Federal officials are proposing sweeping new requirements for U.S. health care facilities from large hospitals to small group homes for the mentally disabled intended to ensure their readiness to care for patients during disasters.
Describing emergency preparedness as an "urgent public health issue," the proposal by the Department of Health and Human Services offers regulations aimed at preventing the severe disruptions to health care that followed Hurricane Katrina and Hurricane Sandy. More than 68,000 institutions would be affected, including large hospital chains, "mom and pop" nursing homes, home health agencies, rural health clinics, organ transplant procurement organizations, outpatient surgery sites, psychiatric hospitals for youths and kidney dialysis centers.
The proposed rule, issued in December and open for comment until later this month, has met resistance from industry officials who question the first-year price tag of $225 million. Some complained that the costs could be "draconian."
The American Hospital Association said in a member advisory that federal officials "may have significantly underestimated the burden and cost associated with complying with this rule."
The regulations would require hospitals, nursing facilities and group homes to have plans to maintain emergency lighting, fire safety systems, and sewage and waste disposal during power losses, and to keep temperatures at a safe level for patients. Those inpatient facilities would also be expected to track displaced patients, provide care at alternate sites and handle volunteers.
Transplant centers would need to identify alternate hospitals for patients awaiting organs – a challenge because centers maintain different transplant criteria.
Home health care agencies would be required to help patients create personalized disaster plans. Hospices and others caring for frail, homebound patients would need procedures to help rescuers locate them. And health care employees would have to conduct disaster drills, while administrators might have to coordinate drills and response plans with local business competitors.
"It’s a big step," said Susan C. Waltman, an executive vice president of the Greater New York Hospital Association, which is urging substantive changes. "It will be a resource-intensive process for many providers."
Others said they were already struggling with Medicare and Medicaid reimbursement cuts and regulatory changes related to health reform.
One of the most contested of the requirements calls for hospitals and nursing homes to test backup generators for extended periods at least yearly, rather than once every three years, as is currently recommended.
The generators have sometimes failed catastrophically during prolonged power losses. The four-hour, full-load tests could involve significant fuel and labor costs. Critics question whether more frequent testing would improve safety.
Administration officials cited a pressing need for regulatory consistency for health care facilities, which are governed by a patchwork of federal, state and local rules. Some institutions are not required to plan extensively for emergencies. Others may already be meeting most goals.
After the attacks of Sept. 11, 2001, and the subsequent anthrax mailings, the federal government offered preparedness grants to state and local health departments, which paid for health care organizations to stockpile equipment and improve readiness for a surge of patients. But that funding has faced deep cuts.
Now officials are trying a different tack: making emergency preparedness a condition for many institutions to participate in the Medicare and Medicaid programs.
The current proposal is unusual because it applies to 17 types of providers at once, which together serve an estimated 9 million fee-for-service patients each month, as well as other patients covered by Medicare Advantage and Medicaid. Federal officials said this broad approach was needed to insure that the health care system pulls together and that poorly prepared institutions do not stress others during a crisis.
Government officials will have three years to finalize the rule. Their calculations suggest a relatively modest financial effect: $8,000 on average for hospitals the year the rule takes effect and about $1,262 each year for skilled nursing facilities.
But some facilities would be required to spend much more. Upgrading emergency power systems to run air-conditioning, if necessary to meet patient safety requirements, alone could cost from tens of thousands to millions of dollars, according to hospital engineering specialists.
Plans for a nationwide regulation on emergency preparedness date to the Bush administration, after an estimated 215 deaths occurred in hospitals and nursing homes in Louisiana following Hurricane Katrina in 2005. "In New Orleans it seems very likely that dozens of lives could have been saved by competent emergency planning and execution," the proposed rule said.
Medical evacuations were chaotic during both Hurricane Katrina and Hurricane Sandy. Hospitals, nursing homes and health clinics lost power and closed for months.
The proposed rule urges hospitals and nursing homes to protect power sources against damage from floods, earthquakes and other hazards. However, it refers to codes that typically call only for newly installed systems to meet these specifications.
Retrofitting existing systems would be costly, but may be crucial to maintaining patient care. New York City officials are considering a proposal to phase in flood-proofing requirements for vulnerable hospitals, nursing homes and adult care facilities, some of which have already begun this work.
NYU Langone Medical Center, which lost power and was evacuated during Hurricane Sandy, later reporting over 1 billion dollars in damages and lost revenue, has not only elevated some critical systems from low-level floors, but is also building a multimillion-dollar cogeneration plant capable of operating independently of the utility grid. The project, planned before the storm, is expected to provide a more reliable source of power and climate control during prolonged city cutoffs than diesel generator systems and could offer daily operating cost efficiencies.
"For hospitals, cooling and heating systems are as critical for life support as maintaining power," Paul Schwabacher, who oversees facilities management at Langone, said last month at a New York forum on hospital resilience.
Some health care groups argue that the proposals should go further. The National Kidney Foundation, for example, is urging the government to require that kidney dialysis clinics maintain a backup power source or a patient diversion plan. The American Academy of Pediatrics recommended that hospitals be required to keep emergency stocks of food, water and medical supplies on hand not only for patients and staff, as the government proposes, but also for visiting family members and volunteers.
The proposed regulations do not require hospitals to have backup water supply systems that might be needed to support decontamination stations, toilet flushing and air conditioning. Equipment for transporting patients down staircases is also not mandated.
Some experts have suggested that the government instead endorse emergency management standards revised recently by the National Fire Protection Association. These should cover "90 percent or 95 percent of things that may go wrong," said Robert Solomon, who oversees the association’s building and life safety codes.
The onslaught of recent disasters has made some safety officials question whether even a 5 percent failure rate is acceptable, however.
"Are there certain things we should be doing to start looking at what we’d call a new minimum performance?" Solomon said. "Maybe the code-writing community should be looking at the optimum performance, rather than just the minimum."