PENNSYLVANIA - COMMUNICABLE, OCCUPATIONAL, AND ENVIRONMENTAL DISEASES AND INJURIES

January 1, 2008

Pennsylvania state laws and regulations that affect your medical practice

1. What cases are required to be reported by Pennsylvania physicians?

( a ) 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.

AIDS. Amebiasis. Brucellosis. CD4 T-lymphocyte test result with a count of less than 200 cells/muL or a CD4 T-lymphocyte percentage of less than 14% of total lymphocytes. Campylobacteriosis. Cancer. Chancroid. Chickenpox (varicella). Chlamydia trachomatis infections. Congenital 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). 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. Pertussis (whooping cough). Phenylketonuria (PKU) in children under 5 years of age. Primary congenital hypothyroidism in children under 5 years of age. Psittacosis (ornithosis). Rickettial 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.

28 PA ADC § 27.21a

2. What are the reporting requirements for Pennsylvania 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.

( 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/muL or less than 14% of total lymphocytes. Campylobacteriosis. Cancer. Chancroid. Chickenpox (varicella). Chlamydia trachomatis infections. Cholera. Congenital 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). 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 disease. Streptococcus pneumoniae, drug-resistant invasive disease. Syphillis. 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

( 1 ) The name, age, address and telephone number of the person from 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 required 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/muL or less than 14% of total lymphocytes, HIV (Human Immunodeficiency Virus), and lead poisoning, which are reported as set forth below.

( 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.

28 PA ADC § 27.22

3. To whom should certain diseases in the newborn child be reported?

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.

28 PA ADC § 27.30

4. What are the procedures for 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 or 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.

28 PA ADC § 27.31

5. What are the procedures for reporting by physicians and hospitals who diagnose AIDS, receive or provide HIV and CD4 T-lymphocyte test results?

( a ) 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:

( 1 ) A diagnosis of AIDS.

( 2 ) 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.

( 3 ) A CD4 T-lymphocyte test result with a count of less than 200 cells/muL or a CD4 T-lymphocyte percentage of less than 14% of total lymphocytes.

( 4 ) A perinatal exposure of a newborn to HIV.

( b ) 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:

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

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

( 3 ) The individual's date of birth.

( 4 ) The individual's sex.

( 5 ) The individual's race or ethnicity.

( 6 ) The date of each test performed.

( 7 ) The type of tests performed.

( 8 ) The test results.

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

( 10 ) The treatment provided.

( 11 ) 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.

( 12 ) 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.

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

( d ) 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 electronically to the Department's Bureau of Epidemiology through a secure electronic mechanism specified by the Department.

28 PA ADC § 27.32a

6. What are the requirements for reporting by laboratories AIDS, HIV, CD4 T-lymphocyte counts and perinatal exposure of newborns to HIV?

( a ) A person in charge of a clinical laboratory shall report CD4 T-lymphocyte test results electronically to the HIV/AIDS Epidemiology Section, Division of Infectious Disease Epidemiology, Bureau of Epidemiology, within 5 days of obtaining the test results.

( b ) 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.

( c ) The report shall include the following information:

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

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

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

( 4 ) The individual's sex.

( 5 ) The individual's race/ethnicity.

( 6 ) The date of each test performed.

( 7 ) The type of tests performed.

( 8 ) The results of the tests.

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

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

( d ) 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 listed in ( c ) above. In addition to that information, the 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.

28 PA ADC § 27.32a

6. Which sexually transmitted diseases are reportable in Pennsylvania?

( 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 report to the LMRO where the case is diagnosed or identified. A clinical laboratory making a case report electronically shall make the report to the Division of Infectious Disease Epidemiology, Bureau of Epidemiology.

28 PA ADC § 27.33

7. What are the requirements for reporting lead poisoning in Pennsylvania?

( 1) Clinical Laboratories:

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

( b ) 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 (mug/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.

( c ) 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.

( d ) 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.

( e ) 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.

( f ) 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.

( 2 ) Health Care Practitioners:

A health care practitioner of 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 mug/dL or greater or a persistent elevated blood lead level (2 or more venous blood lead levels of 15 to 19 mug/dL (inclusive) at least three months apart).

28 PA ADC § 27.34

7. Does Pennsylvania require reporting cases of disease in animals?

Yes. The following diseases, infections and conditions in animals are reportable to the Division of Infectious Disease Epidemiology, Bureau of Epidemiology, within 5 work days after being identified:

Anthrax.

Arboviruses.

Brucellosis.

Plague.

Psittacosis.

Rabies.

Transmissible Spongiform Encephalopathies.

Tuberculosis.

Tularemia.

28 PA ADC § 27.35

Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.