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PREP the Course 2017St. Petersburg, FLGeneral Pediatrics Session II
The speaker has no conflicts of interest to disclose. No commercial support No discussion of off-label usage of drugs or devices/equipment
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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
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
“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 injury caused by medical care (rather than the patient’s underlying disease) 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
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Adverse event 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
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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
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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 circumcised4. Child on ventilator develops PNA
despite rigorous “best” staff hygiene/practices
CLASSIFICATION
A. Medical errorB. Preventable adverse eventC. Non‐preventable adverse eventD. Near missE. 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.S. medical system is 3-9 times deadlier than a gun
Estimated $17-29 billion/year1
1Mello MM, Studdert EM, Thomas EJ, et al. Journal of Empirical Legal Studies, Dec. 2007 4(4):835–60
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Review of 4 studies New methodology Lower limit of 210,000 PAEs that caused patient deaths
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. 2005 ;115:155-60.
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Weight-based dosing Over dosing Under dosing
Long length of stay Complex medical regimens High severity of illness Adolescents
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Most common adverse event (Why?) Multiple opportunities for errors Ordering Transcription Preparation Delivery Administration
Medication errors include errors of commission and omission
Product naming and packaging Medical abbreviations
(e.g., MgSO4 and MSO4, 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
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Error Diverted
People Procedures& Policies
Equipment
People
Procedures
Equipment
System
Etc.
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“Every system is perfectly designed to achieve exactly the results it gets.“
Don Berwick, Former President and CEOInstitute for Healthcare Improvement
“Every system is perfectly designed to achieve exactly the results it gets.“
Don Berwick, Former President and CEOInstitute for Healthcare Improvement
“A bad system will beat a good person every time.”- W. Edwards Deming
Knowledge, skill, training, experience Needs, bias, beliefs, mood, motivations Age (generation), gender, ethnicity Stress Fatigue Distraction
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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
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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
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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
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Hubris Lack of detection/recognition Fear of blame Fear of litigation Time consuming Unclear mechanism for reporting
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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
1Milch CE, Salem DN, et al. Voluntary Electronic Reporting of Medical Errors and Adverse Events. J Gen Intern Med. 2006: 21:165-70.
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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
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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
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UAL Flt 173 to Portland, OR, 1978
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
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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
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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”
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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. (pp401-21. Boca Raton, FL: CRC Press.
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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. (pp401-21. Boca Raton, FL: CRC Press.
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For the patient and family For the physicians and other health care providers
involved
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“Supposing is good, but finding out is better.”
-Mark Twain in Eruption; -Mark Twain's Autobiography
Data measured over time Useful to track trends Run charts Control charts (AKA Shewhart charts)
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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
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Cause-effect diagrams Flow charts Check sheets Scatter diagrams Histograms Pareto charts
AKA “fishbone diagrams” or “Ishikawa diagrams”
Identifies factors leading to overall effect
Schematic representationof an algorithm or step-wise process
Check sheets Scatter plots Histograms Pareto charts
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Pareto Chart of Reasons for Late Clinic Arrivals
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Scatter Diagram Weight v. Height
What is a PDSA Cycle?
Act
• What changesare to be made?
• Next cycle?
Plan• Objective•Questions andpredictions (why)
• Plan to carry outthe cycle (who,what, where, when)
Study• Complete theanalysis of the data•Compare data topredictions•Summarize what
was learned
Do• Carry out the plan• Document problemsand unexpectedobservations
• Begin analysisof the data
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Langley GL, et al. 2009
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.)
IMPROVEMENT MODEL
PlanImprovement
StudyResults
DoImprovement
Act(Stay on courseor try something
new)
PDSA Cycle
P
A D
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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
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
