Chapter 3701-3 Communicable Diseases

3701-3-01 Definitions.

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 established by section 3709.01 of the Revised Code, 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) "Bioterrorism" means the intentional use of any microorganism, virus, infectious substance, or biological product that may be engineered as a result of biotechnology, or any naturally occurring or bioengineered component of a microorganism, virus, infectious substance, or biological product, to cause death, disease, or other biological malfunction in a human, animal, plant, or other living organism as a means of influencing the conduct of government or intimidating or coercing a population.

(E) "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.

(F) "Department" means the Ohio department of health.

(G) "Diarrhea" means three or more loose stools in a twenty-four hour period.

(H) "Director" means the director of health or his or her designee.

(I) "Endemic" means the constant presence of a disease or infectious agent within a given geographic area.

(J) "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.

(K) "Exclude" means to bar from participation.

(L) "Event" means an important happening or occurrence that results from an actual or suspected act of bioterrorism, epidemic or pandemic disease, established or novel infectious agents, or biological or chemical toxins.

(M) "Food handler" means a person who prepares or serves food intended for human consumption.

(N) "Health care provider" means any person or government entity that provides health care services to individuals. "Health care provider" includes, but is not limited to, hospitals, medical clinics and offices, special care facilities, medical laboratories, physicians, dentists, physician assistants, registered and licensed practical nurses, emergency medical service organization personnel, and ambulance service personnel.

(O) "Health district" means a city or general health district as created by Chapter 3709. of the Revised Code.

(P) "Incidence" means the number of new cases of a disease occurring during a specified interval of time in a defined population.

(Q) "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.

(R) "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.

(S) "Pandemic" means an epidemic disease that is occurring throughout a very wide area, usually several countries or continents, and usually affecting a large proportion of the population.

(T) "Poison prevention and treatment center" or "center" means an entity designated as a poison prevention and treatment center by the director of health under section 3701.20 of the Revised Code.

(U) "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.

(V) 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.

(W) "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.

(X) "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.

(Y) "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.

(Z) "Surveillance" means, in the public health service, the systematic collection, analysis, interpretation, and dissemination, of health data on an on-going basis, to gain knowledge of the pattern of disease occurrence and potential in a community in order to control and prevent disease in the community.

(AA) "Susceptible person" means a person that, when exposed to an infectious microorganism, may not possess sufficient resistance to prevent contracting the infection or disease.

Effective: 02/01/2011
R.C. 119.032 review dates: 10/18/2010 and 02/01/2016
Promulgated Under: 119.03
Statutory Authority: 3701.23 , 3701.34
Rule Amplifies: 3701.23
Prior Effective Dates: 3/13/1980, 7/23/98, 10/19/03, 5/20/05, 1/1/09

3701-3-02 [Effective until 1/1/2014]Diseases to be reported.

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, in detail, by health care providers and laboratories 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" - diseases of major public health concern because of the severity of disease or potential for epidemic spread and shall be reported immediately via telephone in accordance with rules 3701-3-03 , 3701-3-04 , and 3701-3-05 of the Administrative Code:

(1) Anthrax

(2) Botulism, foodborne;

(3) Cholera;

(4) Diphtheria;

(5) Influenza "A" - novel virus infection;

(6) Measles;

(7) Meningococcal disease;

(8) Plague;

(9) Rabies, human;

(10) Rubella (not congenital);

(11) Severe acute respiratory syndrome ("SARS")

(12) Smallpox;

(13) Tularemia

(14) Viral hemorrhagic fever ("VHF");

(15) Yellow fever; and

(16) 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.

(B) The following diseases are classified as class "B" and shall be reported in accordance with this rule and rules 3701-3-03 , 3701-3-04 , and 3701-3-05 of the Administrative Code:

(1) Diseases of significant public health concern needing timely response because of potential for epidemic spread shall be reported by the end of the next business day after the case or suspected case presents:

(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 infection;

(vi) Western equine encephalitis virus disease;

(vii) Other arthropod-borne disease;

(b) Chancroid;

(c) Coccidioidomycosis;

(d) Cyclosporiasis;

(e) Dengue;

(f) E. coli O157:H7 and Shiga toxin-producing E. coli (STEC);

(g) Granuloma inguinale;

(h) Haemophilus influenzae (invasive disease);

(i) Hantavirus;

(j) Hemolytic uremic syndrome ("HUS");

(k) Hepatitis A;

(l) Hepatitis B (perinatal);

(m) Influenza-associated pediatric mortality

(n) Legionnaires' disease;

(o) Listeriosis;

(p) Malaria;

(q) Meningitis;

(i) Aseptic (viral);

(ii) Bacterial; (r) Mumps; (s) Pertussis;

(t) Poliomyelitis (including vaccine-associated cases); (u) Psittacosis; (v) Q fever;

(w) Rubella (congenital);

(x) Salmonellosis;

(y) Shigellosis;

(z) Staphylococcus aureus, with resistance or intermediate resistance to vancomycin ("VRSA", "VISA");

(aa) Syphilis;

(bb) Tetanus;

(cc) Tuberculosis ("TB"), including multi-drug resistant tuberculosis ("MDRTB"); and

(dd) Typhoid fever.

(2) Diseases of significant public health concern shall be reported by end of the business week in which the case or suspected case presents:

(a) Amebiasis;

(b) Botulism;

(i) Infant; (ii) Wound;

(c) Brucellosis;

(d) Campylobacteriosis;

(e) Chlamydia infections (urethritis, epididymitis, cervicitis, pelvic inflammatory disease, neonatal conjunctivitis, pneumonia, and lymphogranuloma venereum);

(f) Creutzfeldt-Jakob disease ("CJD");

(g) Cryptosporidiosis;

(h) Cytomegalovirus ("CMV") (congenital);

(i) Ehrlichiosis/anaplasmosis;

(j) Giardiasis;

(k) Gonococcal infections (urethritis, cervicitis, pelvic inflammatory disease, pharyngitis, arthritis, endocarditis, meningitis and neonatal conjunctivitis);

(l) Hepatitis B (non-perinatal);

(m) Hepatitis C;

(n) Hepatitis D (delta hepatitis);

(o) Hepatitis E;

(p) Herpes (congenital);

(q) Influenza-associated hospitalization;

(r) Leprosy ("Hansen Disease");

(s) Leptospirosis;

(t) Lyme disease;

(u) Meningtis, including other bacterial;

(v) Mycobacterial disease, other than tuberculosis ("MOTT");

(w) Rocky Mountain spotted fever ("RMSF");

(x) Streptococcal disease, group A, invasive ("IGAS");

(y) Streptococcal disease, group B, in newborn;

(z) Streptococcal toxic shock syndrome ("STSS");

(aa) Streptococcus pneumoniae, invasive disease ("ISP");

(bb) Toxic shock syndrome ("TSS");

(cc) Trichinosis;

(dd) Typhus fever;

(ee) Varicella;

(ff) Vibriosis; and

(gg) Yersiniosis.

(C) The following are classified as class "C" and shall be reported by the end of the next business day in accordance with this rule and rules 3701-3-03 , 3701-3-04 , and 3701-3-05 of the Administrative Code unless paragraph (C)(7) of this rule applies -outbreak, unusual incidence, or epidemic of other infectious diseases from the following sources:

(1) Community;

(2) Foodborne;

(3) Healthcare-associated;

(4) Institutional;

(5) Waterborne; and

(6) Zoonotic;

(7) If the outbreak, unusual incidence, or epidemic, including but not limited to, histoplasmosis, pediculosis, scabies, and staphylococcal infections, has an unexpected pattern of cases, suspected cases, deaths, or increased incidence of disease that is of a major public health concern pursuant to paragraph (A)(16) of this rule, then such outbreak, unusual incidence, or epidemic shall be reported in accordance with paragraph (A) of rule 3701-3-05 of the Administrative Code.

Effective: 02/01/2011
R.C. 119.032 review dates: 10/18/2010 and 02/01/2016
Promulgated Under: 119.03
Statutory Authority: 3701.23 , 3701.34
Rule Amplifies: 3701.23
Prior Effective Dates: 4/1/1964, 3/13/80, 12/4/81, 9/3/83, 4/17/86, 6/18/90, 10/31/93, 4/9/95, 7/11/96, 1/1/99, 2/15/01, 10/17/02, 4/14/03, 1/1/06

3701-3-02 [Effective 1/1/2014]Diseases to be reported.

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, in detail, by health care providers and laboratories 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) Due to the severity of disease or the potential for epidemic spread, diseases of major public health concern are classified as class "A." The following diseases are classified as class "A" and shall be reported immediately via telephone in accordance with rules 3701-3-03 , 3701-3-04 , and 3701-3-05 of the Administrative Code:

(1) Anthrax;

(2) Botulism, foodborne;

(3) Cholera;

(4) Diphtheria;

(5) Influenza "A" - novel virus infection;

(6) Measles;

(7) Meningococcal disease;

(8) Plague;

(9) Rabies, human;

(10) Rubella (not congenital);

(11) Severe acute respiratory syndrome (SARS);

(12) Smallpox;

(13) Tularemia;

(14) Viral hemorrhagic fever (VHF);

(15) Yellow fever; and

(16) 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.

(B) Due to the potential for epidemic spread, diseases of significant public health concern are classified as class "B." The following diseases are classified as class "B" and shall be reported in accordance with this rule and rules 3701-3-03 , 3701-3-04 , and 3701-3-05 of the Administrative Code:

(1) Amebiasis;

(2) Arboviral neuroinvasive and non-neuroinvasive diseases:

(a) Eastern equine encephalitis virus disease;

(b) LaCrosse virus disease (other California serogroup virus disease);

(c) Powassan virus disease;

(d) St. Louis encephalitis virus disease;

(e) West Nile virus infection;

(f) Western equine encephalitis virus disease;

(g) Other Arthopod-borne diseases;

(3) Babesiosis;

(4) Botulism;

(a) Infant;

(b) Wound;

(5) Brucellosis;

(6) Campylobacteriosis;

(7) Chancroid;

(8) Chlamydia trachomatis infections;

(9) Coccidioidomycosis;

(10) Creutzfeldt-Jakob disease (CJD);

(11) Cryptosporidiosis;

(12) Cyclosporiasis;

(13) Dengue;

(14) E. coli O157:H7 and Shiga toxin-producing E. coli (STEC);

(15) Ehrlichiosis/anaplasmosis;

(16) Giardiasis;

(17) Gonorrhea (Neisseria gonorrhoeae);

(18) Haemophilus influenzae (invasive disease);

(19) Hantavirus;

(20) Hemolytic uremic syndrome (HUS);

(21) Hepatitis A;

(22) Hepatitis B (non-perinatal);

(23) Hepatitis B (perinatal);

(24) Hepatitis C;

(25) Hepatitis D (delta hepatitis);

(26) Hepatitis E;

(27) Influenza-associated hospitalization;

(28) Influenza-associated pediatric mortality;

(29) Legionnaires' disease;

(30) Leprosy (Hansen disease);

(31) Leptospirosis;

(32) Listeriosis;

(33) Lyme disease;

(34) Malaria;

(35) Meningitis;

(a) Aseptic (viral);

(b) Bacterial;

(36) Mumps;

(37) Mycobacterial disease, other than tuberculosis (MOTT);

(38) Pertussis;

(39) Poliomyelitis (including vaccine-associated cases);

(40) Psittacosis;

(41) Q fever;

(42) Rubella (congenital);

(43) Salmonellosis;

(44) Shigellosis;

(45) Spotted Fever Rickettsiosis, including Rocky Mountain spotted fever (RMSF);

(46) Staphylococcus aureus, with resistance or intermediate resistance to vancomycin (VRSA, VISA);

(47) Streptococcal disease, group A, invasive (IGAS);

(48) Streptococcal disease, group B, in newborn;

(49) Streptococcal toxic shock syndrome (STSS);

(50) Streptococcus pneumoniae, invasive disease (ISP);

(51) Syphilis;

(52) Tetanus;

(53) Toxic shock syndrome (TSS);

(54) Trichinellosis;

(55) Tuberculosis (TB), including multi-drug resistant tuberculosis (MDR-TB);

(56) Typhoid fever;

(57) Typhus fever;

(58) Varicella;

(59) Vibriosis; and

(60) Yersiniosis.

(C) The following are classified as class "C" and shall be reported by the end of the next business day in accordance with this rule and rules 3701-3-03 , 3701-3-04 , and 3701-3-05 of the Administrative Code unless paragraph (C)(7) of this rule applies -outbreak, unusual incidence, or epidemic of other infectious diseases from the following sources:

(1) Community;

(2) Foodborne;

(3) Healthcare-associated;

(4) Institutional;

(5) Waterborne; and

(6) Zoonotic;

(7) If the outbreak, unusual incidence, or epidemic, including but not limited to, histoplasmosis, pediculosis, scabies, and staphylococcal infections, has an unexpected pattern of cases, suspected cases, deaths, or increased incidence of disease that is of a major public health concern pursuant to paragraph (A)(16) of this rule, then such outbreak, unusual incidence, or epidemic shall be reported in accordance with paragraph (A) of rule 3701-3-05 of the Administrative Code.

Effective: 01/01/2014
R.C. 119.032 review dates: 08/05/2013 and 02/01/2016
Promulgated Under: 119.03
Statutory Authority: 3701.23 , 3701.34
Rule Amplifies: 3701.23
Prior Effective Dates: 4/1/1964, 3/13/80, 12/3/83, 9/3/83, 4/17/86, 6/18/90, 10/31/93, 4/9/95, 7/11/96, 1/1/99, 2/15/01, 10/17/02, 4/14/03, 1/1/06, 1/1/09, 2/1/11

3701-3-02.1 Reporting of occupational diseases.

(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) Compressed air illness;

(3) Silicosis;

(4) Occupational asthma;

(5) Pesticide poisoning;

(6) Cumulative trauma disorders including, but not limited to carpal tunnel syndrome and persistent and recurring tendinitis;

(7) Poisoning from heavy metals including, but not limited to, lead, nickel and cadmium;

(8) Asbestosis;

(9) Mesothelioma;

(10) Amputation of limb or digit; and

(11) 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.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/15/2008 and 01/01/2014
Promulgated Under: 119.03
Statutory Authority: 3701.25 , 3701.34
Rule Amplifies: 3701.25 , 3701.26
Prior Effective Dates: 7/23/1998, 11/3/90

3701-3-02.2 Air- and blood-borne diseases reasonably likely to be transmitted to emergency medical services workers.

(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

3701-3-03 Reportable disease notification.

(A) A health care provider with knowledge 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 in the manner set forth in rule 3701-3-05 of the Administrative Code .

(1) A health care provider may submit electronic reports in the manner approved by the director .

(2) Unless otherwise demonstrated, a health care provider who submits electronic reports in the manner approved by the director shall be presumed compliant with section 3701.23 of the Revised Code and rules 3701-3-02 , 3701-3-04 , and 3701-3-05 of the Administrative Code.

(B) Reports of cases and suspect cases shall include, but not limited to, the following:

(1) Case or suspect case information: name, diagnosis or suspected diagnosis, date of birth, sex, telephone number, and street address including city, state, and zip code.

(2) Health care provider information: name, telephone number, and street address including city, state, and zip code.

(3) Supplementary information as needed to complete official surveillance forms provided or set forth by the director .

(C) Any individual having knowledge of a person suffering from a disease suspected of being communicable is authorized to report to public health authorities all known facts relating to the case or incident.

Effective: 02/01/2011
R.C. 119.032 review dates: 10/18/2010 and 02/01/2016
Promulgated Under: 119.03
Statutory Authority: 3701.23 , 3701.34
Rule Amplifies: 3701.23
Prior Effective Dates: 4/1/64, 4/13/80, 7/23/1998, 1/1/09

3701-3-04 Laboratory result reporting.

(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 in the manner set forth in rule 3701-3-05 of the Administrative Code .

(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 city or general health district in which the suspect case resides shall make an inquiry through the appropriate health care provider to determine if the suspected case exists.

(C) A laboratory report shall include, but not be limited to, the following:

(1) Case information: name, date of birth, sex, and street address including city, state, and zip code.

(2) Laboratory test information: specimen identification number, specimen collection date, specimen type, test name, test result, and if applicable, the organism and serotype.

(3) Health care provider information: name, telephone number, street address including city, state, and postal zip code.

Effective: 02/01/2011
R.C. 119.032 review dates: 10/18/2010 and 02/01/2016
Promulgated Under: 119.03
Statutory Authority: 3701.23 , 3701.34
Rule Amplifies: 3701.23
Prior Effective Dates: 4/1/64, 4/13/80, 7/23/1998, 1/1/09

3701-3-05 [Effective until 1/1/2014]Time to report.

Reports by health care providers, as specified in rule 3701-3-03 of the Administrative Code, and reports by laboratories of positive results, as specified in rule 3701-3-04 of the Administrative Code, shall be provided in the manner set forth by the director according to the following time and method of reporting:

(A) Cases, suspect cases, and positive laboratory results for diseases specified as class

"A" in paragraph (A) of rule 3701-3-02 of the Administrative Code shall be initially and immediately provided by telephone to the local health jurisdiction in which the case or suspected case resides, or if the residence is unknown, to the Ohio department of health. Follow up reports shall be provided in the manner set forth by the director . If cases, suspect cases, and positive laboratory results for diseases specified as class "A" are reported to a local health district, such local health jurisdiction shall immediately notify the Ohio department of health in the manner set forth by the director .

(B) Case and suspect case reports and reports of positive laboratory results for diseases specified as class "B":

(1) In paragraph (B)(1) of rule 3701-3-02 of the Administrative Code shall be provided by the end of the next business day; or

(2) In paragraph (B)(2) of rule 3701-3-02 of the Administrative Code shall be provided by the end of the business week in which the case or suspected case presents, or a positive laboratory result occurs.

(C) Reports related to an actual or suspected outbreak, unusual incident, or epidemic of any disease specified as class "C" in paragraph (C) of rule 3701-3-02 of the Administrative Code shall be provided by the end of the next business day, unless the unexpected pattern of cases, suspect cases, deaths, or increased incidence of disease is of major public health concern pursuant to paragraph (A) of rule 3701-3-02 of the Administrative Code, then such reports shall be made according to paragraph (A) of this rule.

Effective: 02/01/2011
R.C. 119.032 review dates: 10/18/2010 and 02/01/2016
Promulgated Under: 119.03
Statutory Authority: 3701.23 , 3701.34
Rule Amplifies: 3701.23
Prior Effective Dates: 4/1/64, 4/13/80, 7/23/1998, 1/1/09

3701-3-05 [Effective 1/1/2014]Time to report.

Reports by health care providers, as specified in rule 3701-3-03 of the Administrative Code, and reports by laboratories of positive results, as specified in rule 3701-3-04 of the Administrative Code, shall be provided in the manner set forth by the director according to the following time and method of reporting:

(A) Cases, suspect cases, and positive laboratory results for diseases specified as class "A" in paragraph (A) of rule 3701-3-02 of the Administrative Code shall be initially and immediately provided by telephone to the local health jurisdiction in which the case or suspected case resides, or if the residence is unknown, to the Ohio department of health. Follow up reports shall be provided in the manner set forth by the director. If cases, suspect cases, and positive laboratory results for diseases specified as class "A" are reported to a local health district, such local health jurisdiction shall immediately notify the Ohio department of health in the manner set forth by the director.

(B) Case and suspect case reports and reports of positive laboratory results for diseases specified as class "B" in paragraph (B) of rule 3701-3-02 of the Administrative Code shall be provided by the end of the next business day.

(C) Reports related to an actual or suspected outbreak, unusual incident, or epidemic of any disease specified as class "C" in paragraph (C) of rule 3701-3-02 of the Administrative Code shall be provided by the end of the next business day, unless the unexpected pattern of cases, suspect cases, deaths, or increased incidence of disease is of major public health concern pursuant to paragraph (A) of rule 3701-3-02 of the Administrative Code, then such reports shall be made according to paragraph (A) of this rule.

Effective: 01/01/2014
R.C. 119.032 review dates: 08/05/2013 and 02/01/2016
Promulgated Under: 119.03
Statutory Authority: 3701.23 , 3701.34
Rule Amplifies: 3701.23
Prior Effective Dates: 4/1/1964, 3/13/80, 7/23/98, 1/1/09, 2/1/11

3701-3-06 [Effective until 1/1/2014]Reporting to department.

A board of health that receives a report of a case, suspected case or positive laboratory result pursuant to rules 3701-3-02 , 3701-3-03 , 3701-3-04 , and 3701-3-05 of the Administrative Code shall report the same report to the department as follows:

(A) Diseases specified as class "A" in paragraph (A) 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.

(B) Diseases specified as class "B":

(1) In paragraph (B)(1) 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 or positive laboratory result is known to the board of health; or

(2) In paragraph (B)(2) of rule 3701-3-02 of the Administrative Code shall be reported by the close of the business week in which the existence of such case or suspect case or positive laboratory result is known to the board of health.

(C) Outbreaks, unusual incidence, or epidemics of 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.

Replaces: 3701-3-06

Effective: 01/01/2009
R.C. 119.032 review dates: 01/01/2014
Promulgated Under: 119.03
Statutory Authority: 3701.24 , 3701.34
Rule Amplifies: 3701.24 , 3707.06
Prior Effective Dates: 4/1/64, 3/13/80, 7/23/1998

3701-3-06 [Effective 1/1/2014]Reporting to department.

A board of health that receives a report of a case, suspected case or positive laboratory result pursuant to rules 3701-3-02 , 3701-3-03 , 3701-3-04 , and 3701-3-05 of the Administrative Code shall report the same report to the department as follows:

(A) Diseases specified as class "A" in paragraph (A) 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.

(B) Diseases specified as class "B" in paragraph (B) 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 or positive laboratory result is known to the board of health.

(C) Outbreaks, unusual incidence, or epidemics of 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.

Effective: 01/01/2014
R.C. 119.032 review dates: 08/05/2013 and 02/01/2016
Promulgated Under: 119.03
Statutory Authority: 3701.24 , 3701.34
Rule Amplifies: 3701.24 , 3707.06
Prior Effective Dates: 4/1/64, 3/13/80, 7/23/1998, 1/1/09

3701-3-08 Release of patient's medical records.

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.

Replaces: 3701-3-08

Effective: 01/01/2009
R.C. 119.032 review dates: 01/01/2014
Promulgated Under: 119.03
Statutory Authority: 3701.34
Rule Amplifies: 3701.13 , 3701.14
Prior Effective Dates: 2/4/1983, 7/23/98

3701-3-09 Methods of control. [Rescinded].

Rescinded eff 1-1-09

3701-3-10 Approval of human immunodeficiency virus tests.

(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 onlygp41 antibodies produced bands at the 41-, 120-, and 160-kd positions.

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,andgp41 or gp120/160 (12) (see Table 2). Conversely, a negative Du Pont Western blot test result requires the absence of any and all bands - not just viral-bands. All other patterns are regarded as indeterminate. This interpretation scheme maximizes the specificity of the assay and is mainly intended for use with samples from persons, such as blood donors, for whom there is usually little clinical or virologic information available. (Donated units of blood that are

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 anytwo of the following bands: p24, gp41, and gp120/160 (13). The Consortium for Retrovirus Serology Standardization (CRSS) has defined a positive test result as the presence of eitherp24 or p31, plus a diffuse envelope band (i.e., gp41 or gp120/160) (14). The American Red Cross has defined a positive test result as

3 1 band from eachof the GAG, POL, and ENV gene-product groups (15). These three groups and DuPont all agree that an indeterminate result is the presence of any other band or bands that fail to meet the positive criteria, and that a negative result is the absence of all bands.

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 p24

Laboratory Directors/CDC gp41

gp120/gp 160

*

FDA-licensed Du Pont test p24 and p31andgp41 or gp120/gp160

American Red Cross

3 3 bands - 1 from each gene-product group:

GAG and

POL and

ENV

Consortium for Retrovirus

3 2 bands: p24orp31, plus

Serology Standardization gp41or

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 notinfected with HIV-1. However, no large-scale studies have been done to provide virologic data to confirm independently the serologic findings from the studies of clients whose Western blot test results are consistently indeterminate. In contrast, an asymptomatic person who has an indeterminate Western blot test result and a history of possible exposure to or symptoms compatible with HIV infection requires additional diagnostic follow-up. This should include conducting serial Western blot tasting, assessing the function of the individual's immune system, and eliciting the cooperation of the person's sexual and needle-sharing partners to determine whether they are infected. individuals with a pattern of indeterminate Western blot test results should not donate blood or plasma for either transfusion or use in manufactured blood products.

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

3701-3-11 Requirements related to human immunodeficiency virus testing.

(A) A human immunodeficiency virus (HIV) test may be performed by or on the order of the health care provider who, in the exercise of the provider's professional judgment and within the provider's scope of practice, 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. Prior to performing or ordering an HIV test, the health care provider shall inform the individual to be tested of the individual's right to an anonymous test as set forth in section 3701.242 of the Revised Code and paragraph (C) of this rule.

(B) Pursuant to division (B) of section 3701.242 of the Revised Code, 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 paragraph are not responsible for payments for an HIV test given to the minor without the consent of a parent or the guardian.

(C) 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 the individual requesting an anonymous test to a site where anonymous testing is available.

(D) If an individual tests positive for HIV, the health care provider who performed or ordered the test shall provide post-test counseling. Post-test counseling is suggested for all individuals seeking testing. Post-test counseling may be verbal or in writing and shall included, but is not limited to, the following:

(1) An explanation of the HIV test result. If, at the time of the HIV test, the result is preliminarily positive, the health care provider must explain the next step to confirm the test result;

(2) The nature of HIV disease;

(3) A list of resources for medical treatment, social services and, when necessary, a referral for further counseling to help that individual cope with the emotional consequences of learning of the test result;

(4) The individual will be provided information about the importance of following safer sex practices to protect themselves from sexually transmitted diseases, as well as how to protect others from being infected; and

(5) The individual will be provided information about Ohio's HIV disclosure laws.

(E) The requirements of paragraphs (B) to (D) 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. Post-test counseling shall be given to the individual if the individual received an HIV positive test result 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 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 cause, that a test is necessary; or

(5) 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 service worker, or peace officer, when rendering health or emergency care to an individual, has sustained significant exposure to the body fluids that are known to transmit HIV of that individual, and the individual has refused to give consent for testing.

(F) 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.

Replaces: 3701-3-11

Effective: 10/30/2010
R.C. 119.032 review dates: 04/01/2015
Promulgated Under: 119.03
Statutory Authority: 3701.241
Rule Amplifies: 3701.242
Prior Effective Dates: 3/13/80, 11/30/1989 (Emer.), 2/19/90, 8/17/92, 7/11/96, 7/23/98, 1/1/09

3701-3-12 AIDS, ARC, and HIV test reporting.

(A) As used in this rule:

(1) "AIDS" means the illness designated as acquired immunodeficiency syndrome as further defined in appendix A to 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 pursuant to divisions (B) and (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 health care provider with knowledge of the case. 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. Definitive: Positive results on two separate specimens (excluding cord blood) using one or more of the following HIV virologic (nonantibody) tests:

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. Presumptive: A child who does not meet the criteria for definitive HIV infection but who has:

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. Definitive:

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. Presumptive

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,supra.

fn5 See footnote 3,supra.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/15/2008 and 01/01/2014
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: 6/18/1990, 5/2/02

3701-3-13 Isolation requirement.

A person infected with one of the following specified diseases or conditions shall be isolated as set fort in this rule:

(A) Amebiasis: a person with amebiasis who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation and may return after diarrhea has ceased and three follow-up stool specimens are negative for Entamoeba histolytica.

(B) Campylobacteriosis: a person with campylobacteriosis who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation and may return when the following conditions are met:

(1) A child may return to a child care center after his or her diarrhea has ceased.

(2) A person may return to work in a sensitive occupation after diarrhea has ceased, provided the person's duties do not include food handling.

(3) A food handler may return to work only after diarrhea has ceased and one of the following conditions are met:

(a) Forty-eight hours of effective antimicrobial therapy; or

(b) Two consecutive follow-up stool specimens 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: a person with cholera who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation and may return when the following conditions are met:

(1) A child may return to a child care center after diarrhea has.

(2) A person may return to work in a sensitive occupation after diarrhea has ceased, provided that his or her duties do not include food handling.

(3) A food handler may return to work after diarrhea has ceased and two consecutive follow-up stool specimens are negative for Vibrio cholerae.

(E) Conjunctivitis, purulent: a person with purulent conjunctivitis who attends or works in a child care center shall be excluded from the child care center and may return twenty-four hours after the initiation of effective antimicrobial therapy.

(F) Cryptosporidiosis: a person with cryptosporidiosis who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation and may return when the following conditions are met:

(1) The child may return to the child care center after diarrhea has ceased.

(2) A person may return to work in a sensitive occupation after diarrhea has ceased, provided that his or her duties do not include food handling.

(3) A food handler may return to work after diarrhea has ceased and after three consecutive follow-up stool specimens are negative for Cryptosporidium.

(G) Cyclosporiasis: a person with cyclosporiasis who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation and may return after diarrhea has ceased and effective antimicrobial therapy has begun.

(H) Diarrhea, infectious or of unknown cause: a person with diarrhea, of infectious or unknown cause, who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation and may return only after 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, other enterohemorrhagic (Shiga toxin-producing) E. coli or hemolytic uremic syndrome (HUS): a person with Escherichia coli (E. coli) O157:H7, other enterohemorrhagic (Shiga toxin-producing) E. coli or hemolytic uremic syndrome (HUS) who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation and may return after his or her diarrhea has ceased and after two consecutive follow-up stool specimens are negative for E. coli O157:H7 or other enterohemorrhagic (Shiga toxin-producing) E. coli.

(K) Giardiasis: a person with giardiasis who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation and may return after diarrhea has ceased and one of the following conditions have been met:

(1) Seventy-two hours of effective antimicrobial therapy; or

(2) Three consecutive follow-up stool specimens are negative for Giardia.

(L) Hepatitis A: a person with hepatitis A who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation 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: a 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 five 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 placed in droplet isolation 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: a person with salmonellosis who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation and may return when the following conditions are met:

(1) The child may return to the child care center after diarrhea has ceased.

(2) A person may return to work in a sensitive occupation after diarrhea has ceased, provided that his or her duties do not include food handling.

(3) A person who is a food handler may return to work after diarrhea has ceased and after two consecutive follow-up stool specimens are negative for Salmonella.

(V) SARS (severe acute respiratory distress syndrome): a person with confirmed or suspected SARS shall be placed in airborne isolation until no longer considered infectious.

(W) 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 a scabies preparation.

(X) Shigellosis: a person with shigellosis who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation and may return if diarrhea has ceased and after two consecutive follow-up stool specimens are negative for Shigella.

(Y) Smallpox: a person with confirmed or suspected smallpox shall be placed in airborne isolation in a facility designated by the director. The patient's release from the facility can occur when all scabs have fallen off.

(Z) 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.

(AA) Tuberculosis (TB): a person with infectious tuberculosis shall be isolated according to Chapter 3701-15 of the Administrative Code until the person has three negative AFB sputum smear results, collected eight to twenty-four hours apart (with at least one being an early morning specimen) and the person has responded clinically to an antituberculosis treatment regimen consistent with the results of any susceptibility testing performed 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.

(BB) Typhoid fever person works in a sensitive occupation shall be excluded from work and may return after the person is asymptomatic and after three consecutive follow-up stool specimens are negative for Salmonella Typhi.

(CC) 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.

(DD) Viral hemorrhagic fever (VHF): a person with confirmed or suspected viral hemorrhagic fever shall be placed in airborne isolation until no longer considered infectious.

(EE) 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.

(FF) Yersiniosis: a person with yersiniosis who attends a child care center or works in a sensitive occupation shall be excluded from the child care center or work in the sensitive occupation and may return when the following conditions are met:

(1) A child may return to the child care center after diarrhea has ceased.

(2) A person may return to work in a sensitive occupation after diarrhea has ceased, provided that his or her duties do not include food handling.

(3) A food handler may return to work after diarrhea has ceased and two consecutive follow-up stool specimens are negative for Yersinia.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/15/2008 and 01/01/2014
Promulgated Under: 119.03
Statutory Authority: 3701.34
Rule Amplifies: 3701.13 , 3701.24 , 3701.241 , 3701.242 , 3701.243 , 3701.244 , 3701.245 , 3701.246 , 3701.247 , 3701.248 , 3701.249 , 3707.04 , 3707.05 , 3707.06 , 3707.07 , 3707.08
Prior Effective Dates: 11/15/1976, 7/23/98, 10/17/02

3701-3-14 Reporting requirements-poison control prevention and treatment centers and other health-related entities.

(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.

R.C. 119.032 review dates: 04/27/2010 and 04/01/2015
Promulgated Under: 119.03
Statutory Authority: 3701.201
Rule Amplifies: 3701.201
Prior Effective Dates: 5/20/2005

3701-3-15 Reporting requirements-pharmacies or pharmacists.

(A) As used in this rule:

(1) "Pharmacist" means an individual licensed under Chapter 4729. of the Revised Code to engage in the practice of pharmacy as a pharmacist.

(2) "Pharmacy," means the same as defined in division (A) of section 4729.01 . of the Revised Code.

(3) "Prescription" means the same as defined in division (H) of section 4729.01 . of the Revised Code.

(4) "Significant changes" means observations or occurrences of or related to medication usage that is, based on professional experience and judgment, too closely correlated to be attributed to chance.

(5) "Unexpected increase" means, based on past experience, an unforeseen change in the types, urgency, or volume of sales, inquiries or requests specified in this rule.

(B) All pharmacies and pharmacists shall immediately report information by telephone or electronically to the health commissioner of the health district having jurisdiction:

(1) Any prescription for medication used to treat a disease that is relatively uncommon and may have been caused by bioterrorism, or

(2) Significant changes in medication usage that may be caused by bioterrorism, epidemic or pandemic disease, or established or novel infectious agents or biological toxins posing a risk of human fatality or disability, or

(3) An unexpected increase in:

(a) The number of prescriptions issued for antibiotics;

(b) The number of prescriptions issued for medications to treat fever or respiratory or gastrointestinal complaints;

(c) The sales of or the number of requests for over-the-counter medication to treat fever, respiratory, or gastrointestinal complaints.

(C) Pharmacies and pharmacists shall submit reports required by this rule using forms and formats approved by the director. A pharmacy or pharmacist using an electronic reporting system or systems, to the extent approved by the director, is deemed to comply with the reporting requirements of this rule until such use is no longer considered active by the director.

(D) All health commissioners shall immediately report information received from pharmacies or pharmacists to the director.

(1) Health commissioner reports shall be submitted by telephone or by electronic means approved by the director.

(2) If a pharmacy has submitted an electronic report for over the counter medication sales as authorized by this rule and so advises the health commissioner, no further report is required.

(E) Upon receipt of a request from a health commissioner of the health district having jurisdiction, each pharmacy in the jurisdiction and for each location within the jurisdiction shall:

(1) Within ten business days of receiving such a request, identify an employee or employees of the pharmacy or a pharmacist or pharmacists employed at the pharmacy of who will be the point of contact for purposes of this rule.

(2) Within ten business days advise the health commissioner having jurisdiction of any change in the information of who will be responsible for being the point of contact for purposes of this rule.

(F) In consultation with the Ohio board of pharmacy, the director may publish a list of antibiotics and other medications that are required to be included in reports of significant changes in medication usage required by this rule.

(G) A pharmacy or pharmacist shall report information regarding events as specified in this rule. A pharmacy or pharmacist 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.

R.C. 119.032 review dates: 04/27/2010 and 04/01/2015
Promulgated Under: 119.03
Statutory Authority: 3701.232
Rule Amplifies: 3701.232
Prior Effective Dates: 05/20/2005

3701-3-16 Reporting requirements-trauma centers.

(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 ofregistered 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.

R.C. 119.032 review dates: 04/27/2010 and 04/01/2015
Promulgated Under: 119.03
Statutory Authority: 3701.072
Rule Amplifies: 3701.072
Prior Effective Dates: 5/20/2005, 2/6/06

3701-3-20 Venereal disease (sexually transmitted diseases - (S.T.D.). [Rescinded].

Rescinded eff 1-1-09

3701-3-21 Who shall be considered a suspected case of venereal disease (S.T.D.). [Rescinded].

Rescinded eff 1-1-09

3701-3-22 Information to be obtained regarding suspected cases. [Rescinded].

Rescinded eff 1-1-09

3701-3-23 Examination of cases; notification regarding suspects. [Rescinded].

Rescinded eff 1-1-09

3701-3-24 Isolation of cases or suspected cases. [Rescinded].

Rescinded eff 1-1-09

3701-3-25 Report of discontinuance of treatment. [Rescinded].

Rescinded eff 1-1-09

3701-3-28 Report of bite of dog or other mammal.

Whenever an individual 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 by any health care provider, or by any licensed doctor of veterinary medicine with knowledge of the bite, or by the individual bitten.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/15/2008 and 01/01/2014
Promulgated Under: 119.03
Statutory Authority: 3701.34
Rule Amplifies: 3701.34 , 3707.06 , 3707.07
Prior Effective Dates: 4/1/64, 3/13/1980, 10/19/03

3701-3-29 Biting animal to be confined; veterinarian to report.

(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 an individual, 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 licensed doctor of veterinary medicine shall report to the health commissioner the conclusions reached as a result of the examinations. The examination by a licensed doctor of veterinary 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's bureau of public 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's bureau of public 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 the rabies virus.

(a) Dogs, cats, or ferrets not currently vaccinated against the rabies virus or when vaccination cannot be verified 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) Mammals with a current rabies vaccination 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's bureau of public health laboratories for rabies examination.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/15/2008 and 01/01/2014
Promulgated Under: 119.03
Statutory Authority: 3701.34
Rule Amplifies: 3701.13 , 3707.06 , 3707.07
Prior Effective Dates: 4/1/1964, 3/13/80, 9/21/81, 10/19/03

3701-3-30 Report of suspected rabid mammal.

Any licensed doctor of veterinary medicine 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 after the symptoms or behaviors are observed or known 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 individuals or mammals known or presumed to have been exposed to such rabid mammal.

Effective: 01/01/2009
R.C. 119.032 review dates: 09/15/2008 and 01/01/2014
Promulgated Under: 119.03
Statutory Authority: 3701.34
Rule Amplifies: 3701.13 , 3707.06 , 3707.07
Prior Effective Dates: 4/1/1964, 10/19/03