Share this article on:

Joint Commission and Regulatory Fatigue/Weakness/Overabundance/Distraction: Clinical Context Matters

Morey, Timothy E. MD; Sappenfield, Joshua W. MD; Gravenstein, Nikolaus MD; Rice, Mark J. MD

doi: 10.1213/ANE.0000000000000732
Patient Safety: Special Article

From the Department of Anesthesiology, University of Florida College of Medicine, Gainesville, Florida.

Accepted for publication January 29, 2015.

Funding: None.

The authors declare no conflicts of interest.

Reprints will not be available from the authors.

Address correspondence to Mark J. Rice, MD, Department of Anesthesiology, Vanderbilt University Medical Center, 1301 Medical Center Dr., Suite 4648, Nashville, TN 37232. Address e-mail to mark.j.rice@vanderbilt.edu.

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 high-alert 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 double-checks. 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 unnecessarily on arterial line system preparation, thus distracting personnel when a trauma patient arrives, and thus diverting critical attention (and we would argue more important time) on methods for reducing errors in the administration of medicines, especially high-alert medications.

Inpatient glucose monitoring provides another recent example of a totally unnecessary regulation. With the introduction of self-monitoring blood glucose (SMBG) devices in the 1970s, patients with diabetes mellitus were able to measure their blood sugar at home and adjust their own insulin doses. There is no question that this led to better control of their glucose levels and thereby decreased long-term cardiac, renal, and ocular complications. Although these SMBG devices were not as accurate as laboratory analyzers, they were a huge step forward from urine dipsticks. The U.S. Food and Drug Administration (FDA), believing SMBG technology would improve outcomes (they were correct), approved these even knowing they did not meet hospital accuracy laboratory standards, but thinking the trade-off of accuracy versus better outcomes was a reasonable assumption.8,9

Beginning in the 1990s, these SMBG meters began to appear in hospitals. Initially, patients brought their home devices with them, but hospitals also realized the utility of these meters. This trend has continued exponentially, with over 500 million tests now performed with SMBG devices in American hospitals per year.10 It is easy to see why these meters have gained so much inpatient popularity: they require much less blood (5 μL vs 1 mL for the laboratory), faster testing times (total testing time of a few seconds versus up to 1 hour to send to central laboratory and receive results), and they are much easier to use than other blood glucose monitor point-of-care devices (e.g., i-Stat® [Abbott Laboratories, Abbott Park, IL] or HemoCue [HemoCue America, Brea, CA]). SMBG meters have been developed, regulated, and marketed for home use. Because of this, companies have spent millions of dollars to make sure these devices are simple to use, even by elderly patients with little education. With the clinical emphasis on better glucose control in surgical patients, these meters have made frequent testing a manageable and relatively efficient task.

So why bring up glucose control in a discussion of regulations? Because, although these SMBG devices were originally cleared by the FDA for patients at home, they eventually also came to be used for critically ill patients where the standard for blood glucose accuracy is arguably higher, in general, and certainly if one is pursuing tight glucose control. Interval reports claim that “tight” glucose control, that is, targeting values 80 to 110 mg/dL is counterproductive and risks significant adverse events and that “moderate” glucose control, with a target range of 110 to 180 mg/dL, is effective, while the accuracy required to prevent harm is less and harmful events are fewer.11 In 2006, and with this knowledge in the public domain, the FDA issued a draft guidance that specifically stated that SMBG meters were not to be used in the critically ill hospital population.12 Following the 2006 guidance, the FDA issued further guidance (nonbinding regulations) in 2014 for meters used in hospitals that tightened the accuracy requirements and reiterated that these meters not be used with “critically ill patients.”13 Although this was only draft guidance, Centers for Medicare & Medicaid Services quickly (yes, quickly) issued a statement to the effect that if hospitals were found, upon inspection, to be using SMBG point-of-care glucose meters in the critically ill, the hospital would be cited and subsequently fined.10 Complicating matters further, the FDA did not define “critically ill.” Was the intent to prevent harm, to minimize glucose-monitoring events, or simply to have more nurse time at the patient bedside while doing frequent blood draws? This too, seems another example of a weak regulation and one with the unintended consequences of making patient care and blood glucose management less granular, and more needle stick injury prone, patient unfriendly, blood consuming, and manpower demanding.14

The reason for our concern is that all these regulations are viewed similarly by those actually charged with meeting and auditing hospital credentialing criteria of The Joint Commission. Regulations like the ones we have used to illustrate our concern appear to exist in a regulatory silo divided from clinical context about what is important with limited clinical resources. All regulations are viewed as equally important and are audited for compliance in a binary met/not met assessment. Perhaps it is time to consider subdividing regulations (just like medications) into those that are high alert and others. In this example, we hope that the reader would agree that high-alert medications should have a greater organizational priority than less clinically meaningful and contradictory rules about arterial line system preparation or glucose meter accuracy in a moderate glucose control environment.

It is time for new regulations (and even existing ones) to be held to a similar standard as other medical practices and predicated on convincing evidence. We propose using similar concept structures to rank regulations promulgated to health care facilities:

  • Level I: Evidence obtained from at least 1 properly designed randomized, controlled trial.
  • Level II-1: Evidence obtained from well-designed controlled trials without randomization.
  • Level II-2: Evidence obtained from well-designed cohort or case-control analytic studies, preferably from >1 center or research group.
  • Level II-3: Evidence obtained from multiple time series designs with or without the intervention. Dramatic results in uncontrolled trials might also be regarded as this type of evidence.
  • Level III: Opinions of respected authorities, based on clinical experience, descriptive studies, or reports of expert committees.

Enforcement of compliance with regulations could then be prioritized according to supporting level of evidence rank. In addition, although requiring more effort for regulatory authorities, each new (and contentious existing) regulation should undergo a periodic 5-step evidence-based review similar to that described in the 2003 Conference of Evidence-Based Health Care Teachers and Developers, which includes the clinical importance of results.15

  1. Translation of uncertainty to an answerable question
  2. Systematic retrieval of best evidence available
  3. Critical appraisal of evidence for validity, clinical relevance, and applicability
  4. Application of results in practice
  5. Evaluation of performance15

Having either a scheduled review mechanism or even a sun-down clause for regulations is a way to encourage a review of whether establishing the criteria or enforcing the regulation solved a problem or created another one and should therefore be repealed or revised. Although such a process may increase the work of regulatory bodies, the actual products from these discussions would lead us toward limiting regulations to those that really matter to our patients so that we can prevent further regulatory cynicism and fatigue.

Back to Top | Article Outline

DISCLOSURES

Name: Timothy E. Morey, MD.

Contribution: This author helped prepare the manuscript.

Attestation: Timothy E. Morey approved the final manuscript.

Name: Joshua W. Sappenfield, MD.

Contribution: This author helped prepare the manuscript.

Attestation: Joshua W. Sappenfield approved the final manuscript.

Name: Nikolaus Gravenstein, MD.

Contribution: This author helped prepare the manuscript.

Attestation: Nikolaus Gravenstein approved the final manuscript.

Name: Mark J. Rice, MD.

Contribution: This author helped prepare the manuscript.

Attestation: Mark J. Rice approved the final manuscript.

This manuscript was handled by: Sorin J. Brull, MD, FCARCSI (Hon).

Back to Top | Article Outline

REFERENCES

1. Charles de Secondat Montesquieu B de, De Montesquieu C-L The Spirit of the Laws. 1977 Oakland, CA University of California Press
2. The Joint Commission. Security of anesthesia cart medications. Available at: www.jointcommission.org/mobile/standards_information/jcfaqdetails.aspx?StandardsFAQId=282&StandardsFAQChapterId=40. Accessed January 9, 2015
3. U.S. Pharmacopeia. Pharmaceutical Compounding—Sterile Preparations. 2011;Chap. 797 Rockville, MD The United States Pharmacopeial Convention
4. The Joint Commission.. CLABSI prevention strategies, techniques, and technologies. In: Preventing Central Line-Associated Bloodstream Infections: A Global Challenge, A Global Perspective. 2012;60 Oak Brook, IL The Joint Commission Available at: http://www.jointcommission.org/assets/1/18/clabsi_monograph.pdf
5. Sentinel Event Alert. Available at: http://www.jointcommission.org/assets/1/6/sea_52.pdf. Accessed January 10, 2015
6. O’Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Henry Masur H, Mermel LA, Pearson ML, Raad II, Randolph A, Rupp ME, Saint Sand the Healthcare Infection Control Practices Advisory Committee (HICPAC). and the Healthcare Infection Control Practices Advisory Committee (HICPAC). Guidelines for the Prevention of Intravascular Catheter-Related Infections. 2011 Atlanta GA Center for Disease Control:18
7. Institute for Safe Medication Practices. ISMP List of high-alert medications in acute care settings. Available at: www.ismp.org/tools/highalertmedications.pdf. Accessed January 9, 2015
8. Rice MJ, Pitkin AD, Coursin DB. Review article: glucose measurement in the operating room: more complicated than it seems. Anesth Analg. 2010;110:1056–65
9. Pitkin AD, Rice MJ. Challenges to glycemic measurement in the perioperative and critically ill patient: a review. J Diabetes Sci Technol. 2009;3:1270–81
10. Klonoff DC, Vigersky RA, Nichols JH, Rice MJ. Timely hospital glucose measurement: here today, gone tomorrow? Mayo Clin Proc. 2014;89:1331–5
11. Finfer S, Liu B, Chittock DR, Norton R, Myburgh JA, McArthur C, Mitchell I, Foster D, Dhingra V, Henderson WR, Ronco JJ, Bellomo R, Cook D, McDonald E, Dodek P, Hébert PC, Heyland DK, Robinson BGNICE-SUGAR Study Investigators. . Hypoglycemia and risk of death in critically ill patients. N Engl J Med. 2012;367:1108–18
12. Food and Drug Administration. Draft Guidance for Industry and FDA Staff—Total Product Life Cycle for Portable Invasive Blood Glucose Monitoring Systems. 2006 Rockville, MD Center for Devices and Radiological Health Available at: http://www.gpo.gov/fdsys/pkg/FR-2006-10-24/html/E6-17757.htm. Accessed January 9, 2015
13. Food and Drug Administration. Draft Guidance for Industry and FDA Staff—Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use. 2014 Rockville, MD Center for Devices and Radiological Health Available at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm380325.pdf. Accessed January 9, 2015
14. Prielipp RC, Coursin DB. All that glitters is not a golden recommendation. Anesth Analg. 2015; in press
15. Dawes M, Summerskill W, Glasziou P, Cartabellotta A, Martin J, Hopayian K, Porzsolt F, Burls A, Osborne JSecond International Conference of Evidence-Based Health Care Teachers and Developers. . Sicily statement on evidence-based practice. BMC Med Educ. 2005;5:1
© 2015 International Anesthesia Research Society