CAP Accreditation Checklists – 2023 Edition

The College of American Pathologists (CAP) accreditation checklists contain the CAP accreditation
program requirements, developed on more than 50 years of insight and pathology expertise. The following
is a complete list of the CAP accreditation checklists:

CHECKLISTS SUBDISCIPLINES DESCRIPTION OF CONTENTS

All Common N/A • Proficiency testing
• Policy and procedure manuals
• Specimen collection and handling
• Quality management
• Reporting of results
• Reagents
• Instruments and equipment
maintenance/function checks
• Thermometers and temperature-
dependent equipment and
environments
• Pipettes and analytical balances
• Waived test implementation
• Test method validation/verification –
nonwaived tests
• Individualized quality control plans

Anatomic Pathology • Anatomic Pathology • Surgical pathology

Processing • Intra-operative consultation
• Autopsy Pathology • Fine-needle aspiration
• Circulating Tumor Cell • Histology
Analysis • Immunochemistry and
• Digital Image Analysis immunofluorescence microscopy
• Electron Microscopy • In situ hybridization (ISH)
• Flow Cytometry Data • Predictive marker testing
Interpretation • Digital image analysis
• Intra-operative Consultation • Flow cytometry data interpretation
• In Vivo Microscopy • Circulating tumor cell analysis
• Molecular Anatomic • Autopsy pathology
Pathology • Forensic pathology
• Surgical Pathology • Electron microscopy
• In vivo and ex vivo microscopy

Biorepository • General Specimen • Quality management

Processing • Biospecimen collection and
• Specimen handling
Collection/Procurement • Biospecimen processing and
quality, including DNA/RNA
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 • Specimen Distribution and extraction/amplification, cell
Agreements fractionization, cell and tissue
• Specimen Informatics culture, and histology
• Specimen Storage • Specialized techniques, such as
whole slide imaging, digital image
analysis, tissue microarray, laser
capture microdissection, and
molecular methods
• Inventory management system
• Storage
• Source and sponsor facilities
• Informed consent and institutional
review board
• Distribution policies and
agreements

Chemistry and • Blood Gases • Automated chemistry procedures

Toxicology • Chemistry • Blood gas analysis
• Special Chemistry • Therapeutic drug monitoring
• Toxicology • Toxicology screening and
confirmatory testing
• Prenatal screening
• Cystic fibrosis sweat testing
• Tumor marker, immune system, and
infectious disease immunoassays
• Hemoglobin separation
• Methods, such as thin layer
chromatography (TLC), gas
chromatography (GC), high
performance liquid chromatograph
(HPLC), mass spectrometry (MS),
Imaging MS, atomic absorption,
radioimmunoassay (RIA), and
electrophoresis

Clinical Biochemical • Clinical Biochemical • Diagnostic testing for inborn errors

Genetics Genetics of metabolism
• Newborn Screening • Methods, such as enzyme assays,
TLC, GC, HPLC, MS,
electrophoresis, and RIA
• Newborn screening

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 Cytogenetics • Conventional Cytogenetics • Cytogenetic studies for
• Genomic Copy Number constitutional and neoplastic
Microarray disorders
• In Situ Hybridization • ISH for constitutional and neoplastic
• Remote Data Assessment disorders, including predictive
marker testing
• Digital image analysis
• Genomic copy number analysis
using arrays

Cytopathology • Cytology Processing • Cytology processing and staining

• Cytology Screening • Cytology screening, manual and
• Gynecologic Cytopathology automated
• Non-gynecologic • Immunocytochemistry, including
Cytopathology predictive marker testing
• Gynecologic cytopathology
• Non-gynecologic cytology (including
fine-needle aspiration)

Director Assessment N/A • Laboratory director qualifications

• Laboratory director responsibilities

Flow Cytometry • Flow Cytometry • Blood lymphocyte subset

enumeration
• CD34 stem cell enumeration
• Leukemia and lymphoma
immunophenotyping
• DNA content and cell cycle analysis
• Rare event flow cytometric assays

Forensic Drug • Drug Testing – Hair • Non-medical drug testing

Testing • Drug Testing – Meconium • Screening and confirmatory testing
• Drug Testing – Nails for different specimen types (urine,
• Drug Testing – Oral fluid blood, oral fluid, hair, meconium,
• Drug Testing – Umbilical umbilical cord, and nails)
Cord • Specimen handling and chain-of-
• Drug Testing – Urine custody
• Drug Testing – Urine Screen • Certification/inspection of results
Only • Methods, such as immunoassays,
• Drug Testing – Whole Blood LC, GC, and MS

Hematology and • Body Fluid Analysis • CBC and differentials, automated

Coagulation • Coagulation and manual
• Hematology
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 • Reticulocytes, automated and
manual
• Bone marrow preparations
• Abnormal hemoglobin detection
• Blood film examination for
microorganisms
• Semen analysis, automated and
manual
• Routine coagulation assays
• Specialized coagulation assays,
including factor assays, mixing
studies, D-dimer, electrophoresis
studies, platelet function assays,
and viscoelastic testing.

Histocompatibility • Clinical Transplantation • HLA testing by serologic, molecular,

Support flowcytometry, immunoassay, and
• HLA Cellular Functional solid phase methods
Tests • Class I and II antigen typing
• HLA Flow Cytometry • HLA antibody screening,
• HLA Serology identification, and crossmatching
• HLA Solid Phase Assays • DNA typing, including low and high
• HLA Molecular Non-NGS resolution typing, and DNA
sequence-based typing
• Donor-recipient histocompatibility,
including renal, hematopoietic
progenitor cell, and non-renal organ
transplants
• Hematopoietic progenitor cell
engraftment and monitoring

Immunology • Immunology • General immunology assays,

manual and automated
• Immune system profiles
• Tumor marker and infectious
disease immunoassays
• Microbial antigen testing
• Waived molecular-based
microbiology tests
• ABO/Rh and antibody screening
(non-transfusion related)
• Syphilis serology
• HIV Primary diagnostic testing
• Western blot

Laboratory General N/A • Quality management system

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 • Specimen collection
• Chain-of-custody specimen
collection and handling
• Direct-to-consumer testing
• Specimen transport and tracking
• Result reporting
• Quality of water
• Laboratory computer services
• Telepathology and remote data
assessment
• Whole slide imaging
• Personnel
• Physical facilities
• Laboratory Safety
• California laboratory licensure
requirements

Limited Service • Body Fluid Analysis Contains a limited subset of

• Coagulation requirements from the checklists,
• Hematology including:
• Blood Gas Analysis • Automated and manual hematology
• Chemistry testing, including CBC,
• Special Chemistry reticulocytes, and differentials
• Toxicology • Routine coagulation assays
• Bacteriology • Body fluid analysis, including semen
• Parasitology analysis
• Mycology • Automated general chemistry
• Virology • Blood gas analysis
• Urinalysis • Therapeutic drug monitoring
• Immunology • Screening for drugs of abuse
• Immunohematology • Tumor marker and infectious
disease immunoassays
• Urinalysis dipstick and microscopy,
manual and automated methods
• Microbiology specimen set up,
direct specimen examination,
stains, and antigen typing for
various subdisciplines
• General immunology assays,
including anti-nuclear antibody
testing, HIV primary diagnostic
testing, and immune system profiles
• Microbial antigen/antibody testing
• Non-transfusion-related
immunohematology testing
• Syphilis serology

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 • Waived molecular based
microbiology tests

Microbiology • Bacteriology • Culture setup, staining, antigen

• Molecular Microbiology typing, screening, identification, and
• Mycobacteriology susceptibility testing for
• Mycology bacteriology, mycology,
• Parasitology mycobacteriology, and virology
• Virology • Parasitology, including stool for ova
and parasites and blood films for
microorganisms
• Molecular microbiology, including
waived and non-waived FDA-
cleared/approved methods,
modified methods, and laboratory-
developed methods
• Microbial identification, using
methods such as MALDI-TOF MS,
GC, HPLC, ISH, target and signal
amplification, and sequencing

Molecular Pathology • Inherited Genetics • Clinical molecular genetics testing,

• Molecular Oncology – including oncology, inherited
Hematologic Diseases disease, pharmacogenomics, HLA,
• Molecular Oncology – Solid forensic identity, and relationship
Tumor testing applications
• Infectious Disease NGS • Molecular assay validation
• HLA NGS • ISH for constitutional and neoplastic
disorders, including predictive
marker testing
• Methods, such as electrophoresis,
PCR, arrays, digital image analysis,
and sequencing
• Next-generation sequencing for
inherited diseases, including non-
invasive screening of maternal
plasma to detect fetal trisomy,
inherited diseases, oncology,
infectious disease, and HLA.
• Hematopoietic progenitor cell
engraftment monitoring

Point-of-Care Testing • POCT – Nonwaived • Tests performed at or near the

(POC) • POCT – Provider-Performed patient bedside (non-dedicated
Microscopy and Limited space)
Waived Testing

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 • POCT - Waived • Waived and moderate-complexity
testing
• Kit tests or hand-carried instruments
transported to the patient location
• Blood gas analysis
• D-dimer studies
• HIV primary diagnostic testing
• Waived molecular-based
microbiology testing
• Provider-performed microscopy

Reproductive • Andrology • Complete semen analysis,

Laboratory Medicine • Embryology automated and manual methods
• Biochemical testing
• Anti-sperm antibody testing
• Sperm processing for therapeutic
insemination
• Embryology procedures
• Embryo and gamete
cryopreservation
• Donor reproductive cell/tissue
programs

Transfusion Medicine • Cellular Therapy Services • Immunohematology testing, manual

• Donor Services and automated
• Immunohematology • Compatibility testing, including
• Tissue Storage and Issue computer crossmatches
• Transfusion Services • Perinatal testing
• Transfusion procedures and
adverse reactions
• Therapeutic phlebotomy
• Donor and therapeutic apheresis
• Component preparation, storage,
and modification
• Cellular therapy
• Tissue storage and issue
• Donor section, collection, and
testing

Urinalysis • Urinalysis • Urinalysis dipstick, automated and

manual methods
• Manual urine microscopy
• Automated microscopy systems

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