1. Best Practices for Prevention of Retained Surgical Items Victoria M. Steelman, PhD, RN, CNOR, FAAN 1

2. Victoria Steelman, PhD, RN, CNOR, FAAN Dr. Steelman has focused on implementing evidence-based practice (EBP) changes for over 20 years and has extensively published and presented on EBP and perioperative issues, and authored many of the AORN Recommended Practices. She received two AORN Outstanding Achievement awards for this work. In 2008, she received the AORN Award for Excellence in recognition of her contributions to perioperative nursing. In 2007, she was inducted into the American Academy of Nursing in recognition of the national and global impact of her work. She is currently the President-Elect of AORN. 3

3. Disclosure Information AORN’s policy is that the subject matter experts for this product must disclose any financial relationship in a company providing grant funds and/or a company whose product(s) may be discussed or used during the educational activity. Financial disclosure will include the name of the company and/or product and the type of financial relationship, and includes relationships that are in place at the time of the activity or were in place in the 12 months preceding the activity. Disclosures for this activity are indicated according to the following numeric categories: 1. Consultant/Speaker’s Bureau: Consultant to RF Surgical Systems, Inc. 2. Employee 3. Stockholder 4. Product Designer 5. Grant/Research Support : Principal Investigator, University of Iowa, RF Surgical Grant 6. Other relationship (specify) : RF Surgical - Honoraria 7. Has no financial interest: Speaker: Victoria M. Steelman, RN, PhD, CNOR, FAAN Accreditation Statement AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP 13019. AORN IS PLEASED TO PROVIDE THIS WEBINAR ON THIS IMPORTANT TOPIC. HOWEVER, THE VIEWS EXPRESSED IN THIS WEBINAR ARE THOSE OF THE PRESENTERS AND DO NOT NECESSARILY REPRESENT THE VIEWS OF, AND SHOULD NOT BE ATTRIBUTED TO AORN. Planning Committee: Ellice Mellinger MS, BSN, RN, CNOR Discloses no conflict 4

4. Objectives 1.Describe the incidence of retained surgical items and outcomes to patients 2.Discuss recommendations of the Association of periOperative Registered Nurses (AORN) 3.List steps of a proactive risk analysis for evaluating the processes used to prevent retained surgical sponges. 4.Describe the use of a multidisciplinary process to evaluate adjunct technology for prevention of retained surgical sponges 5

5. Top-rated Patient Safety Issues Reported by Perioperative Nurses* Patient Safety Issue% Preventing wrong site surgery68.6% Preventing retained surgical items61.1% Preventing medication errors43.1% Preventing failures in instrument reprocessing 41.1% Preventing pressure injuries39.8% *N = 3137 5 Steelman, V., Graling, P., Perkhounkova, Y. (2013).

6. Sentinel Events Reported to TJC Sentinel Event201020112012 Retained foreign body133168115 Wrong pt/site/procedure93152109 Delay in treatment95138107 Suicide6713185 Op/postop complication8613383 Falls569676 6 The Joint Commission. Summary data of sentinel events reviewed by The Joint Commission. 2013.

7. Retained Surgical Items Retained surgical items (e.g. sponges, needles, and instruments) are estimated to occur in 1:5500 surgeries. 1 Sponges account for 48-69% of retained surgical items. 1 The abdomen is the cavity most often involved. 1 2 3 7 1. Cima, et al. (2008); 2. Lincourt, et al. (2007); 3. Wan, et al. (2009)

8. Outcomes of Retained Surgical Items Reoperation 69% Readmission/prolonged stay 43% Sepsis/infection 43% Fistula/bowel obstruction 15% Visceral perforation 7% Death 2% 8 Gawande AA, et. al. (2003)

9. Risk Factors for Retained Surgical Items Emergency surgery 1 Unplanned change/event in the operation 1, 2 Higher BMI 1, 2 > # surgical procedures at a time 3 Incorrect count reported 2,3 9 1.Gawande, et al. (2003); 2.Stawicki, et al. (2013); 3.Lincourt, et al. (2007)

10. Retained Surgical Sponges Sponges account for 48-69% of retained surgical items. 1 The abdomen is the cavity most often involved. 1 2 3 10 1. Cima, et al. (2008); 2. Lincourt, et al. (2007); 3. Wan, et al. (2009)

11. Tissue Reactions to Retained Surgical Items Metal - Inert, identified in a manner similar to a surgical implant Gauze - Fibrous response adhesions, encapsulation and granuloma - Exudative Inflammatory response Abscess, chronic internal/external fistula 11 Zantvoord, et al. (2008)

12. Sponges Migrate Intestine Bladder Airway/lung Thorax Stomach Retroperitoneum When sponges migrate into these non-sterile tissues, infection, sepsis, and death can occur. 12 Zantvoord, et al. (2008)

13. Best Practices Start With Recommended practices for prevention of retained surgical items Developed by a multidisciplinary committee 13 AORN (2013)

14. Recommended Practices for Prevention of Retained Surgical Items Multidisciplinary approach - Each team member has a role - Work together Accountability: All team members Use a standardized approach Time activities around key events Minimize distractions 14 AORN (2013)

15. Scrub Person Confirm that instruments and devices are intact when returned from the operative site Verify integrity and completeness of items when counting Ensure that the RN circulator can see items when counting Speak up when a discrepancy exists 15 AORN (2013)

16. Circulating RN Counts should not be performed during critical portions of the procedure Initiate the count Perform the count in concert with the perioperative team Communicate & document count results 16 AORN (2013)

17. Surgeon & First Assistant Communicating placement of surgical items in the wound Acknowledging awareness of the start of the count Removing soft goods and instruments from sterile field at the start of the count process Performing methodological wound exploration Accounting for and communicating about surgical items in the surgical field Notifying scrub person and circulator when items are returned to the surgical site after the count 17 AORN (2013)

18. Anesthesia Provider Plan milestone actions to avoid undue pressure during counts Do not use counted items Verify that throat packs & bite blocks are removed & communicate this to the team 18 AORN (2013)

19. Counting All surgical procedures Prior to start of procedure When dispensed onto the sterile field Upon closing a cavity within a cavity - Sponges, soft goods, sharps Upon closing first layer (e.g. fascia) - Sponges, soft goods, sharps Upon final closure Permanent relief of either the scrub person or RN circulator 19 AORN (2013)

20. Needles - All needles should be counted, regardless of size, for all procedures - Needles are counted when the package is opened - Empty suture packages should not be used to reconcile a count - Needles less than 10mm may not be identified on radiographs 20 AORN (2013)

21. Exceptions to Instrument Counting Based upon facility policy: Complex procedures involving large numbers of instruments (e.g. AP spinal fusion) Trauma Procedures that require complex instruments with numerous small parts Procedures where the width and depth of the incision is too small to retain an instrument 21 AORN (2013)

22. Sponges Items should be radiopaque - Towels if used inside the wound Pocketed sponge bag system should be used When intentionally packed, document: - Reconciled when confirmed by surgeon - Incorrect if unsure - Communicate upon transfer 22 AORN (2013)

23. Effectiveness of Counts Primary measure for prevention of RSI Standard of care for many years 1 Sensitivity 77.2% 2 62% of retained surgical items were detected after the surgical count was reported as correct 3 The limited effectiveness of counts is poorly understood 23 1. AORN (2013); 2. Egorova, et al. (2008); 3. Cima, et al. (2008)

24. Retained Surgical Items Should trigger a thorough analysis: - Processes in place - Causes - Contributing factors - Corrective action Root cause analysis - Reactive - Learn from one event 24

25. Proactive Risk Analyses Uses collective experiences of personnel - not just from a single event Look at processes in place Identify potential failures & causes of these failures Prioritize points in the process that require additional control 25

26. Proactive Risk Analyses Failure Mode and Effect Analysis (FMEA) Institute for Healthcare Improvement (IHI) Healthcare Failure Mode and Effect Analysis (HFMEA) National Patient Safety Center, Department of Veterans Affairs (NCPS) http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-1 27

27. Steps of HFMEA 1. Define the topic 2. Assemble the team 3. Graphically describe the process 4. Conduct the analysis 5. Identify actions and outcome measures Definitions based upon the Healthcare Failure Mode and Effect Analysis (HFMEA) from the VA National Center for Patient Safety http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-1 28

28. 1. Define the topic Example: The management of surgical sponges from case preparation in the operating room to surgery completion, in order to prevent inadvertently retained sponges after surgery, 28

29. 2. Assemble the Team Content experts Methods expert 29

30. 3. Graphically describe the process Observation of entire process Not the policy, but the actual practice - There is always a difference Select one type of surgery as exemplar - Map the process - Example: Routine colon resections -3 No relief, 1 circulating RN, 1 ST Day shift 30

31. Example: Steps of Process Step 1.Room preparation 2.Initial count 3.Adding sponges 4.Removing sponges 5.First closing count 6.Final closing count 31 Steelman & Cullen (2011)

32. 4. Conduct the Analysis For each step of the process: a) Identify all failures that could occur in each step b) Identify the causes of these potential failures 32

33. Examples of Potential Failures Added to field, not recorded Miscount- too few sponges counted Miscount- too many sponges counted Part of sponge missing Uncounted towel placed in wound No methodological wound exploration Surgeon closing during count Steelman & Cullen (2011) 33

34. Examples of Causes Room inadequately cleaned after last case Manufacturing defect Knowledge deficit Not following procedure Distraction Multitasking Emergency event or procedure Time pressure Unable to see- person counting too fast 34

35. Causes of High Risk Potential Failures 35 Steelman & Cullen (2011) Cause of Failures % Distraction21% Multitasking18% Not following procedure14% Time pressure13%

36. Calculate a Hazard Score For each failure cause combination in each step: a) Assign a severity score (1-4) b) Assign a probability score (1-4) c) Severity X probability = Hazard score (1-16) 37

37. Severity Rating SeverityDefinition (Patient Outcome)Score CatastrophicDeath or major permanent loss of function, suicide, rape, hemolytic transfusion reaction, surgery / procedure on the wrong patient or wrong body part, infant abduction or infant discharge to the wrong family (Failure could cause death or injury) 4 MajorPermanent lessening of bodily functioning, disfigurement, surgical intervention required, increased length of stay for 3 or more patients, increased level of care for 3 or more patients (Failure could cause a high degree of customer dissatisfaction) 3 ModerateIncreased length of stay or increased level of care for 1 or 2 patients (minor performance loss) 2 MinorNo injury, nor increased length of stay nor increased level of care (failure would not be noticeable to customer and would not affect delivery of the service) 1 37 http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-9

38. Probability Rating SeverityDefinitionScore FrequentLikely to occur immediately or within a short period (may happen several times in one year 4 OccasionalProbably will occur (may happen several times in 1 to 2 years) 3 UncommonPossible to occur (may happen sometime in 2 to 5 years) 2 RemoteUnlikely to occur (may happen sometime in 5 to 30 years) 1 38 http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-9

39. HFMEA Hazard Scoring Matrix 39 SeverityCatastrophic (4) Major (3) Moderate (2) Minor (1) Frequent (4)161284 Occasional (3)12963 Uncommon (2)8642 Remote (1)4321 A score of =/> 8 requires control http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-9

40. 5. Identify Actions and Controls Need to target causes of the high risk failures 40 Cause of High Risk FailureControl Knowledge deficitEducation Multitasking? Distraction? Not following the procedure? Time Pressure?

41. Control Measures Considered 1. Education would not be effective - Knowledge deficit was not an identified cause 1 2. Enforcement of policy would target 14% of failure points 1 3. Requiring a separate “time out” for closing counts would target 37% of failure points 1 4. Intraoperative radiographs- sensitivity 67% 2 41 1. Steelman & Cullen (2011): 2. Cima et al. (2008)

42. Recommended Practices for Prevention of Retained Surgical Items Recommendation VII: 1. Perioperative staff members may consider the use of adjunct technologies to supplement manual count procedures. a) A mechanism for evaluating and selecting existing and emerging adjunct technology products should be implemented. 42 AORN (2013)

43. Recommended Practices for Prevention of Retained Surgical Items Perioperative RNs, physicians, and other health care providers involved in the use of products and medical devices for prevention of RSIs should be part of a multidisciplinary product evaluation and selection committee when the health care organization is evaluating the purchase of adjunct technology Perioperative personnel should evaluate existing and emerging adjunct technology to determine the application that may be most suitable in their setting. 43 AORN (2013)

44. Adjunct Technology Bar code/dot matrix sponges - Facilitates counting sponges Radiofrequency (RF) - Detects retained sponges Radiofrequency identification - Detects and identifies retained sponges 44

45. Evaluating Adjunct Technology Multidisciplinary team Provide an opportunity for those outside of the OR to understand the OR Evaluate all 3 types of technology Identify changes in workflow that would be required 45

46. Steps of a Multidisciplinary Evaluation Two Phases 1. Simulation - Current process - Repeat with each of the adjunct technologies - Script provided as handout (can be modified) 2. In-use evaluation 47

47. Simulation Participants Circulating RN Surgical Technologist (ST) Surgeon Surgical Assistant Anesthesia Provider Quality Manager Safety Officer/Risk Manager 48

48. Simulation Current practices (initial, relief, first closing count, final closing count) Repeat for each of the technologies All Team Members and observers: On a white board or poster board, list: - Pros of the technology - Cons of the technology - Total time required for baseline and each technology. 49

49. In Use Evaluation Input from end-users Evaluate how the technology works with processes during surgery Engages all evaluators in change process 50

50. Summary Preventing retained surgical items is a high priority for action If you always do what you always did you will always get what you always got. Albert Einstein We need to design safer processes 50

51. References Cima RR, Kollengode A, Garnatz J, Storsveen A, Weisbrod C, Deschamps C. Incidence and characteristics of potential and actual retained foreign object events in surgical patients. J Am Coll Surg. 2008;Jul;207:80-87. Dhillon JS, Park A. Transmural migration of a retained laparotomy sponge. Am Surg. 2002;68:603-05. Egorova NN, Moskowitz A, Gelijns A, et al. Managing the prevention of retained surgical instruments: What is the value of counting? Ann Surg. 2008;247:13-18. Gawande AA, Studdert DM, Orav EJ, Brennan TA, Zinner MJ. Risk factors for retained instruments and sponges after surgery. N Engl J Med. 2003;348:229-235. Kaiser CW, Friedman S, Spurling KP, Slowick T, Kaiser HA. The retained surgical sponge. Ann Surg. 1996;224:79-84. Lincourt AE, Harrell, A, Cristiano, J, Sechrist, C, Kercher, K, Heniford, BT. Retained foreign bodies after surgery. J Surg Res. 2007;138:170-174. 51

52. References (cont.) Recommended practices for prevention of retained surgical items. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2013:305-321. Steelman, VM., Cullen, JJ. Sponges: A Healthcare Failure Mode and Effect Analysis. AORN J. 2011; 94. The Joint Commission. Summary data of sentinel events reviewed by The Joint Commission. 2013. http://www.jointcommission.org/assets/1/18/2004_4Q_2012_SE_Stats_Sum mary.pdf VA National Center for Patient Safety. HFMEA. 2013. http://www.patientsafety.va.gov/CogAids/HFMEA/index.html#page=page-1 Zantvoord Y, van der Weiden RM, van Hooff MH. Transmural migration of retained surgical sponges: A systematic review. Obstet Gynecol Surv. 2008;63(7):465-471. 52

53. The End