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Nine ways to meet USP 797, get ready for your next survey

Hospital Pharmacy Regulation Report, April 1, 2005

Like many healthcare professionals, you may be struggling to figure out how to comply with the U.S. Pharmacopeia (USP) Chapter 797 guidelines on compounding sterile preparations.

If so, stop. Relax and take a deep breath.

"Most people look at it as a costly and difficult process," said E. Clyde Buchanan, MS, FASHP, senior director of pharmaceutical services at Emory Healthcare in Atlanta. "It doesn't have to be."

Buchanan gave the following compliance tips to a crowded room at the Orange County Convention Center in Orlando, FL, during the American Society of Health-System Pharmacists' Midyear Clinical Meeting in December 2004:

1. Set a timeline.

The JCAHO currently surveys hospitals for compliance with Chapter 797. Hospitals should be able to show the JCAHO an action plan outlining how they will move toward compliance in the future.

Surveyors will help educate facilities on USP 797 compliance, the JCAHO has said.

Some states are also exploring adopting the chapter as law. Kentucky is currently the only state that has fully adopted Chapter 797, says Charisse Johnson, PharmD, MS, professional affairs manager for the National Association of Boards of Pharmacy.

2. What makes a clean room?

Hospitals compounding low- and medium-risk preparations need a buffer zone-the clean area where staff compound sterile drugs-as well as an ante area where staff store supplies, don sterile gowns, and clean their hands before compounding. The buffer zone and ante area only need a demarcation line or barrier separating the two, not a physical wall.

Compounding high-risk preparations-which includes using a nonsterile drug that pharmacy staff will eventually sterilize or medications made but not used for several days or more-require a physical wall and doors between a buffer room and an anteroom. No sinks or drains are allowed in the buffer area.

3. Clean air, clean room.

When designing a clean room, make sure the airflow moves from the hood and work bench across the room to the door, Buchanan said. This helps draw contaminants away from the work area.

Also make sure there are no floor drains in the clean room. Drains can be a source of bacterial contamination, Buchanan said.

And minimize the presence of dust in the clean room. This includes having solid surfaces for counters, shelves, carts, floors, walls, and the ceiling. Keep as few furniture and carts as possible in the room because those can gather dust as well, said Buchanan.

Tip: Use an air hand dryer or lint-free towels for handwashing.

4. Keep it comfortable.

Watch the humidity levels in your compounding area, Buchanan said. Humidity levels in a clean room should be between 30% and 60%, and the temperature should be within 5° higher or lower than 72° F.

"If the humidity is too low, static electricity becomes a problem," Buchanan said. "If humidity is too high, the environment is uncomfortable for the operator, which can lead to errors."

5. A cost-effective alternative.

Barrier isolators are an alternative to building a clean room, Buchanan said. Isolators allow staff to compound sterile preparations while placing hands inside two gloves attached to the unit.

Isolators could cost between $25,000 and $55,000, but they pay for themselves over time, Buchanan said. For example, the energy needed to run one clean room can cost $13,400 in one year, compared to three isolators at $525 total.

Isolators can also be placed outside a clean-room setting, but they should not be placed in a dirty area or a hallway, Buchanan said.

A three- to six-month wait exists for isolators from many manufacturers, Buchanan cautioned, so hospitals should not hesitate to place orders if they want to go this route.

6. Check throughout the hospital.

Look outside the pharmacy for any sterile preparations, said Patricia Kienle, MPA, FASHP, operations manager for Cardinal Health in Houston. That includes anesthesia, the obstetrics unit, and dialysis.

If staff mix IVs outside of the pharmacy, ensure that they have a clean, uncluttered area to conduct their work, Kienle said.

Tip: Do not mix IVs in a hallway.

Use a barrier isolator to compound sterile preparations outside of the pharmacy, such as in a satellite pharmacy in the operating room.

"You may have to use different solutions depending on how many areas you have," Buchanan said.

7. Cover yourself.

Staff must be properly clothed in order to compound sterile preparations. Make sure they cover all hair, including beards, Buchanan said. They should also wear shoe covers, a gown or closed coat, gloves, and a mask.

For high-risk compounding, staff should also don a hood before putting on a mask, a coverall instead of a gown, and boots or two shoe covers.

8. Test your staff.

Above all, document staff competence and assess competencies periodically, said John Uselton, BSPharm, vice president of operations improvement for Cardinal Health in Houston.

Provide annual media fill tests for personnel, said Buchanan. Also supervise personnel's behavior to make sure they clothe themselves properly and take necessary precautions while compounding sterile preparations.

Tip: Conduct occasional didactic review and written testing as well.

Make sure you have written policies dictating personnel responsibilities such as handwashing, access to clean areas, and proper clothing, Buchanan said.

Tip: Graphs, charts, and tables about following proper procedures can lend credibility to your statements with surveyors, Uselton said.

9. Assess your contractors.

If your hospital outsources its drug preparation, the JCAHO will want you to make sure the company provides for USP 797 compliance, Buchanan said. You should be able to provide surveyors with proof of this.

You may also need to establish a business associate agreement to comply with the Health Insurance Portability and Accountability Act of 1996.