Quality & Regulatory Affairs  |   September 2019
Just because the Joint Commission says it is so, does not make it so. (Physician oversight is essential to control health care bureaucracy).
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Infectious Disease / Patient Safety / Respiratory System / Technology / Equipment / Monitoring / Quality & Regulatory Affairs
Quality & Regulatory Affairs   |   September 2019
Just because the Joint Commission says it is so, does not make it so. (Physician oversight is essential to control health care bureaucracy).
ASA Monitor 9 2019, Vol.83, 72-73.
ASA Monitor 9 2019, Vol.83, 72-73.
In a recently published issue of Infection Control and Hospital Epidemiology1 we have written a research brief titled: “Spiking of intravenous bag does not cause time-dependent microbial contamination: a preliminary report.”
The results of our study can be summarized: In intravenous bags that were spiked and stored in a normal non-sterile anesthesia workroom environment, no growth of bacteria or fungi was observed in any sample of Normal Saline or Lactated Ringers solution with dextrose, at any time point, up to nine days after spiking.
The impetus for this study stems from an apparent misinterpretation of The United States Pharmacopeia (USP) Chapter <797> Standards for Pharmaceutical compounding by the Association for Professionals in Infection Control and Epidemiology (APIC).2  Based on this misinterpretation, The Joint Commission and other hospital administrative bodies are requiring that intravenous (I.V.) solution bags must be connected to a patient within one hour of spiking. If this one-hour rule cannot be guaranteed, then the bags must be spiked in a sterile ISO Class 5 clean room environment.3  The only ISO Class 5 clean room in our facility is in the basement under the control of Pharmacy and with limited access. Hence, the hospital wanted to build a new ISO class 5 clean room in close proximity to the operating rooms. In so doing displacing the O.R. clinical engineering work room to the basement, a less than an ideal place for such an important workspace. The price tag for this new clean room was estimated to be $2-$3 million.
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