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5/10/2004

JCAHO Gears Up to Survey Sterile Compounding Practices

Cheryl A. Thompson

When a surveyor from the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) visits a hospital pharmacy after June 30, one of the first things he or she evaluates may be the apparel of persons in the i.v. admixture room.

Is everyone wearing a hair cover? shoe covers? a knee-length coat? powder-free gloves?

If not, the department does not comply with the JCAHO infection-control standard that requires hospitals to take action to prevent or reduce the risk of nosocomial infections.

Application of that standard to the garb of personnel who compound sterile formulations stems from JCAHO's decision to survey accredited organizations for compliance with United States Pharmacopeia (USP) general chapter 797, or "Pharmaceutical Compounding—Sterile Preparations," which became official on January 1.

July 1 draws near. Through its monthly publication Joint Commission Perspectives, JCAHO in April informed accredited organizations that surveyors, as of July 1, would look for compliance with the USP chapter in pharmacies and in patient care areas where nurses and physicians compound or prepare sterile medications.

ASHP, JCAHO to Convene Expert Group

The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recently accepted ASHP's invitation to convene a small group of experts in sterile compounding to provide advice on surveying the more challenging aspects of United States Pharmacopeia (USP) chapter 797.

ASHP Executive Vice President Henri R. Manasse Jr., in a March 26 letter to JCAHO President Dennis S. O'Leary, commended the accrediting group for deciding to survey all organizations for compliance with the chapter on sterile compounding.

"The USP standards are sound, and reflect what should be occurring in every organization that compounds sterile products," Manasse wrote. "However, many organizations do not currently have the required facilities to immediately meet the standards, which is a message we are hearing with increasing frequency from our members. ASHP would like to work with JCAHO to identify the most challenging aspects of Chapter 797 in an effort to develop reasonable and workable time frames for organizations to implement those standards, especially ones where major resource allocations will be required for new equipment and construction of facilities."

The expert panel will meet June 3 at JCAHO headquarters in a suburb of Chicago, Illinois.

The April issue also contained a full-page "crosswalk" of USP chapter 797 requirements to the relevant 2004 JCAHO standards for hospitals. Because JCAHO uses the same taxonomy for all its standards, organizations other than hospitals can use the crosswalk to see how the USP chapter applies to them. Pharmacies in hospitals and health systems had initially been told in September 2003 that JCAHO surveyors may look for organizations' compliance with USP chapter 797 in states that included or cited it in laws or regulations (see September 15, 2003, AJHP, News).

Tracers are the key. Darryl S. Rich, an associate director of surveyor management and development at JCAHO, said evaluations of sterile-drug preparation areas "will be related directly to observations of people working in the i.v. room as well as discussions of competency assessment, training, and orientation and how particular i.v.'s are made for particular people."

The key, he said, is the "tracer" methodology JCAHO incorporated into its new survey process, known as Shared Visions–New Pathways, which got under way in January.

On each day of the onsite portion of the accreditation process, every surveyor evaluates the entire course of care provided to two or three tracer patients, Rich said. More than likely, the tracer patients in a hospital would have received at least one sterile medication compounded at the facility, and pharmacy personnel would be asked about the preparation of that therapy.

For a tracer patient who received an i.v. admixture, Rich said, the surveyor will make an unannounced visit to the area where the sterile medication was prepared—including a satellite pharmacy or the intensive care unit—and question someone who might have made the admixture. "We would ask them questions about how they went about preparing it. We may observe them actually preparing if they're in the process of [making] other i.v.'s of a similar nature." The surveyor will also assess the person's training in aseptic technique and knowledge of the proper way to prepare the work area, assign a beyond-use date, and identify products at low, medium, and high risk for contamination.

Information on the sterilization of preparations compounded from nonsterile ingredients will be sought "only as it relates to that specific tracer patient's medication," he said.

Surveyors will ask questions of whoever is in the sterile-drug preparation area, pharmacist and pharmacy technician alike, he said. "We want to get down to the lowest common denominator [in patient care], the individual who actually provided the service, or the compounding in this case."

Rich said to expect the surveyors to look only for information specifically related to the care of the tracer patients. "If we see something odd with a particular document, we could request more documents of that type from other patients that are not tracers. . . . But generally speaking, that's only if we find something [amiss] and we need to validate" whether the surveyor uncovered noncompliance or found an anomaly.

He said sterile compounding practices may also be evaluated during the "medication management tracer" that occurs during surveys lasting at least four days. At that session, the surveyors and persons involved in the health care organization's medication management discuss the system. Questions may be asked about USP chapter 797, he said.

According to the Joint Commission Perspectives article, surveyors will give organizations credit for having a plan for compliance in place.

"We realize that there are things in [USP chapter 797] that they are not going to be able to do quickly," Rich said, noting in particular the requirement for everyone who prepares sterile formulations to be trained in the appropriate procedures and have their competency in aseptic processing validated by media-fill testing. "But we would accept essentially a definitive action plan that gives dates by which various personnel will have fulfilled responsibilities detailed in USP chapter 797."

As for JCAHO itself being prepared to evaluate sterile compounding practices, Rich said, surveyors received an overview of USP chapter 797 and its requirements, including the need for personnel to wear a gown and gloves and the facility to conduct environmental testing and quality control.

But surveyors were not told the details of pyrogen testing, for example, and those assigned to hospital surveys would more than likely not associate a bin of 0.2-micrometer filters with sterilization of a nonsterile solution.

Said Rich of hospital survey teams: "While our surveyors are indeed being trained to some degree on this chapter, they are not pharmacists. So they are not going to know a lot of the specifics or have a lot of expertise in the details. So a lot of their questions will be 'Are you aware of this? What are you doing to come into compliance with this?' And anything that sounds fairly reasonable is probably going to be accepted."

Plans to consider the addition of pharmacists to hospital survey teams have been tabled for at least one year, he said. "Shared Visions basically took all the resources out of doing that option for probably a year or two."