Joint Commission looking for evaluation and action plan for USP 797

Some hospitals spending millions for facilities compliance

The Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, is concerned that some hospitals are spending too much to comply with the facilities requirements of the United States Pharmacopeia (USP) Chapter <797>, Pharmaceutical Compounding: Sterile Preparations. USP 797 is the standard of practice for compounded sterile preparations.

"We are getting lots of complaints from hospitals about the money that is being spent on facilities," reports Darryl S. Rich, PharmD, MBA, FASHP, field representative (surveyor) for the Joint Commission. "We are hearing sums of money in the millions of dollars." Rich spoke at the American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting, held last December in Las Vegas.

"I want you to understand that both the Joint Commission, as well as ASHP — in our panel that we got together — felt that the facility issue is the least important of all the aspects of USP 797," he says. "Whether you choose to be in compliance with the facility requirements is totally up to you. Joint Commission is not requiring you to meet all the requirements of USP 797."

An article soon will be published that addresses this issue, Rich says. "[It] says if you are spending more than $50,000 to fix up your IV room, you need to reevaluate and look very carefully to see if you are using that money appropriately and are not being sold a bill of goods."

The Joint Commission addresses USP 797 under standard MM.8.10: The hospital evaluates its medication management system. For the Joint Commission’s purposes, organizations should consider USP best practice as part of that standard, Rich says. Hospitals should do an evaluation of how well they are in compliance with that chapter. Then they should have an action plan for coming into compliance with those elements of the chapter that they feel are appropriate to their organization. "Surveyors are looking for that evaluation and that action plan," he reports.

This standard is a "B" element of performance, so it also requires some evaluation of the method used to develop the evaluation, to make sure it is complete, thorough, addresses information in the literature, includes the hospital’s own data that it may have collected on the subject, as well as shows involvement of medical staff and experts in this area from the organization.

"We are not only looking to see that you have an analysis and action plan but also that it was done appropriately according to the requirements of the standard," Rich says.

Joint Commission surveyors are not evaluating USP 797 directly, he explains. The surveyors, however, will score issues specific to Joint Commission standards. For example, Rich has seen hospitals in which IVs were prepared in the middle of the pharmacy area, not partitioned off in a functionally separate area.

He scored the hospitals for this. "It’s not a 797 issue," he says. "The standard has been there two years."