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CALIFORNIA CODE OF REGULATIONS
TITLE 17. PUBLIC HEALTH
DIVISION 1. STATE DEPARTMENT OF HEALTH SERVICES
CHAPTER 4. PREVENTIVE MEDICAL SERVICE
SUBCHAPTER 1. REPORTABLE DISEASES AND CONDITIONS
ARTICLE 1. REPORTING
Date:
08/31/2009
Document:
ยง 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 rabies or plague testing) yields microscopical, cultural, immunological, serological, 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 health care provider who first submitted the specimen is located.
(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 in which the health care provider is located within one hour from the time the laboratory notifies the referring laboratory that submitted the specimen.
(2) For those diseases listed in subsection (e)(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 in which the health care provider is located within one working day from the time the laboratory notifies the referring laboratory that submitted the specimen.
(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, and age or 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 laboratory findings for the test performed, the date that any positive laboratory findings were identified, the name, gender, address, telephone number (if known) and age or 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.
(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 health care provider who submitted the specimen is located. 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.
(e) Laboratory reports to the local health officer shall include the information as specified in (c) of this Section and laboratories shall submit the reports within the following timeframes:
(1) The diseases 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 in writing submitted by electronic facsimile transmission or electronic mail to the local health officer. Within one year of the establishment of the state electronic reporting system, all List (e)(1) diseases, in addition to being reported by telephone within one hour, shall be reported electronically to the state electronic reporting system within one working day of identification. Reporting to the state electronic reporting system substitutes reporting by electronic facsimile transmission and electronic mail. The diseases reported pursuant to this requirement are:
Anthrax (see section 2551 for additional reporting instructions)
Avian Influenza (see (j) for additional reporting requirements)
Botulism (see section 2552 for additional reporting instructions)
Brucellosis, by isolation of Brucella species from a clinical specimen, or demonstration by immunofluorescence of Brucella species in a clinical specimen, or fourfold or greater rise in antibody titer to Brucella antigen between acute and convalescent phase serum specimens obtained two or more weeks apart and studied at the same laboratory, or elevated serum antibody to Brucella antigen at a titer of 1:160 or greater in a single serum specimen. (see section 2553 for special reporting instructions)
Burkholderia pseudomallei and B. mallei
Plague, animal or human (see section 2596 for additional reporting instructions)
Smallpox (Variola) (see section 2614 for additional reporting instructions)
Tularemia, by isolation of Francisella tularensis in a clinical specimen, or demonstration by immunofluorescence of F. tularensis in a clinical specimen, or fourfold or greater rise in antibody titers to F. tularensis antigen between acute and convalescent phase serum specimens obtained two or more weeks apart and studied at the same laboratory, or elevated antibody to F. tularensis antigen at a titer of 1:160 or greater in a single serum specimen. (see section 2626 for additional reporting instructions)
Viral Hemorrhagic Fever agents, e.g., Crimean-Congo, Ebola, Lassa, and Marburg viruses (see section 2638 for additional reporting instructions)
(2) The diseases 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 local health officer by courier, mail, electronic facsimile or electronic mail. Within one year of the establishment of the state electronic reporting system, all List (e)(2) diseases shall be reported electronically to the state electronic reporting system within one working day of identification. Reporting to the state electronic reporting system substitutes reporting by courier, mail, electronic facsimile transmission or electronic mail. The diseases reported pursuant to this requirement are:
Acid fast bacillus (AFB) (see (g) for additional reporting requirements)
Anaplasmosis/Ehrlichiosis
Bordetella pertusis acute infection, by culture or molecular identification
Borrelia burgdorferi infection
Chlamydia trachomatis infections, including lymphogranuloma venereum (LGV)
Coccidioidomycosis
Cryptosporidiosis
Cyclospora cayetanensis
Diphtheria
Encephalitis, arboviral
Escherichia coli: shiga toxin producing (STEC) including E. coli O157
Gonorrhea
Haemophilus influenzae (report an incident of less than 15 yers of age, sterile site)
Hepatitis A, acute infection, by lgM anitbody test or positive viral antigen test
Hepatitis B, acute infection, by lgM anti-HBc anitbody test
Hepatitis B surface antigen positively (specify gender)
Hepatitis C (see (i) for additional reporting requirements)
Legionella (antigen or culture)
Listeria
Malaria (see (h) for additional reporting requirements)
Measles (Rubeola), acute infection, by lgM anitbody test or positive viral antigen test
Mycobacterium tuberculosis (see (f) for additional reporting requirements)
Neisseria meningitidis (sterile site isolate)
Poliovirus
Rabies, animal or human
Rubella, acute infection by IgM antibody test or culture
Salmonella sp.
Shiga toxin (detected in feces)
Shigella sp.
Syphilis
Tuberculosis
Typhoid
Vibrio species infections
West Nile virus infection
(f) In addition to notifying the local health officer pursuant to subsection (a), any clinical laboratory or approved public health laboratory that isolates Mycobacterium tuberculosis from a patient specimen shall:
(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 health care provider's office is located. 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.
(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:
(A) Perform or refer for drug susceptibility testing on at least one isolate from each patient from whom Mycobacterium tuberculosis was isolated; and
(B) Report the results of drug susceptibility testing to the local health officer of the city or county where the submitting physician's office is located 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, in addition, submit one culture or subculture from each patient from whom multidrug-resistant Mycobacterium tuberculosis 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 health care provider's office is located. 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 health care provider is located. When requested, all blood films shall be returned to the submitter.
(i) Any laboratory with a positive hepatitis C virus (HCV) test that meets the CDC laboratory criteria for diagnosis of HCV infection in a California resident shall report the positive test to the local health officer.
The following test results are reportable.
(1) All HCV positive recombinant immunoblot assay (RIBA) tests;
(2) All HCV RNA positive tests [e.g., nucleic acid tests (NAT)];
(3) All HCV genotype reports; and
(4) Anti-HCV reactive by a screening test (e.g., enzyme immunoassay [EIA] or chemiluminescence immunoassay [CIA]) with either:
(A) The exact signal-to-cut-off (s/co) ratio or index value; or
(B) A comment that indicates whether or not the screening test s/co ratio or index value is predictive of a true positive as determined for the particular assay as defined by the CDC in the case definition for "laboratory criteria for diagnosis" of Hepatitis C virus infection, past or present. The url for the s/co ratios that meet the CDC case definition is http://www.cdc.gov/ncidod/diseases/hepatitis/c/sc.ratios.htm.
If a laboratory chooses to report a reactive anti-HCV screening test (e.g., EIA or CIA test) with a s/co or index value that is lower than required to meet the CDC case definitions AND does not report the exact s/co or index value (i.e., the laboratory report is positive without a specific s/co or index value reported), then the laboratory report MUST include a comment to indicate that the s/co or index value is low and that supplemental testing (e.g., RIBA or NAT) is recommended by the CDC.
(j) Whenever a laboratory receives a specimen for the laboratory diagnosis of avian influenza in a human such laboratory shall communicate immediately by telephone with the Department's Viral and Rickettsial Disease Laboratory for instruction.
(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.
(l) The local health officer shall disclose any information, including personal information, contained in a laboratory notification to state, federal or local public health officials in order to determine the existence of the disease, its likely cause and the measures necessary to stop its spread.
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