Laboratory Quality and Proficiency Testing: When the Passing Result Hides the Problem

Laboratory proficiency testing fraud hides how a lab actually performs through shared answers, special treatment of proficiency samples or false testing records. The outside reviewer sees a passing result. The people at the bench may know how the lab got that result, which controls failed and whether patient testing continued anyway. Patients rely on the results, and taxpayers pay when the laboratory bills the government for testing whose defects it concealed.

The useful connection runs from the instrument to the report to the claim. A quality-control analyst may see a failed run. A laboratory director may see the warning that followed. A biller may see the service charged to Medicare. We work with insiders to connect those views, including what management knew when the lab released the results and requested payment.

What Is Proficiency Testing?

Proficiency testing checks a laboratory’s performance using samples whose answers are unknown to the laboratory. An approved outside program sends the samples, grades the lab’s responses and returns its scores. The federal proficiency testing rule describes this as an independent check on testing accuracy, reliability and staff competency. Required proficiency testing covers specified moderate- and high-complexity testing. The laboratory enrolls in an approved program for the testing it performs and identifies which program will determine compliance if it uses more than one.

For quantitative tests, the comparison can use a target established through reference methods or results from participating laboratories. A peer group brings together laboratories using similar instruments, methods or reagent systems.

The Clinical Laboratory Improvement Amendments laboratory requirements put the samples into the regular patient workload. The usual personnel use the usual methods and test each sample the same number of times they would a patient’s specimen. Both the analyst and laboratory director attest to that treatment. Giving the proficiency sample extra attempts while patients get a single run makes the outside check a demonstration of a different process.

In routine chemistry, the satisfactory proficiency testing score is at least 80% for each analyte and for the event overall.

External proficiency testing sits alongside the lab’s own accuracy checks. For nonwaived tests outside the required proficiency testing list, or tests for which compatible proficiency samples are unavailable, the laboratory must verify accuracy at least twice annually.

What Happens After a Failed PT?

A failed proficiency testing result calls for review, correction and a record of what changed. For routine chemistry, the laboratory requirements call for remedial action for an unacceptable score and training or technical assistance for an unsatisfactory result. The important question inside the laboratory is what the failure reveals about the testing patients received.

When calibration or quality controls fail, the rule requires the laboratory to evaluate patient results from the unacceptable run and since the last acceptable run. That reaches beyond the particular sample that exposed the problem. Storage conditions, reagents, equipment performance and the method itself can all belong in that review.

If the lab discovers errors in reports already released, it must promptly notify the people who ordered or use the results and issue corrected reports. It must retain both the original and corrected versions. The comparison shows what the clinician first received, what changed and when the laboratory acknowledged the problem.

Laboratory Proficiency Testing Referral, Repeat Violations and Waiver Sanctions

Laboratory proficiency testing referral can replace a lab’s own performance with another lab’s answer. The laboratory requirements prohibit sending proficiency samples to another laboratory for analysis the sending lab is certified to perform. They also prohibit discussion of proficiency testing results between laboratories before the reporting deadline. That includes sister laboratories at separate testing sites or locations: belonging to the same chain does not make sharing answers acceptable.

Ordinary patient testing may involve reflex or confirmatory work at another lab. For a proficiency sample, the routine workflow stops at the point where a patient specimen would be sent out.

The laboratory must document each stage of sample handling, preparation, testing and reporting, retaining the result forms and signed attestation for at least two years. Those records show which sample left, who received it and whose answer went back to the proficiency testing program. A receiving laboratory must notify the Centers for Medicare & Medicaid Services when it receives a proficiency sample from another lab.

A repeat referral, or reporting another laboratory’s answers as its own before the deadline, can cost a lab its certificate. The Taking Essential Steps for Testing Act of 2012 gave regulators discretion over revocation for intentional referral. A false-claims investigation follows what the government was told and paid for.

Waived testing does not require proficiency testing enrollment, but the agency’s final rule explains that intentional-referral sanctions can reach a laboratory holding a Certificate of Waiver. Laboratories certified for moderate- or high-complexity testing that voluntarily perform proficiency testing for waived tests must also follow the sample-handling and referral restrictions. We examine waiver sanctions and the testing behind the payment claim with whistleblower lawyers who understand laboratory quality cases.

Quality Systems Show What Happened Between Proficiency Tests

A laboratory’s quality system covers the daily work that sits between proficiency samples. Written procedures address specimen handling, calibration, controls, interfering substances, reporting and what happens when the test system fails. Changes require the laboratory director’s approval before use. The version in force during a disputed run matters more than a clean procedure written afterward.

Analytical validation asks how the test performs. Before reporting patient results from a newly introduced, unmodified FDA-cleared or approved system, a laboratory must verify accuracy, precision and reportable range and check the reference intervals for its patients. For modified or internally developed systems, the requirements also address analytical sensitivity and specificity, including interference.

A laboratory’s validation records show how it established the test’s performance. Its orders and billing records show what service it claimed to provide. We connect the testing to the claim.

Personnel qualifications belong in that picture. The laboratory requirements assign qualifications and responsibilities by testing complexity and role. For moderate-complexity testing, the director must ensure adequate staffing, appropriate education and training, and demonstrated ability before staff test patient specimens. Delegating work leaves the director responsible for its proper performance.

The scientific record includes unsuccessful attempts as well as the final result. In Fat Finger, Falsification, or Fraud?, published in Spectroscopy in 2010, the discussion of data integrity calls for original, contemporaneous and complete data, including repeat analyses. Its definition of complete data includes the attempts that did not produce the answer the lab wanted:

A final result can look orderly after earlier failures have disappeared. The instrument output, repeat runs and audit trail show how the lab arrived at the answer it released.

Can a Toxicology Report Be Wrong?

Yes. Failed calibration and unacceptable quality controls can undermine a toxicology result that the laboratory reports to a client. At Avertest, a whistleblower’s complaint against the company alleged that staff used older calibration and quality-control data to make failed runs appear acceptable.

Can Employees at a Drug Testing Facility Lie About Results?

Yes. The Spectroscopy paper describes deliberate falsification as writing or entering data with the intent to deceive. The original result, edit history and released report can show where an answer changed. Management instructions and internal warnings can show who directed or understood that change.

What Does Accreditation Validation Examine?

Accreditation validation examines whether an accreditor’s inspection process identifies laboratory deficiencies. The Centers for Medicare & Medicaid Services can inspect accredited laboratories through representative sampling or in response to a substantial allegation of noncompliance, then use those findings to assess the accreditation process.

The Government Accountability Office’s 2006 review found a weakness in that comparison: many validation reviews occurred alongside the original inspection. GAO concluded that collaboration between the teams prevented an independent evaluation of what the original surveyors found. That historical finding explains why an independent look at ordinary work matters.

How Do I Report Unsafe Blood Sample Handling and Potential Lab Fraud?

Talk with our whistleblower experts about the handling problem and the testing the laboratory billed. We connect the quality concern to the order, the work performed, the released result and the claim, including any instructions or warnings that explain the laboratory’s decisions.

We work with you to connect the specimen records, control data and report changes to what the health care provider ordered, what the payer was charged and what management knew.

A senior quality-control analyst brought the whistleblower case in which Alere agreed to pay $33.2 million to resolve allegations involving unreliable diagnostic devices. That parallel puts the person who understands test reliability directly in the false-claims story. Healthcare fraud evidence can begin at the quality-control bench.

The False Claims Act reaches payment claims made with knowledge of false information, deliberate ignorance or reckless disregard for whether it is true. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers. Our work is to connect the technical knowledge to the false claim: what the laboratory represented, what it delivered and what the people making those decisions knew.

When You Know How the Lab Got Its Answer

If you know why the proficiency testing submission, calibration record or patient report concealed what happened at the bench, speak to one of our whistleblower experts about how the lab got its answers. We build your strongest laboratory fraud whistleblower case with you and bring in laboratory fraud whistleblower lawyers who understand the connection between unreliable testing and government payments. We stay beside you as your technical knowledge becomes the evidence the case needs.