Pennsylvania Code
Title 28 - HEALTH AND SAFETY
Part III - Prevention of Diseases
Chapter 27 - COMMUNICABLE AND NONCOMMUNICABLE DISEASES
Subchapter B - REPORTING OF DISEASES, INFECTIONS AND CONDITIONS
DISEASES AND CONDITIONS REQUIRING SPECIAL REPORTING
Section 27.32a - Reporting AIDS, HIV, CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and undetectable viral load results and HIV genotype test results, and perinatal exposure of newborns to HIV
Universal Citation: 28 PA Code ยง 27.32a
Current through Register Vol. 54, No. 44, November 2, 2024
(a) Reporting by clinical laboratories.
(1) A person in charge of a clinical
laboratory shall report CD4 T-lymphocyte counts and percentages electronically
to the Department through the appropriate electronic disease surveillance
system within 5 work 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 appropriate electronic disease
surveillance system within 5 work days of obtaining the test results.
(3) A person in charge of a clinical
laboratory shall report HIV viral load test results, including detectable and
undetectable viral load results, and HIV genotyping results, to the Department
through the appropriate electronic disease surveillance system, within 5 work
days of obtaining the test results.
(4) 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.
(5) 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, a CD4 T-lymphocyte count or percentage, or
HIV viral load test results, including detectable or undetectable test results,
and HIV genotype test results shall provide to the laboratory the information
in subsection (a)(4), with the exception of subparagraphs (vi)-(ix). In
addition to the information included in subsection (a)(4), a person or entity
that requests a laboratory test for HIV, a CD4 T-lymphocyte count or
percentage, an HIV viral load test result, including detectable or undetectable
test results, and HIV genotype test results shall provide to the laboratory the
date each test was requested and the type of test or tests requested.
(b) Reporting by health care practitioners, hospitals, and other persons or entities, who diagnose AIDS or who receive or provide HIV test results, CD4 T-lymphocyte counts and percentages, or HIV viral load test results, including detectable and undetectable results, and HIV genotype test results.
(1) A health care practitioner, 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 test results, CD4
T-lymphocyte counts and percentages, HIV viral load test results, including
detectable and undetectable results, or HIV genotype test results, or who
provides an AIDS diagnosis, HIV test results, CD4 T-lymphocyte counts and
percentages, HIV viral load test results, including detectable and undetectable
test results, and HIV genotype test results to patients, shall report the
following to the Department through the appropriate electronic disease
surveillance system within 5 work 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.
(iii) CD4 T-lymphocyte counts and
percentages.
(iv) A perinatal
exposure of a newborn to HIV.
(v)
HIV viral load results, including detectable and undetectable viral load
results, and HIV genotype test results.
(2) A report of an HIV test result, CD4
T-lymphocyte count and percentage, HIV viral load test result, including
detectable and undetectable test results, and HIV genotype test result, 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 health care practitioner, 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 AIDS diagnosis was made or that
received the HIV test result, CD4 T-lymphocyte count and percentage, HIV viral
load test results, including detectable and undetectable test results, or HIV
genotype test results.
(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) A local health
department receiving reports of diagnoses of AIDS, positive HIV test results,
CD4 T-lymphocyte counts and percentages, HIV viral load test results, including
detectable and undetectable test results, and HIV genotype test results, and
perinatal exposures to HIV shall forward completed case reports containing the
information included in paragraph (2) to the Department through the
Department's electronic disease surveillance system.
The provisions of this §27.32a adopted under section 16(b) of the Disease Prevention and Control Law of 1955 (35 P.S. § 521.16(b)); sections 2102(g), 2106(a) and 2111(b) of The Administrative Code of 1929 (71 P.S. §§ 532(g), 536(a) and 541(b)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803); amended under section 16(a) and (b) of the Disease Prevention and Control Law of 1955 (35 P.S. § 521.16(a) and (b)); sections 2102(g), 2106(a) and 2111(b) of The Administrative Code of 1929 (71 P.S. §§ 532(g), 536(a) and 541(b)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803).
This section cited in 28 Pa. Code § 27.32b (relating to confidential and anonymous testing).
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