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Based on a review of Governing Body Minutes, hospital documentation, and interviews, the Governing Body failed to ensure that the Pharmacy and Therapeutics, Medical Staff, Infection Control and Quality Assurance/Performance Improvement committees/members were cognizant of and documented infection control concerns related to low risk IV medications were compounded in an International Standards Organization (ISO) Class 5 certified Compounding Aseptic Isolator (CAI) in accordance with hospital policy, operator's manual and/or consistent with State and Federal laws (United States Pharmacopeia (USP) 797), and failed to ensure that the environment where the CAI was housed was constructed and maintained in a manner conducive to thorough cleaning, and failed to ensure that staff followed infection control practices. The findings include:


Although compliance with USP 797 was addressed and documented in the minutes of the Regulatory Compliance Committee Meeting of 05/20/15, review of Governing Body Minutes, Medical Staff Minutes, Quality Assurance/Performance Improvement Minutes and/or Infection Control Minutes failed to identify that issues specific to infection control in the pharmacy environment, use of the CAI and/or positive cultures were routinely reported and remedied.

Interview with the Chief Medical Officer on 01/14/16 at 8:45 AM identified that, although there was discussion of pharmacy at many meetings, specific issues were not documented in the minutes.

Based on review of Quality Assurance/Performance Improvement (QAPI) minutes, Pharmacy and Therapeutic Minutes, and interviews regarding Compounded Sterile Products (CSP), the QAPI Program failed to include and/or utilize data collected by the pharmacy department related to contamination during the process of compounding sterile products in the Segregated Compounding Area (SCA) and Compounding Aseptic Isolator (CAI) to identify opportunities for improvement. The findings include:


Although compliance with USP 797 was addressed and documented in the minutes of the Regulatory Compliance Committee Meeting of 05/20/15, review of Quality Assurance/Performance Improvement Minutes failed to identify that issues specific to CAI and/or positive cultures were routinely reported on the agenda and/or recorded in the minutes. Review of the QAPI Minutes lacked documentation that data collected by the Pharmacy was further reviewed.

Interview with the Chief Medical Officer on 01/14/16 at 8:45 AM identified that, although there was discussion of pharmacy at many meetings, specific issues were not documented in the minutes.

The Condition of Participation for Pharmaceutical Services has not been met.

Based on observation, review of hospital policies and procedures, review of manufacturer instructions, and interviews with staff, the hospital failed to ensure that low risk IV medications were compounded in an International Standards Organization (ISO) Class 5 certified Compounding Aseptic Isolator (CAI) in accordance with hospital policy, operator's manual and/or consistent with State and Federal laws (United States Pharmacopeia (USP) 797), failed to ensure that the environment where the CAI was housed was constructed and maintained in a manner conducive to thorough cleaning, and failed to ensure that staff followed infection control practices.

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Based on observation, review of hospital policies and procedures, review of manufacturer instructions, and interviews with staff, the hospital failed to ensure that low risk IV medications were compounded in an International Standards Organization (ISO) Class 5 certified Compounding Aseptic Isolator (CAI) in accordance with hospital policy, operator's manual and/or consistent with State and Federal laws (United States Pharmacopeia (USP) 797), failed to ensure that the environment where the CAI was housed was constructed and maintained in a manner conducive to thorough cleaning, and failed to ensure that staff followed infection control practices. The findings include:


A. During tour of the main pharmacy on 01/11/16 at 11:10 AM with the Director of Pharmacy, one stainless steel handwashing sink that served both the main pharmacy area and the Segregated Compounding Area (SCA) was observed to have a heavy build up of a grayish white substance around the base of each faucet handle, faucet base, midway up the interior of the sink and around the drain (which prohibited proper cleaning). Interview with the Director of Facilities and the Supervisor of Housekeeping at 1:00 PM identified that the grayish substance was consistent with a mineral/calcium build up related to hard water. Routine cleaning included spraying with a disinfectant and wiping with a microfiber cloth, however a special, caustic cleaner would be required to remove the stain/substance and would need to be performed in the evening when there was minimal activity in the pharmacy. The Pharmacy Technician #1 utilized the sink to perform hand hygiene prior to compounding on 1/11/16 at 1:30 PM. Review of Environment of Care Surveys for 1/30/14, 07/24/14, 06/10/15 and 12/01/15 failed to address the staining/substance in the handwashing sink.

B. Observation of Pharmacy Technician (Pharm Tech) #1 garbing, cleaning the CAI, regarbing, and compounding IV medications on 01/11/16 at 1:30 PM identified that shoe covers were donned prior to crossing over the line of demarcation (established by the pharmacy department) and the Tech crossed over the line of demarcation multiple timesworn during garbing and while stocking the pass-through chamber with compounding supplies.

C. Observation on 01/11/16 at 1:30 PM identified that during transfer of compounding supplies including medication vials, IV bags, and syringes into the pass-through chamber of the CAI, Pharm Tech #1 sprayed the items with isopropyl alcohol, but failed to wipe the surface to disinfect and ensure reduction of any bioburden consistent with USP 797 standards.

D. Observation of the main compounding chamber of the CAI during compounding on 01/11/16 identified that a sharps container, plastic container of alcohol wipes, and a plastic tray containing packaged sterile needles was present. Further observation and interview on 01/14/15 at 11:10 AM (prior to cleaning or compounding that day) with Pharm Tech #2 identified that the items were already present in the main chamber. According to Pharm Tech #2, the items were removed during cleaning, then replaced in the main chamber for compounding. They were stored in the chamber between cleanings and during compounding. The CAI operator's manual directed to never store supplies or laboratory equipment in the cabinet (pass-through chamber and/or main chamber).

E. Tour of the SCA, review of cleaning schedules, and interview with the Director of Pharmacy on 01/13/16 identified that, although the pharmacy staff performed all the cleaning activities in the SCA, the ceiling, walls, access door and window grates were not part of the cleaning schedule. Additionally, the ceiling was not sealed and/or cleanable and the window grate was metal with multiple small openings providing an environment susceptible to accumulation of contaminants. Wall paint was not washable and vinyl-like floor tiles were not sealed. The entrance/exit door was wood creating the possibility that particles could, potentially, be released during cleaning. The Director of Pharmacy identified that the SCA ceiling, walls, window grates, and/or doors did not need to be cleaned as the area was not sterile. Interviews with a Department of Consumer Protection (DCP) investigator DPC #1 on 01/12/16 at 8:45 AM and 01/19/16 at 4:25 PM identified that the SCA environment was not cleanable and had inappropriate ceiling tiles (which are expectations of a SCA environment).

F. Review of pharmacy cleaning logs from 01/01/15 through 01/10/16 identified that monthly cleaning of storage shelves lacked documentation for 01/15, 02/15, 04/15, 06/15, and 09/15. The undersurface of the compounding area lacked documentation of cleaning/disinfecting for 01/15. Inside of bins lacked documentation of cleaning/disinfection for 01/15, and 02/15. Daily static pressure in pass through chamber greater than or equal to 0.1 and in work chamber 0.05 greater than pass through chamber lacked daily documentation on 03/01/15, 03/09/15, 03/22/15, 04/16/15, 04/18/15, 04/19/15, 05/13/15, 05/12/1506/01/15, 06/09/15, 07/05/15, 07/06/15, 07/07/15, 07/09/15, 07/11/15, 07/12/15, 07/15/15, 08/08/15, 08/09/15, 08/21/15, and 09/03/15. Interview and review of cleaning logs with the Director of Pharmacy on 01/13/16 at 1:30 PM identified that Pharmacist #1 had been assigned to monitor compliance with USP 797 including review of cleaning logs and other routine monitoring of the SCA and CAI. Sometime in the middle of 2015 the Director of Pharmacy became aware that Pharmacist #1 was not monitoring compliance as directed and remediation for omitted documentation had not been conducted. Pharmacist #2 has been assigned to monitor compliance.

G. Review of every 6 month vendor reports of certification test results for the CAI identified that the report dated 07/13/15 identified one of eight dynamic viable air sample tests with 4 CFUs of a bacillus like bacteria (brevibacillius brevis). Interview with the Director of Pharmacy on 01/13/16 at 2:15 PM identified that he/she had consulted with the vendor immediately regarding the finding and was informed that the bacteria was non-pathogenic and was directed by the vendor to thoroughly clean the CAI hood. Re-culture results performed by the vendor identified zero total bacteria count. The Director of Pharmacy identified that he/she should have reported the actionable bacterial contamination to the Department of Consumer Protection (DCP) immediately per standard procedure, however, it was not report until approximately one week later. In addition, the contamination was not documented in the monthly Pharmacy and Therapeutics (P&T) minutes.

H. Interview with the Infection Preventionist, RN #2, on 01/14/16 identified that neither he/she nor the Medical Director of Infection Prevention reviewed cultures (finger tip testing and/or media fill testing) collected by the pharmacy staff and processed by an outside laboratory and did not review culture results obtained by the outside vendor. Additionally, although the Infection Preventionist regularly attended the P&T Meetings, culture results and/or infection control issues related to the CAI and the CAI environment were not routinely discussed. The Infection Preventionist identified that he/she should be involved in monitoring and/or reviewing cultures and any infection control issues related to the CAI.

I. Although compliance with USP 797 was addressed and documented in the minutes of the Regulatory Compliance Committee Meeting of 05/20/15, review of Infection Control Minutes failed to identify that issues specific to the CAI, the environment, and/or positive cultures were routinely reported on the agenda and/or recorded in the minutes. The
P&T's agenda lacked routine reporting on issues related to CAI.

Based on review of Infection Control Minutes, Pharmacy and Therapeutic Minutes, and interviews regarding Compounded Sterile Products (CSP) the infection prevention officer and/or the Infection Preventionist failed to develop a system for identifying, reporting, investigating, and/or controlling potential product contamination during the process of compounding sterile products in the Segregated Compounding Area (SCA) and Compounding Aseptic Isolator (CAI). The findings include:


A. During tour of the main pharmacy on 01/11/16 at 11:10 AM with the Director of Pharmacy, one stainless steel handwashing sink that served both the main pharmacy area and the Segregated Compounding Area (SCA) was observed to have a heavy build up of a grayish white substance around the base of each faucet handle, faucet base, midway up the interior of the sink and around the drain (which prohibited proper cleaning). Interview with the Director of Facilities and the Supervisor of Housekeeping at 1:00 PM identified that the grayish substance was consistent with a mineral/calcium build up related to hard water. Routine cleaning included spraying with a disinfectant and wiping with a microfiber cloth, however a special, caustic cleaner would be required to remove the stain/substance and would need to be performed in the evening when there was minimal activity in the pharmacy. Pharmacy Technician #1 utilized the sink to perform hand hygiene prior to compounding at 1:30 PM.


B. Review of Environment of Care Surveys for 1/30/14, 07/24/14, 06/10/15 and 12/01/15 in which the Infection Preventionist was present failed to identify infection control issues related to the pharmacy environment, handwashing, and/or the compounding of sterile products.


C. Review of every 6 month vendor reports of certification test results for the CAI identified that the report dated 07/13/15 identified one of eight dynamic viable air sample tests with 4 CFUs of a bacillus-like bacteria (brevibacillius brevis). Interview with the Director of Pharmacy on 01/13/16 at 2:15 PM identified that he/had consulted with the vendor immediately regarding the finding and was informed that the bacteria was non-pathogenic and was directed to thoroughly clean the CAI hood with no recommendation to discontinue use of the hood. Re-culture results performed by the vendor identified zero total bacteria count. The vendor had no recommendations for changes in policy or procedure and re-certification is scheduled for 01/25/16. The contamination was not documented in the monthly Pharmacy and Therapeutics (P&T) minutes and was not reviewed by the Infection Preventionist.


D. Although compliance with USP 797 was addressed and documented in the minutes of the Regulatory Compliance Committee Meeting of 05/20/15; review of Infection Control Minutes failed to identify the pharmacy environment, issues specific to CAI and/or that positive cultures were routinely reported on the agenda and/or recorded in the minutes.


E. Interview with the Infection Preventionist, RN #2, on 01/14/16 at 9:15 AM identified that neither he/she nor the Medical Director of Infection Prevention had reviewed cultures (finger tip testing and/or media fill testing) collected by the facility and processed by an outside lab and/or reviewed culture results obtained by the outside vendor. Additionally, although the Infection Preventionist regularly attended the P&T Meetings, culture results and/or infection control issues related to the CAI were not routinely discussed. The Infection Preventionist identified that he/she should be involved in monitoring and/or reviewing cultures and any infection control issues related to the CAI.