Sedation by Non-Anesthesia Personnel Provokes Safety Concerns; Anesthesiologists Must Balance Joint Commission Standards,

By Jeffrey S. Kelly, MD, FACEP

Sedation administered by non-anesthesiologists not only is exploding in frequency and complexity, but also has become, in certain respects, by The Joint Commission mandate, the responsibility of a facility’s anesthesiologists to organize, monitor, and evaluate. Technological advances over the past 30 years have led to a plethora of  “noninvasive” or “minimally invasive” techniques which are preferred outside of the operating room. These techniques create patient discomfort due to their inherently painful, manipulative, or constraining nature, while simultaneously requiring minimal patient movement for optimal performance. Thus, it is understandable how the administration of sedatives and analgesics has evolved into an integral component of such procedures. Because these new approaches to patient care developed during an era when most anesthesiologists were either unable or unwilling to consistently provide sedation services outside the OR, clinicians in these areas were forced to develop their own individual sedation algorithms. This predictably resulted in (a) sedation techniques based on a rudimentary understanding of the pertinent pharmacology and largely predicated on the specific procedure, (b) inconsistent (or no)preprocedure screening, intraprocedure monitoring, and discharge criteria, and (c) lack of appropriate credentialing for personnel administering the sedation and monitoring the patient.
Over the last 15 years, it has become widely known that the administration of sedatives and analgesics for performance of procedures is a significant independent risk factor for morbidity and mortality both inside and outside the OR 1-4. Consequently, the Joint Commission for Accreditation of Healthcare Organizations (The Joint Commission) has recognized that inconsistent patterns of patient care adversely impact patient outcome. This has led to the development of the “The Joint Commission comparable care mandate,” i.e., that there must be no decrement in the care delivered to patients during their entire continuum of care within the hospital.  Since so-called “conscious sedation” administration for non-operating room procedures represents a dynamic continuum significantly overlapping monitored anesthesia care (MAC), this implies that such areas must have processes (presedation assessment, intraprocedure monitoring, discharge criteria), facilities, equipment, and personnel similar to those utilized for MAC delivered by qualified anesthesia providers in the OR. The Joint Commission further mandates that sedation practices throughout the hospital be “monitored and evaluated by the Department of Anesthesia”. These requirements place the Chair of Anesthesia (and designees such as myself!) in an awkward political position within most institutions. On the one hand, the hospital takes The Joint Commission visits very seriously and is concerned about their potential impact on areas such as Medicare reimbursement and public relations.

They need full participation, and will likely remember their involvement (or lack thereof) during future negotiations. Conversely, “non-OR” clinicians may view such involvement as an unwelcome and uninvited intruder enforcing a capricious, mandated solution when “there isn’t a problem.” They can also suggest to hospital administration that “Anesthesia” assume responsibility for their area’s sedation care, a solution which most Anesthesiology Departments simply cannot afford in this era of declining reimbursement and nationwide shortage of qualified anesthesia providers. Solutions to these disparate issues obviously require that a delicate balance be reached between written The Joint Commission standards and the individualized clinical needs. There must be sufficient standardization of sedation care across all areas to satisfy the comparable care mandate while retaining enough flexibility to accommodate the specific procedures and populations served by an individual area.

An appropriate political mandate and consistent support from the institution’s physician leadership is of paramount importance, with success being unlikely in their absence. Political skill, patience, persistence, and a willingness to compromise without compromising patient safety are critical for reaching a politically acceptable, consensus resolution. Anesthesiologists, The Joint Commission Standards, and Non-OR Sedation Sites The American Society of Anesthesiologists (ASA) has taken a leading role by developing evidence-based guidelines for the use of sedatives and analgesics by non-anesthesiologists6 as well as standardizing the descriptive nomenclature applied to the sedation/analgesia continuum 7. Our approach has been to construct our institution’s sedation policy using the ASA guidelines for preoperative fasting 8, and the latest version of the The Joint Commission standards 9 as our framework. Because the sedative/analgesic guidelines were developed by a consensus panel of 61 physicians from 17 specialties, we have found this document particularly useful in countering arguments by specialty clinicians about why various components of our sedation policy should not apply to their particular area. It is useful at this point to review the current individual The Joint Commission standards along with the steps we have taken to satisfy each one. They will not appear in the same order as they do in the The Joint Commission standards because a number of them have been collectively addressed using a single solution. I openly acknowledge that our approach may neither satisfy a given The Joint Commission reviewer nor prove politically palatable at some institutions. Alternatively, we have been successful in implementing this methodology at a large, tertiary care teaching institution and have recently received a favorable review of our program by a The Joint Commission physician consultant. The Joint Commission Standard #1: Moderate or deep sedation is provided by qualified individuals.

Although this standard includes many subissues (including numbers of personnel, ancillary personnel qualifications, and availability/utilization of appropriate monitoring and resuscitation equipment), I will restrict my comments to the issue of physician qualifications and credentialing. The physician (or “licensed independent practitioner” in The Joint Commission vernacular) who administers sedatives and analgesics during a procedure is responsible for the patient’s global management (including sedation) as well as for supervising all involved ancillary personnel. Broadly summarized, the licensed independent practitioner (LIP) must be “trained in professional standards and techniques” or have “competency-based training, education, and experience” in four specific areas:

(A) presedation assessment and patient selection, (B) agent administration (selection of drug class, drug dose, and route of administration) to predictably achieve the desired sedation level, (C) intraprocedure monitoring to maintain the desired level of sedation, and (D) resuscitation expertise. We have chosen to further lump these together into two generic qualifications: (a) the “ability to give” (A-C above) and (b) the “ability to rescue” (D above).  Our approach toward satisfying the “ability to give” criteria was to require documentation of 1 hour of category 1 CME activity every 3 years. We initially fulfilled this by giving lectures to all involved physician groups covering the latest The Joint Commission standards, the ASA sedation/analgesia guidelines, a review of general pharmacologic principles, the specific pharmacology of narcotics,benzodiazepines, and their respective reversal agents, and some basic concepts of risk management and patient safety. We also videotaped one of these sessions, produced multiple copies, and constructed a 10-question quiz based on the tape’s contents. These materials were then placed in our office of professional services so that physicians unable to attend (or who joined the staff subsequent to) the presentation could utilize this as a substitute. The “ability to rescue” qualification represents a more thorny political problem. First, we decided that physicians currently boarded in resuscitation oriented specialties (such as Emergency Medicine or Pulmonary/Critical Care) would clearly satisfy this requirement. Board certification in cardiology came close, but we were uncertain that our cardiology colleagues could document “competency to manage a compromised airway and to provide adequate oxygenation and ventilation.” We chose to combine current board certification in cardiology and current qualifications in Basic Life Support (now called Healthcare Provider Life Support by the American Heart Association) to add the necessary competency in airway management.

Decisions were also required for the remaining groups with the least resuscitation experience. An initial proposal involved qualifications in either Advanced Cardiac Life Support (ACLS) or Pediatric Advanced Life Support (PALS), arguing that they represented nationally recognized, evidence-based resuscitation guidelines that are routinely taught to less sophisticated audiences (such as paramedic trainees and medical students). Political resistance to this idea ultimately caused the institution’s leadership to compromise on the Healthcare Provider Life Support qualification combined with expected rapid response of the in-house code team staffed by residents from Internal Medicine and Anesthesiology. However, during our recent “mock” The Joint Commission survey, the physician consultant made it clear that basic life support skills and an understanding of reversal drug pharmacology are insufficient to satisfy this “ability to rescue” qualification. He suggested that resuscitation qualifications needed to include diagnosis and treatment of prearrest conditions (hypotension, ominous arrhythmias) as well as malignant arrhythmias. He also stated that ACLS exceeded this requirement, while openly refusing to endorse it as the only solution to this issue. We have obviously taken this problem back to the drawing board, and options are currently under active discussion by all involved parties. The Joint Commission Standard #2: Sedation risks and options are discussed prior to administration. With appropriate input from our legal counsel and the risk management department, we developed a separate sedation and analgesia consent form modeledafter our anesthesia consent form. This form was recently deemed acceptable by our The Joint Commission physician consultant. The Joint Commission Standard #3: A presedation assessment is performed. The Joint Commission Standard #4: Moderate or deep sedation is planned. The Joint Commission Standard #5: Each patient’s physiological status is monitored during sedation. The Joint Commission Standard #6: Each patient’s postprocedure status is assessed on admission to and before discharge from the postsedation recovery area. The Joint Commission Standard #7: Patients are discharged from the postsedation recovery area by the LIP or according to criteria approved by the medical staff. One of the major problems uncovered during this process was that individual record-keeping practice had evolved in a manner analogous to sedation practices.

Each area’s forms had deficiencies (for example, none had an airway exam), and there was no consistent documentation. This made it difficult to document comparable care and make it impossible to have consistent quality improvement (QI) monitoring We eventually synthesized 8 area-specific forms, combined them  with the most recent The Joint Commission standards and the ASA sedation/analgesia guidelines, and developed one standardized record. This tedious and labor-intensive process took over two years to complete. The key to making this work, was an initial decision to approach each area’s nursing staff, solicit their input, and treat them as critical contributors to the form’s development. It also served as an open acknowledgment that we understood they traditionally bore the brunt of all related paperwork. After multiple meetings with each nursing group and countless drafts, a consensus form prototype emerged that all nursing groups found acceptable. This was subsequently presented individually to the chairs of Internal Medicine, Radiology, Emergency Medicine, and Pediatrics, where the form’s necessity and genesis were explained and input from the affected physician groups solicited. Additional revisions were performed and approved in follow-up chair meetings. A final revision was based on reviews by our risk management and medical records departments.

The end result was a single carbonless duplicate form consisting of three contiguous 8.5×11 inch sheets joined side-to-side in a “Z-fold” fashion and resembling the anesthesia records utilized by our outpatient surgery center. It contains (a) a standardized preassessment signed by the LIP (#’s 3 and 4 above), (b) a signature by the LIP at the bottom of the intraprocedure area of the form as well as in the discharge area of the recovery component (#’s 4 and 7 above), (c) a standardized grid for documenting intraprocedure vital signs and level of consciousness (# 5 above), and (d) a systematic recovery admission and discharge assessment (#6 above). Although we have been using this form for only two months and anticipate it will undoubtedly require further modification, our The Joint Commission physician consultant recently told us it satisfied all these key The Joint Commission requirements. The Joint Commission Standard #8: Each patient’sphysiologic status monitored while undergoing moderate or deep sedation is collected and analyzed. The Joint Commission Standard #9: Outcomes of patients undergoing moderate or deep sedation are collected and analyzed. This clearly means sedation and analgesia QI activities which, according to our The Joint Commission physician consultant, must be consistent across all nonoperating room procedure areas. Since all these patients receive sedation irrespective of the specific procedure, we must be able to document that they are comparably monitored and have similar sedation outcomes. Our first hurdle was the global lack of standardized documentation described above.

Now that we finally have uniform data collection, our current question became how to organize and structure the sedation QI process. This may require a two-staged approach. The first stage would be performed, institution-wide, by unbiased members of the hospital’s QI Department to satisfy the global QI consistency mandate. Their role would be to ensure compliance with the above The Joint Commission standards and monitor indicators potentially associated with sedation morbidity and mortality (such as cardiopulmonary arrest, oxygen desaturation, and reversal drug administration). Their involvement would also avoid the obvious conflict of interest that exists when each area “polices” itself. The second stage QI process would be performed by the individual areas, who would develop their own indicators and performance thresholds based on their particular procedures and patient populations. For example, in the outpatient-oriented endoscopy suite, you might consider monitoring measures of patient flow (length of stay, recovery time) or satisfaction (phone surveys of postprocedure function and overall satisfaction). These same measures would be much less appropriate for a primarily inpatient area such as interventional radiology, who instead might want to look at things like the influence of blood pressure on hematoma formation after vascular decannulation. Regardless of what we ultimately decide, implementation of a QI monitoring program will be a major priority as we prepare for our The Joint Commission site visit next summer.

Anesthesiologists, Non-OR Sedation Sites, and Patient Safety: One Teaching Institution’s Approach Anesthesiology has long been nationally recognized as a leader in the patient safety movement, as evidenced by the Anesthesia Patient Safety Foundation, the ASA Closed Claims Data Base1, and the various ASA practice guidelines 6,8. The recent Institute of Medicine report supports our leadership position and generates a substantial amount of positive publicity for Anesthesiology 10. We should be rightfully proud of this, and sincerely grateful to all of the dedicated colleagues within our specialty who have advanced the cause of patient safety. At the risk of sounding radical, I would suggest that extending our proven safety processes outside our traditional workplace and into these non-OR procedure sites represents Anesthesiology’s best opportunity to markedly improve patient safety. The The Joint Commission requirement to “monitor and evaluate” sedation practices mandates our involvement, and provides sufficient political “cover” to justify our active participation. Thus, becoming an integral player in the The Joint Commission and QI process represents the first step necessary toward improving patient safety in non-OR sedation areas. Sedation policy construction, sedation form development, and arbitration of concerns discovered by QI data analysis are but a few examples of visible Anesthesiology leadership in sedation care. The other challenging safety issue involves educating our procedure-performing colleagues in the appropriate use of sedatives and analgesics.

This effort spans the entire continuum of sedation care, and in some instances requires cautiously debunking traditional subspecialty sedation practices (for example, the routine use of intravenous meperidine for brief endoscopic procedures). The following points should be emphasized: (A) the critical importance of patient selection and appropriate involvement of anesthesia providers in patients at high risk for sedation complications, (B) frequent titration of small sedative/analgesic doses and avoidance of fixed sedative/analgesic “recipes,” (C) adequate oxygen saturation does not equal adequate ventilation 6,11, (D) the advisability of supplemental oxygen administration where feasible, (E) the dangers of narcotics (either alone or combined with other sedative agents), even in otherwise healthy patients 2,4,12, (F) the relative safety of benzodiazepines combined with judicious amounts of local anesthetics, and (G) appropriately cautious administration of benzodiazepines in the elderly because of morbidity associated with their use 12,13. Conclusion While fraught with numerous pitfalls, sedative and analgesic use by non-anesthesiologists outside the OR will continue and likely grow. This represents an excellent opportunity for anesthesiologists to exert patient safety leadership within their institutions. I encourage each department to take our specialty’s safety expertise and apply it for the benefit of all patients receiving sedatives and analgesics during procedures, wherever they are performed. Dr. Kelly is Associate Professor of Anesthesiology and Critical Care, Clinical Instructor of Emergency Medicine, and Chairman, Conscious Sedation Committee: Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina.

References

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5. Procedure for Intravenous Conscious Sedation. Comprehensive Accreditation
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6. Gross JB, Bailey PL, Caplan RA, et al. Practice Guidelines for Sedation and Analgesia by Non-Anesthesiologists. A report by the American Society of
Anesthesiologists Task Force on Sedation and Analgesia by Non-Anesthesiologists. Anesthesiology 1996;84:459-71.

7. American Society of Anesthesiologists: Continuum of Depth of SedationÑDefinition of General Anesthesia and Levels of Sedation/Analgesia. Available at:http://www.asahq.org/Standards/20.htm. Accessed on: September 6, 2001.

8. Practice Guidelines for Preoperative Fasting and the Use of Pharmacologic Agents to Reduce the Risk of Pulmonary Aspiration: Application to Healthy Patients Undergoing Elective Procedures. American Society of Anesthesiologists
Task Force on Preoperative Fasting. Anesthesiology 1999;90:896-905

9. Revisions to Anesthesia Care Standards. Comprehensive Accreditation Manual for Hospitals. Effective January 1, 2001. Joint Commission on Accreditation of Healthcare Organizations. Available at:http://www.The Joint Commission.org/
standard/aneshap.html. Accessed: September 6, 2001.

10. Kohn LT, Corrigan, Donaldson MS, eds. To Err is Human: Building a Safer Health System. Washington, DC: National Academy Press, 1999

11. Council on Scientific Affairs, American Medical Association. The use of pulse oximetry during conscious sedation. JAMA 1993;270:1463-8.

12. Marcantonio ER, Juarez G, Goldman L, et al. The relationship of postoperative delirium with psychoactive medications. JAMA 1994;272:1518-22.

13. Cummings SR, Nevitt MC, Browner WS, et al. Risk factors for hip fracture in white women. N Engl J Med 1995;332:767-73.

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