Pediatric Sedation Service Center of Excellence Consensus Statement

January 19, 2016
This document is intended as a Consensus Statement describing the ideal Pediatric Procedural Sedation Service. This document is meant to be a guide for those centers and services striving to improve upon the quality of care they provide as well as a template for those wishing to begin a pediatric procedural sedation service.
Assumptions have been made by the authors of this consensus statement as there is little direct evidence in the sedation literature that the described processes below affect the quality of care. However, there is data to support the extrapolation of many of the conclusions made in this consensus statement:

1. Standardization/minimizing variability of care leads to improved quality of care.^1,2,3
2. Monitoring outcomes identifies areas for structure and process improvement.^4,5
3. Pediatric trained providers are better able to care for children and their specific patient needs.^7,8,9
4. The sedation nurse has specific and special skills beyond and different than those of the acute care nurse.
5. The provision of procedural sedation is not only giving medications and managing an airway, but involves other assessments, medication choices, appropriate referrals and alternatives to sedation.

Definitions

Pediatric Procedural Sedation: the provision of sedation and/or analgesia outside of the operating room by a healthcare provider with the intent to alter the child’s consciousness in order to facilitate a diagnostic or interventional procedure
Pediatric Sedation Center of Excellence (PSCE): a team of pediatric healthcare providers committed to safe and effective pediatric procedural sedation utilizing current best practices in a patient and family centered environment with continual self-review, evaluation and changes aimed at achieving the highest quality of care with efficient use of limited healthcare resources.

General Qualities

The Pediatric Sedation Center of Excellence (PSCE) adheres to all appropriate Joint Commission (TJC) and Center for Medicare/Medicaid Services (CMS) guidelines and these are mirrored in its policies and procedures.
In addition, the PSCE goes beyond TJC and CMS requirements and has mechanisms in place to achieve ongoing process improvement. Outlined below are characteristics of these further qualities grouped under the 6 aims for quality.⁶ In addition are requirements for training/credentialing of providers and of the institutions and systems within which pediatric sedation is provided.

Safety

1. The PSCE has a process by which patients are screened prior to arrival and matched with the appropriate provider for that institution. This process includes specific patient characteristics that prompt review and referral to a more advanced provider.
2. The PSCE has a standardized approach at the start of a sedation case to identify the patient and confirm important system checks (time out, check lists, room setup, etc). The PSCE has protocols in place for standard processes specific to their institution (room setup, screening, hypoglycemia, IVF use, etc.).
3. The PSCE monitors outcomes of all sedations performed. The PSCE participates in a multi-center database for outcome benchmarking purposes.
   1. The PSCE has defined goals/targets for all outcomes that are tracked.
      1. The goal for mortality, CPR and unanticipated increase in level of care should all be zero.
      2. The PSCE has a review process in place for sedation cases that fall outside of the PSCE’s defined targets and goals.
         1. The review process is multi-disciplinary and occurs soon after outlying event occurs.
4. The PSCE has available backup resources and policies/procedures for the timely response to emergencies arising during procedural sedation. Examples might include a rapid response team, pediatric code team, anesthesia back up, emergency/difficult airway protocol.
5. The PSCE has a standard post sedation monitoring protocol and tracks compliance with this protocol. The PSCE has defined discharge criteria following recovery from sedation which includes a policy for post sedation monitoring of former premature infants. The PSCE provides printed discharge instructions for families to take with them including how to contact the PSCE with problems or questions.

Efficiency

1. The PSCE minimizes waste of resources including equipment, supplies, ideas, and energy. This is reflected in appropriate patient scheduling, staffing, processes designed to increase throughput yet maintain safety, minimizing downtime, etc.
2. The PSCE tracks resource utilization and waste such as service hours available and used, staff available to provide sedation and those actually used, and throughput times.
3. The PSCE tracks efficiencies that affect healthcare personnel and hospital resource utilization. Examples include: medication use differences, prolonged recoveries, delayed procedure starts, patient appointment no shows, cancellations, same day referrals to general anesthesia, delays, and postponed procedures.

Timeliness

1. The PSCE provides a timely service by being available when needed and avoiding delays between the initial request/need for procedural sedation through the end of patient recovery and discharge.
2. The PSCE tracks metrics related to timeliness which may include: the time from inpatient order or patient arrival to test start, outpatient 3rd next available appointments, the ability to add-on cases within a set time period, the difference between scheduled start time and actual start time, and patient rescheduling after arrival.

Effectiveness

1. The PSCE should have a goal of zero cases cancelled due to inability to produce effective sedation. Procedures that are cancelled or postponed because of the inability to achieve a sedated state (that is consistent with completing the procedure) should be recorded and reviewed. A strategy for avoiding such failures in the future should be made. This plan could include new methods for sedation by the current sedation team, or recognition of the need for a new referral strategy for challenging patients or procedures – if there is a recurrent issue with sedation failure.
2. The PSCE monitors the adequacy of sedation conditions for procedural sedation with a validated score. In doing so, the service would have a methodology where-in the ability to meet the sedation requirements for each procedure (motionless for MRI, analgesia and anxiety control for bone marrow biopsy) is evaluated. Each service would have to formulate the specific acceptable conditions for each procedure category, but these conditions would have to include the patient being free of significant pain, anxiety, or unwanted movement during the procedure. Any sedation process that is regularly provided by the service should be evaluated in this manner. The outcome of these evaluations should be studied and the service should have a process whereby any strategy that yields conditions that do not meet pre-defined goals for the procedure more than 2-5% of the time, should be revised and re-evaluated.
3. The PSCE should strive to survey all proceduralists and families for opinions on the effectiveness of the sedation provided. These surveys should be considered in the context of the analysis described above and occur within 24 hours of the procedural sedation.

Family/Patient Centered

1. Child Life is available for all patients undergoing procedural sedation and is part of sedation team.
2. Pediatric patient care areas should be separate from adult care areas in institutions that care for all ages.
3. The PSCE allows parents to be with their child as much as possible within the limitations of the procedure and the institution (e.g. parents stay through induction, return at phase 2 in recovery).
4. The PSCE systematically attempts to obtain family/parent feedback on all sedation encounters and has a method by which to act on identified problems.
5. The procedural sedation appointment (if applicable) is made in coordination with families.
6. The PSCE has a standard method for communicating with all families prior to arrival for sedation which includes multiple means of contact (e.g. phone, mail, email, via referring provider, etc). This standard should include a way to communicate with families in their language of choice.
7. The PSCE has policies and procedures in place to address pain and anxiety, topical anesthetic use, child life, and the sedation process for the autistic child or other special needs child.
8. Patient screening and evaluation process should include considerations for non-medication/distraction alternative choices if appropriate for the child and procedure.

Equitable Care

1. The PSCE assesses all patients’ pain with a method that is age appropriate and offers to all patients a method to reduce pain or awareness of pain with IV starts. (e.g. LMX, EMLA, vapo-coolant, hypnosis, etc.)
2. Throughout the PSCE’s institution, patients have access to the same type and quality of sedation and pain management; including the Emergency Department, Inpatient Acute Care, Outpatient Diagnostic areas, etc.
3. Rescue systems throughout the PSCE institution and affiliated institutions where pediatric procedural sedation occurs are equitable in availability and quality.

Credentialing/Personnel

1. All members of the PSCE sedation team should be trained in the care of the pediatric patient, and specifically in the provision of pediatric procedural sedation.
2. The full time PSCE sedation nurse staff should be assigned to the pediatric sedation service for at least 80% of their work hours and not pulled to other areas more than 20% of the time.
3. It is ideal for the PSCE physicians and advanced practice providers performing sedation to spend >= 25% of their patient care time as a sedation provider.
4. The PSCE hospital or governing institution has a formal privileging process for sedation at any depth that includes continuing or renewing criteria as well as simulation training requirements.
5. In general, sedation providers of the PSCE are trained and credentialed as per the requirements of the regulating bodies for the provision of sedation and practice.
   1. More specifically, sedation providers should participate in a didactic course followed by simulation or hands-on training then an initial period of monitored practice.
   2. Ongoing practice reporting should occur after the initial training period along with regularly scheduled simulation sessions to maintain competency for high risk yet rare patient management situations.
   3. Didactic and simulation training should address those core competencies outlined in the SPS Consensus statement “Core Competencies for Pediatric Providers Who Deliver Deep Sedation”.¹⁰

Ideal System Requirements (Institution Characteristics)

The system or institution housing the PSCE has administrative support and advanced patient care support available that allows the institution to better understand the needs of children regarding procedural sedation and provide a voice for the pediatric sedation service to the leadership of the institution. These system requirements would include many of the following: pediatric anesthesia, PICU, pediatric ED, pediatric surgical services, pediatric radiologists, pediatric sedation nurse manager and medical director, separate administrative and nursing leadership for pediatric services, collaborative and cooperative relationship with anesthesia, and a quality and safety division/department to which the PSCE reports.

References

1. Rozich JD, Howard RJ, Justeson JM, et al. Standardization as a mechanism to improve safety in health care. Jt Comm J Qual Saf. 2004 Jan; 30(1):5-14.
2. Donihi AC, DiNardo MM, DeVita, Korytkowski MT. Use of a Standardized Protocol to Decrease Medication Errors and Adverse Events related to Sliding Scale Insulin. Qual Saf Health Care 2006 Apr;15(2):89-91.
3. Standardize Rooms, Equipment, Patient Flow and Information Flow. http://www.ihi.org/resources/Pages/Changes/StandardizeRoomsEquipmentPatientFlowandInformationFlow.aspx
4. Nolan T and Berwick DM. All-or-None Measurement Raises the Bar on Performance. JAMA. 2006;295(10):1168-1170.
5. Almoosa KF, Patel B, Luther K. Identifying “Waste” in the ICU. Memorial Hermann/University of Texas Health Science Center at Houston, Houston, Texas, USA. http://www.ihi.org/resources/Pages/ImprovementStories/IdentifyingWasteinICU.aspx
6. Institute of Medicine, Crossing the Quality Chasm: A New Health System for the Twenty-first Century (Washington:National Academy Press, 2001).
7. Hunt EA, Hohenhaus SM, Iuo X and Frush KS. “Simulation of Pediatric Trauma Stabilization in 35 North Carolina Emergency Departments: Identification of Targets for Performance Improvement.” Pediatrics. 2006 117:641-648.
8. Gausche-Hill M, Schmitz C and Lewis RJ. “Pediatric Preparedness of US Emergency Departments: A 2003 Survey. “Pediatrics, 120 (2007): 1229-1237.
9. All Children Need Children’s Hospitals. Statement from Children’s Hospital Association. August 2013. https://pedsedation.org/wp-content/uploads/2014/01/SPS_Core_Competencies.pdf
10. Connors JM; Cravero JP, Lowrie L, Scherrer P, and Werner D. “Society for Pediatric Sedation® Consensus Statement: Core Competencies for Pediatric Providers who Deliver Deep Sedation.” https://pedsedation.org/wp-content/uploads/2014/01/SPS_Core_Competencies.pdf