Cal. Code Regs. tit. 17 § 1065

Current through Register 2024 Notice Reg. No. 24, June 14, 2024

Section 1065 - Imposition of Sanctions

(a) The department may impose, as applicable, one or more of the following sanctions on a clinical laboratory, a public health laboratory or a provider of service:

(1) Principal sanctions.

(2) Intermediate sanctions.

(3) Alternative sanctions.

(4) Automatic suspension of a license or registration based on federal exclusion from the Medicare or Medicaid program or revocation of CLIA certificate.

(5) State-initiated exclusions from the Medicaid and Medi-Cal programs.

(6) Exclusion from ownership or operation for two years following license or registration revocation.

(7) Civil suit to enjoin statutory or regulatory violations.

(8) Criminal sanctions for unlawful activity.

(9) Automatic revocation of license/registration or other approval based on intentional referral of proficiency testing samples for analysis.

(10) Suspension of Medi-Cal and Medicaid payments for failure to permit an inspection.

(b) The department's decision to impose sanctions shall be based on one or more of the following:

(1) Deficiencies found by the department or its agents in the conduct of inspections or through review of materials submitted by a laboratory (e.g., personnel qualifications).

(2) Unsuccessful participation in proficiency testing.

(c) The department shall base its choice of sanction or sanctions to impose on consideration of one or more factors that include, but are not limited to, the following, as assessed by the department or its agents:

(1) Whether the deficiencies pose immediate jeopardy.

(2) The nature, incidence, severity, and duration of the deficiencies or noncompliance.

(3) Whether the same condition level deficiencies have been identified repeatedly.

(4) The accuracy and extent of laboratory records (e.g., of remedial action) in regard to the noncompliance, and their availability to the department, to its agents, or to the United States Health Care Financing Administration and its agents.

(5) The relationship of one deficiency or group of deficiencies to other deficiencies.

(6) The overall compliance history of the laboratory.

(7) The corrective and long-term compliance outcomes that the department hopes to achieve through application of the sanction.

(8) Whether the laboratory has made any progress toward improvement following a reasonable opportunity to correct deficiencies.

(d) The department shall impose a separate sanction for each condition level deficiency or a single sanction for all condition level deficiencies that are interrelated and subject to correction by a single course of action.

Cal. Code Regs. Tit. 17, § 1065

1. New article 8 (sections 1065-1067.15) and section filed 8-28-97 as an emergency; operative 8-28-97 (Register 97, No. 35). A Certificate of Compliance must be transmitted to OAL by 12-26-97 or emergency language will be repealed by operation of law on the following day.
2. Certificate of Compliance as to 8-28-98 order transmitted to OAL 12-24-97 and filed 2-9-98 (Register 98, No. 7).

Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; Stats. 1995, c.510, Section 1; and Section 14105, Welfare and Institutions Code. Reference: Stats.1995, c.510, Section 1; Section 101160, Health and Safety Code; Sections 1265, 1267, 1280, 1281, 1282, 1283, 1284, 1285, 1286, 1287, 1288.5, 1289, 1310, 1320, 1323, 1324 and 1326, Business and Professions Code; Sections 11503, 11504, 11506 and 11523, Government Code; 42 USC Section 1395x(s) [Section 1861(s) of the Social Security Act]; 42 United States Code, Section 1395w-2 [Section 1846 of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(9)(C) [Section 1902(a)(9)(C) of the federal Social Security Act]; 42 United States Code, Section 1396a(a)(30) [Section 1902(a)(30) of the federal Social Security Act]; 42 USC Section 1396a(p) [Section 1902(p) of the Social Security Act]; 42 CFR Section 1002.2; 42 CFR Sections 1001.201 through 1001.1701; Section 14123, Welfare and Institutions Code; and 42 CFR Section 493.1840.