§ 4119.10
504 words·~2 min read·
/ca/business-and-professions-code/4119-10A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
A pharmacy located in the state may use pharmacists to perform FDA-approved or -authorized tests that are classified as waived pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a) and the regulations adopted thereunder by the federal Health Care Financing Administration, under all of the following conditions:
(a)The pharmacy is appropriately licensed as a laboratory under Section 1265.
(b)The pharmacy maintains policies and procedures that do all of the following:
(1)Establish the initial training requirements, including specimen collection techniques relevant to a test being performed at the pharmacy, and ongoing training.
(2)Establish safety precautions necessary to protect pharmacy staff and consumers and to reduce the risk of transmission, consistent with Cal-OSHA and CDC requirements, including, but not limited to, provisions for the use of personal protective equipment, cleaning and sanitizing procedures, appropriate biohazard waste requirements, and space requirements for pharmacy staff and consumers.
(3)Ensure the availability of dedicated physically distanced space or other segregated space that provides for privacy during the testing process and private consultation with the pharmacist, and limits potential contamination of other consumers in the pharmacy.
(4)Establish requirements for providing test results to the patient in a nonverbal manner, complying with mandatory reporting requirements to local and state reporting systems, and notifying the patient’s health care providers if consent is provided, and referral to licensed sources of care for confirmation, diagnosis, and treatment as appropriate for followup to positive test results. A health care provider shall not be held personally liable for test results, or for any actions or inactions related to test results they did not receive, have knowledge of, or otherwise have access to.
(5)Establish requirements for the pharmacist-in-charge serving as the pharmacy laboratory director to report any reportable disease or condition identified in Section 120130 of the Health and Safety Code or the regulations adopted under that section.
(6)Ensure documentation of testing equipment maintenance and calibration.
(7)Ensure appropriate storage and handling of specimens, testing reagents, and other supplies or equipment that require specialized storage or handling. Specimen collection shall not include vaginal swab, venipuncture, or the collection of seminal fluid.
(c)The test is authorized to be administered by a pharmacist pursuant to paragraph
(1)of subdivision
(b)of Section 4052.4.
(d)The pharmacist-in-charge does both of the following:
(1)Annually reviews the policies and procedures maintained pursuant to subdivision (b), assesses the pharmacy’s compliance with its policies, and documents corrective actions to be taken when noncompliance is found.
(2)Maintains documentation of the annual review and assessment in a readily retrievable format for a period of three years from the date of completion.
(e)The pharmacy maintains documentation related to performing tests that demonstrates compliance with this section, which shall include the name of the pharmacist performing the test, the results of the test, and communication of results to a patient’s primary medical provider, and is maintained in a readily retrievable format for a period of three years from the date of creation.