Wednesday, July 11, 2018

Pa. Hospital Cited for Compounding Errors

By Walter F. Roche Jr.

In a scathing report that eerily echoed details of a five-year-old deadly national outbreak, a Pennsylvania hospital has been cited with multiple violations of drug compounding standards placing cancer patients in immediate jeopardy.
The findings by the Pennsylvania Health Department forced the Pottstown Hospital to immediately shutdown its cancer center pharmacy where supposedly sterile drugs were being compounded for administration to cancer patients.
The report concluded that hospital management and staffers "failed to ensure established procedures for hand hygiene and donning protective gear were followed for the compounding of hazardous drugs."
State surveyors observed staffers working under hoods without required protective gear. Numerous violations of the industry standard code known as Chapter 797 were observed.
Officials of Tower Health, the holding company for the hospital did not respond to requests for comment. The hospital did file a corrective action plan with the state in response to some but not all of the deficiencies.
State surveyors also cited Pottstown, a 232 bed facility, for an array of violations of the federally mandated Life Safety Code. The report states that the main hospital building "exceeds the maximum story height allowed" and multiple areas were found to lack the required fire rating.
Other violations also were noted in several areas other than the cancer center pharmacy.
Staffers failed to follow proper procedures for blood transfusions and mold was observed in an ice machine.
Still other deficiencies included failure to ensure the privacy of patient records, failure to maintain infection control in multiple areas and improper cleaning of endoscopy equipment.
IV bags were observed without expiration dates and expired gloves and drugs were also observed in the endoscopy area.
In the clean room where critical procedures were performed gaps were observed on counter tops, floors were damaged and even when microbial sample showed contamination, no action was taken. According to the report there were over 30 incidents of microbial growth without documented follow up.
The facility "failed to ensure environmental microbial samples were evaluated," the lengthy report states.
The descriptions in the report were similar to the court testimony in the recent trials of former officials of the New England Compounding Center, the company blamed for the 2012 fungal meningitis outbreak.
In those trials federal investigators described similar deviations from the 797 standards including the failure to take corrective action when environmental tests showed evidence of contamination in the clean rooms. The two NECC official were found guilty of racketeering, mail fraud and related charges and are now serving prison sentences.
Still other citations included failure to have adequate post anesthesia services for pediatric
surgical patients and failure to maintain proper temperatures in an operating room.
Pottstown was one of five hospitals purchased by Tower Health from Community Health Associates last year for $418 million.
Another hospital purchased from CHA was the Brandywine Hospital in Coatsville, which was also the subject of a recent critical health department report.
That facility was cited for failure to comply with the state Child Protective Services Act. According to the surveyors, hospital staffers watching a monitor observed a visitor touching a child in an appropriate manner but subsequently failed to properly report the incident immediately. Instead, a report was filed three days late, the report states. The incident occurred on Aug. 27, 2017, two months before the purchase.
Brandywine also was cited for failure to properly follow up on patients who had discharged themselves against medical advice.
The surveyors found that Brandywine failed to contact the patients' outpatient therapists.
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