Safety advocates 'horrified' by UW Medical Center investigation results
SEATTLE -- Patient safety advocates tell us they are "horrified" by what a KOMO investigation has uncovered. For 17 months, patients of the University of Washington Medical Center were put at risk because the hospital repeatedly failed to keep critical drug mixing areas clean and sterile. The state Department of Health oversees all pharmacies but despite inspections showing the UW Pharmacy wasn't meeting minimum safety requirements, it continued to operation. Raising the question: is the UW getting special treatment?
Inside a UW surgical suite, patients might feel pretty safe. The teaching hospital is rated number one in the state in U.S. News and World Report's annual rankings and 5th in the nation for its cancer treatments.
But that's not the entire story. Because from May 2014 through October 2015, the critical drugs going into surgical IVs, cancer care chemotherapy and even simple injectable steroids for joint pain, were produced in University pharmacies that were so dirty, they failed inspections.
"I'm horrified," says patient advocate Karie Fugate. We asked Karie and her husband Wayne Fugate to take a look at inspection records the KOMO Investigators discovered.
In May of 2014 pharmacy investigators from the Department of Health examined the rooms where critical drugs are mixed into IVs. It's called sterile compounding and the rooms where they're prepared are, by law, also supposed to be sterile. In the records we obtained, the investigators note finding ventilation hoods with, "rust and other discoloration," and grates with, "layers of dust and growth of some sort inside."
Investigators found the main sterile room which is supposed to be entirely enclosed, had an open window into the active pharmacy area. There were several surfaces, including ceilings and countertops, with porous and cracked surfaces that could collect dust. They found 56 drugs that were too old to use and some drugs, cleaning compounds and anesthesia liquids incorrectly stored. And they found pharmacy techs were mixing the critical IV drugs without adequate supervision by pharmacists. The hospital failed the inspection and was under orders to fix it within 14 days.
A month later the hospital had improved its score by such things as fixing patient record-keeping and removing all out-dated drugs but still failed with a rating of "conditional" because it wasn't keeping critical areas sterile. UW Spokeswoman Tina Mankowski says the hospital contacted DOH in August of 2014 for a re-inspection but that DOH never responded. But she agrees that the UW Pharmacies again failed a federal inspection in October of 2015.
Karie Fugate: "So it's like no one's doing anything; so this will continue over and over again."
And it remained at that level for 16 months.
"They have a systemic issue," says Wayne Fugate, "I would think it would be time to start holding people accountable."
The Fugates became patient advocates after what happened to Karie's son, Mark Turnage. Mark had been admitted into a different hospital, not the UW, for pancreatitis and gallstones. State investigators cleared the hospital of violating any standards, but Mark developed several drug resistant infections - and died after 68 days in the hospital.
Karie: "It never goes away."
Wayne: "You're a member of a club that nobody wants to be a member of."
The Fugate's turned their grief into action by starting Washington Advocates for Patient safety. And they are outraged that the UW pharmacy left patients at risk for so long.
Karie says, "I think they need to fine them."
So how did the university get away with ignoring the state for so long?
Gary Harris just retired after serving 11 years on the State Pharmacy Quality Assurance Commisson - PQAC. "I don't want to see people injured and if somehow that's going on I want it to stop."
In 2012, 64 people died after a Massachusetts compounding pharmacy sent out hundreds of contaminated injectables. Harris says that was a wake-up call, proving how critical it is that injectable drugs are sterile, particularly for cancer patients and other people with compromised immune systems. "If you have a 50% chance of being around for even one more year and we kill you today - that's unacceptable."
The next year, Washington's state legislature adopted the stricter federal standards here. For the first time, many hospital pharmacies started failing inspections. Most made changes and quickly passed their follow-up inspections. But some hospitals, like the UW, continued to fail. And Harris and other KOMO sources say investigators were pressured to back off. That angers Harris, " Well it's illegal. It's patient safety, which is why we're coming after you."
In September of 2015, PQAC filed a Statement of Charges against the UW Pharmacy saying the alleged violations put patients' health or safety at risk. But instead of prompting the UW to change, the KOMO Investigators found what followed was a flurry of emails, memos and meetings between Secretary of Health John Weisman, the Governor's office and the Washington State Hospital Association - WSHA - a professional and lobbying organization.
Harris told us, "the pressure is from these organizations."
Only when the UW failed a third inspection by the Centers for Medicare and Medicaid and the federal government threatened to pull its funding did the hospital pharmacy clean up its act -- 17 months after that initial failed inspection.
Harris wasn't involved directly in the UW case, but says it's symptomatic of what he believes is happening with some other hospital pharmacies. "I spent 11 years, a whole ton of hours, doing this and I don't want to see that go to hell because someone says, 'Oh, you're being too hard on us.' "
KOMO asked DOH Secretary Weisman for an interview specifically to address the allegations of undue influence and he declined, his office saying that such meetings are common for feedback and do not change the Department's commitment to patient safety. WSHA President and CEO Scott Bond agrees there was no undue influence and goes on to say as a trade organization advocacy is part of their job.
In a written statement, the University of Washington said they have fully responded to the PQAC's allegations and continues to work with them and adds that there were no allegations of patient harm. As former Commissioner Harris put it, in general it's possible for patients to be harmed if drugs are contaminated but he doesn't know how you would ever prove it.