Human error reduction- How to translate it into better cardiac outcomes
Transcription
Human error reduction- How to translate it into better cardiac outcomes
Human error reduction- How to translate it into better cardiac outcomes Today the role of Sol Aronson will be played by Gary Roach, Kaiser San Francisco Sol Aronson, Duke University Why does it really matter • Headlines like this The FOCUS Initiative Dead By Mistake In California State Collects Data; Some Charge It's UnderReported Flawless Operative Cardiovascular Unified Systems Human Error Reduction in Cardiovascular Surgery Hearst Newspapers/San Francisco California August 8, 2009 Society of Cardiovascular Anesthesiologists Foundation FOCUS STEERING COMMITTEE SCA and SCAF MISSION “IMPROVE PATIENT CARE” • Cardiovascular patients are unsafe due to: Chair Bruce D. Spiess, M.D. Alan F. Merry, M.D. University of Auckland VCU Medical Center Christina T. Mora Mangano James H. Abernathy, M.D. Medical University of South Carolina Solomon Aronson, M.D. Duke University Medical Center Paul G. Barash, M.D. Yale Medical School Steven N. Konstadt, M.D. Maimonides Medical Center – Collective lack of knowledge: • When none of us know how to treat this disease/event Stanford University • We improve patient safety here through research Nancy A. Nussmeier, M.D. SUNY Upstate Medical Center Gary W. Roach, M.D. Kaiser Permanente Thor Sundt, M.D. – Individual lack of knowledge: • When the collective intelligence knows how to treat, but the individual practitioner is unaware • We improve patient safety here through education Mayo Clinic Joyce A. Wahr, M.D. Clinical Strategies 1 SCA and SCAF MISSION “IMPROVE PATIENT CARE” • Cardiovascular patients are unsafe due to: – Human error: • “To err is human” • Irreducible rate of occurrence, and not due to lack of knowledge • We must improve patient safety by designing processes to capture and correct error before harm occurs • “Individuals can and will forever commit errors, but teams have the ability to be flawless.” Locating Errors through Networked Surveillance (LENS) Reducing Human Error In Cardiovascular Care Preparation for August 13th, 2009 Meeting – John Nance Suggested Reading • • • • • • • • Carayon P, Hundt A, Karsh B, Gurses AP, Alvarado C, Smith M and Brennan P. Work system and patient safety: The SEIPS Model and Design Approach. Quality and Safety in Health Care. 2006;15 (Suppl. 1): i50-i58. Flin R, Burns C, Mearns K, Yule S, Robertson EM. Measuring safety climate in health care. Qual. Saf. Health Care. 2006;15:109-115. Gurses AP, Seidl K, Vaidya V, Bochicchio G, Harris A, Hebden J, and Xiao Y. Systems ambiguity and guideline compliance: A qualitative study of how intensive care units follow evidencebased guidelines to reduce healthcare-associated infections. British Medical Journal. 2008;17(5):351. Health Care Criteria for Performance Excellence. Baldridge National Quality Program. 2009. Web. 06 August 2009. http://www.baldrige.nist.gov/HealthCare_Criteria.htm. Nieva VF, Sorra J. Safety culture assessment: a tool for improving patient safety in healthcare organizations. Qual Saf. Health Care. 2003;12:ii17-ii23. Pronovost PJ, Goeschel CA, Marsteller J, Sexton B, Pham JC and Berenholtz SM. Framework for Patient Safety Research and Improvement. Circulation, Jan 2009;119: 330-37. Singla AK, Barrett TK, Weissman JS, Campbell EG. Assessing Patient Safety Culture: A Review and Synthesis of the Measurement Tools. J Patient Saf. 2006;2:105-115. Additionally, to gain a better understanding surrounding the theories related to value-based management, please peruse the following websites: – – http://www.valuebasedmanagement.net/methods_quinn_competing_values_framework.html http://www.valuebasedmanagement.net/methods_vroom_expectancy_theory.html Slide 9 Bristol & Winnipeg: Two Disasters Across the Pond • Pediatric cardiac surgical deaths – Bristol: 30-35 more deaths than avg. (1984-95) – Winnipeg: 12 deaths over 1 year • Bristol – Anesthetist raised concerns in 1988 – Internal conflicts resulted in Dept of Health involvement – Temporary moratorium not until 1995 – premise that quality of clinical care cannot be taken for CMAJ; 165: 1461. granted in any specialty or location Walshe, Quality in Health Care; 10: 250. Slide 10 Lessons learned from pediatric cardiac surgery • Errors exist at all levels of cardiac surgery programs: – – – – Hiring procedures Lack of monitoring Lack of complaints procedure Low caseloads/experience – – – – Create “organizational culture of quality” Strong and effective clinical leadership Strong corporate focus Resource investment • Need effective systems of clinical audit • Need strong and shared vision/ values about QI • Involve patients in their care • Credentials do not equal experience: Continue education in quality for all providers CMAJ; 165: 1461. Communication: Lack of redundancy • Event: Duke, February 2003, case of Jessica Santillan – 17 year-old Hispanic female with restrictive cardiomyopathy and pulmonary hypertension underwent heart-lung transplantation with ABO incompatibility that was realized at the end of the surgery – Underwent immunosuppressive therapy and a second heart-lung transplantation within 2 weeks, but died shortly afterward Moss. Quality in Health Care; 7: 119. Walshe. Quality in Health Care;10: 250. Coulter. BMJ; 324: 648. Slide 11 Slide 12 2 Communication: Lack of redundancy • Event: Children’s Medical Center of Dallas/Baylor, July 2002, case of Jeanella Aranda Communication: Lack of redundancy Data collection: – Both cases • Results of the Root Cause Analysis • Reported in the lay press (NY Times, US News and World Report) – 1 year-old with liver hamartoma resection with complications that required liver transplantation – Partial liver donation came from her father – Findings of lack of redundant communication • Santillan case: Surgeon claimed responsibility, but there were numerous points in organ procurement where blood type information was optional (and missed) • Aranda case: Laboratory mix-up confused mother’s and father’s blood types, leading to miscommunication – ABO incompatibility was realized 19 days post-op by her mother, who noted the blood type being transfused; the infant died on the following day Slide 13 Communication: Lack of redundancy • • • • • • • • • Baker, T. (2005). The medical malpractice myth: Jesica and Jeanella. In T. Baker, The medical malpractice myth (pp. 4-6). Chicago, IL: University of Chicago Press. URL: http://books.google.com/books?id=oscj8zwYkgC&pg=PA4&lpg=PA4&dq=children's+medical+center+dallas+aranda&source=bl&ots=Nb0b p074uw&sig=_3LzvhMECkGUjw2icLMyNApxFko&hl=en&ei=FbjkSerLEZzmlQf_6pDgDg&sa=X&oi=book_ result&ct=result&resnum=1#PPA6,M1 Campion, E.W. (2003). A death at Duke. N Engl J Med, 348(12), 1083-1084. (Perspectives) Comarow, A. (2003, Jul 28-Aug 4). Jesica's story. One mistake didn't kill her--the organ donor system was fatally flawed. US News World Rep, 135(3), 51-54, 56, 58. Grady, D., Altman, L.A. (2003, March 23). Suit Says Transplant Error Was Cause in Baby's Death. NY Times, A23. URL: http://www.nytimes.com/2003/03/12/us/suit-says-transplant-error-was-cause-inbaby-s-death.html Grenny, J. (2003). Silence kills [White paper]. Retrieved from http://academy.clevelandclinic.org/Portals/40/Silence_Kills.pdf Powell, C.S. (2003). The death at Duke. N Engl J Med, 348(25), 2578-2579; Author reply 2578-9 Resnick, D. (2003 Jul/Aug). The Jesica Santillan tragedy: lessons learned. Hastings Cent Rep, 33(4), 15-20. Sade, R. (2003). Why illegal aliens get a place in line. Duke case involved a serious medical error, not a transplant policy violation. Mod Healthc, 33, 13,16. Sloane, A. (2003). Grading Duke: "A" for acknowledgment. J Health Law, 36(4), 627-645. Slide 14 Wong et al. studies, 2006-2009 • Three studies of “precursor events”-- events that precede and are requisite for adverse events • Precursor events occurred more often in cases with death or near miss outcomes than with no adverse outcomes • A new surgical center had more precursor events than established centers but quickly reduced them Wong, Eur J Cardiothorac Surg; 29: 447. Wong, Surgery; 141: 715. Wong, Surgery; 145: 131. Slide 15 Slide 16 Wong et al. 2006 • Prospective anonymous reporting of precursor events in the COR • 3 University affiliated teaching facilities • Reports could come from any member of the team. • Data collected 4/2003-5/2004 • 464 cardiac procedures with 1,627 reports of problematic precursor events (990 unique) • Mean was 3.5 + 3.9 events Wong, Eur J Cardiothorac Surg; 29: 447. Slide 17 Precursor events • • • • • • • • • 33.3% prior to incision 31.2% while on Bypass 15.7% post bypass 90% were compensated for 30.9% not discussed by the team Nurses primary reporters - 28% Anesthesiologist reports – 20.4% Perfusionist reports – 16.3 Surgeons, residents, PA/NP- reports 35.3 Wong, Eur J Cardiothorac Surg; 29: 447. Slide 18 3 Major vs. Minor Events Minor Missing ID stickers Contaminated SG Incorrect booking Incorrect count Dropping a retractor Bleeding from leg Asking for the wrong valve And many others… Major Perforating IVC with a chest tube CPB pump failure Making vein graft too short Revising anastomosis secondary to bleeding Clot formation in heart while on pump Inotrope running out unnoticed Giving epinephrine instead of lidocaine bolus Wong, Eur J Cardiothorac Surg; 29: 447. Wong et al. 2007 • Same data as 2006 • Relationship of precursor events (PE) to adverse outcomes • Cases with outcomes of death or near miss complications had more PE’s • Distribution of PE’s: – 36% management – 29% technical – 23% environment-related • “Most affected person” in PE’s – – – – 41% Surgeon 28% Anesthesiologist 21% Nurse 9% Perfusionist Slide 19 Wong, Surgery; 141: 715. Slide 20 Wong et al. 2009 • Same data as 2006 study • Across the first 101 cases at a new surgical center, precursor events were reduced from 9.4 to 2 • Stable PE’s at 2 established comparisons • Decreased environment-related, communication and management PE’s • Global reductions of PE’s for all team members Human Factors Analysis & Classification System (HFACS) for Cardiac Surgery • Showed applicability of a human factors model (HFACS) for error detection in cardiac surgery • HFACS model originally developed for use in aviation • Structured interviews with 68 clinicians • Unsafe acts (skill-based errors, routine violations, etc.) in cardiac surgery associated with following factors: – Organizational influences (climate, resource management, etc.) – Unsafe supervision (inadequate, etc.) – Preconditions to unsafe acts (environment, teamwork, etc.) Wong, Surgery; 145: 131. ElBardissi. Ann Thorac Surg; 83:1412. Slide 21 Slide 22 Surgical Flow Disruptions and Errors Surgical Flow Disruptions and Errors • Identified surgical flow disruptions • Events – Surgical flow disruptions: System design factors – Surgical errors: Technical events in which intended outcome was not achieved • Data collection: – Convenience sample of 31 cardiac surgical operations – Observed by one individual who stood at the patient’s head – – – – – Teamwork (52%) Extraneous interruptions (17%) Supervisory/training related issues (12%) Equipment and technology (11%) Resource-based issues (8%) • Surgical errors increase with surgical flow disruptions (r=0.47*) • Teamwork/communication – Only significant predictor of number of surgical errors (standardized Beta= 0.7 with p<0.000) – Follow-up data analysis conducted on disruptions related to teamwork/communication Wiegmann. Surgery; 142: 658. Slide 23 Wiegmann. Surgery; 142: 658. Slide 24 4 Teamwork/communication related disruptions • Surgeon-technical team failures (51%) • Patient/procedure information (20%) • Surgeon-anesthesiologist communication (15%) • Surgeon-perfusionist communication (10%) • Handoffs (4%) – Initiating CPB – Weaning the patient from CPB ElBardissi. European Journal of Cardio-thoracic Surgery; 34:1027. Works Consulted (2001). Error and blame: the Winnipeg inquest. CMAJ, 165(11), 1461, 1463. Baker, T. (2005). The medical malpractice myth: Jesica and Jeanella. In T. Baker, The medical malpractice myth (pp. 4-6). Chicago, IL: University of Chicago Press. URL: http://books.google.com/books?id=oscj8zwYkgC&pg=PA4&lpg=PA4&dq=children's+medical+center+dallas+aranda&source=bl&ots =Nb0bp074uw&sig=_3LzvhMECkGUjw2icLMyNApxFko&hl=en&ei=FbjkSerLEZzmlQf_6pDgDg&s a=X&oi=book_result&ct=result&resnum=1#PPA6,M1 Campion, E.W. (2003). A death at Duke. N Engl J Med, 348(12), 1083-1084. (Perspectives) Comarow, A. (2003, Jul 28-Aug 4). Jesica's story. One mistake didn't kill her--the organ donor system was fatally flawed. US News World Rep, 135(3), 51-54, 56, 58. Coulter, A. (2002). After Bristol: putting patients at the centre. BMJ, 324, 648–651. ElBardissi, A.W., Wiegmann, D.A., Dearani, J.A., Daly, R.C., and Sundt, T.M.,3rd. (2007). Application of the Human Factors Analysis and Classification System Methodology to the Cardiovascular Surgery Operating Room. Ann Thorac Surg, 83:1412-1419. ElBardissi, A.W., Wiegmann D.A., Henrickson S., Wadhera R., Sundt T.M.,3rd. (2008). Identifying methods to improve heart surgery: an operative approach and strategy for implementation on an organizational level. European Journal of Cardio-thoracic Surgery, 34, 1027-1033. Grady, D., Altman, L.A. (2003, March 23). Suit Says Transplant Error Was Cause in Baby's Death. NY Times, A23. URL: http://www.nytimes.com/2003/03/12/us/suit-says-transplant-error-was-causein-baby-s-death.html Grenny, J. (2003). Silence kills [White paper]. Retrieved from http://academy.clevelandclinic.org/Portals/40/Silence_Kills.pdf Slide 25 Works Consulted Kohn, L.T., Corrigan, J., Donaldson, M.S. (1999). To Err Is Human: Building a Safer Health System. Available from: http://books.google.com/books?id=1NSGBPzemrYC Moss, F. (1998). Learning from tragedies. Qual Health Care, 7(3), 119-120. Powell, C.S. (2003). The death at Duke. N Engl J Med, 348(25), 2578-2579; Author reply 2578-9 Resnick, D. (2003 Jul/Aug). The Jesica Santillan tragedy: lessons learned. Hastings Cent Rep, 33(4), 15-20. Sade, R. (2003). Why illegal aliens get a place in line. Duke case involved a serious medical error, not a transplant policy violation. Mod Healthc, 33, 13,16. Sloane, A. (2003). Grading Duke: "A" for acknowledgment. J Health Law, 36(4), 627-645. Solis-Trapala, I.L., Carthey, J., Farewell, V.T., de Leval, M.R. (2007). Dynamic modelling in a study of surgical error management. Stat Med, 26(28), 5189-5202. Walshe, K., & Offen, N. (2001). A very public failure: lessons for quality improvement in healthcare organisations from the Bristol Royal Infirmary. Qual Health Care, 10(4), 250-256. Wiegmann, D.A., ElBardissi, A.W., Dearani, J.A., Daly, R.C., and Sundt, T.M.,3rd. (2007). Disruptions in surgical flow and their relationship to surgical errors: An exploratory investigation. Surgery, 142, 658-665. Wong, D. R., Ali, I. S., et al. (2009). Learning in a new cardiac surgical center: an analysis of precursor events. Surgery, 145(2): 131-137. Wong, D. R., Torchiana, D. F., et al. (2007). Impact of cardiac intraoperative precursor events on adverse outcomes. Surgery, 141(6): 715-722. Wong, D.R., Vander Salm, T.J. et al. (2006). Prospective assessment of intraoperative precursor events during cardiac surgery. Eur J Cardiothorac Surg, 29(4): 447-455. Slide 26 THE FOCUS INITIATIVE • Flawless Operative Cardiovascular Unified Systems Goal: To improve patient safety by human error reduction The FOCUS initiative is a cooperative effort designed to raise the bar for patient safety through systems analysis and human factors engineering. Slide 27 THE FOCUS RFP PROCESS • Request for Proposals elicited from 60 institutions THE FOCUS PROJECT COLLABORATORS • Johns Hopkins chosen (team led by Peter Pronovost) • Six finalists selected • “we seek a team of consultants with experience in the field of human factors, observational method and error analysis. . . To reduce human error in cardiovascular care” – SCA FOCUS RFP “Nearly a decade after the publication of this landmark report (“To Err is Human”), not a single healthcare organization can provide a credible answer to the question: ‘Are we safer?’” Peter Pronovost, MD, Ph.D. Quality and Safety Research Group Johns Hopkins University 5 SYSTEMS ERRORS SYSTEM FAILURE Multiple Errors Line Up Communication between resident and nurse • Adverse outcomes – rarely have a single cause Inadequate training and supervision – are the result of multiple system errors that “line up” to create a system failure • A human factors engineering “lens” is needed to find and analyze these ailments in the system • Correction of system errors must focus on the system processes, not the individuals Catheter pulled with Patient sitting OUTCOME: Patient suffers venous air embolism Lack of protocol For catheter removal Pronovost Annals IM 2004 Worst Aviation Disaster Ever, Canary Islands 1977 Is Aviation the appropriate model? 543 Dead • What If? • As with most airplane accidents, several seemingly small events occurred which, had any of them not happened, the tragedy would have been prevented. For example: • If the bombing more than 100 miles away at another airport had not happened or if the phony threat of another bombing had not been made, those planes never would have been at Los Rodeos. • If the Pan Am hadn't been 1 1/2 hours late out of Los Angeles, it would have arrived at Los Palmas before the closure. • If the Pan Am had been allowed to remain in a holding pattern, it would not have been at Los Rodeos. • If the KLM hadn't taken the time to refuel, or if the weather hadn't deteriorated, the visibility would have been higher when it took off. • If the Pan Am had been able to make it around the KLM when it was refueling, it wouldn't have been there when the KLM was taking off. • If the Pan Am hadn't missed the third taxiway, it would have avoided a collision. • If the Pan Am and ATC hadn't been speaking at the same time, the KLM would have heard the instruction to wait for clearance. • If the visibility had been even slightly better, both aircraft may have had enough time to avoid one another. • Still, the KLM almost missed the Pan Am CRM Introduced Elements of the Surgical Safety Checklist Selected Process Measures before and after Checklist Implementation, According to Site Haynes A et al. N Engl J Med 2009;360:491-499 Haynes A et al. N Engl J Med 2009;360:491-499 6 Outcomes before and after Checklist Implementation, According to Site SYSTEM FACTORS IMPACT SAFETY Institutional Hospital Departmental Factors Work Environment Team Factors Individual Provider Task Factors Patient Characteristics Haynes A et al. N Engl J Med 2009;360:491-499 Adapted from Vincent BMJ OVERALL APPROACH • Develop partnerships between SCA, Hopkins, other societies (STS, AORN,ASECT to date), organizations, and hospitals to create learning communities • Identify hazards – Literature review LEARNING FROM ERROR REPORTING • National Reporting and Learning System (NRLS) – Web-based error reporting system in the United Kingdom – Incident reports on a diverse and comprehensive range of medical errors – Currently over 1.5 million reports in the national database • The largest known error reporting system in the world. – Error report data – In depth observations at selected sites • Design, implement and evaluate safety improvement efforts • Reviewed Errors in Cardiac Surgery – 4,828 errors designated – 999 identified as occurring in the operating room • Disseminate broadly to all cardiac operating rooms SUMMARY OF LITERATURE REVIEW • Errors common and often lethal • Distractions and disruptions limited ability to recover and increase risk for harm • Multiple types of hazards exists – Organizational PROACTIVE RISK ASSESSMENT – LENS PROJECT • Apply variety of “lenses” to identify hazards in cardiac surgery • Design, implement and evaluate interventions to mitigate those hazards – Cultural and group dynamics – Interpersonal dynamics – Training and supervision • Broadly implement self assessment and risk reduction tools – Equipment • High profile cases • Apply methodology to other areas • Generally used a single lens 7 RESEARCH STAGES of FOCUS project DOMAINS OF LENS PROJECT • Stage 1: Observe cardiac procedures at 3-5 cardiac anesthesia sites Organizational Sociology Applied Organizational Psychology Human Factors Engineering • Stage 2: Based on analysis of observational studies, select hazards for interventions • Stage 3: Design, implement and evaluate safety program at beta sites Industrial Psychology Cardiovascular Anesthesia EARLY FINDINGS • Stage 4: Broadly disseminate self assessment tool and safety program OPPORTUNITIES FOR IMPROVEMENT APPLYING SCIENCE TO SAFETY • Standardize routine processes • Common concerns across cardiac operating rooms and hospitals – Prep – Line placement – Intra-operative transitions • Identifying good practices • Structure communication • Provide training on medical devices • Many opportunities to improve care • Ensure correct interpretation of local policies • Address distractions • Schedule safely • Opportunities for each lens • Use horizontal space efficiently • Optimize utilization of technology available for use (e.g. Smart IV pumps) NEXT STEPS • Complete site visits and analysis of qualitative data NEXT STEPS • Complete site visits and analysis of qualitative data – Data reviewed 8/13/09 • Develop Risk Assessment tool – Numerous problems noted • Lack of “huddles” and debriefing (1/20) • Based on evidence, prioritize tools to be developed & processes of care to be changed • Numerous communication issues • Conduct focus groups of experts to decide where to start • Chlorhexidine vs. povidone (or even alcohol) • Distractions/diversions • Breaks in sterile technique • Ergonomic issues – Next step is to categorize and develop survey instruments – Fall “Summitt” • Design interventions, pilot test, & revise for ease of implementation and management for all • Link measurable processes of care and clinical outcomes 8 PARTNERS IN FOCUS • Formalize participation – make FOCUS a collaborative project – Endorse FOCUS formally • Invite members to participate in FOCUS committees Thanks for your attention – Public Relations, Data Analysis, Publication • Contribute; identify sources of funding – FOCUS will cost >$1.5M over 3-5 years from SCA alone – We need other intellectual and financial contributions SCA AND SCAF: PARTNERS IN FOCUS • Society of Cardiovascular Anesthesiologists CONTACT US SCA Foundation – Established in 1978 – ~7000 members worldwide – Dedicated to: • Excellence in patient care through education and research in perioperative care for patients undergoing cardiothoracic and vascular procedures. 2209 Dickens Road Richmond, VA 23230 [email protected] • SCA Foundation www.scahqgive.org – Established in 2007 to enhance funding for the missions of the Society – In Nov 2007, assumed oversight and financial responsibility for FOCUS – JHU contract signed in 2008; initial observations complete 804-565-6324 9