COLA lab accreditation is a private, CMS-recognized route for a clinical laboratory to prove it meets the federal Clinical Laboratory Improvement Amendments (CLIA) standards without submitting to routine state inspection. The Commission on Laboratory Accreditation, a nonprofit founded in 1988 and granted “deemed status” by the Centers for Medicare and Medicaid Services in 1993, currently accredits roughly 7,000 laboratories and holds authority across every CLIA specialty.1 A lab that earns COLA accreditation receives a Certificate of Accreditation from CMS and is generally exempt from routine state surveys, though CMS can still inspect at any time.
What COLA Accreditation Actually Is
Every U.S. facility that tests human specimens for clinical purposes must comply with CLIA, codified at 42 USC 263a and implemented through 42 CFR Part 493. CLIA covers about 320,000 laboratory entities and sets standards for personnel, quality systems, proficiency testing, facility administration, and record-keeping. CMS administers the program, the CDC provides technical assistance, and the FDA categorizes tests by complexity (waived, moderate, or high).
A lab can demonstrate compliance in one of two ways. It can accept direct inspection by a state survey agency working for CMS and receive a Certificate of Compliance. Or it can seek accreditation from a CMS-approved private organization and receive a Certificate of Accreditation. Deemed status means CMS has evaluated that organization’s standards and found them equal to or more stringent than CLIA’s. COLA is one of seven organizations currently holding that status.
CLIA itself does not apply to employment-related drug testing performed by SAMHSA-certified laboratories, forensic testing for criminal investigations, or research testing whose results are not reported back for clinical decisions. A lab doing only that work does not need CLIA certification, and therefore does not need COLA.
What Labs and Test Types COLA Can Accredit
COLA started out serving physician office laboratories, but its authority has expanded well past that. Its broad reapproval published in the Federal Register on March 6, 2024, runs six years through March 6, 2030, and covers:
- Microbiology, including bacteriology, mycobacteriology, mycology, parasitology, and virology
- Diagnostic immunology, including general immunology and syphilis serology
- Chemistry, including routine chemistry, toxicology, and endocrinology
- Hematology, including routine hematology and coagulation
- Immunohematology, including ABO grouping, D (Rho) typing, antibody detection, compatibility testing, and antibody identification
- Pathology, including histopathology, oral pathology, and cytology
A Federal Register notice published December 19, 2025, added clinical cytogenetics and radiobioassay under a separate five-year approval running from January 20, 2026, through January 20, 2031. With those additions, COLA holds deemed status across all CLIA specialties. COLA is also approved to deem laboratories in California as compliant with state requirements.
How to Get COLA Accredited
Accreditation runs on a two-year cycle built around five phases.
Enrollment
The lab signs up, pays an enrollment fee, and receives a welcome packet with forms for the laboratory director’s signature, annual test volume reporting, and proficiency test data release. Labs get access to COLAcentral, an online portal for managing the accreditation file. Any laboratory whose CLIA certificate was revoked within the prior 24 months is ineligible to enroll.
Self-Assessment
The lab conducts an internal evaluation against COLA’s criteria for quality laboratory performance. COLA reviews the responses and flags areas of non-compliance that must be resolved before the on-site survey.
On-Site Survey
A medical laboratory scientist with at least ten years of bench experience visits the facility. COLA frames the survey as educational rather than purely punitive. Surveyors review documentation, quality assurance procedures, proficiency testing records, and day-to-day operations, and staff should be ready to demonstrate knowledge of the lab’s policies and procedures.
Post-Survey and Corrective Action
COLA analyzes the findings and issues a final report. If problems are identified, the lab receives a Plan of Required Improvement and must implement corrective actions with supporting documentation. COLA’s technical advisors provide support during this phase at no added cost.
Accreditation
Once all criteria are met, the lab receives a COLA accreditation certificate valid for two years. Between surveys, COLA continues to monitor proficiency testing results and keeps its technical advisor team available to accredited labs.
Where COLA Requirements Go Beyond CLIA
Because deemed status requires standards at least as strict as CLIA, some COLA rules are tighter than the federal floor. When a lab replaces an instrument, COLA requires performance comparison (correlation) studies. When quality control lots turn over, COLA requires the old and new lot numbers to overlap at least five times before the old lot is retired. Labs planning changes should build these steps into their timelines.
COLA vs. Other CLIA Accreditors
As of August 2025, seven organizations hold CMS deemed status for laboratory accreditation: AABB, the American Association for Laboratory Accreditation (A2LA), the Accreditation Commission for Health Care (ACHC), the American Society for Histocompatibility and Immunogenetics (ASHI), COLA, the College of American Pathologists (CAP), and the Joint Commission (TJC).
COLA has historically drawn smaller laboratories, particularly physician office labs, with a mentoring-oriented survey approach. CAP is known for more extensive specialty-specific checklists and a peer-review model in which the inspectors are practicing laboratory professionals from other CAP-accredited labs; CAP runs a two-year cycle with a self-inspection in the alternating year. Both COLA and CAP accreditation are considered to exceed baseline CLIA by adding quality system expectations on top of the federal minimums.
One recent change matters for hospital-based labs. Effective January 1, 2023, the Joint Commission ended its cooperative agreement with COLA and stopped recognizing COLA accreditation inside TJC-accredited facilities. Affected labs had a transition period through December 31, 2024, to move to the Joint Commission’s own laboratory accreditation program or another approved partner. COLA said it was “surprised and disappointed” by the decision. TJC did not publicly detail its reasons. The practical result is that a hospital or health system already accredited by TJC cannot use COLA for its laboratory component.
Losing or Appealing Accreditation
When an accredited laboratory fails to meet standards, COLA can deny, suspend, or revoke accreditation, and it must report any such action to CMS within 30 days. Labs that lose accreditation have access to a formal appeal process. CMS has found COLA’s enforcement and appeal procedures equal to or more stringent than the requirements in 42 CFR Part 493, Subpart R.
Federal oversight does not stop at the accreditation certificate. CMS can conduct validation inspections on a representative sample basis or in response to complaints, even at a fully accredited lab. If CMS finds that COLA is not maintaining standards at least as rigorous as CLIA, it can rescind COLA’s deeming authority before the approval term ends.
How Accreditation Fits With Your CLIA Certificate
COLA accreditation does not replace a CLIA certificate. It determines which type of certificate the lab holds. A new laboratory begins by submitting Form CMS-116 to its state survey agency, along with proof of the laboratory director’s qualifications. The lab first receives a Certificate of Registration, a temporary authorization for non-waived testing while accreditation is completed. A lab pursuing COLA accreditation must provide evidence of accreditation, or of an active application, within 11 months of receiving the registration certificate. Once accredited, the lab receives a Certificate of Accreditation.
All CLIA fees are now paid online through pay.gov, and the program has gone fully paperless. CMS no longer mails paper certificates or fee coupons, so labs must keep a valid business email on file. Certificate of Accreditation and Certificate of Compliance holders are surveyed on a two-year cycle. Any change in ownership, name, location, or laboratory director must be reported to the state agency within 30 days.