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Quality Corner

Patient Safety in Procedural Sedation-Goals, Measuring and Metrics

Cheri LandersBy Cheri Landers, MD, FAAP, FCCM
Section Editor

Welcome to the second installment of the SPS Newsletter Quality Corner.  This edition’s column will be devoted to the domain of safety as it applies to procedural sedation.  As you recall, the IOM included safety as one of the six “Aims for Improvement” and defined safety as “avoiding injuries to patients from the care that is intended to help them”.(1)

Considering the nature of illness, complex interventions, and ever expanding cadre of medications encountered in healthcare, this is indeed a tall order. I will review historical safety data in anesthesia and sedation and then propose some safety metrics for use in pediatric procedural sedation.

Anesthesiologists were pioneers in patient safety.  Although not recognized for what the field of patient safety is today, journal articles from the 1920s and 1940s describe recommendations to help recognize anesthetic induced hypotension, prepare in anticipation of airway intervention or resuscitation, prevent intra-operative fires, IV infiltrates, arterial spasm and occlusion.(2,3)  Reports in the 1950s through 1970s led to the determination that mortality from anesthesia was unacceptably high (2000 patients per year).(6) In addition, anesthesiologists’ malpractice claims accounted for a disproportionate amount of liability insurance payout.(7) As a result, the American Society of Anesthesiologists, the Anesthesia Patient Safety Foundation and the Closed Claims Project (all formed in the mid 1980’s) evaluated anesthesia practices and helped to formulate patient safety statements.  

Commonly reported adverse outcomes for anesthesia events include death and the requirement for CPR. Anesthesia related deaths in children decreased from 1 in 10,000 cases to 1 in 60,000 cases with improved equipment and monitoring standards and training.6 Recent publications cite anesthesia related cardiac arrest in children at around 1.5 in 10,000 cases.(7) We might expect outside of the operating room (OR) procedural sedation for outpatients to have even lower mortality and cardiac arrest rates due in part to the semi-elective nature of many outpatient procedures and the relative better health of outpatients than inpatients.

The earliest studies of safety in sedation outside of the OR were in dentistry in the early 1970’s.  Pediatric specific studies started appearing in the 1980s but frequently had low patient numbers and were often compared differing medication approaches addressing efficacy over safety. The late 1990s saw a large volume of single center reports and studies on safety and efficacy of pediatric procedural sedation. In these studies, adverse events are reported to occur in pediatric procedural sedation between 0.01-33.3% of cases, none of which were death.(8-11) This wide range is due to the varying definition of a sedation adverse event.  However, even though these studies found no deaths, severe outcomes can and do occur.  In a eye-opening article by Cote et al in 2000, FDA adverse event reports were reviewed and revealed that in the 95 reports in patients under 20 years of age, there were 51 deaths, nine patients with permanent neurologic injury and 35 without apparent injury.  Adverse events in outpatient settings and those that did not have pulse oximetry monitoring were magnitudes more likely to result in death or neurologic injury than those in the hospital or having the benefit of pulse oximetry.(12)

As one of my anesthesia colleagues told me (and I paraphrase) “putting kids to sleep is easy, it’s getting them to wake up intact that is the challenge”.  Patient safety in anesthesia and procedural sedation can be summed up in that statement:  Our goal is to return the child to their pre-sedation state of health and well being.

Although mortality has been one of the major outcome variables measured in anesthesiology, it certainly doesn’t cover all safety concerns.  In addition, there are limitations of using the same outcomes as anesthesia for procedural sedation. Mortality is thankfully rare, even in general anesthesia cases, however, this means that to show a significant trend in this important safety metric, many, many thousands of cases would have to pass before one “event” would occur. 

More recently, concern for long lasting neurologic impact of anesthetic agents on the developing brain has become a focus of providing safe anesthesia.  Dr. Andropoulos gave a very compelling presentation on the current science and implications for anesthetic choice in young children at the SPS conference (reviewed elsewhere in this newsletter). As it stands currently, there is a lack of practice-driven data for providing anesthesia to young infants and children.  Although we do not yet have the data we need to know which medications are the best choices for sedating young children, as this knowledge becomes available it can be incorporated into our safety metrics as well.

So how does the experience of patient safety in general anesthesia translate to procedural sedation safety? What metrics and trends are reasonable to allow a sedation service to compare themselves to others and to identify opportunities to improve care?

In general there are two types of metrics: outcomes and process.  Outcome metrics are measures including mortality, need for CPR or lack of permanent neurological injury.  There are other less severe outcomes that one could measure with regard to safety such as laryngospasm, significant desaturation (however defined) or hypotension.  Some would argue that these outcomes are only significant if they are unrecognized and/or under treated and lead to one of the more severe outcomes.  However, if services choose to track these less severe outcomes, and evaluate causes for worrisome trends, the assumption is that overall safety will be improved. Since the severe outcomes are rare, the less severe ones could be more useful to use for comparing institution to institution as long as definitions are clearly defined for each institution.

Process measures are things like pre-screening each patient to match the right provider to the patient, ensuring sedation providers have adequate training to recognize and respond to less serious events before they deteriorate, always having the pre-sedation checklist completed or having an emergency drug sheet and emergency airway equipment available.  Process measures are items that are meant to impact the outcomes but don’t by themselves indicate a poor outcome.  In situations like procedural sedation where serious permanent adverse outcomes are rare, the process measures used to prevent adverse outcomes become more valuable.  You might think of process measures as compliance measures. Were checklists and algorithms followed? Standardizing your processes can lead to better outcomes or, fewer adverse events.

Do we have benchmarks against which to judge how our sedation service is performing against the gold standard?  We are much further along in the domain of patient safety with this regard than in the other domains of procedural sedation thanks to the Pediatric Sedation Research Consortium (PSRC). The PSRC was created and began collecting data in 2003 as a collaborative group of institutions dedicated to improving sedation/anesthesia practice through sharing prospective observational outcome data.  Throughout the 10 years of procedural sedation data collection, the PSRC has demonstrated that, in centers committed to an organized dedicated approach to pediatric procedural sedation, mortality is zero in over 300,000 cases.  In two PSRC publications describing more than 79,873 sedations, there were three instances of cardiac arrest (0.375 per 10,000 cases). Minor events such as desaturation, stridor, laryngospasm and apnea occurred from 0.04-1.5%.(13-14) The conclusion of initial publications from the PSRC was that procedural sedation outside the OR was “unlikely to yield serious adverse outcomes in a collection of institutions with highly motivated and organized sedation services.  However, the safety of this practice depends on the systems’ ability to manage less serious events.”(13) It is this last segment of the conclusion (“...the systems’ ability to manage less serious events”) that I believe is where sedation services will benefit the most from monitoring safety metrics. 

Arguably, services may want to measure the more invasive interventions needed in order to prevent severe adverse events; such as intubation or bag valve mask ventilation.  And, while these are not direct outcomes or even process measures, when a trend is identified where these interventions are being required more frequently, a review should be prompted to identify opportunities to improve and standardize the processes in place.

My suggestions on safety metrics for pediatric procedural sedation outside the OR are listed below and are based on what has worked for our sedation service at Kentucky Children’s Hospital.  Over time we have added various items as we felt necessary.  The outcomes data for our safety metrics come from the PSRC database while the process metrics are collected by the sedation team into a specific data tool built by our finance service line manager.


Outcome Measures

  1. Mortality – goal should be zero, with limitations as outlined above
  2. Cardiac arrest – goal should be zero, with limitations as outlined above
  3. Laryngospasm – although often not predictable in an individual patient, evaluating how the team manages a patient with laryngospasm can bring to the surface potential areas of concern
  4. Need for reversal agents – utilized as a screening for opioid/benzodiazepine medication miscalculation/overdose
  5. Cancellation of procedure due to issue related to sedation adverse  events

Intervention Measures

  1. Emergency anesthesia consult –this can be useful in determining if appropriate patient screening criteria were used, etc. Team members should never be discouraged from asking for help when needed therefore measures like this, that could be construed as punitive, need to be approached carefully  
  2. Need for increased level of care post sedation – this implies that the child did not return to their pre sedation level of function, at least briefly
  3. Need for invasive airway interventions (BVM, ETT, LMA) – again the  team should not be deterred from utilizing the skills needed to safely provide for the patient, and the goal incidence for each of these interventions likely varies by institution, patient population, provider type, procedure type, etc.  but, monitoring the incidence over time and investigating a concerning trend is helpful

Process measures

  1. Pre-Sedation Checklist Complete – our checklist includes emergency airway equipment, oxygen and suction setups, sedation plan reviewed with the physician, consent obtained and time out performed, etc.
  2. Emergency Drug list Complete – we have an emergency drug sheet printed for each sedation patient with their weight and relevant dose of various resuscitation medications

Of course, this is just one possible list of safety metrics.  Please e-mail me, cdland2@uky.edu with the ones that your service uses or other suggestions and I will include it in the column for the next edition.

References

  1. Institute of Medicine, Crossing the Quality Chasm: A New Health System for the Twenty-first Century (Washington: National Academy Press, 2001).
  2. Schattenburg, O.L. Safety Factors in Spinal Anesthesia.  California and Western Medicine. 1928; Dec;29(6):397-401.
  3. Leech, B.C. Safety measures in the practice of anaesthetics.  Canadian Medical Association Journal.  1947; Jan;56(1):28-34.
  4. Epstein, R.M. Morbidity and Mortality from Anesthesia: A Continuing Problem.  Anesthesiology.  Dec;49(6):388-389.
  5. http://www.apsf.org/about_history.php
  6. Holzman R. Morbidity and mortality in pediatric anesthesia.  Pediatr Clin North Am. 1994;41:239–256.
  7. Risk in Pediatric Anesthesia.  Paterson N. and Waterhouse P., Paediatr Anaesth. 2011 Aug;21(8):848-57.
  8. Maliviya S, et al.  Prolonged Recovery and Delayed Side Effects of Sedation of Diagnostic Imaging Studies in Children.  Pediatrics. 1997;105(3).
  9. Egelhoff J, et al. Safety and Efficacy of Sedation in Children Using a Structured Sedation Program.  AJR Am J Roentgenol. 1997;168(5):1259-62.
  10. Lowrie L, Weiss AH, and Lacombe C.  The Pediatric Sedation Unit: A Mechanism for Pediatric Sedation.  Pediatrics. 1998;102(3).
  11. Pena BMG and Krauss, B. Adverse Events of procedural Sedation and Analgesia in a Pediatric Emergency Department.  Ann Emerg Med. 1999;34:483-491.
  12. Coté CJ, et al. Adverse sedationevents in pediatrics: a critical incident analysis of contributing factors.  Pediatrics. 2000;105*4 Pt 1):805-14.
  13. Cravero, J et al. Incidence and Nature of Adverse Events During Pediatric Sedation/Anesthesia for Procedures Outside the Operating Room: Report From the Pediatric Sedation Research Consortium.  Pediatrics.  2006 188(3): 1087.
  14. Cravero, J et al. The Incidence and Nature of Adverse Events During Pediatric Sedation/Anesthesia with Propofol for Procedures Outside the Operating Room:  A Report From the Pediatric Sedation Research Consortium. Pediatric Anesthesiology. 2009 108(3):795.

Strategic Management of Pediatric Sedation Services: Challenges, barriers and opportunities in the context of changing healthcare environment

By Subhankar Bandyopadhyay, MD

The current climate of the changing healthcare market is creating pressure with the onus on us to define ourselves, understand our current environment, be aware of existing barriers and threats, add value to our efforts, sustain a competitive advantage and ultimately maintain a steady growth of our practice while having a constant look out for other opportunities. As pediatric sedation service providers, we have come a long way. From creating a work force to meeting the demands and needs of our respective institutions, we are now a nationally recognized force with expertise, striving for the best practice. We have effectively negotiated in many instances to provide an efficient, profitable, and alternative service outside of the operating room while maintaining the highest safety standards in our industry. The evidence-based literature demonstrates that sedation and/or sedation and analgesia for children outside of the operating room can be provided in a safe, efficient, and effective manner. Overall satisfaction with this process is mutually shared by patients, parents, and healthcare providers.

Hospital administrators are beginning to understand the “value” we add while reducing the cost.  Many third-party payers also are “willing to pay” (WTP) for the value we have created beyond our cost.  As the paradigm of healthcare reimbursement shifts from “fee for service” model to a “shared savings model,” the accountable care organizations (ACO) will constantly be looking for these added values. One can make an analogy between the airline industry and healthcare.  For example, the increased cost of operation by Delta or American Airlines, created a successful operational opportunity for Southwest Airlines. As such, Southwest Airlines was able to create a model of operational excellence that translated into a rapidly increasing market share that generated growth through reduced cost and profitability, while maintaining the same safety standards. It should come as no surprise that “profit” in healthcare can be a taboo to many, but the reality is that it is not just a dollar value. We could substitute the word “profit” with “gain”. The big question is how do we add value to the services we are already providing?

At some point in our career, knowingly or unknowingly we have created and followed a strategy. As sedation providers from many specialties we have created this value added service of “sedation.”  This is our operational excellence. However, that being said, our success is still limited to certain geographic areas and within certain institutions. We collectively need to explore areas of opportunity. Looking at the success of Southwest Airlines, we need to” fly into more areas with open skies” and not limit our sedation services.

The continued effort to explore metrics and measure the sub-domains of quality such as safety, efficiency, effectiveness, timeliness, equitable and a patient-centered approach will ultimately lead to the advancement of our sedation services. We all stand to benefit.

We are learning how to remain operationally intact. What is the perceived value of our buyers? What is the relative cost per unit of value? Our productivity frontier is the boundary of efficiency that is achieved with the currently available techniques. The curve of productivity frontier is constantly moving with greater pressure to be productive at a lower cost. How do we implement the resources that we have?  How do we schedule efficiently so that available resources are distributed effectively and equitably? How do we prevent no-shows in our schedules? Are we more operationally effective today than we were five years ago? Are we more productive? Are we more efficient in resource utilization? Are people working harder? Across many institutions, leaders of sedation services are constantly facing these challenges and struggling to find answers.

As sedation services continue to evolve, we should continue to be aware of the threats (both internal and external) to maintain our competitive strategic positioning. A collaborative effort among the various specialties will result in a better chance of survival, particularly when dealing with contracts and benefits.  

Our efforts in continuing to add value in our system makes us able to assess our strengths (what are we doing the best?) and weaknesses (what we could be doing better?). Strategy involves an understanding of opportunities and the ability to deliver. Measuring quality metrics will make us cognizant of the performance gap (if any) with an increased power to deliver while meeting the needs created by the opportunities. Our ability to deliver is measured by value chain and value analysis. Combining all these activities will create a position that is difficult to imitate. As pediatric sedation service providers we have a unique competitive advantage. We are sustainable.

 

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