Part of the problem is the variability with which some regulations are interpreted. The first source of variability is that TJC regulations are proprietary: The 2017 Comprehensive Accreditation Manual can be purchased for somewhere between $299 and $469. In this case, the 1-hour rule is not in the comprehensive manual. Rick Schnatz, PharmD, the USP Chief Liaison Officer for Chapter 797, stated, “USP 797 refers solely to compounded preparations and not the simple spiking of manufactured sterile products.”1 However, on page 7 of the USP 797 guidelines, it refers to single-dose and multiple-dose containers, which are defined as “opened or needle-punctured single-dose containers, such as bags, bottles, syringes, and vials of sterile products.”2 Such products, if opened in worse than ISO Class 5 air quality, should be used within 1 hour.2 Regardless of how the clinician interprets the USP 797 guidelines, what is important is how TJC interprets it when it visits your institution.
A second source of variability in interpretation of TJC regulations is that some of the feedback from TJC, according to Dr David Baker, the Executive Vice President for Health Care Quality Evaluation at TJC, could be an individual site inspector’s interpretation and not a reflection of the opinion of TJC.3 Because it is not necessarily in an institution’s best interests to dispute claims with an inspector who may revisit in the future, this subjectivity can result in regional differences.
The final source of variability can be attributed to the wording of TJC regulations. Regulation MM.05.01.07 is a metric on whether “the hospital safely prepares medications.”4 Medication is defined by TJC as “any prescription medications, sample medications… and intravenous solutions (plain, with electrolytes and/or drugs).”4 Line 5, in reference to medication preparation and administration, includes the caveat “in accordance with hospital policies; medical staff bylaws, rules, and regulations; and law and regulation.”4 This implies that some of the policy that varies from institution to institution is actually created by these individual institutions, by the state they operate within, or by another regulatory body, and then enforced by the Joint Commission. The state of Florida adopted the USP 797 guidelines2 as state law and took them a step further in 64B16-27.797:1:i:2, adding sterile contents of commercially manufactured products and sterile surfaces of devices and containers that are exposed to air quality worse than ISO Class 5 for more than 1 hour as high-risk level compounded sterile preparations. The University of Florida further adopted an internal policy that included intravenous fluids in the 1-hour rule, which is intellectually consistent with the USP 797 guidelines for single-use containers. Depending on the commission’s surveyor assigned to a site, any of these levels of policy/regulation may be interpreted to determine whether a site is compliant with TJC.
All things considered; this dialogue in itself reinforces our concern that confusing regulation distracts clinicians from issues that really affect quality. Serious consideration should be given at every level before changes in policy are made. This should be a herald for more transparency, less variability in implementation, and a shift to more evidence-based and consistently interpreted regulations.