Our Opinion on the Rule of Six vs. Standardized Drips Debate

What are the implications of JCAHO's current stance for your institution? Below is our own interpretation of JCAHO's "clarification"

1.      If you plan to continue using the Rule of Six you can do so ONLY IF you meet the following requirements:
a.      Submit an "ALTERNATIVE" approach to the JCAHO, with evidence that you can use the rule of six method in safe manner. This may be documented by demonstrating that you have smart pumps, 24 hour pharmacy support for emergency drug admixture, aides to assist personnel in using the Rule of six method and more. These are just examples and may not be limited to the above list only.
b.      If your 'alternative' method is found to be acceptable by JCAHO, you may use the rule of six, but only until 12/31/2008, by which date, everyone will be required to change over to Standard Concentrations. IN ADDITION during the transition period YOU MUST demonstrate each year your efforts in moving away from the Rule of six method to the Standard concentration method.
 

2.      If you are already using Standard concentrations, you are compliant with the National Patient Safety Goals and are not required to meet any of the above additional requirements in order to demonstrate your safe use of the Standard Concentration method. (this information is based on our phone conversation with a JCAHO Standards Interpretation Group Associate Director and not on any official, published JCAHO sources).

Comments
Based on our large survey data (1100 respondents) and interaction with numerous hospitals, we find that both methods have been used effectively and safely at many institutions. While there are strong proponents and opponents of each method, there is clearly lack of information to conclusively identify one method as being clearly 'unsafe' enough to recommend its discontinuation. All efforts to enhance patient safety are laudable, and measures such computerized order entry, smart pumps, unambiguous labeling, and some others listed by JCAHO above, would significantly improve safety for both methods.

It is important to realize that the strong objection to JCAHO's mandate is coming from senior, experienced, and safety-conscious practitioners who strongly believe that rule of six method is the safer method. It is unlikely, that all the opposition to JCAHO's recommendation is motivated solely from reluctance to devote increased efforts and resources needed to make the change. Moreover, our survey data revealed that more users recalled sentinel events with the use of SC method. We do acknowledge that these sentinel events were based solely on recall alone and may not represent the true incidence, yet it highlights the fact that the verdict is still unclear.

Until more data is available it is not possible to categorically identify either method as being unsafe.  We hope that when JCAHO publishes its official position on their website, they would hold users of Standard Concentration method to the same safety requirements as those being suggested for the users of rule of six method. Any other approach would seem unfair and discriminatory to the proponents of the rule of six method.

(DISCLAIMER: Please note that the above statements represent only our own personal interpretation, based on our phone conversation, email from JCAHO, and information from the JCAHO website.)