LAW
Writer®
Ohio Laws and Rules
As used in Chapter 3701-3 of the Administrative Code:
(A) “Antimicrobial” means an agent that kills microorganisms or suppresses microorganism multiplication or growth.
(B) “Arthropod” means an organism of the phylum Arthropoda, such as an insect, spider, mite or tick.
(C) “Board of health” means the board of health of the city or general health district, or the authority having the duties of a board of health in any city as authorized by section 3709.05 of the Revised Code.
(D) “Child care center” means any private home, institution, or public or private facility in which child care is provided for one or more infants, toddlers, pre-school children, and school children outside of school hours, during any part of the twenty-four hour day, by persons other than the parents or legal guardians of the children in care.
(E) “Department” means the Ohio department of health.
(F) “Diarrhea” means three or more loose stools in a twenty-four hour period.
(G) “Director” means the director of health or his or her designee.
(H) “Endemic” means the constant presence of a disease or infectious agent within a given geographic area.
(I) “Epidemic” or “outbreak” means the occurrence of cases of disease in numbers greater than expected in a particular population or for a particular period of time.
(J) “Exclude” means to bar from participation.
(K) “Food handler” means a person who prepares or serves food intended for human consumption.
(L) “Health district” means a city or general health district as created by Chapter 3709. of the Revised Code.
(M) “Incidence” means the number of new cases of a disease occurring during a specified interval of time in a defined population.
(N) “Infected individual” means a person whose body harbors a specific microorganism capable of producing disease, whether or not the person is experiencing signs or symptoms of the disease.
(O) “Isolation” means the separation of an infected individual from others during the period of disease communicability in such a way that prevents, as far as possible, the direct or indirect conveyance of an infectious agent to those who are susceptible to infection or who may spread the agent to others.
(P) “Period of communicability” means the interval during which an infected individual or animal is shedding the specific microorganism of a communicable disease in such a manner that those who are susceptible could acquire the infection.
(Q) Mammal means a warm blooded animal, other than a human being, usually with hair, that gives birth to live young, which are fed with milk secreted by the female mammary gland.
(R) “Quarantine” means the restriction of the movements or activities of a well individual or animal who has been exposed to a communicable disease during the period of communicability of that disease and in such a manner that transmission of the disease may have occurred. The duration of the quarantine ordered shall be equivalent to the usual incubation period of the disease to which the susceptible person or animal was exposed.
(S) “Sensitive occupation” means direct food handling, direct patient care, the handling of food or provision of direct care to children in a child care center, or any other occupation which provides significant opportunity for an infected individual to transmit infectious disease agents.
(T) “Sexually-transmitted disease” or “venereal disease” is an infectious disease commonly contracted through sexual contact such as chancroid, chlamydia, gonococcal infection, granuloma inguinale, human immunodeficiency virus infection, lymphogranuloma venereum, or syphilis.
(U) “Susceptible person” means a person that, when exposed to an infectious microorganism, may not possess sufficient resistance to prevent contracting the infection or disease.
HISTORY: Eff 3-13-80; 7-23-98; 10-19-03
Rule promulgated under: RC 119.03
Rule authorized by: RC 3701.13, 3701.24, 3701.34, 3707.06
Rule amplifies: RC 3701.24, 3707.06
Replaces: 3701-3-01
R.C. 119.032 review dates: 07/23/2003 and 07/01/2008
The diseases listed in this rule and classified as “Class A”, “Class B”, and “Class C” are declared to be dangerous to the public health and are reportable. The occurrence of cases or suspected cases of a disease classified as “Class A”, “Class B”, or “Class C” shall be reported to the board of health on forms as prescribed and provided by the director and shall be reported in accordance with this rule and Chapter 3701-3 of the Administrative Code.
(A) The following diseases are classified as “Class A” :
(1) Diseases of major public health concern because of the severity of disease or potential for epidemic spread:
(a) Anthrax
(b) Botulism, foodborne, other botulism as set forth in paragraph (A)(3) of this rule;
(c) Cholera;
(d) Diphtheria;
(e) Measles;
(f) Meningococcal disease;
(g) Plague;
(h) Rabies, human;
(i) Rubella (not congenital);
(j) Severe Acute Respiratory Syndrome (SARS)
(k) Smallpox;
(l) Tularemia
(m) Viral hemorrhagic fever (VHF);
(n) Yellow fever; and
(o) Any unexpected pattern of cases, suspected cases, deaths or increased incidence of any other disease of major public health concern, because of the severity of disease or potential for epidemic spread, which may indicate a newly recognized infectious agent, outbreak, epidemic, related public health hazard or act of bioterrorism.
(2) Diseases of public health concern needing timely response because of potential for epidemic spread:
(a) Arboviral neuroinvasive and non-neuroinvasive diseases:
(i) Eastern equine encephalitis virus disease;
(ii) LaCrosse virus disease (other California serogroup virus disease);
(iii) Powassan virus disease;
(iv) St. Louis encephalitis virus disease;
(v) West Nile virus disease (also current infection);
(vi) Western equine encephalitis virus disease;
(vii) Other arthropod-borne disease;
(b) Chancroid;
(c) Cyclosporiasis;
(d) Coccidioidomycosis
(e) Dengue;
(f) E. coli O157:H7 and other enterohemorrhagic (Shiga toxin-producing) E. coli;
(g) Foodborne disease outbreaks;
(h) Granuloma inguinale;
(i) Haemophilus influenzae (invasive disease);
(j) Hantavirus;
(k) Hemolytic uremic syndrome (HUS);
(l) Hepatitis A, other hepatitis as set forth in paragraph (A)(3) of this rule;
(m) Hepatitis B, perinatal; Hepatitis B, non-perinatal, see A(3);
(n) Influenza-associated pediatric mortality
(o) Legionnaires’ disease;
(p) Listeriosis;
(q) Lymphogranuloma venereum;
(r) Malaria;
(s) Meningitis, aseptic, including viral meningoencephalitis, other meningitis as set forth in paragraph (A)(3) of this rule;
(t) Mumps;
(u) Pertussis;
(v) Poliomyelitis (including vaccine-associated cases);
(w) Psittacosis;
(x) Q fever;
(y) Rubella (congenital);
(z) Salmonellosis;
(aa) Shigellosis;
(bb) Staphylococcus aureus, with resistance or intermediate resistance to vancomycin (VISA, VRSA);
(cc) Syphilis;
(dd) Tetanus;
(ee) Tuberculosis (TB), including multi-drug resistant tuberculosis (MDR-TB);
(ff) Typhoid fever; and
(gg) Waterborne disease outbreaks.
(3) Diseases of significant public health concern:
(a) Amebiasis;
(b) Botulism, other botulism as set forth in paragraph (A)(1) of this rule;
(i) Wound;
(ii) Infant;
(c) Brucellosis;
(d) Campylobacteriosis;
(e) Chlamydia infections (urethritis, epididymitis, cervicitis, pelvic inflammatory disease, neonatal conjunctivitis and pneumonia);
(f) Creutzfeldt-Jakob disease (CJD);
(g) Cryptosporidiosis;
(h) Cytomegalovirus (CMV)(congenital);
(i) Ehrlichiosis;
(j) Encephalitis, except as set forth in paragraph (A)(2) of this rule;
(i) Other viral;
(ii) Post-infection;
(k) Giardiasis;
(l) Gonococcal infections (urethritis, cervicitis, pelvic inflammatory disease, pharyngitis, arthritis, endocarditis, meningitis and neonatal conjunctivitis);
(m) Hepatitis B; Hepatitis B, perinatal, see A(2);
(n) Hepatitis C;
(o) Hepatitis D (delta hepatitis);
(p) Hepatitis E;
(q) Herpes (congenital);
(r) Kawasaki disease (mucocutaneous lymph node syndrome);
(s) Leprosy (Hansen Disease);
(t) Leptospirosis;
(u) Lyme disease;
(v) Meningitis, including other bacterial, other meningitis as set forth in paragraph (A)(2) of this rule;
(w) Mycobacterial disease, other than tuberculosis;
(x) Reye syndrome;
(y) Rheumatic fever;
(z) Rocky Mountain spotted fever (RMSF);
(aa) Streptococcal disease, group A, invasive (IGAS);
(bb) Streptococcal disease, group B, in newborn;
(cc) Streptococcal toxic shock syndrome (STSS);
(dd) Streptococcus pneumoniae, invasive disease (ISP);
(ee) Toxic shock syndrome (TSS);
(ff) Toxoplasmosis (congenital);
(gg) Trichinosis;
(hh) Typhus fever;
(ii) Varicella (deaths only);
(jj) Vibriosis; and
(kk) Yersiniosis.
(B) The following disease is classified as “Class B” : Influenza
(C) The following diseases are classified as “Class C” :
(1) Blastomycosis;
(2) Conjunctivitis, acute;
(3) Histoplasmosis;
(4) Nosocomial infections of any type;
(5) Pediculosis;
(6) Scabies;
(7) Sporotrichosis;
(8) Staphylococcal skin infections;
(9) Toxoplasmosis; and
(10) Outbreak, unusual incidence, or epidemic of other infectious diseases of known etiology not categorized as Class A, Class B, or Class C.
Effective: 01/01/2006
R.C. 119.032 review dates: 08/12/2005 and 01/01/2011
Promulgated Under: 119.03
Statutory Authority: 3701.23, 3701.34
Rule Amplifies: 3701.23, 3707.06
Prior Effective Dates: 4/1/1964, 3/13/80, 12/4/81, 9/30/83, 4/17/86, 6/18/90, 10/31/93, 4/9/95, 7/11/96, 1/1/99, 2/15/2001, 10/17/02, 4/4/03
(A) Every physician attending on or called in to visit a patient whom the physician believes to be suffering from any of the occupational diseases or occupationally related ailments listed in paragraph (B) of this rule shall submit a report to the director of health within forty-eight hours from the time of first attending the patient. This report shall be made on, or in conformity with, the standard schedule blanks which the director is required to provide physicians pursuant to section 3701.26 of the Revised Code and shall contain the following information:
(1) The name, address, telephone number, date of birth, race, gender and occupation of the patient;
(2) The name, address, telephone number and business of the patient’s employer;
(3) The nature of the disease or ailment; and
(4) Name, address and telephone number of the physician.
The mailing of the report, within the time required by this paragraph shall constitute compliance with section 3701.25 the Revised Code and this rule.
(B) The following occupational diseases and ailments are required to be reported:
(1) Poisoning from phosphorous, brass, arsenic, mercury, wood alcohol or their compounds;
(2) Anthrax;
(3) Compressed air illness;
(4) Silicosis;
(5) Occupational asthma;
(6) Pesticide poisoning;
(7) Cumulative trauma disorders including, but not limited to carpal tunnel syndrome and persistent and recurring tendinitis;
(8) Poisoning from heavy metals including, but not limited to, lead, nickel and cadmium;
(9) Asbestosis;
(10) Mesothelioma;
(11) Amputation of limb or digit; and
(12) Burn or burns resulting from exposure or contact to chemical, flame, or heat and of such severity as to cause admission into a hospital, burn unit, or other health care facility.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.25, 3701.34
Rule Amplifies: 3701.25, 3701.26
Prior Effective Dates: 7/23/1998, 11/3/90
(A) Section 3701.248 of the Revised Code allows an emergency medical services worker to ask a health care facility or coroner to notify them of the results of tests for certain diseases, if the worker believes that he or she had a significant exposure through contact with a patient. The diseases subject to this procedure are contagious or infectious diseases that the public health council, by rule, has specified as reasonably likely to be transmitted by air or blood during the normal course of an emergency medical services worker’s duties. The diseases listed in paragraph (B) of this rule are specified for purposes of section 3701.248 of the Revised Code.
(B) The following diseases are specified as reasonably likely to be transmitted by air or blood during the normal course of an emergency medical worker’s duties:
(1) Crimean-Congo hemorrhagic fever;
(2) Diphtheria;
(3) Ebola-marburg virus infection;
(4) Fifth disease (human parvovirus infection);
(5) Hansen’s disease (leprosy);
(6) Acute or chronic infection with hepatitis B virus;
(7) Acute or chronic infection with hepatitis C virus;
(8) Infection with delta hepatitis virus;
(9) Human immunodeficiency virus (HIV) infection, including acquired immunodeficiency syndrome (AIDS) and AIDS-related illnesses;
(10) Infection with human t-lymphotropic virus (HTLV-1 and HTLV-2);
(11) Lassa fever;
(12) Leishmaniasis, visceral (Kala-Azar);
(13) Leptospirosis;
(14) Listeriosis pneumonia;
(15) Measles (rubeola);
(16) Meningococcal infection (neisseria meningitidis);
(17) Mumps (infectious parotitis);
(18) Pertussis (whooping cough);
(19) Pneumonic plague (yersinia pestis);
(20) Rabies;
(21) Rubella (German measles);
(22) Tuberculosis; and
(23) Varicella (herpes zoster) infection, including chicken-pox, disseminated varicella, varicella pneumonia, and shingles.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.248
Rule Amplifies: 3701.248
Prior Effective Dates: 3/8/1992
(A) The physician in attendance of a case or suspect case of a disease which is required by law to be reported, including all “class A”, “class B”, and “class C” categories of disease designated as reportable under rule 3701-3-02 of the Administrative Code, shall submit a case report to the board of health of the health district in which the patient resides.
(B) A person in charge of a hospital, clinic, or other institution providing care or treatment, having knowledge of a reportable disease case or suspect case, shall submit a case report to the board of health unless there is evidence that the case has already been reported.
(C) Any individual having knowledge of a person suffering from a disease suspected of being communicable is authorized to report to the board of health all known facts relating to the case or incident.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 7/23/1998
(A) The person in charge of any laboratory that examines specimens of human origin for evidence of diseases designated as reportable by rule 3701-3-02 of the Administrative Code shall report all positive results of such examinations to the board of health of the health district in which the person from whom the specimen was taken resides.
(B) A positive result of a laboratory examination for a reportable disease shall be considered reason to suspect that a person is infected by that disease. Upon receipt of a laboratory report of a positive result for a reportable disease, the board of health shall cause inquiry to be made through the attending physician or medical facility to determine if the suspected disease exists.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 7/23/98
(A) Case reports by physicians or designated others as specified in rule 3701-3-03 of the Administrative Code, and reports by persons in charge of laboratories of positive results of examinations for class A diseases, shall be provided to the board of health of the local health district in which the patient resides. Cases of reportable diseases that occur outside the local health district of residence also shall be reported to the board of health of the local health district in which the case occurs. The time and method of reporting shall be as follows:
(1) Case reports and reports of positive laboratory results for diseases specified as class A in paragraph (A)(1) of rule 3701-3-02 of the Administrative Code shall be provided by telephone immediately upon recognition that such case, suspected case, or positive laboratory result exists.
(2) Case reports and reports of positive laboratory results for diseases specified as class A in paragraph (A)(2) of rule 3701-3-02 of the Administrative Code shall be provided by the end of the next business day, after the existence of such case, suspected case, or positive laboratory result is known.
(3) Case reports and reports of positive laboratory results for diseases specified as class A in paragraph (A)(3) of rule 3701-3-02 of the Administrative Code shall be provided by the close of each working week after the existence of such case, suspected case, or positive laboratory result is known.
(B) Reports by physicians and designated others of the number of diseases specified as class B in rule 3701-3-02 of the Administrative Code shall be provided to the board of health by the close of each working week.
(C) Reports by physicians and designated others of situations when an outbreak, unusual incidence or epidemic of any disease specified as class C in rule 3701-3-02 of the Administrative Code is suspected shall be reported to the board of health by the end of the next working day.
(D) Except as otherwise required by paragraph (A)(1) of this rule, reports of cases and suspect cases of reportable diseases, and reports of positive results of laboratory tests for reportable diseases shall be in writing. All reports shall include the name and address of the case, suspect case, or person from whom the specimen for laboratory examination was taken. Except as otherwise required by paragraph (A)(1) of this rule, in lieu of written reporting, a board of health may accept verbal reports of class A, class B, or class C diseases by telephone or other electronic systems approved by the director, within the same time limitations. Reports shall include supplementary information relevant to the case or laboratory report as needed to complete official surveillance forms provided or approved by the director.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 7/23/1998
(A) The board of health shall report to the department reports of cases, suspect cases, and positive results of laboratory examinations for notifiable diseases specified in rule 3701-3-02 of the Administrative Code as follows:
(1) Diseases specified as class A in paragraph (A)(1) of rule 3701-3-02 of the Administrative Code shall be reported by telephone immediately after the existence of such case or suspect case is known to the board of health.
(2) Diseases specified as class A in paragraph (A)(2) of rule 3701-3-02 of the Administrative Code shall be reported by the end of the next business day after the existence of such case or suspect case is known to the board of health.
(3) Diseases specified as class A in paragraph (A)(3) of rule 3701-3-02 of the Administrative Code shall be reported by the close of the working week in which the existence of such case or suspect case is known to the board of health.
(4) The number of cases of diseases specified as class B in paragraph (B) of rule 3701-3-02 of the Administrative Code shall be reported by the close of the working week in which the existence of such cases is known to the board of health. The board of health shall eliminate duplicate reports.
(5) Outbreaks, unusual incidence, or epidemics of diseases diseases specified as class C in paragraph (C) of rule 3701-3-02 of the Administrative Code shall be reported by the end of the next business day after the outbreak, unusual incidence, or epidemic is known to the board of health.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 7/23/98
(A) Any person, hospital, clinic, agency or other institution or facility providing care or treatment to an individual suffering from a communicable disease which is required to be reported under Chapter 3701. of the Revised Code and the rules adopted thereunder by the public health council, or a disease that the director requires special inquiry be made under sections 3701.13 and 3701.14 of the Revised Code, shall, upon written request by the director provide access to the patient’s medical record to the director during an investigation of such disease.
(B) All information that is furnished to or procured by the director under Chapter 3701-3 of the Administrative Code shall be used exclusively to carry out the director’s mandated duties, including the duty to control and suppress disease, especially when contagious, infectious, epidemic, or endemic, as set forth in section 3701.14 of the Revised Code The director shall not release such information without the patient’s consent, except as may be necessary to provide services to that individual or as necessary to carry out the director’s mandated duties. However, such information may be disclosed in statistical or other form which does not reasonably tend to disclose the identity of any individual
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34
Rule Amplifies: 3701.13, 3701.14
Prior Effective Dates: 2/4/1983, 7/23/98
The methods of control provided in rules 3701-3-10 to 3701-3-17 of the Administrative Code shall be enforced by the health commissioner and shall be observed by any person afflicted with any one of the diseases listed in rules 3701-3-10 to 3701-3-17 of the Administrative Code.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 4/1/1964, 3/13/80
(A) In approving tests to be used to determine whether an individual has human immunodeficiency virus infection under division (B)(1) of section 3701.241 of the Revised Code, the director of health shall consider:
(1) Whether the test has been approved by the United States food and drug administration, in the case of an enzyme immunoassay test.
(2) The recommendations of the United States centers for disease control and the association of state and territorial public health laboratory directors, in the case of other tests, including tests to confirm the results of an enzyme immunoassay test. The director shall approve the “Western Blot Assay” confirmatory test.
(B) The director shall define a confirmed positive test result as
(1) Two or more reactive enzyme immunoassay tests on the same specimen followed by a positive “Western Blot Assay”;
(2) Two or more reactive enzyme immunoassay tests on the same specimen followed by a positive “Immunofluorescence Assay”;
(3) A positive culture of the human immunodeficiency virus;
(4) A positive reaction to an human immunodeficiency virus antigen test licensed by the United States food and drug administration;
(5) Identification of the human immunodeficiency virus by the use of polymerase chain reaction or nucleic acid probe to detect the presence of human immunodeficiency virus genetic material;
(6) The director may define other confirmed positive test results after consideration of the recommendations of the United States centers for disease control and the association of state and territorial public health laboratory directors.
(C) In developing guidelines for interpreting test results, the director shall:
(1) Require that the results of an enzyme immunoassay test approved by the United States food and drug administration be interpreted in accordance with the instructions of the manufacturer.
(2) Require that the “Western Blot Assay” confirmatory test be interpreted in accordance with the criteria set forth in the appendix to this rule, “Interpretation and use of the Western Blot Assay for Serodiagnosis of Human Immunodeficiency Virus Type 1 Infections,” as published in “Morbidity and Mortality Weekly Report,” United States centers for disease control, volume 38, number S-7, July 21, 1989.
(3) Require that the results of an immunofluorescence assay approved by the United States food and drug administration be interpreted in accordance with the instructions of the manufacturer.
(4) Require that the results of culture for the human immunodeficiency virus be interpreted in accordance with laboratory standards and procedures prescribed or accepted by the association of state and territorial public health laboratory directors.
(5) Require that the results of an antigen test to the human immunodeficiency virus be interpreted in accordance with the instructions of the manufacturer.
(6) Require that the results of a polymerase chain reaction or nucleic acid probe performed to detect the presence of infection with the human immunodeficiency virus be interpreted in accordance with the instructions of the manufacturer.
(7) Consider interpretation criteria established by the United States centers for disease control and the association of state and territorial public health laboratory directors in developing guidelines for interpreting results of other tests that may be approved.
Appendix 1
Centers for disease control
MMWR
Recommendations and Reports
Morbidity and mortality weekly report
Interpretation and Use of the Western Blot Assay for Serodiagnosis of Human Immunodeficiency Virus Type 1 Infections
U.S. Department of Health and Human Services
Public Health Service
Canters for Disease Control
Center for Infectious Diseases
AIDS Program
Atlanta, Georgia 30333
Serial publications to the MMWR is published by the Epidemiology Program Office. Centers for Disease Control, Public Health Service, U.S. Department of Health and Human Services, Atlanta, Georgia 30333.
Suggested citation
Centers for Disease Control. Interpretation and use of the western blot assay for serodiagnosis of human immunodeficiency virus type 1 infections. MMWR 1989:38(No. S-7:(inclusive page numbers).
Centers for Disease Control Walter R. Dowdle, Ph.D.
Acting Director
Gary R. Noble, M.D., M.P.H.
Deputy Director (HIV)
This report was prepared for publication by:
Center for Infectious Diseases Frederick A. Murphy, D.V.M, Ph.D.
Director
AIDS Program James W. Curran, M.D., M.P.H.
Director
Laboratory Investigations Branch Gerald Schochetman, Ph.D.
Chief
Public Health Practice Program Office Joyce D.K. Essien, M.D., M.B.A.
Acting Director
Division of Laboratory Systems Ronald O. Vaidiserri, M.D., M.P.H.
Director
The production of this report as an MMWR serial publication was coordinated in:
Epidemiology Program Office Michael B. Gregg, M.D.
Acting Director
Richard A. Goodman, MD., M.P.H.
Editor, MMWR Series
Editorial Services R. Elliott Churchill, M.A.
Chief
Ruth C. Greenberg
Editorial Assistant
Copies of this document are available from the National AIDS information Hearinghouse, P.O. Box 6003, Rockville, MD 20850: Telephone: 800-458-6281.
Reported by
Association of State and Territorial Public Health
Laboratory Directors and AIDS Program,
Center for Infectious Diseases,
Public Health Practice Program Office,
Centers for Disease Control
*
The Association of State and Territorial Public Health Laboratory Directors (ASTPHLD) and CDC have collaborated in preparing this report. It includes a description of various interpretive criteria associated with the Western blot test for HIV-1, evaluates the sensitivity and specificity of these criteria as tools for public health practice, and provides recommendations for use of the Western blot and the manner in which to report results in order to provide clinicians and public health policy officials with useful information in their efforts to reach an accurate diagnosis for persons tested for HIV-1 infection.
INTRODUCTION
The development of sensitive and specific tests for antibody to human immunodeficiency virus type 1 (HIV-1) progressed rapidly after this retrovirus was identified as the cause of acquired immunodeficiency syndrome (AIDS). These tests have been used for various purposes, including clinical diagnosis of HIV-1 infection – for symptomatic and asymptomatic patients in counseling and testing programs – for sero-prevalence surveys, and for blood-donor screening.
Enzyme immunoassay (EIA) is the most widely used serologic test for detecting antibody to HIV-1. Serum samples that are repeatedly reactive in the EIA for HIV-1 antibody are then retested with a supplemental and more specific test, the most common of which is the Western blot (1-3). To date, only one commercial Western blot test (Du Pont) has been licensed by the Food and Drug Administration (FDA). The purpose of this report is to provide guidance for interpreting Western blot test results and their use in diagnosing HIV-1 infection.
List of participants: ASTPHLD Committee on Testing for Retroviruses: William J. Hausier. Jr., Ph.D. (Chairman), S. Mehsen Joseon, Ph.D., Arthur F. DiSalvo, M.D., Manadeo P. Verma, Ph.D. President), Program Committee ASTPHLD Consensus Conference: ??? P. Getchell, Dr.P.H. CDC: D. Peter Drotman, M.D., M.P.H., ??? Richard George, Ph.D., Gerald Schochetman, Ph.D., Charles A. Schable, M.S., Wanda K. Cones, Dr.P.H., Thomas L. Hearn, M.S., William Schalla, M.S.
The western blot assay
The Western blot assay is a method in which individual proteins of an HIV-1 lysate are separated according to size by polyacrylamide gel electrophoresis. The viral proteins are then transferred onto nitrocallulose paper and reacted with the patient’s serum. Any HIV antibody from the patient’s serum is detected by an antihuman immunoglobulin G (lgG) antibody conjugated with an enzyme that in the presence of substrate will produce a colored band. Positive and negative control serum specimens are run simultaneously to allow identification of viral proteins.
Table 1 lists the major structural proteins coded for by the HIV genome. Antibodies to the HIV-1 major group-specific antigen (GAG) protein p24, and its precursor p55, are the earliest detected after infection by Western blot and tend to decrease or become undetectable with onset or progression of clinical symptoms (4-9). In contrast, antibodies to the envelope (ENV) precursor protein gp 160 and the final ENV proteins (gp120 and gp41) can be detected in specimens from virtually all HIV-infected persons regardless of clinical stage (4-9). Antibodies to the polymerase (POL) gene products (p31, p51, and p66) are also commonly detected if these antigens are present on the Western blot strips. However, in a recent study, the protein with a mobility of 160 kilodaltons (kd) present in commercially available Western blots and in viral lysate antigen preparations was identified as a multimer of the gp41 protein (10,11). Furthermore, this study presented evidence that the reaction observed against the gp120 on certain Western blots may have resulted in part from a reaction with a multimeric form of the gp41. In fact, the true gp120 was shown to be absent from some commercial Western blot antigens. When these reagents were used, serum specimens with
Interpretive Criteria
Although the overall sensitivity and specificity of the Western blot for detection of antibodies to the various viral proteins are high, there has been substantial debate regarding the interpretive criteria. The currently licensed Du Pont Western blot test specifies that the test result should be interpreted as positive only when the detected bands include p24 and p31,
TABLE 1. Major genes and gene products of HIV-1
Gene Gene products
*
Group-specific antigen/core (GAG) p18,p24,p65
Polymerase (POL) p31,p51,p66
Envelope (ENV) gp41,gp120,gp160
*p=protein: gp=glycoprotein, Numbers indicate the approximate molecular weights of the antigens in kilodaltons. repeatedly reactive by EIA are discarded; Western blot results are used to guide donor notification and deferral.) These criteria are not ideal for all situations, especially the testing of persons at increased risk for HIV infection, or with symptoms suggestive of this infection.
Alternative criteria have been proposed by various groups. ASTPHLD has proposed that a positive test result be defined by the presence of
3 1 band from
The criteria for a negative Western blot interpretation specify “no bands.” This interpretation is essential because some observed bands may reflect the presence of antibodies to HIV regulatory proteins or may indicate partially processed or degraded viral structural proteins. Furthermore, different Western blots (commercial, as well as “in-house” preparations) and different virus-antigen preparations used to prepare Western blots may contain different numbers, and concentrations of both viral-specific and contaminating cellular proteins that may have unpredictable molecular weights.
Evaluation of Criteria
To compare the four sets of criteria for Western blot interpretation, CDC selected 424 serum samples on the basis of the patients’ clinical status and EIA results only, and analyzed them using the licensed Du Pont Western blot test (CDC unpublished data). The samples were scored according to each of the criteria (Table 3). For all three categories with repeatedly reactive EIA test results, the Western blot results demonstrate that the ASTPHLD definition gives the highest percentage of positive and the lowest percentage of indeterminate results. The interpretive standards that require
TABLE 2. Criteria for positive interpretation of Western blot tests
Organization Criteria
Association of State and Any two of:
Territorial Public Health ù p24
Laboratory Directors/CDC ù gp41
ù gp120/gp 160
*
FDA-licensed Du Pont test p24 and p31
American Red Cross
3 3 bands – 1 from each gene-product group:
ù GAG
ù POL
ù ENV
Consortium for Retrovirus
3 2 bands: p24
Serology Standardization ù gp41
ù gp120/gp160
Distinguishing the gp120 band from the gp160 band is often very difficult. These two glycoproteins can be considered as one reactant for purposes of interpreting Western blot test results. the identification of bands from each of the three groups of gene products tend to have indeterminate results for some AIDS and other symptomatic patients due to absence of antibodies to p24 (n=5) or to p31 (n=14) or absence of both types of antibodies (n=2). Since these patients clearly are infected with HIV, the three-gene-product approach to Western blot interpretation is not sensitive enough for public health or clinical practice.
The ASTPHLD/CDC criteria for a positive Western blot differ from the CRSS criteria in two ways: first, ASTPHLD/CDC deletes p31, a change that does not affect the sensitivity or specificity of the criteria (Table 3), and second, ASTPHLD/CDC adds “gp41 and gp120/160,” a combination not interpreted as positive with the CRSS criteria. This latter combination of bands represents antibody to envelope glycoproteins only. In practice, this is a rare finding for asymptomatically infected persons, but it has been reported to be specific for HIV-infected persons and should be included in the positive criteria (9). However, when a Western blot test has only the multimeric form of gp41 and no true gp120 present, a serum sample would be scored as positive on the basis of the presence of antibody to a single envelope glycoprotein, gp41. HIV-1-infected persons with this profile have lost their antibodies to the GAG proteins and are usually symptomatic and do not present a diagnostic problem.
The ASTPHLD/CDC interpretive criteria for a negative result are identical to the FDA recommendation for blood-donor reentry or the Western blot interpretive criteria that are specified in the licensed Western blot kit package insert.
RECOMMENDATIONS
On the basis of the results described above, CDC concurred with the ASTPHLD criteria and recommends their use in public health and clinical practice.
Laboratories should report test results as positive, indeterminate, or negative. The Public Health Service recommends that no positive test results be given to clients/ patients until a screening test has been repeatedly reactive (i.e., 3 two tests) on the
TABLE 3. Western blot results of 424 serum samples by four interpretive standards
ASTPHLD/CDC CRSS Du Pont Red Cross
(%) (%) (%) (%)
Clinical BA
status results Po lo No P I N P I N P I N
Group A Repeatedly 83(97) 3( 3) – 76(88) 10(12) – 62(72) 24(28) – 74(86) 12(14) -
(n=86) reactive
Group B Repeatedly 39(98) 1( 2) – 38(96) 2( 5) – 34(86) 5(15) – 36(90) 4(10) -
(n=40) reactive
Group C Repeatedly 45(78) 13(22) – 43(74) 15(26) – 39(67) 19(33) – 41(71) 17(29) -
(n=58) reactive
Group D Nonreactive 0 7( 3) 233(97) 0 7( 3) 233(97) 0 7( 3) 233(97) 0 7( 3) 233(97)
(n=240)
P=Positive, I=Indeterminate, N=negative.
Group A=AIDS patients.
Group B=Other symptomatic patients.
Group C=Asymptomatic homosexual men.
Group D=Volunteer blood donors. same specimen and a supplemental, more specific test such as the Western blot has been used to validate those results (3). Upon request, laboratory reports may also contain a list of the bands detected and reference to the interpretive criteria the laboratory uses. Because of the variability of unlicensed reagents, laboratories using non-FDA-licensed Western blots should compare, on a routine basis, their tests with the FDA-licensed Western blot kit using well-characterized serum specimens.
Clinical diagnosis and follow-up of patients is the responsibility of the clinical practitioner. Serologic test results are but one contribution to a patient’s data base, which contains medical history (including high-risk behavior or exposure to HIV), results of physical examination, and other clinical findings. Clinicians must consider the total profile for a client when attempting to make a diagnosis after indeterminate Western blot results have been obtained. Accurate diagnosis for such persons can be challenging – and the challenge can be complicated by the tendency of some clients to become distressed by the apparent “uncertainty” of their test results.
Clinical follow-up of patients with indeterminate Western blot results may require many months of observation, interviewing, and testing. Most indeterminate patterns involve p18 (also referred to as p17), p24, or p55, or any combination of these three proteins (16-18). In one study of 390 “atypical” or indeterminate samples, 53% reacted against p24, with or without p18 or p55; 47% reacted against p18 (but not p24), with or without p55 (18).
Some indeterminate results may be obtained with serum samples from persons who are in the process of seroconverting. A compilation of 209 volunteer blood donors with GAG-only indeterminate Western blot results were followed for as long as 2 years (17-21). During that time, only five of 134 persons who had initially reacted to p24 developed additional bands on the Western blot test. None of the 75 persons who initially reacted against p18 (but not p24) developed additional bands. The five persons who did seroconvert had positive results when their first follow-up samples were tested. The intervals between initial and follow-up tests were 8 weeks (two persons), 20 weeks (two persons), and 32 weeks (one person). The three longest intervals reflected delays in follow-up testing and not the actual time to seroconversion. These results do not refute earlier findings that seroconversion typically occurs within 3 months of infection (5.22). The importance of careful risk assessment for persons with indeterminate Western blot patterns was reemphasized when in one study (18) two of three people who initially had indeterminate results (but later seroconverted) disclosed histories of risk behavior when they were reinterviewed during follow-up.
A person whose Western blot test results continue to be consistently indeterminate for at least 6 months – in the absence of any known risk factors, clinical symptoms, or other findings – may be considered to be negative for antibodies to HIV-1. Such persons should be reassured that they are almost certainty
As the HIV/AIDS epidemic continues, additional tests of higher specificity will be needed to decrease the number of false-positive reactions and to permit correct diagnosis of HIV infection in a larger spectrum of clinical situations in which an indeterminate antibody profile exists. The use of new antibody tests based on antigens derived by recombinant deoxyribonucteic acid (DNA) technology or the application of DNA probe technology – particularly DNA amplification by the polymerase chain reaction (PCR) – already shows promise in this area (23).
References
1. Centers for Disease Control. Provisional public health service inter-agency recommendations for screening donated blood and plasma for antibody to the virus causing acquired immunodeficiency syndrome. MMWR 1985:34:1-5.
2. Centers for Disease Control. Public health service guidelines for counseling and antibody testing to prevent HIV infection and AIDS. MMWR 1987:36:509-15.
3. Centers for Disease Control. Update: Serologic testing for antibody to human immunodeficiency virus. MMWR 1988:36:833-40, 845.
4. Lange JMA, Coutinho RA, Krone WJA, et al. Distinct lgG recognition patterns during progression of subclinical and clinical infection with lymphadenopathy associated virus/human T lymphotropic virus. Brit Med J 1986:292:228-30.
5. Esteban JI, Shih JW, Tai CC, et al. importance of Western blot analysis in predicting infectivity of anti-HTLV-III/LAV positive blood. Lancet 1985:2:1083-6.
6. Goudsmit J. Lange JMA, Paul DA, et al. 1987. Antigenemia and antibody titers to core and envelope antigens in AIDS. AIDS-related complex, and subclinical human immunodeficiency virus infection, J Infect Dis 1987:155:558-60.
7. Lange JDA, Paul DA, Huisman HG, et al. Persistent HIV antigenemia and decline of HIV core antibodies associated with transition to AIDS. Brit Med J 1986;293:1459-62.
8. Weber JN, Clapham PR, Weiss RA, et al. Human immunodeficiency virus infection in two cohorts of homosexual men: neutralizing sera and association of anti-gag antibody with prognosis. Lancet 1987;1:119-21.
9. McDougal JS, Kennedy MS, Nicholson JKA, et al. Antibody response to human immunodeficiency virus in homosexual men: Relation of antibody specificity, titer, and isotype to clinical status, severity of immunodeficiency and disease progression. J Clin Invest 1987; 80:316-24.
10. Zolla-Pazner S. Gorney MK, Honnen WJ, et al. Reinterpretation of HIV Western blot patterns. NEJM 1989;320:1280-1.
11. Pinter A, Honnen WJ, Tilley SA, et al. Oligomeric structure of gp41, the transmembrane protein of human immunodeficiency virus type 1, J Virology 1989;63:2574-9.
12. Du Pont Diagnostics. Human immunodeficiency virus (HIV); Biotech/Du Pont HIV western biot kit for detection of antibodies to HIV. Wilmington, Delaware:Du Pont Diagnostics, 1987.
13. Committee on Human Retroviruses Testing. Report of Fourth Consensus Conference on Testing for Human Retroviruses. Association of State and Territorial Public Health Laboratory Directors. Infection Control and Hospital Epidemiology 1989; in press.
14. The Consortium for Retrovirus Serology Standardization. Serological diagnosis of human immunodeficiency virus infection by Western biot testing, JAMA 1988;260:674-9.
15. Sandler SG, Dodd RY, Fang CT, Diagnostic tests for HIV infection; Serology, In: DeVita VT, Heilman S. Rosenberg SA, eds. AIDS: Etiology, Treatment, and Prevention, Second Edition. Philadelphia: J.B. Lippincott, 1988:121-6.
16. Fang C, Le P. Mailory D. et al. Western biot patterns of antibodies to human immunodeficiency virus (HIV). Transfusion 1988:27:539.
17. Cock NL, Lamberson HV, O’Brien TA, et al. Evaluation of atypical human immunodeficiency virus immunobiot reactivity in blood donors. Transfusion 1988:28:412-8.
18. Kleinman S. Fitzpatrick L. Second K. et al. Follow-up testing and notification of anti-HIV Western biot atypical (indeterminant) donors. Transfusion 1988:28:280-2.
19. Biberfeld G. Bredberg-Raden U. Bottiger B. et al. Blood donor sera with false-positive Western biot reactions to human immunodeficiency virus (letter). Lancet 1986:2:289-90.
20. Courouce A. Muller J. Richard D. False-positive Western biot reactions to human immunodeficiency virus in blood donors (letter), Lancet 1986:2:921-2.
21. van der Poel CL, Reesink HW, Tersmette T, et al. Blood donations reactive for HIV in Western biot, but non-reactive in culture and recipients of blood, Lancet 1986:2:752-3.
22. Groopman JE, Caiazzo T, Thomas MA, et al. Lack of evidence of prolonged, human immunodeficiency virus infection before antibody seroconversion. Blood 1988:71:1752-4.
23. Schochetman G. Ou C-Y, Jones WK, Polymerase chain reaction, J Infect Dis 1988:158: 1154-7.
Use of trade names is for identification only and does not imply endorsement by DHHS or PHS or by ASTPHLD.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.241
Rule Amplifies: 3701.24, 3701.241, 3701.242, 3701.243, 3701.244, 3701.245, 3701.246, 3701.247, 3701.248, 3701.249, 3901.45, 3901.46
Prior Effective Dates: 11/30/1989, 2/3/90, 7/23/98
(A) A human immunodeficiency virus (HIV) test shall be performed only if, prior to the test, informed consent is obtained either by the person or agency of state or local government ordering the test. A facility or physician may adopt a policy to offer routine and voluntary testing to all patients admitted to a facility or under the physician’s care in accordance with the provisions of this rule. Consent may be given orally or in writing after the person or agency performing or ordering the test or the facility or physician ordering the test has given orally, in writing, or through an electronic means, including videotape, the following information to the individual to be tested or his guardian:
(1) An explanation of the test and testing procedures, including the purposes and limitations of the test and the meaning of its results;
(a) The explanation of the test and testing procedures shall include a statement that:
(1) The test is conducted on a blood sample or another body fluid taken from the individual tested and whether the test determines the presence of antibodies to HIV or detects infection with HIV in another manner.
(2) When the test to be performed is a test for antibodies to HIV, the explanation also shall include a statement that if the first test is positive, additional tests will be performed on the same blood or body fluid sample or an additional sample may be taken; and
(b) The explanation of the meaning of the test results shall include a statement that a positive test result means that the individual tested has been exposed to HIV and is infected but that the symptoms and development of the HIV related disease may take ten years or more to occur. The explanation also shall include a statement that if the individual has been exposed to HIV but presently has negative test results, future retesting is advisable because of the amount of time after exposure required for the body to produce antibodies to HIV.
(2) An explanation that the test is voluntary, that consent to be tested may be withdrawn at any time before the individual tested leaves the premises where the blood or other body fluid sample is taken for the test and that the individual or guardian may elect to have an anonymous test; and
(3) An explanation about behaviors known to pose risks for transmission of HIV infection. This explanation shall focus on ways in which HIV may be transmitted, such as sexual intercourse (i.e. anal, vaginal, or oral sex), sharing of needles, from an infected pregnant woman to her fetus, from infected mother to child through breast feeding, and through blood transfusion that occurred prior to 1985, or other ways in which the person or agency providing the information reasonably believes are possible ways that the individual to whom the information is given may have been exposed to HIV or may transmit HIV.
(B) In preparing the informed consent form referred to by division (A) of section 3701.242 of the Revised Code, the director also may include in the form other information that may be useful to an individual seeking HIV testing. Use of the informed consent form prepared and distributed by the director under division (A) of section 3701.242 of the Revised Code and under this paragraph is not mandatory, but a person or government agency required by division (A) of section 3701.242 of the Revised Code and paragraph (A) of this rule to give information to an individual may satisfy the requirement by obtaining the signature of the individual on the form prepared by the director.
(C) A minor may consent to be given an HIV test. The consent is not subject to disaffirmance because of minority. The parents or guardian of a minor giving consent under this division are not liable for payments for an HIV test given to the minor without the consent of a parent or the guardian.
(D) The person or government agency ordering an HIV test shall provide counseling for the individual at the time he is told of the result of the test or informed of a diagnosis of AIDS or an HIV related condition. If the test was performed upon the request of the individual tested, the person or government agency that performed the test shall provide counseling. The individual shall be given an oral or written explanation of the nature of HIV, HIV related conditions, and AIDS and the relationship between the HIV test and those diseases and a list of resources for further counseling or support. When necessary, the individual shall be referred for further counseling to help that individual cope with the emotional consequences of learning the test result.
(E) Any individual seeking an HIV test shall have the right, on the individual’s request, to an anonymous test. A health care facility or health care provider that does not provide anonymous testing shall refer an individual requesting an anonymous test to a site where it is available.
(F) The requirements of paragraphs (A) to (E) of this rule do not apply to the performance of an HIV test in any of the following circumstances:
(1) When the test is performed in a medical emergency by a nurse or physician and the test results are medically necessary to avoid or minimize an immediate danger to the health or safety of the individual to be tested or another individual, except that counseling shall be given to the individual as soon as possible after the emergency is over;
(2) When the test is performed for the purpose of research if the researcher does not know and cannot determine the identity of the individual tested;
(3) When the test is performed by a person who procures, processes, distributes, or uses a human body part from a deceased person donated for a purpose specified in Chapter 2108. of the Revised Code, if the test is medically necessary to ensure that the body part is acceptable for its intended purpose;
(4) When the test is performed on a person incarcerated in a penal institution if the head of the institution has determined, based on good and medical cause, that a test is necessary;
(5) When the test is performed by or on the order of a physician who, in the exercise of his professional judgement, determines the test to be necessary for providing diagnosis and treatment to the individual to be tested, if the individual or the individual’s parent or guardian has given consent to the physician for medical treatment;
(6) When the test is performed on an individual after the infection control committee of a health care facility, or other body of a health care facility performing a similar function determines that a health care provider, emergency medical services worker, or peace officer, while rendering health or emergency care to an individual, has sustained significant exposure to the body fluids of that individual, and the individual has refused to give consent for testing; and
(G) The consent of the individual to be tested is not required, and the individual or guardian may not elect to have an anonymous test, when the test is ordered by a court in connection with a criminal investigation.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.242
Rule Amplifies: 3701.24, 3701.241, 3701.242, 3701.243, 3701.244, 3701.245, 3701.246, 3701.247, 3701.248, 3701.249
Prior Effective Dates: 7/23/1998
(A) As used in this rule:
(1) “AIDS” means the illness designated as acquired immunodeficiency syndrome as further defined in appendix A of this rule.
(2) “ARC” is a historic term having the same meaning as in section 3701.24 of the Revised Code.
(3) “A CD4 count” means a count of lymphocytes containing the CD4 epitope as determined by the results of lymphocyte phenotyping.
(4) “Health care facility” has the same meaning as in section 3701.24 of the Revised Code.
(5) “HIV” means the human immunodeficiency virus identified as the causative agent of AIDS.
(6) “HIV infection” means the same as defined in appendix B of this rule.
(B) Persons required to report cases of AIDS ARC, HIV, confirmed positive tests for HIV, and HIV infections under division (C) of section 3701.24 of the Revised Code and this rule are as follows:
(1) Cases of AIDS, ARC, HIV infections and a CD4 + T lymphocyte count below two hundred cells per microliter or a CD4 + T lymphocyte percentage of less then fourteen when an HIV infection has not been ruled out as the cause shall be reported by any attending health care provider as defined in section 3701.24 of the Revised Code In an institutional or health care facility setting, a designated agent including, but not limited to, an infection control practitioner may make the report for the attending health care provider.
(2) Confirmed positive HIV tests, as defined in rule 3701-3-10 of the Administrative Code, and a CD4 + T lymphocyte count below two hundred cells per microliter or a CD4 + T lymphocyte percentage of less than fourteen when an HIV infection has not been ruled out as the cause shall be reported by the person in charge of the laboratory performing the test. If a second laboratory is used for additional or confirmatory testing, the person in charge of the laboratory first receiving the specimen shall report the confirmed positive test.
(C) The persons designated by paragraph (B) of this rule shall report promptly every case of AIDS, every ARC, and every confirmed positive HIV test, every HIV infection, and every CD4 + T lymphocyte count below two hundred cells per microliter or a CD4 + T lymphocyte percentage of less than fourteen when an HIV infection has not been ruled out as the cause to the department of health on forms and in a manner prescribed by the director. In each county the director shall designate the health commissioner of a health district in the county to receive the reports.
(D) Every health care provider attending a newborn infant or child born to an HIV infected mother shall report promptly every case of such perinatal exposure to HIV and any subsequent test results on every such exposed newborn infant or child until such time that either an HIV infection or a seroeversion status that is negative is confirmed. In an institutional or health care facility setting, a designated agent, including, but not limited to, an infection control practitioner, may make the report for the attending health care provider.
Appendix A Ohio Case Definition for AIDS for Surveillance Purposes
For Ohio reporting, a case of AIDS is defined as an illness characterized by one or more of the following “indicator” diseases, depending on the status of laboratory evidence of HIV infection, as shown below.
I. Without Laboratory Evidence Regarding HIV Infection.
A. If laboratory tests for HIV were not performed or gave inconclusive results and the patient had no other cause of immunodeficiency listed in subsection B below, then any disease listed in subsection C indicates AIDS if it was diagnosed by a definitive method.
B. Causes of immunodeficiency that disqualify diseases as indicators of AIDS in the absence of laboratory evidence for HIV infection:
1. High-dose or long-term systemic corticosteroid therapy or other immunosuppressive/cytotoxic therapy three or less months before the onset of the indicator disease;
2. Any of the following diseases diagnosed three or less months after diagnosis of the indicator disease: Hodgkin’s disease, non-Hodgkin’s lymphoma (other than primary brain lymphoma), lymphocytic leukemia, multiple myeloma, any other cancer of lymphoreticular or histiocytic tissue, or angioimmumnoblastic lymphadenopathy;
3. A genetic (congenital) immunodeficiency syndrome or an acquired immunodeficiency syndrome atypical of HIV infection, such as one involving hypogammaglobulinemia.
C. Indicator diseases diagnosed definitively:
1. Candidiasis of the esophagus, trachea, bronchi, or lungs;
2. Cryptococcosis, extrapulmonary;
3. Cryptosporidiosis with diarrhea persisting greater than one month;
4. Cytomegalovirus disease of an organ other than liver, spleen, or lymph nodes in a patient greater than one month of age;
5. Herpes simplex virus infection causing a mucocutaneous ulcer that persists longer than one month, or bronchitis, pneumonitis, or esophagitis for any duration affecting a patient greater than one month of age;
6. Kaposi’s sarcoma affecting a patient less than sixty years of age;
7. Lymphoma of the brain (primary) affecting a patient less than sixty years of age;
8. Lymphoid intersitial pneumonia and/or pulmonary lymphoid hyperplasia (LIP/PLH complex) affecting a child less than thirteen years of age;
9. Mycobaterium avium complex or M. kansasii disease, disseminated (at a site other than or in addition to lungs, skin, or cervical or hilar lymph nodes);
10. Pneumocystis carinii pneumonia;
11. Progressive multifocal leukoencephalopathy;
12. Toxoplasmosis of the brain affecting a patient greater than one month of age.
II. With Laboratory Evidence for HIV Infection
A. Regardless of the presence of other causes of immunodeficiency (section I.B), in the presence of laboratory evidence of HIV infection, any disease listed above (section I.C) or below (sections II.B or II.C) indicates a diagnosis of AIDS.
B. Indicator diseases diagnosed definitively:
1. Bacterial infections, multiple or recurrent (any combination of at least two within a two-year period), of the following types affecting a child less than thirteen years of age:
a. Septicemia, pneumonia, meningitis, bone or joint infection, or abscess of an internal organ or body cavity (excluding otitis media or superficial skin or mucosal abscesses), caused by Haemophilus, Streptococcus (including pneumococcus), or other pyogenic bacteria;
2. Coccidiodomycosis, disseminated (at a site other than or in addition to lungs or cervical or hilar lymph nodes);
3. HIV encephalopathy (also called “HIV dementia,” “AIDS dementia,” or “subacute encephalitis due to HIV”);
4. Histoplasmosis, disseminated (at a site other than or in addition to lungs or cervical or hilar lymph nodes);
5. Isosporiasis with diarrhea persisting greater than one month;
6. Kaposi’s sarcoma at any age;
7. Lymphoma of the brain (primary) at any age;
8. Other non-Hodgkin’s lymphoma of B-cell or unknown immunologic phenotype and the following histologic types:
a. Small noncleaved lymphoma (either Burkitt or non-Burkitt type);
b. Immunoblastic sarcoma (equivalent to any of the following, although not necessarily all in combination: Immunoblastic lymphoma, large-cell lymphoma, diffuse histiocytic lymphoma, diffuse undifferentiated lymphoma, or high-grade lymphoma).
Note:Lymphomas are not included here if they are of T-cell immunologic phenotype or their histologic type is not described or is described as “lymphocytic,” “lymphoblastic,” “small cleaved,” or “plasmacytoid lymphocytic.”
9. Any mycobacterial disease caused by mycobacteria other than M. tuberculosis , disseminated (at a site other than or in addition to lungs, skin, or cervical or hilar lymph nodes);
10. Disease caused by M. tuberculosis , extrapulmonary (involving at least one site outside the lungs, regardless of whether there is concurrent pulmonary involvement);
11. Salmonella (nontyphoid) septicemia, recurrent;
12. HIV wasting syndrome (emaciation, “slim disease”).
C. Indicator diseases diagnosed presumptively:
1. Candidiasis of the esophagus;
2. Cytomegalovirus retinitis with loss of vision;
3. Kaposi’s sarcoma;
4. Lymphoid interstitial pneumonia and/or pulmonary lymphoid hyperplasia (LIP/PLH complex) affecting a child less than thirteen years of age;
5. Mycobacterial disease (acid-fast bacilli with species not identified by culture), disseminated (involving at least one site other than or in addition to lungs, skin, or cervical or hilar lymph nodes);
6. Pneumocystis carinii pneumonia;
7. Toxoplasmosis of the brain affecting a patient greater than one month of age.
Note:Given the seriousness of diseases indicative of AIDS, it is generally important to diagnose them definitively, especially when therapy that would be used may have serious side effects or when definitive diagnosis is needed for eligibility for antiretroviral therapy. Nonetheless, in some situations, a patient’s condition will not permit the performance of definitive tests. In other situations, accepted clinical practice may be to diagnose presumptively based on the presence of characteristic clinical and laboratory abnormalities.
D. Other conditions that meet the AIDS case definition in the presence of HIV:
1. A T-helper/inducer (CD4) lymphocyte count of less than 200 cells/μL or a CD4 percentage of less than fourteen;
2. Pulmonary Tuberculosis;
3. Recurrent (two or more episodes within a one year period) pneumonia with or without a bacteriologic diagnosis;
4. Invasive cervical cancer.
III. With Laboratory Evidence Against HIV Infection
A. With laboratory test results negative for HIV infection, a diagnosis of AIDS for surveillance purposes is ruled out unless :
1. All the other causes of immunodeficiency listed above in Section I.B are excluded;AND
2. The patient has had either:
a. Pneumocystis carinii pneumonia diagnosed by a definitive method; or
b. Any of the other diseases indicative of AIDS listed above in Section I.C diagnosed by a definitive method;AND
i. A T-helper/inducer (CD4) lymphocyte count less than 400/mm3.
Appendix B Ohio Surveillance Case Definition For HIV Infection
I. In adults, adolescents, or children aged greater than or equal to eighteen months(fn1)
A. Laboratory Criteria:
1. Positive result on a screening test for HIV antibody (e.g., repeatedly reactive enzyme immunoassay), followed by a positive result on a confirmatory (sensitive and more specific) test for HIV antibody (e.g., Western blot or immunoflourescence antibody test); or
2. Positive result or report of a detectable quantity on any of the following HIV virologic (nonantibody) tests:
a. HIV nucleic acid (DNA or RNA) detection (e.g., DNA polymerase chain reaction [PCR] or plasma HIV-1 RNA); (fn2)
b. HIV p24 antigen test, including neutralization assay;
c. HIV isolation (viral culture).
B. Clinical or Other Criteria (if the above laboratory criteria are not met):
1. Diagnosis of HIV infection, based on the laboratory criteria above, that is documented in a medical record by a physician; or
2. Conditions that meet criteria included in the Ohio case definition for AIDS.
II. In a child aged less than eighteen months, a reportable case of HIV infection must meet at lease one of the following criteria:
A. Laboratory Criteria:
1.
a. HIV nucleic acid (DNA or RNA) detection;
b. HIV p24 antigen test, including neutralization assay, in a child greater than or equal to one month of age;
c. HIV isolation (viral culture).
2.
a. Positive results on only one specimen (excluding cord blood) using the above HIV virologic tests and no subsequent negative HIV virologic or negative HIV antibody tests.
B. Clinical or Other Criteria (if the above definitive or presumptive laboratory criteria are not met):
1. Diagnosis of HIV infection, based on the laboratory criteria above, that is documented in a medical record by a physician; or
2. Conditions that meet criteria included in the Ohio surveillance case definition for AIDS.
III. A child aged less than eighteen months born to an HIV-infected mother will be categorized for surveillance purposes as “Seroreverter/Not Infected with HIV” if the child does not meet the criteria for HIV infection but meets the following criteria:
A. Laboratory Criteria.
1.
a. At least two negative HIV antibody tests from separate specimens obtained at greater than or equal to six months of age; or
a. At least two negative HIV virologic tests (fn3) from separate specimens, both of which were performed at greater than or equal to one month of age and one of which was performed at greater than or equal to four months of age;AND
i. No other laboratory or clinical evidence of HIV infection (i.e., has not had any positive virologic tests, if performed, and has not had an AIDS-defining condition)
2.
a. A child who does not meet the above criteria for definitive “seroreverter/not infected with HIV” status but who has:
i. One negative EIA HIV antibody test performed at greater than or equal to six months of age andNOpositive HIV virologic tests, if performed; or
ii. One negative HIV virologic test (fn4) performed at greater than or equal to four months of age andNOpositive HIV virologic tests, if performed; or
iii. One positive HIV virologic test with at least two subsequent negative virologic tests, (fn5) at least one of which is at greater than or equal to four months of age; or negative HIV antibody test results, at least one of which is at greater than or equal to six months of age;AND
A) No other laboratory or clinical evidence of HIV infection (i.e., has not had any positive virologic tests, if performed, and has not had an AIDS-defining condition).
B. Clinical or Other Criteria (if the above definitive or presumptive laboratory criteria are not met):
1. Determined by a physician to be “not infected,” and a physician has noted the results of the preceding HIV diagnostic tests in the medical record;AND
2. No other laboratory or clinical evidence of HIV infection (i.e., has not had any positive virologic tests, if performed, and has not had an AIDS-defining condition).
IV. A child aged less than eighteen months born to an HIV-infected mother will be categorized as having perinatal exposure to HIV infection if the child does not meet the criteria for HIV infection (section II) or the criteria for “not infected with HIV” (section III).
fn1 Children aged greater than or equal to eighteen months but less than thirteen years are categorized as “not infected with HIV” if they meet the criteria in sectionIII.
fn2 In adults, adolescents, and children infected by other than perinatal exposure, plasma viral RNA nucleic acid tests shouldNOTbe used in lieu of licensed HIV screening tests (e.g., repeatedly reactive enzyme immunoassay). In addition, a negative (i.e., undetectable) plasma HIV-1 RNA test result does not rule out the diagnosis of HIV infection.
fn3 HIV nucleic acid (DNA or RNA) detection tests are the virologic methods of choice to exclude infection in children aged less than eighteen months. Although HIV culture can be used for this purpose, it is more complex and expensive to perform and is less well standardized than nucleic acid detection tests. The use of p24 antigen testing to exclude infection in children aged less than eighteen months is not recommended because of its lack of sensitivity.
fn4 See footnote 3,
fn5 See footnote 3,
R.C. 119.032 review dates: 03/16/2007 and 03/01/2012
Promulgated Under: 119.03
Statutory Authority: 3701.24, 3701.241
Rule Amplifies: 3701.24, 3701.241, 3701.242, 3701.243, 3701.244, 3701.245, 3701.246, 3701.247, 3701.248, 3701.249
Prior Effective Dates: 6/18/1990, 5/2/02
A person infected with one of the following specified diseases or conditions shall be isolated as set forth below:
(A) Amebiasis, where the person works in a sensitive occupation or attends a child care center. Such a person shall be excluded from work or the child care center and may return only after the diarrhea has ceased and he or she has had three follow-up stool specimens with results negative for Entamoeba histolytica.
(B) Campylobacteriosis, where the person works in a sensitive occupation or is a child in a child care center. Such a person shall be excluded from work or the child care center and may return only when the following conditions are met:
(1) The child may return to the child care center and the person may return to work in the sensitive occupation only after his or her diarrhea has ceased, provided that his or her duties do not include food handling.
(2) A food handler may return to work only after his or her diarrhea has ceased and one of the following:
(a) The food handler has had at least forty-eight hours of effective antimicrobial therapy; or
(b) The food handler has had two consecutive follow-up stool specimens that are negative for Campylobacter.
(C) Chickenpox: a person with chickenpox shall be isolated, including exclusion from school, child care center, and public places until the sixth day after onset of rash, or until all lesions are dry. Contagiousness may be prolonged in patients with altered immunity. Persons with chickenpox shall avoid contact with susceptible persons.
(D) Cholera, where the person works in a sensitive occupation or is a child in a child care center. Such a person shall be excluded from work or the child care center and may return only when the following conditions are met:
(1) The child may return to the child care center and the person may return to work in the sensitive occupation only after his or her diarrhea has ceased, provided that his or her duties do not include food handling.
(2) A food handler may only return to work only after his or her diarrhea has ceased and the food handler has had two consecutive follow-up stool specimens that are negative for Vibrio cholerae.
(E) Conjunctivitis, purulent, where the person works in a child care center or is a child in a child care center. Such a person shall be excluded from the child care center and may return to the child care center twenty-four hours after the initiation of effective antimicrobial therapy.
(F) Cryptosporidiosis, where the person works in a sensitive occupation or is a child in a child care center. Such a person shall be excluded from work or the child care center and may return only when the following conditions are met:
(1) The child may return to the child care center and the person may return to work in the sensitive occupation only after his or her diarrhea has ceased, provided that his or her duties do not include food handling.
(2) A food handler may only return to work only after his or her diarrhea has ceased and after three consecutive follow-up stool specimens are negative for Cryptosporidium.
(G) Cyclosporiasis, where the person works in a sensitive occupation or is a child in a child care center. Such a person shall be excluded from work or the child care center, and may return only after his or her diarrhea has ceased and effective antimicrobial therapy has begun.
(H) Diarrhea, infectious or of unknown cause, where the person works in a sensitive occupation or attends a child care center. Such a person shall be excluded from work or the child care center and may return only after his or her diarrhea has ceased. A person with infectious diarrhea of known cause shall be isolated in accordance with the provisions of the rule set forth for the specified disease.
(I) Diphtheria: a person with diphtheria shall be isolated until two cultures, from both throat and nose, and additionally, in the case of cutaneous diphtheria, a culture from skin lesions, are negative for diphtheria bacilli. Cultures shall be taken not less than twenty-four hours apart, and not less than twenty-four hours after cessation of antimicrobial therapy. If culturing is unavailable or impractical, isolation may be ended after fourteen days of effective antimicrobial therapy.
(J) Escherichia coli (E. coli) O157:H7 or hemolytic uremic syndrome (HUS), where the person works in a sensitive occupation or is a child in a child care center. Such a person shall be excluded from work or the child care center, and may return only after his or her diarrhea has ceased and after two consecutive follow-up stool specimens are negative for E. coli O157:H7. For cases of other enterohemorrhagic (Shiga toxin-producing) E. coli, where the person works in a sensitive occupation or is a child in a child care center. Such a person shall be excluded from work or the child care center, and may only return only after his or her diarrhea has ceased and after two consecutive follow-up stool specimens are negative for the other enterohemorrhagic (Shiga toxin-producing) E. coli.
(K) Giardiasis, where the person works in a sensitive occupation or is a child in a child care center. Such a person shall be excluded from work or the child care center, and may return only after his or her diarrhea has ceased and he or she has had one of the following:
(1) Seventy-two hours of effective antimicrobial therapy; or
(2) Three consecutive follow-up stool specimens which are negative for Giardia.
(L) Hepatitis A: a person symptomatic with hepatitis A who works in a sensitive occupation shall be excluded from work and a child attending a child care center shall be excluded from the child care center until ten days after initial onset of symptoms.
(M) Measles: a person with measles shall be isolated, including exclusion from school or child care center, for four days following the onset of rash. Contagiousness may be prolonged in patients with altered immunity.
(N) Meningitis, aseptic, and viral meningoencephalitis, but not including arthropod-borne disease: person with aseptic meningitis or viral meningoencephalitis shall be excluded from school or child care center until he or she is afebrile.
(O) Meningococcal disease: a person with meningococcal disease shall be isolated until twenty-four hours after the initiation of effective antimicrobial therapy.
(P) Mumps: a person with mumps shall be isolated, including exclusion from school or child care center, for nine days after the onset of parotid swelling.
(Q) Pediculosis: a person with body lice shall be excluded from school or child care center until twenty-four hours after application of an effective pediculicide. A person with head lice shall be excluded from school or child care center until after the first treatment with an effective pediculicide.
(R) Pertussis (whooping cough): a person with pertussis, who is not treated with effective antimicrobial therapy, shall be isolated, including exclusion from school or child care center, until three weeks after the onset of paroxysms. If effective antimicrobial therapy is given, the person shall be isolated for five days after initiation of antimicrobial therapy.
(S) Plague: a person with plague shall be isolated until completion of forty-eight hours of effective antimicrobial therapy.
(T) Rubella: a person with rubella shall be isolated, including exclusion from school or child care center, for seven days after the onset of the rash. Persons with congenital rubella shall be isolated until they are one year old unless nasopharyngeal and urine cultures after three months of age are repeatedly negative for rubella.
(U) Salmonellosis, where the person works in a sensitive occupation or is a child in a child care center. Such a person shall be excluded from work or the child care center and may return only when the following conditions are met:
(1) The child may return to the child care center and the person may return to work in the sensitive occupation only after his or her diarrhea has ceased, provided that his or her duties do not include food handling.
(2) A person who is a food handler may return to work only after his or her diarrhea has ceased and after two consecutive follow-up stool specimens are negative for Salmonella.
(V) Scabies: a person with scabies shall be isolated for twenty-four hours following initial treatment with an effective scabicide. A person with the manifestation of scabies known as “crusted scabies” shall be isolated until the mite can no longer be demonstrated on the scabies preparation.
(W) Shigellosis, where the person works in a sensitive occupation or is a child in a child care center. Such a person shall be excluded from work or the child care center and may only return if his or her diarrhea has ceased and after two consecutive follow-up stool specimens are negative for Shigella.
(X) Smallpox: a person with confirmed or suspected smallpox shall be placed in strict isolation in a facility designated by the director. The patient’s release from the facility can occur when all scabs have fallen off.
(Y) Streptococcal infection: a person with a streptococcal infection shall be excluded from school or child care center for twenty-four hours after the initiation of effective antimicrobial therapy.
(Z) Tuberculosis (TB): a person with infectious tuberculosis shall be isolated according to Chapter 3701-15 of the Administrative Code until three consecutive sputums, collected on three different days, are negative for acid fast bacilli on direct smear, and until the local authorized TB authority, as set out in section 339.72 of the Revised Code, or his or her designee approves that person’s removal from isolation.
(AA) Typhoid fever, where the person works in a sensitive occupation or is a child in a child care center. Such a person shall be excluded from work or the child care center and may return only after he or she is asymptomatic and after three consecutive follow-up stool specimens are negative for Salmonella Typhi.
(BB) Typhus: a louse infested person with typhus shall be isolated until twenty-four hours after application of an effective pediculicide for body lice and clothing and environment are free of body lice.
(CC) Viral hemorrhagic fever (VHF): a person with confirmed or suspected viral hemorrhagic fever shall be placed in strict isolation until no longer considered infectious.
(DD) Yellow fever: a person with confirmed or suspected yellow fever shall be isolated to prevent access of mosquitoes to the patient for at least five days after onset of disease.
(EE) Yersiniosis, where the person works in a sensitive occupation or is a child in a child care center. Such a person shall be excluded from work or the child care center, and may return only when the following conditions are met:
(1) The child may return to the child care center and the person may return to work in the sensitive occupation only after his or her diarrhea has ceased, provided that his or her duties do not include food handling.
(2) A food handler may return to work only after his or her diarrhea has ceased and after two consecutive follow-up stool specimens are negative for Yersinia.
R.C. 119.032 review dates: 09/28/2007 and 09/28/2012
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.34
Rule Amplifies: 3701.13, 3707.08
Prior Effective Dates: 11/15/1976, 7/23/98, 10/17/02
(A) For the purpose of this rule
(1) “Biological or chemical toxins” mean poisonous compounds produced by a microorganism or a poisonous chemical compound that pose a risk of human fatality or disability.
(2) “Novel infectious agents” mean agents that are unusual that pose a risk of human fatality or disability.
(3) “Other health-related entity” means an entity that employs health care providers, but that does not have an obligation to report events to the health district having jurisdiction in accordance with the requirements of Chapters 3701. and 3707. of the Revised Code.
(B) A poison control prevention and treatment center or other health-related entity shall report the following events:
(1) An unexpected pattern or increase in the number of telephone inquiries or requests to provide information about poison prevention and treatment and available services;
(2) An unexpected pattern or increase in the number of requests to provide specialized treatment, consultation, information, and educational programs to health care professionals and the public;
(3) An unexpected pattern or increase in the number of requests for information on established or novel infectious agents or biological or chemical toxins posing a risk of human fatality or disability that is relatively uncommon and may have been caused by bioterrorism.
(C) Unless provided otherwise, all reports required by paragraph (B) of this rule shall be submitted to the health commissioner of the health district having jurisdiction over the event. Poison control prevention and treatment centers and other health-related entities shall immediately report an event as specified in rule 3701-3-02 of the Administrative Code, to the extent known or suspected, or upon the request from the director in the manner specified in paragraph (B) of rule 3701-3-03 of the Administrative Code.
(D) As required by division (C) of section 3701.201 of the Revised Code, poison control prevention and treatment centers and other health-related entities shall report information regarding events as specified in this rule. A poison control prevention and treatment center or other entity that does not report events in compliance with this rule is subject to an administrative fine as specified in rule 3701-73-02 of the Administrative Code.
Effective: 05/20/2005
R.C. 119.032 review dates: 05/20/2010
Promulgated Under: 119.03
Statutory Authority: 3701.201
Rule Amplifies: 3701.201
(A) As used in this rule “trauma center” as specified in Section 4765.01 of the Revised Code means all of the following:
(1) Any hospital that is verified by the American college of surgeons as an adult or pediatric trauma center;
(2) Any hospital that is operating as an adult or pediatric trauma center under provisional status pursuant to section 3727.101 of the Revised Code;
(3) Until December 31, 2004, any hospital in this state that is designated by the director as a level II pediatric trauma center under section 3727.081 of the Revised Code;
(4) Any hospital in another state that is licensed or designated under the laws of that state as capable of providing specialized trauma care appropriate to the needs of the trauma patient.
(B) Beginning March 1, 2007, and at least once every two years thereafter or upon request by the director, trauma centers shall confidentially, as provided by division B of section 3701.072 of the Revised Code, report an evaluation of its preparedness to respond to disasters, mass casualties, and bioterrorism to the director. To the extent that adequate information required by this rule is available and provided to the director to comply with this rule, trauma centers are not required to create the information again. Trauma centers may report information required by this rule on a regional basis with prior approval of the director. If trauma centers report as a region, all trauma centers in the region must maintain and individually provide information required by this rule to the director upon request if the director determines the information provide by the regional report is inadequate. Trauma centers may use information and reports from regional medical response systems (RMRS), metropolitan medical response systems (MMRS), or regional physician’s advisory board (RPAB), or other regional information available to trauma centers to assist in preparation of the report required by this rule. The report shall include at least the following:
(1) The population and geographic area served by the trauma center including a list of the counties served;
(2) A copy of any existing emergency response plans developed by the trauma center that specify how the trauma center will respond to disasters, acts of bioterrorism, and the receipt of mass casualties;
(3) Copies of any existing memorandums of understanding, contracts, or other similar documents that provide for how the trauma center will manage patients that exceed the capacity of their respective center due to a bioterrorism or disaster event;
(4) Copies of trauma center confirmed verification/consultative documents provided to the “American College of Surgeons” regarding the trauma center’s capacity, preparedness, and effectiveness to respond to disasters, mass casualties, and bioterrorism and the trauma center’s response either before or after verification is granted. A trauma center may provide a written summary of the information required by this paragraph;
(5) Evidence of participation in exercises sponsored by state or local emergency management agencies or local health departments designed to test local emergency response plans including any existing available after-action reports prepared in response to exercises and provided to trauma centers by state or local emergency management agencies or local health departments;
(6) The trauma center’s assessment of their ability to provide routine care and services and to project their ability to provide identified surge capacity to respond to disasters, mass casualties, and bioterrorism through providing the following information for the trauma center on high utilization dates and low utilization dates specified by the director to each trauma center prior to the director requesting the report:
(a) The number of registered beds;
(b) The number of staffed beds on the dates specified by the director;
(c) The number of critical care beds by category including adult, pediatric, and neonatal intensive care beds;
(d) The minimum and maximum number of staffed critical care beds by category including adult, pediatric, and neonatal intensive care beds on the dates specified by the director;
(e) The number of operating room beds;
(f) The minimum and maximum number of staffed operating room beds on the dates specified by the director;
(g) The minimum and maximum number of staffed emergency department beds on the dates specified by the director;
(h) The number of ambulatory and non-ambulatory patients that can be decontaminated per hour;
(i) The minimum and maximum number of staffed burn beds on the dates specified by the director;
(j) The number of mechanical ventilation devices on site; and
(k) The number of staffed negative air flow rooms available for the entire hospital and the emergency department of the hospital.
(7) Additional information the director determines is necessary to evaluate the trauma center’s preparedness and capacity to respond to disasters, mass casualties, and acts of bioterrorism.
Effective: 02/06/2006
R.C. 119.032 review dates: 05/20/2010
Promulgated Under: 119.03
Statutory Authority: 3701.072
Rule Amplifies: 3701.072
Prior Effective Dates: 05/20/2005
The control measures provided for venereal diseases in rules 3701-3-21 to 3701-3-25 of the Administrative Code shall be in addition to those control measures provided in rules3701-3-01 to 3701-3-13 of the Administrative Code.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 4/1/1964, 3/13/80, 7/23/98
Spouses, common law partners, persons named as sexual contacts, and consorts, when associated with a known or reasonably suspected case of a sexually transmitted disease during the period of communicability shall be reasonably suspected to be infected with a sexually transmitted disease until such time as they are examined and diagnosed by a physician. All prostitutes and persons associating with them shall also be reasonably suspected of having a sexually transmitted disease.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 4/1/1964, 3/13/80
(A) Any physician who diagnoses or treats, or other person who otherwise has knowledge of a case or suspected case of a sexually transmitted disease shall, in addition to the report required in rules 3701-3-02 to 3701-3-07 of the Administrative Code obtain the following information, as applicable and shall include such information with the case report to the health commissioner or his or her designee.
(1) The name, address, age, sex, and race of the infected case individual;
(2) Such other information as will permit such case to be located; and
(3) The information required in paragraphs (A)(1) and (A)(2) of this rule of all persons associated with such case or suspected case who might reasonably be suspected of harboring or having acquired a sexually transmitted disease.
(B) A physician diagnosing or treating an individual for infection with the human immunodeficiency virus, or other person who otherwise provides an individual with a diagnosis of infection with the human immunodeficiency virus, shall make a good faith effort to obtain the following:
(1) The name, address, age, sex, race, and such other information as to permit the location of the case individual’s current marriage partner and the same information as to permit the location of any marriage partner of the case individual within a ten year period prior to diagnosis of infection with the human immunodeficiency virus; and
(2) The name, address, age, sex, race, and such other information as to permit the location of all persons associated with the case individual who might reasonably be suspected of having been exposed to infection with the human immunodeficiency virus.
The diagnosing or treating physician or other person providing the diagnosis shall report the information obtained to the health commissioner or his or her designee in the health district where the individual resides, or shall refer the individual to the Ohio department of health’s sexually transmitted disease partner notification system.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 4/1/1964, 3/13/80, 7/23/98
The health commissioner of each health district is hereby empowered and directed to make, or cause to be made, such examinations of persons reasonably suspected of having a sexually transmitted disease, as may be necessary for carrying out these rules. Such examinations shall be made only by, or under the supervision or direction of, licensed physicians. Each health commissioner shall cooperate in the intrastate, interstate, and international program of notification, referral, and examination of persons reasonably suspected of having a sexually transmitted disease, in accordance with the policies and requirements of the director of health and the federal government.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 4/1/1964, 3/13/80
The health commissioner shall immediately institute measures for the protection of other persons from infection by any person with a sexually transmitted disease and may isolate any person who has, or is reasonably suspected of having a sexually transmitted disease whenever, in his opinion, such isolation is necessary for the protection of the public health. Whenever such isolation is deemed necessary, the health commissioner shall require detention in a hospital or similar place where the isolated person will receive adequate care and approved medical treatment for his disease.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 4/1/1964, 3/13/80
If any person being treated for a sexually transmitted disease discontinues treatment while the disease is still communicable, the physician shall report such discontinuance of treatment to the health commissioner. The health commissioner shall institute such measures for the protection of the public against such diseased person as may be necessary.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 4/1/1964, 3/13/80
Whenever a person is bitten by a dog or other mammal, report of such bite shall be made within twenty-four hours to the health commissioner of the district in which such bite occurred. The report herein required shall be made in the same manner and by the same persons made responsible for reporting diseases listed as class A(2) in rule 3701-3-02 of the Administrative Code, or by the person bitten.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 3/13/1980, 10/19/03
(A) Biting dog, cat, or ferret.
(1) Whenever it is reported to the health commissioner of a health district that any dog, cat, or ferret has bitten a person, that dog, cat, or ferret shall be quarantined under an order issued by the health commissioner of the health district in which the bite was inflicted. The dog, cat, or ferret shall be quarantined by its owner or by a harborer, or shall be quarantined in a pound or kennel. In all cases, said quarantine shall be under the supervision of the health commissioner and shall be at the expense of the owner or harborer. Quarantine shall continue until the health commissioner of the health district in which the bite was inflicted determines that the dog, cat, or ferret is not afflicted with rabies. The quarantine period hereby required shall not be less than ten days from the date on which the person was bitten. If at any time during the quarantine, the health commissioner requires the dog, cat, or ferret to be examined for symptoms of rabies, then the examination shall be by a licensed doctor of veterinary medicine. The veterinarian shall report to the health commissioner the conclusions reached as a result of the examinations. The examination by a veterinarian shall be at the expense of the owner or harborer. No dog, cat, or ferret shall be released from the required quarantine unless and until it has been properly vaccinated against rabies by a licensed doctor of veterinary medicine.
(2) If any quarantined dog, cat, or ferret dies before the quarantine period expires, then the head of the dog, cat, or ferret shall be submitted to the Ohio department of health laboratories for rabies examination.
(3) If the owner or harborer of the dog, cat, or ferret is unknown, the health commissioner may direct that the dog, cat, or ferret be humanely killed in which case the head of the dog, cat, or ferret shall be submitted to the Ohio department of health laboratories for rabies examination.
(4) Any dog, cat, or ferret bitten by a known rabid mammal, or that had reasonable probability to have been bitten by a wild carnivorous mammal or bat that is not available for rabies testing shall be regarded as having been exposed to rabies virus.
(a) Not currently vaccinated dogs, cats, or ferrets shall be humanely killed; or if sufficient justification for preserving the dog, cat, or ferret exists, the exposed dog, cat, or ferret shall be quarantined by the health commissioner of the health district in which the bite was inflicted. The quarantine period shall be for not less than six months. The dog, cat, or ferret shall be vaccinated against rabies by a licensed doctor of veterinary medicine one month before the end of the quarantine period required by this paragraph.
(b) Currently rabies vaccinated mammals shall be given a booster rabies vaccination immediately and quarantined under an order issued by the health commissioner of the health district in which the bite was inflicted. The quarantine period shall be for not less than forty-five days.
(B) Other biting mammals.
Whenever it is reported to the health commissioner of the health district that any other mammal that is known to transmit rabies has bitten a person, the health commissioner at his or her discretion may direct the immediate killing of said mammal by a suitable humane method. The head of said mammal shall then be submitted to the Ohio department of health laboratories for rabies examination.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 4/1/64, 3/13/80, 9/21/81, 10/19/03
Any veterinarian or other person who examines, treats, owns, harbors, or otherwise cares for any mammal which exhibits symptoms or behavior suggestive of rabies, shall confine and isolate such mammal in suitable quarters and shall report such fact within twenty-four hours to the health commissioner of the health district wherein such mammal is confined. Such mammal shall be confined until it has been determined that it is not afflicted with rabies. If it is determined that the mammal is rabid, the health commissioner shall take such action as is necessary to prevent the occurrence of rabies in persons or mammals known or presumed to have been exposed to such rabid mammal.
R.C. 119.032 review dates: 05/08/2008 and 05/01/2013
Promulgated Under: 119.03
Statutory Authority: 3701.13, 3701.24, 3701.34, 3707.06
Rule Amplifies: 3701.24, 3707.06
Prior Effective Dates: 4/1/1964, 10/19/03