JCAHO clarifies expectations and timelines in compliance with USP <797>

At the summer meeting of the American Society of Health-System Pharmacists (ASHP) held in June 2004, Darryl S. Rich, Pharm.D., M.B.A., FASHP presented on the legal and JCAHO implications of USP/NF chapter 797. To view the PowerPoint presentation (with audio) go to www.ashp.org/SterileCpd/education.cfm?cfid=2216070&CFToken=18520230 The presentation is located under the heading ASHP Summer meeting 2004.

In the presentation, Dr. Rich identifies that JCAHO's approach to compliance with the facilities and equipment requirements of USP <797> are similar to their approach to Life Safety Code compliance issues:

Assess gaps in compliance
Establish action plan with leadership commitments for funding and completion date
Implement interim steps to mitigate the impact of noncompliance until the work is completed.

JCAHO expects that by:

1/1/05 - organizations have performed a risk assessment/gap analysis to identify facility and equipment areas of non-compliance, established a written action plan with specific timeframes and funding approval for achieving compliance.
7/1/05 - organizations have implemented any interim steps to mitigate the impact of non-compliance and assure sterility in compounding.
1/1/08 - organizations have completed their action plans and are in full compliance.

Dr. Rich explained specific circumstances, such as construction and occupancy of a new facility may extend the definition of "realistic timeframe" beyond the 1/1/08 deadline. The specific circumstances should be documented and approved by the organization's leadership. The timelines listed above are specific to compliance with facilities requirements. JCAHO anticipates a providing a table of USP requirements and implementation dates in a future issue of Perspectives.

JCAHO to Enforce New USP 797

The April 2004 JOINT COMMISSION PERSPECTIVES identifies that starting July 1, 2004, JCAHO surveyors will begin surveying compliance with a new chapter in the 2004 United States Pharmacopoeia—National Formulary (USP-NF) entitled “USP Tests and Assays Chapter 797, Pharmaceutical Compounding, Sterile Preparations.” This new chapter deals with new requirements for the compounding, preparation, and labeling of sterile drug preparations and applies to health care institutions, pharmacies, physician practices, and other facilities that prepare or compound sterile preparations (for example, intravenous solutions, eye drops).

JCAHO reports that although surveyed in the pharmacy, these new requirements will be judged in the following EC standards

Environment design of drug preparation rooms (EC.8.10)
Air quality testing and environmental monitoring of compounding environment (EC.7.10 testing), (EC.9.10 monitoring)
Temperature testing of drug storage areas (EC.6.10)
Automated compounding device—verification of accuracy, calibration and maintenance (EC.6.10)

In Perspectives, JCAHO recommends “To comply with these requirements, organizations should immediately evaluate their current practices in the light of the new USP-NF chapter and make appropriate changes.”

ASHE Guidance

Contact your pharmacy(s) to determine if they are preparing or compounding sterile preparations
If so, determine the USP Risk Level
Review the following built environmental requirements

Built Environment Requirements[1]
USP Risk Level: Low & Medium Risk

Must provide an ante area but need not be separated from the controlled area with a physical wall
Air quality of ISO class 8*
A certified constant running ISO class 5 laminar air flow work bench for IV prep with visible pressure gauge*
Cytotoxic and other hazardous products should be prepared in a vented class II biological safety cabinet or barrier isolator
Trash can should be below the level of the laminar air flow work bench and should be removed from the controlled area before being emptied
Positive pressure to adjacent areas
Walls floors fixtures and ceilings should be smooth and free of cracks, crevices and be of non-shedding materials
Surfaces should be resistant to damage from sanitizing agents
Shelving should be of a low particulate material
Storage in the controlled area should be limited to items in constant use
Junctures of ceilings and walls should be coved and caulked
If ceilings consist of inlaid panels, the panels should be impregnated with a polymer to render them impervious ands hydrophobic and the should be caulked around each perimeter to seal them to the support frame
Walls may be panels locked together and sealed or epoxy coated gypsum board
Floors should be overlaid with sheet vinyl flooring with heat-sealed seams and coving at the sidewall
The buffer or ante areas should contain no sinks or floor drains

USP Risk Level: High Risk

Same as low risk and: The ante area must be a separate room

American Society of Health-System Pharmacists guidance on assessment and compliance with USP 797

[1]	Reference -- Drug Distribution and Control: Preparations and Handling-Guidelines