DEPARTMENT OF HEALTH Amendments to The Clinical Laboratory Act [44 Pa.B. 4029]
[Saturday, June 28, 2014]Governor Corbett signed the act of December 18, 2013 (P. L. 1232, No. 122) (Act 122) into law, resulting in significant changes to The Clinical Laboratory Act (act) (35 P. S. §§ 2151—2165) regarding licensure requirements, specimen collection, acceptance and handling services, and new sanctioning authority for the Department of Health (Department).
Under Act 122, a clinical laboratory will require licensure (a permit) from the Department if the clinical laboratory operates within this Commonwealth or performs testing on any specimen accepted or collected within this Commonwealth. These requirements apply regardless of the location of the clinical laboratory. In addition, Act 122 also prohibits specific activities that might be used to induce a health care provider or health care practitioner to refer specimens to a particular clinical laboratory. Finally, the Department is now authorized to impose civil fines of up to $500 per day on any person or clinical laboratory that violates the act or the Department's regulations. The fining authority is in addition to any other penalty that may be currently imposed by the Department.
Additional information regarding Act 122 can be found on the Bureau of Laboratories' web site at www.health.state.pa.us/labs under the ''Clinical Lab Licensure'' section. Questions and requests for additional information may be sent to Mary McCormick, Director, Division of Laboratory Improvement, Bureau of Laboratories, 110 Pickering Way, Exton, PA 19341-1310, mamccormic@pa.gov. Applications for clinical laboratory licensure may be downloaded from the Bureau's web site or applicants may contact Mary McCormick for application materials.
Persons with a disability who require an alternative format of this notice (for example, large print, audiotape, Braille) may contact Mary McCormick at the previously referenced information. Persons who are speech or hear-ing impaired may use V/TT (717) 783-6514 or the Pennsylvania AT&T Relay Service at (800) 654-5984 (TT).
MICHAEL WOLF,
Secretary[Pa.B. Doc. No. 14-1354. Filed for public inspection June 27, 2014, 9:00 a.m.]
