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(k) If any person has knowledge that a person infected with a venereal disease is failing to observe adequate precautions to prevent spreading infection, he shall report the facts at once to the local health officer.
(l) Gonorrhea. A case of gonococcus infection of the genitourinary tract shall be regarded as subject to isolation until the local health officer is reasonable satisfied that the disease is no longer communicable.
(m) Syphilis. A case of syphilis shall be regarded as subject to isolation until, under treatment, all syphilitic lesions of the skin or mucous membrane are completely healed and a competent clinical examination fails to show the presence of any area from which infection may be spread. Any patient who refuses or otherwise fails to receive a full course of a currently accepted method of treatment, or who discontinues treatment prematurely, may be subjected to strict isolation if the health officer deems it necessary.
Note: Authority cited: Sections 102.208 and 3194.5, Health and Safety Code. Reference: Section 3194.5, Health and Safety Code.
s 2638. Viral Hemorrhagic Fevers (e.g., Crimean-Congo, Ebola, Lassa and Marburg Viruses). Cases and Suspect Cases to Be Reported by Telephone.
(See Section 2502(c).)
(a) Patient. The patient shall be isolated in accordance with Section 2516. Strict barrier isolation and patient blood, secretion and excreta precautions shall be enforced. The patient shall be instructed to refrain from unprotected sexual activity until secretions are free of virus or for 3 months after illness onset.
(b) Laboratory. Whenever a laboratory receives a specimen for laboratory diagnosis of suspected viral hemorrhagic fevers, such laboratory shall communicate immediately by telephone with the State Department of Health Services Viral and Rickettsial Disease Laboratory for instructions.
Note: Authority cited: Sections 100180, 100275, 120130, 120145 and 120175, Health and Safety Code. Reference: Sections 100180, 100275, 120130, 120185, 120190, 120195, 120215 and 120240, Health and Safety Code.
s 2640. Yellow Fever Cases and Suspect Cases to Be Reported by Telephone or Telegraph.
(See Section 2501(c).) The case shall be confined during the clinical phase of the disease in a room satisfactorily protected against mosquitoes. Contacts shall be kept under observation for a period of seven days after the date of last exposure.
s 2641.5. Alternative Testing Site.
"Alternative Testing Site" means an anonymous HIV testing site funded by the California Department of Health Services, administered by a county health department and operated pursuant to Health and Safety Code, Sections 120890-120895.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.10. Anonymous Counseling and Testing Program.
"Anonymous Counseling and Testing Program" means a program offering HIV counseling and testing while maintaining anonymity of the patient.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.15. Anonymous HIV Test.
"Anonymous HIV Test" means an HIV test that maintains the anonymity of the patient.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.20. Biological Specimen.
"Biological specimen" means any material that is derived from the human body.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Section 1206, Business and Professions Code; and Sections 100180, 101160, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.25. Confidential HIV Test.
"Confidential HIV Test" means an HIV test that links the test results to the patient in a restricted manner to protect against unauthorized disclosure of the identity of the patient.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775 and 121025, Health and Safety Code.
s 2641.30. Confirmed HIV Test.
"Confirmed HIV test" means:
(a) a procedure which verifies the presence of HIV infection as determined by any clinical laboratory test or examination used to detect the presence of HIV, a component of HIV, or antibodies to or antigens of HIV, including the HIV antibody (HIV-Ab), HIV p-24 antigen, Western blot (Wb), and immunofluorescence antibody tests; or
(b) for the purpose of this Article, all tests used to monitor HIV infection, including HIV nucleic acid detection.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 1206, 1206.5, 1241, 1265 and 1281, Business and Professions Code; and Sections 100180, 101150, 101160, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.35. Department.
"Department" means the California Department of Health Services, Office of AIDS.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.45. Health Care Provider.
"Health care provider" means an individual who submits a biological specimen to a laboratory for a test to detect the presence of HIV, a component of HIV or antibodies to or antigens of HIV, receives the test results and is;
(a) licensed under the provisions of Business and Professions Code, Division 2 (Healing Arts) and acting within his or her scope of practice, or;
(b) a designee of a physician and surgeon acting under the general supervision of that physician or surgeon, or;
(c) a person working in a publicly-funded confidential counseling and testing program acting under the general supervision of, and following the protocols approved by, the local Health Officer for the local health department.
Note: Authority cited: Sections 100180, 100275, 101160, 120125 and 120130, Health and Safety Code. Reference: Sections 1206, 1206.5, 1241, 1281 and 1285, Business and Professions Code; and Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.50. Health Officer and Local Health Officer.
"Health Officer and Local Health Officer" means the officer appointed by the local governing body (county, city, and district), as defined in Section 2500.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.55. HIV/AIDS Case Report.
"HIV/AIDS Case Report" means California Department of Health Services HIV/AIDS Confidential Case Report form, Adult (DHS 8641A (9/01) or Pediatric (DHS 8641P (9/01), hereby incorporated by reference in this Article and available from the local health department or the Department.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.60. Laboratory.
"Laboratory" means a 'clinical laboratory,' a 'physician office laboratory,' or a 'public health laboratory,' as defined in Business and Professions Code, Section 1206, that is authorized to perform clinical laboratory tests or examinations in California, or a clinical laboratory located outside of the State of California that is licensed pursuant to Business and Professions Code Section 1241(a) and that tests specimens originating in California.
Note: Authority cited: Sections 1224 and 1288, Business and Professions Code; and Sections 100180, 100275, 101160, 120125 and 120130, Health and Safety Code. Reference: Sections 1206, 1220, 1241, 1265 and 1281, Business and Professions Code.
s 2641.65. Laboratory Test.
"Laboratory test" means a clinical laboratory test or examination as defined in Business and Professions Code, Section 1206(a)(4) and performed by a laboratory as defined in this Article.
Note: Authority cited: Sections 1224 and 1288, Business and Professions Code; and Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 1202.5 and 1206, Business and Professions Code; and Section 101160, Health and Safety Code.
s 2641.70. Local Health Department.
"Local health department" means the governing body providing public health services to cities and/or counties, as identified in Health and Safety Code, Section 101185.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.75. Non-Name Code.
"Non-Name Code" means a designation required by Section 2643.5 of this Article, that does not readily identify an HIV-infected individual. Components of the Non-Name Code shall be listed in the following order, and shall consist of an individual's:
(a) Soundex code;
(b) complete date of birth (2-digit month, 2-digit day, 4-digit year);
(c) gender (male [1], female [2], transgender male-to-female [3], or transgender female-to-male [4]); and
(d) last four digits of the Social Security Number (if not available, use four digits of zero).
Note: Authority cited: Sections 100180, 100275, 120125, 120130 and 120140, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.77. Partial Non-Name Code.
A Partial Non-Name Code means a designation required by Section 2643.10 of this Article, that does not readily identify the HIV-infected individual. Components of the Partial Non-Name Code shall be listed in the following order, and shall consist of an individual's:
(a) Soundex code;
(b) complete date of birth (2-digit month, 2-digit day, 4-digit year) and;
(c) gender (male [1], female [2], transgender male-to-female [3], or transgender female-to-male [4]).
Note: Authority cited: Sections 100180, 100275, 120125, 120130 and 120140 Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.80. Personal Information.
"Personal information" means an individual's complete Social Security Number, complete name or surname, home address, California driver's license or identification number, electronic mail address or telephone number.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.85. Publicly-Funded Confidential Counseling and Testing Program.
"Publicly-funded Confidential Counseling and Testing Program" means a program financed by federal, state or local governmental agencies that provides confidential HIV tests to patients.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2641.90. Soundex Code.
"Soundex code" means a phonetic, alphanumerical formula which is used to convert the first letter and sequential consonants of an individual's surname into an algorithm. The Soundex code instructions are identified by the Department as form DHS 8641 SC (9/01), hereby incorporated by reference in this Article.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2643.5. HIV Reporting by Health Care Providers.
(a) Each health care provider that orders a laboratory test used to identify HIV, a component of HIV, or antibodies to or antigens of HIV shall submit the following to the laboratory performing the test:
(1) A pre-printed laboratory requisition form which includes all documentation as specified in 42 CFR 493.1105 (57 FR 7162, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993) and adopted in Business and Professions Code, Section 1220, or;
(2) A completed Department of Health Services Counseling and Testing Program Confidential HIV Antibody Test laboratory requisition form, DHS 8257C (1/02), hereby incorporated by reference in this Article.
(b) The person authorized to order the laboratory test shall include the following when submitting information to the laboratory:
(1) Patient surname; 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) Date biological specimen was collected; and
(5) Name, address, telephone number of the health care provider and the facility where services were rendered, if different.
(c) Each health care provider shall, within seven calendar days of receipt of a patient's confirmed HIV test and Partial Non-Name Code from a laboratory, complete the Non-Name Code (as specified in Section 2641.75) and report the confirmed HIV test to the local Health Officer for the jurisdiction where the health care provider facility is located. The report shall consist of a completed copy of the HIV/AIDS Case Report form.
(d) HIV reporting by Non-Name Code to the local Health Officer, via submission of the HIV/AIDS Case Report, shall not supplant the reporting requirements in Article 1 of this Subchapter when a patient's medical condition progresses from HIV infection to an Acquired Immunodeficiency Syndrome (AIDS) diagnosis.
(e) When reporting a confirmed HIV test, a health care provider shall not report a patient's personal information to the local Health Officer except for patients whose clinical conditions meet the AIDS reporting criteria, as specified in Article 1 of this Subchapter.
(f) A health care provider who receives notification from an out-of-state laboratory of a confirmed HIV test for a California patient shall report the findings to the local Health Officer for the jurisdiction where the health care provider facility is located.
(g) When a health care provider orders multiple HIV-related viral load tests for a patient, or receives multiple laboratory reports of a confirmed HIV test, the health care provider shall be required to submit only one HIV/AIDS Case Report, per patient, to the local Health Officer.
(h) For all HIV-infected patients without an AIDS diagnosis, the health care provider shall maintain a system which cross-references patient data by using either the Partial Non-Name Code or the Non-Name Code. This system shall be used only to exchange information with the Local Health Officer in order to complete or unduplicate the HIV case reports.
(i) Information reported pursuant to this Article is acquired in confidence and shall not be disclosed by the health care provider 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 that individual.
Note: Authority cited: Sections 100180, 100275, 120125, 120130 and 120140, Health and Safety Code. Reference: Sections 1202.5, 1206, 1206.5, 1220, 1241, 1265 and 1281, Business and Professions Code; and Sections 100180, 101160, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2643.10. HIV Reporting by Laboratories.
(a) The laboratory director or authorized designee shall create a Partial Non-Name Code (as specified in Section 2641.77) for each confirmed HIV test.
(b) 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 of the local health jurisdiction where the health care provider facility is located. The report shall include the:
(1) Partial Non-Name Code of the patient; and
(2) Name, address, and telephone number of the health care provider and the facility that submitted the biological specimen to the laboratory, if different.; and
(3) Name, address, and telephone number of the laboratory; and
(4) Laboratory report number as assigned by the laboratory; and
(5) Laboratory results of the test performed; and
(6) Date the biological specimen was tested in the laboratory.
(c) A laboratory shall not transmit a patient's personal information to the local health department.
(d) 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.
(e) A laboratory shall convey the patient's Partial Non-Name Code to the submitting health care provider when reporting confirmed HIV test results.
(f) 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.
(g) 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.
(h) 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.
(i) 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.
(j) 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.
Note: Authority cited: Section 1224, Business and Professions Code; and Sections 100180, 100275, 120125, 120130 and 120140, Health and Safety Code. Reference: Sections 1206, 1206.5, 1209, 1220, 1241, 1265, 1281 and 1288, Business and Professions Code; and Sections 100180, 101150, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2643.15. HIV Reporting by Local Health Officers.
(a) The local Health Officer or his or her authorized designee shall match and unduplicate laboratory reports of confirmed HIV tests with the local health department HIV/AIDS registry database and with HIV/AIDS Case Reports received from health care providers and not entered into the database.
(b) The Health Officer or his or her authorized designee shall, within 45 calendar days of receipt of a laboratory report of a confirmed HIV test, submit unduplicated HIV/AIDS Case Reports to the Department.
(1) HIV/AIDS Case Reports shall be sent by courier service, U.S. Postal Service Express or Registered mail, or other traceable mail to the California Department of Health Services, Office of AIDS, HIV/AIDS Case Registry.
(2) The local Health Officer or his or her authorized designee shall not report confirmed HIV tests for patients of an Alternative Testing Site or other anonymous counseling and testing program, a blood bank, a plasma center, or for participants of a blinded and/or unlinked HIV seroprevalence study.
(c) The local Health Officer or his or her authorized designee shall not submit an HIV/AIDS Case Report to the Department for an infant under the age of 18 months, unless the infant's HIV infection is confirmed.
(d) Information reported pursuant to this Article is acquired in confidence and shall not be disclosed by the local Health Officer or his or her authorized designee 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.
Note: Authority cited: Sections 100180, 100275, 120125, 120130 and 120140, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2643.20. HIV Reporting Exemptions.
Alternative Testing Sites; other anonymous or unlinked HIV testing programs; blood banks; plasma centers; and blinded and/or unlinked seroprevalence studies are exempt from these HIV reporting regulations.
Note: Authority cited: Sections 100180, 100275, 120125 and 120130, Health and Safety Code. Reference: Sections 100180, 120175, 120775, 120885-120895 and 121025, Health and Safety Code.
s 2650. Canine Rabies Vaccine Advisory Committee.
The Director shall appoint a Canine Rabies Vaccine Advisory Committee consisting of 6 to 8 members. The Committee's responsibility shall be to assist the Department in evaluating the effectiveness of canine rabies vaccines. Membership shall include individuals with recognized professional expertise in at least one of the fields of immunology, virology, epidemiology, public health and veterinary medicine. Committee members shall serve without compensation but shall be reimbursed for actual and necessary expenses incurred during service on the committee. Canine rabies vaccines that have been approved by the Animal and Plant Health Inspection Service (APHIS), U.S. Department of Agriculture, shall be evaluated for the degree of effectiveness by the Canine Rabies Vaccine Advisory Committee. In order to evaluate vaccine effectiveness the committee shall:
(a) Review test data submitted by canine rabies vaccine manufacturing firms, for approval of canine rabies vaccines.
(b) Make recommendations for Departmental approval or disapproval of canine rabies vaccines.
(c) Make recommendations concerning approval of any variances from the established standards for acceptance of canine rabies vaccines.
Note: Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code.
s 2651. Approval of Canine Rabies Vaccines.
(a) In order for a canine rabies vaccine to be approved for use in California, it shall adhere to the following requirements:
(1) Meet Animal and Plant Health Inspection Service (APHIS) standards for sterility and safety. Evidence of product conformance to APHIS Standards will be demonstrated by the United States Department of Agriculture (USDA) product licensing; and
(2) If an inactivated vaccine, it shall have a minimal relative potency (RP) at vaccination of at least 2.0 as determined by the National Institute of Health (NIH)Test for potency or if a modified live virus (MLV) vaccine it shall meet USDA potency Requirements; and
(3) Demonstrate an immunity duration of three or more years based on an immunity duration challenge study conducted in conformity with section 2652; and
(4) Comply with the origin and integrity of Rabies Vaccine Virus Requirements in section 2653.
Note: Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code.
s 2652. Immunity Duration-Challenge Studies.
(a) The demonstration of an acceptable immunity duration of three or more years, as shown by adequate challenge studies in dogs, shall be required. However, the above challenge study shall not suffice for acceptance of a subsequent multiple vaccine product that contains the same rabies vaccine as one of two or more component vaccines.
(b) Vaccine Trial Protocols. Vaccine trial protocols shall be submitted to the Department by vaccine manufacturers prior to beginning the immunity duration challenge study. The protocol shall include animals, materials, methods and procedures. The protocol shall include the identification number of each animal, its source and/or that of its mother, if applicable, sex, age, breed and the name, address, and telephone number of a contact person who can verify personal knowledge of the dog's vaccination history. Annual progress reports and a final report of the immunity-duration challenge study shall be submitted to the Department. The reports shall include by date for each dog its rabies antibody titers, other immunizations, medications, illnesses, unusual events and death, if applicable, as well as any changes or developments in reference to animals, materials, methods, and procedures. The Department shall supply firms with an outline to report the foregoing information. The outline will include the following items:
(1) "Protocol for Proposed Rabies Vaccine Immunity Duration Challenge Study";
(2) "Procedures and Preliminary Data Attending Initiation of Canine Rabies Vaccine Immunity Duration Challenge Study";
(3) "Progress Report: One Year Postvaccination";
(4) "Progress Report: Two Years Postvaccination";
(5) "Final Report";
(6) "Results of Challenge"; and
(7) "Progress Report for Three Years Postvaccination."
The Veterinary Public Health Unit, 714 P Street, Room 760, Sacramento, California 95814 will provide this outline upon request.
(c) Dogs Used in Studies. No pound dogs or other dogs of undeterminable rabies vaccination history shall be used in the study. Dogs shall be obtained from the original owner since birth or have verifiable histories. Groups of vaccinates and control dogs shall be of approximately equal composition, according to numbers, sex ratio (approximately 50:50), age, and origin. As much as is possible, dogs of uniform size or conformation shall be used. No dog shall be used which has had prior rabies immunization or which has detectable serum rabies neutralizing antibodies. Dogs under 8 months of age used in studies shall not originate from rabies-immunized mothers. No dog shall be over 1 1/2 years of age at vaccination or when set aside as a control.
(d) Size of Challenge Groups. Challenge groups, both vaccinates and nonimmunized controls, shall each consist of 30 or more dogs at challenge. Any additional (extra or back-up) dogs, intended to replace vaccinates or controls that die prior to challenge, shall be included in either the vaccinate or the control group prior to the initiation of the study and subsequently treated, sampled and reported on as either a vaccinate dog or as a control dog. The use of additional sets of vaccinate and/or control dogs to be challenged simultaneously, or at an earlier or later date, shall not be recognized as representative of separate trials. Instead, the serological results subsequent to vaccination and the reactions to challenge of all groups, sets, and individual dogs shall be included in the overall analysis on a cumulative basis. Failed antibody response or failed reaction to challenge at any time shall disqualify subsequent trial phases.
(e) Route and Site of Vaccination. MLV vaccines shall be inoculated intramuscularly at one site in the thigh. Inactivated vaccines may be inoculated by any single route and single site which provides the required protection against challenge at least 3 years post vaccination and is shown to be safe. The exact site and route of inoculation shall be described.
(f) New Route and/or Site of Vaccination. If a firm changes its recommended route and/or site of vaccination of a previously approved vaccine, the vaccine shall be tested as a new product, and the firm shall complete another satisfactory immunity duration-challenge study of 3 years or greater duration before the new route and/or site of vaccination shall be approved.
(g) Additional Vaccinations. Excepting food and water, no vaccinate or control dog shall be exposed to any vaccine, drug, or other substance by any route within three weeks prior to any bleeding for antibody test or within three weeks prior to or at any time after challenge with rabies virus except at euthanasia.
(h) Serology. Standard serum virus-neutralization tests done in mice (MSNT) or the rapid rabies fluorescent focus inhibition test (RFFIT) shall be used in comparing the immunogenicity of different products. No substitute test reagents or substitute tests shall be accepted.
(1) Test results shall be reported for the vaccinate group and controls. Serum virus-neutralization titrations shall be performed on sera of (1) all dogs prior to vaccination; (2) vaccinates at the end of post vaccination months 1, 3, 6, 9, 12, 18, 24, 30 and 36 just prior to challenge; (3) controls at the end of month 36 just prior to challenge; and (4) survivors just prior to euthanasia.
(2) At years post vaccination, all vaccinate dogs shall have demonstrable serum rabies antibody titers, the median titer being equal to, or greater than, 1:15 by the MSNT or an equivalent test.
(3) At 3 years post vaccination, at least 90 per cent of vaccinates shall have demonstrable titers by the MSNT, the median titer being equal to, or greater than, 1:10 by the MSNT or an equivalent test.
(i) Incidental Deaths or Deletions. There shall be a complete accounting for all dogs used in the study, including any that die or are killed after the start of the study or any withdrawn from participation for any reason. Each such dog shall be accounted for by dates and details of illness, treatment and death, the cause of death with supportive diagnostic test results, and rabies serology records. Each such dog shall be tested for rabies infection by Fluorescent Rabies Antibody (FRA) test followed by the mouse inoculation test if the FRA test is negative.
(j) Challenge Virus and Dose. The challenge virus inoculum shall be infective carnivore salivary gland suspension supernate of a North American carnivore "street" rabies virus. The dose of challenge virus given shall be estimated by titration prior to challenge and confirmed by titration of residual challenge inoculum. The dose of challenge virus shall be as low as possible while still achieving a mortality of 80 - 100 per cent in controls. The dose given each dog shall not exceed 200,000 mouse intracranial 50 percent lethal doses (MICLD50), or a demonstrably equivalent dose as determined by an alternate method of titration.
(k) Challenge Route and Procedure. Only challenge virus inoculum shall be inoculated into the masseter muscles of vaccinate dogs or control dogs at any time. Challenge virus shall be inoculated intramuscularly into the masseter muscles, the viral dose being divided into two equal parts for bilateral inoculation. Should a challenge route or site other than the intramasseter route be used, the firm employing the route or site shall demonstrate in a trial previously approved by the Department, the effectiveness and appropriateness of the post challenge holding period and compensate for any related increase in incubation period and decrease in susceptibility. All animals, vaccinates and controls, shall be challenged at the same time, either on an alternate basis (i.e., a vaccinate, followed by a control, followed by a vaccinate, etc.) or the vaccinates shall be challenged first and the controls challenged immediately afterwards. A separate needle and a separate syringe shall be used for each dog.
(l) Individual Enclosure for Each Challenged Dog. Each dog shall be kept in an individual enclosure, preventing its contact with any other animal.
(m) Post challenge Observation Period. Challenged dogs, retained in isolation, shall be observed for a minimum of 90 days prior to final bleeding, euthanasia, and rabies testing of their brains.
(n) Mortality in Challenged Animals. With rare exceptions, all vaccinates shall survive challenge. Eighty to one hundred percent of challenged controls shall die of rabies.
(o) Confirmatory Rabies Diagnostic Tests on Brains of Dogs that Die and on Brains of Survivors. Brains of dogs that die and brains of dogs that survive challenge shall be tested by fluorescent rabies antibody (FRA) test, followed by mouse-inoculation test if the former is negative; dead mice shall be confirmed as rabies-infected by FRA test on their brains. Dogs that die at any time following administration of a live virus vaccine shall be tested for possible rabies vaccine virus infection, using tests suitable to disclose, recover, and identify the strain of vaccine virus.
Note: Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code.
s 2653. Origin and Integrity of Rabies Vaccine Virus.
The Department shall be provided with comprehensive information on the origin, passage level, and sub-passage history of rabies viruses used in the development and production of rabies vaccines being submitted for approval. The integrity of the rabies virus used in the production of the vaccine shall be maintained without further modification once the vaccine is approved for use in the Department's rabies control program.
Note: Authority cited: Section 1920(b), Health and Safety Code. Reference: Section 1920(b), Health and Safety Code.
s 2800. Activities of Daily Living.
"Activities of daily living" means bathing, dressing, feeding oneself, brushing one's teeth, and performing more complex tasks such as grocery shopping, cooking, management of personal finances, and operating a motor vehicle.
Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.
s 2802. Alzheimer's Disease and Related Disorders.
"Alzheimer's disease and related disorders" means those illnesses that damage the brain causing irreversible, progressive confusion, disorientation, loss of memory and judgment.
Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.
s 2804. Diagnose.
"Diagnose" means to identify the existence of a medical condition in a patient.
Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.
s 2806. Disorders Characterized by Lapses of Consciousness.
(a) "Disorders characterized by lapses of consciousness" means those medical conditions that involve:
(1) a loss of consciousness or a marked reduction of alertness or responsiveness to external stimuli; and
(2) the inability to perform one or more activities of daily living; and
(3) the impairment of the sensory motor functions used to operate a motor vehicle.
(b) Examples of medical conditions that do not always, but may progress to the level of functional severity described in subsection (a) of this section include Alzheimer's disease and related disorders, seizure disorders, brain tumors, narcolepsy, sleep apnea, and abnormal metabolic states, including hypo-and hyperglycemia associated with diabetes.
Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.
s 2808. Sensory Motor Functions.
"Sensory motor functions" means the ability to integrate seeing, hearing, smelling, feeling, and reacting with physical movement, such as depressing the brake pedal of the car to stop the car from entering an intersection with a green traffic light to avoid hitting a pedestrian crossing the street.
Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.
s 2810. Reporting Requirements.
(a) Except as provided in Section 2812, a physician and surgeon shall notify the local health officer within seven (7) calendar days of every patient 14 years of age or older, when a physician and surgeon has diagnosed a disorder characterized by lapses of consciousness (as defined in Section 2806) in a patient.
(b) The report prepared pursuant to subsection (a) of this section shall include:
(1) The name, address, date of birth, and diagnosis of the patient; and
(2) The name, address, and phone number of the physician and surgeon making the report.
Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.
s 2812. Exceptions to Reporting.
A physician and surgeon shall not be required to notify the local health officer of a patient with a disorder characterized by lapses of consciousness if:
(a) The patient's sensory motor functions are impaired to the extent that the patient is unable to ever operate a motor vehicle, or
(b) The patient states that he or she does not drive and states that he or she never intends to drive, and the physician and surgeon believes these statements made by the patient are true, or
(c) The physician and surgeon previously reported the diagnosis and, since that report, the physician and surgeon believes the patient has not operated a motor vehicle, or
(d) There is documentation in the patient's medical record that another physician and surgeon reported the diagnosis and, since that report, the physician and surgeon believes the patient has not operated a motor vehicle.
Note: Authority cited: Sections 100275 and 103900, Health and Safety Code. Reference: Section 103900, Health and Safety Code.
s 2890. Confidential Nature of Crippled Children's Records.
Note: Authority cited: Sections 208, 249, 268, and 271, Health and Safety Code.
s 2900. Case Finding and Reporting.
Note: Authority cited for s 2900 to 2904, inclusive: Sections 208 and 249, Health and Safety Code.
s 2901. Definition.
Note: Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code.
s 2902. Records and Reports.
s 2903. Diagnostic Services.
Note: Additional authority cited: Section 1509, Health and Safety Code.
s 2904. Treatment.
s 2905. After-Care Services.
s 2906. Authorization for Services.
Note: Authority cited: Sections 102 and 208, Health and Safety Code, Reference: Art. 2, Ch. 2, Pt. 1, Div. 1, Health and Safety Code.
s 2907. Bone Marrow Transplantation for Cancer.
Note: Authority cited: Section 208(a), Health and Safety Code. Reference: Section 273, Health and Safety Code.
s 2910. Program Administration.
Note: Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code.
s 2912. Use of Fund.
Note: Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code.
s 2914. Extensive Medical Care.
Note: Authority cited: Sections 208 and 429.35, Health and Safety Code. Reference: Section 429.35, Health and Safety Code.
s 2920. California Children Services (CCS).
Note: Authority cited: Section 208 (a), Health and Safety Code. Reference: Section 255.5 and 255.6, Health and Safety Code.
s 2921. California Children Services (CCS) Panel.
Note: Authority cited: Section 208(a), Health and Safety Code. Reference: Sections 255.5 and 255.6, Health and Safety Code.
s 2922. Expertise in the Care of Children.
Note: Authority cited: Section 208(a), Health and Safety Code. Reference: Section 255.6, Health and Safety Code.
s 2923. General Supervision.
Note: Authority cited: Section 208(a), Health and Safety Code. Reference: Section 255.5, 262 and 268, Health and Safety Code.
s 2930. Genetically Handicapped Persons Program.
The Genetically Handicapped Persons Program (GHPP) is a health care program within the California Children Services (CCS) Branch which provides medical care and other related services for persons with the genetically handicapping conditions specified in Section 2932 of this chapter.
Note: Authority cited: Sections 208(a) and 341, Health and Safety Code. Reference: Section 341, Health and Safety Code.
s 2931. California Children Services/Genetically Handicapped Persons Program Special Care Center.
(a) A California Children Services (CCS)/Genetically Handicapped Persons Program (GHPP) Special Care Center is a medical center which provides diagnostic and treatment services (inpatient, outpatient and home) to CCS clients under 21 years of age who have GHPP eligible conditions, and to GHPP clients over 21 years of age.
(b) California Children Services/Genetically Handicapped Persons Program Special Care Centers include the following:
(1) Hemophilia Center
(2) Cystic Fibrosis Center
(3) Sickle Cell Disease Center
(4) Specified Inherited Neurologic Disease Center
(5) Amniocentesis Center
(6) Metabolic Disease Center
Note: Authority cited: Sections 208(a) and 341, Health and Safety Code. Reference: Sections 340, 341 and 342, Health and Safety Code.
s 2932. Medical Eligibility -Conditions.
(a) The following medical conditions are eligible for services through the GHPP program:
(1) Hemophilia, which includes any congenital hereditary hemorrhagic state due to a defect in the hemostatic mechanism resulting from a deficiency or abnormality in one of the plasma clotting factors or platelets including:
(A) Factor I deficiency
(B) Factor II deficiency
(C) Factor V deficiency
(D) Factor VII deficiency
(E) Factor VIII deficiency
(F) Factor IX deficiency
(G) Factor X deficiency
(H) Factor XI deficiency
(I) Factor XIII deficiency
(J) von Willebrand's Disease
(K) Congenital hereditary platelet deficiency diseases or dysfunction such as congenital thrombasthenia (Glanzman's thrombasthenia) and thrombocytopathia
(2) Cystic fibrosis
(3) Hemoglobinopathies with anemia including:
(A) Sickle Cell Disease, but not sickle cell trait
(B) Thalassemia
(4) Chronic degenerative neurological diseases:
(A) Huntington's Disease
(B) Joseph's Disease
(C) Friedreich's Ataxia, genetic ataxias due to spinocerebellar degeneration.
1. Hereditary spastic paraplegia
2. Roussy-Levy Syndrome
3. Olivopontocerebellar degeneration
4. Refsum's disease
5. Charcot-Marie-Tooth Syndrome
(5) The following metabolic diseases:
(A) Disorder of amino-acid transport and metabolism
1. Phenylketonuria
2. Other disturbances of armoatic amino-acid metabolism
a. Tyrosinemia
3. Disturbances of branched chain amino-acid metabolism
a. Disturbances of metabolism of leucine, isoleucine, valine
b. Hypervalinemia
c. Intermittent branched-chain ketonuria
d. Leucine-induced hypoglycemia
e. Leucinosis
f. Maple syrup urine disease
g. Propionic and methylmalonic acidemias
h. Lactic and pyruvate metabolism disorders
i. Hereditary orotic (pyrimidine acidemia)
4. Disturbances of sulphur bearing amino-acid metabolism
a. Homocystinuria
b. Hypermethioninemia
5. Urea cycle disorders
a. Argininosuccinic aciduria
b. Citrullinemia
c. Disorders of metabolism of ornithine, citrulline, argininossuccinic acid, arginine, and ammonia
d. Hyperammonemia
e. Hyperornithinemia
(B) Disorders of carbohydrate transport and metabolism
1. Galactosemia
a. Galactose-1-phosphate uridyl transferase deficiency
b. Galactosuria
(C) Disorders of copper metabolism
1. Wilson's disease
Note: Authority cited: Sections 208(a) and 341, Health and Safety Code. Reference: Sections 341 and 341.5, Health and Safety Code.
s 2950. Qualifications.
The qualifications required for registration as school audiometrist shall be as follows:
(a) Satisfactory completion of required training in audiology, audiometry and hearing assessment at an accredited university or college. Such training must include a minimum of eight quarter hours, or equivalent, academic and practical preparation in audiology, identification audiometry and hearing assessment in courses approved by the Hearing Conservation Specialist of the State Department of Health Services. If the applicant completed the required training more than five years prior to the date of application for registration, the applicant must have had at least one year of verified supervised experience in the interim in the administration of hearing tests to school children in the public or parochial schools, or in other tax maintained educational institutions in this State. Verification will be documented in writing by the applicant's supervisor.
(b) Public health nurses and credentialed school nurses may either fulfill the requirements of subsection (a) or demonstrate satisfactory completion, at an accredited university or college, of a four quarter hours, or equivalent, hearing assessment course approved by the Hearing Conservation Specialist of the Department of Health Services.
(c) For purposes of subsections (a) and (b) accreditation of colleges or universities shall be by one of the following accrediting associations:
(1) New England Association of School and Colleges.
(2) Middle States Association of Colleges and Secondary Schools.
(3) North Central Association of Colleges and Secondary Schools.
(4) Northern Association of Schools and Colleges.
(5) Southern Association of Colleges and Schools.
(6) Western Association of Schools and Colleges.
(d) Applicants for registration as school audiometrists shall complete State Form Application for Registration as School Audiometrist PM 101 and submit the completed form to the State Department of Health Services, 714 P Street, Sacramento, CA 95814.
(e) A registration fee of $10.00 shall accompany each application.
(f) An applicant for registration as school audiometrist shall receive written notification informing the applicant that the application is complete and approved, or that the application is deficient and what specific information is required. Notification must occur within two weeks of receipt of the application by the State Department of Health Services. This two week time period is a median based on a minimum of one week and maximum of three weeks actual performance in 1985 and 1986.
(g) Within four weeks of receipt of an approved application, the State Department of Health Services shall issue a certification of registration to the applicant.
Note: Authority cited: Sections 208 and 1686, Health and Safety Code. Reference: Sections 1685 and 1686, Health and Safety Code; and Section 44879, Education Code, and Section 15374 et seq., Government Code.
s 2951. Testing Standards.
Schools conducting hearing testing shall comply with the following criteria:
(a) Equipment.
(1) Hearing threshold tests.
(A) Pure tone audiometers used for testing of hearing thresholds shall be those manufactured to meet or exceed specifications for wide range or limited range audiometers as defined by American National Standards Institute (ANSI) Specification Section 3.6-1969, Subsection 2.1.1 (published in 1969) and shall be maintained to meet such specifications. Such audiometers shall be designed to operate from alternating current supply voltages and meet the stability standards defined in Subsection 4.6 of American National Standards Institute (ANSI) Section 3.6-1969 Specifications.
(2) Hearing screening test.
(A) Pure tone audiometers used for hearing screening tests shall be those manufactured to meet or exceed specifications for wide range audiometers or limited range audiometers as defined by the American National Standards Institute (ANSI) Section 3.6-1969, Subsections 2.1.1 and 2.1.2 and shall be maintained to meet such specifications.
(B) Pure tone audiometers used for hearing screening tests shall not be battery powered. Audiometers in use on the effective date of the amendment to the regulations may be utilized until they no longer meet American National Standards Institute (ANSI) Section 3.6-1969 Specifications, Subsections 1 through 4.9.2.
(3) Care of equipment.
(A) Audiometric testing personnel shall be trained in the proper care of the testing equipment.
(B) Biological checks.
Audiometric testing personnel shall maintain continuous surveillance of the audiometer used, by performing biological checks as follows:
1. Daily. A brief biological check of the audiometer shall be made each day the audiometer is in use. The check shall consist of testing each earphone on a person with stable audiometric thresholds that do not exceed 25 decibel hearing level at any frequency tested between 500 Hertz and 4000 Hertz and comparing the test results with the subject's baseline audiogram. The subject may be the audiometrist.
2. Monthly. A detailed biological check of the audiometer which includes a careful listening test of earphones to insure that the audiometer displays no evidence of
a. Cross talk;
b. Signal distortion;
c. Transient clicks;
d. Abnormal noise; or,
e. Intermittent signal.
(C) Calibration.
1. An electroacoustic calibration check of audiometers shall be made at least every 12 months, or more frequently if indicated by the biological checks, and meet or exceed the specifications outlined in Subsections 1 through 4.9.2., American National Standards for Audiometers, published by the American National Standards Institute (ANSI), Inc. (published in 1969).
2. A calibration chart, showing proof of performance, shall be kept with the audiometer.
(b) Test environment.
(1) For audiometric threshold testing and screening testing, the environmental noise level shall not exceed 41.5 decibel sound pressure level in the 500 Hertz band, 49.5 decibel sound pressure level in the 1000 Hertz band, and 54.5 decibel sound pressure level in the 2000 Hertz band, and 62 decibel sound pressure level in the 4000 Hertz band; or, (continued)