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Based on a review of hospital documentation, staff interviews, and policies, it was determined that the hospital failed to meet the Condition of Participation for Quality Assessment and Performance Improvement as evidenced by:


1. The hospital failed to adhere to a one hour beyond use dating (BUD) after mold was identified in the aseptic compounding area of the pharmacy for eleven patients from 9/18/17 to 10/2/17.


Refer to A-283

Based on a review of the hospital documentation, interviews and policies for eleven of eleven patients (Patient #1, #2, #3, #13, #14, #15, #16, #17, #18, #19 and #20#), the hospital failed to take action after implementing interventions to adhere to a one hour BUD and to ensure that quality improvements were sustained. The findings included:



Review of hospital documentation identified that after a water issue/flood was identified in the hospital pharmacy in September of 2016 the aseptic compounding area had been closed for renovations/remediation's for three months. Compounding was conducted off site and pharmaceutical products were outsourced. On 1/3/17 the compounding area of the pharmacy was re-opened after approval from the Department of Consumer Protection (DCP) and the Department of Public Health (DPH). Subsequent semi-annual and monthly environmental testing was conducted from 5/5/17 through 7/6/17 with results that identified multiple colony forming unit (CFU) of mold in the air of the clean room, ante room and chemo room with interventions that included a 12 hour beyond use date (BUD) for compounding meds, terminal cleaning of all aseptic rooms, addition of a sticky mat, use of bodysuits during compounding, replacement and recertification of the HEPA (High Efficiency Particulate Air) filter in the ante-room, application of a plasma air scrubber in the ante-room, smoke testing and triple cleaning of both the ante-room and chemo room. Despite all the aforementioned interventions, mold growth formation continued to be present in the compounding area of the pharmacy.



a. On 7/26/17 environmental testing (sampling included one air and one surface sample from each room in addition to one surface sample on the pass thru area's), revealed 2 cfu's of aspergillus carneus, 1 cfu of aspergillus ustus and 1 cfu of a non-sporulating colony in the air of the ante room. Interventions included terminal cleaning, a 12 hour BUD, an increase in outsourced medications and monthly environmental testing. On 8/10/17 one air and one surface sample was conducted under the (2) hoods in the clean room and the (1) hood in the chemo room and did not identify microorganisms. On 8/30/17 environmental testing was conducted in all three rooms and each hood (sampling included one air and one surface sample in all three hoods and in each room in addition to one surface sample on the pass thru area's), which identified 1 cfu of a non sporulating colony of mold in the air of the chemo room, 2cfu's of acremonium in the air of the ante-room, 2 cfu's of a non sporulating mold on the surface of the clean room, and 1 non sporulating mold on the surface of hood #2 in the clean room. MD #1, (Infectious disease physician) was consulted and determined that a non sporulating mold would not be harmful clinically. A 12 hour BUD was implemented. Review of repeat environmental testing was conducted on 9/11/17 in all three rooms and in each hood under the same sampling conditions. The results identified 2 cfu's of aspergillus fumigataus on the surface of hood #2 in the clean room. On 9/18/17, when the test results became available to the facility, compounding ceased with all medium risk products being compounded at an alternate facility off site. In addition, low risk products were compounded at the hospital in a segregated area with a 1 hour BUD. Review of facility documentation dated 9/11/17 and 9/13/17 indicated that DCP reviewed the environmental testing that had been conducted by the hospital in August and determined that a state of control had not been met as positive environmental cultures continued to be present in multiple locations of the aseptic compounding area despite each intervention.



b. Interview and review of the facility documentation dated 9/18/17 with MD #2, the Director of Quality, identified the hosptial received notification of mold under hood #2 in the clean room on 9/18/17 and notified the Department of Public Health. The hospital plan in part included a one hour BUD to minimize/eliminate harm to patients receiving intravenous sterile preparations. Audits would be conducted of all intravenous medications to ensure appropriate administration within an hour of preparation. Deviations would be addressed with re-education of the nursing staff and notification to the nurse manager and to the infection control department.


c. Review of the facility documentation on 9/21/17 identified Patient's #1, #2 and #3 who received single or multiple dose sterile preparations during the period of time from 9/18/17 through 9/21/17 were administered CSP's (compounded sterile preparations), that exceeded a one hour BUD with an range of 1 minute to 151 minutes over the one hour BUD.

d. Interview with the Director of Quality on 9/21/17 identified that the pharmacy and nursing staff were educated on the process of maintaining a one hour BUD via email communication, through management and during twice daily safety huddles. The staff was instructed to return the medication to pharmacy if the preparation could not be administered within the hour. The medication would be discarded and prepared again to ensure the one hour BUD time frame. Further interview with the Director of Pharmacy indicated education would be reinforced and the audits would continue to ensure the BUD parameter.

e. Review of the facility documentation on 10/2/17 identified Patient's #13, #14, #15, #16, #17, #18, #19 and #20 who recieved single dose sterile preparations during the period of time from 9/22/17 through 10/2/17 were administered CSP's that exceeded a one hour BUD with a range of 1 minute to 19 minutes over the one hour BUD.


f. Interview with the Director of Quality on 10/2/17 identified that although education was conducted, the one hour BUD was not at 100 % compliance. An immediate plan of correction dated 10/2/17 indicated that the Director of Pharmacy would educate the charge pharmacist, off shift nursing administrative manager, and staff members responsible for transporting the medications to each nursing unit. The plan further directed the staff member transporting the medication to the nurse responsible for administering the medication would communicate the exact expiration time and remain on the nursing unit monitoring the timeframe to ensure the medication was administered prior to the one hour BUD. In any instance in which the one hour BUD could not be met, the medication would not be administered and would be returned to the pharmacy. The plan of correction would be sent to all hospital leadership via email and be presented on each unit during the safety huddle.


g. Interview with the Director of Quality Assurance on 10/2/17 at 4:00 PM identified the hospital failed to ensure for eleven patients from 9/21/17 through 10/2/17 that CSP's were administered within one hour of preparation. The Director of Quality indicated it was the responsibility of the leadership team to ensure the plan of correction was followed and could not identify why it was not.

Based on a review of hospital documentation, policies and interviews, it was determined that the hospital failed to meet the Condition of Participation for Pharmaceutical Services. The finding included:

1. The hospital failed to provide the necessary supervision of Pharmacy services when aseptic intravenous compounding was conducted to ensure environmental testing was comprehensive in accordance with Federal and/or state laws, United States Pharmacopeia, Chapter 797, Pharmaceutical Compounding (USP-797) and/or failed to ensure medications that were couriered over from an alternate campus were monitored for temperature to ensure the efficacy of the medications and/or that a one hour beyond use dating (BUD) was maintained after mold was identified in the aseptic compounding area on 9/18/17.


Please refer to A492

1. Based on hospital documentation, staff interviews and a review of hospital policies and procedures the hospital failed to ensure environmental testing of the aseptic compounding area was comprehensive in accordance with USP 797. The finding included:


Review of hospital documentation identfied that after a water issue/flood was identified in the hospital pharmacy in September of 2016 the aseptic compounding area had been closed for renovations/remediation's for three months. Compounding was conducted off site and pharmaceutical products were outsourced. On 1/3/17 the compounding area of the pharmacy was re-opened after approval from the Department of Consumer Protection (DCP) and the Department of Public Health (DPH). Subsequently, semi-annual and monthly environmental testing was conducted from 5/5/17 through 7/6/17 with results that identified multiple colony forming unit (CFU) of mold in the air of the clean room, ante room and chemo room with interventions that included a 12 hour beyond use date (BUD), terminal cleaning of all aseptic rooms, addition of a sticky mat, use of bodysuits during compounding, replacement and recertification of the HEPA (High Efficiency Particulate Air) filter in the ante-room, application of a plasma air scrubber in the ante-room, smoke testing and triple cleaning of both the ante-room and chemo room. Despite all the aforementioned interventions, mold growth formation continued to be present in the compounding area of the pharmacy.


a. On 7/26/17 environmental testing (sampling included one air and one surface sample from each room in addition to one surface sample on the pass thru area's), revealed 2 cfu's of aspergillus carneus, 1 cfu of aspergillus ustus and 1 cfu of a non-sporulating colony in the air of the ante room. Interventions included terminal cleaning, a 12 hour BUD, an increase in outsourced medications and monthly environmental testing. On 8/10/17 one air and one surface sample was conducted under the (2) hoods in the clean room and the (1) hood in the chemo room and not identify microorganisms. On 8/30/17 environmental testing was conducted in all three rooms and each hood (sampling included one air and one surface sample in all three hoods and in each room in addition to one surface sample on the pass thru area's), which identified 1 cfu of a non sporulating colony of mold in the air of the chemo room, 2cfu's of acremonium in the air of the ante-room, 2 cfu's of a non sporulating mold on the surface of the clean room, and 1 non sporulating mold on the surface of hood #2 in the clean room. MD #1 (Infectious disease physician), was consulted and determined that a non sporulating mold would not be harmful clinically. A 12 hour BUD was implemented. Review of repeat environmental testing conducted on 9/11/17 in all three rooms and in each hood under the same sampling conditions. The results identified 2 cfu's of aspergillus fumigataus on the surface of hood #2 in the clean room. On 9/18/1,7 when the test results became available to the facility, compounding ceased with all medium risk products with compounded at an alternate facility off site. In addition, low risk products were compounded at the hospital in a segregated area with
a one hour BUD. Review of facility documentation dated 9/11/17 and 9/13/17 indicated that DCP reviewed the environmental testing that had been conducted by the hospital in August and determined that a state of control had not been met as positive environmental cultures continued to be present in multiple locations of the aseptic compounding area despite each intervention.

b. Interview with the Intravenous Coordinator of the hospital on 9/21/17 at 11:00 AM identified environmental testing was conducted on 7/26/17 in one area (air and surface) in each room. Further interview identified that testing failed to be conducted in the hoods as the facility did not have a sufficient amount of sampling plates thus delaying testing of the hoods until 8/10/17. Furthermore, the Intravenous Coordinator identified that he/she was not aware that additional sampling within each hood and each aseptic room was necessary to be considered comprehensive in accordance with USP 797.

c. Interview with the Director of the Pharmacy on 9/12/17 at 11:15 AM indicated she was not aware that the facility did not have the number of plates to conduct comprehensive sampling and/or that more than one site in each area was needed to be considered comprehensive in accordance with USP 797.


d. Review of USP 797 standards directed in part the counts of cfu's are to be used as a measure of the environmental microbial bioburden. Action level are determined on the basis of cfu data gathered at each sampling location and trended over time. Regardless of the number of cfu's identified in the pharmacy, further corrective actions would be dictated by the identification of microorganisms recovered (at the genus level). Highly pathogenic microorganisms (e.g. mold and yeasts) can be potentially fatal to patients receiving CSP's (compounded sterile products), and must be immediately remedied, regardless of cfu count, with the assistance of a competent microbiologist, infection control professional, or industrial hygienist.



2. Based on a review of facility documentation, staff interviews and a review of the hospital's policies and procedures, the facility failed to ensure medications that were couriered over from an alternate campus were monitored for temperature to ensure the efficacy of the medications. The finding included:


a. Interview with the Director of Pharmacy on 9/21/17 at 1:30 PM indicated that medium risk sterile preparations were prepared and couriered over from an alternate site when compounding ceased on 9/18/17, so that services would not be interrupted, however, a standard operating procedure for the transport and transfer of the medications failed to include a mechanism to ensure medications were monitored for temperature stability. Subsequent to the surveyor's inquiry, the facilities written procedure for the transportation of sterile preparations was revised and included monitoring of the temperature to ensure the efficacy of the medication was maintained.


3. Based on a review of facility documentation and staff interviews for eleven of eleven patients (Patient #1, #2, #3, #13, #14, #15, #16, #17, #18, #19 and #20), the hospital failed to adhere to a one hour beyond use dating (BUD) after mold was identified in the aseptic compounding area on 9/18/17. The finding included:



a. Review of the facility documentation dated 9/19/17 from the Director of Pharmacy identified the hospital received notification of mold under hood #2 in the clean room on 9/18/17 and notified the State Department of Public Health. The hospital plan in part included a one hour BUD to minimize/eliminate harm to patients receiving intravenous sterile preparations. Audits would be conducted of all intravenous medications to ensure appropriate administration within an hour of preparation. Deviations would be addressed with re-education of the nursing staff and notification to the nurse manager of the unit and to the infection control department.


b. Review of the facility documentation on 9/21/17 identified that Patient's #1, #2 and #3 who received single or multiple dose sterile preparations during the period of time from 9/18/17 through 9/21/17 were administered CSP's that exceeded a one hour BUD.


c. Interview with the Director of Pharmacy on 9/21/17 identified the pharmacy and nursing staff were educated on the process of maintaining a 1 hour BUD via email communication, through management and during twice daily safety huddles. The staff were instructed to return the medication to pharmacy if the preparation could not be administered within the hour. The medication would be discarded and prepared again to ensure a one hour BUD. Further interview with the Director of Pharmacy indicated education would be reinforced and the audits would continue to ensure the BUD parameter.


d. Review of the facility documentation on 10/2/17 identified Patient's #13, #14, #15, #16, #17, #18, #19 and #20 who received single dose sterile preparations during the period of time from 9/22/17 through 10/2/17 were administered CSP's that exceeded a one hour BUD.


e. Interview with the Director of Pharmacy on 10/2/17 identified that although education was conducted, the 1 hour BUD was not at 100 % compliance. An immediate plan of correction dated 10/2/17 indicated that the Director of Pharmacy would educate the charge pharmacist, off shift nursing administrative manager, staff members responsible for transporting the medications to each nursing unit. The plan directed the staff member transporting the medication to the nurse responsible for administering the medication would communicate the exact expiration time and remain on the nursing unit monitoring the timeframe to ensure the medication was administered prior to the one hour BUD. In any instance in which the one hour BUD could not be met, the medication would not be administered and would be returned to the pharmacy. The plan of correction would be sent to all hospital leadership via email and be presented on each unit during the safety huddle.



Review of the job description of the Director of Pharmacy included in part department compliance with pharmacy practice laws, regulations and guidelines developed by state and federal pharmacy oversight agencies included by not limited to the Department of Drug Control. Develops, interprets and implements policies and procedures governing medication management throughout the inpatient and outpatient areas. Monitors and controls the accuracy and safety of all programs and services that required the manipulation compounding or packaging of drugs. Responsible for monitoring and reporting quality indicators, implementing interdisciplinary problem resolution teams when necessary to improve services.

Based on a review of facility documentation, staff interviews and a review of the hospital's policies and procedures the facility failed to have a comprehensive process in place when medications were couriered over from an alternate campus to ensure the efficacy of the medications prior to dispensement. The finding included:


a. Interview with the Director of Pharmacy on 9/21/17 at 1:30 PM indicated medium risk sterile preparations were prepared and couriered over to the hospital from an alternate site when compounding ceased on 9/18/17, so that services would not be interrupted, however, a standard operating procedure for the transport and transfer of the medications failed to include a mechanism to ensure medications were monitored for temperature stability. Subsequent to the surveyor's inquiry on 9/21/17, the facility's written procedure for the transportation of sterile preparations was revised and included monitoring of the temperature to ensure the efficacy of the medication was maintained.