Staff buy-in key to USP 797 implementation

While some aspects of implementing USP 797 ended up being surprisingly easy at Bay-town, TX-based San Jacinto Methodist Hospital, and others were quite challenging, the major lesson learned from the experience was the importance of getting the staff involved and having them take ownership of the changes, according to Charles Hines, PharmD, RPh, the hospital's pharmacy clinical coordinator.

After reading the new standards, Hines says, hospital officials knew they would need a collaborative effort on the part of pharmacy management, pharmacist, and technician staffs, and cooperation and coordination with various hospital departments.

Before implementing USP 797, he tells Drug Formulary Review, the situation at San Jacinto Methodist basically was the same as in all hospital pharmacies. "What we needed to change was our procedures as to exactly how we would prepare IVs based on this new regulation," he says. "We also needed to change how trash was removed from the room, how and when the room was cleaned, what needed to be monitored and how we were going to monitor it, education of our staff regarding the new procedures, updating our policies and procedures to reflect the new procedures being performed, and to reinforce with all the staff who was responsible for each piece and the part that each of us must play in ensuring compliance."

The hospital formed a committee composed of members of pharmacy management, pharmacists, and pharmacy technicians. That committee was divided into subcommittees assigned to particular areas of focus. The subcommittees were given a specific time in which to complete their work and bring the results to the full committee for review and discussion. Each subcommittee's report was reviewed and discussed by the full committee and the appropriate actions were planned to ensure completion of each part of the process.

Planning followed by obtaining needed items

Completion of the project's planning phase led next to the acquisition phase, in which the hospital obtained new shelving units, carts, bins, and all other materials necessary to comply with the new guidelines. This step also included performing particle counts throughout the entire cleanroom.

The next step in the process was implementing new gowning, gloving, and cleaning procedures outlined in USP 797 and ensuring staff compliance with these elements.

"All of this work has paid off in seeing a decrease in our particle counts throughout the entire clean room as well as allowing our department to work together to accomplish this task," Hines reports. "Also, our hospital underwent a survey by JCAHO in April 2005, and they were pleased with our plan and all the work that had been put into this project. The continuation of this process as we review and implement the quality control portion of our program will assist the staff with understanding why the changes were necessary and the impacts made on patient care as a result of these changes, and allow them to take pride in the hard work they have put into this project."

San Jacinto Methodist is a 315-bed private, nonprofit, suburban community hospital that is part of a four-hospital system located in the United States' fourth-largest metropolitan area. The process Hines and his colleagues followed was to review resources and current practices, prepare a gap analysis and budget, develop a compliance/implementation timetable, make committee assignments, make decisions on level of care and service, implement a quality management program, prepare and execute needed education, and implement a continuous quality improvement element.

The gap analysis showed that the main campus pharmacy had an area for sterile admixture with a 90% limit to external access. It was compliant for ceiling, wall, and floor conditions. There were separate physical areas for HLAFH, VLAFH, processing, and storage. Exposure of materials and equipment in the buffer area to less controlled environments required improvement.

A long-term care pharmacy needed a major physical facility upgrade to become compliant with USP 797.

Monitoring was compliant with LAFH ISO Class 5. Environment testing for particulate/airborne microorganisms had not been previously done and was started in September 2004. There was no written plan in place and environmental air quality needed improvement.

The gap analysis showed that in terms of cleaning, elimination of paper particulate was needed, and materials, methods, and frequency for cleaning by pharmacy and housekeeping required significant changes.

While personnel were compliant with hand washing and hair and foot cover requirements, changes were needed for gowning and re-entry issues.

When they evaluated processing and responsibilities in the gap analysis, they found employees had an annual skills evaluation, but that needed to be upgraded to meet the new requirements. Policies and procedures needed to be updated to meet USP 797 and JCAHO standards.

Finally, employee education was needed as was continuous monitoring and quality improvement of the environment, equipment, and personnel.

Subcommittees were formed to work on processing, personnel/equipment, monitoring, environment, cleaning, and quality measurement/ management. The subcommittees were charged with developing solutions to gap issues in their areas of focus. They met with vested individuals, groups, and manufacturers, and found suppliers to review contracts and sales terms. The subcommittees estimated costs and drafted proposed standard operating procedures. They also provided education and testing materials for didactic and physical testing.

Decisions made by the committee on subcommittee recommendations included: 1) management would communicate to medical staff; 2) Level 3 items must be purchased by the physician or patient externally; 3) patients must be transferred to an in-network facility with Level 3 capability; 4) education must be provided to the housekeeping and pharmacy staffs; 5) there should be a routine scheduled cleaning of all surfaces; 6) nonshedding, nonaerosolizing germicidal materials should be used; 7) furniture and equipment should be restricted to the ISO 8 area; 8) all stock entering the ISO 8 area should be wiped down; 9) corrugated cardboard should be eliminated from the ISO 8 area and the surrounding environment; 10) personnel-borne particulate should be reduced through use of tacky mats, operating room-style nonshed gowns, bouffant hats, changing the cover on reentry, and no talking in hoods; 11) all employees required six hours of didactic education from an ACPE provider; 12) all employees were required to pass written and practical tests; 13) environmental air should be tested monthly; 14) personnel microbial testing should be performed annually; 15) routine reports should go to quality management, management, and pharmacy staff; and 16) out-of- compliance items required immediate changes and retesting.

In summary, Hines says, the gap analysis greatly helped identify areas needing improvement to meet USP 797 standards, the division of labor in problem-solving facilitated a timely resolution that had buy-in from all department members; application of the guidelines and avid follow-up of noncompliance areas resulted in meeting air quality and microbial standards; and the gap analysis aided resolution of difficult compounding issues with physicians.

Hines tells DFR that he was surprised to find that the item that was the easiest to change was informing the medical and nursing staffs that the pharmacy would no longer be able to provide compounded sterile products considered to be High Risk by the USP 797 guidelines. The hardest issue to address and change was the new rules for personnel gowning and gloving in the cleanroom. In the past, he says, gowning and gloving were only required when preparing chemotherapeutic agents, but now is required with preparation of all IV products.

Start with gap analysis

For facilities still working to implement USP 797, Hines stresses the value of the gap analysis — a good, hard look at exactly what you are doing as compared with what the guidelines require. "Be honest about what you need to implement these changes and help your administrators understand why it is necessary," he says.

The staff, as many as are willing, need to be included in the evaluation, planning, and implementation of these new processes. If they are unwilling to volunteer, it should be assigned to them. The staff working on the project needs to include management, supervisors, staff pharmacists, and technicians. Be sure to include any and all necessary departments in the initial process so they will be aware of the upcoming changes and your needs.

Lastly, be sure that your policies and procedures reflect actually what you are doing so when JCAHO comes to inspect your facility they will look, evaluate, and then make suggestions on what they would like to see changed rather than write you up for not doing what you say in your policies and procedures.

[Editor's note: Contact Hines at (281) 420-8680 or e-mail him at]