The Health and Human Services Departmental Appeals Board recently upheld the revocation of a clinic laboratory’s Clinical Laboratory Improvement Amendments certificate after it was found in violation of several proficiency testing (PT) requirements. The laboratory admitted to all of the material facts in the case but appealed the Centers for Medicare and Medicaid Services (CMS) decision to revoke its certificate, pleading that the sanction imposed was too harsh based on the circumstances surrounding the violation. Planned Parenthood Choice of Abilene, Texas, a clinical lab certified under CLIA, admitted that prior to submitting its first-quarter 2011 PT report, the lab employee charged with performing the tests called a second lab and compared results. The violation was discovered during an Oct. 6, 2011, certification survey. The surveyor found that the lab did not meet two separate conditions of participation that govern the enrollment and testing of proficiency samples and the requirement that govern a laboratory director’s requirements for labs performing moderate-complexity testing. As a result, CMS revoked the lab’s CLIA certificate and cancelled the laboratory’s approval to receive Medicare payments. According to CLIA regulations, a laboratory must treat and analyze PT samples in the same manner as patient samples and it may […]
The Health and Human Services Departmental Appeals Board recently upheld the revocation of a clinic laboratory’s Clinical Laboratory Improvement Amendments certificate after it was found in violation of several proficiency testing (PT) requirements. The laboratory admitted to all of the material facts in the case but appealed the Centers for Medicare and Medicaid Services (CMS) decision to revoke its certificate, pleading that the sanction imposed was too harsh based on the circumstances surrounding the violation.
Planned Parenthood Choice of Abilene, Texas, a clinical lab certified under CLIA, admitted that prior to submitting its first-quarter 2011 PT report, the lab employee charged with performing the tests called a second lab and compared results. The violation was discovered during an Oct. 6, 2011, certification survey. The surveyor found that the lab did not meet two separate conditions of participation that govern the enrollment and testing of proficiency samples and the requirement that govern a laboratory director’s requirements for labs performing moderate-complexity testing. As a result, CMS revoked the lab’s CLIA certificate and cancelled the laboratory’s approval to receive Medicare payments.
According to CLIA regulations, a laboratory must treat and analyze PT samples in the same manner as patient samples and it may not engage in interlaboratory communications pertaining to PT results until after the due date for reporting results to the PT program. By its own admission, a laboratory employee did contact another laboratory because she was unsure of her results because she was testing proficiency samples for the first time during her one-year tenure at the laboratory. During her interview, she stated that she had contacted the San Angelo, Texas, Planned Parenthood lab to compare results before she submitted her result to the PT program. She also said that both labs arrived at the same result independently.
The surveyor interviewed employees of the San Angelo laboratory who she contacted and confirmed that conversations occurred between the two labs about PT results. However, San Angelo personnel thought the results were not discussed until after they had been submitted.
In the appeal, Planned Parenthood admitted to the call but stated that it was an innocent error by someone unaware of the prohibition regarding calling other sites. The second violation concerned the fact that the laboratory director did not sign the required statements attesting that the PT samples were tested in the same manner as patient specimens. The employee even carefully documented the improper call in the testing record: “Called Nanci about unsure results. Nanci said to call [San Angelo] location and compare results. After speaking with Heather Keeling, all of our results are the same. Submitted the results online.”
To further implicate improper activities may have occurred, the decision document includes a footnote concerning CMS’s observation of “an obvious and unexplained change on the lab’s answer sheet. The answer for sample Rh04 has been changed from positive to negative.” The note further states that the San Angelo lab also reported a negative on the same sample which, according to the note, implies that the testing employee changed her result to match the San Angelo lab’s result.
The judge accepted Planned Parenthood’s denial of any wrongdoing but it was not considered a material fact by the judge. The lab tried to invoke the recent change in CLIA law to allow CMS discretion in revoking a CLIA certificate based on violations of PT provisions, but the judge pointed out that the law allows discretion but does not require that CMS not revoke a certificate. The judge also pointed out the violations occurred well before the CLIA change occurred, and it cannot be applied retroactively.
What are the lessons to be learned? After reviewing this case, it is obvious that this laboratory committed a series of violations, partly because it was not attentive to its CLIA requirements and was not very well managed. As a final irony, by the time this was resolved, the laboratory no longer performed the testing for which it was sanctioned. Laboratory directors and executives are responsible for everything that goes on in their laboratories. It is imperative that these responsible persons take compliance with regulations and laws as seriously as they take other leadership responsibilities. If not, as in this case, the mistakes of one poorly trained and supervised employee can determine the future or nonfuture of a laboratory.
Takeaway: The quality and effectiveness of employee training must be monitored and audited to ensure the critical messages required for their area of responsibility are effectively communicated.
