§ 2505. Notification by Laboratories.
17 CA ADC § 2505Barclays Official California Code of RegulationsEffective: August 10, 2023
Effective: August 10, 2023
17 CCR § 2505
§ 2505. Notification by Laboratories.
(a) To assist the local health officer, the laboratory director, or the laboratory director's designee, of a clinical laboratory, an approved public health laboratory or a veterinary laboratory in which a laboratory examination of any specimen derived from the human body (or from an animal, in the case of a disease or condition in animals made reportable by these regulations) yields microscopic, culture, immunologic, serologic, molecular, pathologic, or other evidence suggestive of those diseases listed in subsections (e)(1) and (e)(2) below, shall report such findings to the health officer of the local health jurisdiction where the patient resides. If the patient residence is unknown, the laboratory shall notify the health officer of the jurisdiction in which the health care provider is located. The reporting specified above shall include any initial findings as well as any subsequent findings as a result of additional laboratory examination. In addition, the laboratory director or the laboratory director's designee shall also report negative laboratory test results or other laboratory findings when requested by the Department or a local health officer.
(1) For those diseases listed in subsection (e)(1), the report of such findings shall be made within one hour after the laboratory notifies the health care provider or other person authorized to receive the report. If the laboratory that makes the positive finding received the specimen from another laboratory, the laboratory making the positive finding shall notify the health officer of the jurisdiction where the patient resides within one hour from the time the laboratory notifies the referring laboratory that submitted the specimen. If the patient residence is unknown, the laboratory shall notify the health officer of the jurisdiction in which the health care provider is located.
(2) For those diseases listed in subsection (e)(2), with the exception of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the report of such findings shall be made within one working day from the time that the laboratory notifies the health care provider or other person authorized to receive the report. If the laboratory that makes the positive finding received the specimen from another laboratory, the laboratory making the positive finding shall notify the health officer of the jurisdiction where the patient resides within one working day from the time the laboratory notifies the referring laboratory that submitted the specimen. If the patient residence is unknown, the laboratory shall notify the health officer of the jurisdiction in which the health care provider is located.
(3) For severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the report of such findings shall be made within eight hours from the time that the laboratory notifies the health care provider or other person authorized to receive the report. If the laboratory that makes the positive finding received the specimen from another laboratory, the laboratory making the positive finding shall notify the health officer of the jurisdiction where the patient resides within eight hours from the time the laboratory notifies the referring laboratory that submitted the specimen. If the patient residence is unknown. the laboratory shall notify the health officer of the jurisdiction in which the health care provider is located.
(b) To permit local health officer follow-up of laboratory findings, all specimens submitted for laboratory tests or examinations related to a disease or condition listed in subsections 2505(e)(1) or 2502(e)(2) shall be accompanied by a test requisition which includes the name, gender, race, ethnicity, pregnancy status, address and date-of-birth of the person from whom the specimen was obtained and the name, address and telephone number of the health care provider or other authorized person who submitted the specimen. Whenever the specimen, or an isolate therefrom, is transferred between laboratories, a test requisition with the above patient and submitter information shall accompany the specimen. The laboratory that first receives a specimen shall be responsible for obtaining the patient and submitter information at the time the specimen is received by that laboratory.
(c) Each notification to the local health officer shall include the date the specimen was obtained, the patient identification number, the specimen accession number or other unique specimen identifier, the specimen site, the diagnosis code, the laboratory findings for the test performed, the date that the laboratory findings were identified, the name, gender, race, ethnicity, address, telephone number (if known), pregnancy status, and date of birth of the person from whom the specimen was obtained, and the name, address, and telephone number of the health care provider for whom such examination or test was performed. Laboratories shall report the elements specified above in a format specified by the Department.
(d) The notification shall be submitted as specified in subsections (e)(1) and (e)(2) of this Section to the local health officer in the jurisdiction where the patient resides. When the specimen is from an out-of-state submitter, the state epidemiologist of the submitter shall be provided the same positive findings per subsections (e)(1) and (e)(2) of this Section. If the laboratory that finds evidence for any of those diseases listed in subsections (e)(1) and (e)(2) is an out-of-state laboratory, the California clinical laboratory that receives a report of such findings from the out-of-state laboratory shall notify the local health officer in the same way as if the finding had been made by the California laboratory.
(1) The diseases or agents specified shall be reported within one hour after the health care provider or other person authorized to receive the report has been notified. Laboratories shall make the initial reports to the local health officer by telephone and follow the initial report within one working day by a report to the state electronic reporting system or local electronic reporting system that is linked to the state electronic reporting system. If reporting to the state or local electronic system is not possible, reporting by electronic facsimile transmission and electronic mail may temporarily substitute for reporting to the state or local electronic reporting system. Laboratories shall also report by other means (e.g., electronic facsimile) if requested by a local health officer or the Department. Laboratory findings for these diseases are those that satisfy the most recent communicable disease surveillance case definitions established by the CDC (unless otherwise specified in this Section). The diseases or agents reported pursuant to this requirement are:
• Anthrax, human (B. anthracis) (see section 2551 for additional reporting instructions)
• Anthrax, animal (B. anthracis)
• Botulism (see section 2552 for additional reporting instructions)
• Brucellosis, human (all Brucella spp.) (see section 2553 for special reporting instructions)
• Burkholderia pseudomallei and B. mallei (detection or isolation from a clinical specimen)
• Coronavirus, novel strains
• Influenza, novel strains (human) (see (i) for additional reporting requirements)
• Plague, human (see section 2596 for additional reporting instructions)
• Plague, animal
• Smallpox (Variola) (see section 2614 for additional reporting instructions)
• Tularemia, human (F. tularensis) (see section 2626 for additional reporting instructions)
• Viral Hemorrhagic Fever agents, human (VHF), e.g., Crimean-Congo, Ebola, Lassa, and Marburg viruses (see section 2638 for additional reporting instructions)
• Viral Hemorrhagic Fever agents, animal (VHF), e.g., Crimean-Congo, Ebola, Lassa, and Marburg viruses
(2) The diseases or agents specified shall be reported within one working day after the health care provider or other person authorized to receive the report has been notified. Laboratories shall transmit these reports to the state electronic reporting system or local electronic reporting system that is linked to the state electronic reporting system, except for acute HIV infection reporting which shall be reported by telephone (see (j) for specific acute HIV infection reporting requirements). Acute HIV infection shall be reported both by telephone and to the state electronic reporting system within one working day of identification. If reporting to the state or local electronic reporting system is not possible, reporting by electronic facsimile transmission or electronic mail may temporarily substitute for reporting to the state or local electronic reporting system. Laboratories shall also report by other means (e.g., electronic facsimile) if requested by a health officer or the Department. Laboratory findings for these diseases are those that satisfy the most recent communicable disease surveillance case definitions established by the CDC (unless otherwise specified in this Section). The diseases or agents reported pursuant to this requirement are:
• Acid fast bacillus (AFB) (see (g) for additional reporting requirements)
• Anaplasmosis
• Babesiosis
• Bordetella pertussis acute infection, by culture or molecular identification
• Borrelia burgdorferi infection
• Brucellosis, animal (Brucella spp. except Brucella canis)
• Campylobacteriosis (Campylobacter spp.) (detection or isolation a clinical specimen)
• Candida auris, colonization or infection (see (r) for additional reporting requirements)
• Carbapenemase-producing organism, colonization or infection
• Chancroid (Haemophilus ducreyi)
• Chikungunya virus infection
• Chlamydia trachomatis infections, including lymphogranuloma venereum (LGV)
• Coccidioidomycosis
• Cryptosporidiosis
• Cyclosporiasis (Cyclospora cayetanensis)
• Dengue virus infection
• Diphtheria
• Ehrlichiosis
• Encephalitis, arboviral
• Escherichia coli: shiga toxin producing (STEC) including E. coli O157 (see (m) for additional reporting requirements)
• Flavivirus infection of undetermined species
• Giardiasis (Giardia lamblia, intestinalis, or duodenalis)
• Gonorrhea
• Haemophilus influenzae, all types (detection of or isolation from a sterile site in a person less than 5 years of age)
• Hantavirus Infections
• Hepatitis A, acute infection
• Hepatitis B, acute or chronic infection (specify gender)
• Hepatitis C, acute or chronic infection
• Hepatitis D (Delta), acute or chronic infection
• Hepatitis E, acute infection (detection of hepatitis E virus RNA from a clinical specimen or positive serology)
• Human Immunodeficiency Virus (HIV), acute infection (see (j) for additional reporting requirements)
• Influenza
• Legionellosis (Legionella spp.) (antigen or culture)
• Leprosy (Hansen Disease) (Mycobacterium leprae)
• Leptospirosis (Leptospira spp.)
• Listeriosis (Listeria) (see (m) for additional reporting requirements)
• Malaria (see (h) for additional reporting requirements)
• Measles (Rubeola), acute infection
• Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
• Monkeypox or orthopox virus infection
• Mumps (mumps virus), acute infection
• Neisseria meningitidis (sterile site isolate or eye specimen) (see (m) for additional reporting requirements)
• Poliovirus
• Psittacosis (Chlamydophila psittaci)
• Q Fever (Coxiella burnetii)
• Rabies, animal or human
• Relapsing Fever (Borrelia spp.) (identification of Borrelia spp. spirochetes on peripheral blood smear)
• Respiratory syncytial virus
• Rickettsia, any species, acute infection (detection from a clinical specimen or positive serology)
• Rocky Mountain Spotted Fever (Rickettsia rickettsii)
• Rubella, acute infection
• Salmonellosis (Salmonella spp.) (see Section 2612 (a) for additional reporting requirements)
• Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (see (p) and (q) for additional reporting requirements)
• Shiga toxin (detected in feces) (see (m) for additional reporting requirements)
• Shigellosis (Shigella spp.) (see (m) for additional reporting requirements)
• Syphilis
• Trichinosis (Trichinella)
• Tuberculosis, including Mycobacterium tuberculosis complex (see (f) for additional reporting requirements)
• Latent Tuberculosis Infection identified by a positive laboratory test (see (o) for additional reporting requirements)
• Tularemia, animal (F. tularensis)
• Typhoid
• Vibrio species infections
• West Nile virus infection
• Yellow Fever (yellow fever virus)
• Yersiniosis (Yersinia spp., non-pestis) (isolation from a clinical specimen)
• Zika virus infection (see (m) for additional reporting requirements)
(1) Submit a culture as soon as available from the primary isolate on which a diagnosis of tuberculosis was established. Such a culture shall be submitted to the public health laboratory designated in Title 17 California Code of Regulations, Section 1075 for the local jurisdiction where the patient resides. The following information shall be submitted with the culture: the name, address, and the date of birth of the person from whom the specimen was obtained, the patient identification number, the specimen accession number or other unique specimen identifier, the date the specimen was obtained from the patient, and the name, address, and telephone number of the health care provider for whom such examination or test was performed. The public health laboratory shall retain the culture received (one culture from each culture-positive patient) in a viable condition for at least six months.
(A) If Mycobacterium tuberculosis complex is identified by molecular testing but no culture isolate is available, a specimen available to the laboratory shall be submitted to the public health laboratory designated in Title 17 California Code of Regulations Section 1075 upon request from the local health officer, public health laboratory, or the Department's Microbial Disease Laboratory.
(2) Unless drug susceptibility testing has been performed by the clinical laboratory on a strain obtained from the same patient within the previous three months or the health care provider who submitted the specimen for laboratory examination informs the laboratory that such drug susceptibility testing has been performed by another laboratory on a culture obtained from that patient within the previous three months, the clinical laboratory shall:
(B) Report the results of drug susceptibility testing including molecular assays for drug resistance, if performed, to the local health officer of the jurisdiction where the patient resides within one working day from the time the health care provider or other authorized person who submitted the specimen is notified; and
(C) If the drug susceptibility testing determines the culture to be resistant to at least isoniazid and rifampin, as soon as available, submit one culture or subculture from each patient from whom multidrug-resistant Mycobacterium tuberculosis complex was isolated to the official public health laboratory designated in Title 17 California Code of Regulations Section 1075 for the local health jurisdiction in which the patient resides. The local public health laboratory shall forward such cultures to the Department's Microbial Diseases Laboratory. The following information shall be submitted with the culture: the name, address, and the date of birth of the person from whom the specimen was obtained, the patient identification number, the specimen accession number or other unique specimen identifier, the date the specimen was obtained from the patient, and the name, address, and telephone number of the health care provider for whom such examination or test was performed.
(g) Whenever a clinical laboratory finds that a specimen from a patient with known or suspected tuberculosis tests positive for acid fast bacillus (AFB) staining and the patient has not had a culture which identifies that acid fast organism within the past 30 days, the clinical laboratory shall culture and identify the acid fast bacteria or refer a subculture to another laboratory for those purposes.
(h) In addition to notifying the local health officer pursuant to subsection (a), any clinical laboratory that makes a finding of malaria parasites in the blood film of a patient shall immediately submit one or more such blood film slides for confirmation to the public health laboratory designated in Title 17 California Code of Regulations Section 1075 for the local health jurisdiction where the patient resides. When requested, all blood films shall be returned to the submitter.
(j) In addition to routine reporting requirements set forth in section 2643.10, for acute HIV infection reporting, laboratories shall report all cases within one working day to the local health officer of the jurisdiction in which the patient resides by telephone. If the patient residence is unknown, the laboratory shall notify the health officer of the jurisdiction in which the health care provider is located. If evidence of acute HIV infection is based on presence of HIV p24 antigen, laboratories shall not wait until HIV-1 RNA is detected before reporting to the local health officer.
(k) All laboratory notifications herein required are acquired in confidence and shall not be disclosed by the local health officer except (1) as authorized by these regulations; (2) as required by state or federal law; or (3) with the written consent of the individual to whom the information pertains or the legal representative of that individual.
(m) An isolate or a specimen as listed in this subsection shall be submitted as soon as available to the public health laboratory designated in Section 1075 for the local health jurisdiction where the patient resides. The following information shall be submitted with the isolate or specimen: the name, address, and the date of birth of the person from whom the isolate or specimen was obtained, the patient identification number, the isolate or specimen accession number or other unique identifier, the date the isolate or specimen was obtained from the patient, the name, address, and telephone number of the health care provider for whom such examination or test was performed, and the name, address, telephone number and the laboratory director's name of the laboratory submitting the isolate or specimen.
• Malaria positive blood film slides (see (h) for additional reporting requirements)
• Neisseria meningitidis eye specimens
• Shiga toxin-positive fecal broths
• Zika virus immunoglobulin M (IgM)-positive sera
• Drug resistant Neisseria gonorrhoeae isolates (cephalosporin or azithromycin only)
• Listeria monocytogenes isolates
• Mycobacterium tuberculosis isolates (see (f) for additional reporting requirements)
• Neisseria meningitidis isolates from sterile sites
• Salmonella isolates (see section 2612 for additional reporting requirements)
• Shiga toxin-producing Escherichia coli (STEC) isolates, including O157 and non-O157 strains
• Shigella isolates
(3) If there is a laboratory test result indicating infection with any one of the pathogens listed in (m)(2), then the laboratory must attempt to obtain a bacterial culture isolate for submission to the public health laboratory in accordance with (m)(2). This requirement includes identification of Shiga toxin in a clinical specimen, but does not include latent tuberculosis infection identified by a positive laboratory test. The laboratory shall take steps necessary to obtain an isolate, including requesting that additional specimens be collected and sending specimens to a laboratory able to carry out bacterial culture as soon as possible.
(n) Upon written request and submission instruction by the Department, a laboratory that receives a specimen that is reactive for HIV-1/2 antigen or antibody, as defined within this subsection, shall submit the specimen to either the local public health laboratory designated in Section 1075 for the local health jurisdiction where the patient resides, the State Public Health Laboratory, or their designee. The specimen submission shall include the information identified in subdivision (m) and the Clinical Laboratory Improvement Amendments number.
(p) Upon written request and submission instruction by the Department or a local health officer, a laboratory that tests any specimen for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), shall submit the specimen and any nucleic acid extract to either the local public health laboratory designated in Section 1075 for the local health jurisdiction where the patient resides, the State Public Health Laboratory, or their designee. The specimen submission shall include the information identified in subdivision (b), the Cycle Threshold (CT) or Relative Light Units (RLU) value, and the federal Clinical Laboratory Improvement Amendments certificate number.
(q) A laboratory that performs genetic sequencing of SARS-CoV-2 shall submit sequence data to the Department in an electronic format specified by the Department. In addition, a laboratory that identifies a SARS-CoV-2 strain designated as a variant of public health importance by the Department shall transmit the report in a format specified by the Department to the state electronic reporting system or local electronic reporting system that is linked to the state electronic reporting system. The sequence data submission and the strain report shall include the information identified in subsection (c), and the federal Clinical Laboratory Improvement Amendments certificate number if applicable.
(r) If a Candida auris isolate(s) is identified from a sterile site, and the laboratory has obtained a fungal culture isolate, the isolate(s) must be submitted to a public health laboratory within 10 working days from the date of collection. The specimen submission shall include the information identified in subdivision (m) and the Clinical Laboratory Improvement Amendments number.
(1) Upon written request and submission instruction by the Department or a local health officer, the laboratory must attempt to obtain a fungal culture isolate from any specimen site for submission as soon as available to the public health laboratory designated in Section 1075 for the local health jurisdiction where the patient resides.
Credits
Note: Authority cited: Sections 100275, 120125, 120130, 120140, 125095, 131050, 131051, 131052, 131080 and 131200, Health and Safety Code. Reference: Sections 100180, 120125, 120130, 120140, 120175, 120575, 121365, 125100 and 131080, Health and Safety Code; Sections 1209, 1246.5 and 1288, Business and Professions Code; Cal. Const., art. 1, Section 1; and Section 1040, Evidence Code.
History
1. New section filed 3-26-62; effective thirtieth day thereafter (Register 62, No.6).
2. Amendment of subsections (a) and (b) filed 6-25-72 as an emergency; effective upon filing (Register 72, No. 27).
3. Certificate of Compliance filed 10-24-72 (Register 72, No. 44).
4. Amendment of subsection (d) filed 3-30-89; operative 3-30-89 (Register 89, No. 14).
5. Amendment of section and Note filed 5-1-95 as an emergency; operative 5-1-95 (Register 95, No. 18). A Certificate of Compliance must be transmitted to OAL by 8-29-95 or emergency language will be repealed by operation of law on the following day.
6. Amendment of section and Note refiled 8-21-95 as an emergency; operative 8-21-95 (Register 95, No. 34). A Certificate of Compliance must be transmitted to OAL by 12-19-95 or emergency language will be repealed by operation of law on the following day.
7. Certificate of Compliance as to 5-1-95 order, including amendment of section, transmitted to OAL 12-19-95 and filed 2-2-96 (Register 96, No. 5).
8. Change without regulatory effect amending subsection (c) filed 7-15-97 pursuant to section 100, title 1, California Code of Regulations (Register 97, No. 29).
9. Amendment of subsections (a)-(d), repealer of subsection (e) and new subsections (e)-(e)(2) and amendment of Note filed 11-5-2001 as an emergency; operative 11-5-2001 (Register 2001, No. 45). A Certificate of Compliance must be transmitted to OAL by 3-5-2002 or emergency language will be repealed by operation of law on the following day.
10. Amendment of subsections (a)-(d), repealer of subsection (e), new subsections (e)-(e)(2) and amendment of Note refiled 3-1-2002 as an emergency; operative 3-1-2002 (Register 2002, No. 9). A Certificate of Compliance must be transmitted to OAL by 7-1-2002 or emergency language will be repealed by operation of law on the following day.
11. Certificate of Compliance as to 3-1-2002 order, including further amendment of subsection (e)(1), transmitted to OAL 6-26-2002 and filed 7-16-2002 (Register 2002, No. 29).
12. Amendment of subsection (e)(2) filed 6-30-2005; operative 6-30-2005. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2005, No. 32).
13. Amendment of subsection (e)(2) filed 10-26-2006; operative 10-26-2006. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130(a) and (d) (Register 2006, No. 43).
14. Amendment of subsections (e)(1)-(2), new subsections (i)-(j) and subsection relettering filed 6-12-2007; operative 6-12-2007. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2007, No. 31).
15. Amendment of subsection (e)(2) filed 7-30-2007; operative 7-30-2007. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2007, No. 31).
16. Amendment of subsections (e)(1) and (e)(2) and amendment of Note filed 9-22-2009; operative 9-22-2009. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130(a) and (d) (Register 2009, No. 39).
17. Amendment of subsections (e)(1)-(2), repealer of subsections (i)-(i)(4)(B), subsection relettering and amendment of newly designated subsection (i) filed 6-30-2011; operative 6-30-2011. Submitted to OAL for printing only pursuant to Health and Safety Code sections 120130(a) and 120130(d) (Register 2011, No. 26).
18. Amendment of subsection (e)(2) filed 9-27-2011; operative 10-27-2011. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2011, No. 39).
19. Amendment of subsection (e)(2), new subsection (l) and amendment of Note filed 12-2-2013; operative 1-1-2014. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2013, No. 49).
20. Amendment of subsections (a), (a)(2) and (e)(2), new subsection (j), subsection relettering, amendment of newly designated subsection (m) and new subsections (m)(1)-(n) filed 5-24-2016; operative 5-24-2016. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 120130(a)-(b) (Register 2016, No. 22).
21. Amendment filed 9-12-2019; operative 10-1-2019. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 120130(a)-(b) (Register 2019, No. 37).
22. Amendment of subsection (e)(1) filed 3-9-2020; operative 3-9-2020. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2020, No. 13).
23. Amendment of subsection (a)(2), new subsection (a)(3) and amendment of subsections (b)-(c) and (e)(1)-(2) filed 7-28-2020; operative 7-28-2020. Submitted to OAL for printing only pursuant to Health and Safety Code section 120130 (Register 2020, No. 31).
24. New subsection (p) and amendment of Note filed 4-7-2021; operative 4-7-2021. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 120130 (Register 2021, No. 15).
25. Amendment of subsection (e)(2) and new subsection (q) filed 5-19-2021; operative 5-19-2021. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 120130 (Register 2021, No. 21).
26. Amendment of subsection (e)(2) and new subsections (r)-(r)(1) filed 8-24-2022; operative 8-24-2022. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 120130 (Register 2022, No. 34).
27. Amendment of subsection (e)(2) filed 8-10-2023; operative 8-10-2023. Submitted to OAL for filing and printing only pursuant to Health and Safety Code section 120130 (Register 2023, No. 32).
This database is current through 5/3/24 Register 2024, No. 18.
Cal. Admin. Code tit. 17, § 2505, 17 CA ADC § 2505
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