- a timely hearing request is received, revocation of the laboratory's CLIA certificate will become effective following the administrative hearing decision, if our determination of noncompliance is upheld. See 42 C.F.R. 493.1840(e)(1).
- 42 C.F.R. §§ 493.1806(b), 493.1812, 493.1840(a)(3), and 493.1840(d)(2)(i)—Principal Sanction: Limitation of the laboratory's CLIA certificate for the specialty of hematology effective July 15, 2016, based on the finding of immediate jeopardy. Pursuant to 42 C.F.R. §§ 493.1840(d)(2)(i) and 493.1844(d)(2)(ii), the limitation will take effect regardless of whether a hearing request is filed and will remain in effect until the laboratory's CLIA certificate is revoked.
- 42 C.F.R. §§ 493.1806(c)(3), 493.1810(d), 493.1834, and 493.1844(d)(1)—Alternative Sanction: Civil Money Penalty(CMP) in the amount of $10,000 per day for each day of noncompliance effective July 12, 2016, and will continue to accrue until it can be verified that all the cited deficiencies have been corrected and the laboratory is in compliance with all Condition-level requirements or the laboratory's CLIA certificate is limited, whichever occurs first. As the laboratory was advised in our March 18, 2016 letter, if the laboratory requests a hearing, the CMP amount will not be collected until after the hearing decision is rendered. If the laboratory does not request a hearing, CMS may reduce the proposed amount by 35 percent. See 42 C.F.R. § 493.1834(e)(2)(iii).
- 42 C.F.R. §§ 493.1806(c)(1), 493.1832, and 493.1844(d)(1) and (g)(1)—Alternative Sanction: Directed Portion of a Plan of Correction effective July 12, 2016. The laboratory is directed to submit to this office within ten (10) calendar days from July 12, 2016, 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. CMS may use this list to advise the laboratory's clients of the nature of its noncompliance and the nature and effective date of any sanctions imposed against the laboratory's CLIA certificate. An appeal will not delay the due date for this submission or client notification by CMS.
-
42 C.F.R. §§ 493.1804(b), 493.1807(b), 493.1808(b), 493.1826, and 493.1844(d)(1) and (h)(2)—Medicare Alternative Sanction: Suspension of the laboratory's approval to receive Medicare payments for any services performed for the specialty of hematology on or after July 15, 2016.
As a consequence of the suspension of the approval to receive Medicare payments 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 July 15, 2016. See also 42 C.F.R. § 493.1809.
-
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 September 5, 2016. This sanction will be effectuated even if the laboratory files a timely appeal.
31
