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Based on observation, interview, and document review, the hospital failed to ensure the drug compounding and storage areas were maintained in accordance with acceptable standards of practice in two (2) of three (3) pharmacies inspected (Bramhall and Scarborough).

Findings include:

Hospitals are required to adhere to the current United States Pharmacopoeia (USP) <797> standards. A review of the facility's policy, titled "Preparation of Medications", revised February 29, 2016, stated "The preparation of compound and sterile preparations (CSP) will be in compliance with the standards set forth in USP/NF General Tests and Assays chapter 797, Pharmaceutical Compounding - Sterile Preparations". This policy requires that all sterile medications are prepared in a sterile environment that is clean and free from possible contaminates.

1. On July 7, 2017 at approximately 10:00 AM, the following was observed in the non-sterile preparation area in the Bramhall pharmacy:

- A supply cart was observed with torn old red adhesive tape which made the surface of the cart not easily cleansed and sanitized.

- The walls had chipped paint.

- There was visible floor debris behind a door.

- A cabinet used for drug antidotes had several rusted areas which made the cabinet not easily sanitized.

- Two (2) of four (4) biohazard red boxes were filled and stored approximately two (2) feet from intravenous bags, clean syringes, clean gloves, and other clean patient supplies.

- The pharmacy area had stained ceiling tiles throughout the Department.

- At the base of a wall there was a detached cove base with a large area of chipped paint. In addition, the ceiling above this area, had hanging, string like, dust/debris hanging from the ceiling tiles.

- The floor and walls, adjacent to four (4) trash bins, were stained and contained trash debris.

- The "Pass-through Cabinet" (cabinets used to maintain a separation between the sub-sterile and sterile areas) had detached, and worn gaskets, preventing an air tight seal, in two (2) of five (5) cabinets.

The above findings were confirmed, with the senior staff Pharmacist and staff from Accreditation and Risk Management, on July 7, 2017 from 9:30 AM to approximately 10:30 AM.

2. On July 7, 2017 at approximately 12:30 PM, the following was observed in the sterile preparation area in the Bramhall pharmacy:

- All four (4) positive pressure sterile compounding hoods (a partially enclosed work area with filtered air flow to prevent contamination of the medication being prepared) contained visible pieces of adhesive tape and adhesive tape residue on the outside surface of the hood. The tape and tape residue made the surface not easily cleansed and sanitized.

- One (1) of four (4) positive pressure sterile compounding hoods (Hood # A2) contained visibly darkened areas at the base of the high level filter. In addition, the floor, under this hood, was visibly stained below the right front leg. These stained areas indicated surfaces that had not been cleansed or sanitized.

- One (1) of one (1) negative pressure sterile compounding hood (Hood # A11) contained an electrical outlet cover with a non-intact surface which made the area not easily cleansed and sanitized.

The above findings were confirmed, with the Pharmacist overseeing the sterile preparation area in the Bramhall pharmacy, on July 7, 2017 at approximately 2:00 PM.

3. On July 7, 2017 at approximately 1:00 PM, in the sterile preparation area in the Scarborough pharmacy, two (2) negative pressure sterile compounding hoods were observed. Each hood contained two (2) screw hole covers with visible rust indicating non-intact surfaces which made the area not easily cleansed and sanitized.

The above finding was confirmed, with the Pharmacist in Charge, on July 10, 2017 at approximately 1:30 PM.