An Innovative Approach to Cleaning the Cleanroom

The challenge
USP <797> has set enforceable standards for compounded sterile preparations. However, the mandate does not provide specific information on how to realistically attain compliance in a hospital setting.

As part of a comprehensive reengineering strategy, numerous quality initiatives have been implemented at Advocate Illinois Masonic Medical Center Pharmacy over the last three years. We initially envisioned improving the compounding of sterile pharmaceuticals in 2001, and the plan to do so was perceived as challenging. Nonetheless, striving for a best practice model, we began preparing for that quality “leapfrog.” In the spring of 2004, our cleanroom/anteroom facility was completed, and compliance with USP environmental standards (ISO 5) was achieved.

Prior to implementing the cleanroom/anteroom, we decided to explore employing pharmacy technicians to clean and sanitize this space. We had been relying upon a minimally staffed, non-specialized housekeeping team, but to meet the high standard of maintenance our cleanroom requires, we needed a new and innovative way to comply with USP <797>.

How do we keep a cleanroom clean?
First, we determined the specifics of the requirements, including what is cleaned, what is used to do the cleaning, how often cleaning should be performed, who would do the cleaning, and finally, where the cleaning would be documented. Then we wrote policies and procedures to delineate cleaning schedules, products, and assignments.

Products and Methods
The most commonly used preparation is 70% Isopropyl alcohol. We purchase empty spray bottles by the case and label each spray bottle with the contents, volume, and expiration date. Alcohol is used on work surfaces, as well as for surface cleaning throughout the IV area.

HoodGard, a broad-spectrum antimicrobial cleanser, is used for cleaning work surfaces at the beginning of each shift.

The floor in the IV room is dusted using Dust-n-Clean, a disposable, dry, static-clean dust cloth, which is attached to a sweeping tool, much like a Swiffer home dust mop. The floor is dusted from the cleanroom core out to the anteroom. The used dust cloth is then disposed of. Consistent with USP <797>, this process is completed when no compounding is taking place, at the end of the PM shift.

25H 3M Twist’n Fill Quat Disinfectant Cleaner is a fourthgeneration, one-step disinfectant and cleaner, used to fill the wetmop unit. The Twist’n Fill is mounted in a housekeeping storage cabinet near the pharmacy, and attached to the water supply by a hose. With the Twist’n Fill system, we are assured of a correct dilution, making it more economical and easier to use. The mop head is attached to the wet-mop unit, and the floor is cleaned daily, after dusting, at the end of the PM shift. As with our dusting process, we begin mopping at the cleanroom core, and move out to the anteroom. Our in-house laundry service cleans the mop heads and returns them to the pharmacy the next day. Early this year, we will transition to the 3M Flat Mop system.

No Losers, Only Winners
Initially, the techs, who were already challenged with a new environment and workflow, felt near unanimous displeasure at the thought of performing what they felt was housekeeping’s responsibility. But the technicians soon realized that if the IV area was to be cleaned and used as designed, the responsibility would be theirs. The pharmacy technicians now own the IV room and are charged with the maintenance of the area. To date, they have responded well. Because the IV techs’ sense of ownership is stronger than the housekeeping associates’ would be, and because we maintain a supply of cleaning tools and supplies, we have a greater degree of control over our workspace.

Quality Assurance/Monitoring
Logbooks are used to document all aspects of the cleaning process. At the beginning of each shift, during our change-of-shift meeting, we ask if all QA reports are signed and if the pharmacy is cleaned. Management acts as a resource to provide guidance and quality assurance, supporting the staff in their efforts to continually strive for best practices.

Challenges and Conclusions
Though few and manageable, we have faced the following challenges:

• Housekeeping restocking supplies poorly
• Housekeeping stocking incorrect products
• Staff members forgetting their new tasks
• Some initial resistance to doing housekeeping work

We, in the pharmacy, had to recognize and accept that our housekeeping staff was unable to meet our expectations, which were based on USP <797>. In order for the IV room to be cleaned and kept clean, pharmacy management needed to provide technicians with education, cleaning supplies, and log books, and then instill in them a sense of pride and ownership in the area. This combination proved to be successful.

Authors:
Thomas R. Wheeler RPh, Pharmacy Quality Coordinator
Janet P. Jaramilla, PharmD, BCPS, Director of Pharmacy
Advocate Illinois Masonic Medical Center Chicago, Illinois