JCAHO: USP/NF Chapter 797 compliance confusing

Hospitals should have action plan in place now

In the April 2004 issue of its Perspectives publication, the Joint Commission on Accreditation of Healthcare Organizations announced it would begin in July to survey compliance with the new chapter in the 2004 United States Pharmacopeia-National Formulary (USP-NF), titled "USP Tests and Assays Chapter 797, Pharmaceutical Compounding, Sterile Preparations."

The chapter details 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, the Joint Commission says. In its announcement, the Joint Commission said its surveyors would address these requirements during surveys of organizations that compound sterile products (for example, intravenous solutions, eye drops) in the following ways:

  • Surveyors would help organizations become aware of these new requirements (if they were unaware).
  • Noncompliance with the major requirements in this USP-NF chapter that relate to Joint Commission standards would be scored at the appropriate element of performance effective immediately using the appropriate track record for compliance with the new requirements.

The announcement apparently confused many health care facilities. They wondered about the applicability of the requirements in Chapter 797, how the Joint Commission would be surveying them, and the expected time frame for compliance. The confusion was discussed in the October issue of Joint Commission Perspectives. On June 3, an advisory panel of 13 pharmacists and other health care professionals met to provide advice on realistic time frames for compliance with the requirements, as well as to "establish compliance priorities based on patient risk and safety," the Joint Commission says. The panel made recommendations on how organizations can achieve compliance with the chapter’s requirements.

Joint Commission expects a plan

Here is what the Joint Commission says it will include in the survey:

  • Provisions of Chapter 797 that are equivalent to the current elements of performance of the 2004 Joint Commission standards.
  • By now, organizations should have conducted a risk assessment, or gap analysis, of their compliance to all provisions of Chapter 797 and have developed a plan for each section of the chapter with specific time frames. The plan should include "any potential renovations or new facility construction and new equipment with budget provisions and completion/acquisition dates," the Joint Commission says. The organization also should select time frames based on its analysis of workload and sterile compounding risk levels and available resources.

The Joint Commission realizes this task may be overwhelming. To help, the advisory panel suggests that organizations focus their efforts on these priorities:

  • Personnel training and evaluation
  • Beyond-use dating and labeling
  • Verification of automated compounding devices
  • Finished preparation release checks and tests
  • Aseptic technique

Hospitals looking for guidance in complying with the requirements can consider several tools offered by the American Society of Health-System Pharmacists (ASHP) in Bethesda, MD. One is the "ASHP Self-Assessment Tool for Compounding Sterile Preparations." This tool includes a 75-question survey that addresses all aspects of the USP chapter, ASHP says. Answers to the survey questions will help users determine their institution’s compounding risk level and current level of compliance with the standards. After completing the survey, users will receive a percentage score and a list of resources to assist with meeting the requirements.

Another tool, ASHP’s "797 Compliance Advisor," allows users to assess risk levels, perform gap analyses, and create action plans for compliance with the new sterile preparation requirements. The advisor features a survey that evaluates a facility’s risk level and assesses its compliance with each of the 12 quality domains addressed in Chapter 797. After completion of the survey, the user will receive a series of reports detailing areas that conform to the USP standards, as well as an action plan to bring areas that need attention into compliance. The tool also allows users to update their progress and compare their performance against other participating facilities. This service costs $799.