/A
REFERENCE: College of American Pathologists.

http://www.cap.org/apps/docs/laboratory_accreditation/RetentionGuidelines010405.pdf.
############################################################################
HISTOLOGY LABORATORY
############################################################################
If the histology laboratory is a separate and distinct laboratory in the Anatomic Pathology section, the
inspector may find it more convenient to use an additional copy of the Anatomic Pathology Checklist
for the inspection, answering all applicable questions.
The questions on procedure manuals in the General Anatomic Pathology section of the checklist apply
to the histology laboratory.
-----------------------------------------------------------------
QUALITY CONTROL/HISTOLOGIC PREPARATIONS
-----------------------------------------------------------------

Is the identity of every specimen maintained through each step of processing and slide
preparation?
NOTE: An unambiguous system of specimen identification coupled with a legible, sequential cassette
and slide labeling system that withstands reagents and stains are essential to fulfill this requirement.
The number of blocks processed and the number of slides prepared for each case must be recorded.
COMMENTARY:
N/A
Are blocks identified adequately?
NOTE: Each block of tissue must be identified by the entire accession number assigned to the case
and by any descriptive letter(s)/number(s) added by the prosector during the dissection. If additional
blocks are prepared later, all lists and logs must reflect these additions. Identification number and
letter(s)/numbers(s) must be affixed to all blocks in a manner that remains legible.
COMMENTARY:
N/A
**REVISED** 09/30/2004
Are slides identified adequately?
NOTE: Slides must be adequately identified. All slide labels must include the entire identification
number and descriptive letters unique to the block from which it is cut, as well as other appropriate
identifiers, i.e., levels of sectioning. Automated prelabeling systems are acceptable. Glass slides that
are manually prelabeled must be inscribed with indelible ink, pencil, or by etching. If slides are
manually prelabeled, the original numbers on the glass slide should be readable from the underside of
the slide. Regardless of whether a manual or automated labeling system is used, adequate procedures
must be in place to ensure positive identification of slides during processing. The permanent slide
label must be legible and indelible.
COMMENTARY:
N/A

REFERENCE: O'Briain DS, et al. Sorting out mix-ups. The provenance of tissue sections may be
confirmed by PCR using microsatellite markers. Am J Clin Pathol. 1996;106:758-764.
Are labels legible?
COMMENTARY:
N/A
**REVISED** 09/30/2004
Examine several prepared slides. Are they of sufficient quality for diagnosis?
NOTE: Histopathology slides must be of adequate technical quality to be diagnostically useful.

Criteria to evaluate include adequate tissue fixation, thickness of sections, absence of interfering tissue
folds and tears, and good staining technique. For hematoxylin and eosin and other routine stains, the
patient slide serves as the internal control to ensure adequate staining technique.
The sections must be cut from sufficient depth in the block to include the entire tissue plane.
COMMENTARY:
N/A
Does the histology laboratory maintain records of the number of blocks, slides, and stains
prepared?
COMMENTARY:
N/A
-----------------------------------------------------------------
SPECIAL STAINS (HISTOCHEMISTRY)
-----------------------------------------------------------------

The inspector must examine and evaluate sample case(s) of all special stains (with controls) routinely
prepared by the histology laboratory. The histochemical stains listed below are neither compulsory
for every laboratory nor all-inclusive, but simply intended to represent some common stains.
Are reagents and solutions properly labeled, as applicable and appropriate, with the following
elements?
1. Content and quantity, concentration or titer

2. Storage requirements
3. Date prepared or reconstituted by laboratory
4. Expiration date
NOTE: The above elements may be recorded in a log (paper or electronic), rather than on the
containers themselves, providing that all containers are identified so as to be traceable to the
appropriate data in the log. While useful for inventory management, labeling with "date received" is
not routinely required. There is no requirement to routinely label individual containers with "date
opened"; however, a new expiration date must be recorded if opening the container changes the
expiration date, storage requirement, etc. The inspector will describe specific issues of non-
compliance in the Inspector's Summation Report.
COMMENTARY:
N/A
24):7164 [42CFR493.1252(c)]; 2) NCCLS. Clinical laboratory technical procedure manuals - fourth
edition; approved guideline GP2-A4. Wayne, PA: NCCLS, 2002.
Are all histological/histochemical reagents used within their indicated expiration dates?
NOTE: The acceptable performance of tissue stains, used before their expiration date, is determined
by technical assessment on actual case material, use of suitable control sections, and as part of the
pathologist's diagnostic evaluation of a surgical pathology or autopsy pathology case.
COMMENTARY:
N/A

**REVISED** 04/28/2005
Are positive controls run routinely on all special stains, with reactivity results documented, and
are they verified for acceptability before reporting results?
NOTE: A positive control slide must be run at the same time as any single or group of slides stained
with the same special stain. The tissue chosen for the special stain control slide must be appropriate
in type and amount. Both the control slide and the test tissue slide must be judged technically
acceptable before the results of the special stains are reported.
COMMENTARY:
N/A
REFERENCE: Sundblad AS. A simplified multitissue block. Am J Clin Pathol. 1994;102:192-193.
Are the following special stains of high quality, and do they satisfactorily demonstrate (on each
day of use), the tissue characteristics for which they were designed?
1. Acid fast organisms

2. Iron
3. Bacteria
4. Elastic tissues
5. Fungi or pneumocystis
6. Mucin
7. Connective tissue
8. Myelin
9. Nerve fibers
10. Periodic acid Schiff (PAS)
11. Glycogen
12. Reticulin fibers
13. Amyloid
14. Methyl green-pyronine (MGP)
NOTE: This list is neither all-inclusive nor exclusive of other "special stains" used in a given
histopathology laboratory. For Gram stains, control slides must demonstrate both Gram-positive and
Gram-negative organisms. With the mucicarmine method, the stain must be sufficiently carminophilic.
If the myelin stain is luxol fast blue, the tissue must be properly differentiated, i.e., myelin must be
turquoise and clearly distinguishable from unmyelinated structures. For nerve fiber stains, axons

must be distinct and black with a Bodian or related stain. With MGP, the control slide must
demonstrate sufficient pyroninophilia.
The Inspector must provide specific details of which stains (this list or others) are deficient in Part B
(Deficiency Summary) of the Inspector's Summation Report.
COMMENTARY:
N/A
24):7166 [42CFR493.1256(e)(2)]; 2) Thaxton PH. Recipes for rapid special stains. Advance/Lab.
1999(Oct);8(10):57-58.
-----------------------------------------------------------------
IMMUNOFLUORESCENCE MICROSCOPY
-----------------------------------------------------------------
**NEW** 04/28/2005
Are appropriate positive and negative controls performed with each case tested
using immunofluorescence?
NOTE: Internal antigens serve as positive controls (e.g., IgA in tubular casts, IgG in protein droplets,
and C3 in blood vessels). Non-reactive elements in the patient specimen may serve as a negative
tissue control. A negative reagent control in which the patient tissue is processed in an identical
manner to the test specimen but with the primary antibody omitted must be performed for each patient
test specimen.
COMMENTARY:
N/A
REFERENCE: Walker PD, et al. Practice guidelines for the renal biopsy. Mod. Pathol. 2004;17:1555-
1563.

-----------------------------------------------------------------
IMMUNOHISTOCHEMISTRY
-----------------------------------------------------------------
If there is an immunohistochemistry laboratory that is separate and distinct from the histology
laboratory, the inspector may find it more convenient to use an additional copy of the Anatomic
Pathology Checklist for that purpose, answering all applicable questions.
to the immunohistochemistry laboratory.
Does the procedure manual address all methods and antibodies currently in use?
COMMENTARY:
N/A
REFERENCES: 1) Varma M, et al. Effect of formalin fixation and epitope retrieval techniques of
antibody 34ßE12 immunostaining of prostatic tissues. Mod Pathol. 1999;12:472-478; 2) Vis AN, et al.
Quantitative analysis of the decay of immunoreactivity in stored prostate needle biopsy sections. Am J
Clin Pathol. 2000;113:369-373; 3) Taylor CR. The total test approach to standardization of
immunohistochemistry. Arch Pathol Lab Med. 2000;124:945-951; 4) Werner M, et al. Effect of
formalin tissue fixation and processing on immunohistochemistry. Am J Surg Pathol. 2000;24:1016-
1019; 5) Rhodes A, et al. Study of interlaboratory reliability and reproducibility of estrogen and
progesterone receptor assays in Europe. Documentation of poor reliability and identification of
insufficient microwave antigen retrieval time as a major contributory element of unreliable assays. Am
J Clin Pathol. 2001;115:44-58; 6) Rohr LR, et al. A comparison of routine and rapid microwave tissue
processing in a surgical pathology laboratory. Quality of histologic sections and advantages of
microwave processing. Am J Clin Pathol. 2001;115:703-708; 7) Rhodes A, et al. A formalin-fixed,
paraffin-processed cell line standard for quality control of immunohistochemical assay of HER-2/neu
expression in breast cancer. Am J Clin Pathol. 2002;117:81-89; 8) Hsi ED, Yegappan S. Lymphoma
immunophenotyping: a new era in paraffin-section immunohistochemistry. Adv Anat Pathol.
2001;8:218-39; 9) Dabbs DJ. Diagnostic Immunohistochemistry. New York: Churchill Livingstone;
2002.
If the laboratory performs immunohistochemical staining on specimens other than formalin-

fixed, paraffin-embedded tissue, does the procedure manual include appropriate modifications to
address such specimens?

NOTE: Such specimens include frozen sections, air-dried imprints, cytocentrifuge or other liquid-
based preparations, decalcified tissue, and tissues fixed in alcohol blends or other fixatives.
COMMENTARY:
N/A
REFERENCE: Perkins SL, Kjeldsberg CR. Immunophenotyping of lymphomas and leukemias in

paraffin-embedded tissues. Am J Clin Pathol 1993:99(4):362-373.
**NEW** 09/30/2004
Are reagents and solutions properly labeled, as applicable and appropriate, with the following
elements?

4. Expiration date
NOTE: The above elements may be recorded in a log (paper or electronic), rather than on the
containers themselves, providing that all containers are identified so as to be traceable to the
appropriate data in the log. While useful for inventory management, labeling with "date received" is
not routinely required. There is no requirement to routinely label individual containers with "date
opened"; however, a new expiration date must be recorded if opening the container changes the
expiration date, storage requirement, etc. The inspector will describe specific issues of non-
compliance in the Inspector's Summation Report. Labeling of concentration or titer is not applicable
to prediluted reagents.
COMMENTARY:
N/A
24):7164 [42CFR493.1252(c)]; 2) NCCLS. Clinical laboratory technical procedure manuals - fourth
edition; approved guideline GP2-A4. Wayne, PA: NCCLS, 2002.

**NEW** 09/30/2004
Are all immunohistochemical reagents used within their indicated expiration dates?
COMMENTARY:
N/A
24):7164 [42CFR493.1252(c)].
Is the pH of the buffers used in immunohistochemistry routinely monitored?
NOTE: pH should be tested when a new batch is prepared or received, and periodically thereafter.
COMMENTARY:
N/A
**REVISED** 09/30/2004
Are positive tissue controls used for each antibody?
NOTE: Positive controls assess the performance of the primary antibody.
Positive controls are performed on sections of tissue known to contain the target antigen, processed
using the same fixation, epitope retrieval and immunostaining protocols as the patient tissue. A
separate tissue section may be used as a positive control, but test sections often contain normal
elements that express the antigen of interest (internal controls). Internal positive controls are
acceptable for these antigens, but the laboratory manual must clearly state the manner in which
internal positive controls are used on a case-by-case basis.
A positive control section included on the same slide as the patient tissue is optimal practice because it
helps identify failure to apply primary antibody or other critical reagent to the patient test slide;
however, one separate positive control per staining run for each antibody in the run (batch control)
may be sufficient provided that the control slide is closely scrutinized by a qualified reviewer.

Ideally, positive control tissues possess low levels of antigen expression, as is often seen in neoplasms.
Exclusive use of normal tissues that have high levels of antigen expression may result in antibody
titers of insufficient sensitivity, leading to false-negative results.
COMMENTARY:
N/A
REFERENCE: O’Leary TJ. Standardization in immunohistochemistry. Appl Immunohistochem

Molecul Morphol 2001;9:3-8.
**REVISED** 09/30/2004
Are appropriate negative controls used?
NOTE: Negative controls must assess the presence of nonspecific staining in patient tissue as well as
the specificity of each antibody.
A negative reagent control is used to assess nonspecific or aberrant staining in patient tissue related
to the antigen retrieval conditions and/or detection system used. A separate section of patient tissue is
processed using the same reagent and epitope retrieval protocol as the patient test slide, except that
the primary antibody is omitted, and replaced by any one of the following:
• An unrelated antibody of the same isotype as the primary antibody (for monoclonal primary
antibodies)
• An unrelated antibody from the same animal species as the primary antibody (for polyclonal
primary antibodies)
• The negative control reagent included in the staining kit
• The diluent/buffer solution in which the primary antibody is diluted
A separate negative reagent control should be run for each block of patient tissue being
immunostained.
The negative reagent control would ideally control for each reagent protocol and antibody retrieval
condition; however, large antibody panels often employ multiple antigen retrieval procedures. In such
cases, a reasonable minimum control would be to perform the negative reagent control using the most
aggressive retrieval procedure in the particular antibody panel. Aggressiveness of antigen retrieval
(in decreasing order) is as follows: Pressure cooker; Enzyme digestion, Boiling; Microwave;
Steamer; Water bath. High pH retrieval should be considered more aggressive than comparable
retrieval in citrate buffer at pH 6.0.

It is also important to assess the specificity of each antibody by a negative tissue control, which must
show no staining of tissues known to lack the antigen. The negative tissue control is processed using
the same fixation, epitope retrieval and immunostaining protocols as the patient tissue. Unexpected
positive staining of such tissues indicates that the test has lost specificity, perhaps because of improper
antibody concentration or excessive antigen retrieval. Intrinsic properties of the test tissue may also
be the cause of "non-specific" staining. For example, tissues with high endogenous biotin activity such
as liver or renal tubules may simulate positive staining when using a detection method based on biotin
labeling.
A negative tissue control must be processed for each antibody in a given run. Any of the following can
serve as a negative tissue control:
1. Multitissue blocks. These can provide simultaneous positive and negative tissue
controls, and are considered “best practice” (see below).
2. The positive control slide or patient test slides, if these slides contain tissue elements
that should not react with the antibody.
3. A separate negative tissue control slide.
The type of negative tissue control used (i.e., separate sections, internal controls or multitissue blocks)
should be specified in the laboratory manual (refer to ANP.22250).
Multitissue blocks may be considered best practice and can have a major role in maintaining quality.
When used as a combined positive and negative tissue control as mentioned above, they can serve as a
permanent record documenting the sensitivity and specificity of every stain, particularly when
mounted on the same slide as the patient tissue. When the components are chosen appropriately,
multitissue blocks may be used for many different primary antibodies, decreasing the number of
different control blocks needed by the laboratory. Multitissue blocks are also ideal for determining
optimal titers of primary antibodies since they allow simultaneous evaluation of many different pieces
of tissue. Finally, they are a useful and efficient means to screen new antibodies for sensitivity and
specificity or new lots of antibody for consistency, which should be done before putting any antibody
into diagnostic use.
COMMENTARY:
N/A
REFERENCES: 1) Leong AS-Y, Cooper K, Leong FJW-M. Manual of Diagnostic Antibodies for
Immunohistology. 2nd ed. London: Greenwich Medical Media; 2003; 2) Dabbs DJ. Diagnostic
Immunohistochemistry. New York: Churchill Livingstone; 2002; 3) Burry RW. Specificity controls
for immunocytochemical methods. J Histochem Cytochem 2000;48:163-166; 4) Weirauch M.
Multitissue control block for immunohistochemistry. Lab Med. 1999;30:448-449; 5) Miller RT.
Multitumor “sandwich” blocks in immunohistochemistry. Simplified method and preparation and
practical uses. Appl Immunohistochem 1993;1: 156-159; 6) Chan JKC, Wong CSC, Ku WT, Kwan
MY. Reflections on the use of controls in immunohistochemistry and proposal for application of a
multitissue spring-roll control block. Ann Diagn Pathol 2000;4: 329-336.

**NEW** 10/06/2005
If the laboratory uses an avidin-biotin complex (ABC) detection system (or a related system such
as streptavidin-biotin or neutravidin-biotin), is there a policy that addresses nonspecific false
positive staining from endogenous biotin?
NOTE: Biotin is a coenzyme present in mitochondria, and cells that have abundant mitochondria such
as hepatocytes, kidney tubules and many tumors (particularly carcinomas) are rich in endogenous
biotin. Biotin-rich intranuclear inclusions are also seen in gestational endometrium and in some
tumors that form morules. If steps are not included in the immunostaining method to block
endogenous biotin before applying the ABC detection complex, nonspecific false-positive staining may
occur, particularly when using heat-induced epitope retrieval (which markedly increases the
detectability of endogenous biotin). This artifact is often exquisitely localized to tumor cells and may
be easily misinterpreted as true immunoreactivity.
Blocking endogenous biotin involves incubating the slides with a solution of free avidin (which binds
to endogenous biotin), followed by incubation with a biotin solution (which saturates any empty biotin-
binding sites remaining on the avidin). Biotin-blocking steps should be performed immediately after
epitope retrieval and before incubation with primary antibody. A number of vendors offer reagent kits
for this purpose, but since avidin is expensive, an economical option available to laboratories involves
using dilute egg whites as a source of avidin (2 egg whites in 200 mL of distilled water). Slides are
incubated in the avidin solution at room temperature for 15 minutes. A distilled water rinse should
then be used to prevent precipitation of egg white proteins by salts present in rinsing buffers. Slides
are then placed in a 0.2% solution of biotin in rinsing buffer for 15 minutes at room temperature.
Biotin is inexpensive, but if desired, reconstituted dried nonfat milk may be used as a source of biotin
(5 gm dried milk in 100 mL of rinsing buffer). Following a buffer rinse, the primary antibody is then
applied.
COMMENTARY:
N/A
REFERENCES: 1) Miller RT, Kubier P. Blocking of endogenous avidin-binding activity in

immunohistochemistry: the use of egg whites. Appl Immunohistochem 1997; 5: 63-66; 2) Miller RT,
Kubier P, Reynolds B, Henry T. Blocking of endogenous avidin-binding activity in
immunohistochemistry: the use of skim milk as an economical and effective substitute for commercial
biotin solutions. Appl Immunohistochem & Molec Morphol 1999;7:63-65.

**REVISED** 09/30/2004
When batch controls are run, does the laboratory director or designee review all control slides
each day of patient testing?
NOTE: Records of this daily review must be maintained and should clearly document that positive
and negative controls for all antibodies stain appropriately.
COMMENTARY:
N/A
REFERENCE: Shellhorn N. IHC troubleshooting tips. Advance/Lab. 2000;9(1):33-37.
Has the laboratory documented evaluation of new antibody lots and new antibodies, prior to use
in patient diagnosis?
NOTE: For newly introduced antibodies, staining conditions should be evaluated in cases expected to
be positive and negative for the antigen of interest. Ideally, a series of sufficient size should be run to
give the laboratory an idea of the sensitivity and specificity of the test. This is particularly important
for antibodies with little available data in the literature. When sensitivity and specificity data are
well-established in the literature, the laboratory's studies should give similar results. Studies may not
be feasible for antigens such as ALK that are only seen in rare tumors. Defining optimum conditions
for such factors as antibody titer, antigen retrieval, as well as types and concentration of other
processing reagents should be a part of this evaluation. New lots of primary antibody or commercial
detection reagent should be compared to the previous lot using an appropriate panel of control
tissues.
COMMENTARY:
N/A
REFERENCE: Hsi ED. A practical approach for evaluating new antibodies in the clinical
immunohistochemistry laboratory. Arch Pathol Lab Med. 2001;125:289-294.
If automatic immunohistochemistry staining equipment is used, are records kept of

recommended maintenance?

COMMENTARY:
N/A
Are the immunohistochemical stains produced of acceptable technical quality?
NOTE: The inspector must examine examples of the immunohistochemical preparations offered by the
laboratory. A reasonable sample might include 5-10 diagnostic antibody panels.
COMMENTARY:
N/A
REFERENCE: Shellhorn N. IHC troubleshooting tips. Advance/Lab. 2000;9(1):33-37.
**NEW** 09/30/2004
For immunohistochemistry tests that provide independent predictive/prognostic information,

does the patient report include information on specimen processing, the antibody clone, and the
scoring method used?
NOTE: For immunohistochemical studies used to provide diagnostic predictive/prognostic

information independent of other histopathologic findings (e.g., hormone receptors in breast
carcinoma, HER-2/neu, EGFR), the laboratory should include the following information in the patient
report:
1. The type of specimen fixation and processing (e.g., formalin-fixed paraffin-embedded

sections, air-dried imprints, etc.)
2. The antibody clone and general form of detection system used (e.g., LSAB, polymer,
proprietary kit, etc.; information on the vendor name or type of equipment used is not
necessary)
3. Criteria used to determine a positive vs. negative result, and/or scoring system (e.g.,
percent of stained cells, staining pattern, etc.)
The laboratory should periodically compare its patient results with published benchmarks, and also
evaluate interobserver variability among the pathologists in the laboratory.
COMMENTARY:

N/A
Are immunostained slides readily available for review with the remainder of the slides from the
case?
NOTE: Laboratories performing immunohistochemical staining on referred cases may return slides to
the referring source.
COMMENTARY:
N/A
REFERENCE: Rüdiger T, et al. Quality assurance in immunohistochemistry: results of an

interlaboratory trial involving 172 pathologists. Am J Surg Pathol. 2002;26:873-882.
-----------------------------------------------------------------
FLUORESCENCE AND NON-FLUORESCENCE IN SITU HYBRIDIZATION (FISH, ISH)
-----------------------------------------------------------------
This section is intended for the application of FISH (e.g., HER-2/neu) and ISH (e.g., HPV, HBV)
techniques in histologic sections.
Is there documentation of validation of commercially available ISH and FISH probes used?
COMMENTARY:
N/A
REFERENCE: American College of Medical Genetics Laboratory. Standards and guidelines for
clinical genetics laboratories, 2nd ed. Bethesda, MD: ACMG, 1999.
Is there documentation of validation of probes that are developed in-house (including those using
class I analyte-specific reagents)?
COMMENTARY:

N/A
Are there documented procedures for scoring results, including the number of cells scored, and
are all analyses scored according to these procedures?
COMMENTARY:
N/A
Are controls (internal or external) used with and documented for each analysis?
COMMENTARY:
N/A
Is appropriate interpretation of FISH results provided in the report?
COMMENTARY:
N/A
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INSTRUMENTS AND EQUIPMENT
-----------------------------------------------------------------

.................................................................
Equipment Maintenance
.................................................................
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
and schedules for instrument maintenance must be as thorough and as frequent as specified by the
manufacturer.
Is there a schedule for checking, servicing, and maintenance of all instruments?
COMMENTARY:
N/A
Are instrument maintenance, service and repair records (or copies) promptly available to, and
usable by, the technical staff operating the equipment?
NOTE: 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
Is there evidence of ongoing evaluation of results of instrument maintenance and function for all
devices?
COMMENTARY:

N/A
.................................................................
Pipettes and Thermometers
.................................................................
NOTE TO THE INSPECTOR: This section applies if the laboratory uses volumetric pipettes, or
procedures requiring precise temperatures. Mark questions N/A that do not apply to the laboratory
being inspected.
Are pipettes that are used for quantitative dispensing of material checked for accuracy and
reproducibility at specified intervals, and results documented?
NOTE: Such checks are most simply done gravimetrically. This consists of transferring a number of
measured samples of water from the pipette to a balance. Each weight is recorded, the weights are
converted to volumes, and then means (for accuracy), and SD/CV (for imprecision) are calculated.
Alternative approaches include spectrophotometry or (less frequently) the use of radioactive isotopes,
and commercial kits are available from a number of vendors. Computer software is useful where there
are many pipettes, and provides convenient documentation. This checklist question does not apply to
Class A volumetric pipettes that meet the American Society for Testing and Materials calibration
(accuracy) specifications.
COMMENTARY:
N/A
REFERENCES: 1) Curtis RH. Performance verification of manual action pipets. Part I. Am Clin Lab.
1994;12(7):8-9; 2) Curtis RH. Performance verification of manual action pipets. Part II. Am Clin Lab.
1994;12(9):16-17; 3) Perrier S, et al. Micro-pipette calibration using a ratiometric photometer-reagent
system as compared to the gravimetric method. Clin Chem. 1995;41:S183; 4) Bray W. Software for
the gravimetric calibration testing of pipets. Am Clin Lab. Oct 1995 (available on the internet at
http://www.labtronics.com/pt_art.htm); 5) Kroll MH, et al (eds). Laboratory instrument evaluation,
verification & maintenance manual, 5th edition. Northfield, IL: College of American Pathologists,
1999:126-127; 6) Johnson B. Calibration to dye for: Artel's new pipette calibration system. Scientist.
1999;13(12):14; 7) Connors M, Curtis R. Pipetting error: a real problem with a simple solution. Parts I
and II. Am Lab News. 1999;31(13):20-22; 8) Skeen GA, Ashwood ER. Using spectrophotometry to
evaluate volumetric devices. Lab Med. 2000;31:478-479; 9) American Society for Testing and
Materials. Standard specification for glass volumetric (transfer) pipets, designation E 969-95.
Philadelphia, PA: ASTM, 1995.

Is an appropriate thermometric standard device of known accuracy (NIST-certified or

guaranteed by manufacturer to meet NIST Standards) available?
NOTE: The laboratory must have an appropriate thermometric standard device (reference
thermometer). Thermometers should be present on all temperature-controlled instruments and
environments, as applicable, and checked daily.
COMMENTARY:
N/A
Are all non-certified thermometers in use checked against an appropriate thermometric

standard device before initial use?
COMMENTARY:
N/A
.................................................................
Tissue Processor
.................................................................
Are solutions changed as needed?
NOTE: Tissue processor solutions must be changed at intervals appropriate for workload.
COMMENTARY:
N/A
REFERENCE: Baunoch DA, et al. Troubleshooting problems in processing, staining. Advance/Lab.

1999(Oct));8(10):59-64.
Is the temperature of the paraffin baths checked regularly and recorded?

COMMENTARY:
N/A
.................................................................
Paraffin Dispenser
.................................................................
Is the instrument clean and well-maintained?
COMMENTARY:
N/A
Is the temperature checked regularly and recorded?
COMMENTARY:
N/A
Is the temperature adjusted properly for the type of paraffin used?
COMMENTARY:
N/A
................................................................
Flotation Baths
.................................................................

Are flotation baths clean and well-maintained, and is there a procedure for preventing cross-
contamination of paraffin sections in the bath?
NOTE: Of particular importance are periodic water changes or blotting of the water surface so that
sections from one patient block are not inadvertently carried over to another case (so-called "floaters"
or "extraneous tissue").
COMMENTARY:
N/A
REFERENCE: Gephardt GN, Zarbo RJ. Extraneous tissue in surgical pathology. A College of
American Pathologists Q-Probes study of 275 laboratories. Arch Pathol Lab Med. 1996;120:1009-
1014.
.................................................................
Microtomes
.................................................................
Are microtomes clean, well-maintained, properly lubricated and without excessive play in the
advance mechanism?
COMMENTARY:
N/A
Are microtome knives sharp and free of nicks?
COMMENTARY:
N/A

****************************************************************************
PHYSICAL FACILITIES
****************************************************************************
**NEW** 10/06/2005
Is there adequate space for technical and clerical work?
COMMENTARY:
N/A
COMMENTARY:
N/A
Are work areas clean and well-maintained?
COMMENTARY:
N/A
----------------------------------------------------------------
STORAGE AND SUPPLY
-----------------------------------------------------------------

Is the working storage area sufficient for routine supplies?
COMMENTARY:
N/A
**REVISED** 10/06/2005
Are slides and paraffin blocks properly stored in an organized manner (i.e., accessible for
retrieval, and properly identified)?
NOTE: Slides and blocks should be stored in a manner to prevent contamination from blood or other
fluids or tissues. The storage area for blocks should be cool to prevent blocks from melting together.
COMMENTARY:
N/A
***************************************************************************
HISTOLOGY LABORATORY SAFETY
***************************************************************************
NOTE TO THE INSPECTOR: The inspector should review relevant questions from the Safety section of
the Laboratory General checklist, to assure that the histology laboratory is in compliance. Please
elaborate upon the location and the details of each deficiency in the Inspector's Summation Report.
The following questions pertain specifically to the histology laboratory.
Is each open (i.e., generative of flammable vapors into the ambient workspace) automated tissue
processor operated at least 5 feet from the storage of combustible materials and from the
paraffin dispenser?
NOTE: Each open (i.e., generative of flammable vapors into the ambient workspace) automated tissue
processor must be located at least 5 feet from the storage of combustible materials unless separated by
one-hour fire-resistive construction (NFPA 99-10- 4.2.1 (1993)). Flammable and combustible liquids,
such as in a paraffin dispenser, must not be positioned near sources of heat or ignition (NFPA

99- 10.7.2.4 (1993)). At least 5 feet must separate each open system tissue processor from the paraffin
dispenser.
Tissue processors that operate as a closed system confine ignitable vapor hazards within the processor
and thus do not pose a hazard requiring a 1.52 m (5 ft) separation.
COMMENTARY:
N/A
REFERENCE: A.11.4.2.1 (NFPA 99-2002).
Are microtome knives stored in original containers or by some other means to avoid personnel
injury or equipment damage?
COMMENTARY:
N/A
Are infectious tissues and other contaminated materials disposed of with minimum danger to
professional, technical, and custodial personnel?
NOTE: Waste disposal must be in accord with all regulations and disposed of with minimum danger
to professional, technical, and custodial personnel.
COMMENTARY:
N/A
Are there documented procedures for the special handling of tissues in the histology laboratory
from cases in which Creutzfeldt-Jakob disease is suspected?
NOTE: Neuropathology tissues from cases of Creutzfelt-Jakob disease should be treated with formic
acid. Paraffin blocks and slides prepared from formic-acid-treated tissue may be handled routinely.
If tissue has not been treated with formic acid, it must be hand-processed and treated as containing
potentially transmissible prions. Double gloves must be worn at all times when handling such tissue.

All solutions, including water washes, must be collected and treated with equal volumes of fresh
undiluted household bleach for 60 minutes before disposal. Disposables, glassware tools, etc. must be
handled according to the procedures employed in the autopsy room described elsewhere in this
checklist. All scraps of paraffin and unused sections should be collected on a disposable sheet. The
microtome may be wiped with bleach or NaOH solution. No special precautions are needed in
handling intact glass slides once they have been coverslipped. Broken slides should be
decontaminated and discarded. Paraffin blocks should be stored in a bag or box and labeled as
infectious. Alternatively, the laboratory may reseal the cut surface of the blocks with paraffin.
COMMENTARY:
N/A
REFERENCES: 1) Brown W, et al. A simple and effective method for inactivating virus activity in
formalin-fixed tissue samples from patients with Creutzfeldt-Jakob disease. Neurology.
1990;40:887-890; 2) Brown P. Guidelines for high risk autopsy cases: special precautions for
Creutzfeldt-Jakob disease. In: Hutchins G, ed. Autopsy performance and reporting. Northfield, IL:
College of American Pathologists, 1990:68-74; 3) Greenblatt, M. Q&A. Northfield, IL: College of
American Pathologists, CAP Today 1993(March);7(3):69-70; 4) Crain BJ. Safety tips for anatomic
studies of possible CJD. Northfield, IL: College of American Pathologists, CAP Today.
1996(Jan);10(1):56; 5) Rank JP. How can histotechnologists protect themselves from Creutzfeldt-
Jakob disease. Lab Med. 1999;30:305; 6) Nixon RR. Prions and prion diseases. Lab Med.
1999;30:335-338.
Are there documented procedures for safe disposal of used glass slides and paraffin blocks?
NOTE: The laboratory must follow CAP retention requirements for slides and blocks (refer to
checklist question in the “Surgical Pathology Reports” section of this checklist).
COMMENTARY:
N/A
REFERENCE: NCCLS. Clinical Laboratory Waste Management; Approved Guideline - Second

Edition GP5-A2. Wayne, PA: NCCLS, 2002.
NOTE: The following four questions apply to microwave devices used in the histology laboratory.

**NEW** 10/06/2005
Are microwave devices monitored at least annually to ensure that there is less than 5 mW/cm2
leakage at a distance of 5 cm from the surface?
COMMENTARY:
N/A
REFERENCE: Clinical and Laboratory Standards Institute. Microwave Device Use in the Histology
Laboratory; Approved Guideline. CLSI document GP28-A [ISBN 1-56238-563-1]. Clinical and
Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898
USA, 2005.
**NEW** 10/06/2005
Are microwave devices periodically monitored for temperature reproducibility?
COMMENTARY:
N/A
USA, 2005.
**NEW** 10/06/2005
Are all containers used in microwave devices made from microwave-transparent material?
NOTE: Examples of microwave-transparent materials include ceramics, sodium borosilicate glass,

unleaded quartz, fluoropolymers, and nonpolar plastics such as polypropylene, polyethylene and
PTFE compounds.
COMMENTARY:

N/A
USA, 2005.
**NEW** 10/06/2005
Are microwave devices properly ventilated?
NOTE: Microwave devices should be placed in an appropriate ventilation hood to contain airborne
chemical contaminants and potentially infectious agents. Microwave devices used outside a fume
hood should have an integral fume extractor that is certified by the manufacturer for use in a clinical
laboratory. This checklist question does not apply if only non-hazardous reagents are used in the
device (e.g., water, certain biological stains).
COMMENTARY:
N/A
USA, 2005.
###########################################################################
AUTOPSY PATHOLOGY
###########################################################################
****************************************************************************
QUALITY MANAGEMENT
****************************************************************************
The purpose of this section is to determine if there is an active program of surveillance of the quality
of autopsy diagnostic reports and utilization of the information obtained to enhance the quality of
patient care.

Is the quality management program defined and documented?
COMMENTARY:
N/A
REFERENCES: 1) McManus BM, et al. A decade of acceptable autopsy rates. Does concordance of
clinician and pathologist views explain relative success? Arch Pathol Lab Med. 1992;116:1128-1136;
2) Young NA, Naryshkin S. An implementation plan for autopsy quality control and quality assurance.
Arch Pathol Lab Med. 1993;117:531-534; 3) Hunt LW Jr, et al. Accuracy of the death certificate in a
population-based study of asthmatic patients. JAMA. 1993;269:1947-1952; 4) Haque AK, et al. High
autopsy rates at a university medical center. What has gone right? Arch Pathol Lab Med.
1996;120:727-732; 5) Pellegrino ED. The autopsy. Some ethical reflections on the obligations of
pathologists, hospitals, families, and society. Arch Pathol Lab Med. 1996;120:739-742; 6) Baker PB,
et al. Quality assurance of autopsy face sheet reporting, final autopsy report turnaround time, and
autopsy rates. A College of American Pathologists Q-Probes study of 10 003 autopsies from 418
institutions. Arch Pathol Lab Med. 1996;120:1003-1008; 7) Nemetz PN, et al. Determinants of the
autopsy decision. A statistical analysis. Am J Clin Pathol. 1997;108:175-183; 8) Schwartz DA,
Herman CJ. The importance of the autopsy in emerging and reemerging infectious diseases. Clin Inf
Dis. 1996;23:248-254; 9) Nichols L, et al. Are autopsies obsolete? Am J Clin Pathol. 1998;110:210-
218; 10) Zarbo RJ, et al. The autopsy as a performance measurement tool - diagnostic discrepancies
and unresolved clinical questions. Arch Pathol Lab Med. 1999;123:191-198; 11) Nakhleh RE, et al.
Autopsy result utilization. A College of American Pathologists Q-Probes study of 256 laboratories.
Arch Pathol Lab Med. 1999;123:290-295; 12) Hutchins GM, et al. Practice guidelines for autopsy
pathology. Autopsy reporting. Arch Pathol Lab Med. 1999;123:1085-1092; 13) Chariot P, et al.
Declining autopsy rate in a French hospital. Physicians' attitudes to the autopsy and use of autopsy
material in research publications. Arch Pathol Lab Med. 2000;124:739-745; 14) Sinard JH, et al.
Quality improvement on an academic autopsy service. Arch Pathol Lab Med. 2001;125:237-245; 15)
Bove KE, et al. The role of the autopsy in medical malpractice cases, I. A review of 99 appeals court
decisions. Arch Pathol Lab Med. 2002;126:1023-1031; 16) Sens MA, et al. Quality assurance in
autopsy pathology. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed. Northfield,
IL: College of American Pathologists: 2003; chap 37.
Are formal intra- and extra-departmental consultations documented and the reports maintained
with the patient's autopsy report?
NOTE: When formal intra- and extra-departmental consultations are obtained, they must be
documented and the reports kept with the patient autopsy report.
COMMENTARY:

N/A
REFERENCE: Tomaszewski JE, et al. Consensus conference on second opinions in diagnostic

anatomic pathology. Who, what, and when. Am J Clin Pathol. 2000;114:329-335..
Are the findings of the postmortem examination used for correlative clinicopathological teaching
purposes designed to enhance the quality of patient care?
NOTE: The autopsy has an important role in medical education and quality improvement. The value
of the final autopsy report is enhanced when the findings are used for teaching that emphasizes
clinicopathological correlations. This teaching activity should be documented and may take any of
several forms, including a correlative note in the autopsy report, interdepartmental note or summary,
or a clinical teaching conference.
COMMENTARY:
N/A
REFERENCES: 1) McPhee SJ. Maximizing the benefits of autopsy for clinicians and families. What
needs to be done. Arch Pathol Lab Med. 1996;120:743-748; 2) Feinstein AR. Epidemiologic and
clinical challenges in reviving the necropsy. Arch Pathol Lab Med. 1996;120:749-752; 3) Baker PB,
et al. Quality assurance of autopsy face sheet reporting, final autopsy report turnaround time, and
autopsy rates. A College of American Pathologists Q-Probes study of 10 003 autopsies from 418
institutions. Arch Pathol Lab Med. 1996;120:1003-1008; 4) Nakhleh RE, et al. Autopsy result
utilization. A College of American pathologists Q-Probes study of 256 laboratories. Arch Pathol Lab
Med. 1999;123:290-295; 5) Hutchins GM, et al. Practice guidelines for autopsy pathology. Autopsy
reporting. Arch Pathol Lab Med. 1999;123:1085-1092; 6) Hanzlick RL. The autopsy lexicon.
Suggested headings for the autopsy report. Arch Pathol Lab Med. 2000;124:594-603; 7) Bayer-Garner
IB, et al. Pathologists in a teaching institution assess the value of the autopsy. Arch Pathol Lab Med.
2002;126:442-447; 8) Baker PB. Communication of autopsy results. In: Collins KA, et al, eds.
Autopsy Performance and Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003;
chap 33; 9) Davis GJ, et al. The autopsy in medical education. In: Collins KA, et al, eds. Autopsy
Performance and Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 34;
10) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and
Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28.
Are the findings from autopsies incorporated into the institutional quality management
program?
COMMENTARY:

N/A
REFERENCES: 1) Suchii-Bernal L, et al. Application of an autopsy report specifically designed for

cardiovascular diseases. Arch Pathol Lab Med. 1994;118:71-78; 2) O'Leary DS. Relating autopsy
requirements to the contemporary accreditation process. Arch Pathol Lab Med. 1996;120:763-766; 3)
Nakhleh RE, et al. Autopsy result utilization. A College of American Pathologists Q-
Probes study of 256 laboratories. Arch Pathol Lab Med. 1999;123:290-295; 4) Sens
MA, et al. Quality assurance in autopsy pathology. In: Collins KA, et al, eds. Autopsy Performance
and Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 37.
Are autopsy findings that were clinically inapparent but important specifically documented and
communicated interdepartmentally?
NOTE: The form in which this is accomplished is at the discretion of the laboratory director. For
example, presentation at a clinical conference or specifically highlighting these findings in the
discussion/case summary of the autopsy report would meet this requirement. The goal is to enhance
the quality of patient care by documenting findings that were not detected antemortem.
COMMENTARY:
N/A
REFERENCES: 1) Anderson RE, et al. A model for autopsy based quality assessment of medical
diagnostics. Hum Pathol.1990;21:174-181; 2) Hill RB, et al. Autopsy-based quality assessment
program for improvement of diagnostic accuracy. Qual Assur Health Care. 1993;5: 351-359; 3)
Nakhleh RE, et al. Autopsy result utilization. a College of American Pathologists Q-Probes study of
256 laboratories. Arch Pathol Lab Med. 1999;123:290-295; 4) Sinard J, Blood D. Quality
Improvement on an academic autopsy service. Arch Pathol Lab Med. 2001;125:237-245; 5) Baker PB.
Communication of autopsy results. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd
ed. Northfield, IL: College of American Pathologists: 2003; chap 33; 6) Hutchins GM, et al. Autopsy
reporting. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed. Northfield, IL:
College of American Pathologists: 2003; chap 28.
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DEATH PROCEDURES
****************************************************************************

Are there documented instructions covering such items as receipt, storage, and release of bodies?
NOTE: In some institutions, such policies and procedures may reside in the Nursing or Security
manuals. In such cases, the laboratory should have copies of such manuals available at the time of
inspection.
COMMENTARY:
N/A
Are the instructions for body handling available at the nursing stations, admitting office,
administration, and/or other appropriate places?
COMMENTARY:
N/A
Is there a documented procedure for obtaining autopsy consent, including who may give
consent?
COMMENTARY:
N/A
REFERENCES: 1) Warren JW, et al. Organ-limited autopsies. Obtaining permission for postmortem
examination of the urinary tract. Arch Pathol Lab Med. 1995;119:440-443; 2) Saqi A, Hoda S.
Limitations on autopsy by next-of-kin: a significant hindrance to pathologic evaluation? Am J Clin
Pathol. 1998;110:512-513; 3) Chariot P, et al. Declining autopsy rate in a French hospital. Physicians'
attitudes to the autopsy and use of autopsy material in research publications. Arch Pathol Lab Med.
2000;124:739-745; 4) Bierig JR. Informed consent in the practice of pathology. Arch Pathol Lab Med.
2001;125:1425-1429; 5) College of American Pathologists documents pertaining to the autopsy. In:
Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed. Northfield, IL: College of
American Pathologists: 2003; chap 5.

Are there instructions covering possible medical examiner or coroner jurisdiction over hospital
deaths to assess the appropriateness of performing a hospital autopsy?
NOTE: To assess the appropriateness of performing a hospital autopsy, the department must be
familiar with applicable statutes and/or regulations that identify hospital deaths subject to medical
examiner or coroner jurisdiction. The department should maintain a copy of applicable statute(s)
and/or regulation(s) that identify those deaths that are in the jurisdiction of the medical examiner
and/or coroner.
COMMENTARY:
N/A
REFERENCE: Randall BB, et al. Forensic pathology. In: Collins KA, et al, eds. Autopsy Performance
and Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 7.
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AUTOPSY ROOM
****************************************************************************
Is there an autopsy room located within the institution or is there a contract/agreement with a
CAP-accredited facility to provide the service?
NOTE: If feasible, the autopsy room should be located within the institution. Requirements relating
to the physical facility, dissection, and handling of organs and tissues apply only to those cases that
are performed at the site under CAP accreditation. The pathologist should encourage off-site
facilities where autopsies are performed (e.g., funeral homes) to meet the standards expected for
on- site autopsy rooms.
COMMENTARY:
N/A
REFERENCE: Hanzlick RL, et al. Autopsy facility design. In: Collins KA, et al, eds. Autopsy
Performance and Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 14.

Are instruments clean, sharp and well-maintained?
COMMENTARY:
N/A
Is there sufficient space?
NOTE: The space should be sufficient for the workload requirements of the service.
COMMENTARY:
N/A
REFERENCES: 1) Hazlett SO. Perspectives in pathology. The newly designed morgue. Advance/Lab.
2000;9(1):10-11; 2) Hanzlick RL, et al. Autopsy facility design. In: Collins KA, et al, eds. Autopsy
Is the autopsy room clean and well-maintained?
COMMENTARY:
N/A
REFERENCES: 1) Hazlett SO. Perspectives in pathology. The newly designed morgue. Advance/Lab.
2000;9(1):10-11; 2) Baker PB. Autopsy safety. In: Collins KA, et al, eds. Autopsy Performance and
Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 11; 3) Hanzlick RL,
et al. Autopsy facility design. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed.
Northfield, IL: College of American Pathologists: 2003; chap 14.
Is the location of the autopsy room convenient in relation to other pathology and institutional
services?

COMMENTARY:
N/A
**REVISED** 10/06/2005
COMMENTARY:
N/A
Are provisions available for satisfactory storage of bodies (refrigeration or embalming)?
NOTE: For refrigeration, the temperature should be in the range of 36-40º F. (2.2-4.4º C).
COMMENTARY:
N/A
REFERENCES: 1) Hanzlick RL, et al. Autopsy facility design. In: Collins KA, et al, eds. Autopsy
2) Cooperation between pathologists and funeral directors. In: Collins KA, et al, eds. Autopsy

**REVISED** 09/30/2004
Is a scale and/or balance provided for reliable weighing of organs?
NOTE: If infants or fetuses are autopsied at the institution, accuracy of balances to 1.0 gm for infants
and 0.1 gm for fetuses must be documented by periodic calibration.
COMMENTARY:
N/A
REFERENCES: 1) Hutchins GM. Autopsy performance. In: Collins KA, et al, eds. Autopsy
2) Hanzlick RL, et al. Autopsy facility design. In: Collins KA, et al, eds. Autopsy Performance and
Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 14; 3) Bove KE, et al.
The Perinatal and Pediatric Autopsy. In: Collins KA, et al, eds. Autopsy Performance and Reporting.
2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 18.
Are ambient temperature and ventilation control adequate?
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) Hazlett SO. Perspectives in pathology. The newly
designed morgue. Advance/Lab. 2000;9(1):10-11; 3) Hanzlick RL, et al. Autopsy facility design. In:
Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed. Northfield, IL: College of
American Pathologists: 2003; chap 14.
Are photographic facilities available and convenient?
COMMENTARY:
N/A

REFERENCES: 1) Belanger AJ, et al. Implementation of a practical digital imaging system for routine
gross photography in an autopsy environment. Arch Pathol Lab Med. 2000;124:160-165; 2) Lantz PE,
et al. Photography in autopsy pathology. In: Collins KA, et al, eds. Autopsy Performance and
Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 26; 3) Hanzlick RL,
et al. Autopsy facility design. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed.
Is there a conveniently located locker and shower available for personnel participating in
autopsies?
COMMENTARY:
N/A
Are appropriate equipment and reagents available and maintained in

accordance with laboratory standards for performance of special
studies (e.g., toxicologic, microbiologic)?
NOTE: Reagents and solutions must be properly labeled, as applicable and appropriate with the
following information:

4. Expiration date
The above elements may be recorded in a log (paper or electronic), rather than on the containers
themselves, providing that all containers are identified so as to be traceable to the appropriate data in
the log. While useful for inventory management, labeling with "date received" is not routinely
required. There is no requirement to routinely label individual containers with "date opened";
however, a new expiration date must be recorded if opening the container changes the expiration date,
storage requirement, etc.
COMMENTARY:
N/A

REFERENCE: Collins KA, et al. Ancillary studies for autopsy pathology. In: Collins KA, et al, eds.
Autopsy Performance and Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003;
chap 24.
****************************************************************************
AUTOPSY PERFORMANCE AND DOCUMENTATION
****************************************************************************
Are available clinical records reviewed and/or clinical information discussed with the attending
physician before conducting the autopsy?
COMMENTARY:
N/A
REFERENCES: 1) Hutchins GM et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy
2) Hanzlick RL. The autopsy: its impact on clinical medicine, health care, and research. In: Collins
KA, et al, eds. Autopsy Performance and Reporting. 2nd ed. Northfield, IL: College of American
Pathologists: 2003; chap 31; 3) Baker PB. Communication of autopsy results. In: Collins KA, et al,
eds. Autopsy Performance and Reporting. 2nd ed. Northfield, IL: College of American Pathologists:
2003; chap 33.
Are all autopsies performed, or directly supervised, by a pathologist qualified in anatomic

pathology?
COMMENTARY:
N/A
Is a documented preliminary report of the gross pathologic diagnoses submitted to the attending
physician and the institutional record within a reasonable time (2 working days)?
COMMENTARY:

N/A
REFERENCES: 1) Zarbo RJ, et al. Quality assurance of autopsy permit form information, timeliness
of performance, and issuance of preliminary report. Arch Pathol Lab Med. 1996;120:346-352; 2)
Adickes ED, Sims KL. Enhancing autopsy performance and reporting. A system for a 5-day
completion time. Arch Pathol Lab Med. 1996;120:249-253; 3) Smith MT, Garvin AJ. Anatomic
pathology turnaround times. Use and abuse. Am J Clin Pathol 1996;106(Suppl
1):S70-S73; 4) Baker PB, et al. Quality assurance of autopsy face sheet reporting, final autopsy
report turnaround time, and autopsy rates. A College of American Pathologists Q-Probes study of 10
003 autopsies from 418 institutions. Arch Pathol Lab Med. 1996;120:1003-1008; 5) Hanzlick RL. The
autopsy lexicon. Suggested headings for the autopsy report. Arch Pathol Lab Med. 2000;124:594-603;
Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28; 7) Baker PB.
ed. Northfield, IL: College of American Pathologists: 2003; chap 33.
Are the majority of autopsy final reports produced within 30 working

days?
NOTE: The clinical and quality management value of the autopsy is enhanced by prompt reporting of
results to the referring physician and the institutional record.
COMMENTARY:
N/A
REFERENCES: 1) Adickes ED, Sims KL. Enhancing autopsy performance and reporting. A system
for a 5-day completion time. Arch Pathol Lab Med. 1996;120:249-253; 2) Smith MT, Garvin AJ.
Anatomic pathology turnaround times. Use and abuse. Am J Clin Pathol
1996;106(Suppl 1):S70-S73; 3) Baker PB, et al. Quality assurance of autopsy face sheet
reporting, final autopsy report turnaround time, and autopsy rates. A College of American Pathologists
Q-Probes study of 10 003 autopsies from 418 institutions. Arch Pathol Lab Med. 1996;120:1003-1008;
4) Hanzlick RL. The autopsy lexicon. Suggested headings for the autopsy report. Arch Pathol Lab
Med. 2000;124:594-603; 5) Bove KE, et al. The role of the autopsy in medical malpractice cases, II.
Controversy related to autopsy performance and reporting. Arch Pathol Lab Med. 2002;126:1032-
1035; 6) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and

For all cases, is the final autopsy report produced within 60 working days?
NOTE: Allowance may be needed if portions of a case are referred for external consultation, and
completion of the case is dependent upon information from such consultations (e.g., complex
neuropathology). If cases exceed 60 days, there should be documentation of the reason for the delay
and of ongoing review of this information by the director of the service.
COMMENTARY:
N/A
REFERENCES: 1) Adickes ED, Sims KL. Enhancing autopsy performance and reporting. A system
for a 5-day completion time. Arch Pathol Lab Med. 1996;120:249-253; 2) Smith MT, Garvin AJ.
Anatomic pathology turnaround times. Use and abuse. Am J Clin Pathol
1996;106(Suppl 1):S70-S73; 3) Baker PB, et al. Quality assurance of autopsy face sheet
reporting, final autopsy report turnaround time, and autopsy rates. A College of American Pathologists
Q-Probes study of 10 003 autopsies from 418 institutions. Arch Pathol Lab Med. 1996;120:1003-1008;
4) Hanzlick RL. The autopsy lexicon. Suggested headings for the autopsy report. Arch Pathol Lab
Med. 2000;124:594-603; 5) Bove KE, et al. The role of the autopsy in medical malpractice cases, II.
Controversy related to autopsy performance and reporting. Arch Pathol Lab Med. 2002;126:1032-
1035; 6) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy Performance and
**REVISED** 10/06/2005
Are gross descriptions clear and concise, are all pertinent findings
adequately described and do the descriptions support the diagnosis?
NOTE: Annotated drawings and photographs are valuable tools for documenting the autopsy
findings, but are not adequate replacements for a text description.
COMMENTARY:
N/A
REFERENCES: 1) Hutchins GM, et al. Autopsy reporting. In: Collins KA, et al, eds. Autopsy
2) Hanzlick RL, et al. The autopsy lexicon: suggested headings for the autopsy report. In: Collins KA,

et al, eds. Autopsy Performance and Reporting. 2nd ed. Northfield, IL: College of American
Pathologists: 2003; chap 29.
If microscopic descriptions are included in the report, are they clear and
concise, and do they support the diagnosis?
COMMENTARY:
N/A
When appropriate, does the report include a key or summary noting block and slide designations
to allow identification of the source of specific microscopic sections?
NOTE: At a minimum, the key should include information on laterality and on specific lesions
sampled.
COMMENTARY:
N/A
Pathologists: 2003; chap 29.
Does the final autopsy report contain sufficient information in an appropriate format so that a
physician may ascertain the patient's major disease processes and probable cause of death?
COMMENTARY:
N/A

Pathologists: 2003; chap 29; 3) Hanzlick RL. Medical certification of death and cause-of-death
statements. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed. Northfield, IL:
Are autopsy records organized and readily available for review?
COMMENTARY:
N/A
REFERENCE: Moore GW. Computer-based indexing. In: Collins KA, et al, eds. Autopsy
Are major diagnoses entered into a database that allows prompt

retrieval?
NOTE: At the facility’s discretion, this could be accomplished through the use of an electronic
database, card file, or log book, depending on the size of the database.
COMMENTARY:
N/A
REFERENCES: 1) Moore GW. Computer-based indexing. In: Collins KA, et al, eds. Autopsy
Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 28.
Are autopsy pathology records and materials retained for an appropriate period?
NOTE: There must be a documented policy for preserving the integrity of retained autopsy service
materials. The laboratory must define the period of time that such materials are retained. The
retention period shall provide for adequate quality control and potential medical care of other
individuals. In establishing retention requirements, care should be taken to comply with state and
federal regulations. Minimum requirements for autopsy pathology, providing these are not less
stringent than state and federal regulations, are:

1. Accession log records - 2 years

2. Wet tissue (stock bottle) - 3 months after final report
3. Paraffin blocks - 10 years
4. Glass slides and reports - 10 years
COMMENTARY:
N/A
REFERENCES: 1) College of American Pathologists. Guidelines for the retention of laboratory

records and materials. Northfield, IL: CAP, current edition; 2) College of American Pathologists
documents pertaining to the autopsy. In: Collins KA, et al, eds. Autopsy Performance and Reporting.
2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 5.
****************************************************************************
AUTOPSY SAFETY
****************************************************************************
NOTE TO THE INSPECTOR: The inspector should review relevant questions from the safety section
of the Laboratory General checklist, to assure that the autopsy laboratory is in compliance. Please
elaborate upon the location and the details of each deficiency in the Inspector's Summation Report.
The following questions pertain specifically to the autopsy laboratory.
Are appropriate facilities, equipment and instruments available to meet safety policies and
procedures?
NOTE: Containers must be available for contaminated waste and hazardous chemicals and policies
in place for their disposal. Equipment and apparel must be available to provide protection to eyes,
hands, and skin surfaces during autopsy performance. Procedures must be in place for the disposition
or cleaning of these items for re- use upon completion of the autopsy. Equipment that limits or
prevents spread of aerosols must be available.
COMMENTARY:
N/A
REFERENCES: 1) Baker PB. Autopsy safety. In: Collins KA, et al, eds. Autopsy Performance and
Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 1; 2) Hanzlick RL, et
al. Autopsy facility design. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed.
Northfield, IL: College of American Pathologists: 2003; chap 14; 3) Bull AD, et al. Should eye

protection be worn when performing necropsies? J Clin Pathol. 1991;44:782-; 4) Towfighi J, et al. A
protective device for performing cranial autopsies. Hum Pathol. 1989;20:288-289; 5)
Kembach-Wighton G, et al. Bone-dust in autopsies: reduction of spreading. Forensic Sci Intl.
1996;83:95-103; 6) Wetli CV. Autopsy safety. Lab Med. 2001;32:451-453.
Are safety policies and procedures for contaminated cases/specimens, hazardous chemicals, etc.
written and posted in the autopsy suite?
NOTE: The responsibility for safety of employees under OSHA regulations is clear: "the employer
must provide a job free of recognized hazards and provide warning of hazards and protective
equipment."
COMMENTARY:
N/A
REFERENCES: 1) Johnson MD, et al. Autopsy risk and acquisition of human immunodeficiency virus
infection. A case report and reappraisal. Arch Pathol Lab Med. 1997;121:64-66; 2) The implantable
cardioverter-defibrillator. A potential hazard for autopsy pathologists. Arch Pathol Lab Med.
1997;121:1076-1080; 3) Wetli CV. Autopsy safety. Lab Med. 2001;32:451-453; 4) Baker PB.
Autopsy safety. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed. Northfield, IL:
Do the safety policies and procedures provide instructions for daily

cleaning, cleaning after an autopsy, proper handling of highly infectious
cases, and disposal of tissues?
NOTE: The safety policies and procedures must include measures to reduce or eliminate hazards,
both chemical and infectious.
COMMENTARY:
N/A
Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 1; 2) Nichols WS, et
al. High risk autopsy cases. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed.

Are tables and reusable instruments and aprons adequately disinfected after use?
NOTE: The safety manual must specify the procedures used. Either autoclaving or chemical
disinfection is acceptable, but the method chosen must be adequate to inactivate the hepatitis B virus.
COMMENTARY:
N/A
Reporting. 2nd ed. Northfield, IL: College of American Pathologists: 2003; chap 11; 2) Nichols WS, et
al. High risk autopsy cases. In: Collins KA, et al, eds. Autopsy Performance and Reporting. 2nd ed.
**REVISED** 09/30/2004
Are there documented procedures for the special handling of cases in which Creutzfeldt-Jakob
disease is suspected?
NOTE: In addition to practicing universal precautions during the autopsy,

procedures must be written for the special precautions to be taken for autopsies
on patients in whom the diagnosis of Creutzfeldt-Jakob disease is suspected.
Pathologists should consider taking these special precautions as well in cases of
(a) rapidly progressive dementia, (b) dementia with seizures, especially
myoclonic seizures, and (c) dementia associated with cerebellar or lower motor
neuron signs. The recommended method for handling these brains to reduce
infectivity is immersion of tissue blocks in 95% formic acid. Aerosol formation
must be avoided during removal of the brain.
If there is any suspicion of Creutzfeldt-Jakob disease, the autopsy should be

limited to the brain, and the tissue treated as outlined below. There should be
very few exceptions to this rule.
Autopsy brain tissues should be handled as follows:
The intact brain is fixed in formalin for 1-2 weeks before cutting. Tissue blocks
(representative regions of neocortex, basal ganglia, and cerebellum) are taken,
agitated in at least 50-100 mL of 95-100% formic acid for 1 hour, and then
returned to formalin for 2 days before embedding. Alternatively, one may take
the necessary diagnostic sections from the fresh brain, fix them in formalin for

2-7 days, treat with formic acid for 1 hour, fix again in formalin for 2 days, and
then embed in paraffin. This method significantly reduces infectivity.
At the conclusion of the autopsy, the area of incision and other contaminated skin surfaces are washed
with freshly opened undiluted commercial household bleach (sodium hypochlorite). As sodium
hypochlorite deteriorates after several months, a newly opened container should be used for each
autopsy. After 10 minutes, the skin may be washed with water. All gowns, gloves, plastic sheets, and
other disposable supplies are placed in a red or orange biohazard bag and incinerated. Alternatively,
they may be autoclaved (132ºC steam) and discarded. Hard surfaces are decontaminated with freshly
opened undiluted bleach or NaOH. 1N NaOH is adequate unless there will be dilution by surface
liquid, in which case 2N NaOH should be used. Bleach and NaOH are equally effective, but NaOH is
preferred for steel instruments and surfaces because it is less corrosive than bleach. The disinfectant
should remain in contact with the surface for at least 15 and preferably 60 minutes. Autopsy
instruments should have any visible blood removed, then decontaminated with undiluted bleach or 1-
2N NaOH as above. Alternatively, they may be autoclaved for 1 hour at 132ºC and 20 psi.
For information on handling slides and blocks, refer to the checklist question in the Histology
Laboratory Safety section of this checklist.
COMMENTARY:
N/A
REFERENCES: 1) Brown PW, et al. A simple and effective method for inactivating virus activity in
formalin-fixed tissue samples from patients with Creutzfeldt-Jakob disease. Neurology.
1990;40:887-890; 2) Greenblatt, M. Q&A. In: CAP Today. 1993(March);7(3):69-70. Northfield, IL:
College of American Pathologists; 3) Brown P. Special precautions for autopsies of
patients with Creutzfeldt-Jakob disease. In: Collins KA, et al. . Autopsy
Performance and Reporting. 2nd ed. Northfield, IL: College of American
Pathologists;2003:chap 1; 4) Johnson MD, et al. Autopsy risk and acquisition of human
immunodeficiency virus infection: a case report and reappraisal. Arch Pathol Lab Med.
1997;121:64-66.
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ELECTRON MICROSCOPY
############################################################################
If the electron microscopy service is a separate and distinct laboratory in the Anatomic Pathology
section, the inspector may find it more convenient to use an additional copy of the Anatomic Pathology
Checklist for the inspection, answering all applicable questions.

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QUALITY CONTROL
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to the electron microscopy service.
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SPECIMEN COLLECTION
-----------------------------------------------------------------
Are written instructions provided for persons collecting specimens for electron microscopic study?
COMMENTARY:
N/A
Do requisitions include sources of tissue and appropriate clinical data?
COMMENTARY:
N/A
Are fixatives suitable for electron microscopy easily accessible to collection areas (such as operating
room, outpatient area(s), and autopsy room)?
COMMENTARY:
N/A

-----------------------------------------------------------------
ELECTRON MICROSCOPY SAMPLE PREPARATION
-----------------------------------------------------------------
Is the identity of every specimen maintained through each step in processing?
COMMENTARY:
N/A
Are blocks identified adequately?
NOTE: Each Epon® block of tissue must be individually labeled with unique patient identifier(s), e.g.,
accession number etched onto the block or embedded into it. Storage of unlabeled blocks in separate
containers that are labeled with patient number or name does not meet this requirement.
COMMENTARY:
N/A
Are sections of embedded tissue (face sections) reviewed by the pathologist to ensure that
appropriate areas are selected for electron microscopic examination?
COMMENTARY:
N/A
Where appropriate, are one micron sections (prepared after trimming or ultra thin sectioning) also
reviewed by the pathologist to ensure that appropriate areas have been selected?
NOTE: An example might be a mesenchymal neoplasm where confusion between tumor cells and
admixed stromal elements could occur.

COMMENTARY:
N/A
Are slides of face (semithin) and one micron sections labeled adequately?
COMMENTARY:
N/A
Are the electron micrographs identified adequately?
NOTE: Each electron micrograph must be individually labeled with unique patient identifier(s).
Unlabeled micrographs should not be stored in separate envelopes that are identified with a patient
number or name. The original magnification should be recorded on each electron micrograph.
COMMENTARY:
N/A
Examine several slides and electron photomicrographs. Are they of sufficient quality for proper
interpretation of ultrastructural changes?
COMMENTARY:
N/A
-----------------------------------------------------------------
INSTRUMENTS AND EQUIPMENT
-----------------------------------------------------------------
Are ultramicrotomes adequate and in good repair?

COMMENTARY:
N/A
Is the electron microscope under a regular maintenance and repair system?
COMMENTARY:
N/A
Is the magnification calibrated after major maintenance, as appropriate?
COMMENTARY:
N/A
Is all unscheduled service and routine maintenance documented?
COMMENTARY:
N/A
Are instrument maintenance, service, and repair records (or copies) promptly available to, and
usable by, the technical staff operating the equipment?
NOTE: Effective utilization of instruments by the technical staff depends upon the prompt availability of
maintenance, repair, and service documentation. 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
-----------------------------------------------------------------
REPORTS
-----------------------------------------------------------------
Does the report format provide for correlation with routine light microscope and other (e.g.,
immunohistochemical and immunofluorescent) studies?
COMMENTARY:
N/A
Are all reports signed by the pathologist?
NOTE: Where diagnostic reports are generated by computer or telecommunications equipment, the
actual signature or initials of the pathologist may not appear. It is nevertheless essential that the
laboratory have a procedure that ensures and documents that the responsible pathologist has reviewed
and approved the completed report before its release.
COMMENTARY:
N/A
Are copies of all reports retained by the laboratory?
COMMENTARY:
N/A
-----------------------------------------------------------------
RECORDS, FILES AND PHOTOGRAPHS
-----------------------------------------------------------------

Are specimen records organized and readily available for review?
COMMENTARY:
N/A
Are photographs properly indexed and filed in a usable manner?
COMMENTARY:
N/A
Are wet/fixed tissues retained for at least 2 weeks after the final report is released?
COMMENTARY:
N/A
Are one micron sections retained by the laboratory?
COMMENTARY:
N/A
***************************************************************************
PHYSICAL FACILITIES
**************************************************************************
Sufficient space and utilities need to be provided for the workload of the department, and to meet all
safety requirements.

Is there adequate space for preparation of sections?
COMMENTARY:
N/A
Is there adequate space for the electron microscope instrument working area?
COMMENTARY:
N/A
Is there adequate space for photographic processing?
COMMENTARY:
N/A
Is there adequate space for supply storage?
COMMENTARY:
N/A
Is there adequate space for filing of records, reports and photographs?
COMMENTARY:
N/A

****************************************************************************
LABORATORY SAFETY
****************************************************************************
NOTE TO THE INSPECTOR: The inspector should review relevant questions from the Safety section of
the Laboratory General checklist, to assure that the electron microscopy laboratory is in compliance.
Please elaborate upon the location and the details of each deficiency in the Inspector's Summation
Report.
The following questions pertain specifically to the electron microscopy laboratory.
Are safety policies and procedures established for electron microscopy sample preparations and
instrument operation?
COMMENTARY:
N/A
Is a safety hood used when handling osmium tetroxide and other volatile and hazardous material?
NOTE: OSHA 29CFR1910, subpart A, has established permissible limits for osmium tetroxide (0.006
mg/m3). Exposure to hazardous material can reasonably be controlled by a proper functioning hood.
NFPA 99 and NFPA 45 have defined fire and safety requirements for fume hoods. Additional information
can be found in the CDC/NIH "Biosafety in Microbiological and Biomedical Laboratories” (GPO stock #
017- 040-00523- 7).
COMMENTARY:
N/A
**REVISED** 09/30/2004
Are procedures adequate for the safe handling and disposal of osmium tetroxide, epoxy resins, and
other hazardous chemicals?

NOTE: Osmium tetroxide is volatile and toxic. Exposure to its vapor can lead to blindness and
serious respiratory complications. There must be a clearly stated and posted policy as to what should
be done if there is accidental spillage. Material for dealing with such a spill should be readily
available, e.g., corn oil and an absorbent such as saw dust. For U.S. laboratories, disposal of osmium
tetroxide should be according to OSHA regulations for toxic compounds. Epoxy resins are highly
allergenic, and direct contact should be avoided. The laboratory should have documentation that
personnel have been trained in the handling of these materials.
COMMENTARY:
N/A
REFERENCES: 1) Cooper K. Neutralization of osmium tetroxide in case of accidental spillage and for
disposal. Micros Soc Canada Bull. 1988;8(3):24-28; 2) Wenk PA. Disposal of histology stains. Lab
Med. 1998;29:337-338.
Has the electron microscope been checked for x-ray leakage at the time of installation and after
major repair?
NOTE: Periodic monitoring is also required for devices operating at 70,000 volts or above. Records of
radiation leakage checks must be maintained.
COMMENTARY:
N/A

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Revised: 10/06/2005

GENERAL ANATOMIC PATHOLOGY..................................................................................................................................6

ANATOMIC PATHOLOGY Page 2 of 86

NEW Checklist Questions

Question Effective Date

REVISED Checklist Questions

Question Effective Date

ANATOMIC PATHOLOGY Page 3 of 86

DELETED Checklist Questions

Question Effective Date

ANATOMIC PATHOLOGY Page 4 of 86

INSPECTION TECHNIQUES – KEY POINTS

READ = Review of Records and Documents

OBSERVE – ASK = Direct Observation and Asking Questions

Use the following techniques:

ANATOMIC PATHOLOGY Page 5 of 86

GENERAL ANATOMIC PATHOLOGY

Do NOT use this Checklist if:

ANATOMIC PATHOLOGY Page 6 of 86

ANP.02000 Phase I N/A YES NO

As applicable, does the laboratory participate in a peer educational program in anatomic

ANP.02888 Phase II N/A YES NO

Is a complete procedure manual available at the workbench or in the work area?

ANATOMIC PATHOLOGY Page 7 of 86

NOTE 1: The use of inserts provided by manufacturers is not acceptable in place of a

NOTE 2: A manufacturer's procedure manual for an instrument/reagent system may be

a. A complete manual is available for reference

ANP.03776 Phase II N/A YES NO

ANATOMIC PATHOLOGY Page 8 of 86

ANP.04664 Phase II N/A YES NO

ANP.05552 Phase II N/A YES NO

ANATOMIC PATHOLOGY Page 9 of 86

ANP.06440 Phase II N/A YES NO

ANP.07328 Phase II N/A YES NO

ANP.08216 Phase II N/A YES NO

8 hr Time-Weighted Exposure Limit Action Level ( 8 hr 15 min Short-Term

ANATOMIC PATHOLOGY Page 10 of 86

ANP.09104 Phase II N/A YES NO

ANATOMIC PATHOLOGY Page 11 of 86

ANP.10000 Phase II N/A YES NO

ANATOMIC PATHOLOGY Page 12 of 86

ANP.10016 Phase I N/A YES NO

ANATOMIC PATHOLOGY Page 13 of 86

ANP.10032 Phase I N/A YES NO

ANP.10050 Phase II N/A YES NO

ANATOMIC PATHOLOGY Page 14 of 86

ANP.10100 Phase II N/A YES NO

REFERENCES: 1) Gephardt GN, Zarbo RJ. Interinstitutional comparison of frozen section

ANP.10150 Phase II N/A YES NO

ANATOMIC PATHOLOGY Page 15 of 86

ANP.10200 Phase II N/A YES NO

Are EXTRA-departmental consultations documented, and are records of these consultations

NOTE: Documentation of extra-departmental consultations must be readily accessible within the

ANP.10250 Phase I N/A YES NO

ANATOMIC PATHOLOGY Page 16 of 86

REFERENCE: Stewardship of Pathologic Specimens. Policy Statement. College of American

SURGICAL SPECIMEN EXAMINATION

ANP.11200 Phase I N/A YES NO

ANP.11250 Phase I N/A YES NO

Is refrigerated storage available for large or unfixed specimens?

ANATOMIC PATHOLOGY Page 17 of 86

ANP.11275 Phase II N/A YES NO

ANP.11300 Phase I N/A YES NO