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COMMONWEALTH OF PENNSYLVANIA

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Pennsylvania Code



Subchapter B. REPORTING OF DISEASES, INFECTIONS AND CONDITIONS


GENERAL

Sec.


27.21.    [Reserved].
27.21a.    Reporting of cases by health care practitioners and health care facilities.
27.22.    Reporting of cases by clinical laboratories.
27.23.    Reporting of cases by persons other than health care practitioners, health care facilities, veterinarians or laboratories.
27.24.    [Reserved].
27.24a.    Reporting of cases by veterinarians.
27.25.    [Reserved].
27.26.    [Reserved].
27.27.    [Reserved].
27.28.    [Reserved].
27.29.    Reporting for special research projects.

DISEASES AND CONDITIONS REQUIRING SPECIAL REPORTING


27.30.    Reporting cases of certain diseases in the newborn.
27.31.    Reporting cases of cancer.
27.32.    [Reserved].
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.
27.32b.    Confidential and anonymous testing.
27.32c.    Partner services relating to HIV and AIDS.
27.32d.    Department authority to require complete reporting.
27.32e.    Record audits.
27.33.    Reporting cases of sexually transmitted disease.
27.34.    Reporting cases of lead poisoning.
27.35.    Reporting cases of disease in animals.

REPORTING BY LOCAL MORBIDITY REPORTING OFFICES


27.41.    [Reserved].
27.41a.    Reporting by local morbidity reporting ofices of case reports received.
27.42.    [Reserved].
27.42a.    Reporting by local morbidity reporting offices of completed case investigations.
27.43.    [Reserved].
27.43a.    Reporting by local morbidity reporting offices of outbreaks and selected diseases.
27.44—27.47.    [Reserved].
27.51.    [Reserved].

Cross References

   This subchapter cited in 28 Pa. Code §  27.2 (relating to specific identified reportable diseases, infections and conditions); 28 Pa. Code §  27.3 (relating to reporting outbreaks and unusual diseases, infections and conditions); and 28 Pa. Code §  101.4 (relating to definitions).

GENERAL


§ 27.21. [Reserved].


Source

   The provisions of this §  27.21 amended November 26, 1982, effective November 27, 1982, 12 Pa.B. 4057; amended January 16, 1987, effective January 17, 1987, 17 Pa.B. 250; amended August 2, 1991, effective October 2, 1991, 21 Pa.B. 3416; amended January 25, 2002, effective January 26, 2002, 32 Pa.B. 491; reserved July 19, 2002, effective July 20, 2002, 32 Pa.B. 3597. Immediately preceding text appears at serial page (288385).

§ 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 counts and percentages.

  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).

  HIV viral load test results, including detectable and undetectable viral load    results, and all HIV genotyping results.

  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    Neisseria 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).

Authority

   The provisions of this 27.21a amended under section 16(a) and (b) of the Disease Control and Prevention Act 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)); section 803 of the Health Care Facilities Act (35 P.S. §  448.803); and sections 3 and 5 of the Newborn Child Testing Act (35 P.S. § §  623 and 625).

Source

   The provisions of this §  27.21a adopted January 25, 2002, effective January 26, 2002, 32 Pa.B. 491; amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435; amended July 19, 2002, effective July 20, 2002, 32 Pa.B. 3597; amended October 30, 2020, effective October 31, 2020, 50 Pa.B. 5981. Immediately preceding text appears at serial pages (290015) to (290019).

Cross References

   This section cited in 28 Pa. Code §  27.23 (relating to reporting of cases by persons other than health care practitioners, health care facilities, veterinarians or laboratories); and 28 Pa. Code §  211.1 (relating to reportable diseases).

§ 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 counts and percentages.

  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).

  HIV viral load results, including detectable and undetectable viral load    results, and HIV genotype test results.

  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.

  Staphylococcus aureus Vancomycin-resistant (or intermediate) invasive dis-    ease.

  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 through the appropriate electronic disease surveillance system. Reports of CAH, galactosemia maple syrup urine disease, phenylketonuria, primary congenital hypothyroidism, sickle cell disease and cancer, shall be made in the manner specifically designated in this subchapter. See § §  27.30 and 27.31 (relating to reporting cases of certain diseases in the newborn; and reporting cases of cancer).

 (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.

Authority

   The provisions of this §  27.22 issued under sections 2101—2111 of The Administrative Code of 1929 (71 P.S. § §  531—561); amended under sections 4 and 16 of the Disease Prevention and Control Law of 1955 (35 P.S. § §  521.4 and 521.16); sections 2102(g), 2106(a) and 2111(b) of The Administrative Code of 1929 (71 P.S. § §  532(g), 536(a) and 541(b)); section 803 of the Health Care Facilities Act (35 P.S. §  448.803); and sections 3 and 5 of the Newborn Child Testing Act (35 P.S. § §  623 and 625).

Source

   The provisions of this §  27.22 amended March 28, 1980, effective March 29, 1980, 10 Pa.B. 1387; amended January 16, 1987, effective January 17, 1987, 17 Pa.B. 250; amended August 19, 1988, effective August 20, 1988, 18 Pa.B. 3697; amended August 2, 1991, effective October 2, 1991, 21 Pa.B. 3416; amended January 25, 2002, effective January 26, 2002, 32 Pa.B. 491; amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435; amended July 19, 2002, effective July 20, 2002, 32 Pa.B. 3597; amended October 30, 2020, effective October 31, 2020, 50 Pa.B. 5981. Immediately preceding text appears at serial pages (290019) to (290022).

Cross References

   This section cited in 28 Pa. Code §  5.49 (relating to reportable diseases); and 28 Pa. Code §  27.1 (relating to definitions).

§ 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 counts and percentages, HIV test results or perinatal exposure of a newborn to HIV, HIV viral load results, including detectable and undetectable viral load results, and HIV genotype test results, 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:

   (1)  Institutions maintaining dormitories and living rooms.

   (2)  Orphanages.

   (3)  Child care group settings.

Authority

   The provisions of this §  27.23 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).

Source

   The provisions of this §  27.23 amended January 25, 2002, effective January 26, 2002, 32 Pa.B. 491; amended July 19, 2002, effective July 20, 2002, 32 Pa.B. 3597; amended October 30, 2020, effective October 31, 2020, 50 Pa.B. 5981. Immediately preceding text appears at serial page (290022).

§ 27.24. [Reserved].


Source

   The provisions of this §  27.24 amended January 16, 1987, effective January 17, 1987, 17 Pa.B. 250; reserved January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial pages (243662) to (243663).

§ 27.24a. Reporting of cases by veterinarians.

 A veterinarian is required to report a case, as specified in §  27.4 (relating to reporting cases), only if the veterinarian treats or examines an animal which the veterinarian suspects of having a disease set forth in §  27.35(a) (relating to reporting cases of disease in animals).

Source

   The provisions of this §  27.24a adopted January 25, 2002, effective January 26, 2002, 32 Pa.B. 491.

§ 27.25. [Reserved].


Source

   The provisions of this §  27.25 amended November 26, 1982, effective November 27, 1982, 12 Pa.B. 4057; amended January 16, 1987, effective January 17, 1987, 17 Pa.B. 250; reserved January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial page (243663).

§ 27.26. [Reserved].


Source

   The provisions of this §  27.26 amended November 26, 1982, effective November 27, 1982, 12 Pa.B. 4057; amended January 16, 1987, effective January 17, 1987, 17 Pa.B. 250; reserved January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial pages (243663) to (243664).

§ 27.27. [Reserved].


Source

   The provisions of this §  27.27 reserved January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial page (243664).

§ 27.28. [Reserved].


Source

   The provisions of this §  27.28 reserved January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial page (243664).

§ 27.29. Reporting for special research projects.

 A person in charge of a hospital or other institution for the treatment of disease shall, upon request of the Department, make reports of a disease or condition for which the Board has approved a specific study to enable the Department to determine and employ the most efficient and practical means to protect and to promote the health of the people by the prevention and control of the disease or condition. The reports shall be made on forms prescribed by the Department and shall be transmitted to the Department or to local health authorities as directed by the Department.

Source

   The provisions of this §  27.29 amended January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial page (243664).

DISEASES AND CONDITIONS REQUIRING SPECIAL REPORTING


§ 27.30. Reporting cases of certain diseases in the newborn child.

 Reports of congenital adrenal hyperplasia (CAH), galactosemia, maple syrup urine disease, phenylketonuria, primary congenital hypothyroidism and sickle cell disease shall be made to the Division of Newborn Disease Prevention and Identification, Bureau of Family Health, as specified in Chapter 28 (relating to screening and follow-up for diseases of the newborn) and those provisions of §  27.4 (relating to reporting cases) consistent with Chapter 28 and this section.

Authority

   The provisions of this §  27.30 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. §  521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § §  532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § §  623 and 625).

Source

   The provisions of this §  27.30 adopted January 27, 1978, effective January 28, 1978, 8 Pa.B. 248; amended March 28, 1980, effective March 29, 1980, 10 Pa.B. 1387; amended January 25, 2002, effective January 26, 2002, 32 Pa.B. 491; amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial pages (287142) to (287143).

Cross References

   This section cited in 28 Pa. Code §  27.22 (relating to reporting of cases by clinical laboratories).

§ 27.31. Reporting cases of cancer.

 (a)  A hospital, clinical laboratory, or other health care facility providing screening, diagnostic or therapeutic services for cancer to cancer patients shall report each case of cancer to the Department in a format prescribed by the Cancer Registry, Bureau of Health Statistics and Research, within 180 days of the patient’s discharge, if an inpatient or, if an outpatient, within 180 days following diagnosis or initiation of treatment.

 (b)  A health care practitioner providing screening, diagnostic or therapeutic services to cancer patients for cancer shall report each cancer case to the Department in a format prescribed by the Cancer Registry, Bureau of Health Statistics and Research, within 5 work days of diagnosis. Cases directly referred to or previously admitted to a hospital or other health care facility providing screening, diagnostic or therapeutic services to cancer patients in this Commonwealth, and reported by those facilities, are exceptions and do not need to be reported by the health care practitioner.

 (c)  The Department or its authorized representative shall be afforded physical access to all records of physicians and surgeons, hospitals, outpatient clinics, nursing homes and all other facilities, individuals or agencies providing services to patients which would identify cases of cancer or would establish characteristics of the cancer, treatment of the cancer or medical status of any identified cancer patient.

 (d)  Reports submitted under this section are confidential and may not be open to public inspection or dissemination. Information for specific research purposes may be released in accordance with procedures established by the Department with the advice of the Pennsylvania Cancer Control, Prevention and Research Advisory Board.

 (e)  Case reports of cancer shall be sent to the Cancer Registry, Division of Health Statistics, Bureau of Health Statistics and Research, unless otherwise directed by the Department.

Authority

   The provisions of this §  27.31 issued under The Administrative Code of 1929 (71 P.S. § §  531—545); the Disease Prevention and Control Law of 1955 (35 P.S. § §  521.1—521.21); and the Pennsylvania Cancer Control, Prevention and Research Act (35 P.S. § §  5631—5637).

Source

   The provisions of this §  27.31 adopted November 26, 1982, effective November 27, 1982, 12 Pa.B. 4057; amended January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial pages (243664) to (243665).

Cross References

   This section cited in 28 Pa. Code §  27.21a (relating to reporting of cases by health care practitioners and health care facilities); and 28 Pa. Code §  27.22 (relating to reporting of cases by clinical laboratories).

§ 27.32. [Reserved].


Source

   The provisions of this §  27.32 adopted January 16, 1987, effective January 17, 1987, 17 Pa.B. 250; reserved January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial page (243665).

§ 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.

 (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.

Authority

   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).

Source

   The provisions of this §  27.32a adopted July 19, 2002, effective July 20, 2002, 32 Pa.B. 3597; amended October 30, 2020, effective October 31, 2020, 50 Pa.B. 5981. Immediately preceding text appears at serial pages (290026) to (290028).

Cross References

   This section cited in 28 Pa. Code §  27.32b (relating to confidential and anonymous testing).

§ 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 percentages, HIV viral load test results, including detectable and undetectable test results, and HIV genotype test results 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.

Authority

   The provisions of this §  27.32b 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).

Source

   The provisions of this §  27.32b adopted July 19, 2002, effective July 20, 2002, 32 Pa.B. 3597; amended October 30, 2020, effective October 31, 2020, 50 Pa.B. 5981. Immediately preceding text appears at serial pages (290028) to (290029).

§ 27.32c. Partner services relating to HIV and AIDS.

 (a)  A person providing an AIDS diagnosis, HIV test results, CD4 T-lymphocyte counts and percentages, HIV viral load test results including detectable and undetectable viral load test results, or HIV genotype test results to an individual may ask for the Department’s assistance with counseling if the person chooses to do so.

 (b)  A person providing an AIDS diagnosis, HIV test results, CD4 T-lymphocyte counts and percentages, HIV viral load test results, including detectable and undetectable viral load test results, or HIV genotype test results to an individual shall inform the individual that the Department or a local health department may contact the individual for a voluntary confidential interview to discuss partner services, including counseling, testing, referral and partner notification.

 (c)  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).

Authority

   The provisions of this §  27.32c adopted under section 16(b) of the Disease Prevention and Control Law of 1955 (35 P.S. § §  521.1—521.21); 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).

Source

   The provisions of this §  27.32c adopted July 19, 2002, effective July 20, 2002, 32 Pa.B. 3597; amended October 30, 2020, effective October 31, 2020, 50 Pa.B. 5981. Immediately preceding text appears at serial page (290029).

§ 27.32d. Department authority to require complete reporting.

 The Department will have access to and may review the patient records of health care practitioners, 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, CD4 T-lymphocyte counts or percentages, HIV viral load test results including detectable and undetectable test results, or HIV genotype 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.

Authority

   The provisions of this §  27.32d 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).

Source

   The provisions of this §  27.32d adopted July 19, 2002, effective July 20, 2002, 32 Pa.B. 3597; amended October 30, 2020, effective October 31, 2020, 50 Pa.B. 5981. Immediately preceding text appears at serial pages (290029) to (290030).

§ 27.32e. Record audits.

 (a)  The Department may conduct record audits of the records of health care practitioners, 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, CD4 T-lymphocyte counts and percentages, HIV viral load test results including detectable and undetectable test results, or HIV genotype test results for the purpose of obtaining information allowing the Department to complete HIV, CD4 T-lymphocyte case reports, and viral load and HIV genotyping 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.

Authority

   The provisions of this §  27.32e adopted under section 16(b) of the Disease Prevention and Control Law of 1955 (35 P.S. § §  521.1—521.21); 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).

Source

   The provisions of this §  27.32e adopted July 19, 2002, effective July 20, 2002, 32 Pa.B. 3597; amended October 30, 2020, effective October 31, 2020, 50 Pa.B. 5981. Immediately preceding text appears at serial page (290030).

§ 27.33. Reporting cases of sexually transmitted disease.

 (a)  Reportable sexually transmitted diseases and infections are as follows:

   (1)  Chancroid.

   (2)  Chlamydia trachomatis infections.

   (3)  Gonococcal infections.

   (4)  Granuloma inguinale.

   (5)  Lymphogranuloma venereum.

   (6)  Syphilis.

 (b)  Health care practitioners and health care facilities shall make case reports of these diseases to the LMRO where the case is diagnosed or identified.

 (c)  A clinical laboratory making a case report by paper shall make the reportto the LMRO where the case is diagnosed or idenitifed. A clinical laboratory making a case report electronically shall make the report to the Division of Infectious Disease Epidemiology, Bureau of Epidemiology.

Source

   The provisions of this §  27.33 adopted January 25, 2002, effective January 26, 2002, 32 Pa.B. 491.

§ 27.34. Reporting cases of lead poisoning.

 (a)  Reporting by clinical laboratories.

   (1)  A clinical laboratory shall report all blood lead test results on both venous and capillary specimens for persons under 16 years of age to the Childhood Lead Poisoning Prevention Program, Division of Maternal and Child Health, Bureau of Family Health.

   (2)  A clinical laboratory shall report an elevated blood lead level in a person 16 years of age or older to the Division of Environmental Health Epidemiology, Bureau of Epidemiology or to other locations as designated by the Department. An elevated blood lead level is defined by the National Institute For Occupational Safety And Health (NIOSH). As of January 26, 2002, NIOSH defines an elevated blood lead level as a venous blood lead level of 25 micrograms per deciliter (µg/dL) or higher. The Department will publish in the Pennsylvania Bulletin any NIOSH update of the definition within 30 days of NIOSH’s notification to the Department.

   (3)  A clinical laboratory which conducts blood lead tests of 100 or more specimens per month shall submit results electronically in a format specified by the Department.

   (4)  A clinical laboratory which conducts blood lead tests of less than 100 blood lead specimens per month shall submit results either electronically or by hard copy in the format specified by the Department.

   (5)  A laboratory which performs blood lead tests on blood specimens collected in this Commonwealth shall be licensed as a clinical laboratory and shall be specifically approved by the Department to conduct those tests.

   (6)  Blood lead analyses requested for occupational health purposes on blood specimens collected in this Commonwealth shall be performed only by laboratories which are licensed and approved as specified in paragraph (5), and which are also approved by the Occupational Safety and Health Administration of the United States Department of Labor under 29 CFR 1910.1025(j)(2)(iii) (relating to lead).

   (7)  A clinical laboratory shall complete a blood lead test within 5 work days of the receipt of the blood specimen and shall submit the case report to the Department by the close of business of the next work day after the day on which the test was performed. The clinical laboratory shall submit a report of lead poisoning using either the hard-copy form or electronic transmission format specified by the Department.

   (8)  When a clinical laboratory receives a blood specimen without all of the information required for reporting purposes, the clinical laboratory shall test the specimen and shall submit the incomplete report to the Department

 (b)  Reporting by health care practitioners or health care facilities. A health care practitioner or health care facility shall report all cases of lead poisoning for persons under 16 years of age and pregnant women to the Lead Poisoning Prevention Program, Child and Adult Health Services Division, Bureau of Family Health. A case of lead poisoning shall be a lead level of 20 µg/dL or greater or a persistent elevated blood lead level ( 2 or more venous blood lead levels of 15 to 19 µg/dL (inclusive) at least three months apart).

Source

   The provisions of this §  27.34 adopted January 25, 2002, effective January 26, 2002, 32 Pa.B. 491.

§ 27.35. Reporting cases of disease in animals.

 (a)  The following diseases, infections and conditions in animals are reportable to the Division of Infectious Disease Epidemiology, Bureau of Epidemiology, as specified in §  27.4 (relating to reporting cases) within 5 work days after being identified:

 Anthrax.

 Arboviruses.

 Brucellosis.

 Plague.

 Psittacosis.

 Rabies.

 Transmissible Spongiform Encephalopathies.

 Tuberculosis.

 Tularemia.

 Any disease, infection or condition covered by §  27.3(b) (relating to reporting outbreaks and unusual diseases, infections and conditions).

 (b)  This chapter applies only to animals having or suspected of having one of the diseases, infections or conditions listed in subsection (a).

Source

   The provisions of this §  27.35 adopted January 25, 2002, effective January 26, 2002, 32 Pa.B. 491.

Cross References

   This section cited in 28 Pa. Code §  27.24a (relating to reporting of cases by veterinarians).

REPORTING BY LOCAL MORBIDITY OFFICES


§ 27.41. [Reserved].


Source

   The provisions of this §  27.41 reserved January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial page (243666).

§ 27.41a. Reporting by local morbidity reporting offices of case reports received.

 An LMRO that is not one of the Department’s district offices shall report a case that has been reported to it to the district office for the State health district in which it is located, or to the central office when this chapter directs that reports are to be filed with that office.

Source

   The provisions of this §  27.41a adopted January 25, 2002, effective January 26, 2002, 32 Pa.B. 491.

§ 27.42. [Reserved].


Source

   The provisions of this §  27.42 reserved January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial page (243666).

§ 27.42a. Reporting by local morbidity reporting offices of completed case investigations.

 An LMRO that is not one of the Department’s district offices shall submit, on a weekly basis, a case investigation report of the information from each case investigation which has resulted in confirmation of the incidence of a reportable disease, infection or condition. The report shall be submitted to the appropriate Department office as follows in a format and within the length of time set forth in this chapter:

   (1)  AIDS. To the HIV/AIDS Epidemiology Section, Division of Infectious Disease Epidemiology, Bureau of Epidemiology.

   (2)  Chickenpox, diphtheria, measles, mumps, pertussis, polio, rubella, and tetanus. To the Division of Immunizations, Bureau of Communicable Diseases.

   (3)  Chancroid, chlamydia trachomatis infections, gonococcal infections, granuloma inguinale, lymphogranuloma venereum, syphilis and tuberculosis. To the Division of Tuberculosis and Sexually Transmitted Diseases, Bureau of Communicable Diseases.

   (4)  Other reportable diseases and conditions. To the Division of Infectious Disease Epidemiology, Bureau of Epidemiology.

Source

   The provisions of this §  27.42a adopted January 25, 2002, effective January 26, 2002, 32 Pa.B. 491.

§ 27.43. [Reserved].


Source

   The provisions of this §  27.43 reserved January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial page (243666).

§ 27.43a. Reporting by local morbidity reporting offices of outbreaks and selected diseases.

 (a)  An LMRO that is not one of the Department’s district offices shall report an outbreak by telephone on the same day that the outbreak is reported or otherwise made known to it, as follows:

   (1)  AIDS. To the HIV/AIDS Epidemiology Section, Division of Infectious Disease Epidemiology, Bureau of Epidemiology.

   (2)  Chancroid, chlamydia trachomatis infections, gonococcal infections, granuloma inguinale, lymphogranuloma venereum, syphilis and tuberculosis. To the Division of Tuberculosis and Sexually Transmitted Diseases, Bureau of Communicable Diseases.

   (3)  Chickenpox, diphtheria, measles, mumps, pertussis, polio, rubella and tetanus. To the Division of Immunizations, Bureau of Communicable Diseases.

   (4)  Other reportable diseases and conditions. To the Division of Infectious Disease Epidemiology, Bureau of Epidemiology.

 (b)  An LMRO that is not one of the Department’s district offices shall report by telephone on the same day any of the following diseases is reported or otherwise made known to it, as follows:

   (1)  Diphtheria, measles, pertussis and polio. To the Division of Immunizations, Bureau of Communicable Diseases.

   (2)  Anthrax, arbovirus disease, cholera, enterohemorrhagic Escherichia coli, hantavirus pulmonary syndrome, food borne botulism, Haemophilus influenzae invasive disease in a child under 15 years of age, hemorrhagic fever, hepatitis E, human rabies, Legionellosis, plague, smallpox, typhoid fever and yellow fever. To the Division of Infectious Disease Epidemiology, Bureau of Epidemiology.

Source

   The provisions of this §  27.43a adopted January 25, 2002, effective January 26, 2002, 32 Pa.B. 491.

§ § 27.44—27.47. [Reserved].


Source

   The provisions of these § §  27.44—27.47 reserved January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial page (243667).

§ 27.51. [Reserved].


Source

   The provisions of this §  27.51 reserved January 25, 2002, effective January 26, 2002, 32 Pa.B. 491. Immediately preceding text appears at serial page (243667).



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