The yearly list of laboratories that got into trouble

A register exists, and it is written for you

Most regulatory records are built for regulators and reach the public by accident. This one is not.

The rule opens with its audience. "Once a year CMS makes available to physicians and to the general public specific information" that is useful in evaluating how laboratories perform.

It then lists eight things that information includes.

Laboratories convicted under federal or state laws relating to fraud and abuse, false billing or kickbacks. Laboratories whose certificates were suspended, limited or revoked, "and the reason for the adverse actions".

People convicted of violating the laboratory law, with the circumstances of each case and the penalties imposed. Laboratories on which alternative sanctions were imposed. Laboratories whose accreditation was withdrawn or revoked, with reasons.

All appeals and hearing decisions. Laboratories the agency has sued. And laboratories excluded from the federal health programs, with the reasons for exclusion.

The entry for a sanctioned laboratory has four parts

The alternative sanctions list is the most detailed of the eight, and its structure is worth reading closely.

Each entry shows the effective date of the sanctions and the reasons for imposing them.

It also shows any corrective action the laboratory took.

And it shows the ending. "If the laboratory has achieved compliance, the verified date of compliance."

That fourth item is what keeps the register from being a permanent accusation. A laboratory that fixed the problem has the fix recorded, and dated, in the same place as the finding.

The register is compiled for the calendar year before it is published, and it carries explanatory information to help interpret the data. It also does something registers rarely do: "It also contains corrections of any erroneous statements or information that appeared in the previous registry."

What the sanctions are for, in the rule's own words

The enforcement subpart states its purposes before it states its powers, which makes the rest easier to read.

The first is "To protect all individuals served by laboratories against substandard testing of specimens."

The second is safeguarding the public against health and safety hazards arising from laboratory activities. The third is motivating laboratories to comply so that results are accurate and reliable.

Two things trigger a sanction decision. Deficiencies found during an inspection or through review of materials the laboratory submitted, such as personnel qualifications. Or unsuccessful participation in proficiency testing.

The severity of the finding matters more than the fact of it. Sanctions follow when a laboratory has condition level deficiencies, meaning failures of a whole condition rather than a single standard beneath it.

Three heavy sanctions and three lighter ones

The powers split into two tiers, and the rule names them plainly.

The principal sanctions are three: "suspension, limitation, or revocation of any type of CLIA certificate". Limitation is the middle option and it is the one most people have never heard of. It removes a specialty rather than the whole certificate.

The alternative sanctions are also three. A directed plan of correction, state onsite monitoring, and a civil money penalty. They can be imposed instead of a principal sanction or alongside one.

A laboratory holding only a certificate of waiver is outside the alternative sanctions entirely.

Beyond both tiers sit two further routes. The agency may sue in federal court to stop an activity it believes would be a significant hazard to public health. And an individual convicted of intentionally violating a requirement may be imprisoned or fined.

How the choice of sanction is made

The choice is not mechanical, and the regulation lists nine factors it is based on.

Whether the deficiencies pose immediate jeopardy. Their nature, incidence, severity and duration. Whether the same condition level deficiencies have been identified repeatedly.

The accuracy and extent of the laboratory's own records, including records of remedial action, and whether those records were available to the inspectors.

The relationship between deficiencies. The laboratory's overall compliance history. The outcome the agency is trying to achieve. Whether the laboratory has made progress after a reasonable opportunity to correct. And the state agency's own recommendation.

Money penalties have their own five-factor list, including whether the same condition level deficiencies appeared in three consecutive inspections, and the laboratory's intent or reason for the noncompliance.

The amounts are set as ranges rather than fixed sums, charged per day of noncompliance or per violation, adjusted annually. There are two ranges, and the higher one applies where the deficiency poses immediate jeopardy. Removing the jeopardy while the deficiency continues moves the charge to the lower range.

One procedural detail is worth knowing. If the laboratory does not request a hearing, "CMS may reduce the proposed penalty amount by 35 percent."

The clocks: five days, twelve months, two years

Three time periods do most of the work in this subpart.

Where deficiencies pose immediate jeopardy, the laboratory must act immediately to remove it. If a revisit shows the jeopardy remains, the certificate is suspended or limited "no earlier than 5 days after the date of notice of suspension or limitation".

Where condition level deficiencies do not pose immediate jeopardy, the laboratory gets a longer runway. If it has not corrected them "within 12 months after the last day of inspection", approval for federal payment is cancelled and the agency notifies it of a proposed suspension, limitation or revocation.

Deficiencies below the condition level start with a plan of correction, and run on the same twelve-month outer limit.

The clock can also stop early in the laboratory's favor. If during a visit the laboratory "produces credible evidence that it achieved compliance before the visit", the sanctions are lifted as of that earlier date.

The two-year clock is about people rather than laboratories, and it appears further down.

The grounds that reach the owner, not just the laboratory

A certificate can be suspended, limited or revoked for what the owner, the operator or an employee did.

The list starts with the certificate itself. Having "Been guilty of misrepresentation in obtaining a CLIA certificate".

Then performing, or representing the laboratory as entitled to perform, examinations outside the categories the certificate authorizes. Failing to comply with certificate requirements and performance standards.

Refusing a reasonable request to inspect the laboratory and its records during operating hours. Failing to comply with an alternative sanction already imposed.

And one that follows a person between businesses: having, "Within the preceding two-year period, owned or operated a laboratory that had its CLIA certificate revoked."

The proficiency testing referral rules carry the sharpest version of this. On the findings the rule specifies, the certificate is revoked for at least a year. The same paragraph "prohibits the owner and operator from owning or operating a CLIA-certified laboratory for at least 1 year".

That ban has a narrow, reasoned exit. The agency may exempt an owner laboratory by laboratory. It may do so only after finding no evidence of three things. That patients would be put at risk, that the other laboratory was complicit, or that it received a sample from another laboratory and failed to report it.

What this is useful for, and what it is not

For anyone trying to check a laboratory, the value here is knowing that a purpose-built public register exists and is annual. It names reasons rather than just outcomes, and it records the date compliance was verified.

It is also worth knowing what it cannot do. It is compiled for the preceding calendar year, so it is a look backwards rather than a live status. A laboratory sanctioned this month is not in the edition on the shelf.

It covers laboratories under this certificate scheme. It is not a register of the businesses that arrange testing, sell products alongside it, or resell someone else's bench.

And an absence in it is thin evidence. A laboratory can be absent because it was never sanctioned, or because the events fell outside the compiled year.

Two limits on this article. Only subpart R of part 493 was read, plus the registry section at 493.1850. And no edition of the register itself was retrieved, so nothing here describes what any published version actually contains.

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 493.1850, Laboratory registry, read in full for the eight lists, the four-part sanction entry and the corrections requirement — Electronic Code of Federal Regulations, Office of the Federal Register, February 1992
2. Title 42 Code of Federal Regulations section 493.1804, General considerations, read for the three purposes, the two bases for a sanction decision and the nine choice-of-sanction factors — Electronic Code of Federal Regulations, Office of the Federal Register, December 2023
3. Title 42 Code of Federal Regulations section 493.1806, Available sanctions: All laboratories, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, January 1993
4. Title 42 Code of Federal Regulations section 493.1812, Action when deficiencies pose immediate jeopardy, read in full — Electronic Code of Federal Regulations, Office of the Federal Register, February 1992
5. Title 42 Code of Federal Regulations section 493.1814, Action when deficiencies are at the condition level but do not pose immediate jeopardy, read for the twelve-month rule — Electronic Code of Federal Regulations, Office of the Federal Register, April 1995
6. Title 42 Code of Federal Regulations section 493.1820, Ensuring timely correction of deficiencies, read for the early-compliance provision — Electronic Code of Federal Regulations, Office of the Federal Register, February 1992
7. Title 42 Code of Federal Regulations section 493.1834, Civil money penalty, read for the five factors, the structure of the ranges and the hearing-waiver reduction — Electronic Code of Federal Regulations, Office of the Federal Register, September 2020
8. Title 42 Code of Federal Regulations section 493.1840, Suspension, limitation, or revocation of any type of CLIA certificate, read for the eight grounds and the ownership prohibition — Electronic Code of Federal Regulations, Office of the Federal Register, May 2014