Public Health Emergency Preparedness

Appendix D. Legal & Regulatory Issues (continued)

Chapter 5. Summary

The sections above detail current Federal and State regulatory requirements and issues that may need attention, if States decide to pursue the use of shuttered hospitals (or other settings such as churches, hotels, schools) for surge capacity expansion during a mass casualty event. In some cases clarification from Federal authorities is needed, in other mechanisms are needed to waive State regulations in emergency circumstances. 

Recommendation: Federal officials could create 'model' legislation and regulations for states to use as a starting point, to address surge facility issues.

The following table summarizes the most important Federal and State regulations, identifies those that may require waivers and those that probably do not.

Issue		Responsible Entity
	Guidance/Waiver Likely Needed	Federal Government	State/Local Government>
Hospital Administration		X	X
Compliance with Federal, State and Local Laws		X	X
Governing Body	X	X	X
Quality Assessment and Performance Improvement Program	X	X
Services		X	X
Pharmaceutical Services		X	X
Radiologic Services		X	X
Laboratory Services	X	X	X
Food and Dietetic Services		X	X
Utilization Review	X	X	X
Physical Environment		X	X
Infection Control		X	X
Discharge Planning	X	X	X
Organ, Tissue, and Eye Procurement	X	X
Surgical Services	N/A
Anesthesia Services	N/A
Nuclear Medicine	N/A
Outpatient Services	N/A
Rehabilitation Services	N/A
Respiratory Care Services	N/A
Staffing		X	X
Medical staff		X	X
Nursing services		X	X
Medical records	X	X	X
Pharmaceutical services	X	X	X
Radiologic services		X	X
Laboratory services	X	X	X
Food and Dietetic services		X	X
Long-term Care Staffing		X
Nursing		X
Dietary		X
Social services		X
Patient Rights		X	X
Notice of rights		X	X
Exercise of rights		X	X
Confidentiality of patient records		X	X
Restraint for acute medical and surgical care		X
Seclusion and restraint for behavior mgt		X
Patient Information and Privacy Standards		X	X
Organization and staffing		X	X
Form and retention of records	X	X	X
Health information privacy	X	X
Other Issues		X	X
Status of a new hospital	X		X
Determination of need	X		X
Construction plan approval for renovations	X		X
Public safety and fire certificates	X		X
Obtaining a license	X		X
Medical personnel credentialing	X		X
Complaints and incident reports			X
Sharps and disposal of medical waste			X
Reportable diseases, isolation, and quarantine			X
Authority to open a surge facility	X		X
Operation and control of a surge facility	X		X
Liability	X	X	X
Medical personnel—crossing State lines	X		X
Physician back-up by other health-care providers		X	X

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