Hey Dave,

www.cap.org has the cap checklist you can download.  I
save you the problem by copying it on your e-mail.

Dave Low
HT(ASCP)QIHC

.................................................................
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. 
 
ANP.22200 Phase II
Is there a complete procedure manual for
immunohistochemistry available at the workbench or in
the work area?
COMMENTARY:
A documented procedure manual must be developed for
the immunohistochemistry section of the laboratory and
be available at the workbench. Its elements should
include: test principle, clinical significance,
specimen type(s), required reagents, calibration,
quality control, procedural steps, calculations,
reference intervals, and interpretation, as
applicable.
REFERENCES: 1) Tubbs RR, et al. Atlas of
immunohistology. Chicago, IL: American Society of
Clinical Pathologists Press, 1986; 2) Department of
Health and Human Services, Health Care Financing
Administration. Clinical laboratory improvement
amendments of 1988; final rule. Federal Register.
1992(Feb 28):7164 [42CFR493.1211]; 3) National
Committee for Clinical Laboratory Standards. Clinical
laboratory technical procedure manuals - third
edition; approved guideline GP2-A3. Wayne, PA: NCCLS,
1996; 4) Check W. Immunostains making the difference.
Northfield, IL: College of American Pathologists CAP
Today. 1997;11(10):1; 5) Werner M, et al. Effect of
formalin tissue fixation and processing on
immunohistochemistry. Am J Surg Pathol.
2000;24:1016-1019.
ANP.22250 Phase II
Does the procedure manual address all methods and
antibodies currently in use?
COMMENTARY:
The immunohistochemistry procedure manual must be
improved to address all methods and antibodies
currently in use.
 
ANP.22300 Phase II
Does the procedure manual address the fixative(s) used
and the use of frozen sections, air-dried imprints,
anticoagulated specimens, cytocentrifuge preparations,
decalcified specimens, etc.?
COMMENTARY:
The immunohistochemistry procedure manual must be
improved to address the various fixatives used and
items such as the use of frozen sections, air-dried
imprints, anticoagulated specimens, cytocentrifuge
preparations, bone marrow biopsies, and other
decalcified specimens. If certain combinations of
antibody and various specimen types fail to yield the
expected results, that should be noted and not used in
diagnostic specimens.
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. 
 
ANP.22350 Phase II
Is there documentation of at least annual review of
all policies and procedures in the
immunohistochemistry laboratory 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:
There must be documentation of at least annual review
of all policies and procedures in the
immunohistochemistry laboratory by the current
Laboratory Director or designee. The Director is
responsible for ensuring that the collection of
documents 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.
REFERENCES: 1) Department of Health and Human
Services, Health Care Financing Administration.
Clinical laboratory improvement amendments of 1988;
final rule. Federal Register. 1992(Feb 28):7173
[42CFR493.1407(e)(13)]; 2) National Committee for
Clinical Laboratory Standards. Clinical laboratory
technical procedure manuals - third edition; approved
guideline GP2-A3. Wayne, PA: NCCLS, 1996.
ANP.22360 Phase II
Does the Director or designee review and approve all
new policies and procedures, as well as substantial
changes to existing documents, before implementation? 
NOTE: Current practice must match the policy and
procedure documents.
COMMENTARY:
The Director or designee must review and approve all
new immunohistochemistry policies and procedures, as
well as substantial changes to existing documents
before implementation. Current practice must match
these documents. 
REFERENCES: 1) Department of Health and Human
Services, Health Care Financing Administration.
Clinical laboratory improvement amendments of 1988;
final rule. Federal Register. 1992(Feb 28):7164
[42CFR493.1211(f)]; 2) Hsi ED. A practical approach
for evaluating new antibodies in the clinical
immunohistochemistry laboratory. Arch Pathol Lab Med.
2001;125:289-294.
ANP.22370 Phase II
If there is a change in directorship, does the new
Director ensure (over a reasonable period of time)
that laboratory procedures are well-documented and
undergo at least annual review?
COMMENTARY:
If there is a change in directorship of the
immunohistochemistry laboratory, the new Director must
ensure (over a reasonable period of time) that all
immunohistochemistry laboratory procedures are
well-documented and undergo at least annual review.
REFERENCE: Department of Health and Human Services,
Health Care Financing Administration. Clinical
laboratory improvement amendments of 1988; final rule.
Federal Register. 1992(Feb 28):7164
[42CFR493.1211(e)]. 
 
ANP.22380 Phase II
When a procedure is discontinued, is a paper or
electronic copy maintained for at least 2 years,
recording initial date of use, and retirement date?
COMMENTARY:
A paper or electronic copy of a discontinued
immunohistochemistry procedure must be maintained for
at least 2 years, recording initial date of use, and
retirement date.
REFERENCE: Department of Health and Human Services,
Health Care Financing Administration. Clinical
laboratory improvement amendments of 1988; final rule.
Federal Register. 1992(Feb 28):7164
[42CFR493.1211(g)]. 
 
ANP.22390 Phase II
Does the laboratory have a system documenting that all
personnel are knowledgeable about the contents of
procedure manuals relevant to the scope of their
testing activities?
NOTE: This does not specifically require annual
procedure sign-off by testing personnel. The form of
this system is at the discretion of the Laboratory
Director.
COMMENTARY:
The immunohistochemistry laboratory must have a system
documenting that all personnel are knowledgeable about
the contents of procedure manuals relevant to the
scope of their testing activities. This does not
specifically require annual procedure sign-off by
testing personnel. The form of this system is at the
discretion of the Laboratory Director.
 
ANP.22400 Phase II
Where appropriate, are tissue and slide processing
temperatures defined and monitored?
COMMENTARY:
Tissue and slide processing temperatures may affect
the quality of immunohistochemical staining.
Monitoring of temperature must be improved.
REFERENCES: 1) Taylor CR. Immunomicroscopy: a
diagnostic tool for the surgical pathologist.
Philadelphia, PA: WB Saunders, 1986:48; 2) Elias JM.
Immunohistopathology: a practical approach to
diagnosis. Chicago, IL: American Society of Clinical
Pathologists Press, 1990:39-41. 
 
ANP.22450 Phase II
Are storage conditions of immunoreagents optimal for
maintaining expected shelf life?
COMMENTARY:
The storage conditions of the immunoreagents in use
must be improved to maintain their expected shelf
life.
REFERENCES: 1) Tubbs RR, et al. Extension of useful
reagent shelf life beyond manufacturers'
recommendations. Arch Pathol Lab Med.
1998;122:1051-1052; 2) Balaton AJ. Satisfactory
performance of primary antibodies beyond
manufacturer's recommended expiration dates. Appl
Immunohisto Mol Pathol. 1999;7:221-225. 
 
ANP.22470 Phase II
Are all reagents stored as recommended by the
manufacturer?
COMMENTARY:
Immunohistochemistry reagents must be stored as
recommended by the manufacturer to prevent
environmentally-induced alterations that could affect
test performance. If ambient temperature is indicated,
there must be documentation that the defined ambient
temperature is maintained and corrective action is
taken when tolerance limits are exceeded.
 
ANP.22500 Phase II
Is the pH of the buffers used in immunohistochemistry
routinely monitored?
COMMENTARY:
The laboratory must routinely monitor the pH of
buffers in the immunohistochemistry laboratory.
 
ANP.22550 Phase II
Are positive controls used for each antibody?
NOTE: Positive controls optimally include a separate
section of tissue known to contain the target antigen
and immunostained in identical fashion as the test
tissue. For ubiquitous antigens, internal positive
controls are acceptable, but the laboratory manual
must clearly state the manner in which internal
positive controls are used on a case-by-case basis for
quality assurance.
COMMENTARY:
Use of similarly processed positive staining controls
is essential for interpretation of immunohistochemical
reactions and must be done for each antibody.
Positive controls optimally include a separate section
of tissue known to contain the target antigen and
immunostained in identical fashion as the test tissue.
For ubiquitous antigens, internal positive controls
are acceptable, but the laboratory manual must clearly
state the manner in which internal positive controls
are used on a case-by-case basis for quality
assurance.
REFERENCE: Weirauch M. Multitissue control block for
immunohistochemistry. Lab Med. 1999;30:448-449. 
 
ANP.22570 Phase II
Are negative controls used for each antibody?
NOTE: A negative control for each primary antibody
must be used. Alternatively, buffer controls can be
used if multiple antibodies for each species are
included. The controls used should also control for
pre-treatment conditions.
COMMENTARY:
A negative control for each primary antibody must be
used. Alternatively, buffer controls can be used if
multiple antibodies for each species are included. The
controls used should also control for pre-treatment
conditions.
REFERENCE: Weirauch M. Multitissue control block for
immunohistochemistry. Lab Med. 1999;30:448-449. 
 
ANP.22600 Phase II
Are control slides and/or tissues stored properly to
ensure antigen retention?
COMMENTARY:
Because of the importance of proper controls in
immunohistochemistry, storage of these slides/tissues
must be improved.
 
ANP.22650 Phase II
Are records maintained regarding reactivity of control
tissue blocks?
COMMENTARY:
Records must be maintained regarding reactivity of
control tissue blocks in immunohistochemistry.
 
ANP.22750 Phase II
Are records maintained for evaluation of new antibody
lots and new antibodies introduced into the
laboratory?
COMMENTARY:
Records must be maintained for evaluation of new
antibody lots and for new antibodies introduced into
the immunohistochemistry laboratory.
REFERENCE: Hsi ED. A practical approach for evaluating
new antibodies in the clinical immunohistochemistry
laboratory. Arch Pathol Lab Med. 2001;125:289-294. 
 
ANP.22800 Phase II
If automatic immunohistochemistry staining equipment
is used, are records kept of recommended maintenance?
COMMENTARY:
Records must be kept of maintenance performed on
automatic immunohistochemistry equipment.
 
ANP.22850 Phase II
Are daily records maintained of the quality of
immunohistochemical preparations?
NOTE: This refers to the daily output of the
laboratory and not necessarily to individual slides.
COMMENTARY:
Daily monitoring of the quality of immunohistochemical
preparations must be documented as an important
element of quality control.
REFERENCE: Shellhorn N. IHC troubleshooting tips.
Advance/Lab. 2000;9(1):33-37. 
 
ANP.22900 Phase II
Are the immunohistochemical stains produced of
acceptable technical quality? (The inspector must
examine examples of the immunohistochemical
preparations offered by the laboratory.)
COMMENTARY:
The quality of the immunohistochemical stains must be
improved for proper interpretation.
REFERENCE: Shellhorn N. IHC troubleshooting tips.
Advance/Lab. 2000;9(1):33-37. 
 
ANP.22950 Phase I
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:
Because immunostained slides are an important
permanent component of the case, slides should be
readily available for review with the remainder of the
slides from the case. If the laboratory performs
immunohistochemical staining on referred cases, the
slides may be returned to the referring source.

--- "hpmail.netservers.net"  wrote:
> Does anyone have a CAP inspection guide for IHC that
> they could fax to me;
> or could someone give me a telephone number on how
> to get it.
> 
> Dave
> 
> 


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