BILL NUMBER: SB 165 CHAPTERED 09/05/03 CHAPTER 319 FILED WITH SECRETARY OF STATE SEPTEMBER 5, 2003 APPROVED BY GOVERNOR SEPTEMBER 4, 2003 PASSED THE SENATE AUGUST 21, 2003 PASSED THE ASSEMBLY JULY 29, 2003 AMENDED IN ASSEMBLY JUNE 16, 2003 AMENDED IN SENATE MARCH 19, 2003 INTRODUCED BY Senator Machado FEBRUARY 11, 2003 An act to amend Sections 655.6, 1260, 1262, and 1275 of the Business and Professions Code, relating to healing arts. LEGISLATIVE COUNSEL'S DIGEST SB 165, Machado. Clinical laboratories. (1) Existing law makes it unlawful, subject to specific exceptions, for a healing arts practitioner to charge for cytologic services relating to the examination of gynecologic slides that were not performed by that practitioner or under his or her direct supervision. This bill would add another exception to these provisions, allowing a clinical laboratory to bill for cytologic services relating to the examination of gynecologic slides performed by an affiliated clinical laboratory, as defined. (2) Existing law provides for the licensure and regulation of clinical laboratory personnel by the State Department of Health Services. Under existing law, an applicant for a clinical bioanalyst license is required to hold a degree in a biological science and successfully pass an examination conducted by the department. Existing law also requires that an applicant for a limited chemical laboratory scientist's license successfully complete an examination. This bill would authorize the department to issue a temporary limited clinical laboratory scientist's license to an individual who has not taken the licensure examination but who has satisfied other licensing requirements. The bill would also revise the requirement for a clinical bioanalyst licensure to designate particular sciences acceptable in satisfaction of the degree criterion. The bill would authorize the department to waive the examination for an applicant who has successfully completed an examination of a national accrediting board that, in the determination of the department, has requirements equal to or greater than those required under state law. The bill would additionally revise the continuing education requirements that must be completed prior to clinical laboratory personnel licensure renewal. THE PEOPLE OF THE STATE OF CALIFORNIA DO ENACT AS FOLLOWS: SECTION 1. Section 655.6 of the Business and Professions Code is amended to read: 655.6. (a) It is unlawful for any person licensed under this division or under any initiative act referred to in this division to charge, bill, or otherwise solicit payment from any patient, client, customer, or third-party payer for cytologic services relating to the examination of gynecologic slides if those services were not actually rendered by that person or under his or her direct supervision. (b) (1) Clinical laboratories performing cytologic examinations of gynecologic slides shall directly bill either the patient or the responsible third-party payer for the cytology services rendered by those laboratories. Clinical laboratories shall not bill the physician and surgeon who requests the tests. (2) Notwithstanding subdivision (a), it is not unlawful for a clinical laboratory to bill for cytologic services relating to the examination of gynecologic slides that were performed by an affiliated clinical laboratory. An "affiliated clinical laboratory" means a clinical laboratory that is wholly owned by, is the parent company of, or is under common ownership with, the clinical laboratory billing for the cytologic services. For these purposes, "wholly owned" means 100 percent ownership directly or through one or more subsidiaries, and "common ownership" means 100 percent ownership by a common parent company. (c) For the purposes of this section, any person or entity who is responsible to pay for cytologic examination of gynecologic slides services provided to that patient shall be considered a responsible third-party payer. (d) This section shall not apply to any of the following: (1) Any person who, or clinical laboratory that, contracts directly with a health care service plan licensed pursuant to Section 1349 of the Health and Safety Code, if services are to be provided to members of the plan on a prepaid basis. (2) Any person who, or clinic that, provides cytologic examinations of gynecologic slides services without charge to the patient, or on a sliding scale payment basis if the patient's charge for services is determined by the patient's ability to pay. (3) Health care programs operated by public entities, including, but not limited to, colleges and universities. (4) Health care programs operated by private educational institutions to serve the health care needs of their students. (5) Any person who, or clinic that, contracts with an employer to provide medical services to employees of the employer if the cytologic services relating to the examination of gynecologic slides are provided under the contract. SEC. 2. Section 1260 of the Business and Professions Code is amended to read: 1260. The department shall issue a clinical laboratory bioanalyst' s license to each person who is a lawful holder of a degree of master of arts, master of science, or an equivalent or higher degree as determined by the department with a major in chemical, physical, biological, or clinical laboratory sciences. This education shall have been obtained in one or more established and reputable institutions maintaining standards equivalent, as determined by the department, to those institutions accredited by the Western Association of Schools and Colleges or an essentially equivalent accrediting agency, as determined by the department. The applicant also shall have a minimum of four years' experience as a licensed clinical laboratory scientist, performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the department. The quality and variety of this experience shall be satisfactory to the department and shall have been obtained within the six-year period immediately antecedent to admission to the examination. The applicant shall successfully pass a written examination and an oral examination conducted by the department or a committee designated by the department to conduct the examinations, indicating that the applicant is properly qualified. The department may issue a license without conducting a written examination to an applicant who has passed a written examination of a national accrediting board having requirements that are, in the determination of the department, equal to or greater than those required by this chapter and regulations adopted by the department. The department shall establish by regulation the required courses to be included in the college or university training. SEC. 3. Section 1262 of the Business and Professions Code is amended to read: 1262. No clinical laboratory scientist's or limited clinical laboratory scientist's license shall be issued by the department except after examination; provided, that a temporary clinical laboratory scientist's license or a temporary limited clinical laboratory scientist's license may be issued to an individual who fulfills the requirements for admission to the examination unless the individual has failed a previous examination for the license. The department may issue licenses without examination to applicants who have passed examinations of the national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The department may issue licenses without further examination to applicants who have passed examinations of another state whose laws and regulations are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of national or state accrediting boards for the purposes of this chapter shall be carried out by the department with assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by a national board or another state examination prior to the establishment of requirements that are equal to or exceed those of this chapter or the regulations of the department. The department may, however, make exceptions if individuals are otherwise qualified. SEC. 4. Section 1275 of the Business and Professions Code is amended to read: 1275. The department shall develop and implement regulations for continuing education for persons licensed pursuant to this chapter on or before January 1, 1992, after consulting with the multidisciplinary committee established pursuant to Section 1228, and other appropriate organizations. On and after January 1, 1994, the department shall require not more than 12 hours of continuing education completed within a 12-month period or not more than 24 hours of continuing education completed within a 24-month period as a condition for renewal of a license issued under this chapter. The department may establish a fee for the implementation of this section, the total fees collected not to exceed the total costs to the program for the implementation of this requirement.