Accreditation

JCAHO backs off enforcement of USP 797 requirements

Briefings on The Joint Commission, July 1, 2006

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A JCAHO clarification says surveys will not cover the requirements

After reading this article, you will be able to

1. define what U.S. Pharmacopeia (USP) 797 is

2. -describe the JCAHO's clarification for USP 797 compliance requirements

3. -explain why hospitals should not ignore the requirements in USP 797

The USP seeks field comments about proposed changes to its Chapter 797, while the JCAHO is backing off enforcement during its surveys.

Short history

USP 797 outlines procedures and requirements for compounding sterile preparations. Shortly after it was published in January 2004, the JCAHO published a crosswalk in its Perspectives newsletter linking the USP 797 requirements to its standards (e.g., medication management, etc.).

Later in 2004, the JCAHO issued a timeline detailing when hospitals should have implemented the various USP 797 standards.

These moves by the JCAHO led hospitals to grow concerned about how strictly surveyors would check for compliance with USP 797. For example, the JCAHO's recommended deadlines called for hospitals to determine how well they conformed to USP 797 and what renovations would be needed by January 1, 2005. As of July 1, 2005, hospitals were to have instituted any interim measures to offset deficiencies in USP 797.

But now USP is proposing revised standards, and the JCAHO is leaving compliance up to hospitals.

There are a handful of state boards of pharmacy that have already adopted USP 797 as a state regulation. Therefore, hospitals in those states are expected to be compliant with the requirements of the current version of USP 797. They may be subject to identification of deficiencies by their state board of pharmacy inspectors, state health departments, or the JCAHO if they are not compliant with state regulations.

JCAHO clarification

In the April Perspectives, the JCAHO clarified its stance on USP 797: "An accredited organization determines how it best can comply with the requirements specified in USP 797, and what time frames for compliance are reasonable."

"The Joint Commission will not survey for compliance with the details of USP 797," the clarification continued. "How 'exacting' the organization complies with the USP 797 guidelines and the suggested time frames for compliance are based on organizational decisions."

This is an excerpt from a member only article. To read the article in its entirety, please login or subscribe to Briefings on The Joint Commission.

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