HospitalInspections.org

21980

Based on record review and staff interview, it has been determined that the hospital has failed to ensure patient safety relative to sterile compounding areas in accordance with State Regulation and applicable standards of practice.

Findings are as follows:

1) The State of Rhode Island Rules and Regulations Pertaining to Pharmacists, Pharmacies, and Manufacturers, Wholesalers and Distributors,
[R5-19.1-PHAR], State of Rhode Island and Providence Plantations, Department of Health, March 1985 and revised April 2014, under 19.28 A, States, in part:

"...written plan and schedule for the environmental monitoring procedures for viable micro organisms shall be established and followed. The plan shall be adequate to evaluate the various controlled air environment areas (LAFW, barrier isolators, biological safety cabinets, buffer or clean room, and anteroom) of the designated sterile compounding area(s). For sterile compounding areas used for low- and medium-risk preparations, a minimum monthly evaluation shall be required...".

Review of the Department of Pharmacy Services Corrective Action Plan dated 6/23/2015 revealed that fungus was found in the Ante and Clean Room of the sterile compounding areas. There was one location in Clean Room (#6 on their diagram) and two locations in Ante Room (#'s 8 and 10 on their diagram).

The document further reveals that environmental monitoring was conducted on 9/21/2015 which revealed fungus was still found in the air sampling for location 10 in the Ante Room.

A Testing Certificate dated 12/21/2015 identified bacteria on the floor in the Ante Room.

The Director of Pharmacy was interviewed on 2/2/2016 at 2:15 PM and was unable to produce evidence that the monthly testing was conducted as required between June and September and between September and December 2015.

2) The USP (United States Pharmacopeia) 797 guidelines for Pharmaceutical Compounding, under Action Levels, Documentation, and Data Evaluations, states, in part:

"...Any cfu [colony-forming unit] count that exceeds its respective action level...should prompt re-evaluation of the adequacy of personal work practices, cleaning procedures...The source of the problem shall be eliminated, the affected area cleaned, and resampling performed."

Review of the Department of Pharmacy Services Corrective Action Plan dated 6/23/2015 revealed that the corrective action for these findings was to only "...Wipe down the 3 locations with Sporicidin where the fungi was found and to be completed by 6/28...".

21980

Based upon record review and staff interview, it has been determined that the hospital has failed to ensure that the overall hospital environment is maintained in a manner that provides an acceptable level of safety and well-being of patients.

Findings are as follows:

The USP (United States Pharmacopeia) 797 guidelines for Pharmaceutical Compounding, under Facility Design and Environmental Controls
Compounding, states, in part:"...facilities are physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. These facilities shall also provide a comfortable and well-lighted working environment, which typically includes a temperature of 20° [68 degrees Fahrenheit] or cooler, to maintain comfortable conditions for compounding personnel to perform flawlessly when attired in the required aseptic compounding garb...".

Record review of the "RWMC Department of Pharmacy Temperature, Humidity, and Pressure Log for Ante Room, Clean Room and Chemo Room" between February 2015 thru February 2016 revealed temperatures documented on a daily basis. The temperature was documented as above 72 degrees Fahrenheit (F) on numerous days throughout each month.

For example, for the month of March, 2015, the following was revealed:

March 6, the Ante room's temperature was 72.4 degrees Fahrenheit (F), the Clean room's temperature was 77.2 degrees F, and the Chemo room's temperature was 74 degrees F.

March 6, the Ante room's temperature was 76 degrees F, the Clean room's temperature was 80.1 degrees F, and the Chemo room's temperature was 77 degrees F.

Overall, for the month of March 2015, the Clean Room temperature was above 72 degrees F on 28 out of 31 days of the month.

For the month of September, 2015, the following was revealed:

September 3rd, the Clean room's temperature was 77.4 degrees F.
September 8th, the Clean room's temperature was 78.5 degrees F.
September 28th, the Clean room's temperature was 75.1 degrees F.

Overall, for the month of September 2015, the Clean Room temperature was above 72 degrees F on 25 out of 27 days of the month.

The last documented temperature was on 2/1/2016, when the Clean Room's temperature was 73.6 degrees F.

When interviewed on 2/2/2016 at 9:30 AM, the Pharmacist stated that the temperature should be maintained between 64 to 72 degrees F. The pharmacy technician (Staff A) was interviewed at this time and stated that when the temperature is above 72 degrees F, maintenance is contacted as they are responsible for the temperature readings.

When interviewed on 2/2/2016 at 10:30 AM, the Director of Engineering & Maintenance Management stated that they are aware that there are issues with the heating and air conditioning system for the pharmacy and there was a Capital Request for 2016-2018 to replace the system. However, he was unable to produce evidence that temporary interventions were put into place to rectify the high temperatures.

Additionally, on 2/2/2016 at approximately 10:00 AM in the presence of a pharmacy technician (Staff B), the Clean room was observed with a 2 to 3 inch crack in the floor where it meets the wall. The Chemo room was observed with an 8 to 10 inch crack right above the baseboard where it meets the wall. Another crack was observed near the entrance door measuring approximately 2 to 3 feet long. This crack was covered with blue tape that was torn/cracked and appeared worn.

Subsequent interview with the Director of Pharmacy on 2/2/2016 at 10:15 AM failed to reveal evidence that these floor cracks were brought to the attention of maintenance services.

The Director of Engineering and Maintenance Management was interviewed after this observation at 10:30 AM and stated that cracks in the floor could hold moisture.

21980

Based on record review and staff interview, it has been determined that the pharmacy has failed to report adverse environmental findings in the sterile compounding areas to the Infection and Prevention Control Program.

Findings are as follows:

Review of the Department of Pharmacy Services Corrective Action Plan dated 6/23/2015 revealed that fungus was found in the Ante and Clean Rooms of the Main Hospital Sterile Compounding) Areas. There was one location in the Clean Room (#6 on their diagram) and two locations in the Ante Room (#s 8 and 10 on their diagram).

The document further reveals that environmental monitoring was conducted on 9/21/2015 which revealed fungus was still found in the air sampling for location 10 in the Ante Room.

A Testing Certificate dated 12/21/2015 identified bacteria on the floor in the Ante Room.

Review of the Infection Prevention and Control Committee Meeting revealed the meetings were held on 10/15/2015, 11/19/2015, 12/17/2015 and 1/21/2016. There were no evidence that the committee has reviewed the results of the above findings.

Additionally, there was no evidence that any representative from pharmacy attended the meetings on 12/17/2015 and 1/21/2016.

The Director of Infection and Prevention Control was interviewed on 2/2/2016 at 1:25 PM and was unaware of the above findings as they had not been reported to infection control.

During a subsequent interview on 2/2/2016 at 2:00 PM, the Director of Pharmacy stated the above findings had not been reported to the Infection Prevention and Control Committee.