(a) Nothing in this chapter shall restrict, limit, or prevent a program of nondiagnostic general health assessment provided that:
(1) The program meets the requirements of Section 1265 and complies with the requirements of CLIA for waived testing.
(2) The purpose of the program is to screen asymptomatic individuals for chronic health disorders and to refer individuals to licensed sources of care as indicated.
(3) The program does not test for human immunodeficiency virus or any reportable disease or condition identified in Section 120130 of the Health and Safety Code or the regulations adopted under that section.
(4) The program utilizes only those devices that comply with all of the following:
(A) Meet all applicable state and federal performance standards pursuant to Section 111245 of the Health and Safety Code.
(B) Are not adulterated as specified in Article 2 (commencing with Section 111250) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.
(C) Are not misbranded as specified in Article 3 (commencing with Section 111330) of Chapter 6 of Part 5 of Division 104 of the Health and Safety Code.
(D) Are not new devices unless they meet the requirements of Section 111550 of the Health and Safety Code.
(E) Are approved as waived tests and are used according to the manufacturer’s instructions.
(5) Blood collection is performed by skin puncture only.
(6) Testing of a urine specimen is performed by the dipstick method only.
(7) Testing is performed on site and reported directly to the person requesting the test.
(8) The program maintains a supervisory committee consisting of, at a minimum, a licensed physician and surgeon and a clinical laboratory scientist licensed pursuant to this code.
(9) The supervisory committee for the program adopts written protocols that shall be followed in the program and that shall contain all of the following:
(A) Provision of written information to individuals to be assessed that shall include, but not be limited to, the following:
(i) The potential risks and benefits of assessment procedures to be performed in the program.
(ii) The limitations, including the nondiagnostic nature, of assessment examinations of biological specimens performed in the program.
(iii) Information regarding the risk factors or markers targeted by the program.
(iv) The need for followup with licensed sources of care for confirmation, diagnosis, and treatment as appropriate.
(B) Proper use of each device utilized in the program including the operation of analyzers, maintenance of equipment and supplies, and performance of quality control procedures including the determination of both accuracy and reproducibility of measurements in accordance with instructions provided by the manufacturer of the assessment device used.
(C) Proper procedures to be employed when collecting blood, if blood specimens are to be obtained.
(D) Proper procedures to be employed in handling and disposing of all biological specimens to be obtained and material contaminated by those biological specimens. These procedures shall comply with all county and city ordinances for medical waste management and blood-borne pathogen control that apply to the location where the program operates.
(E) Proper procedures to be employed in response to fainting, excessive bleeding, or other medical emergencies.
(F) Documentation that the testing personnel are following the instructions of the instrument’s manufacturer, are trained in the performance of the test, and are competent to perform the testing without supervision.
(G) Reporting of assessment results to the individual being assessed.
(H) Referral and followup to licensed sources of care as indicated.
The written protocols adopted by the supervisory committee shall be maintained for at least one year following completion of the assessment program during which period they shall be subject to review by department personnel and the local health officer or his or her designee, including the public health laboratory director.
(b) If skin puncture to obtain a blood specimen is to be performed in a program of nondiagnostic general health assessment, the individual performing the skin puncture shall be authorized to perform skin puncture under this chapter.
(c) A program of nondiagnostic general health assessment that fails to meet the requirements set forth in subdivisions (a) and (b) shall not operate.
(d) For purposes of this section, “skin puncture” means the collection of a blood specimen by the finger prick method only and does not include venipuncture, arterial puncture, or any other procedure for obtaining a blood specimen.
(e) Nothing in this chapter shall be interpreted as prohibiting a licensed clinical laboratory from operating a program of nondiagnostic general health assessment provided that the clinical laboratory complies with the requirements of this section.
(f) A program for a health fair providing diagnostic or screening tests is not a nondiagnostic general health assessment program if all of the requirements of this chapter are met, and the laboratory performing the testing is licensed or registered under subdivision (a) of Section 1265. For a test that is not authorized for self-ordering pursuant to Section 1246.5 and that is not for a nondiagnostic general health assessment pursuant to this section, the licensed or registered clinical laboratory participating in the health fair shall assure that the test is ordered on-site only by a person licensed under this division who is authorized under his or her scope of practice to order the test or by a person authorized by that licensee. The results of a test performed at a health fair shall be provided to the test subject along with an explanation of the results.
(Amended by Stats. 2004, Ch. 450, Sec. 3. Effective January 1, 2005.)
Last modified: October 25, 2018