{'fraction_non_alphanumeric': 0.02967877094972067, 'fraction_numerical': 0.013442737430167597, 'mean_word_length': 5.437078651685393, 'pattern_counts': {'":': 0, '<': 0, '<?xml version=': 0, '>': 0, 'https://': 0, 'lorem ipsum': 0, 'www.': 0, 'xml': 0}, 'pii_count': 0, 'substrings_counts': 1, 'word_list_counts': {'cursed_substrings.json': 0, 'profanity_word_list.json': 0, 'sexual_word_list.json': 0, 'zh_pornsignals.json': 0}}
Joint Commission and Regulatory Fatigue/Weakness/Overabundance/Distraction: Clinical Context Matters

August 2015 • Volume 121 • Number 2 Copyright © 2015 International Anesthesia Research Society DOI: 10.1213/ANE.0000000000000732 To paraphrase Charles de Montesquieu (1689–1755), the Enlightenment philosopher who, in regard to the creation of laws, famously commented: “Useless laws weaken the necessary laws,”1 there is a growing sentiment that “Useless regulations weaken the necessary regulations.” We have extrapolated that to mean unnecessary regulations perceived to be of minimal-to-no value weaken those that are truly necessary and, moreover, generate cynicism for ever-accumulating administrative bureaucratic requirements. Health care functions in a highly regulated and audited environment, with more regulations arriving each year. We do not disagree that many regulations are indeed important, improve patient safety, and add value. Some, however, are not necessary or, worse yet, cause harm and distract organizational and clinical focus from those that are essential. That is, the weak and arbitrary rules diminish those that are essential. It is also significant that the threshold for adding or deleting a regulatory requirement is asymmetric, with the former seeming much lower and earlier than the latter. An example of this is the persistence of perioperative β-blockade requirements, despite evidence of harm. Several current examples serve to make this point. Some health care organizations have devoted great resources to developing and maintaining level I trauma centers to provide the most advanced and complete range of specialty care for patients experiencing traumatic injury. For anesthesiology, immediate service to these patients in the operating room (OR) must be provided at all times (i.e., 24/7/365), with little or no notice before a patient with potentially fatal injuries arrives for surgery. Because patients may have experienced significant blood loss and may exsanguinate during surgery, anesthesiologists will commonly use intravascular arterial blood pressure monitoring to allow continuous and near-instantaneous blood pressure measurement. This monitoring system requires an irrigating flush solution, a pressure bag, connecting tubing, a transducer, and fluid-filled, low-compliance tubing to connect to the intravascular catheter. Setting up and “de-bubbling” this entire device minimally require 5 to 10 minutes and the gathering of supplies, including gloves, gauze, towels, skin preparation solution, appropriate-sized cannula for the artery, adhesive tape, sterile dressing, and an arm board of appropriate size for the patient. Ideally, the setup would occur and the anesthesiologist would be prepared before a severely traumatized patient emergently arrives in the OR. Tasking a provider with constructing a pressure-monitoring setup (after he/she unlocks the required-to-be-locked anesthesia cart2 and draws up his/her required to be drawn up just before use emergency drugs) completely distracts that provider from focusing on the patient’s evolving clinical state. Unfortunately, the regulations prevent a more focused approach. Currently, arterial line setups must be used within an hour of preparation, preventing health care providers from having a setup ready for the patient. According to the USP 797 guidelines, “sterile contents of commercially manufactured products” such as an arterial line setup that are created in “room air quality worse than ISO [International Organization of Standardization] Class 5” are considered “contaminated or at high risk to become contaminated” if they are not used within 1 hour.3 ISO air quality refers to the level of air cleanliness in regard to airborne concentrations of substances such as dust or microbes. An ISO Class 5 environment contains a maximum of 100 particles per cubic foot and is achieved using special equipment such as “laminar airflow workbenches, biological safety cabinets, compounding aseptic isolators, compounding aseptic containment isolators.”3 The Joint Commission has upheld the USP 797 guidelines as the standard when administering products to curb infections.4,5 Naturally, trauma patients do not have elective times of arrival into the OR. Paradoxically and per regulation, if this transducer and tubing were actually connected to a patient instead of a sterile cap, it can be used for up to 96 hours before needing to be replaced.6 This is an example of a weak and intellectually inconsistent regulation that potentially endangers patients by misfocusing the health care provider from his/her central focus on the patient. We believe this to be a “useless law.” In contrast, a very necessary regulation that prevents harm to the patient is the focus on proper color labeling and the identification of “high-alert” medications that “...bear a heightened risk of causing significant patient harm when used in error. Although mistakes may or may not be more common with these drugs, the consequences of an error are clearly more devastating to patients.”7 The list of highalert medications includes insulin, potassium, vasopressin, and neuromuscular blocking drugs, among others. Special safeguards should be used with these medications, such as limited access, additional labeling, and independent doublechecks. These additional actions clearly make sense to avoid, for example, IV administering vasopressin (20 U/mL) when one intended to inject ondansetron (4.0 mg/mL), both of which may appear in a vial similar in size, color, and cap. Notwithstanding, organizations may spend personnel time Joint Commission and Regulatory Fatigue/Weakness/ Overabundance/Distraction: Clinical Context Matters