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RIDOH issues compliance order against Women & Infants over delays in pharmacy improvements

By

Katie Castellani

-

04/02/2024

women-infants — WOMEN & INFANTS HOSPITAL must make improvements to its pharmacy after the R.I. Department of Health issued a compliance order against the hospital./COURTESY OF WOMEN & INFANTS HOSPITAL

PROVIDENCE – Women & Infants Hospital must make improvements to its pharmacy after the R.I. Department of Health issued a compliance order against the facility. The compliance order filed March 19 comes in response to Women & Infants failing to hold up its end of a June 2022 agreement it entered with RIDOH and the

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PROVIDENCE – Women & Infants Hospital must make improvements to its pharmacy after the R.I. Department of Health issued a compliance order against the facility. The compliance order filed March 19 comes in response to Women & Infants failing to hold up its end of a June 2022 agreement it entered with RIDOH and the Board of Pharmacy to clean and update its pharmacy suites. According to the agreement, RIDOH and the Board of Pharmacy had conducted an unannounced inspection of two of Women & Infants’ sterile pharmacy suites in January 2022. During the investigation, inspectors found several things that were not up to state code including: test results that showed several organisms in sterile areas; both suites had outdated design and materials and needed maintenance in several areas; unlabeled syringes left in the non-hazardous hood of what was identified as the “main” compounding suite; dust, dirt and grime in areas of both rooms; expired MESNA tablets in the “anteroom” of the main suite; multiple dates on the cleaning logs that weren’t completed in a timely manner; hoods used in both pharmacy suites that had passed tests and certifications by third-party inspectors, but were out of compliance with state code; and there were “particle-generating” items in anterooms of both suites like computers, a rolling medication delivery tower and refrigerators. Then in June 2022, Women & Infants entered into a Consent Order & Agreement and took steps to clean up its pharmacy suites. Specifically, the agreement required Women & Infants to clean its pharmacy suites, show proof of cleaning logs, replace old equipment, remodel and renovate both pharmacy suites – or condense them and remodel the remaining one – and hire a third-party monitor for one year. Also, as part of the agreement Women & Infants was placed on probation for one year, with the possibility of extending it until the conditions of the agreement are met. According to the agreement, Women & Infants says it has and will continue to make sure its compounded drugs and patients are safe. Also, before the agreement was signed Women & Infants had taken steps to renovate the pharmacy suites, remove “particle generating materials” from rooms, planning of remodeling as well as training staff and implementing policies to prevent the same issues. However, the hospital still has work to do as the Compliance Order filed in March 2024 says Women & Infants “failed to commence work to timely remodel and renovate pharmacy suite(s) as agreed.” Now, Women & Infants is still under probation and has been given a series of steps and deadlines as far out as April 25, 2025, it must meet to renovate the pharmacy suites. Along with this, Women & Infants must pay to be monitored by Health Quality Assurance Advisor Group, which is an independent pharmacy monitoring service, or another vendor approved by RIDOH. This monitor will remain until the renovation and remodel is complete and is responsible for providing quarterly reports to RIDOH about how the hospital is following the schedule. Additionally, once the renovations are complete they must be inspected by RIDOH and the National Association of Boards of Pharmacy, also paid for by Women & Infants. It was not immediately clear exactly what areas in the pharmacy suites needed to be renovated and remodeled. A spokesperson for Care New England did not respond to PBN’s questions about the Compliance Order or how much renovations, monitoring and inspection will cost the hospital. Katie Castellani is a PBN staff writer. You may contact her at Castellani@PBN.com.