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.  Therefore, 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. 

• Instructions
  
• 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 Department of Health reserves the right to revoke any exception for justifiable reason.

Structured (formally referred to as Expedited) Exceptions: Hospitals and Ambulatory Surgical Facilities

The department offers a structured 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 identifies the specific regulations for which these 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. 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. 

• Structured Exception Request Form

• 555.32(a) Administration of Anesthesia (CRNA Students)
  
• 569.35(7) General Safety Precautions (Flammable Agents in ASF)
• 555.31(a) Anesthesia Services (Propofol)

• 567.53 Sterilization Control

Exceptions Following a Change of Ownership: Hospitals and Ambulatory Surgical Facilities

You may not need to reapply for exceptions that were granted to the previous owner of a facility.  There are certain conditions in which the exception may be transferred to a new owner.  Please review the document below to see if these conditions apply to you.