Pennsylvania Department of Health
Health Facility Licensure Regulations
[28 PA. Code Chs. 51,136,138,139 and 158]
Health Facility Licensure
The Department of Health (Department) amends Part IV (relating to health facilities) by adding Chapters 51, 136, 138, and 158 and by amending Chapter 139.
The official text of all final regulations is published in the Pennsylvania Bulletin. Copies of the official text can be obtained from Fry Communications, 1-800-524-3232 (Pennsylvania callers), 1-800-334-1429 (all other callers) ext. 340 for both telephone numbers.
Title 28. Health and Safety
Part IV. Health Facilities
Subpart A. General Provisions
Subpart B General and Special Hospitals
Exceptions to Health Facility Regulations – Hospitals and Ambulatory Surgical Facilities
General Information – Exceptions to Regulations for Hospitals and Ambulatory Surgical Facilities
The Department is aware that, in certain cases, compliance with existing regulations may create unreasonable hardship for hospitals and ambulatory surgical facilities. In addition, certain regulations may present barriers that impede a facility’s ability to provide higher quality care, to operate more efficiently, or to develop an innovative program. 28 PA Code §51.31 – 51.34 authorizes the Department to grant exceptions.
The Department’s exceptions process provides an effective way to be responsive to facilities’ needs for flexibility within the current rules and regulations while maintaining the Department’s highest priority - the health, safety and welfare of patients. (Click for instructions. Click for exception request form.)
These exceptions address state regulatory requirements/standards only. Facilities that are certified by CMS for Medicare and Medicaid, or plan to seek certification, are responsible to ensure that the facility remains in compliance with the Conditions of Participation Coverage. The exceptions requested and granted by the Department will not be transferred to a new owner should a change of ownership occur. The Department of Health reserves the right to revoke any exception for justifiable reason.
Expedited exceptions – hospitals and ambulatory surgical facilities
The department offers an expedited process to pre-approve exceptions to some regulations, provided that the facility complies with the Department’s minimum requirements which demonstrate that the original intent of the regulation is met. The Department has identified the specific regulations for which expedited exceptions will be considered, and believes that granting these exceptions under the prescribed conditions will not endanger the health, safety or welfare of patients. The existing exceptions request/advanced approval process will be waived for these “tags”. Hospital and ambulatory surgical facility surveys will include review of all the exceptions under which the facility is operating and review of evidence to assure compliance with the Department’s minimum requirements for each exception. Please see below for the form and guidance for each regulation for which expedited exception is permitted.