Laboratory Accreditation and Inspections

Overview of Laboratory Accreditation in the United States

Clinical laboratories in the United States operate within a layered (and often confusing) regulatory and accreditation environment designed to ensure analytical accuracy, patient safety, and clinical reliability. Unlike hospitals, which typically hold a single institutional accreditation, laboratories may be regulated and accredited through a combination of federal requirements, private accrediting organizations, and state-level oversight. For laboratory professionals, understanding the distinctions among these systems is essential, as accreditation status directly affects licensure, reimbursement, inspection frequency, and operational standards.

If it seems like overkill, sometimes it is. The laboratory is the most highly regulated part of a hospital.

At the federal level, laboratory testing is governed by the Clinical Laboratory Improvement Amendments of 1988, commonly referred to as Clinical Laboratory Improvement Amendments. CLIA establishes minimum quality standards for all non-research laboratory testing performed on human specimens for diagnosis, prevention, or treatment of disease. Accreditation organizations such as CAP, Joint Commission (referred to as JCO), COLA, and in some cases, state departments of health function within this framework, often serving as substitutes for direct federal inspection (we'll talk about "exempt" states later). And we'll do deep dives on these organizations in the next few weeks.

Here is a list of all the organization that do laboratory inspections. This does not include states that do their own inspections.

You haven't been writing an open date on your reagents???

How Do They Relate to CMS?

The relationship between these organizations and the Centers for Medicare & Medicaid Services is central to understanding its practical importance. CMS is the federal agency responsible for administering Medicare, Medicaid, and other federal health programs, and it establishes Conditions of Participation that hospitals must meet in order to receive reimbursement. Rather than conducting routine inspections of every hospital itself, CMS grants certain accrediting organizations “deeming authority,” meaning that accreditation by those organizations is accepted as evidence of compliance with CMS requirements.

Deeming Authority: CAP, JCO, COLA and states are organizations with deeming authority. When a hospital is accredited by one of these organizations, CMS generally considers it to be in compliance with Medicare and Medicaid Conditions of Participation, without requiring a separate CMS survey. While CMS retains the right to conduct validation or complaint-driven surveys, accreditation effectively serves as a proxy for CMS regulatory compliance, making it financially critical for hospitals, because most cannot remain viable without

College of American Pathologists Accreditation (Hard Mode)

The College of American Pathologists accreditation program is widely regarded as the gold standard for clinical laboratory quality, particularly in hospital-based and high-complexity laboratories. CAP accreditation is rooted in peer inspection, meaning surveys are conducted by practicing laboratory professionals and pathologists who bring direct operational experience to the inspection process. This peer-based model is highly valued within the profession, as it emphasizes practical application of standards rather than purely regulatory compliance.

CAP checklists are detailed and discipline-specific, covering areas such as chemistry, hematology, transfusion medicine, microbiology, molecular diagnostics, and anatomic pathology. These standards frequently exceed baseline CLIA requirements and are updated regularly to reflect advances in laboratory science and evolving best practices. Laboratories accredited by CAP are deemed to meet CLIA requirements, and CAP holds deeming authority from Centers for Medicare & Medicaid Services, allowing CAP inspections to substitute for federal surveys. While CAP accreditation demands significant preparation and resources, it is often viewed as a marker of excellence and professional rigor.

The Joint Commission and Laboratory Accreditation (Easy Mode)

The Joint Commission plays a distinct but important role in laboratory oversight, particularly within hospital-based laboratories that are embedded in larger health care organizations. While the Joint Commission is not a laboratory-specific accrediting body in the same manner as CAP or COLA, it evaluates laboratory services as an integral component of hospital accreditation. Its standards address laboratory governance, quality control, test result reporting, specimen management, personnel competency, and integration with clinical care, all within the broader framework of patient safety and organizational performance. When a hospital laboratory is accredited through the Joint Commission, it is generally deemed to meet CLIA requirements via CMS deeming authority, even though the laboratory standards are less granular than CAP checklists. For laboratory professionals, this means that Joint Commission surveys tend to emphasize system-level processes, communication, and patient impact rather than test-by-test technical detail. As a result, many hospital laboratories maintain dual alignment, relying on Joint Commission accreditation for institutional compliance while pursuing CAP accreditation to achieve deeper discipline-specific rigor and professional recognition.

You haven't been documenting corrective action on your failed QC???

COLA Accreditation (less common)

COLA, originally known as the Commission on Office Laboratory Accreditation, was established to support physician office laboratories and other smaller testing environments. Over time, COLA has expanded its scope to include a wide range of laboratory settings, from waived and moderate-complexity laboratories to certain high-complexity operations. Its accreditation model emphasizes education, consultation, and continuous improvement, making it particularly attractive to laboratories with limited administrative infrastructure.

COLA surveys are generally perceived as less prescriptive and less burdensome than CAP inspections, while still meeting CLIA requirements. Like CAP, COLA is recognized by CMS and holds deeming authority, meaning its accredited laboratories are considered compliant with federal regulations. For many outpatient clinics and independent laboratories, COLA provides a practical balance between regulatory compliance and operational feasibility, especially where the full breadth of CAP standards may not be necessary or cost-effective.

Exempted State Programs (even less common)

CLIA will exempt laboratories in States that have been determined to have laws and regulations in effect that are equal to, or more stringent than, CLIA requirements. Exempt laboratories must hold a valid State license within the exempt State. Oregon and Washington State have been granted complete exemption. New York State has been granted a partial exemption. For instance, in Washington State, labs may be inspected by the state department of health in place of another organization such as CAP, JCO, etc.

Let the punishments begin.

With proper preparation, there should be nothing to worry about during an inspection. The key is doing the work ahead of time whether it comes to personnel competency, documentation, corrective actions, quality control, or anything else.

Remember, the key to getting ahead is getting started!