Physician Oversight Is Essential to Control the Health Care Bureaucracy

Anesthesiology News

Just Because the Joint Commission Says It Is So, Does Not Make It So

John G. Brock-Utne, MD, PhD

Professor of Anesthesia, Emeritus
Department of Anesthesiology, Perioperative and Pain Medicine
Stanford University Medical Center
Stanford, Calif.

Richard A. Jaffe, MD, PhD

Professor of Anesthesiology, Perioperative and Pain Medicine,
and, by courtesy, of Neurosurgery
Stanford University Medical Center
Stanford, Calif.

In an upcoming issue of Infection Control and Hospital Epidemiology,¹ 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 thusly: In IV bags that were spiked and stored in a normal nonsterile anesthesia workroom environment, no growth of bacteria or fungi was observed in any sample of normal saline or lactated Ringer’s 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 U.S. Pharmacopeial Convention (USP) Chapter <797> Standards for Pharmaceutical Compounding by the Association for Professionals in Infection Control and Epidemiology (APIC).² On the basis of this misinterpretation, the Joint Commission and other hospital administrative bodies are requiring that IV 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 International Organization for Standardization (ISO) class 5 cleanroom environment.³

The only ISO class 5 cleanroom 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 cleanroom in close proximity to the operating rooms (ORs). In so doing, the hospital displaced the OR clinical engineering workroom to the basement, a less than an ideal place for such an important workspace. The price tag for this new cleanroom was estimated to be $2 million to $3 million.

The intent of APIC and the Joint Commission mandate is commendable. Unfortunately, it is based on a misinterpretation of USP <797> and unsupported by any objective data. Furthermore, the arbitrary imposition of this unnecessary requirement fails to consider the associated increased cost, decreased efficiency and safety implications for the hospital and patient care. The urgent need for intravascular fluids in acute situations, whether in the form of IV crystalloid infusion or arterial line catheterization, demands the ready availability of prespiked fluid bags.

While the time to spike and prime an IV fluid bag and administration set (without any air bubbles) may be less than 60 seconds in an assembly line environment, this time will be much longer in acute care situations. For example, if the anesthesia technician is busy—or taken away from other tasks to find supplies, assemble the administration set, and deliver it to the patient care area—then an unacceptably long period of time may ensue, compromising patient care. While anesthesiologists can do the spiking and IV line assembly, in most circumstances their attention should be focused on direct patient care.

The USP is the organization that sets standards for drugs, supplements and food ingredients, and is responsible for creating the current standards under which medication compounding is monitored. The Joint Commission deferred to APIC, which quotes USP Chapter <797> as the standard for managing commercially prepared IV bags after they have been spiked.⁴ USP <797> states that compounded medications must be prepared under sterile conditions in an ISO class 5 cleanroom or used within one hour from the time of preparation.³ Unfortunately, APIC and, consequently, the Joint Commission appear to have confused the simple spiking of a commercially prepared and sterile IV solution with compounding.

The FDA defines compounding as “a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.” In addition, the introduction to USP <797> states, “The standards in this chapter do not pertain to the clinical administration (emphasis by the authors) of compounded sterile preparations to patients via application, implantation, infusion, inhalation, injection, insertion, installation, and irrigation, which are the routes of administration.”³

Given the USP definition of compounding and the fact that clinical administration of a commercially prepared IV or arterial line flush solution requires spiking, USP <797> compounding standards do not pertain in that circumstance (verified by personal communication from the USP Liaison Officer for Chapter 797). The costly misinterpretation of USP <797> used by APIC and adopted by the Joint Commission, Occupational Safety and Health Administration⁵ and CDC should be of great concern to all medical providers and patients. We are alarmed that this policy, unsupported by any evidence,^6,7 has been permitted to go unchallenged and is spreading its way through various regulatory organizations, and even becoming Florida state law.⁸

From an economic standpoint, spending $2 million to $3 million for a new ISO class 5 cleanroom and an estimated $500,000 per year for additional staff without any evidence of patient benefit is reckless. The elimination of the clinical engineering OR workspace to accommodate the proposed and unnecessary cleanroom would result in a delayed response time for repairing malfunctioning equipment, which could directly compromise patient safety.

Our study should serve to emphasize the need for evidence-based decisions and oversight by practicing physicians. This oversight should extend to all aspects of hospital management to ensure that the efficient and cost-effective delivery of high-quality health care is the first priority. Arbitrary and unfounded time limitations on spiked intravascular fluids are an unnecessary compromise of efficiency without any evidence of improved patient safety. Although these non–evidence-based measures are well intentioned, in acute care settings, when timely intravascular access is crucial, these policies may not only be costly but also detrimental to patient care.

References

Brock-Utne JG, Smith SC, Banaei N, et al. Spiking of intravenous bags does not cause time-dependent microbial contamination: a preliminary report. Infect Control Hosp Epidemiol. 2018:1-2. doi: 10.1017/ice.2018.143
Dolan SA, Felizerda G, Barnes S, et al. APIC position paper: safe injection, infusion, and medication vial practices in health care. Am J Infect Control. 2010;38(3):167-172.
U.S. Pharmacopeial Convention (USP). General Chapter <797> Pharmaceutical Compounding—Sterile Preparations. Rockville, MD: USP; 2011.
FDA. Compounding and the FDA: questions and answers. www.fda.gov/ Drugs/ GuidanceComplianceRegulatoryInformation/ PharmacyCompounding/ ucm339764.htm. Accessed July 15, 2018.
Palmer J. IV spiking recommendations from the Joint Commission. HCPro OSHA Healthcare Advisor. http://blogs.hcpro.com/ osha/ 2010/ 07/ iv-spiking-recommendations-from-the-joint-commission/ . July 30, 2010. Accessed July 15, 2018.
Brock-Utne JG, Sanford J, Jaffe RA. Overregulation revisited. Anesth Analg. 2017;124(5):1743.
Pantin E. USP-797 guidelines raise concerns. Anesthesia Patient Safety Foundation Newsletter. 2014;29(2):32.
Stappenfield JW, Gravenstein N, Rice MJ, et al. More regulatory frustration, indeed. Anesth Analg. 2017;124(5):1743-1744.

Leave a Reply Cancel reply

Testimonials

Add a Testimonial