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