(a) Each provider that dispenses, as defined in Section 4024 of the Business and Professions Code, or that furnishes, as defined in Section 4026 of the Business and Professions Code, a controlled drug, a dangerous drug, or a dangerous device to a Medi-Cal beneficiary, or a drug or device requiring a written order or prescription for the drug or device to be covered under the Medi-Cal program, or who obtains a biological specimen from a Medi-Cal beneficiary for the performance of a clinical laboratory test or examination shall maintain a record of the signature of the person receiving the drug or device or from whom a biological specimen was obtained; the printed name of the recipient or person from whom the biological specimen was obtained; the date signed; for a drug or device, the prescription number or a description of the item or items dispensed or furnished; and if the recipient is not the beneficiary for whom the drug or device was ordered or prescribed or from whom a biological specimen was obtained, a notation of the recipient’s relationship to that beneficiary. The signature and printed name of the person from whom a biological specimen is obtained on the requisition provided to the clinical laboratory for performance of the test or examination for which the specimen was obtained shall be sufficient to comply with this section if a copy of the signed requisition is kept by the provider obtaining the biological specimen. Furthermore, no signature is required under this section where the biological specimen is obtained for the purpose of anatomical pathology examinations performed during the inpatient or outpatient surgery if a notation of the performance of the anatomical pathology examination appears in the medical record.
(b) For purposes of this section:
(1) “Biological specimen” shall have the same meaning as in Section 1206 of the Business and Professions Code.
(2) “Clinical laboratory test or examination” shall have the same meaning as in Section 1206 of the Business and Professions Code.
(3) “Controlled substance” shall mean any substance listed in Chapter 2 (commencing with Section 11053) of Division 10 of the Health and Safety Code.
(4) “Dangerous drug” or “dangerous device” has the same meaning as in Section 4022 of the Business and Professions Code.
(5) “Drug or device” means:
(A) “Drug,” as defined in Section 4025 of the Business and Professions Code.
(B) “Device,” as defined in Section 4023 of the Business and Professions Code.
(C) Pharmaceuticals, medical equipment, medical supplies, orthotics and prosthetics appliances, and other product-like supplies or equipment.
(c) Nothing in this section shall require a provider who dispenses or furnishes a complimentary sample of a dangerous drug to maintain the signature of the person receiving that drug, provided no charge is made to the patient, and an appropriate record is entered in the patient’s chart.
(d) If the dispensing or furnishing of a drug or device occurs on a periodic basis within an established provider-patient relationship, the signature shall only be required upon the initial dispensing or furnishing of the drug, so long as an appropriate record of each dispensing or furnishing is entered in the patient’s chart.
(e) If the obtaining of a biological specimen is required in order that a test or examination occur on a periodic basis within an established provider-patient relationship, the signature shall only be required upon obtaining the biological specimen necessary for the initial test or examination so long as an appropriate record of each test or examination is entered in the patient’s chart.
(f) The requirement of this section to obtain a signature shall not apply to a licensed pharmacy or clinical laboratory that is owned and operated by a nonprofit health care service plan that has at least 3,500,000 enrollees or that is owned and operated by a nonprofit hospital corporation that has a mutually exclusive contract with a nonprofit health care service plan that has at least 3,500,000 enrollees, or to a licensed provider who practices within a physician organization that meets either of the requirements set forth in paragraph (2) of subdivision (g) of Section 1375.4 of the Health and Safety Code.
(Added by Stats. 2003, Ch. 601, Sec. 8. Effective January 1, 2004.)
Last modified: October 25, 2018