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Based on observations, interviews, policy and documentation review, the hospital failed to promote a safe medication compounding process and failed to maintain the hospital pharmacy in a safe and sanitary manner as evidenced by:

The hospital failed to ensure the pharmacy's IV Admixture room was maintained according to professional standards and failed to ensure proper infection control practices were maintained. Please refer to A0491 and A0749.

Based on observations, review of hospital documentation, review of hospital policies and interviews with hospital personnel, the hospital failed to ensure that the pharmacy maintained an adequate anteroom to the IV admixture room and/or failed to reflect that air sampling of the Pharmacy's IV Admixture Room was conducted and/or failed to ensure that monthly hood surface testing was conducted and/or failed to ensure that pharmacy refrigerator/freezer temperatures were within range and/or failed to ensure that the out of range refrigerator/freezer temperatures were corrected when identified. The findings include:
1. Observations of the hospital's pharmacy conducted on 3/22/13 identified that the pharmacy anteroom, the designated area where non sterile compounding activities should occur such as handwashing, storage, and measuring/weighing/mixing of non-sterile substances, was located inside the pharmacy's intravenous (IV) admixture room, the room where sterile compounding takes place. The two areas were divided only by a red demarcation line on the floor. Observation and interview with the Director of Pharmacy on 3/26/13 at 10:00 AM identified that the red demarcation line had been positioned based on the laminar hood location and that sterile preparation of medications was conducted beyond the red line. Although the IV admixture room was intended as an "open" clean room design, the environment was not conducive to maintaining the integrity of the sterile compounding area. Observations on 3/22/13 identified that a Pyxis medication station, a refrigerator, a sink, were located in the designated anteroom that was opened to the IV admixture room, as well as numerous supplies stored on shelves and in cabinets. The stainless steel sink was positioned atop a locked, white cabinet. Upon opening of the cabinet, the base of the cabinet had black flakes, the rear of the cabinet had an outlet that was discolored with a brownish material, and the wall at the bottom side of the sink was black/brown in color. Although interview with the Director of Pharmacy on 3/26/13 at 10:00 AM indicated that cleaning of the IV admixture room was completed subsequent to surveyor inquiry during the tour on 3/22/13 and included removal of the sink, observations on 3/26/13 at 10:00 AM identified that the anteroom area remained cluttered. Although the sink had been removed, the sink counter and cabinet remained in the room. Further observations on 3/26/13 identified papers, a gown, and other debris were found behind the refrigerator in the IV admixture room and cardboard boxes that were stored in the cabinet in the IV admixture room. Cultures of the sink cabinet area in the anteroom were taken at the time of the first observation on 3/22/13. Review of laboratory culture reports dated 3/22/13 of the sink cabinet, located in the pharmacy IV Admixture room identified Aspergillus inside the sink cabinet on the outlet top and the base.
Review of the IV Admixture Program policy indicated that all supplies would be unboxed outside the IV room to avoid introduction of cardboard contamination in the IV room and would be disinfected prior to entry into the admixture room. The Director of Pharmacy identified that the pharmacy anteroom had been moved years ago into the IV admixture room due to storage/space limitations.
2. Observation of the hospital's pharmacy and interview with the Director of Pharmacy on 3/26/13 at 10:00 AM identified that two laminar air flow hoods and two vertical hoods were located in the Pharmacy IV Admixture room, the room where sterile compounding takes place. Review of the environmental culture results for the pharmacy identified that from the period of January 2012 until March 22, 2013, cultures were performed on the following days: February 10, 2012, April 25, 2012, July 30, 2012 and August 6, 2012. Interview with the Pharmacy Director and Director of Patient Safety on 3/22/13 at 11:00 AM identified that required monthly cultures had only been performed four (4) times over the last fifteen months. Review of the Structure Standards for Departmental Infection Control Activities indicated that the infection prevention activities relating to the IV admixture program included routine environmental testing of the IV Admixture room. Review of hospital documentation and interview with the Director of Pharmacy on 3/27/13 at 2:00 PM identified that the air sampling of the Laminar Air Flow Hood had not been conducted since August 2012, more than seven months overdue. Review of the Laminar Air Flow Hood policy directed in part, that air sampling be conducted monthly in the IV Admixture room

3. Observation of the hospital's pharmacy and interview with the Director of Pharmacy on 3/26/13 at 10 AM identified two laminar air flow hoods and two vertical hoods were located in the Pharmacy IV Admixture room. Review of the Laminar Air Flow Hood policy directed in part, that hood surface testing be conducted monthly. Review of hospital documentation and interview with the Director of Pharmacy on 3/27/13 at 2:00 PM identified that hood surface testing had not been conducted monthly as per policy and could not identify the last time the surface testing was performed.

4. Review of the pharmacy's January 2013 refrigerator/freezer temperature log on 3/22/13 identified that the freezer temperatures in the refrigerator/freezer in the IV room were not within acceptable range on three occasions: January18; zero degrees, January 30; minus two degrees, and January 31; minus two degrees. Review of the pharmacy's February 2013 refrigerator/freezer temperature log on 3/22/13 identified that the freezer temperatures in the refrigerator/freezer in the pharmacy were not within acceptable range on two occasions: February 17; minus three degrees and February 25; minus two degrees. In addition, the log identified that the temperatures in the refrigerator section of the same refrigerator/freezer were not within acceptable range on two occasions: February 21; fifty five degrees and February 24; forty eight degrees. Interview with the Pharmacy Director and Pharmacist #1 on 3/22/13 at 11:00 AM identified that when refrigerator/freezer temperatures were out of range, the practice/protocol was to adjust temperature, to recheck the temperatures in thirty (30) minutes, and to document the results. Review of the Medication Refrigerator Temperature Monitoring Policy directed in part, that if the temperature of the refrigerator/freezer was outside the acceptable range, the settings would be adjusted and the temperature would be rechecked thirty minutes later. Acceptable ranges included a freezer temperature of minus four degrees or below and refrigerator temperatures of thirty five to forty six degrees. Review of the temperature logs with pharmacy staff on 3/22/13 lacked documentation to reflect that the troubleshooting protocol was followed and/or recorded.

Based on observations, interviews, policy and documentation review, the hospital failed to promote a safe and sanitary environment within the hospital pharmacy as evidenced by:

The hospital failed to ensure that the pharmacy was in compliance with state and federal fire safety codes and that equipment was maintained as required. Please refer to A0710 and AO724.





1. During an interview on 3/26/13 with the Director of Regulatory Compliance, it was identified that the hospital conducts semi-annual environmental rounds of all departments in the hospital. Although documentation was provided that environmental rounds were scheduled for the pharmacy on 2/29/12, 8/29/12, and 3/6/13, review and interview with the Director of Regulatory Compliance identifed that rounds were conducted only on 2/29/13. Further documentation was provided to indicate that environmental rounds were conducted on 2/29/13 and the pharmacy was in compliance with the hospitals environmental rounds inspection, however after a review of the document it was identified that the environmental rounds in the pharmacy showed a list of areas that were not applicable or were in compliance. An interview with the hospital Director of Engineering identified that the areas should have been applicable and that areas that were found to be in compliance were not in compliance. Observations on 3/26/13 identified that although the compliance document identified sanitary conditions and fire safety compliance, the environment was noted to be extremely cluttered, signs of dirt and debris, an employee lunch bag with evidence of mold, and egress paths signifcantly obstructed and only passable stepping over and/or around obstructions.

2. During a tour of the hospital pharmacy conducted on 3/22/13 and 3/26/13, it was observed that all electrical equipment within the area of the pharmacy was not being maintained as required by NFPA 99. Documentation was not provided and there were no visible inspection tags on any equipment i.e refrigerators including refrigerators utilized for medication storage, microwaves, coffee pots, and receptacle plug strips. An interview with the Director of Pharmacy indicated that it was the responsibility of the bio-medical engineering department to conduct these inspections as required. Interview with the Bio-Medical Engineer sub-contracted by the hospital indicated that it was not part of the contract to inspect and support the pharmacy equipment. Further interviews with the Director of Hospital Engineering indicated that the hospital did not have a policy or procedure for the required inspections of equipment in the pharmacy and that it was unknown as to why.

Based on observations, interviews, policy and documentation review, the hospital failed to maintain a safe environment in the pharmacy.

1. During a tour of the hospital pharmacy conducted on 3/22/13 and 3/26/13, it was observed that the exit egress paths of travel were blocked by shelving, boxes stored on the floor and office equipment blocking doorways. Observations and interview with the Director of Pharmacy identified that the pharmacy has outgrown the space that is provided and storage space is very limited.

2. During a tour of the hospital pharmacy conducted on 3/22/13 and 3/26/13, it was observed that a fire protection pendant sprinkler head located in the pre-ante room was obstructed by storage of boxes on shelves that impacted the eighteen (18 " ) inch requirement of open space around a sprinkler head.

3. During a tour of the hospital pharmacy conducted on 3/22/13 and 3/26/13, it was observed that fire protection pendant sprinkler heads located throughout the pharmacy had a buildup of dust and debris on them.

4. During an interview on 3/26/13 with the Director of Regulatory Compliance, it was identified that the hospital conducts semi-annual environmental rounds of all departments in the hospital. Documentation was provided that environmental rounds were scheduled for the pharmacy on 2/29/12, 8/29/12, 3/6/13 and 8/14/13. Further documentation was provided to indicate that environmental rounds were conducted on 2/29/13 and the pharmacy was in compliance with the hospitals environmental rounds inspection. After a review of the document it was identified that the environmental rounds in the pharmacy showed a list of areas that were not applicable or were in compliance however an interview with the hospital Director of Engineering identified that the areas should have been applicable and that areas that were found to be in compliance were not in compliance. The hospital also failed to provide documentation that environmental rounds were conducted on 8/29/12.

Based on observations, interviews, policy and documentation review, the hospital failed to maintain all equipment located in the pharmacy.

1. During a tour of the hospital pharmacy conducted on 3/22/13 and 3/26/13, it was observed that all electrical equipment within the area of the pharmacy was not being maintained as required by NFPA 99. Documentation was not provided and there were no visible inspection tags on any equipment i.e refrigerators, microwaves, coffee pots, receptacle plug strips. An interview with the Director of Pharmacy indicated that it was the responsibility of the bio-medical engineering department to conduct these inspections as required. Interview with the Bio-Medical Engineer sub-contracted by the hospital indicated that it was not part of the contract to inspect and support the pharmacy equipment. Further interviews with the Director of Hospital Engineering indicated that the hospital did not have a policy or procedure for the required inspections of equipment in the pharmacy and that it was unknown as to why.

Based on observations, review of hospital documentation, review of hospital policies and interviews with hospital personnel, documentation and interviews failed to reflect that the hospital pharmacy maintained a clean and sanitary environment and/or that the facility implemented and/or maintained a comprehensive infection control system specific to the pharmacy to prevent the spread of infection in the pharmacy. The findings include:

1. Observation of the hospital pharmacy on 3/26/13 at 10 AM identified multiple food items (cashews, vinegar, olive oil, marshmallow spread and candy), an employee water bottle and an employee lunch bag (which contained a very old sandwich and opened yogurt) located in a cabinet over a medication storage area. Review of the pest control vendor documentation dated 3/12/13 and interview with the Director of Pharmacy on 3/27/13 at 2:00 PM identified that the same area had been treated for ants.
2. Observation of the IV Admixture room identified a heavily soiled, grey appearing floor, many supplies in the anteroom, as well as clutter and debris behind the refrigerator in the IV room. Review of the Structure Standards for Departmental Infection Control Activities identified that the Pharmacy Department would be maintained in a sanitary and clean condition by the Environmental Services Department. Review of the IV Admixture Program policy directed in part, that the anteroom storage shelving be cleaned monthly and the buffer zone would be emptied of all supplies and cleaned weekly. Although review of the Daily Cleaning of Pharmacy IV Room, Buffer Space and Anteroom policy and subsequent interviews with the Facilities Director and the Director of Pharmacy on 3/26/13 at 10:00 AM identified that the IV Admixture room was cleaned daily, the facility was unable to provide documentation of daily cleaning. Subsequent to surveyor inquiry, the facility submitted an Action Plan dated 3/26/13 which included that all floors in the pharmacy were scrubbed and washed.
3. Review of hospital documentation and interview with the Infection Prevention Manager and the Employee Health Nurse, RN #1 on 3/26/13 at 11:30 AM indicated that although Infection Prevention Rounds were conducted in clinical patient areas, the rounds did not include the pharmacy. Although two other types of rounds were performed in the pharmacy, bi-annual safety rounds and monthly department specific rounds, review of the General Workplace Inspection Reports dated 2/29/12, 8/29/12 and 3/12/13 and the monthly Pharmacy Department Environmental Round Reports dated 1/25/13, 2/20/13 and 3/7/13 failed to identify any pharmacy infection control issues. The tools utilized for the bi-annual safety rounds and monthly department rounds failed to address pharmacy-specific infection control indicators and/or IV Admixture room infection control indicators. During the 3/26/13 interview with the Infection Prevention Manager and RN #1, they identified that no pharmacy concerns had been brought to their attention.
4. Review of the Laminar Air Flow Hood policy identified that all daily, weekly and monthly cleaning activities would be recorded and reviewed on a regular basis to help maintain the integrity of compounding activities. Review of the Laminar Air Flow Hood policy directed in part, that hood surface testing be conducted monthly. Review of hospital documentation and interview with the Director of Pharmacy on 3/27/13 at 2:00 PM identified that hood surface testing had not been conducted monthly as per policy and could not identify the last time the surface testing was performed.

Documentation and interviews failed to identify that a pharmacy specific infection control program was implemented and/or maintained in order to prevent the spread of infection. Review of laboratory culture reports of the anteroom sink cabinet in the IV Admixture room dated 3/22/13 identified aspergillus inside the sink cabinet, on the outlet top and the base.