Cal. Code Regs. Tit. 17, § 2643.10 - HIV Reporting by Laboratories

(a) The laboratory director or authorized designee shall, within seven calendar days of determining a confirmed HIV test, report the confirmed HIV test to the Health Officer for the local health jurisdiction where the health care provider facility is located. The report shall include the:

(1) Complete name of patient; and

(2) Patient date of birth (2-digit month, 2-digit day, 4-digit year); and

(3) Patient gender (male, female, transgender male-to-female, or transgender female-to-male); and

(4) Name, address, and telephone number of the health care provider and the facility that submitted the biological specimen to the laboratory, if different; and

(5) Name, address, and telephone number of the laboratory; and

(6) Laboratory report number as assigned by the laboratory; and

(7) Laboratory results of the test performed; and

(8) Date the biological specimen was tested in the laboratory; and

(9) Laboratory Clinical Laboratory Improvement Amendments (CLIA) number.

(b)

(1) All reports containing personal information, including laboratory reports, shall be sent to the local Health Officer or his or her designee by:

(A) Courier service, U.S. Postal Service Express or Registered mail, or other traceable mail; or

(B) Person-to-person transfer with the local Health Officer or his or her designee; or

(C) Provided that, commencing July 1, 2009, or within one year of the establishment of a state electronic laboratory reporting system, whichever is later, a report generated pursuant to Section 120130, or Section 121022, by a laboratory shall be submitted electronically in a manner specified by the department.

(2) The laboratory shall not submit reports containing personal information to the local Health Officer or his or her designee by electronic facsimile transmission or by electronic mail or by non-traceable mail.

(c) A laboratory that receives incomplete patient data from a health care provider for a biological specimen with a confirmed HIV test, shall contact the submitting health care provider to obtain the information required pursuant to Section 2643.5(b)(1)-(5), prior to reporting the confirmed HIV test to the local Health Officer.

(d) If a laboratory transfers a biological specimen to another laboratory for testing, the laboratory that first receives the biological specimen from the health care provider shall report confirmed HIV tests to the local Health Officer.

(e) Laboratories shall not submit reports to the local health department for confirmed HIV tests for patients of an Alternative Testing Site or other anonymous HIV testing program, a blood bank, a plasma center, or for participants of a blinded and/or unlinked seroprevalence study.

(f) When a California laboratory receives a biological specimen for testing from an out-of-state laboratory or health care provider, the California director of the laboratory shall ensure that a confirmed HIV test is reported to the state health department in the state where the biological specimen originated.

(g) When a California laboratory receives a report from an out of state laboratory that indicates evidence of a confirmed HIV test for a California patient, the California laboratory shall notify the local Health Officer and health care provider in the same manner as if the findings had been made by the California laboratory.

(h) Information reported pursuant to this Article is acquired in confidence and shall not be disclosed by the laboratory except as authorized by this Article, other state or federal law, or with the written consent of the individual to whom the information pertains or the legal representative of the individual.

Notes

Cal. Code Regs. Tit. 17, § 2643.10

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).
2. Amendment of section and NOTE filed 1-8-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or emergency language will be repealed by operation of law on the following day.
3. Amendment of section and NOTE refiled 4-18-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or emergency language will be repealed by operation of law on the following day.
4. Amendment refiled with further amendment of NOTE 8-21-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or emergency language will be repealed by operation of law on the following day.
5. Certificate of Compliance as to 8-21-2007 order, including redesignation of former subsections (b)(1)A. and (b)(1)B. as subsections (b)(1)(A) and (b)(1)(B), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).
6. Change without regulatory effect amending subsections (b)(1)(A)-(B) and adding subsection (b)(1)(C) filed 2-11-2015 pursuant to section 100, title 1, California Code of Regulations (Register 2015, No. 7).

Note: Authority cited: Section 1224, Business and Professions Code; and Sections 120125, 120130, 120140, 121022, 131080 and 131200, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241, 1265, 1281 and 1288, Business and Professions Code; and Sections 101150, 120175, 120775, 120885- 120895, 120975, 120980, 121022, 121025, 121035, 131051, 131052, 131056 and 131080, Health and Safety Code.

1. New section filed 5-2-2002; operative 7-1-2002 (Register 2002, No. 18).
2. Amendment of section and Note filed 1-8-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 1-8-2007 (Register 2007, No. 2). A Certificate of Compliance must be transmitted to OAL by 5-8-2007 or emergency language will be repealed by operation of law on the following day.
3. Amendmentof section and Note refiled 4-18-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 5-9-2007 (Register 2007, No. 16). A Certificate of Compliance must be transmitted to OAL by 9-6-2007 or emergency language will be repealed by operation of law on the following day.
4. Amendmentrefiled with further amendment of Note 8-21-2007 as an emergency pursuant to Health and Safety Code section 121022, subdivision (c); operative 9-7-2007 (Register 2007, No. 35). A Certificate of Compliance must be transmitted to OAL by 1-7-2008 or emergency language will be repealed by operation of law on the following day.
5. Certificate of Compliance as to 8-21-2007 order, including redesignation of former subsections (b)(1)A. and (b)(1)B. as subsections (b)(1)(A) and (b)(1)(B), transmitted to OAL 12-21-2007 and filed 2-6-2008 (Register 2008, No. 6).
6. Change without regulatory effect amending subsections (b)(1)(A)-(B) and adding subsection (b)(1)(C) filed 2-11-2015 pursuant to section 100, title 1, California Code of Regulations (Register 2015, No. 7).