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College of Physicians and Surgeons of Saskatchewan
Laboratory Accreditation Inspection Checklist
for
Anatomical Pathology
Laboratory Quality Assurance Program
3475 Albert Street
Regina, Saskatchewan S4S 6X6
Phone: (306) 787-8239
Fax: (306) 787-7240
FACILITY: __________________________________________________
Lab Licensing #: __________________________________________________
Lab QA Program/CPSS September 2007
TABLE OF CONTENTS
INTRODUCTION……………………………………………………………………….….3
Staffing…………………………………………………………………………………..…. 3
Extent of services……………………………………………………………………………4
Laboratory Space……………………………………………………………………………4
Utilities………………………………………………………………………………………5
Environment…………………………………………………………………………………6
Procedures………………………………………………………………………………….. .7
Equipment and Preventative Maintenance……………………………………………….….8
SURGICAL PATHOLOGY Collection and Accessioning…...……..………………………9
Safety in Specimen Examination……………………………………………………………13
Surgical Specimen Examination…………………………………………………………… 13
Intraoperative Consultation………………………………………………………………… 13
Histology Laboratory Storage……………………………………………………………… 15
Histology Preparation Area Safety………………………………………………………….15
Histological Preparations……………………………………………………………….….. 16
Special Stains………………………………………………………………………………. 16
Immunohistochemistry and Immunofluorescence……………………………………….….18
Surgical Pathology Reports…………………………………………………………………20
Histology Quality Assurance………………………………………………………………. 22
AUTOPSY PATHOLOGY……………………………………………………………..…..26
Autopsy Room………………………………………………………………………………26
Performance of Autopsy…………………………………………………………………… 28
Safety in Autopsy Suite……………………………………………………………………. 29
Autopsy Pathology Quality Assurance…………………………………………………….. 30
ELECTRON MICROSCOPY……………………………………………………………… 31
Specimen Collection……………………………………………………………………….. 31
Procedures………………………………………………………………………………….. 32
Sample Preparation………………………………………………………………………….32
Equipment………………………………………………………………………………….. 32
Reports………………………………………………………………………………….….. 32
Safety………………………………………………………………………………………. 33
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Lab QA Program/CPSS September 2007
AP.00 INTRODUCTION
Name of facility______________________________________________
Date of inspection_____________________________________________
Name of laboratory physician responsible for the section
____________________________________________________________
Qualifications, training and experience
____________________________________________________________
Name of technical supervisor responsible for this section
____________________________________________________________
Qualifications, training and experience
____________________________________________________________
AP.01 STAFFING
List of full time equivalents the numbers of:
Laboratory physicians ________________________
Laboratory scientists ________________________
Supervisory technologists ________________________
Technologists other than supervisors ________________________
Certified Combined Technicians ________________________
Laboratory assistants ________________________
Clerical staff ________________________
Other staff (please specify) ________________________
Laboratory Consultants:
Name of consulting pathologist(s) ________________________
Name of consulting technologist(s) ________________________
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Lab QA Program/CPSS September 2007
ANNUAL WORKLOAD WORKLOAD UNITS TESTS PER YEAR
(for both surgical and autopsies) PER YEAR
Inpatients ___________________ __________________
Outpatients ___________________ __________________
Referred in ____________________ __________________
Other ____________________ __________________
Total ____________________ __________________
AP.02 EXTENT OF SERVICES
What services are provided? ____________________________________
____________________________________________________________
________________________________________________________________________
Are specimens referred out? yes no n/a
Names of referral laboratories:
____________________________________________________________
____________________________________________________________
AP.03 LABORATORY SPACE
Total Space (m2 ) Bench Space (m)
Surgical Pathology _______________ _______________
Autopsy Suite _______________ _______________
Immunohistochemistry _______________ _______________
Electron Microscopy _______________ _______________
Total Lab _______________ _______________
Is the overall space adequate? yes no n/a
Is the space used efficiently?(if no please explain)
_________________________________________________________
Is there adequate space for:
Surgical specimen examination? yes no n/a
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Lab QA Program/CPSS September 2007
Fresh specimens and frozen sections? yes no n/a
The gross examination area should have sufficient space and
utilities to allow for proper examination of the specimens.
Histological preparations? yes no n/a
Stain preparation? yes no n/a
Administrative and clerical functions? yes no n/a
Technical functions? yes no n/a
Instrumentation? yes no n/a
Storage, including refrigeration? yes no n/a
Standard: Refrigerated storage should be provided to preserve large
or unfixed specimens.
Photography? yes no n/a
AP.04 UTILITIES
Are the benches and floors clean and uncluttered? yes no n/a
Is the garbage removed regularly? yes no n/a
Is the waste segregated and bagged properly? yes no n/a
Are there and adequate number of sinks present? yes no n/a
Are these sinks located properly to their related work stations? yes no n/a
Are the sinks of proper types? yes no n/a
Are there adequate numbers of telephones? yes no n/a
Are there adequate amounts of other communicative devices?
(faxes, e-mail, etc.) yes no n/a
Are these communication devices correctly located? yes no n/a
Is patient confidentiality ensured when using these devices? yes no n/a
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Lab QA Program/CPSS September 2007
Are sensitive electronic instruments including computers equipped with
surge protectors? yes no n/a
Are there emergency power outlets for critical areas and are these clearly
identified? yes no n/a
Are the essential instruments on dedicated power circuits? yes no n/a
Are the power outlets in the proper locations and in sufficient numbers? yes no n/a
AP.05 ENVIRONMENT
Is lighting adequate? yes no n/a
Is there emergency lighting in all critical areas? yes no n/a
Are temperature, ventilation and noise levels acceptable? yes no n/a
If not please specify ________________________________________
Are the levels of formalin and xylene monitored and documented, yes no n/a
as well as the corrective action taken if the results are out of range?
Expected Standards:
Formalin – short-term exposure limit (15 min) - 2 PPM
Formalin – time weighted average (7-8 hours) – 0.75 PPM
Xylene – short-term exposure limit (15 min) – 150 PPM
Xylene – time weighted average (7-8 hours) – 100 PPM
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 is only mandated 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 no change in
production, equipment, process or personnel or control measures that may result in new or
additional exposure to formaldehyde, and no reports of conditions that may be associated with
formaldehyde exposure. Initial monitoring of xylene levels must not exceed 100ppm (8-hr TWA)
or 150ppm (STEL). Once xylene levels are established, there is no requirement for periodic
monitoring of xylene.
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Lab QA Program/CPSS September 2007
AP.06 PROCEDURES
AP.06.001 Is there a complete set of written procedure manuals reflecting the current
methods used? (manufacturer’s package inserts may supplement but do not
replace procedure manuals) yes no n/a
Standard: The use of inserts provided by a manufacturer 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
procedure must be detailed in the procedure manual. In all
cases, appropriate reviews must occur.
AP.06.002 Is the procedure manual written in a Standardized CLSI format? (refer to CLSI
Document GP2) yes no n/a
Standard: The complete procedure manual should be written in substantial compliance and meet the intent
of the most current CLSI GP2 document.
Are the following included for each method:
AP.06.003 Principle? yes no n/a
AP.06.004 Specimen type and fixatives? yes no n/a
AP.06.005 Materials required? yes no n/a
AP.06.006 Preparations of reagents, Standards and controls? yes no n/a
AP.06.007 Step by step procedural instructions? yes no n/a
AP.06.008 Quality control instructions including steps to be taken if the
controls are unsatisfactory? yes no n/a
AP.06.009 Interpretation of results? yes no n/a
AP.06.010 Safety instructions or precautions? yes no n/a
AP.06.011 References? yes no n/a
AP.06.012 Are procedure manuals available on the workbench? yes no n/a
(the copies must agree with the original manuals)
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AP.06.013 Are all procedures reviewed yearly and signed and dated by the
pathologist in charge and all relevant staff? yes no n/a
AP.06.014 Are all recent changes signed and dated by authorized staff? yes no n/a
AP. 06.015 Does the laboratory have a system documenting that all personnel are
knowledgeable about the contents of procedure manuals? yes no n/a
AP.06.016 Are retired procedures kept on file for at least 2 years? yes no n/a
AP.07 EQUIPMENT AND PREVENTATIVE MAINTENANCE
AP.07.001 Is all equipment clean and well maintained? yes no n/a
AP.07.002 Is there a posted schedule for checking and servicing instruments? yes no n/a
AP.07.003 Does the schedule indicate that preventative maintenance activity has
occurred and that there has been review by a supervisor and designated
pathologist? yes no n/a
AP.07.004 Are the instrument maintenance and repair records readily available to the
technical staff? yes no n/a
AP.07.005 Are the tissue processor solutions changed at regular intervals and the changes
documented? yes no n/a
Standard: Tissue processor solutions must be changed at regular intervals.
AP.07.006 Is the temperature of the tissue processor checked and recorded and as
well as corrective action if any is necessary? yes no n/a
AP.07.007 Is there adequate venting of the fumes from the tissue processors,
stainers or coverslippers? yes no n/a
AP.07.008 Are fume hoods available in the appropriate numbers? yes no n/a
AP.07.009 Are fume hood air flow readings taken and documented as well as yearly
maintenance checks? yes no n/a
AP.07.010 Is the temperature of the paraffin dispensers checked and recorded? yes no n/a
AP.07.011 Is the temperature suitable for the type for paraffin being used? yes no n/a
AP.07.012 Are the flotation baths cleaned and well maintained? yes no n/a
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Lab QA Program/CPSS September 2007
Standard: Flotation baths should be cleaned between each block
(i.e. forceps or tissue wipes) so that sections from one patient block
are not inadvertently carried over to another case.
AP.07.013 Are the temperatures of the flotation baths documented if outside yes no n/a
normal parameters?
AP.07.014 If embedding centers are used, are they clean and well maintained? yes no n/a
AP.07.015 Are the embedding center temperatures taken and documented yes no n/a
if outside of normal parameters?
AP.07.016 Are the microscopes clean and well maintained? yes no n/a
AP.07.017 Are all major preventative records available? yes no n/a
AP.07.018 Are the microtomes clean, well maintained , and properly lubricated
without excessive play in the advance mechanism? yes no n/a
AP.07.019 Are the microtome knives sharp and free of nicks? yes no n/a
AP.07.020 Are the microtome knives stored safely? yes no n/a
AP.07.021 If disposable blades are used, are they disposed of safely? yes no n/a
AP.07.022 Are there posted records of maintenance for any stainers or cover- yes no n/a
slippers?
AP.08 SURGICAL PATHOLOGY COLLECTION AND ACCESSIONING
OF SPECIMENS
AP.08.001 Are requisitions prepared and specimens labeled in the operating room
or other locations where the specimen is collected? yes no n/a
AP.08.002 Do the requisitions contain:
AP.08.003 Specific patient identification? yes no n/a
AP.08.004 Secondary patient ID (e.g.: personal health number) yes no n/a
AP.08.005 Date of collection and if appropriate, time of collection yes no n/a
AP.08.006 Source of the specimen? yes no n/a
AP.08.007 Name of the submitting physician? yes no n/a
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Lab QA Program/CPSS September 2007
AP.08.008 Pertinent clinical information, history or clinical diagnosis? yes no n/a
AP.08.009 Are written instructions available to physicians and other personnel for the
proper collection of surgical pathology specimens? yes no n/a
AP.08.010 If multiple specimens are received from the same patient, on the same
procedure or day, are these all identified with the same accession
number and sub-categorized by separate numbers? yes no n/a
AP.08.011 Are specimens delivered promptly from the collection areas? yes no n/a
AP.08.012 If no, is the delay documented? yes no n/a
AP.08.013 Are there criteria for the rejection of specimens due to incorrect
labelling, insufficient specimen or unidentified specimens? yes no n/a
AP.08.014 Is there a record kept of rejected specimens as well as corrective actions? yes no n/a
AP.08.015 Are all specimens adequately fixed with the appropriate fixative and in
adequate volumes? yes no n/a
AP.08.016 Are problems with fixation documented and investigated? yes no n/a
AP.08.017 Are all surgical specimens accessioned prior to analysis? yes no n/a
AP.08.018 Is the receipt of specimens recorded in an accession book, worksheet or
computer? yes no n/a
AP.08.019 Are requisitions and slides labelled with the accession number? yes no n/a
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.
AP.08.020 If specimens are referred to other laboratories, is a record maintained of all
specimens referred out? yes no n/a
AP.08.021 Does this record include:
AP.08.022 Date of referral? yes no n/a
AP.08.023 Date of receipt of the report? yes no n/a
AP.08.024 Is there a procedure to return the specimen to the patient, when requested,
and documentation of such? yes no n/a
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AP.08.025 Is there a policy to assure chain of evidence is maintained in medical legal
situations? yes no n/a
AP.08.026 Is there a tissue exclusion list that designated types of tissues not requiring
examination by the surgical pathology department? yes no n/a
Standard: There should be an institutional policy regarding defining types of surgical specimens
(if any) that may be exempt from microscopic examinations.
AP.09 QUALITY MANAGEMENT
AP.09.001 Is the quality management program defined and documented for yes no n/a
surgical pathology?
Standard: The type of program may vary depending upon factors such as number
of staff and workload.
AP.09.002 Is there a policy that lists types of specimens (if any) that an institution yes no n/a
may choose to exclude from routine submission to the pathology
department for examination, and for recording their disposition?
Standard: 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.
AP.09.003 Is there a policy regarding what types of surgical specimens (if any) yes no n/a
may be exempt from microscopic examination?
Standard: 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.
AP.09.004 Whenever possible, is pertinent previous cytologic and/or histologic yes no n/a
material from the patient reviewed with current material being examined?
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Lab QA Program/CPSS September 2007
Standard: 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.
AP.09.005 When significant disparities exist between initial intraoperative yes no n/a
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?
AP.09.006 Does the laboratory have a policy for inclusion of INTRA-departmental yes no n/a
consultations in the patient's final report?
Standard: 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.
AP.09.007 Are EXTRA-departmental consultations documented, and are records yes no n/a
of these consultations maintained in a systematic manner within the
pathology department?
Standard: 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.
AP.09.008 When extra-departmental cases are submitted to the laboratory for yes no n/a
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?
Standard: 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.
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Lab QA Program/CPSS September 2007
AP.10 SAFETY IN SPECIMEN EXAMINATION
AP.10.001 Are appropriate personal protective devices available and used? yes no n/a
AP.10.002 Such as: gloves? yes no n/a
AP.10.003 aprons? yes no n/a
AP.10.004 gowns? yes no n/a
AP.10.005 masks? yes no n/a
AP.10.006 protective eyewear? yes no n/a
AP.10.007 face shields? yes no n/a
AP.10.008 Are sharps disposed of in a puncture resistant container? yes no n/a
AP.10.009 Are solvents disposed of safely? yes no n/a
AP.10.010 Or recycled? yes no n/a
AP.10.011 Are bulk solvent storage containers grounded? yes no n/a
AP.10.012 Is formalin disposed of safely? yes no n/a
AP.10.013 Or recycled? yes no n/a
AP.10.014 Are there formalin or xylene respirator masks available? yes no n/a
AP.10.015 Are all flammable liquids stored in fireproof cabinets? yes no n/a
AP.10.016 Are infectious tissues disposed of with minimal danger to staff? yes no n/a
AP.10.017 Are there procedures for handling tissues of suspect Creutzfeldt-Jacob
disease? yes no n/a
AP.11 SURGICAL SPECIMEN EXAMINATION
AP.11.001 Is there sufficient space for collection, examination and storage? yes no n/a
AP.11.002 Is there adequate light, water and drainage? yes no n/a
Standard: The examination area should be improved by better illumination and adequate water
and drain facilities.
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Lab QA Program/CPSS September 2007
AP.11.003 Is there refrigerated storage for large or unfixed specimens? yes no n/a
Standard: Refrigerated storage should be provided to preserve large or unfixed specimens.
AP.11.004 Is the examination area adequately ventilated to remove noxious fumes
and odors? yes no n/a
Standard: The examination area must have adequate ventilation by an exhaust fan or
fume hood to remove noxious fumes and odors.
AP.11.005 Are dictation facilities available and convenient to use? yes no n/a
Standard: Dictating facilities should be provided or improved.
AP.11.006 Is the area clean and uncluttered? yes no n/a
AP.11.007 Are photographic facilities available? yes no n/a
Standard: Facilities should be available and convenient for gross photography of surgical pathology
specimens. In addition to providing material for a teaching collection, such photographs can
serve as valuable documentation for the report.
AP.11.008 Is the identification of every specimen maintained at all times? yes no n/a
Standard: Procedures for maintaining specimen identification in all stages of processing must be improved.
NEW Are there documented procedures for handling sub-optimal yes no n/a
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)?
AP.11.009 Are all gross specimens retained for at least four weeks after the final
report is issued? yes no n/a
Standard: Gross specimens must be retained until at least 4 weeks after reports have been signed and
results reported to the referring physician.
AP.11.010 Are all specimens examined grossly by a qualified pathologist or under
the direct supervision of a qualified pathologist? yes no n/a
Standard: The gross examination of specimens must be performed by a pathologist or pathology resident, or
under the supervision of a qualified pathologist.
AP.11.011 If gross examination is done by other lab staff, are there clearly defined
protocols? yes no n/a
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Lab QA Program/CPSS September 2007
Standard: The types of specimens examined and the extent of the examination performed by a
non-pathologist must be clearly defined in a documented policy or protocol.
AP.11.012 If other lab staff does gross examination, does a qualified pathologist
do periodic evaluations of their gross dissecting? yes no n/a
Standard: There must be documentation of the nature of the pathologist supervision
(direct vs. indirect) for each type of specimen grossly examined by a non-pathologist. The
performance of non-pathologists who perform gross tissue examinations must be evaluated by the
pathologist on a regular, periodic basis.
AP.11.013 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.)?
Standard: Documented instructions or guidelines should be developed for the proper dissections,
description, and histologic evaluation, including specimen handling, of various specimen types.
These include or complicated specimen types and smaller specimens requiring special handling,
such as muscle biopsies and renal biopsies.
AP.11.014 Are gross descriptions clear, concise and do they contain adequate information regarding
type, size and/or weight of specimens, measurements and extent of gross lesions and
other information essential to the diagnosis and patient care?
Standard: Gross descriptions must be improved to provide essential information for diagnosis and patient
care.
AP.11.015 Are all microscopic analysis and diagnoses made by a qualified
pathologist? yes no n/a
Standard: All microscopic tissue examinations of surgical tissue must be performed by a pathologist and all
surgical tissue diagnosis made by a pathologist.
AP.12 INTRAOPERATIVE CONSULTATION (QUICK SECTION)
AP.12.001 Are there written guidelines for the preparation of frozen sections? yes no n/a
AP.12.002 Are the frozen specimens sectioned and stained routinely by a technologist? yes no n/a
AP.12.003 Is the slide available for examination within 15 minutes of receipt of the
specimen? yes no n/a
Standard: Frozen section interpretations should be rendered within 15 minutes of specimen arrival in the
frozen section area.
AP.12.004 Is each slide permanently stained, mounted, and labeled with the patient name
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Lab QA Program/CPSS September 2007
and/or number and retained with the rest of the slides from that case? yes no n/a
Standard: All frozen section slides must be permanently stained, mounted, properly labeled, and retained
with the rest of the case.
AP.12.005 Are the results of the frozen section examination written and signed by the
pathologist? yes no n/a
Standard: Results of surgical consultations must be documented and signed by the pathologist. The
laboratory must maintain a contemporaneous signed report of the surgical consultation. This
may be a handwritten, signed report or a computer-generated report with electronic signature.
AP.12.006 If verbal reports are given, does the pathologist speak directly to the surgeon? yes no n/a
Standard: If results of surgical consultations are given verbally, precautions must be taken to ensure that
information is transferred accurately. The pathologist should be able to talk directly with the
surgeon.
AP.12.007 Is the patient identification checked and confirmed before delivery of a
verbal report? yes no n/a
Standard: The patient's identification must be checked routinely before delivery of any verbal report.
AP.12.008 Is there a written method to ensure that different specimens held in the
cryostat at one time will not be confused? yes no n/a
AP.12.009 Are all frozen section reports made a part of the final surgical pathology
report? yes no n/a
Standard: Reports of intraoperative consultations must be made a part of the final surgical pathology
report.
AP.12.010 Is there documentation of the turnaround time between specimen receipt
and communication with the surgeon for frozen section diagnosis? yes no n/a
AP.12.011 Is the frozen section diagnosis turn around time reviewed and analyzed at
least quarterly? yes no n/a
AP.12.012 Are there established written criteria for the appropriateness of frozen
sections? yes no n/a
AP.12.013 Is there reconciliation of any discrepancies between the frozen section
diagnosis and the permanent section diagnosis? yes no n/a
AP.12.014 Are these discrepancies documented and a course of action recorded? yes no n/a
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Lab QA Program/CPSS September 2007
AP.12.015 Are there written guidelines for the decontamination of cryostats? yes no n/a
Standard: The interior of cryostats should be decontaminated regularly with 70% ethanol. Trimmings and
sections of tissue that accumulate inside the cryostat should be
removed during decontamination.
AP.12.016 Are universal precautions used when handling fresh tissue? yes no n./a
AP.13 HISTOLOGY LABORATORY STORAGE
AP.13.001 Is the working storage area sufficient for supplies? yes no n/a
AP.13.002 Are paraffin blocks stored in an appropriate, organized manner? yes no n/a
AP.13.003 Are the permanent slides stored in an appropriate manner? yes no n/a
AP.13.004 Are the paraffin blocks and slides stored –routine cases for 20 years? yes no n/a
AP.13.005 Are the paraffin blocks and slides stored - pediatric cases for 50 years? yes no n/a
AP.14 HISTOLOGY PREPARATION AREA SAFETY
AP.14.001 Is each open (i.e., generative of flammable vapors into the ambient yes no n/a
workspace) automated tissue processor operated at least 5 feet from the storage of
combustible materials and from the paraffin dispenser?
Standard: 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. Flammable and combustible liquids such as in
a paraffin dispenser must not be position near sources of heat of ignition. At least 5 feet must
separate each open system tissue processor from the paraffin dispenser.
AP.14.002 Are adequate provisions available for the examination of highly infectious
cases? yes no n/a
AP.14.003 Are contaminated tissues disposed of in a safe manner? yes no n/a
Standard: Waste disposal must be in accord with all regulations and disposed of with
minimum danger to professional, technical, and custodial personnel.
AP.14.004 Are knives stored in original containers or by some means to avoid injury
during their handling and storage? yes no n/a
Standard: Microtome knives, because of their extreme sharpness, should be kept
the original container or some other suitable device to reduce the possibility
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Lab QA Program/CPSS September 2007
of injury to personnel or damage to the knives.
NEW 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?
NEW Are microwave devices periodically monitored for temperature reproducibility?
NEW 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.
NEW 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).
AP.15 HISTOLOGICAL PREPARATIONS
AP.15.001 Is the identity of each block maintained through each step of the processing
and slide preparations? yes no n/a
Standard: 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 during the dissection. If additional blocks are
prepared at a later date, all lists and logs must reflect these additions and the blocks must be
labelled to continue the original numbering/ lettering sequence of the case. Identification number
and letter(s)/numbers(s) must be affixed to all blocks in a manner that remains legible.
AP.15.002 Are slides adequately labeled and legible? yes no n/a
Standard: All slides must be adequately identified. Relabeled glass slides must be inscribed with indelible
ink, pencil, or by etching, and include the entire identification number and descriptive letters
unique to the block from which it is cut. The permanent slide label must be legible, indelible and
have the same number and descriptive letter(s) and any other appropriate identifiers, i.e., levels
of sectioning. The original numbers on the glass slide must be readable from the underside of the
slide.
AP.15.003 Are the slides of sufficient quality for diagnosis? yes no n/a
Standard: Histopathology slides must be of adequate technical quality to be diagnostically useful.
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AP.15.004 Is there a log for section/staining quality? yes no n/a
AP.15.005 Is this log monitored and any corrective actions documented? yes no n/a
AP.15.006 Are there records maintained of the number of blocks, slides and stains
done on case? yes no n/a
Standard: Records should be maintained of the number of blocks, slides, and stains prepared.
AP.15.007 Is there appropriate records of blocks and slides sent out and returned? yes no n/a
AP.15.008 Are there procedures in place to have materials returned which have been yes no n/a
absent for more than six months?
AP.16 SPECIAL STAINS
AP.16.001 Are the special stains of high quality and are the specific tissue character-
istics for which they are intended demonstrated satisfactorily? yes no n/a
AP.16.002 Are controls run routinely on all special stains and their reactivity results
documented as well as corrective actions if necessary? yes no n/a
Standard: 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.
AP.16.003 Are the controls examined with the representative stained sample? yes no n/a
AP.16.004 Are the following stains available, including control sections:
AP.16.005 Acid-fast bacilli? yes no n/a
AP.16.006 Iron stain? yes no n/a
AP.16.007 Bacterial stain? yes no n/a
AP.16.008 Elastic stain? yes no n/a
AP.16.009 Fungus/pneumocystis stain? yes no n/a
AP.16.010 Mucin stain? yes no n/a
AP.16.011 Connective tissue stain? yes no n/a
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Lab QA Program/CPSS September 2007
AP.16.012 Myelin stain? yes no n/a
AP.16.013 Nerve fiber stain? yes no n/a
AP.16.014 PAS (with and without glycogen digestion)? yes no n/a
AP.16.015 Reticulin stain? yes no n/a
AP.16.016 Amyloid stain? yes no n/a
AP.16.017 Methyl green pyronine? yes no n/a
Standard: Special stains are of high quality, and they must satisfactorily demonstrate (on each day of use),
the tissue characteristics for which they were designed.
AP.16.018 Are the histological and histochemical stains inventoried at least annually
for proper storage and acceptable quality? yes no n/a
AP.17 IMMUNOHISTOCHEMISTRY AND
IMMUNOFLUORESCENCE
Specimen collection
AP.17.001 Are there written procedures available on the proper collection and storage
of sample material? yes no n/a
AP.17.002 Are special fixatives (e.g. IF) readily accessible to the collection sites? yes no n/a
AP.17.003 Do the specimen requisitions state the source of the tissue and appropriate
patient history? yes no n/a
AP.17.004 Is there a log kept of all specimens received? yes no n/a
Procedures
AP.17.005 Is there a complete procedure manual available for all testing? yes no n/a
AP.17.006 Are the procedure manuals available at the working bench top? yes no n/a
AP.17.007 Are these procedures reviewed annually and signed by the head pathologist
and all relevant staff? yes no n/a
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Standard: 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.
AP.17.008 Are retired procedures kept for a minimum of two years? yes no n/a
Standard: 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.
AP.17.009 Does the procedure manual address all methods and antibodies in use? yes no n/a
Standard: The immunohistochemistry procedure manual must include all methods and antibodies currently
in use.
AP.17.010 Do the procedures address the use of different fixative types and specimen
preparations? yes no n/a
Standard: The immunohistochemical procedure manual must address various fixatives used and specimens
such as , frozen sections, cytocentrifuge preparations, other non-decalcified specimens, etc.
NEW 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.
Equipment
AP.17.011 Is all the equipment well maintained and maintenance documents available
(this includes cryotomes)? yes no n/a
AP.17.012 Are the maintenance documents retained for the life of the instrument? yes no n/a
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AP.17.013 Are these records available to all relevant staff? yes no n/a
AP.17.014 Are the microwave ovens checked at least yearly for leakage? yes no n/a
AP.17.015 Is there proper ventilation for specific reagent storage? yes no n/a
AP.17.016 Are the tissue processors temperatures defined and monitored? yes no n/a
Standard: Tissue and slide processing temperatures may affect the quality of
immunohistochemical staining. Temperature monitoring must be performed.
Storage
AP.17.017 Are all permanent slides filed with the original cases? yes no n/a
Quality Control
AP.17.018 Are the reagent solutions changed at regular intervals? yes no n/a
AP.17.019 Is this documented? yes no n/a
AP.17.020 Is there a daily log kept of quality control reactivity? yes no n/a
AP.17.021 Is there a log of new reagent lot number opened stating their reactivity? yes no n/a
AP.17.022 Are there both positive and negative controls run daily for each antibody? yes no n/a
Standard: 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.
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.
NEW 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:
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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.
AP.17.023 Is the pH of buffers checked and documented on a regular basis? yes no n/a
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Standard: The laboratory must routinely monitor the pH of buffers in the immunohistochemistry laboratory.
AP.17.024 Are all the reagents/antibodies stored appropriately to maintain optimal
reactivity (according to manufacturer instructions)? yes no n/a
AP.17.025 Are control slides or tissue specimens stored properly to maintain antigen-
icity? yes no n/a
AP.17.026 Are records maintained regarding the reactivity of control tissue blocks? yes no n/a
AP.17.027 Are the stains performed of acceptable technical quality? yes no n/a
Standard: The quality of the immunohistochemical stains must be improved for proper interpretation.
AP.17.028 Are the immuno slides stored/available with the rest of the case? yes no n/a
Standard: 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.
AP.17.029 Which method of color development is used for the immunoperoxidase
stains?
AP.17.030 Are antigen retrieval methods or enhancement techniques used? yes no n/a
(please list)_________________________________________________
AP.18 SURGICAL PATHOLOGY REPORTS
Do the reports indicate:
AP.18.001 Name of the facility? yes no n/a
AP.18.002 Patient name? yes no n/a
AP.18.003 Patient identification number? yes no n/a
AP.18.004 Physician name? yes no n/a
AP.18.005 Are all reports reviewed and signed by the reporting pathologist? yes no n/a
AP.18.006 Are routine reports completed within two working days? yes no n/a
Standard: Reports on routine cases must be completed within 2 working days. Unusual,
complex or special specimens may require prolonged fixation before dissecting
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Lab QA Program/CPSS September 2007
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 laboratory.
AP.18.007 Are gross descriptions clear and concise? yes no n/a
Standard: Gross descriptions must be improved to provide essential information for
diagnosis and patient care.
AP.18.008 Do they contain adequate information regarding type, size and/or weight
of the specimen, the measurement and extent of the gross lesions? yes no n/a
AP.18.009 Do they contain the clinical diagnosis and relevant patient history? yes no n/a
AP.18.010 Do the gross descriptions include the relationship of macroscopic lesions
to the surgical margins? yes no n/a
AP.18.011 Do these descriptions include block and slide designation for special
sections i.e.: margins of resection, specific groups of lymph nodes, etc? yes no n/a
AP.18.012 Is the diagnosis supported by the gross and microscopic findings? yes no n/a
Standard: Gross descriptions and microscopic findings of surgical pathology specimens must support the
pathologic diagnosis.
AP.18.013 Does the final diagnosis provide sufficient information on tumor grade and
extent of disease for use in standard grading and staging systems? yes no n/a
Standard: 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).
AP.18.014 Is there a mechanism in place to correlate the results of specialized studies
with the morphological diagnosis? yes no n/a
Standard: The surgical pathology section must have a mechanism to correlate the results of specialized
studies (e.g., electron microscopy, immunohistochemistry, nucleic acid probes, cytogenetics) with
the morphologic diagnosis. 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.
AP.18.015 Are reports cross-referenced to allow retrieval by patient name and
diagnosis? yes no n/a
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Lab QA Program/CPSS September 2007
Standard: An index or cross-reference system must be provided to allow retrieval of
information by patient name and/or diagnosis.
AP.18.016 Is a coding system used for surgical pathology diagnoses? yes no n/a
What coding system is used? _______________________
AP.18.017 Is the coding system used for major diagnoses only? yes no n/a
AP.18.018 Are accessioning logs kept for a minimum of 2 years? yes no n/a
AP.18.019 Are the surgical reports kept indefinitely? (microfilmed or hard copy) yes no n/a
AP.18.020 Is there a policy in place to ensure the appropriate handling and document-
ation of the use, circulation, referral, transfer and receipt of original slides
and blocks, so as to ensure availability of materials for consultation and
legal proceedings? yes no n/a
Standard: There must be a policy to ensure defined handling and documentation of surgical pathology
slides/blocks for consultation and legal proceedings. This must include
the use, circulation, referral, transfer, and receipt of original slides and blocks.
AP.19 HISTOLOGY QUALITY ASSURANCE
AP.19.001 Is there a defined, documented Quality Assurance program? yes no n/a
AP.19.002 Is pertinent previous cytologic and/or histological material reviewed with
the current material being examined? yes no n/a
AP.19.003 Are intra-and extradepartmental consultations documented and maintained
with the patient’s surgical pathology report? yes no n/a
AP.19.004 When significant differences between frozen section reports and the final
diagnosis occur, are these reconciled in writing in the surgical pathology
report? yes no n/a
AP.19.005 Are these differences documented along with the resolution? yes no n/a
AP.19.006 When cases are submitted to the laboratory for consultation, are they
accessioned, a written report prepared and a copy of the report sent to
the original pathologist? yes no n/a
AP.19.007 Is there an institutional policy defining which surgical specimens may be
excluded from pathological examination? yes no n/a
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Lab QA Program/CPSS September 2007
Continuing Medical Education
AP.19.008 Is continuing medical education promoted and supported for both technol-
ogists and medical staff? yes no n/a
Quality Control
AP.19.009 Are the quality control programs explained in each procedure manual? yes no n/a
AP.19.010 Are quality control records complete? yes no n/a
AP.19.011 Are the quality control records monitored by senior staff regularly? yes no n/a
AP.19.012 Are all quality control records maintained for at least 2 years? yes no n/a
AP.19.013 Does the quality control program monitor turnaround times? yes no n/a
AP.19.014 When problems arise with the turnaround times, is there adequate docu-
mentation of the corrective actions? yes no n/a
AP.19.015 Is there a documented peer review in place that reviews previous diagnoses
(selected or random) made by the pathologists? yes no n/a
AP.19.016 Is there a documented tracking system for referred out slides and blocks
that ensures retrieval and return of material to the original institution? yes no n/a
Reagents
AP.19.017 Are all reagents labeled with:
AP.19.018 Received date? yes no n/a
AP.19.019 Date of preparation? yes no n/a
AP.19.020 Date opened? yes no n/a
AP.19.021 Expiry date? yes no n/a
Standard: Are reagents and solutions properly labeled, as applicable and appropriate.
AP.19.022 Are the appropriate reagents refrigerated? yes no n/a
AP.19.023 Are the outdated reagents disposed of safely? yes no n/a
Histological Preparations
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AP.19.024 Are all of the paraffin blocks stored in a cool area and properly identified
and accessible? yes no n/a
Standard: The temperature of the paraffin baths must be checked periodically, and results recorded.
AP.19.025 Are any tissue blocks and/or glass slides stored off site? yes no n/a
AP.19.026 Are all labels legible (blocks and slides)? yes no n/a
Instrumentation
AP.19.027 Is there clearly defined routine maintenance schedule for each instrument? yes no n/a
AP.19.028 Are there routine maintenance and troubleshooting records available for
all major instruments? yes no n/a
AP.19.029 Are all maintenance and repair records kept for 2 years after the instrument
is taken out of service? yes no n/a
AP.19.030 Are all records easily available to all staff? yes no n/a
AP.19.031 Are instructions for minor troubleshooting included in all manuals? yes no n/a
Equipment – Thermometers
AP.19.032 Are all thermometers calibrated against a recognized Standard before being
placed into service? yes no n/a
AP.19.033 Are they recalibrated each year against Standard thermometers? yes no n/a
Equipment – Balances
AP.19.034 Are analytical balances mounted on vibration-free base, away from drafts? yes no n/a
AP.19.035 Are they regularly serviced and this service documented? yes no n/a
AP.19.036 Are Standard weight(s) available? yes no n/a
AP.19.037 Are they calibrated on a monthly basis? yes no n/a
Equipment – Fume Hoods
AP.19.038 Are the filters and airflow certified annually and is it documented? yes no n/a
Safety –Flammables
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AP.19.039 Are all flammables properly stored? yes no n/a
AP.19.040 Are they disposed of following all government regulations? yes no n/a
AP.19.041 Are bulk flammables stored in a safety room or cabinet? (They must be
vented) yes no n/a
AP.19.042 Are large containers grounded? yes no n/a
AP.19.043 Are safety cans in use? yes no n/a
Safety – Chemicals
AP.19.044 Are all toxic and corrosive reagents WHMIS labeled? yes no n/a
AP.19.045 Do procedures contain precautions for handling toxic or corrosive
materials? yes no n/a
AP.19.046 Are spill kits readily available for acids, bases and mercury? yes no n/a
AP.19.047 Are there eyewashes and emergency showers located in high risk areas? yes no n/a
AP.19.048 Are the eyewashes and showers flushed regularly (with documentation) to
ensure a clean water supply? yes no n/a
Safety – Training
AP.19.049 Is there documentation of annual update in training for laboratory
staff in:
AP.19.050 General safety? yes no n/a
AP.19.051 Universal precautions? yes no n/a
AP.19.052 WHMIS? yes no n/a
AP.19.053 Transport of Dangerous Goods (if applicable)? yes no n/a
Safety – Fire
AP.19.054 Are there periodic fire drills? yes no n/a
AP.19.055 Are there sufficient fire extinguishers? yes no n/a
AP.19.056 Are the extinguisher of an appropriate type for the lab situation? yes no n/a
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Lab QA Program/CPSS September 2007
AP.19.057 Are there fire pull stations in the immediate area? yes no n/a
AP.19.058 Are personnel instructed regarding the use of extinguishers? yes no n/a
AP.19.059 Are fire blankets available in the lab? yes no n/a
AP.20 AUTOPSY PATHOLOGY
AP.20.001 Are there written procedures covering entry, storage, and release of
bodies and clear instructions for autopsy consent including whom
may give consent and the order of precedence of the next of kin? yes no n/a
Standard: There must be written instructions concerning such items as receipt,
storage and release of bodies. The institution must have a documented
procedure for obtaining autopsy consent, including a listing of who may
give consent.
AP.20.002 Are these instructions available in nursing units, admitting and other
relevant places? yes no n/a
Standard: Written body handling procedures must be available at the nursing
stations, admitting office, administration and/or other appropriate places.
AP.21 QUALITY MANAGEMENT
AP.21.001 Is the quality management program defined and documented? yes no n/a
AP.21.002 Are formal intra- and extra-departmental consultations documented and yes no n/a
the reports maintained with the patient's autopsy report?
Standard: When formal intra- and extra-departmental consultations are obtained,
they must be documented and the reports kept with the patient autopsy report.
AP.21.003 Are the findings of the postmortem examination used for correlative yes no n/a
clinicopathological teaching purposes designed to enhance the quality
of patient care?
Standard: 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.
AP.21.004 Are the findings from autopsies incorporated into the institutional quality yes no n/a
management program?
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Lab QA Program/CPSS September 2007
AP.21.005 Are autopsy findings that were clinically inapparent but important yes no n/a
specifically documented and communicated interdepartmentally?
AP.22 AUTOPSY ROOM
AP.22.001 Is the space available adequate? yes no n/a
AP.22.002 Is a record book kept for recording admission and release of bodies
as well as the signatures of those involved? yes no n/a
AP.22.003 Are the instruments sharp, clean and well maintained? yes no n/a
Standard: Dissection equipment and instruments should be sufficient, cleaned,
and well maintained.
AP.22.004 Is the autopsy room clean and well maintained? yes no n/a
Standard: The cleanliness and maintenance of the autopsy room should be maintained.
AP.22.005 Is the location of the autopsy room convenient to other pathology
services? yes no n/a
Standard: The location of the autopsy room should be conveniently located in relation
to other pathology services.
AP.22.006 Is the lighting satisfactory? yes no n/a
AP.22.007 Is the emergency lighting adequate for safe termination of an
Autopsy, if the main lighting should fail? yes no n/a
AP.22.008 Is there adequate provision for refrigeration of bodies? yes no n/a
AP.22.009 Are X-ray facilities available? yes no n/a
AP.22.010 Is there a scale or balance for the weighing of organs? yes no n/a
AP.22.011 Are the scales serviced or calibrated regularly? yes no n/a
AP.22.012 Is ventilation adequate to eliminate or reduce noxious fumes? yes no n/a
AP.22.013 Are the levels of formalin monitored and documented,
as well as the corrective action taken if results are out of range? yes no n/a
AP.22.014 Expected Standard for formalin:
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Lab QA Program/CPSS September 2007
AP.22.015 Short-term exposure (15 minutes) – 2 PPM
AP.22.016 Time-weighted exposure (7-8 hours) – 0.75 PPM
AP.22.017 Are photographic facilities available and close at hand? yes no n/a
AP.22.018 Is a change room and shower facilities available? yes no n/a
Standard: A conveniently located, locker and shower area must be provided for personnel participating in
autopsies.
AP.22.019 Is there appropriate materials close at hand to perform special testing
(e.g. toxicology, virology or microbiology)? yes no n/a
Standard: Because special studies may be critical in autopsies, equipment and materials for performance of
these studies must be provided.
AP.23 PERFORMANCE OF AUTOPSY
AP.23.001 Are clinical records reviewed or clinical information discussed with the
attending prior to performance of the autopsy? yes no n/a
Standard: The autopsy is an important medical and medical legal consultation and, therefore, available
records must be reviewed and/or clinical information discussed with the attending physician
before conducting the autopsy.
AP.23.002 Are autopsies performed or directly supervised by a qualified pathologist? yes no n/a
Standard: All autopsies must be performed or directly supervised by a pathologist qualified in anatomic
pathology.
AP.23.003 Is a written preliminary report of the gross pathology findings issue for the
attending physician and institutional record with 2 working days? yes no n/a
Standard: A documented preliminary report of the gross autopsy findings must be provided within 2
working days.
AP.23.004 Is the final autopsy report issued within a reasonable period (30 days for
routine cases and 90 days for complicated cases)? yes no n/a
Standard: The majority of autopsy final reports should be produced within 30 days. The
clinical and quality improvement value of the autopsy is enhanced by prompt
reporting of results to the referring physician and the institutional record.
AP.23.005 Is there documentation of when cases are completed, as well as the corrective
action, where the completion fell out of these ranges? yes no n/a
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AP.23.006 Are the gross and microscopic descriptions clear and adequately described? yes no n/a
Standard: Autopsy gross and microscopic descriptions must be clear, concise and adequate.
AP.23.007 Do microscopic descriptions (if included) support the diagnosis? yes no n/a
AP.23.008 Where appropriate, does the report include a key noting block and slide
to allow identification of the specific site of origin of the microscopic
sections? yes no n/a
Standard: Autopsy reports must include a key or summary noting block and slide designations for special
sections
AP.23.009 Does the final report contain sufficient information to determine the
patients major disease processes? yes no n/a
Standard: The information included in the final autopsy report must be improved, so that the reader may
more readily ascertain the patient's major disease processes and probable cause of death.
AP.23.010 Are major diagnoses coded? yes no n/a
Standard: An index of autopsy cases by major diagnoses should be maintained.
AP.23.011 Are wet tissues retained for 3 months after the issuance of the final report? yes no n/a
AP.23.012 Are the accessioning logs kept at least 2 years? yes no n/a
AP.23.013 Are paraffin blocks and slides retained for 20 years? yes no n/a
AP.23.014 Are the reports retained indefinitely? yes no n/a
AP.23.015 Is there a process in place to track blocks and slides referred out and
returned, to ensure availability of materials for consultation and legal
purposes? yes no n/a
Standard: There must be a policy to ensure defined handling and documentation
of circulation referral, transfer and receipt of original slides and blocks,
for consultation and legal proceedings.
AP.24 SAFETY IN AUTOPSY SUITE
AP.24.001 Are there written safely procedures in the autopsy suite? yes no n/a
AP.24.002 Are there appropriate facilities and equipment to meet the safety policies
and procedures? yes no n/a
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Lab QA Program/CPSS September 2007
Standard: 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.
AP.24.003 Are the provisions for lifting and moving bodies adequate? yes no n/a
AP.24.004 If an electric bone saw is used, are there methods in place to help minimize
the creation of aerosols? yes no n/a
AP.24.005 Do the safety procedures include instructions for cleaning and proper hand-
ling of infectious cases as well as disposal of contaminated tissue? yes no n/a
Standard: Safety policies must be improved to provide instructions for daily cleaning,
cleaning after an autopsy, proper handling of highly infectious cases,
disposal of contaminated tissues. The safety manual must reflect
procedures that reduce or eliminate hazards, both chemical and infectious.
AP.24.006 Are there policies and procedures provides for the examination of highly
infectious cases? yes no n/a
AP.24.007 Are the facilities adequately disinfected after autopsies? yes no n/a
Standard: Tables, instruments and protective apparel (aprons or gowns) must be
disinfected before re-use. The safety manual must specify the procedures
to be used. Either autoclaving or chemical disinfection is acceptable, but
the method chosen must be adequate to inactivate the Hepatitis B virus.
AP.24.008 Are there written procedures for the special handling of cases with
suspected spongiform encephalopathy and other cases of undiagnosed
encephalopathy? yes no n/a
Standard: Safety policies and 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,
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.
AP.25 AUTOPSY PATHOLOGY QUALITY ASSURANCE
AP.25.001 Is there a documented quality assurance program? yes no n/a
AP.25.002 Does the autopsy report contain correlative statements designed to enhance
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Lab QA Program/CPSS September 2007
the quality of patient care? yes no n/a
AP.25.003 Are autopsy findings incorporated into the institutional Quality Assurance
Program? yes no n/a
Standard: To enhance the value of the autopsy, the findings should be incorporated into the institutional
quality improvement program.
AP.25.004 Do the autopsy reports include:
AP.25.005 Date of death? yes no n/a
AP.25.006 Name of the requesting physician/health care provider? yes no n/a
AP.25.007 Testing required (limited or full autopsy)? yes no n/a
AP.25.008 Date and time of autopsy? yes no n/a
AP.24.009 Name of the pathologist involved, as well as anyone assisting? yes no n/a
AP.25.010 Are the temperatures monitored and documented for the refrigerators
used to store bodies? yes no n/a
AP.25.011 Is there documentation of annual update in training for all laboratory
staff in:
AP.25.012 General safety? yes no n/a
AP.25.013 Universal precautions? yes no n/a
AP.25.014 WHMIS? yes no n/a
AP.25.015 Transport of Dangerous Goods (if applicable)? yes no n/a
AP.26 ELECTRON MICROSCOPY
AP.26.001 Is the available space adequate:
AP.26.002 To perform the work in a safe, effective manner? yes no n/a
AP.26.003 For section preparation? yes no n/a
AP.26.004 For instrument working area? yes no n/a
AP.26.005 For photographic process? yes no n/a
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Lab QA Program/CPSS September 2007
AP.26.006 For storage, supply, filing of records, etc.? yes no n/a
AP.27 SPECIMEN COLLECTION
AP.27.001 yes no n/a
Are there written instructions provided for persons collecting sample for
EM examinations?
AP.27.002 Do requisitions include sources of tissue and appropriate data? yes no n/a
AP.27.003 Are EM fixatives readily accessible to collection areas? yes no n/a
AP.28 PROCEDURES
AP.28.001 Is there a complete procedure manual written in a coherent manner
consistent with the format of other surgical pathology manuals? yes no n/a
AP.29 SAMPLE PREPARATION
AP.29.001 Is the identity of all tissues maintained through each step in processing? yes no n/a
AP.29.002 Are the blocks identified adequately? yes no n/a
AP.29.003 Are sections of embedded tissue reviewed by the pathologist to ensure that
appropriate portions are selected for electron microscope examination? yes no n/a
AP.29.004 Are one micron sections prepared after trimming, also reviewed by the path-
ologist to ensure that appropriate areas have been selected? yes no n/a
AP.29.005 Are slides and electron micrographs adequately identified? yes no n/a
AP.29.006 Are slides and electron micrographs of adequate quality? yes no n/a
AP.30 EQUIPMENT
AP.30.001 Is the ultramicrotome adequate and in good repair? yes no n/a
AP.30.002 Is a stereo microscope used? yes no n/a
AP.30.003 Is the electron microscope suitable for the type of service offered? yes no n/a
AP.29.004 Are regular maintenance and repair schedules documented? yes no n/a
AP.30.005 Is the magnification calibrated after major service? yes no n/a
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Lab QA Program/CPSS September 2007
AP.30.006 Are all scheduled and unscheduled maintenance activities documented? yes no n/a
AP.30.007 Are maintenance records available to staff? yes no n/a
AP.31 REPORTS
AP.31.001 Does the report include correlation with light microscopic and immuno-
pathology reports? yes no n/a
Standard: The report format must provide for correlation with light or immunofluorescence microscopy.
AP.31.002 Are all reports signed by a pathologist? yes no n/a
AP.31.003 Are records organized and readily available for review? yes no n/a
AP.31.004 Are photographs labeled, indexed and filed in a suitable manner? yes no n/a
AP.31.005 Are wet tissues retained until final reports are completed? yes no n/a
Standard: Wet or fixed tissues should be retained for at least 2 weeks after the final
report is released.
AP.31.006 Are one micron sections retained? yes no n/a
AP.32 SAFETY
AP.32.001 Are safety policies and procedures established for EM sample preparation? yes no n/a
AP.32.002 Is a safety hood available for use with osmium tetroxide and other volatile
substances? yes no n/a
Standard: A safety hood must be provided for use with osmium tetroxide and other
volatile or hazardous materials.
AP.32.003 Is there a policy to deal with spillage and disposal of osmium tetroxide? yes no n/a
Standard: 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.
AP.32.004 Is the electron microscope checked periodically for radiation leakage? yes no n/a
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Lab QA Program/CPSS September 2007
Standard: The electron microscope must be checked for radiation leakage at time
of installation and after major repair. periodic monitoring is also required
for devices operating at 70,000 volts or greater, as these can produce hard
x-rays records of radiation leakage checks must be maintained.
These standards have been referenced to current available standards and good laboratory practice.
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