Public Health Law Flashcards
§ 1075
Local Health Departments.
‘Each local health department SHALL have available the services of an official public health laboratory. The laboratory of the State Department of Health is hereby designated as the official laboratory for all local health department jurisdictions NOT covered by local laboratory service.’
17 CCR § 1076
Certificates of Approval Required.
‘A certificate of approval issued after inspection by the Department SHALL be required to be in the possession of AND be on display in every principal and branch public health laboratory AND no such laboratory shall continue to operate following receipt of notice of cancellation of any existing certificate, OR of refusal of the Department to issue a certificate.’
17 CCR § 1078
Minimum Requirements Specified.
Any laboratory approved under Section 1076 SHALL meet the following minimum requirements:
(e) Demonstrate satisfactory performance in a proficiency testing program approved by the Department
(h) Accept specimens for examination as an aid to patient management only from, AND issue reports only to, persons licensed under the provisions of the law relating to the healing arts OR their representatives.’
17 CCR § 1079
Professional Personnel to be Certified.
‘(a) No person may act as a Public Health Microbiologist in any laboratory certified under Section 1076 who is NOT in possession of a Public Health Microbiologist’s Certificate issued by the Department.
(c) Examinations, either written or oral, or both, for the certificate of Public Health Microbiologist shall be held as needed and where designated by the Department. Such examinations shall be under the supervision of the Department.’
‘(d) The minimum requirements for admission to the examinations for a certificate as Public Health Microbiologist SHALL be as follows:
(1) Holds an earned doctoral degree from an accredited institution with a chemical, physical or biological science as a major, AND has completed at least one year of postdoctoral laboratory training in medical and public health microbiology approved by the Department; OR
(2) A baccalaureate or higher degree with a major in Medical or Public Health Microbiology, or equivalent major as determined by the Department, with courses acceptable to the Department, ……………; AND experience represented by at least six months as a Public Health Microbiologist-trainee in a public health laboratory approved by the Department for such training; OR experience equivalent to this training as determined by the Department in a laboratory acceptable to the Department.
‘(e) No person SHALL perform Any test or make any examination in Any laboratory certified under Section 1076 unless he is in possession of a valid Public Health Microbiologist’s certificate OR is otherwise approved by the Department to perform specified laboratory procedures.
(f) Every person certified as a Public Health Microbiologist SHALL report to the Department within 30 days Any change of name or mailing address giving both the old and new names and addresses.’
17 CCR § 1080
Professional Training.
‘(a) For purposes of this section a person receiving professional training required for certification as a Public Health Microbiologist SHALL be designated as a Public Health Microbiologist-trainee.
(b) The credentials of a Public Health Microbiologist-trainee SHALL be approved by the Department PRIOR to appointment.
(e) A Public Health Microbiologist-trainee SHALL NOT be entrusted with ANY microbiological examination EXCEPT under the supervision of qualified personnel, NOR SHALL he issue OR sign a laboratory report for ANY test which he is scheduled for training for certification as a Public Health Microbiologist.’
17 CCR § 1081
Certain Cultures and Specimens to be Sent to the State Laboratory.
(a) All laboratories making examinations for identification of typhoid carriers SHALL, in all positive cases, forward to the Department a culture of the organism, the isolation of which established the diagnosis.
(b) Whenever a laboratory receives a specimen for the laboratory diagnosis of suspected human cases of plague or botulism such laboratory SHALL communicate immediately by telephone or telegraph with the Department for instructions.
(c) Any other specimens or cultures SHALL be submitted as required by the communicable disease regulations, Sections 2500 to 2699.’
17 CCR § 1082
Certain Specimens to be Sent to Approved Laboratories.
‘Whenever specimens are taken for laboratory diagnosis of rabies or botulism, OR for release from isolation of cases of diphtheria, typhoid fever, salmonellosis, or shigellosis, they SHALL be sent by the physician to a Public Health Laboratory approved for such work by the Department in accordance with Section 1076.’
17 CCR § 1083
Inspections to be Made.
‘Laboratories approved under Section 1076 SHALL be inspected by a duly authorized representative of the Department, for maintenance AND conduct in conformity with these regulations. ……..’
17 CCR § 2500.
‘(8) ‘Communicable disease’ means an illness due to a specific microbiological or parasitic agent or its toxic products which arises through transmission of that agent or its products from an infected person, animal, or inanimate reservoir to a susceptible host, either directly or indirectly through an intermediate plant or animal host, vector, or the inanimate environment.’
(15) ‘Health care provider’ means a physician and surgeon, a veterinarian, a podiatrist, a nurse practitioner, a physician assistant, a registered nurse, a nurse midwife, a school nurse, an infection control practitioner, a medical examiner, a coroner, or a dentist
(16) ‘Health officer’ and ‘local health officer’ as used in this subchapter includes county, city, and district health officers.’
(b) It SHALL be the duty of every health care provider, knowing of or in attendance on a case or suspected case of any of the diseases or conditions listed in subsection (j) of this section, to report to the local health officer for the jurisdiction where the patient resides as required in subsection (h) of this section. Where no health care provider is in attendance, any individual having knowledge of a person who is suspected to be suffering from one of the diseases or conditions listed in subsection (j) of this section may make such a report to the local health officer for the jurisdiction where the patient resides.’
‘(h) The urgency of reporting is identified by symbols in the list of diseases and conditions in subsection (j) of this section.
Those diseases with a diamond (<>) are considered emergencies and SHALL be reported immediately by telephone.
Those diseases and conditions with a cross (+) SHALL be reported by mailing, telephoning, or electronically transmitting a report within one (1) working day of identification of the case or suspected case, EXCEPT for acute HIV infection reporting which SHALL be reported by telephone (see (k) for specific requirements). ‘
‘Those diseases and conditions NOT otherwise identified by a diamond or a cross SHALL be reported by mailing a written report, telephoning, or electronically transmitting a report within seven (7) calendar days of the time of identification.’
‘(i) For foodborne disease, the bullet (•) symbol indicates that, when two (2) or more cases or suspected cases of foodborne disease from separate households are suspected to have the same source of illness, they SHALL be reported immediately by telephone.’ Health care providers SHALL submit reports for the following diseases or conditions. <> Anthrax, human or animal <> Botulism (Infant, Foodborne, Wound, Other) <> Brucellosis, human <> Cholera <> Ciguatera Fish Poisoning <> Dengue virus infection <> Diphtheria <> Domoic Acid Poisoning (Amnesic Shellfish Poisoning) <> Escherichia coli: shiga toxin producing (STEC) including E. coli O157 <> Flavivirus infection of undetermined species <> Hemolytic Uremic Syndrome <> Influenza, novel strains (human) <> Measles (Rubeola) <> Meningococcal Infections <> Novel virus infection with pandemic potential <> Paralytic Shellfish Poisoning <> Plague, human or animal <> Rabies, human or animal <> Scombroid Fish Poisoning <> Shiga toxin (detected in feces) <> Tularemia, human <> Viral Hemorrhagic Fevers, human or animal (e.g., Crimean- Congo, Ebola, Lassa and Marburg viruses) <> Yellow Fever <> Zika virus infection <>
OUTBREAKS of ANY DISEASE (Including diseases not listed in Section 2500). Specify if institutional and/or open community <> OCCURRENCE of ANY UNUSUAL DISEASE \+ Amebiasis \+ Babesiosis \+ Campylobacteriosis \+ Chickenpox (Varicella) (outbreaks, hospitalizations and deaths) \+ Chikungunya virus infection \+ Cryptosporidiosis Cyclosporiasis Cysticercosis or taeniasis \+ Encephalitis, Specify Etiology: Viral, Bacterial, Fungal, Parasitic \+ Haemophilus influenzae, invasive disease, all serotypes (report an incident of less than five years of age) \+ Hantavirus Infections \+ Hepatitis A, acute infection
+
Human Immunodeficiency Virus (HIV), acute infection,
(see (k) for additional reporting requirements)
\+ Listeriosis \+ Malaria \+ Meningitis, Specify Etiology: Viral, Bacterial, Fungal, Parasitic \+ Pertussis (Whooping Cough) \+ Relapsing Fever \+ Salmonellosis (Other than Typhoid Fever) \+ Smallpox (Variola) \+ Tuberculosis
+
Shigellosis
\+ Streptococcal Infections (Outbreaks of Any Type and Individual Cases in Food Handlers and Dairy Workers Only) \+ Syphilis Tetanus \+ Trichinosis \+ Typhoid Fever, Cases and Carriers \+ Vibrio Infections \+ West Nile virus infection \+ Yersiniosis \+ • Foodborne Disease Giardiasis Gonococcal Infections
Anaplasmosis
Brucellosis, animal (except infections due to Brucella canis)
Chancroid
Chlamydia trachomatis infections, including lymphogranuloma venereum (LGV)
Coccidioidomycosis
Creutzfeldt-Jakob Disease (CJD) and other Transmissible Spongiform Encephalopathies (TSE)
Hepatitis B (specify acute case or chronic)
Hepatitis C (specify acute case or chronic)
Hepatitis D (Delta) (specify acute case or chronic)
Hepatitis E, acute infection
Human Immunodeficiency Virus (HIV) infection, stage 3 (AIDS)
Legionellosis
Leprosy (Hansen’s Disease)
Leptospirosis
Lyme Disease
Mumps
Respiratory syncytial virus (only report a death in a patient less than five years of age)
Rickettsial Diseases (non-Rocky Mountain Spotted Fever), including Typhus and Typhus-like Illnesses
Rocky Mountain Spotted Fever Rubella (German Measles) Rubella Syndrome, Congenital Tularemia, animal ‘(k) In addition to routine reporting requirements set forth in section 2643.5, for acute HIV infection reporting, health care providers SHALL report all cases within one (1) working day to the local health officer of the jurisdiction in which the patient resides by telephone.
If evidence of acute HIV infection is based on presence of HIV p24 antigen, providers SHALL NOT wait until HIV-1 RNA is detected before reporting to the local health officer.’
17 CCR § 2502
‘(a)Summary Reports: Each local health officer SHALL report at least weekly, ……… to the Director the number of cases of those diseases, conditions, unusual diseases or outbreaks of disease reported pursuant to Section 2500. ‘
(c) Immediate Reports: Cases and suspect cases of anthrax (human or animal), botulism, brucellosis (human only), cholera, dengue, diphtheria, measles (rubeola), plague (human or animal), rabies (human only), smallpox (variola), tularemia (human only), varicella deaths, viral hemorrhagic fevers (human or animal), yellow fever, occurrence of any unusual diseases, and outbreaks of any disease are to be reported by the local health officer to the Director immediately by telephone.’
17 CCR § 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,
EXCEPT for acute HIV infection reporting which SHALL be reported to the local health jurisdiction in which the patient resides by telephone (see (j) for specific acute HIV infection reporting requirements). If the patient residence is unknown, the laboratory SHALL notify the health officer of the jurisdiction in which the health care provider is located.’
‘(a)
(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.’
‘(a).
(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, EXCEPT for acute HIV infection reporting which SHALL be reported to the local health jurisdiction in which the patient resides by telephone (see (j) for specific acute HIV infection reporting requirements). 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, 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.’
‘(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. …….’
‘(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 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 in writing submitted by electronic facsimile transmission or electronic mail to the local health officer.
‘ ………..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.. ……..’
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)
Influenza, novel strains (human) (see (i) for additional reporting requirements)
Plague, human (see section 2596 for additional reporting instructions)
Plague, animal
Tularemia, human (F. tularensis) (see section 2626 for additional reporting instructions)
Viral Hemorrhagic Fever agents, human AND animal (VHF), e.g., Crimean-Congo, Ebola, Lassa, and Marburg viruses (see section 2638 for additional reporting instructions)
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:
(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 local health officer by courier, mail, electronic facsimile or electronic mail, EXCEPT for acute HIV infection reporting which SHALL be reported by telephone (see (j) for specific acute HIV infection reporting requirements).
‘……. all List (e)(2) diseases SHALL be reported electronically to the state electronic reporting system within one working day of identification.
Acute HIV infection SHALL be reported both by telephone AND to the state electronic reporting system within one working day of identification. …..’
‘The diseases or agents reported pursuant to this requirement are:’
Acid fast bacillus (AFB) (see (g) for additional reporting requirements)
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)
Cryptosporidiosis
Dengue virus infection
Entamoeba histolytica (not E. dispar)
Escherichia coli shiga toxin producing (STEC) including E. coli O157(see (m) for additional reporting requirements)
Giardiasis (Giardia lamblia, intestinalis , or duodenalis)
Rocky Mountain Spotted Fever (Rickettsia rickettsii)
Salmonellosis Salmonella spp.) (see Section 2612 (a) for additional reporting requirements)
Shiga toxin (detected in feces) (see (l) for additional reporting requirements)
Shigellosis (Shigella spp.)
Syphilis
Tuberculosis
Tularemia, animal (F. tularensis)
Typhoid
Vibrio species infections
West Nile virus infection
Yersiniosis (Yersinia spp., non-pestis) (isolation from a clinical specimen)
Zika virus infection
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. ‘
‘(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. ……….‘
‘(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. …..’
‘(i) Whenever a laboratory receives a specimen for the laboratory diagnosis of influenza, novel strains in a human such laboratory SHALL communicate immediately by telephone with the Department’s Viral and Rickettsial Disease Laboratory for instruction.’
ANTHRAX, BOTULISM, BRUCELLOSIS, GLANDERS, INFLUENZA, NOVEL STRAINS, MELIOIDOSIS, PLAGUE, SMALLPOX, TULAREMIA, and VIRAL HEMORRHAGIC FEVERS
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 Influenza, novel strains, Smallpox or Viral Hemorrhagic Fevers, with the Viral and Rickettsial Disease Laboratory) of the Department of Public Health for instruction.
‘(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 business 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.’
‘(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 health care provider is located. ……..’
The specimens pursuant to the requirements in (m) are:’
HIV-1/2 antigen or antibody reactive sera or plasma submitted as part of a diagnostic HIV test algorithm, as defined in section 2641.57 (see (n) for additional reporting requirements)
Malaria positive blood film slides (see (h) for additional reporting requirements)
Measles immunoglobulin M (IgM)-positive sera
Shiga toxin-positive fecal broths
Zika virus immunoglobulin M (IgM)-positive sera
‘(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 health care provider is located. ……..’
(2) The isolates pursuant to the reporting requirements in (m) are:’
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), including identification of Shiga toxin in a clinical specimen, then the laboratory MUST attempt to obtain a bacterial culture isolate for submission to the public health laboratory in accordance with (m)(2). 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) A laboratory which receives a specimen that is reactive for HIV-1/2 antigen or antibody SHALL communicate with the Department’s Viral and Rickettsial Disease Laboratory for instructions on the specimen submission process. In addition to the information required in (m), a laboratory SHALL also submit the Clinical Laboratory Improvement Amendments number.’
17 CCR § 2506
(b) Isolation. Any rabid animal, clinically suspected rabid animal, or biting animal SHALL be isolated in strict confinement as follows:
(1) Isolation of Rabid Animals or Clinically Suspected Rabid Animals. Any rabid animal or clinically suspected rabid animal SHALL be isolated in strict confinement under proper care and under the observation of a licensed veterinarian, in a pound, veterinary hospital, or other adequate facility in a manner approved by the local health officer, except where such responsibility has been delegated to a comparable officer by the governing body, and SHALL NOT be killed or released for at least 10 days after the onset of symptoms suggestive of rabies, with the exception that such animals may be sacrificed with permission of the local health officer for the purpose of laboratory examination for rabies using the fluorescent rabies antibody (FRA) test in an approved public health laboratory.’
‘(b) Isolation. Any rabid animal, clinically suspected rabid animal, or biting animal SHALL be isolated in strict confinement as follows:
(4) Laboratory Examination of Rabid Animals, Clinically Suspected Rabid Animals or Biting Animals Which Die or Have Been Killed. If any rabid animal, clinically suspected rabid animal or biting animal dies or has been killed, adequate specimens SHALL be obtained AND examined in a public health laboratory approved by the department.
No person SHALL destroy or allow to be destroyed the brain of an animal of a species subject to rabies that has bitten or otherwise exposed a person before the destruction of such brain has been authorized by the local health department; provided, however, that the provisions of this paragraph (4) shall not apply to rodents (members of the order Rodentia ) and rabbits or hares (members of the order Lagomorpha ).’
17 CCR § 2612.
‘(a) Any illness in which organisms of the genus Salmonella (except the typhoid bacillus) have been isolated from feces, blood, urine or pathological material SHALL be reported as a Salmonella infection. A culture of the organisms on which the diagnosis is established SHALL be submitted first to a local public health laboratory AND then to the State Microbial Diseases Laboratory for definitive identification. The period of isolation in accordance with Section 2518 shall be until clinical recovery. The patient shall be subject to supervision by the local health officer who may require, at his discretion, release specimens of feces for testing in a laboratory approved by the State Department of Health Services.’
17 CCR § 2643.10
‘(a) The laboratory director or authorized designee shall, within seven calendar days of determining a confirmed HIV test, report the confirmed HIV test to the Health Officer for the local health jurisdiction where the health care provider facility is located. ‘
‘(b)(1) All reports containing personal information, including laboratory reports, SHALL be sent to the local Health Officer or his or her designee by:
(A) Courier service, U.S. Postal Service Express or Registered mail, or other traceable mail; OR
(B) Person-to-person transfer with the local Health Officer or his or her designee; OR
(C) Provided that, commencing July 1, 2009, or within one year of the establishment of a state electronic laboratory reporting system, whichever is later, a report generated pursuant to Section 120130, or Section 121022, by a laboratory SHALL be submitted electronically in a manner specified by the department.’
‘(2)
(d) If a laboratory transfers a biological specimen to another laboratory for testing, the laboratory that first receives the biological specimen from the health care provider SHALL report confirmed HIV tests to the local Health Officer.’
Kochs Postulate
The microorganism must be found in abundance in all organisms suffering from the disease, but should not be found in healthy organisms.
The microorganism must be isolated from a diseased organism and grown in pure culture.
The cultured microorganism should cause disease when introduced into a healthy organism.
The microorganism must be reisolated from the inoculated, diseased experimental host and identified as being identical to the original specific causative agent.
