California 2021-2022 Regular Session

California Assembly Bill AB2326 Compare Versions

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1-Assembly Bill No. 2326 CHAPTER 528An act to amend Section 124130 of the Health and Safety Code, relating to health. [ Approved by Governor September 25, 2022. Filed with Secretary of State September 25, 2022. ] LEGISLATIVE COUNSEL'S DIGESTAB 2326, Reyes. Lead poisoning prevention: laboratory reporting.Existing law, the Childhood Lead Poisoning Prevention Act of 1991, requires the State Department of Public Health to adopt regulations establishing a standard of care at least as stringent as the most recent federal Centers for Disease Control and Prevention (CDC) screening guidelines, whereby all children are evaluated for risk of lead poisoning by health care providers during each childs periodic health assessment. Existing law requires a laboratory that performs a blood lead analysis on a specimen of human blood drawn in California to report specified information to the State Department of Public Health for each analysis on every person tested and requires other specified information to be reported when the laboratory has that information. Existing law authorizes the department to fine a laboratory that knowingly fails to meet the reporting requirements.This bill would, beginning on July 1, 2023, require the laboratory to report additional information, including the National Provider Identifier (NPI) of the health care provider that ordered the analysis, the Clinical Laboratory Improvement Amendments (CLIA) number and the NPI of the laboratory, and the persons race, ethnicity, and pregnancy status. The bill would require a laboratory to request all of the required information from the health care provider who obtained the blood sample or ordered the test, but would waive the laboratorys reporting requirement when the health care provider cannot, or will not, provide the requested information.Existing law requires the laboratory to report within 3 working days if the result of the blood lead analysis is a blood lead level equal to or greater than 10 micrograms of lead per deciliter of blood and within 30 working days if the blood lead level is lower that threshold.This bill would make the threshold for reporting within 3 working days the most recent CDC reference level for an elevated blood lead level.Existing law requires that all information reported be confidential, except that the department is authorized to share the information for the purpose of surveillance, case management, investigation, environmental assessment, environmental remediation, or abatement with the local health department, environmental health agency, or building department, and 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.This bill would authorize the department to share the information for purposes of care coordination as well. The bill would authorize the department to share the information with specified health care providers and with the person to whom the information pertains, with the voluntary written consent of the person to whom the information pertains or the person authorized to give consent on behalf of the individual, and when required by state or federal law, or court order. The bill would also authorize the department to share the information for research, as specified.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 124130 of the Health and Safety Code is amended to read:124130. (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 persons birth date.(D) The persons 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 persons 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 persons sex.(K) The persons race and ethnicity.(L) The persons pregnancy status. (M) The name, address, and telephone number of the persons 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 childs 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 departments 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 beneficiarys 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 patients 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.
1+Enrolled August 24, 2022 Passed IN Senate August 18, 2022 Passed IN Assembly August 22, 2022 Amended IN Senate August 08, 2022 Amended IN Senate June 21, 2022 Amended IN Assembly May 02, 2022 CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Assembly Bill No. 2326Introduced by Assembly Members Reyes and Cristina Garcia(Coauthor: Assembly Member Salas)(Coauthors: Senators Durazo, Gonzalez, and Rubio)February 16, 2022An act to amend Section 124130 of the Health and Safety Code, relating to health. LEGISLATIVE COUNSEL'S DIGESTAB 2326, Reyes. Lead poisoning prevention: laboratory reporting.Existing law, the Childhood Lead Poisoning Prevention Act of 1991, requires the State Department of Public Health to adopt regulations establishing a standard of care at least as stringent as the most recent federal Centers for Disease Control and Prevention (CDC) screening guidelines, whereby all children are evaluated for risk of lead poisoning by health care providers during each childs periodic health assessment. Existing law requires a laboratory that performs a blood lead analysis on a specimen of human blood drawn in California to report specified information to the State Department of Public Health for each analysis on every person tested and requires other specified information to be reported when the laboratory has that information. Existing law authorizes the department to fine a laboratory that knowingly fails to meet the reporting requirements.This bill would, beginning on July 1, 2023, require the laboratory to report additional information, including the National Provider Identifier (NPI) of the health care provider that ordered the analysis, the Clinical Laboratory Improvement Amendments (CLIA) number and the NPI of the laboratory, and the persons race, ethnicity, and pregnancy status. The bill would require a laboratory to request all of the required information from the health care provider who obtained the blood sample or ordered the test, but would waive the laboratorys reporting requirement when the health care provider cannot, or will not, provide the requested information.Existing law requires the laboratory to report within 3 working days if the result of the blood lead analysis is a blood lead level equal to or greater than 10 micrograms of lead per deciliter of blood and within 30 working days if the blood lead level is lower that threshold.This bill would make the threshold for reporting within 3 working days the most recent CDC reference level for an elevated blood lead level.Existing law requires that all information reported be confidential, except that the department is authorized to share the information for the purpose of surveillance, case management, investigation, environmental assessment, environmental remediation, or abatement with the local health department, environmental health agency, or building department, and 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.This bill would authorize the department to share the information for purposes of care coordination as well. The bill would authorize the department to share the information with specified health care providers and with the person to whom the information pertains, with the voluntary written consent of the person to whom the information pertains or the person authorized to give consent on behalf of the individual, and when required by state or federal law, or court order. The bill would also authorize the department to share the information for research, as specified.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 124130 of the Health and Safety Code is amended to read:124130. (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 persons birth date.(D) The persons 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 persons 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 persons sex.(K) The persons race and ethnicity.(L) The persons pregnancy status. (M) The name, address, and telephone number of the persons 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 childs 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 departments 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 beneficiarys 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 patients 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.
22
3- Assembly Bill No. 2326 CHAPTER 528An act to amend Section 124130 of the Health and Safety Code, relating to health. [ Approved by Governor September 25, 2022. Filed with Secretary of State September 25, 2022. ] LEGISLATIVE COUNSEL'S DIGESTAB 2326, Reyes. Lead poisoning prevention: laboratory reporting.Existing law, the Childhood Lead Poisoning Prevention Act of 1991, requires the State Department of Public Health to adopt regulations establishing a standard of care at least as stringent as the most recent federal Centers for Disease Control and Prevention (CDC) screening guidelines, whereby all children are evaluated for risk of lead poisoning by health care providers during each childs periodic health assessment. Existing law requires a laboratory that performs a blood lead analysis on a specimen of human blood drawn in California to report specified information to the State Department of Public Health for each analysis on every person tested and requires other specified information to be reported when the laboratory has that information. Existing law authorizes the department to fine a laboratory that knowingly fails to meet the reporting requirements.This bill would, beginning on July 1, 2023, require the laboratory to report additional information, including the National Provider Identifier (NPI) of the health care provider that ordered the analysis, the Clinical Laboratory Improvement Amendments (CLIA) number and the NPI of the laboratory, and the persons race, ethnicity, and pregnancy status. The bill would require a laboratory to request all of the required information from the health care provider who obtained the blood sample or ordered the test, but would waive the laboratorys reporting requirement when the health care provider cannot, or will not, provide the requested information.Existing law requires the laboratory to report within 3 working days if the result of the blood lead analysis is a blood lead level equal to or greater than 10 micrograms of lead per deciliter of blood and within 30 working days if the blood lead level is lower that threshold.This bill would make the threshold for reporting within 3 working days the most recent CDC reference level for an elevated blood lead level.Existing law requires that all information reported be confidential, except that the department is authorized to share the information for the purpose of surveillance, case management, investigation, environmental assessment, environmental remediation, or abatement with the local health department, environmental health agency, or building department, and 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.This bill would authorize the department to share the information for purposes of care coordination as well. The bill would authorize the department to share the information with specified health care providers and with the person to whom the information pertains, with the voluntary written consent of the person to whom the information pertains or the person authorized to give consent on behalf of the individual, and when required by state or federal law, or court order. The bill would also authorize the department to share the information for research, as specified.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO
3+ Enrolled August 24, 2022 Passed IN Senate August 18, 2022 Passed IN Assembly August 22, 2022 Amended IN Senate August 08, 2022 Amended IN Senate June 21, 2022 Amended IN Assembly May 02, 2022 CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION Assembly Bill No. 2326Introduced by Assembly Members Reyes and Cristina Garcia(Coauthor: Assembly Member Salas)(Coauthors: Senators Durazo, Gonzalez, and Rubio)February 16, 2022An act to amend Section 124130 of the Health and Safety Code, relating to health. LEGISLATIVE COUNSEL'S DIGESTAB 2326, Reyes. Lead poisoning prevention: laboratory reporting.Existing law, the Childhood Lead Poisoning Prevention Act of 1991, requires the State Department of Public Health to adopt regulations establishing a standard of care at least as stringent as the most recent federal Centers for Disease Control and Prevention (CDC) screening guidelines, whereby all children are evaluated for risk of lead poisoning by health care providers during each childs periodic health assessment. Existing law requires a laboratory that performs a blood lead analysis on a specimen of human blood drawn in California to report specified information to the State Department of Public Health for each analysis on every person tested and requires other specified information to be reported when the laboratory has that information. Existing law authorizes the department to fine a laboratory that knowingly fails to meet the reporting requirements.This bill would, beginning on July 1, 2023, require the laboratory to report additional information, including the National Provider Identifier (NPI) of the health care provider that ordered the analysis, the Clinical Laboratory Improvement Amendments (CLIA) number and the NPI of the laboratory, and the persons race, ethnicity, and pregnancy status. The bill would require a laboratory to request all of the required information from the health care provider who obtained the blood sample or ordered the test, but would waive the laboratorys reporting requirement when the health care provider cannot, or will not, provide the requested information.Existing law requires the laboratory to report within 3 working days if the result of the blood lead analysis is a blood lead level equal to or greater than 10 micrograms of lead per deciliter of blood and within 30 working days if the blood lead level is lower that threshold.This bill would make the threshold for reporting within 3 working days the most recent CDC reference level for an elevated blood lead level.Existing law requires that all information reported be confidential, except that the department is authorized to share the information for the purpose of surveillance, case management, investigation, environmental assessment, environmental remediation, or abatement with the local health department, environmental health agency, or building department, and 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.This bill would authorize the department to share the information for purposes of care coordination as well. The bill would authorize the department to share the information with specified health care providers and with the person to whom the information pertains, with the voluntary written consent of the person to whom the information pertains or the person authorized to give consent on behalf of the individual, and when required by state or federal law, or court order. The bill would also authorize the department to share the information for research, as specified.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NO
44
5- Assembly Bill No. 2326 CHAPTER 528
5+ Enrolled August 24, 2022 Passed IN Senate August 18, 2022 Passed IN Assembly August 22, 2022 Amended IN Senate August 08, 2022 Amended IN Senate June 21, 2022 Amended IN Assembly May 02, 2022
66
7- Assembly Bill No. 2326
7+Enrolled August 24, 2022
8+Passed IN Senate August 18, 2022
9+Passed IN Assembly August 22, 2022
10+Amended IN Senate August 08, 2022
11+Amended IN Senate June 21, 2022
12+Amended IN Assembly May 02, 2022
813
9- CHAPTER 528
14+ CALIFORNIA LEGISLATURE 20212022 REGULAR SESSION
15+
16+ Assembly Bill
17+
18+No. 2326
19+
20+Introduced by Assembly Members Reyes and Cristina Garcia(Coauthor: Assembly Member Salas)(Coauthors: Senators Durazo, Gonzalez, and Rubio)February 16, 2022
21+
22+Introduced by Assembly Members Reyes and Cristina Garcia(Coauthor: Assembly Member Salas)(Coauthors: Senators Durazo, Gonzalez, and Rubio)
23+February 16, 2022
1024
1125 An act to amend Section 124130 of the Health and Safety Code, relating to health.
12-
13- [ Approved by Governor September 25, 2022. Filed with Secretary of State September 25, 2022. ]
1426
1527 LEGISLATIVE COUNSEL'S DIGEST
1628
1729 ## LEGISLATIVE COUNSEL'S DIGEST
1830
1931 AB 2326, Reyes. Lead poisoning prevention: laboratory reporting.
2032
2133 Existing law, the Childhood Lead Poisoning Prevention Act of 1991, requires the State Department of Public Health to adopt regulations establishing a standard of care at least as stringent as the most recent federal Centers for Disease Control and Prevention (CDC) screening guidelines, whereby all children are evaluated for risk of lead poisoning by health care providers during each childs periodic health assessment. Existing law requires a laboratory that performs a blood lead analysis on a specimen of human blood drawn in California to report specified information to the State Department of Public Health for each analysis on every person tested and requires other specified information to be reported when the laboratory has that information. Existing law authorizes the department to fine a laboratory that knowingly fails to meet the reporting requirements.This bill would, beginning on July 1, 2023, require the laboratory to report additional information, including the National Provider Identifier (NPI) of the health care provider that ordered the analysis, the Clinical Laboratory Improvement Amendments (CLIA) number and the NPI of the laboratory, and the persons race, ethnicity, and pregnancy status. The bill would require a laboratory to request all of the required information from the health care provider who obtained the blood sample or ordered the test, but would waive the laboratorys reporting requirement when the health care provider cannot, or will not, provide the requested information.Existing law requires the laboratory to report within 3 working days if the result of the blood lead analysis is a blood lead level equal to or greater than 10 micrograms of lead per deciliter of blood and within 30 working days if the blood lead level is lower that threshold.This bill would make the threshold for reporting within 3 working days the most recent CDC reference level for an elevated blood lead level.Existing law requires that all information reported be confidential, except that the department is authorized to share the information for the purpose of surveillance, case management, investigation, environmental assessment, environmental remediation, or abatement with the local health department, environmental health agency, or building department, and 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.This bill would authorize the department to share the information for purposes of care coordination as well. The bill would authorize the department to share the information with specified health care providers and with the person to whom the information pertains, with the voluntary written consent of the person to whom the information pertains or the person authorized to give consent on behalf of the individual, and when required by state or federal law, or court order. The bill would also authorize the department to share the information for research, as specified.
2234
2335 Existing law, the Childhood Lead Poisoning Prevention Act of 1991, requires the State Department of Public Health to adopt regulations establishing a standard of care at least as stringent as the most recent federal Centers for Disease Control and Prevention (CDC) screening guidelines, whereby all children are evaluated for risk of lead poisoning by health care providers during each childs periodic health assessment. Existing law requires a laboratory that performs a blood lead analysis on a specimen of human blood drawn in California to report specified information to the State Department of Public Health for each analysis on every person tested and requires other specified information to be reported when the laboratory has that information. Existing law authorizes the department to fine a laboratory that knowingly fails to meet the reporting requirements.
2436
2537 This bill would, beginning on July 1, 2023, require the laboratory to report additional information, including the National Provider Identifier (NPI) of the health care provider that ordered the analysis, the Clinical Laboratory Improvement Amendments (CLIA) number and the NPI of the laboratory, and the persons race, ethnicity, and pregnancy status. The bill would require a laboratory to request all of the required information from the health care provider who obtained the blood sample or ordered the test, but would waive the laboratorys reporting requirement when the health care provider cannot, or will not, provide the requested information.
2638
2739 Existing law requires the laboratory to report within 3 working days if the result of the blood lead analysis is a blood lead level equal to or greater than 10 micrograms of lead per deciliter of blood and within 30 working days if the blood lead level is lower that threshold.
2840
2941 This bill would make the threshold for reporting within 3 working days the most recent CDC reference level for an elevated blood lead level.
3042
3143 Existing law requires that all information reported be confidential, except that the department is authorized to share the information for the purpose of surveillance, case management, investigation, environmental assessment, environmental remediation, or abatement with the local health department, environmental health agency, or building department, and 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.
3244
3345 This bill would authorize the department to share the information for purposes of care coordination as well. The bill would authorize the department to share the information with specified health care providers and with the person to whom the information pertains, with the voluntary written consent of the person to whom the information pertains or the person authorized to give consent on behalf of the individual, and when required by state or federal law, or court order. The bill would also authorize the department to share the information for research, as specified.
3446
3547 ## Digest Key
3648
3749 ## Bill Text
3850
3951 The people of the State of California do enact as follows:SECTION 1. Section 124130 of the Health and Safety Code is amended to read:124130. (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 persons birth date.(D) The persons 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 persons 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 persons sex.(K) The persons race and ethnicity.(L) The persons pregnancy status. (M) The name, address, and telephone number of the persons 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 childs 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 departments 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 beneficiarys 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 patients 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.
4052
4153 The people of the State of California do enact as follows:
4254
4355 ## The people of the State of California do enact as follows:
4456
4557 SECTION 1. Section 124130 of the Health and Safety Code is amended to read:124130. (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 persons birth date.(D) The persons 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 persons 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 persons sex.(K) The persons race and ethnicity.(L) The persons pregnancy status. (M) The name, address, and telephone number of the persons 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 childs 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 departments 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 beneficiarys 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 patients 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.
4658
4759 SECTION 1. Section 124130 of the Health and Safety Code is amended to read:
4860
4961 ### SECTION 1.
5062
5163 124130. (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 persons birth date.(D) The persons 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 persons 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 persons sex.(K) The persons race and ethnicity.(L) The persons pregnancy status. (M) The name, address, and telephone number of the persons 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 childs 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 departments 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 beneficiarys 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 patients 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.
5264
5365 124130. (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 persons birth date.(D) The persons 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 persons 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 persons sex.(K) The persons race and ethnicity.(L) The persons pregnancy status. (M) The name, address, and telephone number of the persons 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 childs 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 departments 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 beneficiarys 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 patients 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.
5466
5567 124130. (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 persons birth date.(D) The persons 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 persons 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 persons sex.(K) The persons race and ethnicity.(L) The persons pregnancy status. (M) The name, address, and telephone number of the persons 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 childs 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 departments 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 beneficiarys 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 patients 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.
5668
5769
5870
5971 124130. (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.
6072
6173 (b) (1) The analyzing laboratory shall report all of the following:
6274
6375 (A) The test results in micrograms of lead per deciliter.
6476
6577 (B) The name of the person tested.
6678
6779 (C) The persons birth date.
6880
6981 (D) The persons address, including the ZIP Code, and telephone number.
7082
7183 (E) The name, address, telephone number, and National Provider Identifier (NPI) of the health care provider that ordered the analysis.
7284
7385 (F) The name, address, telephone number, Clinical Laboratory Improvement Amendments (CLIA) number, and NPI of the analyzing laboratory.
7486
7587 (G) The accession number of the specimen.
7688
7789 (H) The date the analysis was performed.
7890
7991 (I) The persons Medi-Cal client identification number (CIN) or, for other health plans, the name of the health plan and the medical plan identification number.
8092
8193 (J) The persons sex.
8294
8395 (K) The persons race and ethnicity.
8496
8597 (L) The persons pregnancy status.
8698
8799 (M) The name, address, and telephone number of the persons employer, if any.
88100
89101 (N) The date the specimen was drawn.
90102
91103 (O) The source of the specimen, specified as venous, capillary, arterial, cord blood, or other.
92104
93105 (P) The name, address, telephone number, and CLIA number of the referring laboratory, if any.
94106
95107 (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.
96108
97109 (2) The changes made to this subdivision by the act adding this paragraph shall become operative on July 1, 2023.
98110
99111 (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.
100112
101113 (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.
102114
103115 (e) A report required by this section shall be submitted by electronic transfer.
104116
105117 (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:
106118
107119 (1) To the individual to whom the information pertains.
108120
109121 (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 childs parent or guardian.
110122
111123 (3) When required by state or federal law.
112124
113125 (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.
114126
115127 (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.
116128
117129 (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 departments 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.
118130
119131 (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.
120132
121133 (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 beneficiarys health care provider to proactively offer and coordinate care and treatment services and administer payment programs.
122134
123135 (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.
124136
125137 (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.
126138
127139 (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.
128140
129141 (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.
130142
131143 (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:
132144
133145 (1) The test sample was sent to the laboratory by another health care provider.
134146
135147 (2) The laboratory requested the information from the health care provider who obtained the sample.
136148
137149 (3) The health care provider who obtained the sample and sent it to the laboratory failed to provide the patients information.
138150
139151 (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.