CMS-Approved Accreditation Organizations
A lab can meet CLIA through accreditation instead of a state survey, but only with an organization CMS has approved. CMS lists 7, ACHC included. Of those, 5 may accredit every CLIA specialty; AABB and ASHI hold narrower scopes built around the blood bank and histocompatibility.
Approved organizations by specialty
Rows are the organizations, lettered in the order of CMS's list; columns are the specialties and subspecialties on CMS's September 2026 matrix, split into two plates. A filled well means CMS marks the organization approved for that column; a blank well means it does not.
- approved per the CMS list
- not listed
Scroll sideways for more specialties
| Organization | 1Bacteriology | 2Mycobacteriology | 3Mycology | 4Parasitology | 5Virology | 6General immunology | 7Syphilis serology | 8Routine chemistry | 9Urinalysis | 10Endocrinology | 11Toxicology | 12Hematology |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AAssociation for the Advancement of Blood & Biotherapies (AABB) | Association for the Advancement of Blood & Biotherapies (AABB), Bacteriology: approved | Association for the Advancement of Blood & Biotherapies (AABB), Mycobacteriology: not listed | Association for the Advancement of Blood & Biotherapies (AABB), Mycology: approved | Association for the Advancement of Blood & Biotherapies (AABB), Parasitology: approved | Association for the Advancement of Blood & Biotherapies (AABB), Virology: approved | Association for the Advancement of Blood & Biotherapies (AABB), General immunology: approved | Association for the Advancement of Blood & Biotherapies (AABB), Syphilis serology: approved | Association for the Advancement of Blood & Biotherapies (AABB), Routine chemistry: approved | Association for the Advancement of Blood & Biotherapies (AABB), Urinalysis: not listed | Association for the Advancement of Blood & Biotherapies (AABB), Endocrinology: not listed | Association for the Advancement of Blood & Biotherapies (AABB), Toxicology: approved | Association for the Advancement of Blood & Biotherapies (AABB), Hematology: approved |
| BAmerican Association for Laboratory Accreditation (A2LA) | American Association for Laboratory Accreditation (A2LA), Bacteriology: approved | American Association for Laboratory Accreditation (A2LA), Mycobacteriology: approved | American Association for Laboratory Accreditation (A2LA), Mycology: approved | American Association for Laboratory Accreditation (A2LA), Parasitology: approved | American Association for Laboratory Accreditation (A2LA), Virology: approved | American Association for Laboratory Accreditation (A2LA), General immunology: approved | American Association for Laboratory Accreditation (A2LA), Syphilis serology: approved | American Association for Laboratory Accreditation (A2LA), Routine chemistry: approved | American Association for Laboratory Accreditation (A2LA), Urinalysis: approved | American Association for Laboratory Accreditation (A2LA), Endocrinology: approved | American Association for Laboratory Accreditation (A2LA), Toxicology: approved | American Association for Laboratory Accreditation (A2LA), Hematology: approved |
| CAccreditation Commission for Health Care, Inc (ACHC) | Accreditation Commission for Health Care, Inc (ACHC), Bacteriology: approved | Accreditation Commission for Health Care, Inc (ACHC), Mycobacteriology: approved | Accreditation Commission for Health Care, Inc (ACHC), Mycology: approved | Accreditation Commission for Health Care, Inc (ACHC), Parasitology: approved | Accreditation Commission for Health Care, Inc (ACHC), Virology: approved | Accreditation Commission for Health Care, Inc (ACHC), General immunology: approved | Accreditation Commission for Health Care, Inc (ACHC), Syphilis serology: approved | Accreditation Commission for Health Care, Inc (ACHC), Routine chemistry: approved | Accreditation Commission for Health Care, Inc (ACHC), Urinalysis: approved | Accreditation Commission for Health Care, Inc (ACHC), Endocrinology: approved | Accreditation Commission for Health Care, Inc (ACHC), Toxicology: approved | Accreditation Commission for Health Care, Inc (ACHC), Hematology: approved |
| DAmerican Society for Histocompatibility and Immunogenetics (ASHI) | American Society for Histocompatibility and Immunogenetics (ASHI), Bacteriology: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Mycobacteriology: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Mycology: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Parasitology: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Virology: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), General immunology: approved | American Society for Histocompatibility and Immunogenetics (ASHI), Syphilis serology: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Routine chemistry: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Urinalysis: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Endocrinology: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Toxicology: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Hematology: not listed |
| ECommission on Laboratory Accreditation (COLA) | Commission on Laboratory Accreditation (COLA), Bacteriology: approved | Commission on Laboratory Accreditation (COLA), Mycobacteriology: approved | Commission on Laboratory Accreditation (COLA), Mycology: approved | Commission on Laboratory Accreditation (COLA), Parasitology: approved | Commission on Laboratory Accreditation (COLA), Virology: approved | Commission on Laboratory Accreditation (COLA), General immunology: approved | Commission on Laboratory Accreditation (COLA), Syphilis serology: approved | Commission on Laboratory Accreditation (COLA), Routine chemistry: approved | Commission on Laboratory Accreditation (COLA), Urinalysis: approved | Commission on Laboratory Accreditation (COLA), Endocrinology: approved | Commission on Laboratory Accreditation (COLA), Toxicology: approved | Commission on Laboratory Accreditation (COLA), Hematology: approved |
| FCollege of American Pathologists (CAP) | College of American Pathologists (CAP), Bacteriology: approved | College of American Pathologists (CAP), Mycobacteriology: approved | College of American Pathologists (CAP), Mycology: approved | College of American Pathologists (CAP), Parasitology: approved | College of American Pathologists (CAP), Virology: approved | College of American Pathologists (CAP), General immunology: approved | College of American Pathologists (CAP), Syphilis serology: approved | College of American Pathologists (CAP), Routine chemistry: approved | College of American Pathologists (CAP), Urinalysis: approved | College of American Pathologists (CAP), Endocrinology: approved | College of American Pathologists (CAP), Toxicology: approved | College of American Pathologists (CAP), Hematology: approved |
| GThe Joint Commission (TJC) | The Joint Commission (TJC), Bacteriology: approved | The Joint Commission (TJC), Mycobacteriology: approved | The Joint Commission (TJC), Mycology: approved | The Joint Commission (TJC), Parasitology: approved | The Joint Commission (TJC), Virology: approved | The Joint Commission (TJC), General immunology: approved | The Joint Commission (TJC), Syphilis serology: approved | The Joint Commission (TJC), Routine chemistry: approved | The Joint Commission (TJC), Urinalysis: approved | The Joint Commission (TJC), Endocrinology: approved | The Joint Commission (TJC), Toxicology: approved | The Joint Commission (TJC), Hematology: approved |
Source: CMS, Specialty/Subspecialty Information for Approved Accreditation Organizations under CLIA, dated , read
- approved per the CMS list
- not listed
Scroll sideways for more specialties
| Organization | 1Histocompatibility (transplant) | 2Histocompatibility (nontransplant) | 3ABO & Rh group | 4Antibody detection (transfusion) | 5Antibody detection (nontransfusion) | 6Antibody identification | 7Compatibility testing | 8Histopathology | 9Oral pathology | 10Cytology | 11Radiobioassay | 12Clinical cytogenetics |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| AAssociation for the Advancement of Blood & Biotherapies (AABB) | Association for the Advancement of Blood & Biotherapies (AABB), Histocompatibility (transplant): not listed | Association for the Advancement of Blood & Biotherapies (AABB), Histocompatibility (nontransplant): not listed | Association for the Advancement of Blood & Biotherapies (AABB), ABO & Rh group: approved | Association for the Advancement of Blood & Biotherapies (AABB), Antibody detection (transfusion): approved | Association for the Advancement of Blood & Biotherapies (AABB), Antibody detection (nontransfusion): approved | Association for the Advancement of Blood & Biotherapies (AABB), Antibody identification: approved | Association for the Advancement of Blood & Biotherapies (AABB), Compatibility testing: approved | Association for the Advancement of Blood & Biotherapies (AABB), Histopathology: not listed | Association for the Advancement of Blood & Biotherapies (AABB), Oral pathology: not listed | Association for the Advancement of Blood & Biotherapies (AABB), Cytology: not listed | Association for the Advancement of Blood & Biotherapies (AABB), Radiobioassay: not listed | Association for the Advancement of Blood & Biotherapies (AABB), Clinical cytogenetics: not listed |
| BAmerican Association for Laboratory Accreditation (A2LA) | American Association for Laboratory Accreditation (A2LA), Histocompatibility (transplant): approved | American Association for Laboratory Accreditation (A2LA), Histocompatibility (nontransplant): approved | American Association for Laboratory Accreditation (A2LA), ABO & Rh group: approved | American Association for Laboratory Accreditation (A2LA), Antibody detection (transfusion): approved | American Association for Laboratory Accreditation (A2LA), Antibody detection (nontransfusion): approved | American Association for Laboratory Accreditation (A2LA), Antibody identification: approved | American Association for Laboratory Accreditation (A2LA), Compatibility testing: approved | American Association for Laboratory Accreditation (A2LA), Histopathology: approved | American Association for Laboratory Accreditation (A2LA), Oral pathology: approved | American Association for Laboratory Accreditation (A2LA), Cytology: approved | American Association for Laboratory Accreditation (A2LA), Radiobioassay: approved | American Association for Laboratory Accreditation (A2LA), Clinical cytogenetics: approved |
| CAccreditation Commission for Health Care, Inc (ACHC) | Accreditation Commission for Health Care, Inc (ACHC), Histocompatibility (transplant): approved | Accreditation Commission for Health Care, Inc (ACHC), Histocompatibility (nontransplant): approved | Accreditation Commission for Health Care, Inc (ACHC), ABO & Rh group: approved | Accreditation Commission for Health Care, Inc (ACHC), Antibody detection (transfusion): approved | Accreditation Commission for Health Care, Inc (ACHC), Antibody detection (nontransfusion): approved | Accreditation Commission for Health Care, Inc (ACHC), Antibody identification: approved | Accreditation Commission for Health Care, Inc (ACHC), Compatibility testing: approved | Accreditation Commission for Health Care, Inc (ACHC), Histopathology: approved | Accreditation Commission for Health Care, Inc (ACHC), Oral pathology: approved | Accreditation Commission for Health Care, Inc (ACHC), Cytology: approved | Accreditation Commission for Health Care, Inc (ACHC), Radiobioassay: approved | Accreditation Commission for Health Care, Inc (ACHC), Clinical cytogenetics: approved |
| DAmerican Society for Histocompatibility and Immunogenetics (ASHI) | American Society for Histocompatibility and Immunogenetics (ASHI), Histocompatibility (transplant): approved | American Society for Histocompatibility and Immunogenetics (ASHI), Histocompatibility (nontransplant): approved | American Society for Histocompatibility and Immunogenetics (ASHI), ABO & Rh group: approved | American Society for Histocompatibility and Immunogenetics (ASHI), Antibody detection (transfusion): not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Antibody detection (nontransfusion): not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Antibody identification: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Compatibility testing: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Histopathology: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Oral pathology: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Cytology: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Radiobioassay: not listed | American Society for Histocompatibility and Immunogenetics (ASHI), Clinical cytogenetics: not listed |
| ECommission on Laboratory Accreditation (COLA) | Commission on Laboratory Accreditation (COLA), Histocompatibility (transplant): approved | Commission on Laboratory Accreditation (COLA), Histocompatibility (nontransplant): approved | Commission on Laboratory Accreditation (COLA), ABO & Rh group: approved | Commission on Laboratory Accreditation (COLA), Antibody detection (transfusion): approved | Commission on Laboratory Accreditation (COLA), Antibody detection (nontransfusion): approved | Commission on Laboratory Accreditation (COLA), Antibody identification: approved | Commission on Laboratory Accreditation (COLA), Compatibility testing: approved | Commission on Laboratory Accreditation (COLA), Histopathology: approved | Commission on Laboratory Accreditation (COLA), Oral pathology: approved | Commission on Laboratory Accreditation (COLA), Cytology: approved | Commission on Laboratory Accreditation (COLA), Radiobioassay: approved | Commission on Laboratory Accreditation (COLA), Clinical cytogenetics: approved |
| FCollege of American Pathologists (CAP) | College of American Pathologists (CAP), Histocompatibility (transplant): approved | College of American Pathologists (CAP), Histocompatibility (nontransplant): approved | College of American Pathologists (CAP), ABO & Rh group: approved | College of American Pathologists (CAP), Antibody detection (transfusion): approved | College of American Pathologists (CAP), Antibody detection (nontransfusion): approved | College of American Pathologists (CAP), Antibody identification: approved | College of American Pathologists (CAP), Compatibility testing: approved | College of American Pathologists (CAP), Histopathology: approved | College of American Pathologists (CAP), Oral pathology: approved | College of American Pathologists (CAP), Cytology: approved | College of American Pathologists (CAP), Radiobioassay: approved | College of American Pathologists (CAP), Clinical cytogenetics: approved |
| GThe Joint Commission (TJC) | The Joint Commission (TJC), Histocompatibility (transplant): approved | The Joint Commission (TJC), Histocompatibility (nontransplant): approved | The Joint Commission (TJC), ABO & Rh group: approved | The Joint Commission (TJC), Antibody detection (transfusion): approved | The Joint Commission (TJC), Antibody detection (nontransfusion): approved | The Joint Commission (TJC), Antibody identification: approved | The Joint Commission (TJC), Compatibility testing: approved | The Joint Commission (TJC), Histopathology: approved | The Joint Commission (TJC), Oral pathology: approved | The Joint Commission (TJC), Cytology: approved | The Joint Commission (TJC), Radiobioassay: approved | The Joint Commission (TJC), Clinical cytogenetics: approved |
Source: CMS, Specialty/Subspecialty Information for Approved Accreditation Organizations under CLIA, dated , read
Organization by organization
- A
Association for the Advancement of Blood & Biotherapies (AABB)
Covers: All five immunohematology subspecialties, plus hematology, routine chemistry, toxicology, both immunology subspecialties and microbiology other than mycobacteriology.
Fits: Blood banks and transfusion services. CMS's notice grants AABB deeming authority for its blood bank and transfusion service, immunohematology reference laboratory, molecular testing and cellular therapy programs.
Association for the Advancement of Blood & Biotherapies (AABB) website
- B
American Association for Laboratory Accreditation (A2LA)
Covers: Every specialty and subspecialty on CMS's matrix.
Fits: Labs that want ISO 15189 accreditation alongside CLIA: A2LA's clinical program pairs the two.
American Association for Laboratory Accreditation (A2LA) website
- C
Accreditation Commission for Health Care, Inc (ACHC)
Covers: Every specialty and subspecialty on CMS's matrix.
Fits: Mixed-complexity labs that want one accreditor for the whole menu. ACHC says its accreditation covers testing from waived to high complexity and all specialties, pathology included.
Accreditation Commission for Health Care, Inc (ACHC) website
- D
American Society for Histocompatibility and Immunogenetics (ASHI)
Covers: Histocompatibility (transplant and nontransplant), general immunology, and ABO & Rh group.
Fits: HLA and transplant immunology labs. A lab with a wider menu needs a second accreditor or a CMS survey for the rest.
American Society for Histocompatibility and Immunogenetics (ASHI) website
- E
Commission on Laboratory Accreditation (COLA)
Covers: Every specialty and subspecialty on CMS's matrix, since histocompatibility was added in 2026.
Fits: Labs of all types, in COLA's own words. It calls itself physician-directed and the first accreditor to obtain federal approval under CLIA.
- F
College of American Pathologists (CAP)
Covers: Every specialty and subspecialty on CMS's matrix.
Fits: Hospital, reference and pathology labs. CAP inspects on site every two years with teams of practicing laboratory professionals, using discipline-specific checklists.
- G
The Joint Commission (TJC)
Covers: Every specialty and subspecialty on CMS's matrix.
Fits: Hospital labs, above all where the hospital already holds Joint Commission accreditation; its laboratory program page (an archived copy; the live site was down for maintenance on 23 October 2026) also lists physician office, reference and anatomic pathology labs.
Approval terms and lab counts
CMS approves each organization for a term "not to exceed 6 years" (§ 493.559) and announces it in the Federal Register. Terms below are quoted from those notices; lab counts are CMS's September 2026 statistics for non-exempt labs holding a certificate of accreditation.
| Organization | Current CMS approval, per the Federal Register | Labs, CMS count |
|---|---|---|
| AAssociation for the Advancement of Blood & Biotherapies (AABB) | April 25, 2024 to April 25, 2030 (89 FR 31755) | 192 |
| BAmerican Association for Laboratory Accreditation (A2LA) | March 23, 2022, until March 22, 2028 (87 FR 16190) | 8 |
| CAccreditation Commission for Health Care, Inc (ACHC) | March 27, 2023 to March 27, 2029 (88 FR 18142) | 149 |
| DAmerican Society for Histocompatibility and Immunogenetics (ASHI) | April 15, 2022 to April 15, 2028 (87 FR 22534) | 107 |
| ECommission on Laboratory Accreditation (COLA) | March 6, 2024 to March 6, 2030 (89 FR 15994)clinical cytogenetics and radiobioassay: January 20, 2026 to January 20, 2031 (90 FR 59524)histocompatibility: July 10, 2026 to June 10, 2031 (91 FR 35217) | 5,639 |
| FCollege of American Pathologists (CAP) | March 27, 2021 until March 26, 2027 (86 FR 16371) | 6,966 |
| GThe Joint Commission (TJC) | May 24, 2024 to May 24, 2030 (89 FR 45900) | 2,336 |
CAP's current term ends in March 2027
What accreditation replaces, and what it does not
Accreditation gives a lab deemed status: CMS treats it as meeting CLIA requirements through the accreditor (§ 493.551(a)), and the accreditor's inspection takes the place of the routine CLIA survey. The CLIA certificate still comes from CMS: in CMS's words, "If you apply for accreditation by one of the CMS-approved AOs, you also need to apply for a CoA through CMS" (CLIA Certification brochure). The full sequence is in how to get a CLIA certificate.
Under § 493.551(b), an accredited lab must still hold a certificate of accreditation, pay CMS's fees, meet the proficiency testing rules of Subpart H, and authorize its PT program to send its results to the accreditor. So every accredited lab still enrolls with a program on the CMS-approved proficiency testing programs list.
If you are weighing the three broad accreditors against each other, see CAP accreditation vs COLA vs The Joint Commission. AABB and ASHI are specialist choices; their columns on the plates show where their scope stops.