Compliance with state and federal regulations and laws was the topic of at a recent Northern Inyo Healthcare District’s Board of Directors meeting. Faced with a violation of state pharmacy regulations, the District has taken a hard-learned lesson and turned it into a positive outcome for the future of health care in the Eastern Sierra.
Annual regulatory audits are conducted throughout the hospital by numerous agencies, explained Chief Executive Officer Kevin S. Flanigan, MD MBA. In this case, the state pharmacy board ordered the hospital to complete three corrective actions. Two were completed, but the third involving the compounding room – where chemotherapy agents, analgesics for surgery, and antibiotics are mixed – was not.
In 2015, the state ordered NIH to ventilate the room to the outdoors. “That was recited again this year which escalates us from a correction to a violation,” Dr. Flanigan said. He explained NIHD’s team thought if a construction plan addressing the room was in place, a correction extension would be issued, but that was not the case.
Also, the pharmacy board cited the hospital for using what is now deemed to be the wrong paint within the room. The state requires non-porous oil-based epoxy. Past audits did not list the latex paint used by NIHD as a correction, but this time it did. The hospital received an additional citation for the Director of Pharmacy not completing one of the required online policies.
“She had clicked on the wrong link, went to the wrong policy,” Dr. Flanigan said. “Once it came to our attention, she went back on completed the correct one while the auditors were on site. The same applies to a labeling issue brought to our attention.”
For a week, NIHD maintenance and facility managers as well as local contractors worked together to correct the ventilation and paint issues. “By the time our letter of correction reaches the pharmacy board, all of the issues will be corrected. Our team has completed solutions for the short-term and has identified solutions for the long-term issues at hand,” Dr. Flanigan said.
All pharmacies are facing increased regulations involving compounding rooms within the next two years. Dr. Flanigan said NIHD is working with the California-based company Clean Air Solutions to fabricate a modular insert system to be installed in one of the hospital’s former operating rooms. The cost of the system will likely exceed the $80,000 budgeted for the pharmacy remodel.
“We were already looking to make better use of our space in the old hospital facility, and part of that called for a remodel of the pharmacy to meet these new standards,” he said. “This insert system will allow us to continue providing services while meeting standards. It is also mobile so if we want to move it, we can. It is also upgradable.”
Dr. Flanigan noted NIHD will still need to apply for a waiver as it is currently taking the pharmacy board between four and six months to inspected and certified the new system.
With the new regulations focusing on pharmacy compounding rooms across the state, Dr. Flanigan said other facilities may no longer offer compounded therapies.
“Dwayne’s Pharmacy, which produces the chemotherapy and other compounding pharmaceutical supplies for other area facilities, is shutting down its program as of Dec. 31,” Dr. Flanigan said. “I’ve had a brief conversation with Mammoth’s Chief of Staff about what they are facing. When we ask for the waiver, we will tell the Pharmacy Board that we are now the only compounding pharmacy in the Eastern Sierra. Without us being able to provide this service, everybody in the Eastern Sierra, not just those who we serve in our district, has to go five hours or so to get access to infusion therapy.”
Dr. Flanigan is optimistic the pharmacy board can come here sooner than the four to six-month time-frame, and that NIHD will be able to secure the waiver. As for the cited violation, Dr. Flanigan said the hospital could receive a letter of admonishment, which would stay on NIHD’s and its Director of Pharmacy’s record for up to three years, and/or a fine.
When staff in the board audience attempted to take blame for the violation, Dr. Flanigan reminded them he was ultimately responsible. They reminded him of the first four words of the hospital’s mission statement: one team, one goal.
Dr. Flanigan smiled. “A lot of lessons learned,” he concluded. “We are fortunate that the staff could come together and make the corrections in an exceptionally timely fashion. In the future, copies of all survey reports will always go to the Compliance Officer, who will monitor the progress of the compliance efforts.”