§ 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:
An unusual cluster of isolates.
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).
Chlamydia trachomatis infections.
Congential adrenal hyperplasia (CAH) in children under 5 years of age.
Enterohemorrhagic E. coli 0157 infections, or infections
caused by other subtypes producing shiga-like toxin.
Galactosemia in children under 5 years of age.
HIV (Human Immunodeficiency Virus) (effective October 18, 2002).
Haemophilus influenzae infectionsinvasive from sterile sites.
Hepatitis, viral, acute and chronic cases.
Leprosy (Hansens disease).
Maple syrup urine disease (MSUD) in children under 5
years of age.
Meningococcal infectionsinvasive from sterile sites.
Phenylketonuria (PKU) in children under 5 years of age.
Primary congenital hypothyroidism in children under 5
years of age.
Respiratory syncytial virus.
Sickle cell disease in children under 5 years of age.
Staphylococcus aureus Vancomycin-resistant (or
intermediate) invasive disease.
Streptococcus pneumoniae, drug-resistant invasive
Tuberculosis, confirmation of positive smears or cultures,
including results of drug susceptibility testing.
(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 Departments 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 Departments 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 Departments Bureau of Laboratories for serogrouping within 5 work days of isolation.
(g) A clinical laboratory shall send isolates of enterohemorrhagic E. coli to the Departments 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 Departments 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.
The provisions of this § 27.22 issued under sections 21012111 of The Administrative Code of 1929 (71 P. S. § § 531561); 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).
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. Immediately preceding text appears at serial pages (288388) to (288391).
This section cited in 28 Pa. Code § 5.49 (relating to reportable diseases).
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