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The two lab certificates, and who actually inspects
A laboratory can satisfy the federal scheme by being inspected by the government or by a private accreditor. The paperwork looks similar. What the public can see afterward is not similar at all.
Two routes to the same permission
A laboratory doing more than the simplest tests needs a certificate. There are two main ways to hold one, and they are not variants of a single process.
A certificate of compliance means the government inspects the laboratory and decides. A certificate of accreditation means a private accreditation organization inspects it, and the government accepts that organization's judgment.
The second route only exists because the rules allow the agency to treat an accreditor's standards as a substitute. The test is written into the regulation.
The accreditor's requirements must be "equal to, or more stringent than, the CLIA condition-level requirements" of the federal part, and the laboratory would have to meet those federal requirements if it were inspected against them.
Both certificates carry the same expiry. Each "is valid for no more than 2 years".
What a certificate of compliance obliges a laboratory to accept
The compliance route is the more visible of the two, because the inspector is the government.
A laboratory holding one "Must permit announced or unannounced inspections by HHS" for four stated purposes.
To determine compliance. To evaluate complaints. Where the agency has substantive reason to believe testing or operations pose an imminent and serious risk to human health. And to collect information about how tests are categorized.
Renewal is not a last-minute affair. The renewal application must be completed and returned "9 to 12 months prior to the expiration" of the certificate.
If a certificate is revoked, suspended or limited, the laboratory gets a statement of the grounds and an appeal. Requesting a hearing within sixty days generally lets it keep the certificate until a judge decides.
That protection has exceptions, and they are the serious ones. It does not apply where conditions pose an imminent and serious risk to human health, or where two of the enforcement grounds are met.
Changes a laboratory has to report, and how fast
Certificates go stale when the laboratory changes underneath them, so the rules put reporting duties on specific events.
Five changes must be reported "within 30 days of any change in" them: ownership, name, location, director, and, for high complexity laboratories, technical supervisor.
Two more run on a longer clock. A laboratory must give notice "no later than 6 months after performing any test or examination within a specialty or subspecialty area that is not included" on its certificate.
The same six-month window applies to deletions or changes in test methodologies for tests already covered.
The accreditation route mirrors this with one difference that matters. The thirty-day list there is four items rather than five, and the notice goes both to the government and to the accreditation program.
The practical reading is that a certificate describes a laboratory as it was, with a reporting lag built in. A change of ownership or director can be up to a month old before anyone official is told.
What an accredited laboratory signs up to
Accreditation is not a lighter obligation, it is a different chain of custody for the same information.
A laboratory on this route must treat proficiency testing samples in the same manner as patient samples, and comply with the approved accreditation program's requirements.
It must also permit random sample validation and complaint inspections by the government, and permit the government to monitor the correction of anything those find.
Three authorizations are required, and they are the interesting part. The laboratory must authorize the accreditation program to release its inspection findings to the government during those inspections.
It must authorize its proficiency testing organization to give results to the accreditor, for monitoring and for making annual results available on a reasonable basis upon request of any person.
And it must authorize the accreditor to tell the government about unsuccessful proficiency testing, and about the actions the accreditor took, within thirty days of starting them.
Refusing the proficiency testing release has a stated consequence. The laboratory is no longer deemed to meet the requirements and becomes subject to a full government review.
The forty-five day gap when accreditation is withdrawn
One provision here is easy to misread and worth stating plainly.
When an accreditation organization withdraws or revokes a laboratory's accreditation, the laboratory "retains its certificate of accreditation for 45 days after the laboratory receives notice of the withdrawal or revocation". That runs until the effective date of any government action, if one comes first.
So the federal certificate does not vanish at the moment the accreditor walks away. There is a defined window.
That is a sensible transition rule rather than a loophole, but it means a laboratory can be operating on a federal certificate during a period when its accreditor has already stopped vouching for it.
If the accreditation organization itself loses approval, the laboratories under it fall back to the government route.
The inspection that inspects the inspector
Because accreditation is delegated, the government audits the delegation rather than every laboratory.
Validation inspections are the mechanism. The agency may inspect an accredited laboratory "on a representative sample basis or in response to a substantial allegation of noncompliance".
Those results are used to validate the accreditation organization's process, not only to judge the individual laboratory. The sample is sized to allow a reasonable estimate of how the organization is performing.
A validation inspection prompted by an allegation focuses on the requirements related to that allegation. If a deficiency is substantiated at the condition level, a full inspection follows.
The audit can also reach the accreditor's own offices, including a review of documents, an audit of meetings about the accreditation process, evaluation of its decision-making, and interviews with its staff.
The same structure applies to a state licensure program that has been approved as an exemption route.
The asymmetry in what the public gets to see
This is the part that explains a frustration people run into and rarely get an answer for.
Government validation inspections are disclosable. "CMS may disclose the results of all validation inspections conducted by CMS or its agent."
Accreditation inspections are not, except in one circumstance. "CMS may disclose accreditation organization inspection results to the public only if the results are related to an enforcement action taken by the Secretary."
State inspection results are a third case again. Their disclosure is the approved state program's responsibility, under that state's own law.
The consequence is concrete. For a laboratory on the accreditation route, the routine inspection that actually happened is generally not public, and what surfaces is the exception rather than the record.
A laboratory with no visible inspection findings may have been inspected thoroughly by an accreditor whose report simply is not disclosable.
What an inspector may do, and what this article leaves open
The inspection powers themselves are broad, and reading them tells you what a certificate is actually backed by.
The agency may require the laboratory to test samples, including proficiency testing samples, or perform procedures. It may interview all personnel about compliance.
It may "Permit laboratory personnel to be observed performing all phases of the total testing process", meaning the preanalytic, analytic and postanalytic phases rather than the bench alone.
It may enter specimen procurement and processing areas, storage for specimens, reagents, supplies, records and reports, and testing and reporting areas. It may take copies or exact duplicates of records and data.
It "may reinspect a laboratory at any time", and refusing an inspection carries its own sanction.
Three limits belong here. Only subparts C, D, E and Q of part 493 were read. No accreditation organization is named, and no laboratory's certificate or inspection history was looked up, so nothing here describes any company's actual status.
Key takeaways
- Both a certificate of compliance and a certificate of accreditation are valid for no more than two years.
- Accreditation is accepted only where the accreditor's requirements are equal to or more stringent than the federal ones.
- Renewal applications are due nine to twelve months before a certificate expires.
- Ownership, name, location and director changes must be reported within thirty days.
- A new specialty or a changed test methodology must be reported no later than six months afterward.
- A laboratory keeps its certificate for forty-five days after an accreditor withdraws accreditation.
- Validation inspections audit the accreditation organization, not only the laboratory.
- Government validation results are disclosable; accreditation inspection results generally are not.
Frequently asked questions
What is the difference between a certificate of compliance and a certificate of accreditation?
Who does the inspecting. A certificate of compliance follows government inspection. A certificate of accreditation follows inspection by an approved private accreditation organization. That organization's requirements must be equal to, or more stringent than, the federal condition-level requirements, and its laboratories would have to meet those federal requirements if inspected against them. Both are valid for no more than two years.
Can I see a laboratory's inspection report?
It depends which route it is on. The agency may disclose the results of all validation inspections it or its agent conducted. It may disclose accreditation organization inspection results only if they relate to an enforcement action taken by the Secretary. Disclosure of state inspection results is the approved state program's responsibility under state law. So a routine accreditation inspection is generally not public.
Does a laboratory have to tell anyone when it changes owner?
Yes, within thirty days. On the compliance route the thirty-day list is ownership, name, location, director, and technical supervisor for high complexity laboratories. On the accreditation route it is four items, and notice goes both to the government and to the accreditation program. Adding a new specialty or changing a test methodology runs on a longer clock, with notice due no later than six months afterward.
What happens if an accreditor drops a laboratory?
There is a defined transition. The laboratory retains its certificate of accreditation for forty-five days after receiving notice of the withdrawal or revocation, or until the effective date of any government action, whichever is earlier. If the accreditation organization itself loses approval, its laboratories fall back to the government certificate route.
Does anyone check the accreditors?
That is the point of validation inspections. The agency may inspect an accredited laboratory on a representative sample basis or in response to a substantial allegation of noncompliance, and uses the results to validate the accreditation organization's process. The sample is sized to allow a reasonable estimate of the organization's performance. The audit can extend to the accreditor's offices, its meeting records, its decision-making and interviews with its staff.
What can an inspector actually do inside a laboratory?
A great deal. Require the laboratory to test samples or perform procedures, interview all personnel, and observe staff performing every phase of the testing process. Enter specimen procurement and processing areas, storage areas, and testing and reporting areas. Take copies or exact duplicates of records and data. Reinspection may happen at any time. Refusing an inspection triggers suspension of federal payment and action against the certificate.
Is an accredited laboratory better than a government-inspected one?
The regulation does not frame it that way. The accreditation route exists only where the accreditor's requirements are equal to or more stringent than the federal ones, so the floor is the same by design. What differs is visibility: routine accreditation findings are generally not disclosable to the public, while government validation results are. An absence of public findings is therefore weak evidence either way.
Sources
Each document below is named as it names itself, with the date printed on that document rather than the day it was read.
- Title 42 Code of Federal Regulations section 493.49, Requirements for a certificate of compliance, read in full for the inspection consent, the two-year validity, the renewal window and the appeal provisions — Electronic Code of Federal Regulations, Office of the Federal Register, January 2003
- Title 42 Code of Federal Regulations section 493.51, Notification requirements for laboratories issued a certificate of compliance, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, April 1995
- Title 42 Code of Federal Regulations section 493.61, Requirements for a certificate of accreditation, read in full for the seven laboratory duties and the two-year validity — Electronic Code of Federal Regulations, Office of the Federal Register, January 1993
- Title 42 Code of Federal Regulations section 493.63, Notification requirements for laboratories issued a certificate of accreditation, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, February 1992
- Title 42 Code of Federal Regulations section 493.551, General requirements for laboratories, read for the deeming test, the required authorizations and the forty-five day retention — Electronic Code of Federal Regulations, Office of the Federal Register, May 1998
- Title 42 Code of Federal Regulations section 493.563, Validation inspections, Basis and focus, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, May 1998
- Title 42 Code of Federal Regulations section 493.571, Disclosure of accreditation, State and CMS validation inspection results, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, May 1998
- Title 42 Code of Federal Regulations section 493.1773, Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, June 1998