PREP the Course 2017 St. Petersburg, FL General Pediatrics Session II

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1 PREP the Course 2017 St. Petersburg, FL General Pediatrics Session II

2 The speaker has no conflicts of interest to disclose. No commercial support No discussion of off-label usage of drugs or devices/equipment CS = Content specification

3 Medical errors remain problematic in clinical practice Pediatric patients may be particularly susceptible to medical errors There are opportunities to redesign practice to make patient care safer

4 Review the cost (in terms of morbidity/mortality and finances) of medical errors in the U.S. Define adverse events, medical errors, near misses, and sentinel events Determine which tools of QI are best suited for process analysis and which are best suited to follow data over time Describe the components of a PDSA cycle and articulate the role of PDSA cycles in quality improvement

5 Everyone in healthcare really has two jobs when they come to work every day: to do their work and to improve it. Paul Batalden

Medical error act of commission (do something wrong) or omission (fail to do the right thing) that leads to an undesirable outcome or significant potential for such an outcome Adverse event any

6 Medical error act of commission (do something wrong) or omission (fail to do the right thing) that leads to an undesirable outcome or significant potential for such an outcome Adverse event any injury caused by medical care (rather than the patient s underlying disease) CS CS Preventable adverse event based on available medical knowledge, could have been prevented Non-preventable adverse event based on available medical knowledge, could not have been prevented

7 Adverse event CS Does not imply error, negligence, or poor quality care Simply indicates that an undesirable clinical outcome resulted from some aspect of diagnosis or therapy, not from underlying disease process

8 Near-miss event close call an error/event that did not produce harm Intercepted Non-intercepted (no harm by chance) Sentinel event - adverse event in which death or serious harm to a patient has occurred Usually refers to events that are not at all expected or acceptable Word sentinel reflects the egregiousness of the injury (e.g., wrong site surgery); high likelihood that investigation of such events will reveal serious problems in current policies/procedures CS CS

EVENT 1. Patient develops Stevens Johnson syndrome after taking Ibuprofen 2. PCN is ordered on a patient who is PCN allergic, but pharmacy catches the mistake 3. Wrong child gets circumcised 4.

9 EVENT 1. Patient develops Stevens Johnson syndrome after taking Ibuprofen 2. PCN is ordered on a patient who is PCN allergic, but pharmacy catches the mistake 3. Wrong child gets circumcised 4. Child on ventilator develops PNA despite rigorous best staff hygiene/practices CLASSIFICATION A. Medical error B. Preventable adverse event C. Non preventable adverse event D. Near miss E. Sentinel event

Estimated 44,000-98,000 hospitalized patients die each year as a result of medical errors in the U.S. In 2015 there were 33,693 deaths in the U.S. due to guns (11,208 murders, 21,175 suicides, and the remainder were accidental) U.

10 Estimated 44,000-98,000 hospitalized patients die each year as a result of medical errors in the U.S. In 2015 there were 33,693 deaths in the U.S. due to guns (11,208 murders, 21,175 suicides, and the remainder were accidental) U.S. medical system is 3-9 times deadlier than a gun Estimated $17-29 billion/year 1 CS 1 Mello MM, Studdert EM, Thomas EJ, et al. Journal of Empirical Legal Studies, Dec (4):835 60

11 Review of 4 studies New methodology Lower limit of 210,000 PAEs that caused patient deaths

13 CS Some estimate 3x more risk of AEs in children Study of hospitalized children in Colorado and Utah AEs affected 1% of hospitalized children 70,000 children/year 60% are felt to be preventable Adverse drug events are the most common Birth related Diagnostic related Higher rates of AEs in adolescent patients Woods D, et al. Adverse events and preventable adverse events in children. Pediatrics ;115:

14 CS Weight-based dosing Over dosing Under dosing Long length of stay Complex medical regimens High severity of illness Adolescents

15 Most common adverse event (Why?) Multiple opportunities for errors Ordering Transcription Preparation Delivery Administration Medication errors include errors of commission and omission

16 Product naming and packaging Medical abbreviations (e.g., MgSO 4 and MSO 4, a.u. and o.u., etc.) Electronic prescribing v. handwritten Rxs Role of ancillary services (e.g., pharmacy) to prevent medication errors Medical device design CS

17 Error Diverted

19 People Procedures & Policies Equipment

20 CS System People Procedures Equipment Etc.

21 Every system is perfectly designed to achieve exactly the results it gets. Don Berwick, Former President and CEO Institute for Healthcare Improvement

22 Every system is perfectly designed to achieve exactly the results it gets. Don Berwick, Former President and CEO Institute for Healthcare Improvement

23 A bad system will beat a good person every time. - W. Edwards Deming

24 Knowledge, skill, training, experience Needs, bias, beliefs, mood, motivations Age (generation), gender, ethnicity Stress Fatigue Distraction CS

25 Failure mode effect analysis (FMEA) proactive QI process used to anticipate/determine system vulnerability, including points of potential failure and what their effect would be before an error actually happens Root cause analysis (RCA) is a reactive process, employed after an error occurs, to identify its underlying causes CS CS

26 CS Identifies the what, how, and why something happened Goal is to prevent recurrence of the event 4 steps Collect data Chart causal factors Identify root causes Make recommendations/implement changes

27 Recognition of potential for errors and detection of medical errors/aes is key first step Missed detection of errors = missed opportunities for improvement Near misses great opportunities to reflect on system and how errors can be eliminated prior to actual patient harm CS

28 Hubris Lack of detection/recognition Fear of blame Fear of litigation Time consuming Unclear mechanism for reporting CS

CS Non-punitive, non-blaming culture Focus on the system Anonymous reporting systems Non-discoverable Trigger methodology where specific events trigger a detailed case review/chart audit Ordering of

29 CS Non-punitive, non-blaming culture Focus on the system Anonymous reporting systems Non-discoverable Trigger methodology where specific events trigger a detailed case review/chart audit Ordering of certain drugs (e.g., antidiarrheals) Orders for antidotes Certain abnormal laboratory values Abrupt stop orders Voluntary systems for reporting adverse medical event Strongly endorsed by IOM e-ers underused by physicians (< 2%) 1 1 Milch CE, Salem DN, et al. Voluntary Electronic Reporting of Medical Errors and Adverse Events. J Gen Intern Med. 2006: 21:

30 Effective communication (e.g. SBAR) Computerized physician order entry (CPOE) and dose-range checking, allergy verification Maintain a culture of safety/quality improvement e.g., MMI conferences, QI training courses/conferences, morning report Role for institutional leadership Transparency (Practice-based learning and improvement) Practice EBM Utilize best-practice guidelines/protocols CS

31 CS Team approach to patient care (AND to QI) - physicians, nursing, pharmacy, etc. with all empowered to voice concerns/share ideas (System-based practice) Avoid situations that increase errors (fatigue, distractions, stress, etc.) Empower patients and families to help reduce errors National patient safety goals UAL Flt 173 to Portland, OR, 1978

32 Identify patients correctly Use at least 2 patient identifiers Eliminate transfusion errors Improve communication Timely communication of critical lab and diagnostic test results Use medicines safely Labeled medications drawn up for procedures Reduce harm from anticoagulation Rxs Update medication lists CS

33 CS Prevent health care associated infections Hand hygiene EBM practices to prevent multi-drug resistance infections EBM practices to prevent CLABSI EBM practices to prevent surgical site infections EBM practices to prevent CAUTI Prevent falls

34 CS Prevent decubitus ulcers Assess and reassess each patient s risk and take appropriate action to address identified risks Universal protocol to prevent wrong site, wrong procedure, wrong person surgery Conduct pre-procedure verification Mark surgical sites Procedural time out

36 CS Choose private area/set the stage Provide brief review of the course of care Warning shot to signal what is coming Be frank, kind, and PAUSE Empathy Comfort with silence Gauge patient/family readiness for information Invite future questions Advise regarding physician availability (dispel abandonment fears) Pichert JW, Hickson GB, et al. (2012) Communicating about Unexpected Outcomes, Adverse Events, and Errors. In: P. Carayon, ed. Handbook of Human Factors and Ergonomics in Health Care and Patient Safety. (pp Boca Raton, FL: CRC Press.

37 CS Precise apology When and where error occurred Causes, results of harm, action taken to reduce harm/prevent recurrence Who will manage ongoing care Describe error review process, reporting, how system issues are identified Provide contact for ongoing communication Offer counseling/support Address bills for additional care Pichert JW, Hickson GB, et al. (2012) Communicating about Unexpected Outcomes, Adverse Events, and Errors. In: P. Carayon, ed. Handbook of Human Factors and Ergonomics in Health Care and Patient Safety. (pp Boca Raton, FL: CRC Press.

38 For the patient and family For the physicians and other health care providers involved CS

39 VS

40 Supposing is good, but finding out is better. -Mark Twain in Eruption; -Mark Twain's Autobiography

42 CS Data measured over time Useful to track trends Run charts Control charts (AKA Shewhart charts)

43 When an intervention works Positive reinforcement When an intervention does not work Truthful assessment should lead to reallocation of resources/effort to find a better way When an intervention works differently than was expected Identification of unintended consequences CS

44 Cause-effect diagrams Flow charts Check sheets Scatter diagrams Histograms Pareto charts

45 AKA fishbone diagrams or Ishikawa diagrams Identifies factors leading to overall effect

46 Schematic representation of an algorithm or step-wise process

47 Check sheets Scatter plots Histograms Pareto charts Pareto Chart of Reasons for Late Clinic Arrivals Weight (lbs) Scatter Diagram Weight v. Height Number of times reason cited Cumulative Percent Height (in)

48 What is a PDSA Cycle? CS Act What changes are to be made? Next cycle? Study Complete the analysis of the data Compare data to predictions Summarize what was learned Plan Objective Questions and predictions (why) Plan to carry out the cycle (who, what, where, when) Do Carry out the plan Document problems and unexpected observations Begin analysis of the data Langley GL, et al. 2009

49 IMPROVEMENT MODEL What are we trying to accomplish? -AIM - How will we know that a change is an improvement? - Data Over Time (Tools: Run Charts, Control Charts) What changes can we make that will result in an improvement? - Process Analysis (Tools: Flowchart, Cause & Effect Diagram, Pareto Chart, etc.) P Act (Stay on course or try something new) Plan Improvement A Study Results Do Improvement D PDSA Cycle S

Health care can be dangerous we need to make it safer for patients Medical errors and AEs have a lot of cost morbidity, mortality, and financial When errors occur disclosure

51 Health care can be dangerous we need to make it safer for patients Medical errors and AEs have a lot of cost morbidity, mortality, and financial When errors occur disclosure is needed Quality Improvement necessary and part of our professional responsibilities IHI model for health care improvement PDSA cycle Importance of following data over time

52 Evaluate your practice in terms of its safety culture Consider educating your practice staff on the importance of recognizing medical errors Challenge all members of your health care team to become patient safety and quality care advocates Remind patients and family members of their roles in making patient care safer

53 One person can make a difference, and everyone should try. - John F. Kennedy waldon.garriss@wellstar.org

THE AMERICAN BOARD OF PATHOLOGY PATIENT SAFETY COURSE APPLICATION

THE AMERICAN BOARD OF PATHOLOGY PATIENT SAFETY COURSE APPLICATION Requirements: Component I Patient Safety Self-Assessment Program Programs must meet the following criteria to be an ABP approved Patient