What kind of lab can run the blood test you were sent

A federal scheme most people never see

Bloodwork arrives as a number on a portal. Behind it is a certificate scheme with its own part of the Code of Federal Regulations, at title 42 part 493.

The basic rule is in section 493.3. A laboratory will be cited as out of compliance unless it has one of five. The regulation names "a current, unrevoked or unsuspended certificate of waiver, registration certificate, certificate of compliance, certificate for PPM procedures, or certificate of accreditation issued by HHS." That certificate must be "applicable to the category of examinations or procedures performed."

The alternative is to be exempt under the scheme. There is no third option for a lab reporting patient results.

Section 493.5 restates the same five certificate types and describes what a lab may do with each. "A laboratory may perform only waived tests, only tests of moderate complexity, only PPM procedures, only tests of high complexity or any combination of these tests."

The exception that matters most here

Section 493.3(b) lists what the rules do not apply to, and one item is directly relevant to a market that sells testing alongside products.

The rules do not apply to "Research laboratories that test human specimens but do not report patient specific results." The results in question are those given "for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of individual patients."

Read the two halves. Testing human specimens does not bring a lab into the scheme. Reporting patient-specific results for diagnosis, prevention, treatment or health assessment does.

The other two exceptions are narrower. They cover facilities that only perform forensic testing, and laboratories certified by the federal substance abuse agency for drug testing meeting that agency's rules. All other testing such a lab does is covered.

So a laboratory can genuinely test human blood and sit outside this scheme, provided it does not hand individual results back for those purposes. That is a real category, not a loophole, and it is a different thing from a clinical laboratory.

Complexity is scored, not asserted

Section 493.17 sets out how a test lands in a category, and the mechanism is a scoring system rather than a judgment call.

Seven criteria are each scored 1, 2 or 3. The regulation explains the scale: a score of 1 indicates the lowest level of complexity, and a score of 3 indicates the highest level.

The criteria are the things that make a test hard to run reliably: knowledge required, training and experience, reagent and materials preparation, characteristics of operational steps, calibration and quality control materials, and interpretation and judgment.

The scores are added. "Test systems, assays or examinations receiving scores of 12 or less will be categorized as moderate complexity, while those receiving scores above 12 will be categorized as high complexity."

For commercial test systems, the manufacturer submits supporting data as part of its device application, and FDA determines the complexity category and notifies the manufacturer and the other agencies.

The default is the strictest category

Buried in paragraph (c) is a rule that inverts the usual assumption about unlisted things.

If a test system, assay or examination "does not appear on the lists of tests in the Federal Register notices, it is considered to be a test of high complexity." That holds until the matter is reviewed on request and the applicant is notified.

Uncategorized therefore means high complexity, not unregulated.

Recategorization is possible but rationed. A request "will be accepted for review if it is based on new information not previously submitted" by the same applicant, "and will not be considered more frequently than once per year."

What a waived test actually is

Section 493.15 defines the easiest category, and its criteria are about error, not about importance.

Waived test systems are "simple laboratory examinations and procedures" which are cleared by FDA for home use. Alternatively they "Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible," or "Pose no reasonable risk of harm to the patient if the test is performed incorrectly."

The section then lists the tests a certificate of waiver covers, and the list is short and specific. It covers non-automated dipstick or tablet urinalysis for a named set of analytes, fecal occult blood, and visual ovulation and urine pregnancy tests. It also covers non-automated erythrocyte sedimentation rate, blood glucose by monitoring devices cleared specifically for home use, spun microhematocrit, and two hemoglobin methods.

A laboratory qualifies for a certificate of waiver only if "it restricts the tests that it performs to one or more of the following tests or examinations" on that list "and no others."

And two obligations attach even at this level. A waived laboratory must "Follow manufacturers' instructions for performing the test" and meet the requirements of the certificate of waiver subpart.

A certificate of waiver is not an absence of oversight

Subpart B sets out what holding one involves, and it is more than a filing.

Section 493.35 requires an application describing the laboratory operation. It must include "The name and the total number of test procedures and examinations performed annually," the methodologies used, and "The qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory."

It also requires agreement to inspection in four situations. One is where HHS "has substantive reason to believe that the laboratory is being operated in a manner that constitutes an imminent and serious risk to human health." Two others are to evaluate public complaints, and "On a random basis to determine whether the laboratory is performing tests not listed."

Section 493.37 adds that a certificate of waiver "is valid for no more than 2 years." Renewal must be applied for "not less than 9 months nor more than 1 year before the expiration of the certificate."

Non-compliance can lead to suspension, revocation or limitation, with a statement of grounds and an appeal route, and with consequences for federal program payments.

The category that only exists in a clinic

Section 493.19 covers provider-performed microscopy, which is an unusual category because it is defined partly by who is holding the microscope.

The examination must be personally performed by a physician, a dentist, or a midlevel practitioner within defined practice arrangements, "during the patient's visit on a specimen obtained from his or her own patient."

The procedure must be categorized as moderately complex, and "The primary instrument for performing the test is the microscope, limited to bright-field or phase-contrast microscopy."

Two further criteria explain why the category exists. "The specimen is labile or delay in performing the test could compromise the accuracy of the test result," and "Control materials are not available to monitor the entire testing process."

It is a carve-out for tests that have to happen immediately, in the room, and cannot be run through the usual quality controls.

What a reader can do with this, and what was not checked

The useful move is to ask a different question about bundled testing than the obvious one.

Not is there a lab, but which certificate covers the tests being run. A certificate of waiver permits only the tests on a specific short list and no others.

And whether individual results are being reported back for diagnosis, prevention, treatment or health assessment. Where they are not, the research exception in section 493.3(b) can put the work outside this scheme altogether.

Two limits on this page. Only subparts A and B of part 493 were read, so nothing here describes what a certificate of compliance or a certificate of accreditation actually requires beyond naming that both exist.

And no laboratory was examined. This describes a regulation, names no seller, assesses nobody, and is not medical or legal advice.

Sources

Each document below is named as it names itself, with the date printed on that document rather than the day it was read.

1. Title 42 Code of Federal Regulations section 493.3, Applicability — Electronic Code of Federal Regulations, Office of the Federal Register, January 2003
2. Title 42 Code of Federal Regulations section 493.5, Categories of tests by complexity — Electronic Code of Federal Regulations, Office of the Federal Register, April 1995
3. Title 42 Code of Federal Regulations section 493.15, Laboratories performing waived tests — Electronic Code of Federal Regulations, Office of the Federal Register, October 2017
4. Title 42 Code of Federal Regulations section 493.17, Test categorization — Electronic Code of Federal Regulations, Office of the Federal Register, January 1993
5. Title 42 Code of Federal Regulations section 493.19, Provider-performed microscopy (PPM) procedures — Electronic Code of Federal Regulations, Office of the Federal Register, August 2003
6. Title 42 Code of Federal Regulations section 493.35, Application for a certificate of waiver — Electronic Code of Federal Regulations, Office of the Federal Register, April 1995
7. Title 42 Code of Federal Regulations section 493.37, Requirements for a certificate of waiver — Electronic Code of Federal Regulations, Office of the Federal Register, April 1995