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The Taking Essential Steps for Testing Act of 2012 (TEST Act)  is a amendment to the Clinical Laboratory Improvement Amendments(CLIA) passed in the 112th United States Congress and signed into law by President Barack Obama on December 4, 2012.

The bill revised sanctions that the Centers for Medicare and Medicaid Services (CMS) must impose on clinical laboratories that refer proficiency testing samples. To demonstrate their proficiency, laboratories are required to perform tests on samples periodically. Under current law, if CMS determines that a laboratory has intentionally referred such a sample to another laboratory for testing, CMS is required to revoke the laboratory’s certification for at least one year and may impose other intermediate sanctions, including requiring laboratories to implement plans for corrective action, pay civil penalties, or pay for the costs of onsite monitoring. S. 3391 would revise those sanctions to allow CMS the flexibility to choose whether or not to revoke the laboratory’s certification. Other intermediate sanctions would continue to be available.

The Congressional Budget Office (CBO) forecasted no increased expenditures and found that the legislation would increase the number of laboratories retaining certification compared with current law resulting in a shift of laboratory services among certified laboratories rather than increasing the number of laboratory services provided.

Background
Under CLIA 1988,the revocation of a CLIA certificate and two years of probation for the owner and laboratory director were the automatic penalties for PT referrals regardless of the circumstance. In some cases, the penalties were for new laboratory employees who in following standard operating procedures for patients, sent out PT specimens for confirmatory or reflex testing.

There have been several cases where laboratories referred out PT HIV specimens for confirmatory workups because that was their procedures for patient samples. These laboratories subsequently had their CLIA certificates revoked due to PT referral. As the number of inadvertent PT referrals grew, there was a negative impact on laboratories and healthcare systems. From 2009 to 2011, 16 CLIA laboratories had their certificates revoke due to improper PT referrals. Of the 18 intentional PT referral appeals lodged with HHS between 1994 and 2011, only a single case was overturned.

In September 2010, CLIAC recommended updating the PT referral regulations to distinguish acceptable PT referral from unacceptable PT referral with the “intent to defraud” allowing CMS more flexibility in imposing sanctions on laboratories. CLIAC also recommended that acceptable PT referral would allow laboratories to treat PT exactly as patient samples and perform reflex or referral testing when it is included in their standard procedure for patients. The recommendation suggested there should be documentation to the referral laboratory on the nature of the referral and that referral laboratories should not be penalized.

Ohio State University Wexner Medical Center Proficiency Testing Referral
On the evening of Feb. 15, 2012, a medical technology student at Ohio State University Wexner Medical Center(OSUWMC) inadvertently reflexed a positive Lyme disease proficiency testing (PT) sample to the Mayo Clinic reference lab for Western Blot confirmation. The student had not yet been educated on PT and had only received limited verbal information in new-employee orientation. The following morning, Mayo Clinic notified OSUWMC that an the improper PT referral was made. OSUWMC conducted an internal investigation and found five other proficiency-test samples, routine blood culture specimens, had also been improperly routed to another OSU CLIA lab between 2009 and 2011. Many laboratory staff members didn’t know that the two OSU laboratories were distinct CLIA laboratories with their own CLIA numbers and should not refer proficiency tests to each other. OSUWMC proceeded to self-report the six improper testing referrals to its CLIA accreditation organization, the College of American Pathologists (CAP), and the Ohio Department of Health(ODH), the state agency responsible for enforcing CLIA.

The Ohio Department of Health and CMS conducted a complaint survey on March 12, 2011. On June 11, 2011, CMS sent OSUWMC a deficiency notice that it intended to revoke it CLIA certificate due to non-compliance on PT referrals. OSUWMC sent a response of over 100 pages to CMS that it had addressed the issue. On July 12, 2011 CMS notified OSUWMC that's its CLIA certificate would be revoked effective August 10, 2011 if it did not appeal. OSUWMC filed an appeal to stay the revocation. The impacted laboratory performed over 7 million out of the 9 million annual tests in the Ohio State's medical laboratory network. In response, OSUWMC lobbied the Ohio congressional delegation, who sent a bipartisan letter to the United States Secretary of Health and Human Services, Kathleen Sebelius, expressing their concerns about the CMS decision stating "is an extreme interpretation of the applicable statutory provision—it is a punishment that exceeds the nature of the offense". On Dec 4, 2011 the Taking Essential Steps for Testing (TEST) Act of 2012 (Pub. L. 112-202) law was enacted granting CLIA more leeway in imposing sanctions instead of certificate revocation. On Jan 16, 2013, a settlement between CMS and OSUWMC was announced requiring a new laboratory medical director, a fine of US$268000 2013, and additional staff training in PT. The previous laboratory director was reassigned within the department. A government mandated analysis of OSUWMC PT referral mishap that was conducted by Vanderbilt University and it was found that the successful appeal has cost it almost a US$1000000 2011 — $646,551 in legal fees, a $268,000 fine and $9,925 for the analysis of what went wrong in addition to the internal costs such as subsequent staff retraining. OSUWMC now includes proficiency-test training as part of its orientation, requires all laboratory employees to complete an annual computer course on proficiency testing, and have modified their laboratory information system (LIS) so that positive proficiency tests no longer automatically show up on a send-out list. The CMS OSUWMC settlement is not a legal precedent and CMS retains discretion on imposing a sanction or revocation for improper PT referral.

Bill
The bill softened the CLIA statutory language from mandating that a lab's CLIA license "shall be suspended" to "may be suspended" and gave CMS the latitude to substitute intermediate sanctions where appropriate, including a directed plan of correction, civil money penalties, and costs or on-site monitoring or any combination thereof.

Reception
The bill was supported by American Association for Clinical Chemistry (AACC), College of American Pathologists (CAP), the American Clinical Laboratory Association (ACLA), and American Medical Technologists (AMT). CLIA officials welcomed the enforcement discretion noting the rule allows for a better fit between the nature and extent of an intentional PT referral violation and the penalties that are imposed.

On May 2, 2014, CMS published the regulations (CMS–1443–FC) outlining the alternative sanctions for PT referrals per the TEST Act that would be effective July 1, 2014.

Unintentional reflex and confirmatory testing PT referrals may arise from a literal interpretation of the PT regulations, that that the PT specimen must be tested in the same manner as specimens. For a patient specimen, a pathologist may review an abnormal smear that has been flagged by a medical laboratory scientist, but on a PT specimen, the pathologist review must be completed in the same CLIA lab. If the pathologist completes the review at a CLIA laboratory with a different CLIA identifier than the ordering laboratory, even if completed within the same hospital, this would be construed as a PT referral. Likewise, any reflex testing on the specimen must be completed by the laboratory with the same CLIA identifier, even if there are co-located laboratories sharing the same floor or building. In highly automated laboratories, PT samples may require different handling than patient samples to prevent reflexing.


 * https://www.govinfo.gov/content/pkg/FR-2014-05-02/pdf/2014-09908.pdf#page=1

PT is a major component of the CLIA regulations and plays an integral role in the overall quality assurance of a laboratory. We emphasize that there is no on-site, external proctor for PT in laboratories, and the testing relies in large part on an honor system. The PT program places heavy reliance on each laboratory and laboratory director to self-police their analysis of PT samples to ensure that the testing is performed in accordance with the CLIA requirements.


 * https://www.captodayonline.com/pt-referral-rules-bring-regulatory-relief-for-labs/
 * https://assets.hcca-info.org/Portals/0/PDFs/Resources/Compliance_Today/1014/ct-2014-10-cilek.pdf
 * https://www.cdc.gov/clia/docs/CLIA-88-TEST-Act-2012-Changes.pdf
 * https://www.cms.gov/medicare/provider-enrollment-and-certification/surveycertificationgeninfo/policy-and-memos-to-states-and-regions-items/survey-and-cert-letter-14-23
 * https://health.wyo.gov/wp-content/uploads/2018/11/HLS-SC-18-07-CLIA.pdf



SO

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