Steps to Build a USP 797 Compliant Facility

Steps to Build a USP 797 Compliant Facility

A suggested step-by-step methodology for USP 797 compliance is as follows:
JCAHO began surveying for compliance with USP 797 on July 1, 2004, so efforts to comply with USP 797 should have begun and/or must begin immediately

To begin with, assemble a team within your healthcare institution consisting of : Chief Pharmacist, Director of Facilities, Director of Engineering, and Appropriate Administrator
Identify, with the guidance of the Chief Pharmacist, those pharmacies within the health care institution where sterile compounding is done

Create a Gap Analysis document, either in-house, or by hiring a consultant that specializes in Gap Analysis documents, such as Clinical IQ (http://www.clinicaliq.com/)

Create a Compliance Action Plan, either in-house, or by hiring an architect that specializes in Compliance Action Plans, such as Bernstein & Assoc. (http://www.bernarch.com/)

Have the architect create construction documents and specifications, indicating the detailed scope required for the project

Send out the drawings and specifications to 3-5 qualified general contractors who specialize in health care and laboratory space

Award the project to the selected contractor Work with architect and contractor to complete work in a thorough manner, meeting all project specifications.

For more information about usp 797, go to: http://www.usp797.org/

For more information about usp 797-compliant architecture, engineering and construction, go to: http://www.bernarch.com/.