STATE STATUTES & CODES
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CALIFORNIA STATUTES AND CODES
SECTIONS 1260-1275
BUSINESS AND PROFESSIONS CODE
SECTION 1260-1275
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. 1260.1. The department shall issue a histocompatibility laboratory director's license to each person who meets the qualifications specified in Section 1209.1. 1260.3. (a) The department shall issue a medical laboratory technician license to each person who meets the following requirements: (1) Has met the requirements of this chapter and any reasonable qualifications established by regulations of the department, including, but not limited to, any of the following: (A) Lawfully holds an associate degree or an equivalent or higher degree in chemical, physical, biological, or clinical laboratory science, which includes a minimum of 36 semester units of physical or biological sciences. (B) The completion of 60 semester (90 quarter) units from an accredited college or university, with 36 semester units in physical or biological sciences. (C) Graduation from a medical laboratory technician training program accredited by the National Accrediting Agency for Clinical Laboratory Sciences or other recognized accrediting program approved by the department. (D) Graduation from an advanced military medical laboratory specialist program approved by the department. (2) Has applied for the license on forms provided by the department. (3) Has paid a license fee established in regulations of the department in accordance with subdivision (v) of Section 1300. (b) A licensed medical laboratory technician may perform clinical laboratory tests or examinations classified as waived or of moderate complexity under CLIA, and may report the test results. However, a licensed medical laboratory technician shall not perform microscopic analysis or immunohematology procedures. The medical laboratory technician shall work under the supervision of a licensed physician and surgeon or a baccalaureate, masters, or doctoral level person licensed pursuant to this chapter. The supervision shall be required during the entire time a medical laboratory technician performs clinical laboratory tests or examinations. (c) The department shall adopt emergency regulations to implement this section as soon as possible. 1261. The department shall issue a clinical laboratory scientist's or a limited clinical laboratory scientist's license to each person who is a lawful holder of a baccalaureate or an equivalent or higher degree, who has applied for the license on forms provided by the department and has met the requirements of this chapter and any reasonable qualifications established by regulations of the department. However, an exception to the degree requirement may be made by the department for the clinical laboratory scientist's license only if the applicant for the license has completed a minimum of two years of experience as a licensed trainee or the equivalent thereof, as determined by the department, doing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the department. In addition, the applicant applying under this section must have 90 semester hours or equivalent quarter hours of university or college work or the equivalent thereof, as may be determined by the department, which shall have included at least 23 semester hours or equivalent quarter hours of science courses as specified by regulations of the department. Additional college or university work that includes courses in the fundamental sciences may be substituted for one of the two years of experience in the ratio of 30 semester hours or equivalent quarter hours for each year of experience. This exception shall not apply to the limited clinical laboratory scientist's license. The department shall hold examinations to aid it in judging the qualifications of applicants. Licenses may be issued in any or all of the sciences applied in a clinical laboratory as determined by regulation established by the department. The department shall establish by regulation the college courses or majors to be included in the college or university training and the amount and kind of training or experience required. Examinations, training, or experience requirements for limited licenses shall cover only the science concerned. The department may identify by regulation the appropriate sciences and shall establish the minimum requirements for training and experience and required courses or major for each. Experience as a clinical laboratory technician in any branch of the armed forces of the United States may be considered equivalent to the experience as a trainee, if the experience is approved by the department. Each year of training and experience as a clinical laboratory technician in the armed forces shall be equivalent to 15 semester hours, which shall be credited to the minimum number of hours required to qualify for licensure as a trainee. The semester hours acquired in this manner shall not consist of the science courses required by the department under this section. The maximum number of hours granted shall not exceed 60 semester hours or its equivalent. 1261.5. The department may issue limited clinical laboratory scientist's licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, genetic molecular biology, cytogenetics, or other areas of laboratory specialty or subspecialty when determined to be necessary by the department in order for licensure categories to keep abreast of changes in laboratory or scientific technology. Whenever the department determines that a new limited clinical laboratory scientist license category is necessary, it shall adopt regulations identifying the category and the areas of specialization included within the category. To qualify for admission to the examination for a special clinical laboratory scientist's license, an applicant shall have all the following: (a) Have graduated from a college or university 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 with a baccalaureate or higher degree with a major appropriate to the field for which a license is being sought. (b) Have one year of full-time postgraduate training or experience in the various areas of analysis in the field for which a license is being sought in a laboratory that has a license issued under this chapter or which the department determines is equivalent thereto. (c) Whenever a limited clinical laboratory scientist's license is established for a specific area of specialization, the department may issue the license without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations. (d) The department shall adopt regulations to implement this section. 1261.6. The department may issue a limited clinical laboratory scientist's license in cytogenetics to any person with a minimum of seven years of work experience in this state as a cytogenetic technologist who provides evidence of satisfactory performance on a written examination administered by the National Credentialing Agency for Laboratory Personnel on or before December 31, 1991, in the specialty of cytogenetics, and who meets the federal regulatory requirements for personnel performing high-complexity testing. 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. 1262.5. Notwithstanding Section 135, an applicant for a clinical laboratory or limited technologist license who fails to pass the written examination two times shall not be eligible to be reexamined a third time until at least one year has elapsed from the date of the second examination. An applicant who fails the third examination shall not be eligible to take the examination a fourth time until two years have elapsed from the date of the third examination. Thereafter, the examination may not be taken more frequently than once in two years. 1263. The department shall license as trainees those individuals desiring to train for either a clinical laboratory scientist's license or a limited clinical laboratory scientist's license, providing those individuals meet the academic requirements. No trainee license shall be issued unless the applicant has completed at least 90 semester hours or equivalent quarter hours of university or college work or the essential equivalent as determined by the department which must have included at least 23 semester hours or equivalent quarter hours of courses in the sciences as determined by regulations of the department. Applicants who have completed military training schools may be granted academic credit toward licensure by the department on the basis of recommendations made by the American Council on Education. Applicants shall apply for the license on forms provided by the department and meet the requirements of this chapter and any standards as are established by regulations of the department. 1264. The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical molecular biologist, or clinical cytogeneticist license to each person who has applied for the license on forms provided by the department, who is a lawful holder of a master of science or doctoral degree in the specialty for which the applicant is seeking a license and who has met such additional reasonable qualifications of training, education, and experience as the department may establish by regulations. The department shall issue an oral and maxillofacial pathologist license to every applicant for licensure who has applied for the license on forms provided by the department, who is a registered Diplomate of the American Board of Oral and Maxillofacial Pathology, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulation. (a) The graduate education shall have included 30 semester hours of coursework in the applicant's specialty. Applicants possessing only a master of science degree shall have the equivalent of one year of full-time, directed study or training in procedures and principles involved in the development, modification or evaluation of laboratory methods, including training in complex methods applicable to diagnostic laboratory work. Each applicant must have had one year of training in his or her specialty in a clinical laboratory acceptable to the department and three years of experience in his or her specialty in a clinical laboratory, two years of which must have been at a supervisory level. The 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 an agency acceptable to the department. The department shall determine by examination that the applicant is properly qualified. Examinations, training, or experience requirements for specialty licenses shall cover only the specialty concerned. (b) The department may issue licenses without examination to applicants who have passed examinations of other states or national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of other state requirements or requirements of national accrediting boards shall be carried out by the department with the assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by another state or national accrediting board prior to the establishment of requirements that are equal to or exceed those of this chapter or regulations of the department. (c) The department may issue licenses without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations. (d) The department shall adopt regulations to conform to this section. 1265. (a) (1) A clinical laboratory performing clinical laboratory tests or examinations classified as of moderate or of high complexity under CLIA shall obtain a clinical laboratory license pursuant to this chapter. The department shall issue a clinical laboratory license to any person who has applied for the license on forms provided by the department and who is found to be in compliance with this chapter and the regulations pertaining thereto. No clinical laboratory license shall be issued by the department unless the clinical laboratory and its personnel meet the CLIA requirements for laboratories performing tests or examinations classified as of moderate or high complexity, or both. (2) A clinical laboratory performing clinical laboratory tests or examinations subject to a certificate of waiver or a certificate of provider-performed microscopy under CLIA, shall register with the department. The department shall issue a clinical laboratory registration to any person who has applied for the registration on forms provided by the department and is found to be in compliance with this chapter, the regulations pertaining thereto, and the CLIA requirements for either a certificate of waiver or a certificate of provider-performed microscopy. (b) An application for a clinical laboratory license or registration shall include the name or names of the owner or the owners, the name or names of the laboratory director or directors, the name and location of the laboratory, a list of the clinical laboratory tests or examinations performed by the laboratory by name and total number of test procedures and examinations performed annually (excluding tests the laboratory may run for quality control, quality assurance, or proficiency testing purposes). The application shall also include a list of the tests and the test kits, methodologies, and laboratory equipment used, and the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and test procedures, and any other relevant information as may be required by the department. If the laboratory is performing tests subject to a provider-performed microscopy certificate, the name of the provider or providers performing those tests shall be included on the application. Application shall be made by the owners of the laboratory and the laboratory directors prior to its opening. A license or registration to conduct a clinical laboratory if the owners are not the laboratory directors shall be issued jointly to the owners and the laboratory directors and the license or registration shall include any information as may be required by the department. The owners and laboratory directors shall be severally and jointly responsible to the department for the maintenance and conduct thereof or for any violations of this chapter and regulations pertaining thereto. (c) The department shall not issue a license or registration until it is satisfied that the clinical laboratory will be operated within the spirit and intent of this chapter, that the owners and laboratory directors are each of good moral character, and that the granting of the license will not be in conflict with the interests of public health. (d) A separate license or registration shall be obtained for each laboratory location, with the following exceptions: (1) Laboratories that are not at a fixed location, that is, laboratories that move from one testing site to another, such as mobile units providing laboratory testing, health screening fairs, or other temporary testing locations, may apply for and obtain one license or registration for the designated primary site or home base, using the address of that primary site. (2) Not-for-profit, or federal, state, or local government laboratories that engage in limited (not more than a combination of 15 moderately complex or waived tests, as defined under CLIA, per license) public health testing may apply for and obtain a single license or registration. (3) Laboratories within a hospital that are located at contiguous buildings on the same campus and under common direction, may file a single application or multiple applications for a license or registration of laboratory locations within the same campus or street address. (4) Locations within a single street and city address that are under common ownership may apply for and obtain a single license or registration or multiple licenses or registrations, at the discretion of the owner or owners. (e) (1) A license or registration shall be valid for one year unless revoked or suspended. A clinical laboratory license or registration shall be automatically revoked 30 days from a major change of laboratory directorship or ownership. The clinical laboratory shall be required to submit a completed application for a new clinical laboratory license or registration within those 30 days or cease engaging in clinical laboratory practice. (2) If a clinical laboratory intends to continue to engage in clinical laboratory practice during the 30 days after a major change in directorship occurs and before the laboratory license or registration is automatically revoked, the laboratory owner may appoint an interim director who meets the requirements of this chapter and CLIA. The interim director shall be appointed within five business days of the major change of the directorship. Written notice shall be provided to the department of the appointment of the laboratory director pursuant to this paragraph within five business days of the appointment. (f) If the department does not within 60 days after the date of receipt of the application issue a license or registration, it shall state the grounds and reasons for its refusal in writing, serving a copy upon the applicant by certified mail addressed to the applicant at his or her last known address. (g) The department shall be notified in writing by the laboratory owners or delegated representatives of the owners and the laboratory directors of any change in ownership, directorship, name, or location, including the addition or deletion of laboratory owners or laboratory directors within 30 days. However, notice of change in ownership shall be the responsibility of both the current and new owners. Laboratory owners and directors to whom the current license or registration is issued shall remain jointly and severally responsible to the department for the operation, maintenance, and conduct of the clinical laboratory and for any violations of this chapter or the regulations adopted thereunder, including any failure to provide the notifications required by this subdivision, until proper notice is received by the department. In addition, failure of the laboratory owners and directors to notify the department within 30 days of any change in laboratory directors, including any additions or deletions, shall result in the automatic revocation of the clinical laboratory's license or registration. (h) The withdrawal of an application for a license or registration or for a renewal of a license, or registration, issuable under this chapter, shall not, after the application has been filed with the department, deprive the department of its authority to institute or continue a proceeding against the applicant for denial of the license, registration, or renewal upon any ground provided by law or to enter an order denying the license, registration, or renewal upon any such ground, unless the department consents in writing to the withdrawal. (i) The suspension, expiration, or forfeiture by operation of law of a license or registration issued under this chapter, or its suspension, forfeiture, or cancellation by order of the department or by order of a court of law, or its surrender without the written consent of the department, shall not deprive the department of its authority to institute or continue an action against a license or registration issued under this chapter or against the laboratory owner or laboratory director upon any ground provided by law or to enter an order suspending or revoking the license or registration issued under this chapter. (j) (1) Whenever a clinical laboratory ceases operations, the laboratory owners, or delegated representatives of the owners, and the laboratory directors shall notify the department of this fact, in writing, within 30 calendar days from the date a clinical laboratory ceases operation. For purposes of this subdivision, a laboratory ceases operations when it suspends the performance of all clinical laboratory tests or examinations for 30 calendar days at the location for which the clinical laboratory is licensed or registered. (2) (A) Notwithstanding any other provision of law, owners and laboratory directors of all clinical laboratories, including those laboratories that cease operations, shall preserve medical records and laboratory records, as defined in this section, for three years from the date of testing, examination, or purchase, unless a longer retention period is required pursuant to any other provision of law, and shall maintain an ability to provide those records when requested by the department or any duly authorized representative of the department. (B) For purposes of this subdivision, "medical records" means the test requisition or test authorization, or the patient's chart or medical record, if used as the test requisition, the final and preliminary test or examination result, and the name of the person contacted if the laboratory test or examination result indicated an imminent life-threatening result or was of panic value. (C) For purposes of this subdivision, "laboratory records" means records showing compliance with CLIA and this chapter during a laboratory's operation that are actual or true copies, either photocopies or electronically reproducible copies, of records for patient test management, quality control, quality assurance, and all invoices documenting the purchase or lease of laboratory equipment and test kits, reagents, or media. (D) Information contained in medical records and laboratory records shall be confidential, and shall be disclosed only to authorized persons in accordance with federal, state, and local laws. (3) The department or any person injured as a result of a laboratory's abandonment or failure to retain records pursuant to this section may bring an action in a court of proper jurisdiction for any reasonable amount of damages suffered as a result thereof. 1265.1. (a) A primary care clinic that submits an application to the State Department of Public Health for clinic licensure pursuant to subdivision (a) of Section 1204 of the Health and Safety Code may submit prior to that submission, or concurrent therewith, an application for licensure or registration of a clinical laboratory to be operated by the clinic. (b) An application for licensure of a clinical laboratory submitted pursuant to this section shall be subject to all applicable laboratory licensing laws and regulations, including, but not limited to, any statutory or regulatory timelines and processes for review of a clinical laboratory application. 1266. The clinical laboratory license and the license or current renewal permit of each person performing tests shall be conspicuously posted in the clinical laboratory. 1267. Any denial, suspension, or revocation of a license under this chapter shall be conducted in compliance with Section 100171 of the Health and Safety Code. 1268. Upon filing application therefor, containing such information as the department may require, and the payment of the license fee, the department shall issue to any person duly licensed under this chapter a duplicate license for one previously issued or, where there has been a change of name, another license in lieu of one previously issued. 1269. (a) Unlicensed laboratory personnel may perform any of the activities identified in subdivision (b), in a licensed clinical laboratory, under the direct and constant supervision of a physician and surgeon, or a person licensed under this chapter other than a trainee, upon meeting all of the following criteria: (1) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA. (2) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities: (A) The skills required for proper specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens. (B) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory. (C) The skills required for performing preventive maintenance, and troubleshooting. (D) A working knowledge of reagent stability and storage. (E) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory. (F) An awareness of the factors that influence test results. (b) The activities that may be performed are: (1) Biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens. (2) Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory. (3) Assisting in preventive maintenance, and troubleshooting. (4) Preparation and storage of reagents and culture media. (5) Assisting in the performance of quality control procedures. (c) Notwithstanding subdivision (a), unlicensed laboratory personnel, other than a trainee, may, under the supervision and control of a physician and surgeon or person licensed under this chapter, perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing if he or she meets the requirements of subparagraph (A) of paragraph (2) of, and paragraph (1) of, subdivision (a). (d) Unlicensed laboratory personnel shall not do any of the following: (1) Record test results, but he or she may transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed under this chapter, or automatically by a testing instrument. (2) Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure. (3) Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation. (e) When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows: (1) In the case of qualitative and semi-quantitative "spot, tablet, or stick" tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter. (2) In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. (f) When any of the following mechanical or electronic instruments are employed, unlicensed laboratory personnel shall not perform any of the following activities: (1) Standardizing or calibrating the instrument or assessing its performance by monitoring results of appropriate standards and control. (2) Reading or recording test results, except that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. (3) Quantitatively measuring any sample or reagents unless done automatically by the instrument in the course of its normal operation or by the use of previously calibrated and approved automatic syringes or other dispensers. 1269.3. (a) Notwithstanding Sections 1206.5 and 1269, within the specialty of pathology, a person certified as a pathologists' assistant by the American Association of Pathologists' Assistants, the Board of Registry of the American Society for Clinical Pathology, or another national accrediting agency approved by the department, who demonstrates competency to perform all job duties and responsibilities before an assignment to those duties and responsibilities, at the completion of six months of performing those duties and responsibilities, and annually thereafter, may perform the following activities under the supervision and control of a pathologist: (1) Prepare human surgical specimens for gross description and dissection, including, but not limited to, description of gross features and selection of tissues for histological examination. (2) Prepare and perform human postmortem examinations, including, but not limited to, selection of tissues and fluids for further examination. (3) Gather other information necessary for an autopsy report. (4) Prepare a body for release. (b) Notwithstanding Section 1206.5 or subdivisions (b), (c), and (d) of Section 1269, the following persons may prepare human surgical specimens for gross description and dissection under the direct supervision of a qualified pathologist, including, description of gross features and selection of tissues for histological examination, if they meet the requirements specified in subdivision (a) of Section 1269 and the minimum education and training requirements for high complexity testing personnel under the CLIA: (1) A pathologists' assistant who does not meet the certification requirements of subdivision (a). (2) A histologic technician. (3) A histotechnologist. (c) For the purposes of subdivision (b), direct supervision means that a qualified pathologist shall be physically present onsite in the vicinity of the clinical laboratory where the specialty of pathology is performed and shall be available for consultation and direction during the time the personnel specified in subdivision (b) are engaged in the processing of specimens that involve dissection. For tissue processing that does not involve dissection, a qualified pathologist may be available by telephone or other electronic means. (d) A histologic technician or histotechnologist who meets the requirements specified in subdivision (a) of Section 1269, may accession specimens, perform maintenance of equipment, stain, cover slip, label slides, and process tissues by embedding in paraffin or performing microtomy. (e) On and after January 1, 2011, the department may adopt regulations establishing additional qualification requirements to perform the duties described in this section. 1269.5. The department may deny, suspend, or revoke any license, registration, or certificate issued under this chapter for performance by unlicensed laboratory personnel of any activity that is not authorized by Section 1269. 1270. (a) On and after January 1, 1991, no person may perform examinations of cytological slides without first obtaining a license as a cytotechnologist from the department, except that those persons employed by licensed clinical laboratories as cytotechnologists and certified as cytotechnologists by the department on or before January 1, 1991, shall be licensed by the department on or before January 1, 1993. Cytotechnologist licenses shall be issued and renewed by the department for periods of two years. This subdivision shall not apply to persons holding a valid, unrevoked, unsuspended physician's and surgeon's certificate issued pursuant to Chapter 5 (commencing with Section 2000). (b) The issuance of a cytotechnologist license shall be contingent upon the applicant's satisfactory performance, as defined in regulation, in a competency testing program for cytotechnologists which may be administered by the department or by a competency testing service or program approved by the department. The competency testing program established pursuant to this section shall be periodically reviewed and revised by the department, if necessary, to ensure that the program is consistent with federal competency testing requirements issued under the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578; 42 U.S.C. Sec. 263a, Section 353 of the Public Health Service Act). (c) Notwithstanding subdivision (b), the department may issue a temporary cytotechnologist's license to a person who satisfies the requirements for admission to the examination unless the person has failed a previous examination for a cytotechnologist's license. A temporary license issued by the department pursuant to this subdivision shall be valid for a period of time not exceeding 90 days after the date the department has adopted a competency testing program pursuant to subdivision (b). (d) The department may issue a cytotechnologist's license without examination to an applicant who satisfies one of the following: (1) Passage of an examination of a national accrediting board whose requirements are equal to or greater than those required by this chapter or by regulations adopted pursuant to this chapter, as determined by the department. (2) Passage of an examination of another state in which the requirements imposed by laws and regulations regarding the examination are equal to or greater than those required by this chapter or by regulations adopted pursuant to this chapter, as determined by the department. This subdivision shall not apply to a person who has passed an examination of a national accrediting board or another state prior to that board's or state's establishment of requirements which are equal to or greater than those required by this chapter or by regulations adopted pursuant to this chapter, as determined by the department. The department may, however, make exceptions to the requirements of this subdivision in cases where the department determines that the applicant is otherwise qualified for licensure. (e) The department shall not issue any temporary cytotechnologist' s license pursuant to subdivision (c) or any cytotechnologist's license without examination pursuant to subdivision (d) after the department adopts a competency testing program pursuant to subdivision (b). 1270.5. (a) Notwithstanding Section 1301, an application for the renewal of, and payment of the renewal fees for, a cytotechnologist license shall be governed by this section. (b) Application for renewal of a cytotechnologist license, accompanied by the fee set forth in Section 1300, shall be filed with the department not less than 30 days prior to the expiration date. (c) If the renewal fee is not paid during the 30 days prior to the expiration date, the license shall automatically expire at midnight on the expiration date. However, a cytotechnologist who has failed to timely pay a renewal fee may have his or her license reinstated, without completing a competency testing program, provided that he or she mails to the department a written request for reinstatement postmarked no later than the 60th day after the expiration date of the license and a reinstatement fee equal to two times the annual renewal fee set forth in Section 1300. The license shall be reinstated on the date the request for reinstatement and fee are received by the department. If the request for reinstatement and fee are received prior to the expiration date of the license, there shall be no lapse in licensure. No cytotechnologist shall perform services for which a license or certification is required under this chapter during any period for which licensure or certification has lapsed. 1271. (a) A cytotechnologist shall not examine more than 80 gynecologic slides in a 24-hour period when performing a manual review of slides. (b) The maximum workload limit in subdivision (a) is the maximum number of gynecologic slides that a cytotechnologist shall examine in a 24-hour period without regard to the number of clinical laboratories or other persons for which the work is performed. Cytotechnologists, who examine both gynecologic and nongynecologic slides, shall do so on a pro rata basis so that the maximum workload limit in subdivision (a) is not exceeded, and so that the number of gynecologic slides examined is reduced proportionally if both gynecologic and nongynecologic slides are examined in a 24-hour period. (c) The maximum workload limit in subdivision (a) is for a cytotechnologist who has no duties other than the evaluation of gynecological slides. Cytotechnologists who have other duties, including, but not limited to, the preparation and staining of cytologic slides, shall decrease on a pro rata basis the number of slides examined. (d) All cytologic slides shall be examined in a clinical laboratory that has been licensed by the department, or in a municipal or county laboratory established under Section 101150 of the Health and Safety Code. All slides examined under the name of a clinical laboratory shall be examined on the premises of that laboratory. (e) Each clinical laboratory shall maintain records of the number of cases and slides for gynecologic and nongynecologic samples examined on a monthly and annual basis. (f) Each cytotechnologist shall maintain current records in a form prescribed by the department of hours worked and the names and addresses of the clinical laboratories or other persons for whom slides are examined. (g) Each clinical laboratory shall retain all cytology slides and cell blocks examined for a minimum of five years and all cytology reports for a minimum of 10 years. (h) The presence of any factor that would prohibit the proper examination of a cytologic slide, including, but not limited to, damaged slides or inadequate specimens, as determined by the director of the laboratory, shall result in the issuance of a statement of inadequacy to the referring physician and no report of cytologic findings shall be issued on that slide. (i) Each clinical laboratory shall maintain records of the number of cases and slides for gynecologic and nongynecologic slides each cytotechnologist in the laboratory reads each 24-hour period, the number of hours devoted during each 24-hour period to screening cytology slides by each individual, and shall determine weekly and cumulatively the frequency of abnormal slides found by each cytotechnologist employed. (j) Ten percent of the negative or normal slides examined by each cytotechnologist employed by a clinical laboratory shall be rescreened at least weekly by a cytopathologist or supervising cytotechnologist other than the original examiner. (k) When reviewing gynecologic slides using automated or semiautomated screening devices approved by the federal Food and Drug Administration, a laboratory shall follow the workload requirements established by Section 493.1274 of Title 42 of the Code of Federal Regulations. (1) Any slide reviewed using automated or semiautomated screening devices approved by the federal Food and Drug Administration that requires full manual review shall be counted against the applicable limits established in subdivision (a) and this subdivision. (2) On or before June 30, 2007, the State Department of Health Services shall review published evidence-based peer review journal articles that review the performance of both automated and semiautomated screening devices, subsequent to the approval of the device by the federal Food and Drug Administration, and shall determine whether increasing the number of slides reviewed on a daily basis increases the rate of error. If the department determines that the volume of screening on these devices increases the rate of error, the department may issue new regulations in that regard that are consistent with Section 493.1274 of Title 42 of the Code of Federal Regulations. (l) The technical supervisor of an individual who performs primary screening shall establish the maximum workload limit for the individual, based on the individual's performance, in accordance with the criteria set forth in Section 493.1274(d)(1) of Title 42 of the Code of Federal Regulations. (m) Where cytotechnologists are represented by a labor organization, the maximum workload limitations otherwise established pursuant to this section shall be contained in a collective bargaining agreement or memorandum of understanding negotiated between the employer and the labor organization. 1271.1. (a) Clinical laboratories which are licensed pursuant to this chapter and provide cytology services shall, if the licensee ceases operation, preserve records, reports, cytology slides, and cell blocks as prescribed in subdivision (g) of Section 1271 and Section 1274. (b) Any person injured as a result of the licensee's abandonment of records may bring an action in any court of competent jurisdiction for the amount of any damages suffered as a result. In the event the licensee was a corporation or partnership which has been dissolved, the person injured may bring an action against that corporation's or partnership's principal officers of record at the time of the dissolution. (c) For purposes of this section, the following definitions shall apply: (1) "Abandonment of records" means violating subdivision (a) and thereby leaving patients and physicians and surgeons without access to information to which they are entitled pursuant to this chapter. (2) "Principal officers" means: (A) In the case of a partnership other than a limited partnership, any partner. (B) In the case of a limited partnership, any general partner, as defined in subdivision (i) of Section 15611 of the Corporations Code. (C) In the case of a corporation, the chairperson of the board, the chief executive officer, and the president of the corporation. 1272. A clinical laboratory shall participate in a state-approved proficiency testing program and demonstrate satisfactory performance in all of the laboratory specialities that include tests performed in the laboratory. Proficiency shall be tested in the following specialties: microbiology, serology, clinical chemistry, hematology, cytology, and immunohematology. 1272.4. The department shall establish standards for the evaluation of cytologic slides, for reporting the adequacy of cytologic slides, for a cytotechnologist competency program, and for a proficiency testing program for clinical laboratories providing cytology services. 1272.6. The department shall, on or before January 1, 1992, develop or adopt a proficiency testing program for laboratories providing cytology services which may be administered by the department or by a proficiency testing service or program approved by the department. The proficiency program established pursuant to this section shall include announced and unannounced onsite proficiency testing, with that testing to take place, to the extent practicable, under normal working conditions. 1274. (a) A laboratory shall document to persons submitting cytologic samples for evaluation, on a quarterly basis, informational letters on all cases of HSIL (high-grade squamous intraepithelial lesions), adenocarcinoma, or other malignant neoplasm. Documentation may consist of followup correspondence, telephone calls, or requests included in the report. Copies of that documentation, and any responses received to those letters, shall be maintained on file by the laboratories for a period of five years. (b) Whenever it becomes known to a clinical laboratory that an abnormality of HSIL (high-grade squamous intraepithelial lesions, adenocarcinoma, or other malignant neoplasm) has been identified for a patient for whom the clinical laboratory earlier reported a normal finding, all previous available cytologic slides on that patient shall be reexamined by the clinical laboratory. (c) Records of the review of previous slides required by subdivision (b) shall be maintained by the clinical laboratory, including the name of the individual performing the earlier examination. (d) A clinical laboratory shall maintain records of all false positive and false negative cases. When any errors in the reporting of a smear evaluation are discovered, a corrected report shall be immediately sent, when medically applicable. Copies of corrected reports shall be maintained in the laboratory records for a period of 10 years. 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.
SECTION 1260-1275
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. 1260.1. The department shall issue a histocompatibility laboratory director's license to each person who meets the qualifications specified in Section 1209.1. 1260.3. (a) The department shall issue a medical laboratory technician license to each person who meets the following requirements: (1) Has met the requirements of this chapter and any reasonable qualifications established by regulations of the department, including, but not limited to, any of the following: (A) Lawfully holds an associate degree or an equivalent or higher degree in chemical, physical, biological, or clinical laboratory science, which includes a minimum of 36 semester units of physical or biological sciences. (B) The completion of 60 semester (90 quarter) units from an accredited college or university, with 36 semester units in physical or biological sciences. (C) Graduation from a medical laboratory technician training program accredited by the National Accrediting Agency for Clinical Laboratory Sciences or other recognized accrediting program approved by the department. (D) Graduation from an advanced military medical laboratory specialist program approved by the department. (2) Has applied for the license on forms provided by the department. (3) Has paid a license fee established in regulations of the department in accordance with subdivision (v) of Section 1300. (b) A licensed medical laboratory technician may perform clinical laboratory tests or examinations classified as waived or of moderate complexity under CLIA, and may report the test results. However, a licensed medical laboratory technician shall not perform microscopic analysis or immunohematology procedures. The medical laboratory technician shall work under the supervision of a licensed physician and surgeon or a baccalaureate, masters, or doctoral level person licensed pursuant to this chapter. The supervision shall be required during the entire time a medical laboratory technician performs clinical laboratory tests or examinations. (c) The department shall adopt emergency regulations to implement this section as soon as possible. 1261. The department shall issue a clinical laboratory scientist's or a limited clinical laboratory scientist's license to each person who is a lawful holder of a baccalaureate or an equivalent or higher degree, who has applied for the license on forms provided by the department and has met the requirements of this chapter and any reasonable qualifications established by regulations of the department. However, an exception to the degree requirement may be made by the department for the clinical laboratory scientist's license only if the applicant for the license has completed a minimum of two years of experience as a licensed trainee or the equivalent thereof, as determined by the department, doing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory approved by the department. In addition, the applicant applying under this section must have 90 semester hours or equivalent quarter hours of university or college work or the equivalent thereof, as may be determined by the department, which shall have included at least 23 semester hours or equivalent quarter hours of science courses as specified by regulations of the department. Additional college or university work that includes courses in the fundamental sciences may be substituted for one of the two years of experience in the ratio of 30 semester hours or equivalent quarter hours for each year of experience. This exception shall not apply to the limited clinical laboratory scientist's license. The department shall hold examinations to aid it in judging the qualifications of applicants. Licenses may be issued in any or all of the sciences applied in a clinical laboratory as determined by regulation established by the department. The department shall establish by regulation the college courses or majors to be included in the college or university training and the amount and kind of training or experience required. Examinations, training, or experience requirements for limited licenses shall cover only the science concerned. The department may identify by regulation the appropriate sciences and shall establish the minimum requirements for training and experience and required courses or major for each. Experience as a clinical laboratory technician in any branch of the armed forces of the United States may be considered equivalent to the experience as a trainee, if the experience is approved by the department. Each year of training and experience as a clinical laboratory technician in the armed forces shall be equivalent to 15 semester hours, which shall be credited to the minimum number of hours required to qualify for licensure as a trainee. The semester hours acquired in this manner shall not consist of the science courses required by the department under this section. The maximum number of hours granted shall not exceed 60 semester hours or its equivalent. 1261.5. The department may issue limited clinical laboratory scientist's licenses in chemistry, microbiology, toxicology, histocompatibility, immunohematology, genetic molecular biology, cytogenetics, or other areas of laboratory specialty or subspecialty when determined to be necessary by the department in order for licensure categories to keep abreast of changes in laboratory or scientific technology. Whenever the department determines that a new limited clinical laboratory scientist license category is necessary, it shall adopt regulations identifying the category and the areas of specialization included within the category. To qualify for admission to the examination for a special clinical laboratory scientist's license, an applicant shall have all the following: (a) Have graduated from a college or university 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 with a baccalaureate or higher degree with a major appropriate to the field for which a license is being sought. (b) Have one year of full-time postgraduate training or experience in the various areas of analysis in the field for which a license is being sought in a laboratory that has a license issued under this chapter or which the department determines is equivalent thereto. (c) Whenever a limited clinical laboratory scientist's license is established for a specific area of specialization, the department may issue the license without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations. (d) The department shall adopt regulations to implement this section. 1261.6. The department may issue a limited clinical laboratory scientist's license in cytogenetics to any person with a minimum of seven years of work experience in this state as a cytogenetic technologist who provides evidence of satisfactory performance on a written examination administered by the National Credentialing Agency for Laboratory Personnel on or before December 31, 1991, in the specialty of cytogenetics, and who meets the federal regulatory requirements for personnel performing high-complexity testing. 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. 1262.5. Notwithstanding Section 135, an applicant for a clinical laboratory or limited technologist license who fails to pass the written examination two times shall not be eligible to be reexamined a third time until at least one year has elapsed from the date of the second examination. An applicant who fails the third examination shall not be eligible to take the examination a fourth time until two years have elapsed from the date of the third examination. Thereafter, the examination may not be taken more frequently than once in two years. 1263. The department shall license as trainees those individuals desiring to train for either a clinical laboratory scientist's license or a limited clinical laboratory scientist's license, providing those individuals meet the academic requirements. No trainee license shall be issued unless the applicant has completed at least 90 semester hours or equivalent quarter hours of university or college work or the essential equivalent as determined by the department which must have included at least 23 semester hours or equivalent quarter hours of courses in the sciences as determined by regulations of the department. Applicants who have completed military training schools may be granted academic credit toward licensure by the department on the basis of recommendations made by the American Council on Education. Applicants shall apply for the license on forms provided by the department and meet the requirements of this chapter and any standards as are established by regulations of the department. 1264. The department shall issue a clinical chemist, clinical microbiologist, clinical toxicologist, clinical molecular biologist, or clinical cytogeneticist license to each person who has applied for the license on forms provided by the department, who is a lawful holder of a master of science or doctoral degree in the specialty for which the applicant is seeking a license and who has met such additional reasonable qualifications of training, education, and experience as the department may establish by regulations. The department shall issue an oral and maxillofacial pathologist license to every applicant for licensure who has applied for the license on forms provided by the department, who is a registered Diplomate of the American Board of Oral and Maxillofacial Pathology, and who meets any additional and reasonable qualifications of training, education, and experience as the department may establish by regulation. (a) The graduate education shall have included 30 semester hours of coursework in the applicant's specialty. Applicants possessing only a master of science degree shall have the equivalent of one year of full-time, directed study or training in procedures and principles involved in the development, modification or evaluation of laboratory methods, including training in complex methods applicable to diagnostic laboratory work. Each applicant must have had one year of training in his or her specialty in a clinical laboratory acceptable to the department and three years of experience in his or her specialty in a clinical laboratory, two years of which must have been at a supervisory level. The 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 an agency acceptable to the department. The department shall determine by examination that the applicant is properly qualified. Examinations, training, or experience requirements for specialty licenses shall cover only the specialty concerned. (b) The department may issue licenses without examination to applicants who have passed examinations of other states or national accrediting boards whose requirements are equal to or greater than those required by this chapter and regulations established by the department. The evaluation of other state requirements or requirements of national accrediting boards shall be carried out by the department with the assistance of representatives from the licensed groups. This section shall not apply to persons who have passed an examination by another state or national accrediting board prior to the establishment of requirements that are equal to or exceed those of this chapter or regulations of the department. (c) The department may issue licenses without examination to applicants who had met standards of education and training, defined by regulations, prior to the date of the adoption of implementing regulations. (d) The department shall adopt regulations to conform to this section. 1265. (a) (1) A clinical laboratory performing clinical laboratory tests or examinations classified as of moderate or of high complexity under CLIA shall obtain a clinical laboratory license pursuant to this chapter. The department shall issue a clinical laboratory license to any person who has applied for the license on forms provided by the department and who is found to be in compliance with this chapter and the regulations pertaining thereto. No clinical laboratory license shall be issued by the department unless the clinical laboratory and its personnel meet the CLIA requirements for laboratories performing tests or examinations classified as of moderate or high complexity, or both. (2) A clinical laboratory performing clinical laboratory tests or examinations subject to a certificate of waiver or a certificate of provider-performed microscopy under CLIA, shall register with the department. The department shall issue a clinical laboratory registration to any person who has applied for the registration on forms provided by the department and is found to be in compliance with this chapter, the regulations pertaining thereto, and the CLIA requirements for either a certificate of waiver or a certificate of provider-performed microscopy. (b) An application for a clinical laboratory license or registration shall include the name or names of the owner or the owners, the name or names of the laboratory director or directors, the name and location of the laboratory, a list of the clinical laboratory tests or examinations performed by the laboratory by name and total number of test procedures and examinations performed annually (excluding tests the laboratory may run for quality control, quality assurance, or proficiency testing purposes). The application shall also include a list of the tests and the test kits, methodologies, and laboratory equipment used, and the qualifications (educational background, training, and experience) of the personnel directing and supervising the laboratory and performing the laboratory examinations and test procedures, and any other relevant information as may be required by the department. If the laboratory is performing tests subject to a provider-performed microscopy certificate, the name of the provider or providers performing those tests shall be included on the application. Application shall be made by the owners of the laboratory and the laboratory directors prior to its opening. A license or registration to conduct a clinical laboratory if the owners are not the laboratory directors shall be issued jointly to the owners and the laboratory directors and the license or registration shall include any information as may be required by the department. The owners and laboratory directors shall be severally and jointly responsible to the department for the maintenance and conduct thereof or for any violations of this chapter and regulations pertaining thereto. (c) The department shall not issue a license or registration until it is satisfied that the clinical laboratory will be operated within the spirit and intent of this chapter, that the owners and laboratory directors are each of good moral character, and that the granting of the license will not be in conflict with the interests of public health. (d) A separate license or registration shall be obtained for each laboratory location, with the following exceptions: (1) Laboratories that are not at a fixed location, that is, laboratories that move from one testing site to another, such as mobile units providing laboratory testing, health screening fairs, or other temporary testing locations, may apply for and obtain one license or registration for the designated primary site or home base, using the address of that primary site. (2) Not-for-profit, or federal, state, or local government laboratories that engage in limited (not more than a combination of 15 moderately complex or waived tests, as defined under CLIA, per license) public health testing may apply for and obtain a single license or registration. (3) Laboratories within a hospital that are located at contiguous buildings on the same campus and under common direction, may file a single application or multiple applications for a license or registration of laboratory locations within the same campus or street address. (4) Locations within a single street and city address that are under common ownership may apply for and obtain a single license or registration or multiple licenses or registrations, at the discretion of the owner or owners. (e) (1) A license or registration shall be valid for one year unless revoked or suspended. A clinical laboratory license or registration shall be automatically revoked 30 days from a major change of laboratory directorship or ownership. The clinical laboratory shall be required to submit a completed application for a new clinical laboratory license or registration within those 30 days or cease engaging in clinical laboratory practice. (2) If a clinical laboratory intends to continue to engage in clinical laboratory practice during the 30 days after a major change in directorship occurs and before the laboratory license or registration is automatically revoked, the laboratory owner may appoint an interim director who meets the requirements of this chapter and CLIA. The interim director shall be appointed within five business days of the major change of the directorship. Written notice shall be provided to the department of the appointment of the laboratory director pursuant to this paragraph within five business days of the appointment. (f) If the department does not within 60 days after the date of receipt of the application issue a license or registration, it shall state the grounds and reasons for its refusal in writing, serving a copy upon the applicant by certified mail addressed to the applicant at his or her last known address. (g) The department shall be notified in writing by the laboratory owners or delegated representatives of the owners and the laboratory directors of any change in ownership, directorship, name, or location, including the addition or deletion of laboratory owners or laboratory directors within 30 days. However, notice of change in ownership shall be the responsibility of both the current and new owners. Laboratory owners and directors to whom the current license or registration is issued shall remain jointly and severally responsible to the department for the operation, maintenance, and conduct of the clinical laboratory and for any violations of this chapter or the regulations adopted thereunder, including any failure to provide the notifications required by this subdivision, until proper notice is received by the department. In addition, failure of the laboratory owners and directors to notify the department within 30 days of any change in laboratory directors, including any additions or deletions, shall result in the automatic revocation of the clinical laboratory's license or registration. (h) The withdrawal of an application for a license or registration or for a renewal of a license, or registration, issuable under this chapter, shall not, after the application has been filed with the department, deprive the department of its authority to institute or continue a proceeding against the applicant for denial of the license, registration, or renewal upon any ground provided by law or to enter an order denying the license, registration, or renewal upon any such ground, unless the department consents in writing to the withdrawal. (i) The suspension, expiration, or forfeiture by operation of law of a license or registration issued under this chapter, or its suspension, forfeiture, or cancellation by order of the department or by order of a court of law, or its surrender without the written consent of the department, shall not deprive the department of its authority to institute or continue an action against a license or registration issued under this chapter or against the laboratory owner or laboratory director upon any ground provided by law or to enter an order suspending or revoking the license or registration issued under this chapter. (j) (1) Whenever a clinical laboratory ceases operations, the laboratory owners, or delegated representatives of the owners, and the laboratory directors shall notify the department of this fact, in writing, within 30 calendar days from the date a clinical laboratory ceases operation. For purposes of this subdivision, a laboratory ceases operations when it suspends the performance of all clinical laboratory tests or examinations for 30 calendar days at the location for which the clinical laboratory is licensed or registered. (2) (A) Notwithstanding any other provision of law, owners and laboratory directors of all clinical laboratories, including those laboratories that cease operations, shall preserve medical records and laboratory records, as defined in this section, for three years from the date of testing, examination, or purchase, unless a longer retention period is required pursuant to any other provision of law, and shall maintain an ability to provide those records when requested by the department or any duly authorized representative of the department. (B) For purposes of this subdivision, "medical records" means the test requisition or test authorization, or the patient's chart or medical record, if used as the test requisition, the final and preliminary test or examination result, and the name of the person contacted if the laboratory test or examination result indicated an imminent life-threatening result or was of panic value. (C) For purposes of this subdivision, "laboratory records" means records showing compliance with CLIA and this chapter during a laboratory's operation that are actual or true copies, either photocopies or electronically reproducible copies, of records for patient test management, quality control, quality assurance, and all invoices documenting the purchase or lease of laboratory equipment and test kits, reagents, or media. (D) Information contained in medical records and laboratory records shall be confidential, and shall be disclosed only to authorized persons in accordance with federal, state, and local laws. (3) The department or any person injured as a result of a laboratory's abandonment or failure to retain records pursuant to this section may bring an action in a court of proper jurisdiction for any reasonable amount of damages suffered as a result thereof. 1265.1. (a) A primary care clinic that submits an application to the State Department of Public Health for clinic licensure pursuant to subdivision (a) of Section 1204 of the Health and Safety Code may submit prior to that submission, or concurrent therewith, an application for licensure or registration of a clinical laboratory to be operated by the clinic. (b) An application for licensure of a clinical laboratory submitted pursuant to this section shall be subject to all applicable laboratory licensing laws and regulations, including, but not limited to, any statutory or regulatory timelines and processes for review of a clinical laboratory application. 1266. The clinical laboratory license and the license or current renewal permit of each person performing tests shall be conspicuously posted in the clinical laboratory. 1267. Any denial, suspension, or revocation of a license under this chapter shall be conducted in compliance with Section 100171 of the Health and Safety Code. 1268. Upon filing application therefor, containing such information as the department may require, and the payment of the license fee, the department shall issue to any person duly licensed under this chapter a duplicate license for one previously issued or, where there has been a change of name, another license in lieu of one previously issued. 1269. (a) Unlicensed laboratory personnel may perform any of the activities identified in subdivision (b), in a licensed clinical laboratory, under the direct and constant supervision of a physician and surgeon, or a person licensed under this chapter other than a trainee, upon meeting all of the following criteria: (1) Have earned a high school diploma, or its equivalent, as determined by HCFA under CLIA. (2) Have documentation of training appropriate to ensure that the individual has all of the following skills and abilities: (A) The skills required for proper specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens. (B) The skills required for assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory. (C) The skills required for performing preventive maintenance, and troubleshooting. (D) A working knowledge of reagent stability and storage. (E) The skills required for assisting in the performance of quality control procedures, and an understanding of the quality control policies of the laboratory. (F) An awareness of the factors that influence test results. (b) The activities that may be performed are: (1) Biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens. (2) Assisting a licensed physician and surgeon or personnel licensed under this chapter, other than trainees, in a licensed clinical laboratory. (3) Assisting in preventive maintenance, and troubleshooting. (4) Preparation and storage of reagents and culture media. (5) Assisting in the performance of quality control procedures. (c) Notwithstanding subdivision (a), unlicensed laboratory personnel, other than a trainee, may, under the supervision and control of a physician and surgeon or person licensed under this chapter, perform specimen labeling, handling, preservation or fixation, processing or preparation, transportation, and storing if he or she meets the requirements of subparagraph (A) of paragraph (2) of, and paragraph (1) of, subdivision (a). (d) Unlicensed laboratory personnel shall not do any of the following: (1) Record test results, but he or she may transcribe results that have been previously recorded, either manually by a physician and surgeon or personnel licensed under this chapter, or automatically by a testing instrument. (2) Perform any test or part thereof that involves the quantitative measurement of the specimen or test reagent, or any mathematical calculation relative to determining the results or the validity of a test procedure. (3) Perform any phase of clinical laboratory tests or examinations in the specialty of immunohematology beyond initial collection and centrifugation. (e) When any of the following manual methods are employed, the activities of unlicensed laboratory personnel shall be limited as follows: (1) In the case of qualitative and semi-quantitative "spot, tablet, or stick" tests, the personnel may add the test reagent to the specimen or vice versa, but the results must be read by a physician and surgeon or person licensed under this chapter. (2) In the case of microbiological tests the unlicensed laboratory personnel may make primary inoculations of test material onto appropriate culture media, stain slide preparations for microscopic examination, and subculture from liquid media. (f) When any of the following mechanical or electronic instruments are employed, unlicensed laboratory personnel shall not perform any of the following activities: (1) Standardizing or calibrating the instrument or assessing its performance by monitoring results of appropriate standards and control. (2) Reading or recording test results, except that the personnel may transcribe results that have been previously recorded automatically by a testing instrument. (3) Quantitatively measuring any sample or reagents unless done automatically by the instrument in the course of its normal operation or by the use of previously calibrated and approved automatic syringes or other dispensers. 1269.3. (a) Notwithstanding Sections 1206.5 and 1269, within the specialty of pathology, a person certified as a pathologists' assistant by the American Association of Pathologists' Assistants, the Board of Registry of the American Society for Clinical Pathology, or another national accrediting agency approved by the department, who demonstrates competency to perform all job duties and responsibilities before an assignment to those duties and responsibilities, at the completion of six months of performing those duties and responsibilities, and annually thereafter, may perform the following activities under the supervision and control of a pathologist: (1) Prepare human surgical specimens for gross description and dissection, including, but not limited to, description of gross features and selection of tissues for histological examination. (2) Prepare and perform human postmortem examinations, including, but not limited to, selection of tissues and fluids for further examination. (3) Gather other information necessary for an autopsy report. (4) Prepare a body for release. (b) Notwithstanding Section 1206.5 or subdivisions (b), (c), and (d) of Section 1269, the following persons may prepare human surgical specimens for gross description and dissection under the direct supervision of a qualified pathologist, including, description of gross features and selection of tissues for histological examination, if they meet the requirements specified in subdivision (a) of Section 1269 and the minimum education and training requirements for high complexity testing personnel under the CLIA: (1) A pathologists' assistant who does not meet the certification requirements of subdivision (a). (2) A histologic technician. (3) A histotechnologist. (c) For the purposes of subdivision (b), direct supervision means that a qualified pathologist shall be physically present onsite in the vicinity of the clinical laboratory where the specialty of pathology is performed and shall be available for consultation and direction during the time the personnel specified in subdivision (b) are engaged in the processing of specimens that involve dissection. For tissue processing that does not involve dissection, a qualified pathologist may be available by telephone or other electronic means. (d) A histologic technician or histotechnologist who meets the requirements specified in subdivision (a) of Section 1269, may accession specimens, perform maintenance of equipment, stain, cover slip, label slides, and process tissues by embedding in paraffin or performing microtomy. (e) On and after January 1, 2011, the department may adopt regulations establishing additional qualification requirements to perform the duties described in this section. 1269.5. The department may deny, suspend, or revoke any license, registration, or certificate issued under this chapter for performance by unlicensed laboratory personnel of any activity that is not authorized by Section 1269. 1270. (a) On and after January 1, 1991, no person may perform examinations of cytological slides without first obtaining a license as a cytotechnologist from the department, except that those persons employed by licensed clinical laboratories as cytotechnologists and certified as cytotechnologists by the department on or before January 1, 1991, shall be licensed by the department on or before January 1, 1993. Cytotechnologist licenses shall be issued and renewed by the department for periods of two years. This subdivision shall not apply to persons holding a valid, unrevoked, unsuspended physician's and surgeon's certificate issued pursuant to Chapter 5 (commencing with Section 2000). (b) The issuance of a cytotechnologist license shall be contingent upon the applicant's satisfactory performance, as defined in regulation, in a competency testing program for cytotechnologists which may be administered by the department or by a competency testing service or program approved by the department. The competency testing program established pursuant to this section shall be periodically reviewed and revised by the department, if necessary, to ensure that the program is consistent with federal competency testing requirements issued under the Clinical Laboratory Improvement Amendments of 1988 (P.L. 100-578; 42 U.S.C. Sec. 263a, Section 353 of the Public Health Service Act). (c) Notwithstanding subdivision (b), the department may issue a temporary cytotechnologist's license to a person who satisfies the requirements for admission to the examination unless the person has failed a previous examination for a cytotechnologist's license. A temporary license issued by the department pursuant to this subdivision shall be valid for a period of time not exceeding 90 days after the date the department has adopted a competency testing program pursuant to subdivision (b). (d) The department may issue a cytotechnologist's license without examination to an applicant who satisfies one of the following: (1) Passage of an examination of a national accrediting board whose requirements are equal to or greater than those required by this chapter or by regulations adopted pursuant to this chapter, as determined by the department. (2) Passage of an examination of another state in which the requirements imposed by laws and regulations regarding the examination are equal to or greater than those required by this chapter or by regulations adopted pursuant to this chapter, as determined by the department. This subdivision shall not apply to a person who has passed an examination of a national accrediting board or another state prior to that board's or state's establishment of requirements which are equal to or greater than those required by this chapter or by regulations adopted pursuant to this chapter, as determined by the department. The department may, however, make exceptions to the requirements of this subdivision in cases where the department determines that the applicant is otherwise qualified for licensure. (e) The department shall not issue any temporary cytotechnologist' s license pursuant to subdivision (c) or any cytotechnologist's license without examination pursuant to subdivision (d) after the department adopts a competency testing program pursuant to subdivision (b). 1270.5. (a) Notwithstanding Section 1301, an application for the renewal of, and payment of the renewal fees for, a cytotechnologist license shall be governed by this section. (b) Application for renewal of a cytotechnologist license, accompanied by the fee set forth in Section 1300, shall be filed with the department not less than 30 days prior to the expiration date. (c) If the renewal fee is not paid during the 30 days prior to the expiration date, the license shall automatically expire at midnight on the expiration date. However, a cytotechnologist who has failed to timely pay a renewal fee may have his or her license reinstated, without completing a competency testing program, provided that he or she mails to the department a written request for reinstatement postmarked no later than the 60th day after the expiration date of the license and a reinstatement fee equal to two times the annual renewal fee set forth in Section 1300. The license shall be reinstated on the date the request for reinstatement and fee are received by the department. If the request for reinstatement and fee are received prior to the expiration date of the license, there shall be no lapse in licensure. No cytotechnologist shall perform services for which a license or certification is required under this chapter during any period for which licensure or certification has lapsed. 1271. (a) A cytotechnologist shall not examine more than 80 gynecologic slides in a 24-hour period when performing a manual review of slides. (b) The maximum workload limit in subdivision (a) is the maximum number of gynecologic slides that a cytotechnologist shall examine in a 24-hour period without regard to the number of clinical laboratories or other persons for which the work is performed. Cytotechnologists, who examine both gynecologic and nongynecologic slides, shall do so on a pro rata basis so that the maximum workload limit in subdivision (a) is not exceeded, and so that the number of gynecologic slides examined is reduced proportionally if both gynecologic and nongynecologic slides are examined in a 24-hour period. (c) The maximum workload limit in subdivision (a) is for a cytotechnologist who has no duties other than the evaluation of gynecological slides. Cytotechnologists who have other duties, including, but not limited to, the preparation and staining of cytologic slides, shall decrease on a pro rata basis the number of slides examined. (d) All cytologic slides shall be examined in a clinical laboratory that has been licensed by the department, or in a municipal or county laboratory established under Section 101150 of the Health and Safety Code. All slides examined under the name of a clinical laboratory shall be examined on the premises of that laboratory. (e) Each clinical laboratory shall maintain records of the number of cases and slides for gynecologic and nongynecologic samples examined on a monthly and annual basis. (f) Each cytotechnologist shall maintain current records in a form prescribed by the department of hours worked and the names and addresses of the clinical laboratories or other persons for whom slides are examined. (g) Each clinical laboratory shall retain all cytology slides and cell blocks examined for a minimum of five years and all cytology reports for a minimum of 10 years. (h) The presence of any factor that would prohibit the proper examination of a cytologic slide, including, but not limited to, damaged slides or inadequate specimens, as determined by the director of the laboratory, shall result in the issuance of a statement of inadequacy to the referring physician and no report of cytologic findings shall be issued on that slide. (i) Each clinical laboratory shall maintain records of the number of cases and slides for gynecologic and nongynecologic slides each cytotechnologist in the laboratory reads each 24-hour period, the number of hours devoted during each 24-hour period to screening cytology slides by each individual, and shall determine weekly and cumulatively the frequency of abnormal slides found by each cytotechnologist employed. (j) Ten percent of the negative or normal slides examined by each cytotechnologist employed by a clinical laboratory shall be rescreened at least weekly by a cytopathologist or supervising cytotechnologist other than the original examiner. (k) When reviewing gynecologic slides using automated or semiautomated screening devices approved by the federal Food and Drug Administration, a laboratory shall follow the workload requirements established by Section 493.1274 of Title 42 of the Code of Federal Regulations. (1) Any slide reviewed using automated or semiautomated screening devices approved by the federal Food and Drug Administration that requires full manual review shall be counted against the applicable limits established in subdivision (a) and this subdivision. (2) On or before June 30, 2007, the State Department of Health Services shall review published evidence-based peer review journal articles that review the performance of both automated and semiautomated screening devices, subsequent to the approval of the device by the federal Food and Drug Administration, and shall determine whether increasing the number of slides reviewed on a daily basis increases the rate of error. If the department determines that the volume of screening on these devices increases the rate of error, the department may issue new regulations in that regard that are consistent with Section 493.1274 of Title 42 of the Code of Federal Regulations. (l) The technical supervisor of an individual who performs primary screening shall establish the maximum workload limit for the individual, based on the individual's performance, in accordance with the criteria set forth in Section 493.1274(d)(1) of Title 42 of the Code of Federal Regulations. (m) Where cytotechnologists are represented by a labor organization, the maximum workload limitations otherwise established pursuant to this section shall be contained in a collective bargaining agreement or memorandum of understanding negotiated between the employer and the labor organization. 1271.1. (a) Clinical laboratories which are licensed pursuant to this chapter and provide cytology services shall, if the licensee ceases operation, preserve records, reports, cytology slides, and cell blocks as prescribed in subdivision (g) of Section 1271 and Section 1274. (b) Any person injured as a result of the licensee's abandonment of records may bring an action in any court of competent jurisdiction for the amount of any damages suffered as a result. In the event the licensee was a corporation or partnership which has been dissolved, the person injured may bring an action against that corporation's or partnership's principal officers of record at the time of the dissolution. (c) For purposes of this section, the following definitions shall apply: (1) "Abandonment of records" means violating subdivision (a) and thereby leaving patients and physicians and surgeons without access to information to which they are entitled pursuant to this chapter. (2) "Principal officers" means: (A) In the case of a partnership other than a limited partnership, any partner. (B) In the case of a limited partnership, any general partner, as defined in subdivision (i) of Section 15611 of the Corporations Code. (C) In the case of a corporation, the chairperson of the board, the chief executive officer, and the president of the corporation. 1272. A clinical laboratory shall participate in a state-approved proficiency testing program and demonstrate satisfactory performance in all of the laboratory specialities that include tests performed in the laboratory. Proficiency shall be tested in the following specialties: microbiology, serology, clinical chemistry, hematology, cytology, and immunohematology. 1272.4. The department shall establish standards for the evaluation of cytologic slides, for reporting the adequacy of cytologic slides, for a cytotechnologist competency program, and for a proficiency testing program for clinical laboratories providing cytology services. 1272.6. The department shall, on or before January 1, 1992, develop or adopt a proficiency testing program for laboratories providing cytology services which may be administered by the department or by a proficiency testing service or program approved by the department. The proficiency program established pursuant to this section shall include announced and unannounced onsite proficiency testing, with that testing to take place, to the extent practicable, under normal working conditions. 1274. (a) A laboratory shall document to persons submitting cytologic samples for evaluation, on a quarterly basis, informational letters on all cases of HSIL (high-grade squamous intraepithelial lesions), adenocarcinoma, or other malignant neoplasm. Documentation may consist of followup correspondence, telephone calls, or requests included in the report. Copies of that documentation, and any responses received to those letters, shall be maintained on file by the laboratories for a period of five years. (b) Whenever it becomes known to a clinical laboratory that an abnormality of HSIL (high-grade squamous intraepithelial lesions, adenocarcinoma, or other malignant neoplasm) has been identified for a patient for whom the clinical laboratory earlier reported a normal finding, all previous available cytologic slides on that patient shall be reexamined by the clinical laboratory. (c) Records of the review of previous slides required by subdivision (b) shall be maintained by the clinical laboratory, including the name of the individual performing the earlier examination. (d) A clinical laboratory shall maintain records of all false positive and false negative cases. When any errors in the reporting of a smear evaluation are discovered, a corrected report shall be immediately sent, when medically applicable. Copies of corrected reports shall be maintained in the laboratory records for a period of 10 years. 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.
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