California § 124130 - A laboratory that performs a blood lead analysis on a specimen of human blood dra

§ 124130. A laboratory that performs a blood lead analysis on a specimen of human blood dra

(a) A laboratory that performs a blood lead analysis on a specimen of human blood drawn in California shall report the information specified in this section to the department for each analysis on every person tested. (b) (1) The analyzing laboratory shall report all of the following: (A) The test results in micrograms of lead per deciliter. (B) The name of the person tested. (C) The person’s birth date. (D) The person’s address, including the ZIP Code, and telephone number. (E) The name, address, telephone number, and National Provider Identifier (NPI) of the health care provider that ordered the analysis. (F) The name, address, telephone number, Clinical Laboratory Improvement Amendments (CLIA) number, and NPI of the analyzing laboratory. (G) The accession number of the specimen. (H) The date the analysis was performed. (I) The person’s Medi-Cal client identification number (CIN) or, for other health plans, the name of the health plan and the medical plan identification number. (J) The person’s sex. (K) The person’s race and ethnicity. (L) The person’s pregnancy status. (M) The name, address, and telephone number of the person’s employer, if any. (N) The date the specimen was drawn. (O) The source of the specimen, specified as venous, capillary, arterial, cord blood, or other. (P) The name, address, telephone number, and CLIA number of the referring laboratory, if any. (Q) The testing methodology used for blood lead analysis specified as point of care, inductively coupled plasma mass spectrometry, graphite furnace atomic spectroscopy, or other. (2) The changes made to this subdivision by the act adding this paragraph shall become operative on July 1, 2023. (c) The analyzing laboratory may report to the department other information that directly relates to the blood lead analysis or to the identity, location, health care management, or environmental management of the person tested. (d) If the result of the blood lead analysis is a blood lead level equal to or greater than the most recent federal Centers for Disease Control and Prevention (CDC) reference level for an elevated blood lead level (BLL), the report required by this section shall be submitted within three working days of the analysis. If the result is less than the CDC reference level for an elevated BLL, the report required by this section shall be submitted within 30 calendar days of the analysis. Timing of reporting shall be based on rounding of results to the nearest whole number. (e) A report required by this section shall be submitted by electronic transfer. (f) All information reported pursuant to this section shall be confidential, as provided in Section 100330, except that the department may share the information as follows: (1) To the individual to whom the information pertains. (2) With the prior written voluntary consent of the individual to whom the information pertains or the person authorized to give consent on behalf of the individual, such as a child’s parent or guardian. (3) When required by state or federal law. (4) When compelled by an order of the court or an administrative hearing officer, if a protective order that prohibits any further disclosure is secured prior to disclosure. (5) For the purpose of surveillance, case management, coordination of care, investigation, environmental assessment, environmental remediation, or abatement with the local health department, environmental health agency authorized pursuant to Section 101275, building department, health care providers treating patients with elevated blood levels or receiving case management services, or a federal, state, or local governmental agency. (6) For research, as defined in Part 46 of Title 45 of the Code of Federal Regulations, as may be amended, if the request for information is approved by the Committee for the Protection of Human Subjects (CPHS) for the California Health and Human Services Agency, the requesting entity provides documentation to the department that demonstrates, to the department’s satisfaction, that the entity has established the procedures and ability to maintain the confidentiality of the information, and the requesting entity has agreed, in writing, to maintain the confidentiality of the information. (7) With the State Department of Health Care Services for the purpose of determining whether children enrolled in Medi-Cal are being screened for lead poisoning and receiving appropriate related services. (g) (1) The State Department of Health Care Services and health care providers may further disclose the information reported pursuant to this section to a managed health care plan in which a beneficiary who is the subject of the information is enrolled, who may further disclose this information to the beneficiary’s health care provider to proactively offer and coordinate care and treatment services and administer payment programs. (2) The local health department, environmental health agency, building department, researcher, or federal, state, or local governmental entity shall not further disclose the information and shall otherwise maintain the confidentiality of the information in the manner provided in Section 100330. (3) Notwithstanding any other law, a disclosure authorized pursuant to this section, except to the State Department of Health Care Services and to health care providers, shall include only the information necessary for the stated purpose of the requested disclosure, be used only for the approved purpose, and not be further disclosed. (4) The State Department of Health Care Services and health care providers shall use, disclose, and maintain the confidentiality of information shared with it pursuant to this subdivision in accordance with the federal Health Insurance Portability and Accountability Act of 1996, as may be amended, and pursuant to regulations promulgated thereto, and other laws applicable to information in possession of the State Department of Health Care Services and health care providers. (h) The director may assess a fine up to five hundred dollars ($500) against a laboratory that knowingly fails to meet the reporting requirements of this section. (i) A laboratory shall not be fined or otherwise penalized for failure to provide the patient information required by this section if the result of the blood lead analysis is a blood lead level less than the most recent CDC reference level for an elevated BLL and if all of the following circumstances exist: (1) The test sample was sent to the laboratory by another health care provider. (2) The laboratory requested the information from the health care provider who obtained the sample. (3) The health care provider who obtained the sample and sent it to the laboratory failed to provide the patient’s information. (j) A laboratory shall request from the health care provider who obtained the blood sample or ordered the test all information required by this section, as applicable. If the health care provider cannot, or will not, provide the requested information, the laboratory is not required to report the information.