- laboratory director of a laboratory performing high complexity testing, specified in 42 C.F.R. §§ 493.1443 and 493.1445; (8) the laboratory failed to meet all requirements for a technical supervisor overseeing high complexity testing specified in 42 C.F.R. §§ 493.1449 and 493.1451; (9) the laboratory failed to meet all requirements for testing personnel performing high complexity testing specified in 42 C.F.R. §§ 493.1489 and 493.1495; and (10) the laboratory has expressed no rational reasons for its failure to achieve compliance with all applicable Condition-level CLIA requirements.
- 42 C.F.R. §§ 493.1806(c)(1), 493.1832(b)(2), 493.1844(d)(1), and 493.1844(g)(1)—Alternative Sanction: Directed Portion of a Plan of Correction effective five calendar days from the notice of imposition. The laboratory will be directed to submit to this office within ten calendar days from the date of the notice of imposition of sanctions a list of the names and addresses of all physicians and other clients who have used some or all of the laboratory's services from January 2014 to the present date. This list may be used to advise the laboratory's clients of the nature of its non-compliance and the nature and effective date of any sanctions imposed against the laboratory. The effective date of this sanction will not be delayed due to the filing of a hearing request.
- 42 C.F.R. §§ 493.1804(b)(1)(ii), 493.1804(b)(2), 493.1807(b), 493.1808(b), 493.1826, 493.1844(d)(1), and 493.1844(h)(2)—Medicare Principal Sanction: Suspension of the laboratory's approval to receive Medicare payments for any services performed for the specialty of hematology on or after eight calendar days from the notice of imposition. As a consequence of the suspension of the approval to receive Medicare for services performed for the specialty of hematology, under Section 1902(a)(9)(C) of the Social Security Act and 42 C.F.R. § 440.30(c), payment under the Medicaid program, Title XIX of the Social Security Act, will no longer be available to the laboratory for all laboratory services performed for the specialty of hematology effective eight calendar days from the notice of imposition.
- 42 C.F.R. §§ 493.1807(a), 493.1808(a), 493.1842, and 493.1844(d)(3)—Principal Sanction: Cancellation of the laboratory's approval to receive Medicare payments for all laboratory services effective 60 calendar days from the notice of imposition. This sanction will be effectuated even if the laboratory files a timely appeal. Moreover, in accordance with Section 1902(a)(9)(C) of the Social Security Act and 42 C.F.R. § 440.30(c) and 493.1809, payment under the Medicaid program, Title XIX of the Social Security Act, will no longer be available to the laboratory for all laboratory services effective 60 calendar days from the notice of imposition. See 42 C.F.R. § 440.2(b).
The laboratory is advised that the above sanctions cannot be avoided by the closure of the laboratory, discontinuation of testing, voluntary withdrawal from the CLIA program, or changes in certificate to a lower level of testing.
When the laboratory's CLIA certificate is revoked, the laboratory will not be permitted to perform any testing, including waived testing and provider performed microscopy
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