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Based on a review of hospital documentation, hospital committee meeting minutes, e-mail communications, interviews and policies, the hospital failed to regain a state of control in the Clean Room, where sterile products are compounded, after a small water leak was identified. Subsequent to the water leak and before proper sanitation of the room, staff compounded 37 medications that were administered to twenty (20) patients. The finding includes:


Review of facility documentation dated 7/23/18 identified that during a heavy rainstorm on 7/17/18, water penetrated the exhaust system of the biological safety cabinet (BSC) located in the pharmacy Clean Room which is utilized to compound chemotherapy. Facility documentation noted that 37 medications were compounded using the LAFW, located in the same room as the BSC during the period of 7/17/18 at 11:00 PM through 7:00 AM on 7/18/18 and administered to Patient #1-20 on 7/18/17.

Interview with Pharmacy Technician (PT) #1 on 9/17/18 at 11:10 AM indicated that on 7/17/18 at approximately 8:00 PM she observed a small amount of water on the floor of the Clean Room in front of the entry door next to the BSC. PT #1 stated she wiped up the water and notified the charge pharmacist (Pharmacist #1). PT #1 stated that the Pharmacist told her she should clean the room like she normally does, since this was not a good thing and should take major steps to clean. PT #1 stated she cleaned the room utilizing bleach, alcohol, Cavicide wipes, and alcohol again. Review of the cleaning log dated 7/17/18 failed to identify that PT#1 cleaned the room. The cleaning log reflected that a three time clean was completed on 7/18/18 by another pharmacy technician.

Interview with Pharmacist #1 on 9/17/18 at 8:50 AM indicated that when she was notified of the issue on the evening of 7/17/18 by PT #1, she asked PT #1 to check for further leaks and when informed that there were none, asked PT #1 to clean the room as she normally does. Pharmacist #1 indicated that the other pharmacist on duty (Pharmacist #2) texted the Operations Director to notify him of the issue at that time.

Interview with the Operations Director on 9/17/18 at 11:30 AM indicated that he was notified of the water leak on 7/17/18, however, he misunderstood the text and assumed the water leak was in the "new clean room" that was under construction and had been leaking earlier in the day.

Interview with the Director of the Pharmacy on 9/17/18 at 8:50 AM and 12:15 PM respectively stated she was notified in the morning of 7/18/18 that PT #1 observed water on the BSC and on the floor beneath the cabinet (on 7/17/18) and notified the charge pharmacist. The Director stated the area was cleaned, however, she was not notified of the incident and compounding was not suspended until she was notified in the morning.

The Director stated she was informed that a three-time clean was completed by PT#1 on 7/17/18 but during her discussion with PT#1, the Technician revealed that the products utilized to disinfect the cleanroom after the water leak failed to include a sporicidal. The Director identified she directed only low risk medications be compounded with a one-hour beyond use date (BUD) effective 7/18/18.

Review of facility documentation identified that weekly environmental samples of the clean room were obtained during the period of 11/17 through 9/17/18 and revealed no growth.

Review of the policy entitled, Sanitation of the Controlled Sterile Compounding Environment, stated that the LAFW and BSC are most intimate to the exposure of critical sites and require disinfection most frequently. Three-time cleaning of controlled environments include the use of two germicidals (alcohol and Cavicide), and a sporicidal (Peridox) and may be performed when the following conditions occur, in part; first use and testing of a new facility, after maintenance work, after action levels are identified, and/or at the discretion of the Pharmacy Manager. The policy directed that the cleaning must be documented.