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Community Epidemiology

Disease Reporting Requirements for Laboratorians

For more information phone 619-515-6620 or send us an email.

California Code of Regulations, Title 17, Section 2505 requires laboratories to report laboratory testing results suggestive of the following diseases of public health importance to the local health department.

§ 2505. NOTIFICATION BY LABORATORIES.

§ 2505 (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.

 

URGENCY REPORTING REQUIREMENTS [17 CCR §2505(e)]

Reportable to the local health officer of the health jurisdiction where the health care provider who first submitted the specimen is located within one (1) hour from the time that the laboratory notifies that health care provider or other person authorized to receive the report.
Reportable to the local health officer of the health jurisdiction where the health care provider who first submitted the specimen is located within one (1) working day from the time that the laboratory notifies that health care provider or other person authorized to receive the report.

SUPPLEMENTARY REPORTING & SPECIMEN SUBMISSIONS

In addition to laboratory reporting and culture referral required by the California Code of Regulations, Title 17, Section 2505, 2612 and 2628, clinical laboratories in San Diego County are also requested to report and/or submit the following diseases and conditions:

Please use the Confidential Morbidity Report (CMR) form to report the following to the Community Epidemiology Branch: Phone (619) 515-6620, Fax (619) 515-6644.
Please submit the following organisms to the San Diego County Public Health Laboratory for further testing: Phone (619) 692-8500, Fax (619) 692-8558.

 

LABORATORY REPORTABLE DISEASES AND CONDITIONS
Acid fast bacillus (AFB)1
Anaplasmosis/Ehrlichiosis
 Anthrax 2
 Avian Influenza 3 (specimen only)
Bordetella pertussis acute infection, by culture or molecular identification
Borrelia burgdorferi
 Botulism 4
 Brucellosis 5 (specimen only)
 Burkholderia mallei and pseudomallei
Campylobacter species
Chlamydia trachomatis infections including lymphogranuloma venereum (LGV)
Coccidioidomycosis
Cryptosporidiosis
Cyclospora cayetanensis
Diphtheria
Encephalitis, arboviral
 Escherichia coli STEC including E. coli O157:H7 Infection
Giardia species
Gonorrhea
Haemophilus influenzae* (report an incident of less than 15 years of age, sterile site)
Hepatitis A, acute infection, by lgM antibody test or positive viral antigen test
Hepatitis B, acute infection, by lgM anti-HBc antibody test
Hepatitis B surface antigen positively (specify gender of case)
Hepatitis C6
 Human Immunodeficiency Virus (HIV)
Invasive Group A streptococci isolated from sterile sites or wound/skin infections
Legionella pneumophila (antigen or culture)
 Listeria monocytogenes
 Malaria 7
Measles (Rubeola), acute infection, by lgM antibody test or positive viral antigen test
 Mycobacterium tuberculosis 8
 Neisseria meningitidis (sterile site isolate)
 Plague, animal or human 9
Poliovirus
 Quinilone resistant Neisseria gonorrhoeae
Rabies, animal or human
Rubella, acute infection by IgM antibody test or culture
 Salmonella species, including S. typhi 10
Shiga toxin (detected in feces)
 Shigella species
Syphilis
 Smallpox (Variola) 11
 Tularemia 12 (specimen only)
 Typhoid
 Vibrio species infections
 Viral hemorrhagic fever agents (e.g., Crimean-Congo, Ebola, Lassa, and Marburg viruses - specimen only) 13
West Nile virus infection
 Yersinia species
* For positive influenza test results, please contact Jill Giesick at phone (619) 692-8500 or fax (619) 692-8558.

 

1 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.

2 See section 2551 for additional reporting instructions.

3 Whenever a laboratory receives a specimen for the laboratory diagnosis of avian influenza in a human, such laboratory shall communicate immediately by phone with the CDPH Viral and Rickettsial Disease Laboratory for instruction.

4 See section 2552 for additional reporting instructions.

5 Brucellosis, by isolation of Brucella species from a clinical specimen, or demonstration by immunoflourescence 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.

6 (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.

7 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.

8 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
    • 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:

    • Perform or refer for drug susceptibility testing on at least one isolate from each patient from whom Mycobacterium tuberculosis was isolated; and
    • 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
    • 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.

9 See section 2596 for additional reporting instructions.

10 California Code of Regulations, Title 17, Section 2612 requires that a culture of the organisms on which a diagnosis of salmonellosis is established must be submitted to the local public health laboratory and then to the State Microbial Diseases Laboratory for definitive identification.

11 See section 2614 for additional reporting instructions.

12 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).

13 See section 2638 for additional reporting instructions.

Note: Whenever a laboratory receives a specimen for the laboratory diagnosis of a suspected human case of one of these diseases, such laboratory shall communicate immediately by telephone with the Microbial Diseases Laboratory (or, for Avian influenza, Smallpox or Viral Hemorrhagic Fevers, with the Viral and Rickettsial Disease Laboratory) of the California Department of Public Health for instruction.

 

WHEN TO REPORT

These laboratory findings are reportable to the local health officer of the health jurisdiction where the health care provider who first submitted the specimen is located within one (1) hour (List (e)(1) diseases) or within one (1) working day (List (e)(2) diseases) from the time that the laboratory notifies that 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 local health officer of the jurisdiction in which the health care provider is located within the time specified above from the time the laboratory notifies the referring laboratory that submitted the specimen. If the laboratory is an out-of-state laboratory, the California laboratory that receives a report of such findings shall notify the local health officer in the same way as if the finding had been made by the California laboratory.

 

HOW TO REPORT

Laboratory reports must be made in writing and give the following information:

  • 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 patient,
  • the name, address, and telephone number of the health care provider who ordered the test.

The notification for List (e)(1) diseases shall be reported by telephone within one (1) hour, followed by a written report submitted by electronic facsimile transmission or electronic mail within one (1) working day, to the local health officer in the jurisdiction where the health care provider who submitted the specimen is located. The notification for List (e)(2) diseases shall be submitted by courier, mail, electronic facsimile transmission or electronic mail within one (1) working day to the local health officer in the jurisdiction where the health care provider who submitted the specimen is located. 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.

All laboratory notifications 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 the 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.

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.

NOTE: Authority cited: Sections 100180, 100275, 120130 and 125095, Health and Safety Code. Reference: Sections 100180, 120125, 120130, 120140, 120175, 120575, 121365, and 125100, 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.

 

HOW TO SUBMIT A SPECIMEN

  • The following information should be submitted with the culture:
  • The name, address, and 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
  • The name, address, and telephone number of the health care provider who ordered the test
  • For bacterial cultures for identification, please use lab form Lab-17a. For tuberculosis isolates use form Lab-6CI and for tuberculosis cultures use form Lab-6. A legible copy of a laboratory report containing all of the above information is satisfactory if you don't have the correct form. To request forms and/or mailers, contact the Public Health Laboratory at (619) 692-8500.

NOTE: All laboratory notifications are acquired in confidence. Patient information and reporting source are confidential.

 

PACKAGING AND SHIPPING INFORMATION

All samples submitted to the San Diego County Public Health Laboratory must comply with all applicable U.S. Postal Service, DOT or IATA requirements (i.e. packaged, labeled and documented as per applicable regulations).

 

Laboratory Phone Number:

(619) 692-8500

Laboratory FAX Number:

(619) 692-8558

Mailing Address (w/ Mail Stop):

San Diego County Public Health Laboratory
3851 Rosecrans St., Suite 716
MS P572
San Diego, CA 92110-3115

NOTE: Special forms or clinical history are required for the following tests: Avian Influenza, Botulism, Encephalitis Project, Hantavirus, Hepatitis E, Lyme Disease, and West Nile Virus. Contact the Public Health Laboratory for further details.

 

For more information phone 619-515-6620 or send us an email.