SAFETY EVENTS: Challenges of a different type of data ACS NSQIP National Conference July 27, 2015

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1 SAFETY EVENTS: Challenges of a different type of data ACS NSQIP National Conference July 27, 2015 R. Lawrence Moss, MD Surgeon-in-Chief Nationwide Children s Hospital....

2 What do we mean by patient safety events? A patient safety incident is any unintended or unexpected incident which could have or did lead to harm for one or more patients receiving care. Events indicative of an adverse event directly related to the performance of a procedure Distinct from outcome assessment Many, but not all, are related to the anesthesia care

3 Why does the ACS Children s Surgery Verification Committee think this is important? Primum non nocere A core concept of children s surgery verification is ensuring the environment is appropriate to the care NSQIP Peds is NOT designed or structured to capture safety events Attention to these events underscores the importance of the anesthesia and nursing care in the surgical experience It biopsies a different aspect of the organization than would be captured by traditional outcome assessment or structural measures

4 What are the unique challenges of capturing safety events? Our intention is to capture 100% of these events in contrast to investigating a representative sample of care events and assessing outcome The current methods for capturing events vary widely among institutions The ACS-CSV has not yet developed standards for the method of data capture or assessment of the accuracy of data reported Many of these events are captured for other purposes. We would like to leverage these to avoid redundancy of effort while maintaining programmatic standards for accuracy

5 Other Potential Sources of Safety Data Pediatric Hospital Information System (PHIS) JCAHO Reporting Make Safe Happen Institutional SSE and RCA process Anesthesiology M & M process

6 What information does the program currently require that applicant institutions provide? Special thanks for the following individuals for contributing to the development Richard Beren, MD Jayant Deshpande, MD Constance Houck, MD Randall Flick, MD

7 Airway Inadvertent Extubation Unanticipated Reintubation Respiratory Definite Aspiration Safety Events-Intraprocedure Cardiovascular Anaphylaxis-severe with hives, wheezing or hemodynamic effects Cardiac Arrest(chest compressions or defibrillation) Malignant Hyperthermia, definite, suspected or use of dantrolene Hemorrhage Unanticipated need for hemodynamic(vasopressor) support Unanticipated need for ECMO Vascular access complication with vascular injury or pneumothorax Regional Epidural Hematoma Major systemic local anesthetic toxicity Peripheral neurologic deficit following regional anesthesia-residual sensory, motor or autonomic block Unanticipated high spinal with bradycardia, respiratory insufficiency or intubation Neurologic Stroke or Coma Unanticipated seizure Other Death Dental Trauma- unanticipated loss of permanent tooth(teeth) Intraoperative awareness-explicit awareness during anesthesia Medication error-wrong medication or dosing Operation on incorrect patient Operation on incorrect side Operation-wrong operation performed Surgical fires and/or patient burns Transfusion reaction Unanticipated ICU admission Unanticipated return to OR Unanticipated inpatient admission Unanticipated transfer to another institution for higher level of patient care Visual loss-permanent impairment or total loss of sight....

8 Airway Inadvertent Extubation Unanticipated Reintubation Respiratory Definite Aspiration Safety Events- within 48 hours Cardiovascular Anaphylaxis-severe with hives, wheezing or hemodynamic effects Cardiac Arrest(chest compressions or defibrillation) Malignant Hyperthermia, definite, suspected or use of dantrolene Hemorrhage Unanticipated needed for hemodynamic(vasopressor) support Unanticipated need for ECMO Vascular access complication with vascular injury or pneumothorax Neurologic Stroke or Coma Unanticipated Seizure Regional Epidural Hematoma infection following epidural or spinal anesthesia-abscess, meningitis or sepsis Infection following peripheral nerve block Major systemic local anesthetic toxicity Peripheral neurologic deficit following regional anesthesia-residual sensory motor or autonomic block Post-dural headache Unanticipated high spinal with bradycardia, respiratory insufficiency or intubation Other Death Dental trauma-unanticipated loss of permanent tooth(teeth) Intraoperative awareness-explicit awareness during anesthesia Medication error-wrong medication or dosing Surgical fires and/or patient burns Other continued Transfusion reaction Unanticipated ICU admission Unanticipated return to OR Unanticipated inpatient admission....

9 Other Perioperative Safety Events Operations on incorrect site-sentinel evelt Vascular access complication with vascular injury or pneumothorax Pressure ulcers related to events in the OR or perioperative environment within 30 days Unscheduled admission to the hospital for impatient care within 30 days Transfer to another institution for higher level care within 30 days Venous thromboemolic event (VTE) within 30 days....

10 What does the PRQ say? Provide a report of the clinical quality and safety events detailed in Appendix 2 of Optimal Resources for Children s Surgical Care for the 12 month reporting period. (CD 7-2) (CD 7-7) (CD 7-8) (CD 7-9) (See Children s Surgical Safety Report attachment.) Describe process and be prepared to demonstrate accuracy of this data collection process to site review team How and with what frequency are the NSQIP Pediatric and Appendix 2 data reviewed by the medical director of children s surgery, the children s surgery program manager, and the Surgical Program Peer Review Committee? (Describe) What quality improvement initiatives have been developed based on the analysis of these data? Describe one such initiative in detail, including loop closure or outcome. (CD 7-4) (CD 7-5)....

11 How was this issue managed for the pilot site visits? The ACS-CSV Committee regards this as a WORK-IN-PROGRESS Institutions were given credit for developing a plan to collect and a good faith effort The ACS-CSV is looking for partnership and collaboration from ACS- NSQIP to develop a structure and process to collect and manage this information....

12 Key Principles Moving Forward Safety event collection and management will be managed by ACS NSQIP This process will be distinct from the outcomes assessment done by ACS NSQIP Pediatric Use of data already collected for other purposes will be optimized and redundancy of effort will be minimized Data collection responsibility will be administered in a manner that does not place inappropriate burden in SCR time and institutional resources Input and engagement of surgeon champions, SCRs and other NSQIP stakeholders is encouraged

13 Questions for the audience? What information are you currently collecting and for what purpose? What concerns do you have about the SCR burden and resource burden of collecting this information? What could the ACS-CSV do to mitigate these concerns? How can we best insure uniform reliability of data collection between institutions? How would you suggest the site visitors and CSV committee utilize this information?

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