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Based on observation, interviews, and policy review, the hospital, who compounds sterile pharmaceuticals, failed to ensure proper infection control practices were maintained. The findings include:

During tour of the hospital pharmacy compounding rooms on 11/24/14 during the period of 10:25 AM and 3:00 PM with the Acting Pharmacy Director and Representative from the Quality Department identified the following concerns:

a. Technician #11 compounding in the biological safety cabinet (BSC) was observed wearing a necklace, although policy directs that no jewelry can be worn upon entry into the ante room.

b. Technician #11 was observed placing the overwrap from the sterile gloves on the air vent throughout the compounding process obstructing the air vents.

c. Technician #11 working in the BSC, was observed to finish compounding a chemotherapy agent, reach into the Laminar Flow work bench (LAFW) to obtain vial seals without changing any Personal Protective equipment (PPE) including the gloves. This was observed on multiple occasions.

d. Technician #10 failed to clean the (BSC) before starting a batch preparation.

e. During compounding, Technician #10 was seen stacking all the overwraps from gloves, needles, syringes and other supplies against the back wall of the BSC obstructing the air vents.

f. Observed alcohol swabs and needle left in an unused LAFW from previous compounding activities. No explanation could be provided for this practice.

g. In the Ante area, dust and construction debris was observed on the coving ledge under the new sink that was installed around 9/26/14 (2 months prior to this inspection). Facility policy directs that any horizontal surface must be cleaned daily.

h. Observed yellow material on the left side of the LAFW including in the channel where the side partition sits. Using a sterile alcohol pad, parts of the yellow material could be easily removed. Interview with Pharmacy staff stated this substance was not from mixing on that day. Facility policy directs that this area should be cleaned daily.

i. Near the door of the Ante area from the main pharmacy, uneven caulking was visualized around the interface between the new door frame and the old door frame. Streaks of caulking was observed on the grid over the HEPA filter in the buffer area. Large beaded caulking was observed behind the BSC at the juncture of ceiling and wall and excess caulking was noted on the areas of the grid holding the ceiling tiles in place and around the duct work used for venting the BSC. This created non-smooth surfaces rendering proper cleaning difficult and creating a potential for dirt to gather.

j. Observed abrasions on two ceiling tiles in the buffer area which removed the top layer and exposed the material underneath rendering an inability to properly cleanse the surface.


During interview on 11/25/14 at 2:50 PM, the ICN (infection control nurse) stated that while surveillance rounds continued within all parts of the inpatient and outpatient areas of the hospital, the pharmacy had not been surveyed until 11/25/14, for a preplanned visit. Review of the plan of correction relative to the initial survey completed on 8/5/14 identified that the ICN would include the pharmacy compounding rooms into routine surveillance with reports back to the Infection Control Committee and Quality Improvement beginning 8/30/14.

Interview with the interim Pharmacy Director on 11/24/14 at 3:30 PM stated s/he is new in this position and is working closely with Administration and a Pharmacy Consultant to remediate concerns identified in the Pharmacy Department.


Review of the job description for the Manager of Pharmacy reflected responsibility for the management and coordination of resources on a daily basis including anticipation and identification of potential problems in either direct pharmaceutical care and/or assigned area of operations with facilitation of an effective resolution of problems.