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(A) the underlying scientific principles as well as the technical and procedural aspects of the examination of cytology specimens;
(B) the physiological, biochemical, microbiological, and genetic factors which affect cell health and disease, and the importance of cytology laboratory examinations to medical care;
(C) quality assurance sufficient to monitor and to implement quality control programs;
(D) the introduction and implementation of new procedures and the evaluation of new instruments;
(E) basic management theory and functions.
(2) Technical skills so that the examinee is capable of:
(A) performing examinations on cytology specimens;
(B) exercising initiative and independent judgment in dealing with the broad scope of procedural and technical problems;
(C) participating in, or being delegated, the responsibility for decisions involving quality control programs, or reagent purchases;
(D) communicating technical or general information to medical, paramedical, or lay individuals;
(E) participating in and developing responsibility for the establishment of technical and administrative procedures;
(F) supervising technicians, aides, and clerical personnel, as directed; and,
(G) providing instruction in the basic theory, technical skills, and application of cytology laboratory procedures.
(e) "Examinee" means an individual who meets the following requirements:
(1) Has a baccalaureate degree from a college or university accredited by the Western Association of Schools and Colleges or its equivalent with 20 semester hours (30 quarter hours) of biological science, 8 semester hours (12 quarter hours) of chemistry and 3 semester hours (4 quarter hours) of mathematics; and
(2) Has completed:
(A) A 12-month cytotechnology program accredited by the Council on Accreditation of Allied Health Educational Program (CAAHEP) or its equivalent; or
(B) Five years, of at least 40 hours a week, clinical laboratory experience in cytopreparatory techniques, microscopic analysis and evaluation of the body systems within the last ten years. At least two of these years must be subsequent to the completion of the academic component and at least two years must be under the supervision of a licensed physician who is a pathologist certified or eligible for certification by the American Board of Pathology in Anatomic Pathology or has other qualifications acceptable to the competency testing service or program.
(f) "Evidence of Satisfactory Performance" means (1) a copy of a document issued to an examinee after January 1, 1993 by a cytotechnology competency testing service or program indicating satisfactory performance by the examinee on a cytotechnologist competency examination; or (2) a copy of a document issued to an individual by the American Society of Clinical Pathologists (ASCP) Board of Registry (BOR) indicating satisfactory performance by the individual on an ASCP Cytotechnology Examination taken prior to the approval of a competency testing service or program under the provisions of this article.
(g) "Satisfactory performance" means (1) receipt of a passing score on a cytotechnologist competency examination given after January 1, 1993; or (2) passage of an ASCP Cytotechnology Examination prior to the approval of a competency testing service or program under the provisions of this article.
(h) "Passing score" means a score determined by a cytotechnologist competency testing service or program utilizing the criteria approved by the Department pursuant to section 1062.
(i) "Owner(s)" means any person who is a sole proprietor, or holds a partnership interest in, or who is an officer, director, or 5% (five percent) or more shareholder in a corporation which owns an organization that is applying for approval as a cytotechnologist testing service or program.


Note: Authority cited: Sections 1224 and 1270, Business and Professions Code. Reference: Section 1270, Business and Professions Code.


s 1061. Cytotechnology Licensure.
(a) A cytotechnologist license shall be issued to an individual who submits the following to the Department:
(1) A verified and complete application as described in subsection (b);
(2) Evidence of satisfactory performance;
(3) The application fee required under Business and Professions Code Section 1300 and Health and Safety Code Section 116.
(b) A complete application for a cytotechnologist license shall include the following verified information on a form, Application for Cytotechnologist License (LAB 124, Rev. 11/93), provided by the Department:
(1) Name, address, social security number (optional), and ASCP registration number, if any, of the applicant; and
(2) The applicant's education, training and experience in gynecological and non-gynecological cytology including:
(A) An official copy of any and all college credits including a statement of any degrees conferred; and
(B) Documentation of each of the following, if completed or obtained by the applicant:
1. The completion of a 12 month training program approved by CAAHEP or its equvalent, or
2. The completion of five years of full-time, of at least 40 hours a week, clinical laboratory experience in cytology;
3. ASCP registration certificate;
4. Licensure by the Department under Business and Professions Code section 1270 subsection (c) or subsection (d); and
(3) The name and address of the applicant's current laboratory employer(s), and the number of hours employed (by each) and the time devoted, and volume of types of specimens examined at each location.
(c) Within 30 calendar days of receipt of an application for a cytotechnologist license, the Department shall inform the applicant in writing that the application is either complete and accepted for filing or that it is incomplete and what specific information is required before the application may be accepted for filing.
(d) Within 90 calendar days from the date the Department receives the information and documentation required in subdivision (a), it shall inform the applicant in writing whether a cytotechnologist license shall be issued or denied. If a license is denied, the Department shall indicate the reasons therefor.
(e) The Department's time periods for processing an application for cytotechnologist license, from receipt of the initial application to the final decision regarding the license, are as follows:
(1) The median time for processing is 240 calendar days.
(2) The minimum time for processing is 120 calendar days.
(3) The maximum time for processing is 360 calendar days.
(f) Each licensed cytotechnologist shall notify the Department within 30 calendar days of any and all changes in his or her employment, including any changes in the name and address of his or her employer(s), the hours employed by each, and the information specified in subsection (b)(3) above.


Note: Authority cited: Sections 1224, 1270 and 1271(f), Business and Professions Code. Reference: Sections 1270, 1271 and 1300, Business and Professions Code; Section 15376, Government Code; and Section 116, Health and Safety Code.


s 1062. Cytotechnologist Competency Testing Services Or Programs.
(a) Any organization seeking approval by the Department as a cytotechnologist competency testing service or program shall submit an application to the Department which shall include documentation of the following:
(1) The organization's name, address, and owner(s);
(2) The organization's mechanism for assuring that each individual for whom a cytotechnologist competency testing examination is administered meets the criteria as an examinee;
(3) The organization's mechanism for assuring that each cytotechnologist competency examination administered by the organization shall test each examinee on his or her entry level skills and understanding of:
(A) The underlying scientific principles and the technical and procedural aspects of cytology;
(B) The identification of cellular changes in gynecologic and non-gynecologic specimens through both a written and visual component;
(C) Cytopreparatory techniques; and
(D) Cytology laboratory operations, and that each test shall include the following subject areas in the following ratios: 48% to 52% female reproductive system (to include both genital system and breast); 13%-17% respiratory system; 9%-12% male and/or female genitourinary system; 6%-10% alimentary system; and 13%-17% body cavity fluids and other body sites;
(4) The organization's mechanism for determining the validity and passing score for each cytotechnologist competency examination administered by the organization in order that there is a consistency between and among all testing events as to entry level skills that must be demonstrated in order for an examinee to pass the examination; and,
(5) The organization's mechanism for assuring the security of each cytotechnologist competency examination administered by it.
(b) Upon receipt of the above, and the determination by the Department that the documentation provides assurances of the following, the Department shall approve the organization as a cytotechnologist competency testing service or program and shall issue an approval document indicating the terms of the organization's approval:
(1) The organization shall only administer cytotechnologist competency examinations to persons who qualify as an examinee;
(2) Each cytotechnologist competency examination administered by the organization shall challenge each examinee on his or her entry level skills and understanding of the subjects, and shall contain the subject matter in the ratios identified in subsection (a) (3), above;
(3) Each cytotechnologist competency examination administered by the organization shall be validly constructed and have a passing score that fosters a consistency between and among all testing events as to entry level skills that must be demonstrated in order for an examinee to pass the examination; and,
(4) Each cytotechnologist competency examination shall be administered in a secure fashion.
(c) Within 15 days of receipt of an application by an organization for approval as a cytotechnologist competency testing service, the Department shall inform the organization in writing that the application is complete and accepted for review or deficient and what specific information or documentation is required to complete the application.
(d) Within 30 calendar days from the date of filing of a completed application, the Department shall inform the applicant organization in writing whether the organization has been approved as a cytotechnologist competency testing service or program.
(e) The Department's time periods for processing an application for approval as a cytotechnologist competency testing service or program, from the receipt of the initial application to the final decision regarding the approval, are as follows:
(1) The median time for processing is 90 calendar days.
(2) The minimum time for processing is 45 calendar days.
(3) The maximum time for processing is 135 calendar days.
(f) Cytotechnologist competency testing services or programs shall issue a document to each examinee who obtains a passing score on each cytotechnologist competency examination administered by the service or program.
(g) Cytotechnologist competency testing services or programs shall maintain, for a minimum of five years, and shall make available to the Department, records showing the validation, content, passing score, date and place of each competency testing examination administered by it, and a record of each examinee tested.
(h) A cytotechnologist competency testing service or program shall be subject to review by the Department to determine adherence to the requirements of this article and its approval. Failure of a cytotechnologist competency testing service or program to meet the requirements of this article or its terms of approval shall constitute good cause for revocation of approval by the Department.


Note: Authority cited: Sections 1224 and 1270, Business and Professions Code. Reference: Section 1270, Business and Professions Code; and Section 15376, Government Code.


s 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.


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.


s 1065.5. Principal Sanctions.
(a) The department may impose on a clinical laboratory the principal sanctions of denial, revocation or suspension of a registration or license issued under chapter 3 of division 2 of the Business and Professions Code whenever it determines that any of the grounds identified in Business and Professions Code section 1320 exist and it has complied with the requirements of Business and Professions Code sections 1267 and 1322. A clinical laboratory that has had a Statement of Issues or an Accusation filed against it for the denial, revocation or suspension of its license or registration may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. A clinical laboratory that is dissatisfied with a final decision regarding a denial, revocation or suspension may seek judicial review in accordance with section 11523 of the Government Code.
(b) The department may impose on a public health laboratory the principal sanctions of denial, revocation or suspension of the approval to operate a public health laboratory granted under article 5 (commencing with section 101150) of the Health and Safety Code whenever it determines that the requirements identified in 17 CCR section 1078 are not being met and it has complied with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code. A public health laboratory that has had a Statement of Issues or an Accusation filed against it for the denial, revocation or suspension of its approval to operate may defend itself by filing a notice of defense in accordance with section 11506 of the Government Code. A public health laboratory that is dissatisfied with a final decision regarding a denial, revocation or suspension may seek judicial review in accordance with section 11523 of the Government Code.
(c) The department may impose on a provider of service the principal sanction of suspension from further participation in, including reimbursement from, the Medi-Cal and Medicaid programs whenever it determines that any of the grounds identified in Welfare and Institutions Code section 14123 exist and it has complied with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code, except that hearings may be conducted by departmental hearing officers appointed by the director. A provider of service that has had an Accusation filed against it for its suspension from further participation in the Medi-Cal program may defend itself, its owner(s) or director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. A provider of service that is dissatisfied with a final decision regarding suspension from further participation in the Medi-Cal program may seek judicial review in accordance with section 11523 of the Government Code.


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.


s 1065.10. Intermediate Sanctions.
(a) The department may impose on a clinical laboratory the intermediate sanction of temporary suspension of a registration or license issued under chapter 3 of division 2 of the Business and Professions Code based on a departmental finding of immediate jeopardy or other grounds identified in Business and Professions Code section 1323. The intermediate sanction becomes effective upon the serving of an Accusation. A clinical laboratory that has had an Accusation filed against it for temporary suspension of its license or registration may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 1323 of the Business and Professions Code. Regardless of a notice of defense being filed, the temporary suspension remains in effect at least until the hearing is completed and the department has made a final determination on the merits. A clinical laboratory that is dissatisfied with a final determination on the merits may seek judicial review in accordance with section 11523 of the Government Code.
(b) The department may impose on a public health laboratory the intermediate sanction of temporary suspension of the approval to operate a public health laboratory granted under article 5 (commencing with section 101150) of the Health and Safety Code based on a departmental finding of immediate jeopardy. The intermediate sanction becomes effective upon the serving of an Accusation. A public health laboratory that has had an Accusation filed against it for temporary suspension of its approval may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. Regardless of a notice of defense being filed, the temporary suspension remains in effect at least until the hearing is completed and the department has made a final determination on the merits. A public health laboratory that is dissatisfied with a final determination on the merits may seek judicial review in accordance with section 11523 of the Government Code.
(c) The department may impose on a provider of service the intermediate sanction of temporary suspension from participation in, including reimbursement from, the Medi-Cal and Medicaid programs based on a departmental finding of immediate jeopardy or condition level deficiencies and when in the opinion of the director of the department such action is necessary to protect the public welfare or the interests of the Medi-Cal program. The intermediate sanction becomes effective upon the serving of an Accusation. A provider of service that has had an Accusation filed against it for temporary suspension from participation in the Medi-Cal program may defend itself, its owner(s) and director(s) by filing a notice of defense in accordance with section 11506 of the Government Code. Regardless of a notice of defense being filed, the temporary suspension remains in effect at least until the hearing is completed and the department has made a final determination on the merits. A provider of service that is dissatisfied with a final determination on the merits may seek judicial review in accordance with section 11523 of the Government Code.


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.


s 1065.15. Alternative Sanctions.
(a) The department may impose on a clinical laboratory one or more of the following alternative sanctions in lieu of or in addition to imposing a principal sanction:
(1) Directed plans of correction, as set forth in section 1067.
(2) Onsite monitoring, as set forth in section 1067.10.
(3) Civil money penalties, as set forth in section 1067.5.
(b) Prior to the imposition of an alternative sanction a clinical laboratory shall be given a Notice of Intent and an opportunity to respond. A clinical laboratory that is dissatisfied with the imposition of an alternative sanction may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure.


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.


s 1065.20. Automatic Suspension.
The department shall automatically suspend a clinical laboratory license or registration based on federal exclusion from the Medicare or Medicaid program or revocation of CLIA certificate. A clinical laboratory that is dissatisfied with the imposition of an automatic suspension may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure.


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.


s 1065.25. State-Initiated Exclusions from Medicaid and Medi-Cal.
The department may initiate exclusions from Medicaid and Medi-Cal when the grounds for taking a permissive exclusion under 42 CFR part 1002 exist. The department shall initiate exclusions from Medicaid and Medi-Cal when the grounds for taking a mandatory exclusion under 42 CFR part 1002 exist. Before imposing an exclusion, the department shall give a provider of service an opportunity to submit documents and written argument against the exclusion. A provider of service that is dissatisfied with the imposition of an exclusion may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure.


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.


s 1065.30. Exclusion from Ownership or Operation.
The department shall exclude for a period of two years following revocation any person or entity from owning, operating, or directing a laboratory, whenever the person or entity has been the owner, operator or laboratory director of a clinical laboratory that has had its clinical laboratory license or registration revoked. A person or entity that is dissatisfied with the imposition of an exclusion from owning or operating a clinical laboratory may seek judicial review by filing a petition for writ of mandate in accordance with the provisions of the Code of Civil Procedure.


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.


s 1065.35. Civil Suit to Enjoin Violations.
The department shall initiate a civil suit whenever such suit is necessary to enjoin the violation or threatened violation of chapter 3 (commencing with section 1200) of the Business and Professions Code or the regulations adopted thereunder. A person or entity against whom a civil suit is filed shall have all the rights of defense afforded by California civil law.


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.


s 1065.40. Criminal Sanctions for Unlawful Activity.
The department may refer for prosecution to the Attorney General's office or a District Attorney's office, when appropriate, any person or entity it has reason to believe has engaged in any of the unlawful activities identified in sections 1280 through 1287, inclusive of the Business and Professions Code. A person or entity against whom a criminal action is filed shall have all the rights of defense afforded by California criminal law.


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 , Section1395x(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.


s 1065.45. Revocation for Referral of Proficiency Testing Samples.
If the department determines that a laboratory has intentionally referred proficiency testing samples to another laboratory for analysis, it shall take action to revoke the license/registration or other approval for at least one year and may take action to impose any other available sanction.


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.


s 1066. Condition Level Requirements.
(a) Any requirement specified in subsections (b) through (i) shall constitute a condition level requirement.
(b) Each clinical laboratory performing clinical laboratory tests or examinations classified as of moderate or of high complexity under CLIA shall obtain and maintain a valid clinical laboratory license issued pursuant to section 1265 of the Business and Professions Code.
(c) Each clinical laboratory shall employ:
(1) A sufficient number of laboratory personnel with the appropriate education and either experience or training to:
(A) Provide appropriate direction, supervision and consultation;
(B) Accurately perform tests; and
(C) Report test results.
(2) Laboratory personnel who meet the personnel qualifications, duties, and responsibilities required in CLIA and sections 1203, 1204, 1206.5, 1207, 1209, 1209.1, 1210, 1270 and 1271 of the Business and Professions Code.
(d) Each clinical laboratory shall:
(1) Enroll in a proficiency testing program approved by the department or by the United States Health Care Financing Administration if required to enroll under Business and Professions Code section 1220(a)(2)(A); and if required to enroll, demonstrate successful participation, as defined under CLIA, for each specialty and subspecialty in which it performs clinical laboratory tests or examinations, to the same extent as required under CLIA,
(2) Authorize its proficiency test results to be reported to the department in an electronic format that is compatible with the department's proficiency testing data monitoring system, and
(3) Authorize the release of proficiency tests results to the public to the same extent required by CLIA.
(e) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(A) shall establish and maintain a patient test management system that meets the standards of CLIA;
(f) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(B) shall:
(1) Establish and maintain a quality control program that meets the requirements of CLIA,
(2) Perform all clinical laboratory tests or examinations classified as waived under CLIA in conformity with the manufacturer's instructions.
(g) Each clinical laboratory required to do so under Business and Professions Code section 1220(d)(2)(C) shall:
(1) Establish and maintain a comprehensive quality assurance program that meets the standards of CLIA,
(2) Maintain records, equipment, and facilities that are adequate and appropriate for the services rendered,
(3) Be conducted, maintained and operated without injury to the public health, and
(4) If providing cytology services and its licensee ceases operation, preserve
(A) Records,
(B) Reports,
(C) Cytology slides, and
(D) Cell blocks as prescribed in subdivision (g) of section 1271 and section 1274 of the Business and Professions Code.
(h) Each licensed or registered clinical laboratory shall submit to the inspections identified in Business and Professions Code section 1220, which inspections may be conducted by department employees or contractors, or the United States Health Care Financing Administration (HCFA), or HCFA agents. The department may conduct announced or unannounced inspections of any premises, building, equipment, materials, records, or information at any reasonable time to secure compliance with, or prevent a violation of chapter 3 of division 2 of the B&P Code. A clinical laboratory shall permit, as part of this inspection, the department or its contractors or agents to:
(1) Inspect, photograph, or copy any records, reports, test results, test specimens, or other information related to the requirements of chapter 3 of division 2 of the Business and Professions Code or the regulations adopted pursuant thereto. (The laboratory shall make all records and data accessible and retrievable within a reasonable time frame during the course of the inspection.);
(2) Secure any sample, photograph, or other evidence from any building or premises for the purpose of enforcing chapter 3 of division 2 of the Business and Professions Code or the regulations adopted pursuant thereto;
(3) Observe laboratory personnel performing tests (including proficiency testing), data analysis and reporting;
(4) Interview all personnel of the clinical laboratory concerning compliance with chapter 3 of division 2 of the Business and Professions Code and the regulations adopted thereunder;
(5) Upon request, review all information and data necessary to:
(A) Determine that testing is being performed or the laboratory is being operated in a manner that does not constitute an imminent and serious risk to public health;
(B) Evaluate complaints from the public; and
(C) Determine whether or not the laboratory is performing tests without a license or registration applicable to the category of tests or examinations being performed; and
(6) Provide copies to the department or its contractors or agents of all records and data required under chapter 3 of division 2 of the Business and Professions Code and the regulations adopted thereunder.
(i) Each laboratory shall comply with the requirements identified as "conditions" in subparts G through P of CLIA.


Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, Chapter 510, Section 1. Reference: Statutes 1995, Chapter 510, Section 1; and Sections 1203, 1204, 1206.5, 1207, 1209, 1209.1, 1210, 1220, 1223, 1225 and 1265, Business and Professions Code.


s 1067. Procedures for the Imposition of Directed Plans of Correction.
(a) The department may impose a directed plan of correction as an alternative sanction for any clinical laboratory that has condition level deficiencies.
(b) If the department is imposing a directed plan of correction, the following procedures shall apply:
(1) The department shall give the laboratory a written Notice of Intent to impose a directed plan of correction. The Notice of Intent shall include the following:
(A) The condition level deficiency that has been identified,
(B) The sanction or sanctions that the department proposes to impose against the laboratory,
(C) The rationale for the proposed sanction or sanctions,
(D) The projected effective date and duration of the proposed sanction or sanctions,
(E) The authority for the proposed sanction or sanctions, and
(F) The time allowed for the laboratory to respond to the notice. (During the period specified, the laboratory may submit to the department written evidence or other information against the imposition of the proposed sanction or sanctions.)
(2) After the period specified in (b)(1)(F) has elapsed, the department shall give the laboratory a written Notice of Sanction to impose a Directed Plan of Correction that acknowledges any evidence or information received from the laboratory and specifies the following:
(A) The sanction or sanctions to be imposed against the laboratory,
(B) The authority and rationale for imposing the sanction or sanctions,
(C) The effective date and duration of sanction, and
(D) A direction to the laboratory to take specific corrective action within specific time frames in order to achieve compliance.


Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Stats.1995, c.510, Section 1; Section 1310, Business and Professions Code; and Sections 11503, 11505 and 11506, Government Code.


s 1067.5. Procedures for the Imposition of Civil Money Penalties.
(a) The department may impose civil money penalties as an alternative sanction for any clinical laboratory that has condition level deficiencies.
(b) If the department is imposing civil money penalties, the following procedures apply:
(1) In determining the amount of the penalty, the department shall take into account the following factors:
(A) The nature, scope, severity, and duration of the deficiency or noncompliance.
(B) Whether the same condition level deficiencies have been identified during prior inspections.
(C) The laboratory's intent or reason for noncompliance.
(D) The accuracy and extent of laboratory records and their availability to the department or its contractors or agents.
(2) For a condition level deficiency that does not pose immediate jeopardy, the range of the penalty amount shall be $50-$3,000 per day of noncompliance or per violation. The department may, before any hearing, propose to increase the penalty amount into the range specified in (b)(3) for a laboratory that has deficiencies which, after imposition of a lower penalty amount, become sufficiently serious to pose immediate jeopardy.
(3) For a condition level deficiency that poses immediate jeopardy, the range of the penalty shall be $3,050-$10,000 per day of noncompliance or per violation. If the immediate jeopardy is removed, but the deficiency continues, the department shall shift the penalty amount to the range specified in (b)(2).
(4) The department shall send the laboratory written notice of intent to impose a civil money penalty. The notice shall include the following information:
(A) The statutory basis for the penalty,
(B) The proposed daily or per violation amount of the penalty,
(C) The factors (as described in paragraph (b)(1) of this section) that the department considered, and
(D) The time allowed for the laboratory to respond to the notice. (During the period specified, the laboratory may submit to the department written evidence or other information against the imposition of the proposed sanction or sanctions.)
(5) After the period specified in (b)(4)(D) has elapsed, the department shall give the laboratory a written Notice of Sanction that acknowledges any evidence or information received from the laboratory and specifies the following:
(A) The sanction or sanctions to be imposed against the laboratory,
(B) The authority and rationale for imposing the sanction or sanctions,
(C) The effective date and duration of sanction, and
(D) A specific statement regarding the laboratory's appeal rights and a Notice of Defense in the following form: Unless a written request for a hearing signed by the laboratory owner(s) or director(s) is delivered or mailed to the department within 15 days after the Notice of Sanction was mailed, the department may proceed upon imposition of the sanctions identified in the Notice of Sanction without a hearing. A request for a hearing may be made by delivering or mailing the enclosed form entitled Notice of Defense, or by delivering or mailing a notice of defense as provided by section 11506 of the Government Code to: The Department of Health Services at the address noted on the Notice of Sanction. The laboratory may, but need not, be represented by counsel at any or all stages of the proceedings.
(6) The laboratory shall have 15 days from the date of receipt of the Notice of Sanction to request a hearing by delivering or mailing a Notice of Defense. Hearings shall be conducted in accordance with chapter 5 (commencing with section 11500) of part 1 of division 3 of title 2 of the Government Code, except that hearings may be conducted by departmental hearing officers appointed by the director.
(7) The effective date of an alternative sanction of a civil money penalty shall be delayed if the laboratory has appealed and the hearing or the hearing decision is pending.


Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Stats.1995, c.510, Section 1; Section 1310, Business and Professions Code; and Section 11505, Government Code.


s 1067.10. Procedures for the Imposition of On-site Monitoring.
(a) The department may require continuous or intermittent monitoring of a plan of correction to ensure that the laboratory makes the improvements necessary to bring it into compliance with the condition level requirements.
(b) The laboratory shall pay the costs of on-site monitoring by the department.
(c) If the department imposes on-site monitoring, the following procedures apply:
(1) The department shall provide written notice of the following:
(A) The condition level noncompliance that it has identified,
(B) The sanction or sanctions that the department proposes to impose against the laboratory,
(C) The rationale for the proposed sanction or sanctions,
(D) The projected effective date and duration of the proposed sanction or sanctions,
(E) The authority for the proposed sanction or sanctions, and
(F) The time allowed for the laboratory to respond to the notice. [During the period specified, the laboratory may submit to the department written evidence or other information against the imposition of the proposed sanction or sanctions.]
(2) After the period specified in (c)(1)(F) has elapsed, the department shall give the laboratory written notice that acknowledges any evidence or information received from the laboratory and specifies the following:
(A) The sanction or sanctions to be imposed against the laboratory,
(B) The authority and rationale for imposing the sanction or sanctions, and
(C) The effective date and duration of sanction.


Note: Authority cited: Section 1224, Business and Professions Code; Section 100275, Health and Safety Code; and Stats. 1995, c.510, Section 1. Reference: Stats.1995, c.510, Section 1; Section 1310, Business and Professions Code; and Sections 11503, 11505 and 11506, Government Code.


s 1067.15. Procedures for the Imposition of a Temporary Suspension of a Laboratory or Clinical Laboratory under the Medi-Cal Program.
(a) The department may impose a Temporary Suspension on a provider of laboratory services prior to hearing if the laboratory has condition level deficiencies or there is immediate jeopardy and in the director's opinion such action is necessary to protect the public welfare or the interests of the Medi-Cal program.
(b) If the department is imposing a Temporary Suspension on a provider of service, the following procedures apply:
(1) The department shall serve the laboratory with a Notice of Sanction which includes the following information:
(A) The sanction or sanctions to be imposed against the laboratory, and
(B) The effective date and duration of sanction.
(2) At the same time as the Notice of Sanction is served, the department shall serve the laboratory with an Accusation. Included with the Accusation is a Notice of Defense in the following form: Unless a written request for a hearing signed by the owner(s) or director(s) of the laboratory is delivered or mailed to the department within 15 days after the Notice of Sanction and Accusation were served, no hearing shall be held regarding the imposition of the sanctions identified in the Notice of Sanction. A request for a hearing may be made by delivering or mailing the enclosed form entitled Notice of Defense, or by delivering or mailing a notice of defense as provided by section 11506 of the Government Code to: The Department of Health Services at the address noted on the Notice of Sanction. The laboratory may, but need not, be represented by counsel at any or all stages of these proceedings. (continued)