Public Health Emergency Preparedness

Appendix D. Legal & Regulatory Issues

Contents

1.0 Background and Introduction
   1.1 Scenarios for Surge Capacity Expansion Using a Shuttered Hospital
   1.2 Assumptions for Opening a Shuttered Hospital as a Surge Facility
2.0 Federal Laws and Regulations
   2.1 Administration
   2.2 Services
      2.2.1 Basic Services
      2.2.2 Emergency Services
      2.2.3 Optional Services
   2.3 Staffing
      2.3.1 Hospital Staffing
      2.3.2 Long-term Care Staffing
   2.4 Patient Rights
   2.5 Transport
   2.6 Patient Information and Privacy Standards
3.0 State Laws and Regulations Governing Hospitals
   3.1 Background
   3.2 Preparing to Open a Shuttered Hospital
      3.2.1 Status as a New Hospital
      3.2.2 Determination of Need
      3.2.3 Construction Plan Approval for Renovations
      3.2.4 Public Safety Certificate and Fire Safety Certificate
      3.2.5 Obtaining a License
      3.2.6 Waivers
      3.2.7 Physician Credentialing
      3.2.8 Nurse Staffing
      3.2.9 Complaints and Incident Reports
      3.2.10 Patient Rights
      3.2.11 Medical Records
      3.2.12 Discharge Planning; Advocacy Office
      3.2.13 Clinical Laboratory
      3.2.14 Sharps and Medical Waste Disposal
      3.2.15 Reportable Diseases, Isolation and Quarantine
      3.2.16 Ambulance Transportation
      3.2.17 Hospital Pharmacy Services
4.0 Other Issues
   4.1 Responsibility for a Surge Hospital
   4.2 Operation and Control of a Surge Facility
   4.3 Liability
   4.4 Medical Personnel—Crossing State Lines
   4.5 Physician Back-up by Other Health Care Providers
5.0 Summary
References

Chapter 1.  Background and Introduction

America's health-care system is at or near capacity with little ability to expand in response to an unusually large mass casualty event. There is little surge capacity in the system, particularly in major urban areas. Due to the economics of health-care delivery and low financial margins, hospitals are at virtually 100 percent capacity in many cities.  Moreover, there is little excess capacity in the nursing home, home health or other health-care sectors.  Patients cannot readily be moved out of hospitals to make room for large numbers of trauma victims or infectious patients, because there is nowhere for them to be placed.  These factors severely constrain the ability of the hospital sector to absorb a large influx of trauma or infectious disease victims. Although most hospitals plan and drill to operate at 125 percent capacity or more, for up to 72 hours, most cannot maintain this level of service beyond 3 days.

Recognizing that reallocating patients among existing facilities would not be adequate for a large-scale disaster, States and the Federal governments have begun to investigate the feasibility of rapidly converting non-hospital buildings for use as temporary hospitals. The Department of Health and Human Services is particularly interested in the feasibility of reopening former (shuttered or partially shuttered) hospitals to temporarily increase capacity.  The conversion of former hospitals to medical surge facilities could be an option for many communities given the large number of hospital closures and conversions in recent years.  Originally designed and operated as inpatient facilities, shuttered hospitals might be better alternatives than hotels, schools, offices, or churches for providing inpatient care. 

To assess the feasibility of converting former hospitals to inpatient surge facilities, Abt Associates and experts from Partners Healthcare System evaluated two hospitals in suburban Boston using a set of basic criteria for a surge facility operating in a mass casualty event.  The assessment of the two hospitals encompassed physical structure of the facility, supplies and staffing needs, security, patient transport, and information requirements (see main body of this report). In addition, the team recognized that legal issues could pose challenges to converting a shuttered facility into a surge hospital. 

This appendix examines the primary legal and regulatory issues related to converting a former hospital (now closed or partially in use for non-hospital services) into an inpatient surge hospital. Relevant Federal laws and regulations pertaining to hospitals and personnel are identified and analyzed, as well as State regulations and other legal issues. For the State analysis, we examined regulations from Kansas, Illinois, Texas, and Massachusetts to illustrate how this surge facility concept might play out in different regulatory environments.

The remainder of the appendix is organized as follows:

• Chapter 2. Federal Laws and Regulations.
• Chapter 3. Four States' Laws and Regulations.
• Chapter 4. Other Legal Issues.

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1.1 Scenarios for Surge Capacity Expansion Using a Shuttered Hospital

There are two general scenarios where reopening a shuttered hospital as a surge facility might be appropriate:

Scenario 1

Generic mass casualty events (conventional terrorism or war, weapon of mass destruction, natural disaster) in which hundreds of ambulatory med/surg patients need to be transferred out of the tertiary care hospitals to make capacity for mass casualty victims. In this scenario, every possible patient at the major tertiary hospitals would be transferred to other settings of care and all elective and nonurgent admissions and procedures would be delayed; if this still did not reduce demand sufficiently, the surge facility would be opened. The most critically ill patients would remain in the tertiary care facilities, and the most medically stable patients would be relocated to the surge facility. It is conceivable that there would also be a domino effect in which patients from a tertiary care setting would be transferred to a community hospital and then those less acutely ill patients from the community hospital would be transferred to the surge facility. 

Scenario 2

An infectious BT agent or communicable disease epidemic (e.g., smallpox, flu, SARS) that requires the creation of an infectious-disease/isolation or quarantine hospital at the surge facility. 

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1.2 Assumptions for Opening a Shuttered Hospital as a Surge Facility

This section describes the assumptions made by Abt Associates and experts from Massachusetts General Hospital and Brigham and Women's Hospital for the purpose of evaluating requirements for reopening a shuttered hospital as a surge facility. 

Timing

Since area hospitals plan to deal with dramatically increased capacity for up to 72 hours, we adopted the assumption that the surge facility would need to open within 3-7 days after a mass casualty event. We anticipate that the surge facility would need to operate for a range of 2-8 weeks, depending on the nature of the disaster and the needs of mass casualty victims, although there is no maximum operational period and the facility could remain open for a longer period if needed.

Inappropriate Services/Patients

Since the goal of the surge facility is to maintain community standards of care, as nearly as possible, it would be inappropriate to relocate certain types of patients. Under either scenario, it would not be possible to reconstitute an Intensive Care Unit (ICU) in a shuttered hospital, nor an operating room (OR) or suite. We assume that no emergency department would be created at a shuttered hospital being reopened to meet surge demands. In addition, because of a lack of ICU and OR services, it would probably not be possible to create a large inpatient acute burn or trauma unit in such a hospital. Under certain circumstances, however, trauma or burn patients in the later stages of convalescence might be appropriately relocated to the surge facility. Medical experts advise that it would be inappropriate to relocate acutely ill oncology patients to such the surge facility, as the patients' chemotherapy, radiation therapy and other care needs are too sophisticated for such a place. It would not be appropriate to relocate psychiatric inpatients, since most psychiatric patients in acute care hospitals are immediate suicide risks and the entire relocation procedure would further exacerbate their very tenuous stability. Pediatric patients would probably not be relocated either, since their needs (and their parents' needs) could not be met as completely in a surge facility as in a dedicated children's hospital.

We further determined that a shuttered hospital would probably not be appropriate as a surge facility in the following circumstances: 

• A BT agent that is airborne and infectious and has no vaccine (e.g., Ebola) therefore posing a significant immediate risk to health-care providers. This was ruled out as a viable option because a shuttered hospital would be unlikely to have an adequate airflow system to handle these patients although there might not be an adequate airflow system at any functional hospital either.
• A hospice for patients needing pain care and supportive care while dying from chemical or radiation terrorism events. This was ruled out because victims of chemical terrorism will probably either die almost immediately, need 24 hours of ICU care, or walk away with minimal treatment. There would probably be no need for a large-scale inpatient hospice.

Surge Facility Patient Population Assumptions

We assume that patients would continue to be cared for in the surge facility for at least 30 days (and perhaps as long as 60 days or more), and that all patients would not arrive on day 1 of the event. Instead, their arrival would most likely be spread out between days 3 and 11 following a mass casualty event, or spread out even more in the case of an evolving epidemic.  For Scenario 1 we assume an average patient stay of 2 to 3 days; for Scenario 2 the length of stay is more difficult to predict but could be 1-3 weeks. Patients would be discharged gradually, over the course of several days or weeks, until the surge facility is no longer needed.

Ideally, the required amount of supplies held in inventory at the surge facility should be adequate to last at least 3 days per patient, regardless of the patient population. For the purposes of estimating ease of implementing regulatory requirements, we assume the surge facility will be operating at 100 percent capacity beginning 3-7 days after an emergency is declared, and will continue for at least 30 days. Under Scenario 1, a surge facility could end peak operation before day 30, while under Scenario 2, peak operation may continue for more than 60 days. Following the mass casualty event, we assume any remaining patients will be directed back into one of the tertiary or community hospitals.

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