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(continued)
(a) Every laboratory director, under whom high complexity tests or examinations are performed, shall either perform the duties of a technical supervisor or employ a technical supervisor who is responsible for the technical and scientific oversight of the laboratory.
(b) A technical supervisor of a laboratory performing high complexity testing shall:
(1) Possess an active, valid, license issued by the state to perform high complexity testing pursuant to chapter 3 of Business and Professions Code or to practice medicine, osteopathy or podiatry, pursuant to chapter 5 of Business and Professions Code appropriate to the specialty or specialties for which they are consulting; and
(2) Meet the experience requirements in Section 493.1449 of Title 42 of the Code of Federal Regulations, as published October 1, 1994.
(c) While not required to be on site at all times testing is performed, a technical supervisor shall be available to laboratory testing personnel at all times to provide either on-site, telephone or electronic consultation.
(d) A technical supervisor shall be responsible for all the activities listed in Section 493.1451 of Title 42 of the Code of Federal Regulations, as published October 1, 1994.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1207, 1208, 1209, 1209.1 and 1210, Business and Professions Code.
s 1038. Definitions.
(a) The definitions set forth in subsections b through j inclusive shall govern the interpretation of this article.
(b) "Contact Hour" means the actual time a licensee participates in continuing education offered by an approved provider, utilizing the following conversion standards:
50-60 minutes = 1 contact hour
0.1 continuing education unit (CEU) = 1 contact hour
1 quarter unit = 10 contact hours
1 semester unit = 15 contact hours
(c) "Accredited Academic Institution" means an academic institution accredited by the Western Association of Schools and Colleges or an accrediting organization recognized by the Council of Post Secondary Education.
(d) "Accrediting Agency" means an organization approved by the Department pursuant to Section 1038.2 which evaluates and grants approval to providers of continuing education who comply with the standards of that agency, and who are other than those identified in (c) above.
(e) "Approved Provider" means an accredited academic institution or any person or entity offering continuing education who has been approved by an accrediting agency.
(f) "Licensee" means those persons other than clinical laboratory technologist trainees licensed pursuant to Chapter 3 (commencing with section 1200) of Division 2 of the Business and Professions Code.
(g) "Quarter Unit" and "Semester Unit" means the hours of instruction offered by an accredited academic institution which are credited by that institution as a quarter unit and semester unit respectively.
(h) "Active Status" means a current license in good standing which authorizes the licensee to perform the functions described in this chapter.
(i) "Inactive Status" means a license which is not in good standing because the holder has not completed the continuing education requirements of this article or has voluntarily requested that the license be made inactive.
(j) "Continuing Education Program" means a presentation given by an approved provider at a scheduled time or times which conforms to the requirements of section 1038.3.
Note: Authority cited: Sections1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.
s 1038.1. Continuing Education Requirements.
(a) All persons licensed under Division 2, Chapter 3 of the Business and Professions Code, commencing with Section 1200, whose license is in active status shall complete 12 contact hours of continuing education each calendar year. All persons licensed with more than one active license type pursuant to Division 2, Chapter 3 of the Business and Professions Code shall be able to renew all license types after completion of a total of 12 contact hours of continuing education each calendar year.
(b) At the time of renewal, each licensee shall provide the Department with the date, name and number of contact hours received for each continuing education program successfully completed by the licensee in the previous calendar year.
(c) The licensee shall retain continuing education documents received from approved providers under Section 1038.4 for a minimum of four years.
(d) A random sample of licensees shall be audited by the Department to determine compliance with the continuing education requirement. Those licensees selected for audit shall submit to the Department, within 30 calendar days of notification of selection, a copy of each document provided the licensee under section 1038.4(c) since the date of last license renewal.
(e) Any licensee who is found to have not successfully completed the continuing education requirement of this article will be placed in inactive status. The licensee shall have the right to appeal such findings to the Department. An appeal shall be conducted in compliance with chapter 5 (commencing with section 11500) of Part 1 of Division 3 of Title 2 of the Government Code.
Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.
s 1038.2. Accrediting Agencies.
(a) Any organization seeking approval as an accrediting agency shall submit an application to the Department which shall include documentation of the following:
(1) The organization's name, address, and owner(s);
(2) The organization's structure, function, and philosophy for monitoring the content, quality, and faculty of approved programs; and,
(3) The person designated by the organization to be responsible for overseeing the administration and coordination of all continuing education providers approved by the organization.
(b) The Department's review of an accrediting agency shall include an evaluation of the following:
(1) Whether the organization's philosophy shows an identifiable commitment to continuing education;
(2) Whether the organization's mechanism for monitoring the content, faculty, education methods, quality, and facilities of approved providers meets the criteria of section 1038.3; and,
(3) Effective mechanisms for responding to complaints about approved providers and the ability to take effective action to insure that approved providers comply with sections 1038.3 and 1038.4.
(c) The Department shall approve an organization as an accrediting agency and issue an approval upon satisfactory review under subsections (a) and (b). Such approval may be subject to special terms as specified by the Department.
(d) Within 30 calendar days of receipt of an application by an organization for approval as an accrediting agency, the Department shall inform the organization in writing that the application is either complete and accepted for review or that it is deficient and what specific information or documentation is required to complete the application.
(e) Within 30 calendar days from the date of filing of a completed application, the Department shall inform the applicant organization in writing whether the organization has been approved as an accrediting agency.
(f) The Department's time periods for processing an application for approval as an accrediting agency, from the receipt of the initial application to the final decision regarding the approval, are as follows:
(1) The median time for processing is 60 calendar days.
(2) The minimum time for processing is 45 calendar days.
(3) The maximum time for processing is 90 calendar days.
(g) An accrediting agency shall maintain for five years and shall make available to the Department, the name of each approved provider, the title, date, and number of contact hours awarded for each program offered by its approved providers, and a list of all participants in each program offered.
(h) An accrediting agency shall be subject to review by the Department to determine adherence to requirements of this article. Failure of an accrediting agency to meet the requirements of this article or its terms of approval is good cause for revocation of approval by the Department.
Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.
s 1038.3. Approval of Providers.
(a) An accrediting agency shall approve only providers who offer continuing education programs that meet all of the following criteria:
(1) Use instructors who are competent in subject matter by education, training or experience;
(2) Are a minimum of 50 minutes in duration excluding evaluation by participants of the continuing education program;
(3) Are relevant to the scope of practice of clinical laboratory science and may include education, supervision, and management;
(4) Have clearly stated, measurable, education objectives; and,
(5) Use teaching methods which are consistent with the objectives of the continuing education program.
Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.
s 1038.4. Approved Providers.
(a) No person or entity shall represent itself as an approved provider unless approved by an accrediting agency or unless it is an accredited academic institution.
(b) Approved providers shall issue certificates to participants which include:
(A) The participant's name;
(B) Contact hours;
(C) Date of continuing education provided;
(D) Name and address of both program provider and accrediting agency; and,
(E) Signature of instructor and/or provider or provider designee.
(c) Accredited academic institutions shall provide certificates to every participant upon completion of a continuing education program which includes all the information in subsection (b), except the approved provider will not be required to issue a certificate when the continuing education program is a regularly scheduled class and documented on a student transcript.
(d) An approved provider shall maintain an official record verifying all participants' attendance at continuing education programs for at least four years after the completion date. The provider shall include the participant on the official record of attendance only if the participant's signature was obtained at the time of attendance at the program. The official record of attendance shall contain the name of the participant and shall identify the time, date, location, subject matter, and length of the continuing education program and shall be provided to the Department upon request at no cost to the Department.
(e) If two or more approved providers jointly provide a continuing education program, the providers shall designate the provider responsible for keeping records and issuing certificates to participants.
(f) An approved provider shall evaluate the effectiveness of continuing education programs to determine whether the program objectives required under section 1038.3 subsection (a)(5) were met. This evaluation shall include a written evaluation by the participants, or pre- and post-examination.
(g) An approved provider shall allow, at no cost, in-person observation of continuing education programs by employees of the Department of Health Services for purposes of monitoring compliance with sections 1038.3 and 1038.4.
Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.
s 1038.5. Waiver of Requirement.
(a) At the time of making application for renewal of a license issued pursuant to Division 2, Chapter 3 of the Business and Professions Code (BPC), a licensee may request a waiver of all or part of the continuing education requirement. To be eligible for a waiver, a license holder shall verify in writing that he or she:
(1) Was residing in another country for at least half the license period since the license was issued or, if the license was previously renewed, since it was last renewed, and that this reasonably prevented completion of the continuing education requirements; or
(2) Was absent from California for at least half the license period since the license was issued or, if previously renewed, since it was last renewed, because of military service, and that this reasonably prevented completion of the continuing education requirements; or
(3) Was prevented from completing the continuing education requirements for reasons of ill health or other good cause, including, but not limited, to:
(A) Total physical and/or mental disability of the licensee for at least half of the period since the license was issued or, if previously renewed, since it was last renewed; or
(B) Total physical and/or mental disability of an immediate family member for at least half of the period since the license was issued or, if previously renewed, since it was last renewed, where the licensee has total responsibility for the care of that family member.
(4) Verification of a disability under paragraph (3) shall include a corroborating statement by a licensed physician.
Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.
s 1038.6. Inactive Status.
A licensee whose license issued pursuant to Division 2, Chapter 3 of the Business and Professions Code is in inactive status shall document 12 hours of continuing education for the year prior to reinstatement or pass the examination for licensure prior to reinstatement to active status.
Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.
s 1038.7. Fees.
(a) A fee of $250.00 shall accompany an application for approval or renewal as an accrediting agency.
(b) At the time of initial application or renewal of a clinical laboratory personnel license, an additional fee of $8.00 shall be paid by each licensee to support the costs of administering and enforcing the continuing education requirements of this article.
Note: Authority cited: Sections 1224 and 1275, Business and Professions Code; and Section 208, Health and Safety Code. Reference: Section 1275, Business and Professions Code.
s 1039.1. Recognition of CLIA Certification for Limited Purpose and Period.
(a) Except for a certificate of accreditation issued by HHS, a CLIA certificate issued to a clinical laboratory that on December 31, 1995 was not required to obtain a state license pursuant to Section 1241 of Chapter 3, shall be considered to be a state license or registration issued pursuant to Chapter 3 until such time as CLIA exempt status is obtained, provided that the CLIA certificate is for the type and complexity of clinical laboratory tests or examinations performed and that it remains in effect, unsuspended and unrevoked during the entire period covering January 1, 1996 to when CLIA exempt status is granted by HHS.
(b) A certificate of accreditation issued by HHS to a clinical laboratory that on December 31, 1995 was not required to obtain a state license pursuant to Section 1241 of Chapter 3, shall be considered a state license or registration issued pursuant to Chapter 3 until such time as the accreditation body, upon whose accreditation the certificate of accreditation was issued by HHS, fails to be approved by the department as having accreditation standards that are equal to, or more stringent than, state requirements for licensure; and, provided that:
(1) The certificate of accreditation issued by HHS is for the type and complexity of clinical laboratory tests or examinations performed and that it remains in effect, unsuspended and unrevoked; and
(2) After exempt status is obtained, the accredited laboratory pays the department the $100 annual certificate of accreditation renewal fee.
(c) A certificate of waiver issued by HHS, to a clinical laboratory that on December 31, 1995 was required to obtain a state license, and that performs only waived tests, physician performed microscopy, or both, shall be considered to be a state registration issued pursuant to Chapter 3 until such time as CLIA exempt status is obtained, provided that the certificate of waiver remains in effect, unsuspended and unrevoked during the entire period covering January 1, 1996 to when CLIA exempt status is granted by HHS.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1220, 1241, 1265, 1281 and 1288.5, Business and Professions Code.
s 1039.2. Clinical Laboratory Personnel Requirements.
(a) All persons performing, supervising, consulting on, or directing clinical laboratory tests or examinations in California shall meet the requirements for performing, supervising, consulting on, or directing laboratory tests or examinations as set forth in Chapter 3 for the type and complexity of tests performed and irrespective of whether the clinical laboratory is operated under a CLIA certificate or under a state license or registration.
(b) All persons performing, supervising, consulting on, or directing clinical laboratory tests or examinations outside California on biological specimens originating in California, and irrespective of whether the clinical laboratory where the tests or examinations are performed is operated under a CLIA certificate or under a state license or registration, shall meet all personnel requirements set forth in Chapter 3 for the type and complexity of testing performed, or shall provide evidence to the department that they substantially meet those requirements by documenting inclusion, licensure or certification in a class of personnel similar to those required in Chapter 3 or requiring equivalent standards.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1241, 1244, 1265, 1281 and 1288.5, Business and Professions Code.
s 1039.3. State Licensure or Approval Required During CLIA Exemption.
All clinical laboratories except those identified in subdivision (b) of Section 1241, or in Section 1244 of the Business and Professions Code, shall have in effect a state license or state registration, and all public health laboratories shall be approved public health laboratories during any period for which HHS grants CLIA exempt status for clinical laboratories or public health laboratories licensed, registered or approved by the department.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206, 1241, 1244, 1265, 1281 and 1288.5, Business and Professions Code.
s 1040. Forfeited Licenses.
(a) No license which has been forfeited for failure to pay the required fee shall be reinstated until a written request for reinstatement and all unpaid fees have been received by the department.
(b) If the renewal fee is not paid for five or more years, an examination will be required in addition to the requirements of subsection (a) above before the license may be reinstated, except as otherwise provided in Division 2, Chapter 3, Section 1301 of the Business and Professions Code.
Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Section 1303, Business and Professions Code.
s 1041. Fee Credits.
Each clinical laboratory that pays a fee subject to reduction under subdivision (u) of Section 1300 of the Business and Professions Code shall have any reduction credited against the clinical laboratory's future license, registration or other fees payable under Chapter 3.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1300, Business and Professions Code.
s 1042. Substantial Relationship Criteria.
Four purposes of denial, suspension or revocation of a license, certificate or permit pursuant to Division 1.5 (commencing with Section 475) of the Business and Professions Code, a crime or act shall be considered to be substantially related to the qualifications, functions, or duties of a person who is an applicant or holder of a license, certificate or permit under Chapter 3, Division 2, of the Business and Professions Code if to a substantial degree it evidences present unfitness of a person holding a license, certificate or permit to perform the functions authorized by such license, certificate or permit in a manner consistent with the public health, safety or welfare. Such crimes or acts shall include but not be limited to the following:
(a) Violating or attempting to violate, directly or indirectly, or assisting in or abetting the violation of, or conspiring to violate, any provision of Chapter 3, Division 2 of the Business and Professions Code.
(b) Acts of dishonesty, fraud or deceit with intent to substantially benefit himself or another, or substantially injure another.
(c) Acts of gross negligence in the performance of functions authorized by the license, certificate or permit under Chapter 3, Division 2, of the Business and Professions Code.
A license, certificate or permit shall not be denied, suspended or revoked because of a lack of good moral character or any similar ground relating to a person's character, reputation, personality or habits.
Note: Authority cited: sections 208, 3901, 15020 and 25800-25870, Health and Safety Code; section 1224, Business and Professions Code. Reference: Sections 3901, 1500-15023 and 25811, Health and Safety Code; Sections 475, 480, 481, 482, and 1242.5, Business and Professions Code.
s 1042.1. Criteria for Evaluating Rehabilitation.
(a) When considering the denial of a license, permit or certificate under Section 480 of the Business and Professions Code, for which application has been made under Chapter 3, Division 2, of the Business and Professions Code, the Department, in evaluating the rehabilitation of the applicant and his present eligibility for a license, permit or certificate, shall consider the following criteria:
(1) The nature and severity of the act(s) or crime(s) under consideration as grounds for denial.
(2) Evidence of any act(s) committed subsequent to the act(s) or crime(s) under consideration as grounds for denial which also could be considered as grounds for denial under Section 480 of the Business and Professions Code.
(3) The time that has elapsed since commission of the act(s) or crime(s) referred to in subsection (a) (1) or (a) (2).
(4) The extent to which the applicant has complied with any terms of parole, probation, restitution or any other sanctions lawfully imposed upon the applicant.
(5) Evidence, if any, of rehabilitation submitted by the applicant.
(b) When considering the suspension or revocation of a license, permit or certificate issued under Chapter 3, Division 2 of the Business and Professions Code on the grounds of conviction of a crime, the Department, in evaluating the rehabilitation of such person and his present eligibility for a license, permit or certificate shall consider the following criteria:
(1) Nature and severity of the act(s) or offense(s).
(2) Total criminal record.
(3) The time that has elapsed since commission of the act(s) or offense(s).
(4) Whether the licensee has complied with any terms of parole, probation, restitution or any other sanctions lawfully imposed against the licensee.
(5) If applicable, evidence of expungement proceedings pursuant to Section 1203.4 of the Penal Code.
(6) Evidence, if any, of rehabilitation submitted by the licensee.
(c) When considering a petition for reinstatement of a license, permit or certificate, the Department shall evaluate evidence of rehabilitation, considering those criteria of rehabilitation listed in subsection (b).
Note: Authority cited: Sections 208, 3901, 15020 and 25800-25870, Health and Safety Code: Section 1224, Business and Professions Code. Reference: Sections 3901, 1500-15023 and 25811, Health and Safety Code; Sections 475, 480, 481, 482 and 1242.5, Business and Professions Code.
s 1045. Personnel Report.
All clinical laboratory directors shall on or before December 15th of each calendar year transmit to the department, on forms provided by the department, the names of all persons performing clinical laboratory procedures including, but not limited to biochemical, bacteriological, parasitological, hematological, or serological procedures. All clinical laboratory directors shall keep the department advised of current changes in employment of such technical personnel giving employment and/or separation dates of personnel.
s 1050. Clinical Laboratory Standards.
(a) All licensed clinical laboratories shall be conducted, maintained, and operated without injury to the public health and shall maintain records, equipment, and facilities which are adequate and appropriate for the services rendered and demonstrate satisfactory performance in a proficiency program approved by the department.
(b) Proficiency Testing.
(1) The laboratory must participate in a state approved proficiency testing program and demonstrate satisfactory performance in all of the laboratory specialties that include tests performed in the laboratory. Proficiency shall be tested in the following specialties: microbiology, serology, clinical chemistry, hematology, and immunohematology.
(2) The participating laboratory must test applicable materials each time they are distributed by the approved proficiency testing service according to a schedule approved by the department.
(3) Those procedures performed by the laboratory for which test materials are provided by the approved proficiency testing service and which have been designated by the department as a requirement for measuring test performance, must be proficiency tested by the participating laboratory each time test materials are received.
(4) The participating laboratory must authorize the approved proficiency testing service to report proficiency test results to the department.
(5) The participating laboratory must test applicable materials only in the laboratory to which the license and the proficiency testing requirement applies using personnel and equipment used in that facility in providing services.
(6) A laboratory may be required to discontinue providing a service in a procedure or category of procedures if:
(A) For three consecutive quarters the laboratory fails to report on test materials received for procedures for which the laboratory is required to be proficiency tested, or
(B) For three consecutive quarters the laboratory demonstrates unsatisfactory performance in a procedure or category of procedures. A determination of satisfactory performance for a procedure shall be based upon results being within acceptable limits established by the proficiency testing service for that procedure and approved by the department. A determination of satisfactory performance for a category of procedures shall be based upon an average of performance within the category over four consecutive quarters.
(7) A laboratory whose services have been disapproved because of unsatisfactory performance may apply to the department for reapproval to provide these services after demonstrating satisfactory performance during the two consecutive quarters or testing periods immediately prior to requesting reapproval.
(c) Direction. The person or persons directing a licensed clinical laboratory shall assume the following responsibilities:
(1) Determine what laboratory procedures will be performed, the techniques that will be followed, and the equipment and reagents that will be used.
(2) Determine the scope and nature of procedures to control the reliability of test performance and personally monitor these control programs.
(3) Regularly assess the activities of the laboratory by personal observation, evaluation, and review of reports of laboratory findings.
(4) Establish qualification criteria of laboratory personnel.
(5) Determine the format of laboratory report forms and decide what information is to be contained on these report forms.
(6) Regularly consult with supervisors and other staff members.
(7) Confer with those served by the laboratory on matters that relate to test performance and determine the nature and scope of technical and administrative information to be released by the laboratory staff.
(8) Be available daily in any laboratory performing cytology and serve as director of no more than three (3) laboratories.
(9) Cause a licensed physician or dentist, qualified in cytopathology, to personally examine and report findings on abnormal or questionable gynecologic and all non-gynecologic specimens.
(d) Facilities. The laboratory must provide for and assure that:
(1) There is adequate space including working surface to conduct and control the performance of all test procedures performed in the laboratory.
(2) There is adequate area for safe storage and use of equipment and supplies.
(3) All areas are well lighted and properly ventilated.
(4) Fume hoods and biological safety cabinets, properly installed and regulated, are used if required for safe performance of tests or for safe preparation of materials.
(5) Instructions to be followed in case of fire and other emergencies are posted in a conspicuous place.
(e) Equipment and Test Materials.
(1) The laboratory must provide for and assure that equipment, instruments, glassware, and reagents are maintained in proper working order by periodic inspection, testing, or calibration in a manner acceptable to the department.
(2) All reagents and stains shall be dated at the time of preparation and initialed by the person making the reagents or stains, or the date received and date opened if commercially prepared reagents or stains are used. All reagents and stains shall be labeled to indicate identity, and titer, strength, or concentration. Recommended storage temperature and expiration date, and other pertinent information necessary for quality control must be on the label.
(f) Records.
(1) Retention of Records: The laboratory must maintain for a period of at least two years documentation of the following:
(A) Records of specimens received and tested, including identification of the patient, name of the submitter, dates of receipt and report, type of test performed, and test results.
(B) Records of inspection, validation, calibration, repair, and replacement to insure proper maintenance and operation of equipment and proper reactivity of test materials.
(C) Manuals, card files, or flow charts for each procedure performed in the laboratory which include:
1. Name of procedure.
2. Source or reference for the test method.
3. Date the procedure was last reviewed or modified by the director or supervisor.
4. Current specific instructions for test performance.
5. The standards and controls required.
6. Instructions for collecting and handling specimens to insure test reliability.
(D) Records of quality control procedures in use in the various technical areas of the laboratory, including results on standards and reference materials and action limits when appropriate.
(E) Additional requirements for cytology. The laboratory shall retain all cytology slides and cell blocks for a minimum of five (5) years and all cytology reports for a minimum of ten (10) years.
(2) Cytology Specimen Documents. The laboratory shall maintain cytology records indicating the daily accession of specimens, each of which is numbered, and an appropriate cross-filing system according to patient's name.
(A) Requests shall contain at least the following information:
1. The laboratory accession number when assigned by the laboratory.
2. The name of the person from whom the specimen was taken.
3. The name of the licensed physician or other authorized person or clinical laboratory who submitted the specimen.
4. Minimum information provided shall include: source of specimen (anatomic site), age of patient, previous therapy (endocrine, surgical, radiation, birth control, etc.), gynecologic history on cervical-vaginal specimens, including date and normalcy of patient's last menstrual period, duration of patient's current pregnancy, if any, and patient's menopausal status or essential history on non-gynecologic specimen.
5. The date the specimen was collected.
(B) Reports shall contain at least the following information:
1. The dates the specimen was collected, received in the laboratory and reported by the laboratory; and the accession number.
2. The result of the laboratory examination.
(3) Cytology Laboratory Records.
(A) The laboratory director shall be responsible for the final laboratory report and shall sign all abnormal and all non-gynecological reports. Each report, or a laboratory copy, shall be signed or initialed by the cytopathologist and/or cytotechnologist who examined the preparation and evaluated the final report. The names of all persons who examined the specimen and their evaluation, if inconsistent with the final report, shall be indicated on the laboratory work sheet or report copy.
(B) Duplicate copies of laboratory reports are filed in a manner which permits ready identification and accessibility.
(C) Laboratories shall utilize reporting systems that are as explicit as is cytologically feasible and must include acceptable morphologic terminology.
(D) If a specimen is judged by the laboratory director or cytotechnologist to be suboptimal, an accompanying statement shall indicate the reason, e.g., samples of sparse cellularity, poor preservation, or exhibiting other factors interfering with the laboratory evaluation, such as, excessive blood, inflammatory cells, etc.
(g) Quality Control.
(1) The laboratory must conduct, maintain, and operate programs for controlling the quality of test performance in a manner acceptable to the department.
(2) Additional Cytology.
(A) Specimen Identification. All smears and other specimens shall be labelled for patient identification and appropriately prepared by the submitter.
(B) Specimen Preparation.
1. The laboratory shall use the Papanicolaou staining technique or its equivalent as determined by the laboratory director.
2. Staining quality of cytologic specimens shall be checked at least once daily, with suboptimal results corrected immediately.
3. Gynecologic specimens shall be processed totally separately from non-gynecologic specimens.
(C) Microscopy.
1. Each specimen shall be evaluated to determine whether the material is satisfactory and consistent with the patient source. For satisfactory specimens, a cytologic evaluation shall be rendered according to the reporting system, as outlined in Section 1050(f)(3)(C).
2. The laboratory shall have a sufficient number of certified cytotechnologists to handle, under general supervision, the volume and diversity of tests performed requiring the exercise of independent judgment. No cytotechnologist shall be required to examine more than 75 one-slide gynecologic cases or 50 two-slide gynecologic cases per day; not including aspiration cytology specimens, cell block specimens, and other not normally examined by a cytotechnologist. Work load ratios for cytotechnologists who also prepare and stain slides shall be based on time spent in examining cytologic preparations.
3. The director or a supervising cytotechnologist shall examine (to verify proper staining and correct interpretation) at least ten (10) percent of all gynecologic smears previously examined and classified as not abnormal or questionable, including smears initially examined by a supervising cytotechnologist.
(3) Clinical Correlation. The laboratory shall maintain records for a minimum of 10 years of histologic or clinical confirmation of cytologic findings on abnormal cases and false negative and false positive results for each category of specimens, when such results are made available to them.
(h) Clinical Laboratory Test Results. Clinical laboratory test results shall not be reported from the laboratory until these results have been critically reviewed and verified for accuracy, reliability, and validity by a licensed physician and surgeon or a person, other than a trainee, duly licensed under Chapter 3, Division 2, Business and Professions Code (commencing with Section 1200).
Note: Authority cited: Sections 1224 and 1245, Business and Professions Code. Reference: Sections 1220, 1224 and 1245, Business and Professions Code.
s 1051. Proficiency Testing Services.
A service may be approved by the department for proficiency testing laboratories providing the service:
(a) Makes available to each participating laboratory
(1) Materials not less than four times during each calendar year for testing those procedures which have been designated by the department for evaluation,
(2) Acceptable forms for reporting results of proficiency testing,
(3) An evaluation of test results reported by the participating laboratory showing acceptable results based on a reference system approved by the department, and
(4) A summary of results reported by all participating laboratories prepared at least annually.
(b) Provides the department with an adequate description of acceptable procedures for
(1) The preparation and distribution of test materials,
(2) The determination of limits of acceptable test results, and
(3) The reporting of results of performance to the laboratories subscribing to the service.
(c) Establishes and maintains an adequate reference system for each procedure evaluated. The names and addresses of all laboratories used as reference or referee laboratories by the service must be provided to and approved by the department.
(d) Maintains records of proficiency testing including reports for participating laboratories for a period of not less than five years, such records being available to the department for reference upon request. These records must include:
(1) The names and addresses of laboratories subscribing to the service,
(2) The test procedures evaluated,
(3) The results of performance reported by each laboratory, and
(4) The results or range of results which were considered acceptable performance by the service.
(e) Makes application for approval on forms provided by the department.
s 1052. Satisfactory Performance in Proficiency Testing.
The standards for satisfactory performance for laboratories operating in accordance with Subsections (b) and (g), Sections 1241, Division 2, Chapter 3, Business and Professions Code shall be those outlined in Section 1050(b) of this Title.
Note: Authority cited: Sections 1224 and 1241.1, Business and Professions Code.
s 1053. Definitions.
Note: Authority cited: Sections 1220(a), 1224 and 1245, Business and Professions Code. Reference: Sections 1206, 1209, 1220(a), 1224, 1245, 1265, 1282 and 1285, Business and Professions Code.
s 1053.5. HIV Tests.
The Department hereby adds to the tests that may be requested and reported pursuant to Business and Professions Code section 1246.5 any laboratory test or examination to identify HIV, a component of HIV, or antibodies or antigens to HIV when the test or examination has been approved by the United States Food and Drug Administration for sale to the public without a prescription in the form of an over-the-counter test kit.
Note: Authority cited: Sections 1224 and 1246.5, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Section 1246.5, Business and Professions Code; and Section 120775, Health and Safety Code.
s 1054.1. Conditions for Performance.
(a) A Respiratory Care Practitioner may engage in clinical laboratory practice by performing a blood electrolyte analysis when all of the following conditions are met:
(1) The blood electrolyte analysis is performed on an instrument which is designed to perform both blood gas analysis and blood electrolyte analysis simultaneously or concurrently and from the same blood specimen;
(2) The blood electrolyte analysis is performed in a licensed laboratory that:
(A) is within a licensed surgical clinic or a licensed general acute care hospital;
(B) has a CLIA certificate to perform blood gas analysis and blood electrolyte analysis; and
(C) has established and maintains protocols for the performance and reporting of blood gas analysis and blood electrolyte analysis simultaneously or concurrently from the same blood specimen by Respiratory Care Practitioners;
(3) The blood electrolyte analysis is performed:
(A) under the overall operation and administration of the laboratory director, as required in Section 1029 of the Business and Professions Code; and
(B) in conformity with the protocols required in (2)(C), above; and
(C) in conformity with the manufacturer's instructions.
(4) The Respiratory Care Practitioner:
(A) has been trained in accordance with Section 1054.2; and,
(B) performs and reports simultaneous or concurrent blood gas analysis and blood electrolyte analysis in compliance with the requirements in (3), above; and
(C) meets CLIA testing personnel qualifications for the type and complexity of tests being performed.
Note: Authority cited: Section 1224, Business and Professions Code. Reference: Sections 1206, 1209, 1220, 1265, 1282 and 1285, Business and Professions Code.
s 1054.2. Training.
(a) Prior to performing a blood electrolyte analysis, a Respiratory Care Practitioner shall have completed the following training:
(1) instruction by the laboratory director, or by a person who qualifies as a technical consultant or a technical supervisor under CLIA, depending on the type and complexity of the tests being performed, in:
(A) the operation of each instrument to be used for simultaneous or concurrent blood gas analysis and blood electrolyte analysis by the Respiratory Care Practitioner, including the following:
1. Equipment maintenance and calibration;
2. Method performance including the normal ranges and critical values for each test protocol;
3. Quality Control and Assurance requirements including remedial action and reagent and specimen handling and integrity; and,
4. Clinical significance of test results and clinical applications for simultaneous or concurrent blood gas analysis and blood electrolyte analysis.
Note: Authority cited: Section 1224, Business and Professions Code. Reference: Sections 1209, 1220 and 1265, Business and Professions Code.
s 1054.5. Conditions for Performance.
Note: Authority cited: Sections 1220(a) and 1224, Business and Professions Code. Reference: Sections 1206, 1209, 1220(a), 1265, 1282 and 1285, Business and Professions Code.
s 1054.6. Testing Authority for Licensed Psychiatric Technicians, Licensed Vocational Nurses, Licensed Midwives, Certified Nurse Assistants, and Certified Home Health Aides.
Note: Authority cited: Section 1224 Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5, and 1209, Business and Professions Code.
s 1054.7. Preceptor Program Requirements for Licensed Psychiatric Technicians, Licensed Vocational Nurses, Licensed Midwives, Certified Emergency Medical Technicians II, Paramedics, Certified Nurse Assistants, and Certified Home Health Aides Performing Moderate Complexity Testing on Point-of-Care Laboratory Testing Devices.
(a) Prior to the performance of any clinical laboratory test or examination authorized in Business and Professions Code Section 1206.5(b)(11), a licensed psychiatric technician, licensed vocational nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant or certified home health aide shall have been trained by a preceptor in:
(1) The operation of each instrument to be used by the licensed psychiatric technician, licensed vocation nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant or certified home health aide including:
(A) Each instrument's requirements for maintenance and calibration which shall include training regarding all manufacturer's instructions;
(B) Each instrument's performance criteria including the reference ranges, critical values for each test method, and actions to be taken for values outside the analytical range; and
(C) Each instrument's quality control and quality assurance protocols, including remedial action and reagent and specimen handling and integrity; and,
(2) The clinical significance of test results for each instrument and the clinical application for use of the instruments by licensed psychiatric technicians, licensed vocational nurses, licensed midwives, certified emergency medical technicians II, paramedics, certified nurse assistants or certified home health aides; and,
(3) The common physiological conditions of patients that may impact specimen integrity and cause inaccurate test results; and
(4) Principles of good laboratory practice including laboratory safety and universal precautions.
(b) Prior to the utilization, for patient care, prognosis, monitoring, treatment, or disease prevention, of any clinical laboratory test or examination performed by him or her, a licensed psychiatric technician, licensed vocational nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant, certified home health aide shall have the following experience and shall have been determined to be competent to perform moderate complexity tests by the laboratory director or a person who qualifies as a technical consultant pursuant to Business and Professions Code Section 1209:
(1) He or she shall participate in a preceptor program until such time as he or she is able to perform clinical laboratory tests or examinations with results that are consistent with the preceptor's results 90% of the time over 20 separate testing events which taken together, cover the entire range of expected values for the instrument.
(2) The experience requirement in subsection (b)(1) shall be met for each instrument to be used by the licensed psychiatric technician, licensed vocational nurse, licensed midwife, certified emergency medical technician II, paramedic, certified nurse assistant or certified home health aide.
Note: Authority cited: Section 1224, Business and Professions Code; and Section 100275, Health and Safety Code. Reference: Sections 1206.5, 1209, and 1220, Business and Professions Code.
s 1055. Reports.
Any report of results issuing from a clinical laboratory operating under the provisions of Chapter 3, Division 2, Business and Professions Code shall show clearly the name of a director of said laboratory.
Note: Authority cited: Sections 102 and 208, Health and Safety Code. Reference: Sections 1220, 1225, 1284 and 1285, Health and Safety Code.
s 1056. Prenatal and Neonatal Blood Typing.
For purposes of compliance with Sections 291 and 304 of the California Health and Safety Code, rhesus (Rh) blood typing (as defined in Title 17, California Administrative Code, Chapter 2, Subchapter 1, Group 1, Section 1002, Number 3, [Determination of Rh type]) shall consist of D and if this is negative, D<>u typing.
Note: Additional authority cited: Sections 290-293 and 304-305, Health and Safety Code.
s 1057. Prenatal Blood Typing Reports.
Licensed clinical laboratories or approved public health laboratories performing tests on pregnant women as required by Sections 290 and 291 of the California Health and Safety Code shall provide the requesting physician with a copy of the report to be stamped or imprinted as follows: "State law requires that the woman tested be informed as to the rhesus (Rh) typing test results."
Every licensed physician and surgeon or other person engaged in the prenatal care of a pregnant woman, or attending such woman at time of delivery after receiving such report, shall be responsible for notifying the woman tested of the results of the test.
s 1060. Definitions: Cytotechnologist License.
(a) The definitions in subsections (b) though (i) shall govern the interpretation of this article.
(b) "Competency testing service or program" means an organization that has been approved by the Department pursuant to section 1270 of the California Business and Professions Code to administer a cytotechnology competency examination.
(c) "Cytotechnologist competency examination" means an examination which evaluates a person's entry level skills and abilities in cytotechnology, including his or her understanding of: (1) the underlying scientific principles, technical and procedural aspects of cytotechnology; (2) the identification of cellular changes in gynecological and non-gynecological specimens through both a written and visual component; (3) cytopreparatory techniques; and (4) cytology laboratory operations; and which include the following subject areas in the following ratios: 48% to 52% female reproductive system (to include both the genital system and breast); 13% to 17% respiratory system; 9% to 12% male and female genitourinary systems; 6% to 10% alimentary system; and 13% to 17% body cavity fluids and other body sites.
(d) "Entry Level Skills" means the following skills and abilities expected at career entry:
(1) Knowledge and understanding of: (continued)