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HIV Reportability

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RULES AND REGULATIONS

Title 28--HEALTH AND SAFETY

DEPARTMENT OF HEALTH
[28 PA. CODE CH. 27]

Reporting of AIDS, HIV Test Results, CD4 T-Lymphocyte Counts and Perinatal Exposure of Newborns to HIV
[32 Pa.B. 3597]

The Department of Health (Department), with the approval of the Advisory Health Board (Board), adopts amendments to Chapter 27 (relating to communicable and noncommunicable diseases) to read as set forth in Annex A.

A. Purpose and Background

The Department's regulations require name reporting of individuals who: (1) have had positive test results established from any test approved by the Food and Drug Administration (FDA) to establish the presence of the Human Immunodeficiency Virus (HIV); (2) have low CD4 T-lymphocyte cell counts as described in this Preamble; or (3) are pregnant women who have had positive HIV test results or are newborns who have been perinatally exposed to HIV. The regulations also clarify that cases of Acquired Immune Deficiency Syndrome (AIDS) are reportable based on the case definition of the Centers for Disease Prevention and Control (CDC). Reports of AIDS include reports of presumptive diagnoses of AIDS based on the presence of an AIDS defining illness (for example, Kaposi's sarcoma) with laboratory confirmation of HIV.

The rest of the Preamble to these regulations is accessible at the web page of the Pennsylvania Bulletin. This page presents Annex A only, which contains the relevant regulations.

Annex A

TITLE 28. HEALTH AND SAFETY

PART III. PREVENTION OF DISEASES CHAPTER 27.

COMMUNICABLE AND NONCOMMUNICABLE DISEASES

Subchapter A. GENERAL PROVISIONS

§ 27.1. Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

* * * * *

AIDS (Acquired Immune Deficiency Syndrome)--As defined by the CDC case definition published in the CDC Morbidity and Mortality Weekly Report (MMWR). (The Department will publish in the Pennsylvania Bulletin a reference to a CDC update of the case definition within 30 days of its publication in the MMWR).

Anonymous HIV Testing--HIV testing performed at a State-designated HIV testing site for an individual who chooses not to provide his name in giving consent for the testing.

CDC--Centers for Disease Control and Prevention.

* * * * *

Confidential HIV testing--HIV testing performed for an individual who, in giving his consent for the testing, provides his name and other personal or demographic identifiers.

* * * * *

FDA--Food and Drug Administration.

* * * * *

HIV services--The range of services, including prevention, counseling, testing, treatment, case management, support and referral services, which are provided to persons infected with or affected by HIV or AIDS, and are intended to alleviate physical and psychosocial problems created by these diseases and conditions.

* * * * *

Perinatal exposure of a newborn to HIV--The potential perinatal transmission of HIV to a newborn indicated by a positive HIV test result for the pregnant woman or mother of a newborn.

* * * * *

State-designated anonymous HIV testing site--An HIV testing site supported by the Department either through direct funding or payment for testing, which provides anonymous and confidential testing and which agrees to adhere to the CDC's counseling and testing standards and guidelines issued by the Department.

* * * * *

Subchapter B. REPORTING OF DISEASES

§ 27.21. (Reserved).

§ 27.21a. Reporting of cases by health care practitioners and health care facilities.

(a) Except as set forth in this section or as otherwise set forth in this chapter, a health care practitioner or health care facility is required to report a case of a disease, infection or condition in subsection (b) as specified in § 27.4 (relating to reporting cases), if the health care practitioner or health care facility treats or examines a person who is suffering from, or who the health care practitioner or health care facility suspects, because of symptoms or the appearance of the individual, of having a reportable disease, infection or condition:

(1) A health care practitioner or health care facility is not required to report a case if that health care practitioner or health care facility has reported the case previously.

(2) A health care practitioner or health care facility is not required to report a case of influenza unless the disease is confirmed by laboratory evidence of the causative agent.

(3) A health care practitioner or health care facility is not required to report a case of chlamydia trachomatis infection unless the disease is confirmed by laboratory evidence of the infectious agent.

(4) A health care practitioner or health care facility is not required to report a case of cancer unless the health care practitioner or health care facility provides screening, therapy or diagnostic services to cancer patients.

(5) Only physicians and hospitals are required to report cases of AIDS.

(b) The following diseases, infections and conditions in humans are reportable by health care practitioners and health care facilities within the specified time periods and as otherwise required by this chapter:

(1) The following diseases, infections and conditions are reportable within 24 hours after being identified by symptoms, appearance or diagnosis:

Animal bite.

Anthrax.

Arboviruses.

Botulism.

Cholera.

Diphtheria.

Enterohemorrhagic E. coli.

Food poisoning outbreak.

Haemophilus influenzae invasive disease.

Hantavirus pulmonary syndrome.

Hemorrhagic fever.

Lead poisoning.

Legionellosis.

Measles (rubeola).

Meningococcal invasive disease.

Plague.

Poliomyelitis.

Rabies.

Smallpox.

Typhoid fever.

(2) The following diseases, infections and conditions are reportable within 5 work days after being identified by symptoms, appearance or diagnosis:

AIDS.

Amebiasis.

Brucellosis.

CD4 T-lymphocyte test result with a count of less than 200 cells/µL or a CD4 T-lymphocyte percentage of less than 14% of total lymphocytes (effective October 18, 2002).

Campylobacteriosis.

Cancer.

Chancroid.

Chickenpox (varicella) (effective January 26, 2005).

Chlamydia trachomatis infections.

Congential adrenal hyperplasia (CAH) in children under 5 years of age.

Creutzfeldt-Jakob Disease.

Cryptosporidiosis.

Encephalitis.

Galactosemia in children under 5 years of age.

Giardiasis.

Gonococcal infections.

Granuloma inguinale.

Guillain-Barre syndrome.

HIV (Human Immunodeficiency Virus) (effective October 18, 2002).

Hepatitis, viral, acute and chronic cases.

Histoplasmosis.

Influenza.

Leprosy (Hansen's disease).

Leptospirosis.

Listeriosis.

Lyme disease.

Lymphogranuloma venereum.

Malaria.

Maple syrup urine disease (MSUD) in children under 5 years of age.

Meningitis (All types not caused by invasive Haemophilus influenza or Neis seria meningitis).

Mumps.

Perinatal exposure of a newborn to HIV (effective October 18, 2002).

Pertussis (whooping cough).

Phenylketonuria (PKU) in children under 5 years of age.

Primary congenital hypothyroidism in children under 5 years of age.

Psittacosis (ornithosis).

Rickettsial diseases.

Rubella (German measles) and congenital rubella syndrome.

Salmonellosis.

Shigellosis.

Sickle cell disease in children under 5 years of age.

Staphylococcus aureus, Vancomycin-resistant (or intermediate) invasive disease.

Streptococcal invasive disease (group A).

Streptococcus pneumoniae, drug-resistant invasive disease.

Syphilis (all stages).

Tetanus.

Toxic shock syndrome.

Toxoplasmosis.

Trichinosis.

Tuberculosis, suspected or confirmed active disease (all sites).

Tularemia.

(c) A school nurse shall report to the LMRO any unusual increase in the number of absentees among school children. A caregiver at a child care group setting shall report to the LMRO any unusual increase in the number of absentees among children attending the child care group setting.

(d) A health care facility or health care practitioner providing screening, diagnostic or therapeutic services to patients with respect to cancer shall also report cases of cancer as specified in § 27.31 (relating to reporting cases of cancer).

§ 27.22. Reporting of cases by clinical laboratories.

(a) A person who is in charge of a clinical laboratory in which a laboratory test of a specimen derived from a human body yields microscopical, cultural, immunological, serological, chemical, virologic, nucleic acid (DNA or RNA) or other evidence significant from a public health standpoint of the presence of a disease, infection or condition listed in subsection (b) shall promptly report the findings, no later than the next work day after the close of business on the day on which the test was completed, except as otherwise noted in this chapter.

(b) The diseases, infections and conditions to be reported include the following:

Amebiasis.

Anthrax.

An unusual cluster of isolates.

Arboviruses.

Botulism--all forms.

Brucellosis.

CD4 T-lymphocyte test result with a count of less than 200 cells/µL or less than 14% of total lymphocytes (effective October 18, 2002).

Campylobacteriosis.

Cancer.

Chancroid.

Chickenpox (varicella).

Chlamydia trachomatis infections.

Cholera.

Congential adrenal hyperplasia (CAH) in children under 5 years of age.

Creutzfeldt-Jakob disease.

Cryptosporidiosis.

Diphtheria infections.

Enterohemorrhagic E. coli 0157 infections, or infections caused by other subtypes producing shiga-like toxin.

Galactosemia in children under 5 years of age.

Giardiasis.

Gonococcal infections.

Granuloma inguinale.

HIV (Human Immunodeficiency Virus) (effective October 18, 2002).

Haemophilus influenzae infections--invasive from sterile sites.

Hantavirus.

Hepatitis, viral, acute and chronic cases.

Histoplasmosis.

Influenza.

Lead poisoning.

Legionellosis.

Leprosy (Hansen's disease).

Leptospirosis.

Listeriosis.

Lyme disease.

Lymphogranuloma venereum.

Malaria.

Maple syrup urine disease (MSUD) in children under 5 years of age.

Measles (rubeola).

Meningococcal infections--invasive from sterile sites.

Mumps.

Pertussis.

Phenylketonuria (PKU) in children under 5 years of age.

Primary congenital hypothyroidism in children under 5 years of age.

Plague.

Poliomyelitis.

Psittacosis (ornithosis).

Rabies.

Respiratory syncytial virus.

Rickettsial infections.

Rubella.

Salmonella.

Shigella.

Sickle cell disease in children under 5 years of age.

hemoglobinopathies in children under 5 years of age.

Staphylococcus aureus Vancomycin-resistant (or intermediate) invasive disease.

Streptococcus pneumoniae, drug-resistant invasive disease.

Syphilis.

Tetanus.

Toxoplasmosis.

Trichinosis.

Tuberculosis, confirmation of positive smears or cultures, including results of drug susceptibility testing.

Tularemia.

Typhoid.

(c) The report shall include the following, except as provided in subsection (d):

(1) The name, age, address and telephone number of the person from whom the specimen was obtained.

(2) The date the specimen was collected.

(3) The source of the specimen (such as, serum, stool, CSF, wound).

(4) The name of the test or examination performed and the date it was performed.

(5) The results of the test.

(6) The range of normal values for the specific test performed.

(7) The name, address and telephone number of the physician for whom the examination or test was performed.

(8) Other information requested in case reports or formats specified by the Department.

(d) Laboratory test results shall be reported by the person in charge of a laboratory directly to the Department's Bureau of Epidemiology through secure electronic mechanisms in a manner specified by the Department, except for the following: Reports of CAH, galactosemia maple syrup urine disease, phenylketonuria, primary congenital hypothyroidism, sickle cell disease, cancer, CD4 T-lymphocyte test results with a count of less than 200 cells/µL or less than 14% of total lymphocytes, HIV (Human Immunodeficiency Virus), and lead poisoning shall be made in the manner and to the location specifically designated in this subchapter. See §§ 27.30, 27.31, 27.32a and 27.34.

(e) A clinical laboratory shall submit isolates of salmonella and shigella to the Department's Bureau of Laboratories for serotyping within 5 work days of isolation.

(f) A clinical laboratory shall submit isolates of Neisseria meningitidis obtained from a normally sterile site to the Department's Bureau of Laboratories for serogrouping within 5 work days of isolation.

(g) A clinical laboratory shall send isolates of enterohemorrhagic E. coli to the Department's Bureau of Laboratories for appropriate further testing within 5 work days of isolation.

(h) A clinical laboratory shall send isolates of Haemophilus influenzae obtained from a normally sterile site to the Department's Bureau of Laboratories for serotyping within 5 work days of isolation.

(i) The Department, upon publication of a notice in the Pennsylvania Bulletin, may authorize changes in the requirements for submission of isolates based upon medical or public health developments when such departure is determined by the Department to be necessary to protect the health of the people of this Commonwealth. The change will not remain in effect for more than 90 days after publication unless the Board acts to affirm the change within that 90-day period.

§ 27.23. Reporting of cases by persons other than health care practitioners, health care facilities, veterinarians or laboratories.

Except with respect to reporting cancer, AIDS, CD4 T-lymphocyte test result with a count of less than 200 cells/µL or less than 14% of total lymphocytes, HIV test results or perinatal exposure of a newborn to HIV, individuals in charge of the following types of group facilities identifying a disease, infection or condition listed in § 27.21a (relating to reporting of cases by health care practitioners and health care facilities) by symptom, appearance or diagnosis shall make a report within the timeframes required in § 27.21a (relating to reporting of cases by health care practitioners and health care facilities):

(1) Institutions maintaining dormitories and living rooms.

(2) Orphanages.

(3) Child care group settings.

§ 27.32a. Reporting AIDS, HIV, CD4 T-lymphocyte counts and perinatal exposure of newborns to HIV.

(a) Reporting by clinical laboratories.

(1) A person in charge of a clinical laboratory shall report CD4 T-lymphocyte test results as defined in § 27.22(b) (relating to reporting of cases by clinical laboratories) electronically to the HIV/AIDS Epidemiology Section, Division of Infectious Disease Epidemiology, Bureau of Epidemiology, within 5 days of obtaining the test results.

(2) A person in charge of a clinical laboratory shall report positive test results of any test approved by the FDA to establish the presence of HIV, including a serologic, virologic, nucleic acid (DNA or RNA) or any other type of test the FDA approves to establish the presence of HIV. The report shall be made to the HIV/AIDS Epidemiology Section, Division of Infectious Disease Epidemiology, Bureau of Epidemiology, within 5 days of obtaining the test results.

(3) The report shall include the following information:

(i) The individual's name and the address, city, county, and zip code of the individual's residence.

(ii) The patient identifying number assigned to the individual by the physician or at the facility requesting the laboratory test.

(iii) The individual's date of birth (month, day, year).

(iv) The individual's sex.

(v) The individual's race/ethnicity.

(vi) The date of each test performed.

(vii) The type of tests performed.

(viii) The results of the tests.

(ix) The name of the person or entity submitting the specimen for testing.

(x) The address of the person or entity submitting the specimen for testing, including the zip code, physical address and telephone number of the submitter.

(4) To enable the laboratory to complete the report it is required to file with the Department, a person or entity that requests a laboratory test for HIV or a CD4 T-lymphocyte count shall provide to the laboratory the information in subsection (a)(3) as listed above, with the exception of subparagraphs (vi)--(ix). In addition to the information included in subsection (a)(3), a person or entity that requests a laboratory test for HIV or a CD4 T-lymphocyte count shall provide to the laboratory the date each test was requested and the type of test or tests requested.

(b) Reporting by physicians, hospitals, persons or entities, who diagnose AIDS or who receive or provide HIV and CD4 T-lymphocyte test results.

(1) A physician, hospital, person providing HIV services or person in charge of an entity providing HIV services, who makes a diagnosis of AIDS or who receives HIV or CD4 T-lymphocyte test results or provides HIV or CD4 T-lymphocyte test results to patients, shall report the following to the LMRO responsible for the geographic area in which the person is tested or diagnosed within 5 business days of the diagnosis of AIDS or the receipt of the results of the test:

(i) A diagnosis of AIDS.

(ii) A positive result of any test approved by the FDA to establish the presence of HIV, including a serologic, virologic, nucleic acid (DNA or RNA) or any other type of test the FDA approves to establish the presence of HIV (effective October 18, 2002).

(iii) A CD4 T-lymphocyte test result with a count of less than 200 cells/µL or a CD4 T-lymphocyte percentage of less than 14% of total lymphocytes (effective October 18, 2002).

(iv) A perinatal exposure of a newborn to HIV (effective October 18, 2002).

(2) A report of an HIV test result, CD4 T-lymphocyte count, AIDS case based on the CDC case definition, or perinatal exposure of a newborn to HIV shall include the following information:

(i) The individual's name and the address, city, county and zip code of the individual's residence.

(ii) The patient identifying number assigned to the individual by the physician or at the facility requesting the laboratory test.

(iii) The individual's date of birth.

(iv) The individual's sex.

(v) The individual's race or ethnicity.

(vi) The date of each test performed.

(vii) The type of tests performed.

(viii) The test results.

(ix) The patient's history on probable modes of transmission.

(x) The treatment provided.

(xi) The name, address and telephone number of the physician, hospital, or other person or entity that secured a specimen from the individual and submitted it for laboratory testing.

(xii) The name, address and telephone number of the entity in which the diagnosis was made or that received the HIV test result or CD4 T-lymphocyte count.

(3) In addition to reporting the AIDS diagnosis or the receipt of test results, the reporter shall maintain the data required in paragraph (2) in the patient file on the Department's HIV/AIDS report form.

(4) An LMRO receiving reports of diagnoses of AIDS, positive HIV test results, reportable CD4 T-lymphocyte counts, and perinatal exposures to HIV shall forward completed case reports containing the information included in paragraph (2) electronically to the Department's Bureau of Epidemiology through a secure electronic mechanism specified by the Department.

§ 27.32b. Confidential and anonymous testing.

(a) Anonymous testing for HIV, except for blinded HIV testing authorized under section 5(f) of the Confidentiality of HIV-Related Information Act (35 P. S. § 7605(f)), may only be provided at State-designated anonymous testing sites. All other HIV testing shall be conducted confidentially with the name of the tested individual collected, and the name of the individual reported when the result of the test is reportable. A person or entity reporting as required in this section shall offer all HIV and AIDS-related services confidentially and may not provide anonymous testing, or consider any test or its results to be anonymous, unless it is a State-designated anonymous HIV testing site.

(b) Anonymous test results shall be reported in accordance with § 27.32a(b)(2) (relating to reporting AIDS, HIV, CD4 T-lymphocyte counts and perinatal exposure of newborns to HIV. In lieu of the information required in § 27.32a(b)(2)(i), the report of an anonymous test shall include an assigned number preprinted on the HIV counseling and testing report form. The report shall also include the individual's county of residence.

(c) The Department may create and fund an additional anonymous HIV-testing site in a particular area when it finds, based on demographic information reported to it under this chapter, that there is a lack of access to anonymous HIV testing in that particular area.

(1) The Department may begin the process of designating an anonymous HIV testing site either by contacting a provider or by responding to a request from a provider to increase the number of sites in the geographic area specified by the request.

(2) If a provider is designated as an anonymous HIV-testing site, the provider shall adhere to the CDC's Guidelines for Counseling, Testing, Referral and Partner Notification and to the terms set out by the Department in any grant agreement.

§ 27.32c. Counseling, testing, referral and partner notification services.

Counseling, testing, referral and partner notification services shall be performed in accordance with the Confidentiality of HIV-Related Information Act (35 P. S. §§ 7601--7612). A person providing HIV test results to a patient may ask for the Department's assistance with counseling if the person chooses to do so.

§ 27.32d. Department authority to require complete reporting.

The Department will have access to and may review the patient records of physicians, hospitals, persons providing HIV services and persons in charge of entities providing HIV services, who make diagnoses of AIDS, or who receive or provide HIV and CD4 T-lymphocyte test results. Access and review will enable the Department to conduct case investigations, to determine whether under-reporting is occurring, to investigate reporting delays and to investigate other reporting problems.

§ 27.32e. Record audits.

(a) The Department may conduct record audits of the records of physicians, hospitals, persons providing HIV services and persons in charge of entities providing HIV services who make diagnoses of AIDS or who receive or provide HIV test results for the purpose of obtaining information allowing the Department to complete HIV and CD4 T-lymphocyte case reports to aid it in tracking trends in disease and obtaining additional funding for prevention and treatment programs. The Department may audit records going back to January 1, 2000, for this purpose.

(b) The Department may require special reports of persons or entities required to report under this chapter to ensure compliance with this chapter.

[Pa.B. Doc. No. 02-1301. Filed for public inspection July 19, 2002, 9:00 a.m.]

[32 Pa.B. 3622]

Last Updated on Friday, 30 April 2010 12:38