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3/10/2004

JCAHO to Survey for Compounding Compliance

Cheryl A. Thompson

Health care organizations that compound sterile formulations can expect, starting July 1, to be surveyed for compliance with the new United States Pharmacopeia (USP) chapter on pharmaceutical compounding, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) announced in the April Joint Commission Perspectives, one of the group's monthly newsletters.

JCAHO surveyors will expect health care institutions, pharmacies, physician practices, and other facilities in which sterile compounding is performed to comply with the major requirements of General Tests and Assays Chapter 797 regardless of whether an organization's state, by virtue of law or regulation, requires such compliance.

The final version of the USP chapter, also known as "Pharmaceutical Compounding—Sterile Preparations," was released in November 2003 and became official on Jan. 1.

Darryl S. Rich, Pharm.D., JCAHO associate director of surveyor management and development, in the April article said the USP chapter's requirements "match extremely well with our 2004 standards, but are more detailed."

According to the article, JCAHO surveyors during site visits will help organizations become aware of the new requirements and will score related Joint Commission standards at the "appropriate element of performance." Organizations will receive credit for implementing plans of action to comply with the chapter's requirements. As Rich had said in August 2003, surveyors will not focus during their visit on an organization's compliance with USP chapter 797.

The article includes a full-page "crosswalk" of USP chapter 797 requirements to the relevant 2004 JCAHO standards for hospitals.

According to the crosswalk, JCAHO expects compliance with the following 19 requirements: formal written quality assurance program for sterile compounding; adequate training and instruction of personnel who perform compounding activities; competence assessment of personnel who perform compounding activities; environment design of drug preparation rooms; air-quality testing and environmental monitoring of the compounding environment; routine disinfection of the compounding environment; temperature monitoring of drug storage areas; verification of accuracy, calibration, and maintenance of automated compounding devices; proper attire; proper scrubbing; standard compounding procedures in writing; sterilization of nonsterile drugs; expiration dating per microbial contamination risk level; end-product testing; packaging and transport; redispensing of compounded sterile preparations; patient education; patient monitoring and adverse-reaction reporting; and other.

The above requirements relate to JCAHO standards for infection control, leadership, management of human resources, management of environment of care, medication management, and provision of care and a national patient safety goal.