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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]
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