Ohio is the only state that doesn't license its hospitals, prompting the Ohio Nurses Association and some lawmakers to call for increased regulation. However, others say there's already enough state oversight and warn that adding more could take away from patient care.
Concerned that Ohio is the only state in the nation that does not license general hospitals, the governor and state director of public health are looking at ways to increase regulation at such facilities.
Their interest comes with the revelation that two central Ohio hospitals lacked policies to prevent staff members from bypassing alerts and approval systems to access and administer inappropriately high or fatal amounts of painkillers to patients. The amounts had been ordered by an intensive-care doctor over a period of about four years.
While the work toward more regulation has support from some lawmakers and the Ohio Nurses Association, others say hospitals have enough oversight — and maybe even too much — to protect patients.
Gov. Mike DeWine took office Jan. 14, the same day the Columbus-based Mount Carmel Health System publicly announced the December firing of Dr. William Husel, an ICU physician from Liberty Township near Dublin, for what executives say was his ordering of excessive painkiller doses for 35 patients who died shortly after receiving them.
About six weeks later, Dr. Amy Acton was sworn in as the new director of the Ohio Department of Health.
Ever since, the two have been pulling people together and examining other state policies to determine what recommendations they will make to state legislators, the governor said.
"It makes absolutely no sense that Ohio is the only state that does not license hospitals," DeWine told The Dispatch last week. "We owe this to the citizens in the state of Ohio to be able to look at a situation and say 'Look, what have we learned from this tragedy?'"
The Ohio Nurses Association also has been researching state licensing laws, spurred in part by the Mount Carmel investigation and DeWine's openness, said spokeswoman Molly Homan.
The tragic events show that the current system cannot be trusted, said Kelly Trautner, the association’s interim chief executive officer. She thinks past resistance comes from a tendency to view government regulation as a hindrance to business.
“There’s a strong cultural proclivity to believe that the market will ferret out the bad actors in any industry," Trautner said. "And that might make sense if you're selling tuxedos or making some sort of widgets. But when you’re dealing with human life, that does not make sense.”
While Ohio general hospitals — defined as short-term, acute-care facilities — are not subject to licensing, certain units, including maternity and psychiatric wards, are licensed.
The state does require hospitals to register with the Ohio Department of Health annually and to be inspected and accredited every three years by a government-approved private agency.
Through registration, the Health Department collects such data as number of beds, types of services provided, number of patient discharges and deaths and number of staff members and their specialties. Hospitals also must report the date of their last accreditation inspection.
State law allows the Health Department to conduct its own inspections if the director “has reason to believe that there may be a violation” of any relevant laws, but such inspections are rarely, if ever, performed.
State surveyors, however, conduct complaint-driven inspections at the request of the federal Centers for Medicare & Medicaid Services (CMS), which has its own standards, including private accreditation for facilities receiving payments through the government-funded health insurance plans.
These federal inspections are limited to the specific allegations, but followed up by facility-wide inspections if serious or multiple violations are found, said Department of Health spokesman J.C. Benton. Since July 1, the start of the state's fiscal year, Ohio has performed 35 CMS-directed inspections, a number that includes not only general hospitals but also other types of health-care facilities.
Three inspections were at Mount Carmel West hospital in Franklinton, where 34 of the patients involved in the painkiller investigation died, and another three were at Mount Carmel St. Ann’s in Westerville, where one patient died, according to Ohio Department of Health and CMS records.
Inspectors initially discovered pharmacy-service violations deemed serious enough to place patient health and safety in immediate jeopardy, records show. The hospitals corrected the deficiencies, and subsequent full-hospital inspections found physical-environment problems that have not yet been disclosed by CMS.
Mount Carmel West last received an accreditation inspection in August 2017, and Mount Carmel St. Ann’s received one two months earlier, both by the independent, nonprofit Joint Commission, which accredits nearly 21,000 U.S. hospitals, facilities and programs.
Trautner said accrediting agencies are problematic because they are paid by hospitals to conduct inspections, and they set appointments, allowing institutions to prepare in advance.
The Joint Commission's work "supports but does not supplant" the role of the public regulatory agencies that are responsible for imposing penalties, enforcing laws and deciding whether hospitals can serve the public or receive public funds, said spokeswoman Maureen Lyons.
"In the end, we all want the same thing: a health-care system that consistently delivers the best quality care and exhibits a culture of excellence that inspires institutions to continually improve their performance," she said.
To provide oversight of accrediting agencies, CMS directs states to inspect a small sampling of U.S. general hospitals within 60 days of accrediting inspections. Three percent of such hospitals received one of these follow-up visits in the fiscal year ending in September 2016, the latest for which data are available.
Over that year, state inspections showed that accrediting agencies missed deficiencies at 45 of 98 general hospitals reviewed, according to an October CMS report. In fiscal year 2015, missed deficiencies were found at 40 of 102 hospitals reviewed, and in fiscal year 2014, missed deficiencies were found at 39 of 103 hospitals reviewed.
While patient safety requires constant vigilance by health-care teams, the regulations already in place are overwhelming, said John Palmer, spokesman for the Ohio Hospital Association, a trade group that has not been involved with the Mount Carmel matter.
Hospitals, he said, must comply with hundreds of regulations, with federal requirements driven largely by several offices in the U.S. Department of Health and Human Services.
Palmer said if state regulation is changed, there must be conversation about desired outcomes and whether the issues are already addressed.
The Mount Carmel case is an isolated one, and the health system has improved its processes, said state Sen. Steve Huffman, R-Tipp City, a physician who is vice chairman of the Senate’s Health, Human Services and Medicaid Committee.
"That's an unfortunate situation that probably should have been caught sooner, but I think every hospital has looked at their process because of what happened at Mount Carmel, and they’re all making sure that they have the right processes so it doesn’t happen to them," he said. "I think that’s how it’s going to be fixed, not legislatively.”
State Rep. Tom West, D-Canton, serves on the House Health Committee, where he said he expects the licensing issue to arise. He said it will be key to hear from the Nurses Association, the Hospital Association and the Ohio Medical Association and to reach out to the Health Department.
"It's something, definitely, that we should be looking into and seeing why there isn't this type of oversight," he said. "It's time to do a deeper dive as a far as 'what are the regulations for Ohio hospitals and why isn't there licensure?'"
Yet additional regulation could have the unintended effect of making hospitals less safe, because the effort devoted to required paperwork detracts attention from patients, said Dr. Annette Ticoras, founder of Westerville-based Guided Patient Services, a private patient health-advocacy company.
“So much documentation doesn’t necessarily provide for better engagement, better communication or safer hospitals,” she said. “We have a lot of people spending a lot of resources and time checking boxes. ... Too much is being asked from too many people, and perhaps patient care is suffering.”