Research · 11 min read
What a CLIA Certificate Is, and Which Lab May Run Your Bloodwork
A weight program that includes lab work is sending your blood somewhere, and federal regulation sorts every such place into five certificates and three difficulty levels. The category decides how much oversight the lab gets, and the lightest one is inspected only in named situations.
Key takeaways
- A laboratory is defined by examining materials derived from the human body to inform diagnosis, prevention, treatment or health assessment, and a facility that only collects or mails specimens is expressly not one.
- Every laboratory must hold one of five certificates, or be CLIA-exempt under a state program the agency has determined is equal to or more stringent.
- Tests are sorted into waived, moderate complexity including provider-performed microscopy, and high complexity.
- Category is decided by seven criteria scored 1 to 3; 12 or less is moderate and above 12 is high.
- A test not on the published lists is treated as high complexity until reviewed on request.
- The list of waived tests printed in the regulation is not the current complete list — revisions are published in the Federal Register with an opportunity for comment.
- A waived-only laboratory is inspected on risk, on public complaint, at random to check for unwaived testing, and to assess the waiver itself.
- A registration certificate lasts no more than two years, is not renewable, and requires notice within 30 days of a change in ownership, name, location, director or technical supervisor.
- A certificate of accreditation means the laboratory is deemed to meet requirements through an approved private program rather than found compliant by the agency directly.
Answer first: a lab is a legal category, not a room
Federal regulation defines a laboratory by what it does with your sample, not by its signage.
A laboratory is a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological, or other examination of materials derived from the human body. The purpose has to be providing information for the diagnosis, prevention, or treatment of any disease or impairment, or the assessment of the health of human beings.
One sentence in that definition matters for a mail-in kit. Facilities only collecting or preparing specimens, or only serving as a mailing service and not performing testing, are not considered laboratories.
So the box that arrives at your door and the place that runs the test can be two different businesses under two different rules. The certificate question attaches to the second one.
Five certificates, and a laboratory must hold one
The rule is stated as a compliance test rather than a permission.
A laboratory will be cited as out of compliance with section 353 of the Public Health Service Act unless one of two things is true. It has a current, unrevoked or unsuspended certificate applicable to the category of examinations it performs, or it is CLIA-exempt.
The regulation then names the five. A certificate of registration, a certificate of waiver, a certificate for provider-performed microscopy procedures, a certificate of compliance, and a certificate of accreditation.
CLIA-exempt is the sixth path and it is a state one. It means a laboratory licensed or approved by a state where the agency has determined that the state's laws are equal to or more stringent than the federal requirements. The state licensure program itself also has to have been approved.
Three kinds of work sit outside the rules entirely. Testing performed only for forensic purposes, research laboratories that do not report patient-specific results for diagnosis or treatment, and drug testing under one federal certification program.
Three difficulty levels, and one of them is the default
Every test is sorted into a complexity category, and the category drives everything else.
The three are waived tests, tests of moderate complexity including the subcategory of provider-performed microscopy, and tests of high complexity.
A laboratory may perform only waived tests, only moderate ones, only microscopy procedures, only high-complexity ones, or any combination.
The default when nothing has been decided is the strict one. If a test system, assay or examination does not appear on the published lists, it is considered a test of high complexity until the matter is reviewed on request and the applicant is notified.
That default is worth holding onto. An unlisted test is not unregulated. It is treated as the hardest category until somebody asks and gets an answer.
How a test gets its category: seven criteria and a score
The sorting is arithmetic, and the regulation prints the whole scheme.
Seven criteria are scored 1, 2 or 3, where 1 is the lowest level of complexity and 3 the highest. The scores are totaled. A score of 12 or less is moderate complexity, and a score above 12 is high complexity.
The seven are knowledge, training and experience, reagents and materials preparation, characteristics of operational steps, calibration and quality control and proficiency testing materials, troubleshooting and equipment maintenance, and interpretation and judgment.
Reading the score-1 and score-3 descriptions tells you what the categories actually mean. Score 1 for knowledge is minimal scientific and technical knowledge obtainable through on-the-job instruction. Score 3 is specialized scientific and technical knowledge that is essential.
Who does the scoring depends on the product. For new commercial test systems the manufacturer submits supporting data as part of its application to FDA, and FDA determines the complexity category and notifies the manufacturer directly.
A recategorization request is accepted only if it rests on new information not previously submitted by the same applicant, and it will not be considered more than once a year.
What a waived test is, and what the printed list is not
The waived category is the light-touch one, and its criteria are narrow on paper.
Test systems qualify if they are simple laboratory examinations and procedures meeting one of three descriptions. Cleared by FDA for home use. Employing methodologies so simple and accurate as to render the likelihood of erroneous results negligible. Or posing no reasonable risk of harm to the patient if the test is performed incorrectly.
The regulation then prints an actual list. Dipstick or tablet reagent urinalysis for ten named analytes. Non-automated fecal occult blood, visual ovulation and urine pregnancy tests, and non-automated erythrocyte sedimentation rate. Copper sulfate hemoglobin, blood glucose by monitoring devices cleared specifically for home use, spun microhematocrit, and hemoglobin by single analyte instruments.
⚠ That printed list is not the current complete list of waived tests, and treating it as one would be a mistake. The same section says the agency determines whether a test meets the criteria, and that revisions to the list will be published in the Federal Register in a notice with opportunity for comment.
A laboratory holding a certificate of waiver has two standing obligations named in the regulation. Follow manufacturers' instructions for performing the test, and meet the requirements of the certificate-of-waiver subpart.
The inspection difference, which is the practical one
This is where the categories stop being paperwork.
A laboratory performing only waived tests agrees to permit announced and unannounced inspections in four named circumstances. When the agency has substantive reason to believe the laboratory is being operated in a manner that constitutes an imminent and serious risk to human health. To evaluate complaints from the public.
The other two are on a random basis to determine whether the laboratory is performing tests not on the waived list, and to collect information about whether waiving those tests was appropriate.
Nonwaived testing runs on a different track. Before a registration certificate expires, the laboratory must remit the fee, be inspected, and demonstrate compliance with the applicable requirements of several subparts.
So two facilities can both hold a valid federal certificate while one is routinely inspected and the other is inspected on complaint, on suspicion, or at random. That is a real difference and it is not visible from a marketing page.
How long a certificate lasts, and what a registration certificate is for
The clocks are short, and one certificate is deliberately temporary.
A certificate of waiver is valid for no more than two years. A laboratory seeking to renew completes the renewal application and returns it not less than nine months nor more than one year before the certificate expires.
A registration certificate is the entry document for nonwaived testing. It is required initially for all laboratories performing moderate or high complexity testing, and for a waived or microscopy laboratory that intends to add such testing.
It is valid for no more than two years or until an inspection to determine program compliance can be conducted, whichever is shorter. And it is not renewable, though it may be reissued if compliance has not been determined before the expiration date.
To get one, the laboratory agrees to notify the agency within 30 days of any change in ownership, name, location, director or technical supervisor. It also agrees to treat proficiency testing samples the same way it treats patient specimens.
The accreditation route, and what deemed means
A laboratory can satisfy the requirement through a private organization instead of a direct federal inspection.
A certificate of accreditation may be issued in place of the otherwise applicable certificate, provided the laboratory meets the standards of a private non-profit accreditation program approved by the agency.
The definition spells out what that certificate signifies. It is issued on the basis of the laboratory's accreditation by an approved accreditation organization, indicating that the laboratory is deemed to meet applicable requirements.
The word deemed is doing real work there. Compliance is inferred from the accreditation rather than found by the agency itself, which is why the approval of the accrediting program is its own regulated step.
There is a clock on the handoff. A laboratory must provide proof of accreditation by an approved program within eleven months of the registration certificate being issued, or before its certificate of compliance expires.
What the application has to describe
The contents of the application are the closest thing here to a public description of a laboratory's operation.
An application must be made on a prescribed form and signed by an owner or an authorized representative who attests that the laboratory will be operated in accordance with the requirements.
It has to describe the characteristics of the laboratory operation and the examinations and other test procedures performed. Three items are named: the name and total number of test procedures and examinations performed annually, the methodologies for each, and the qualifications of the personnel directing, supervising and performing the testing.
The default is one application per location. A separate application is filed for each laboratory location, with named exceptions.
One exception matters for anything mobile. Laboratories that are not at a fixed location, moving from testing site to testing site, may be covered under the certificate of the designated primary site or home base, using its address.
So an address on a certificate is not proof of where a sample was examined, if the operation is one of those.
What to ask a program that bundles lab work
All of that turns into a short list of answerable questions.
Which laboratory performs the testing, and at what address. The certificate is issued to a laboratory, so a question that does not produce a name cannot be checked further.
Which certificate it holds, and whether the tests being run are waived, moderate or high complexity. Those are the two facts that determine the inspection regime described above.
Whether the collection is a mail-in kit, and if so who examines the sample. The regulation says a facility that only collects or prepares specimens, or only serves as a mailing service, is not a laboratory.
A program that cannot answer the first question has not refused. It has told you that the answer is somewhere else, which is a reason to ask again in writing.
What this page does not tell you
Two boundaries, stated where you can see them.
Everything above is drawn from the federal laboratory requirements regulation. It describes categories, certificates, scoring and inspection triggers. It does not report which certificate any company or laboratory holds, and no seller's arrangements were examined for it.
The second boundary is the waived-test list. What is printed here is the list as it appears in the regulation, and the regulation itself says revisions are published separately in the Federal Register. Anyone who needs to know whether a specific test is waived today has to check those notices rather than rely on the printed list.
Sources
- 42 CFR Part 493 — Laboratory RequirementsSection 493.2 for the definition of laboratory as a facility for the biological, microbiological, serological, chemical, immunohematological, hematological, biophysical, cytological, pathological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, human beings, and for the sentence that facilities only collecting or preparing specimens or only serving as a mailing service and not performing testing are not considered laboratories; also 493.2 for the definitions of certificate of waiver, certificate of compliance, certificate of accreditation as issued on the basis of accreditation by an approved accreditation organization indicating that the laboratory is deemed to meet applicable requirements, certificate of registration, and CLIA-exempt laboratory as one licensed or approved by a state whose laboratory laws the agency has determined are equal to or more stringent. Section 493.3(a) for the rule that a laboratory will be cited as out of compliance with section 353 of the Public Health Service Act unless it holds a current, unrevoked or unsuspended certificate applicable to the category of examinations performed, or is CLIA-exempt; 493.3(b) for the three exceptions covering forensic-only testing, research laboratories that do not report patient-specific results for diagnosis, prevention or treatment, and testing under one federal drug-testing certification. Section 493.5(a) for the three complexity categories, 493.5(b) for a laboratory being able to perform any combination of them, and 493.5(c) for the five certificates. Section 493.15(b) for the three waiver criteria — cleared by FDA for home use, methodologies so simple and accurate as to render the likelihood of erroneous results negligible, or posing no reasonable risk of harm to the patient if performed incorrectly; 493.15(c) for the printed list of waived tests including dipstick or tablet reagent urinalysis for ten named analytes, non-automated fecal occult blood, visual ovulation and urine pregnancy tests, non-automated erythrocyte sedimentation rate, copper sulfate hemoglobin, blood glucose by monitoring devices cleared specifically for home use, spun microhematocrit, and hemoglobin by single analyte instruments; 493.15(d) for the agency determining whether a test meets the criteria and publishing revisions to the list in the Federal Register in a notice with opportunity for comment; 493.15(e) for the two obligations to follow manufacturers' instructions and meet the certificate-of-waiver subpart. Section 493.17(a) for the seven scoring criteria, the 1-to-3 scale where 1 indicates the lowest level of complexity and 3 the highest, the totaling of scores, and the rule that 12 or less is moderate complexity while above 12 is high complexity, and for the score-1 and score-3 descriptions of the knowledge criterion; 493.17(c)(1) for the manufacturer submitting supporting data with its 510(k) and PMA application and FDA determining the complexity category and notifying the manufacturer directly; 493.17(c)(3) for a recategorization request being accepted only on new information not previously submitted by the same applicant and not more than once per year; 493.17(c)(4) for a test not appearing on the Federal Register lists being considered high complexity until reviewed on request and the applicant notified. Section 493.19(b)(1) for provider-performed microscopy being personally performed by a physician, midlevel practitioner or dentist during the patient's visit. Section 493.35(a) for a separate application for each laboratory location; 493.35(b)(1) for mobile and temporary testing operations being covered under the certificate of a designated primary site or home base using its address; 493.35(c) for the application format and the three described items; 493.35(d)(2) for the four inspection circumstances a waived-only laboratory agrees to. Section 493.37(e)(1) for a certificate of waiver being valid for no more than two years and 493.37(f)(1) for the renewal window of not less than nine months nor more than one year before expiration. Section 493.43(c)(3) for the application contents describing the name and total number of test procedures and examinations performed annually, the methodologies, and personnel qualifications. Section 493.45(a) for when a registration certificate is required, 493.45(b)(2) for the 30-day notice of changes in ownership, name, location, director or technical supervisor, 493.45(b)(3) for treating proficiency testing samples in the same manner as patient specimens, 493.45(c) for the pre-expiration requirements to remit the fee, be inspected and demonstrate compliance, and 493.45(e) for validity of no more than two years or until a compliance inspection can be conducted, whichever is shorter, and for it not being renewable though it may be reissued. Section 493.55(a) for a certificate of accreditation being issued in lieu of the otherwise applicable certificate where the laboratory meets the standards of a private non-profit accreditation program approved by the agency. Section 493.57(b)(1) for proof of accreditation within eleven months of issuance of the registration certificate or before expiration of a certificate of compliance.
Frequently asked questions
Is a company that mails me a blood collection kit a laboratory?
Not by itself. The definition covers a facility that examines materials derived from the human body to provide information for diagnosis, prevention or treatment, or for assessing health. It then says facilities only collecting or preparing specimens, or only serving as a mailing service and not performing testing, are not considered laboratories. The certificate question attaches to whoever actually runs the test, which may be a different business at a different address.
What are the five CLIA certificates?
The regulation lists a certificate of registration or registration certificate, a certificate of waiver, a certificate for provider-performed microscopy procedures, a certificate of compliance, and a certificate of accreditation. A laboratory must hold one that is current and unrevoked and applicable to the category of testing it performs, or else be CLIA-exempt. CLIA-exempt means licensed or approved by a state whose laboratory laws have been determined to be equal to or more stringent than the federal ones.
How is a test decided to be waived, moderate or high complexity?
By a printed scoring scheme. Seven criteria are each scored 1, 2 or 3, where 1 is the lowest level of complexity and 3 the highest, and the scores are totaled. Twelve or less is moderate complexity and above 12 is high complexity. For new commercial test systems the manufacturer submits supporting data with its FDA application and FDA determines the category. A test that does not appear on the published lists is considered high complexity until reviewed on request.
Does a certificate of waiver mean less oversight?
It means a different inspection trigger. A waived-only laboratory agrees to permit announced and unannounced inspections in four named circumstances. When the agency has substantive reason to believe operations pose an imminent and serious risk to human health. To evaluate complaints from the public. On a random basis, to check whether unwaived tests are being run. And to collect information on whether the waiver was appropriate. Nonwaived laboratories must be inspected and demonstrate compliance before a registration certificate expires.
Is the list of waived tests in the regulation the complete list?
No, and this is the most common misreading of that section. The regulation prints a list of tests a laboratory may restrict itself to. It then says the agency determines whether a test meets the waiver criteria, and that revisions to the list will be published in the Federal Register in a notice with opportunity for comment. The printed list is a starting point in the rule text, not a current inventory.
How long does a CLIA certificate last?
A certificate of waiver is valid for no more than two years, and a renewal application is returned not less than nine months nor more than one year before expiration. A registration certificate is valid for no more than two years or until a compliance inspection can be conducted, whichever is shorter. It is not renewable, though it can be reissued if compliance has not been determined before the expiration date.
What does an accredited laboratory mean here?
It means a certificate of accreditation was issued on the basis of accreditation by an organization the agency has approved, indicating the laboratory is deemed to meet the applicable requirements. Compliance is inferred from the accreditation rather than found directly, which is why approval of the accrediting program is itself a regulated step. A laboratory has to supply proof of accreditation within eleven months of its registration certificate being issued.
Can I tell from a program's website which certificate its lab holds?
Not from the regulation, which is what the answers above are drawn from. The certificate is issued to a named laboratory at a location, so the first question is which laboratory performs the testing and where. No seller's arrangements were examined, and nothing here states what any company's laboratory holds.