The Division of Laboratory Improvement implements state and federal laboratory licensure laws, which apply to Pennsylvania's over 9,000 clinical laboratories. On-site inspections, proficiency assessment and personnel training are utilized to ensure laboratories generate accurate and reliable results. The division also collects data regarding the testing of sexual assault evidence as required by the Pennsylvania Sexual Assault Testing and Evidence Collection Act.
The Pennsylvania Clinical Laboratory Act and the Clinical Laboratory Improvement Amendments of 1988
Applications and Forms
Clinical Laboratory Improvement Amendments
Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments (CLIA) website for information on federal requirements.
The Pennsylvania Sexual Assault Testing and Evidence Collection Act
On July 10, 2015, Governor Wolf signed Act 27 which amended the Sexual Assault Testing and Evidence Collection Act (Act), 35 P.S. §§ 10172.1-10172.5. Under the Act, local law enforcement agencies have responsibility to take possession of the sexual assault evidence collected by health care facilities for sexual assaults reported to have occurred in the agency's jurisdiction and, upon receipt of consent from the victim, to submit the evidence awaiting testing to a laboratory approved by the Department of Health (Department) for testing or analysis.
See 35 P.S. § 10172.3(c)(1) and (3) (relating to sexual assault evidence collection program).
The Act requires local law enforcement agencies and testing laboratories to submit certain reports to the Department, in a form and manner prescribed by the Department, regarding the status of laboratory testing of sexual assault evidence. The Act requires initial reporting by local law enforcement agencies of sexual assault evidence awaiting testing and by laboratories of sexual assault evidence submitted for testing but not yet analyzed by the laboratory, collectively referred to as "Inventory."
See 35 P.S. § 10172.3(d).
The Act also requires annual reporting by both entities of "Backlogged Evidence."
See 35 P.S. § 10172.3(e).
On September 6, 2016, the Department and the Pennsylvania State Police (PSP) signed a Memorandum of Understanding (MOU) to improve the way both agencies will work together in establishing the laboratory standards and data collection procedures regarding sexual assault testing and evidence collection. The PSP will now assist in establishing the forensic laboratory guidelines and gathering the annual backlogged data reports mandated by Act 27 from approved laboratories and Law Enforcement Agencies. Effective Jan 1, 2017, the PSP Bureau of Forensic Services (BFS) will be collecting and collating the data from Pennsylvania Law Enforcement agencies and testing laboratories through an online electronic survey system (SurveyMonkey). The Pennsylvania Department of Health developed reporting forms previously used will no longer be required.
All reporting agencies should register with the new Act 27 reporting process by sending an email to the following email address:
Sending an email message to the above email address will ensure that a law enforcement agency or approved testing laboratory is registered on the distribution list for Act 27 reporting information and updates. This will also ensure that the listing of currently active Law Enforcement Agencies is up to date. Additionally, each agency registered on the distribution list will be provided with a link to the online survey (SurveyMonkey) for collection of the data for the annual Act 27 report(s).
Applicable Dates for Preparation and Submission of Annual Reports
Reports of Backlogged Evidence must be submitted annually by January 31. If no backlogged evidence exists, local law enforcement agencies and laboratories are still required to complete annual report with that information by January 31. With the 2016 Annual report and going forward, the all reporting agencies must contact the Pennsylvania State Police Bureau of Forensic Services via email at:
Email contact to the above address will ensure the reporting agency is added to the distribution list and will be provided with a link to the online electronic survey (SurveyMonkey) where the reporting will be collected.
DO NOT SUBMIT REPORTS DIRECTLY TO THE DEPARTMENT OF HEALTH AS DONE IN 2015/2016!
Additional Information related to Act 27
Storage and Preservation Policy for Sexual Assault Evidence
At the request of the PA State Police Bureau of Forensic Services the following link is being provided to provide information concerning the proper policies for the Storage and Preservation of Sexual Assault Evidence. This information was published in the PA Bulletin on August 15, 2020:
Department Contact Person
Questions from local law enforcement agencies and laboratories concerning the reporting process may be submitted to the Department's Bureau of Laboratories by mail or e-mail as follows:
Dr. James Lute, Assistant Bureau Director
Pennsylvania Department of Health
Bureau of Laboratories
110 Pickering Way
Exton, PA 19341-1310
Persons with a disability who require an alternate format of this notice (for example, large print, audiotape, Braille) should contact Dr. Lute at the Department of Health, Bureau of Laboratories 110 Pickering Way, Exton, PA 19341-1310, 610-280-3464. Speech or hearing impaired persons may call by using V/TT: 717-783-6154 or the Pennsylvania AT&T Relay Service at 800-654-5984 [TT].