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Patient Safety 2012 DeconstructedWhat the evidence (and a bit of personal opinion) revealsChuck Biddle PhD, CRNAVirginia Commonwealth University

I wish to divulge…………

ComplexityCognitivelimitsDemand for certaintyPracticalsolutions

Average Rate per Exposure of Catastropheor Death in Various Human ActivitiesNoSystemExistsBeyondThisPoint1/100 1/1,000 1/10,000 1/100,000 1/1,000,000

12 / 1903 1 st Flight 09 / 1908 1 st Death01 / 1846 1 st Ether Anesthetic 01 / 1848 1 st DeathMortality is not the best metric for gauging patient safety

Roller-ball model of patient safetyEquipment&TechnologyStandardofPracticeExpertise&ProficiencyClinicalJudgment= adverse eventNegative PatientOutcome


Risk taker Calm under pressure Tense VulnerableImpulsiveMacho attitudeResignationInvulnerableAnti-authoritarianCompassionateEasily angeredEasy goingConscientiousExtravertedAgreeableNeuroticCooperativeOpen to new ideasConfident Easily agitated Curious Organized

Safety?The avoidance of complicationsRisk management?The process that ensures better patient safetyOur routine involves very dangerousprocedures and drug administrationRisk of putting a patient in a life-threatening situation is real

What is a culture of safety?•Social energy that moves people to act•Construct relying on attitudes & beliefs•Culture : Organization ! Personality : Individual

“Culture” is molded by many forces•The players•Technology•Competition•Personnel policies•The organization’s “product”•Desired position with the industry•Deeply engrained: resistant to change!Rational Medicine 1938Bernard Zakheim- Think of the “culture” of your Department -

ComplexityUnpredictabilityInstabilityEmergencewhole > sum of parts


Progression of aircraft instrumentationAs the technology-- the ability to monitor it allComputers to the rescue!“Fly-by-wire”AIMS* and integrated electronic “navigation” : mimic aviationAIMS is not a threat, it is a benefit to patient safety*anesthesia information management system

Drug errors: a substantial issue in anesthesiologyAnesthesiaDrug ErrorAnaesthesia 2005;60:220ASA Newsletter 2003;67:11Anaesthesia 2008;63:337Qual Saf Hlth Care 2005;14:156

Vials contain from 10 µ / mL up to 10,000 µ / mL

HeparinNaClDistilled H 2 OKCl12341=promethazine 2= heparin 3=phenytoin 4= ketorolacAtropinePhenylephrineHeparinDroperidolNitroprussideFurosemide

Preservative freeEpinephrine Decadronwithmethylparaben

Epinephrine 1mg/mLEpinephrine 1mg/mLEphedrine 50 mg/mL

AntipsychoticAnti-ParkinsonianRisperidoneRopiniroleJAMA, July 27, 2011

Anesthesiology 2002;97:139-147considerotherthingsthatwedo

•Preventable events involving pumps & equipment are frequent•Training / in-servicing too often inadequateJ Gen Intern Med 2007;23:41 JAMA 2004;291:325Reliable Design of Medical Devices. CRC Press, 2006 Critical Care 2006;33:533

Reliance onautomated check-out?Loss of trouble-shooting skill?Overly complicated?

How are we doing after ~10 years?

Harm to patients remains very commonApplication of EB safety practice is modest at bestNEJM. 2010;363:2124British Med J. 2008;337:a2426JAMA. 2005;293:2384

US 1999 ! How are we doing?NEJM. 2010;363:2124-213498,000 deaths / year> 1 million injuries / yearRetrospective study of 5 years10 NC Hospitals 2341 admissions25 “harms” / 100 hospital admissions“Harms” are commonLittle evidence of widespread improvement

What % of patients areharmed by their care?Traditionally: 3 – 17%Voluntary reporting

3 tertiary U.S. hospitals with established safety programsAdverse event detection processes:-- voluntary adverse event reporting-- AHRQ patient safety indicators-- Global Trigger ToolInstitutional confidentiality assured

Note majordiscrepanciesin reportingbased onprocess usedE - I: Error categories that actually “reach” the patientE = temporary harm ! I = deathHealth Affairs. 2011;30:4

Conclusions:Traditional methods underestimate realityAdverse events occur in 1/3 of admissions in high quality hospitals10 years since IOM report: Adverse events extremely common

Objectives:•Estimate the incidence of adverse eventsin hospitalized Medicare beneficiaries•Assess preventability•Assess costFindings:1 in 7 experience a significant harm(November 2010)! 180,000 deaths per year! ~ $4.4 billion per year in additional cost

Central line infectionin ICUs nationwidedecreased by 58%EB bundles reduce central lineand sternotomy woundinfection ratesMMWR 2011;60:243Arch Intern Med 2011;171:73

Am J Infect Control 2002; 30:S1–46Anesthesiology. 2009;110:959-960Anesthesiology. 2009;110:959-96AANA J. 2009;77:229-237Anesthesia Analgesia. 2011;112:98-105We actively contributeto healthcare acquiredinfection•Major killer•Epidemic proportions•1 o hand hygiene issue

Only with focused, determinedeffort in maintaining excellenttechnique is asepsis evenremotely possible with ourcurrent stopcock configuration

is ‘sterile’ techniquetruly feasible?

TRALIAwarenessAcute ischemic strokeCancer recurrence (?)Cognitive impairmentPeripheral nerve injuryOccult vision disturbanceOccult hearing disturbanceInfection… …

Putting a ‘Face’ on Patient Safety

In May 2009 XXX was convicted of manslaughter in the deathof a toddler, sentenced to 8 years in prison. YYY was 3 whenshe died during strabismus surgery after XXX induced generalanesthesia and intentionally disabled all alarm monitors. TheJudge stated, "The defendant effectively went to sleep duringthe surgery without concern."

The effect of fatigueon the roller-ball modelEquipment&TechnologyStandardofPracticeExpertise&ProficiencyClinicalJudgment= adverse event

The National Sleep Study of Nurse AnesthetistsAANA Journal August 2011John Aker, CRNA, DNAPUniversity of IowaChuck Biddle, CRNA, PhDVirginia Commonwealth University

5-14-2008Testifying before acongressional panelPutting a high profile “face” to patient safety

Kim Hiatt, longtime criticalcare RN at Seattle Children'sHospital, committed suicideafter accidentally overdosingan infant with CaCl(2010)In America, we just don't believe in "mistakes". We live under the delusionthat if we pay attention, nothing will go wrong, that perfection is attainableThere is a provider cost to patient error as well……….

Production pressure & other opportunities for disaster

Closed Claims 05-26532 year old mother of 31 year post-partial thyroidectomyc/o unrelenting neck painCervical-epidural steroid, repeated next dayDense tetraplegia within 3 hoursVentilation in a specialized care facility

Provider privileged to do interventional painBusy clinic, delay for patient. Provider was to have receivedoversight but was told to “get it done.” Felt pressured to complyEntirety of training ! 3-day workshop of lectures & cadaversHad never performed a cervical epidural on a living person

Provider new but requested “bigger cases”Told: “surgeon is difficult & aggressive”Recently privileged to place central linesTraining: placed 4 central lines, all in the neck, close supervisionNever placed a subclavian line. Deposition: “felt uncomfortableand awkward” with anatomy and technique“…….wanted to please……….wanted to avoid conflict”

2011 Hospital National Patient Safety Goals*Identify patientsImprove communicationUse medicines safelyPrevent infectionIdentify safety risksPrevent mistakes in surgery*The Joint Commission, 2011

Behaviors undermining a culture of safetyIntimidating & disruptive behaviors•Verbal outbursts / Physical threats•Contribute to adverse outcomes•Good staff may not tolerate & quitEssential issues•Teamwork & good communication•Collaborative work environment

A rich history of tolerating bad behavior in health careOrganizations that fail to address it: indirectly promote itOur “culture”:•Embedded hierarchies•Fear / stress of retaliation•Demands of high productivity•High revenue generating staff: often ”tolerated”Have you ever experienced it?

Inadvertent epidural injection of…….•Ephedrine•Muscle relaxants•Antibiotics•Pitocin•Propofol•Esmolol•IV fluids•Etc……If it’s a liquid and if it’s in a syringe (or IV bag) someone,somewhere has or will inject it into an epidural catheter……..--Chuck Reese, CRNA, PhD

Capnography tubing ! IV tubingEpidural tubing ! IV tubingNIBP line ! needleless IV portO2 tubing ! needleless IV portSequential compression device ! needleless IV port*

Despite the cumulative and overwhelming evidence,little progress has been made to safeguard patients fromtubing misconnectionsWe have all play a part in normalizing deviance

Personal thoughts?

Current problems" Medication: too many look-alikes" Muscle relaxant recovery poorly assessed" Complacency with “simple” cases (e.g., MAC)" Nerve blocks by some who are inadequately trained" Task density increasing / Production pressure increasing

Current problems" Apparatus complexity growing" Iatrogenic transmission of pathogens" Hand-off process too-rushed, too-superficial" Failure to appreciate risk factors for FIRE on the patient" Personal factors ( sleep dysfunction, drug/alcohol use, stress )

Anesth Analg 2010;110:1499AANA Journal 2010;78:284•Removing monitors too soon•Non-sterile dressings on IVs & arterial lines•Excessive noise / talking at key times in care•Handoffs occurring at ‘vital’ / ‘critical’ times•No monitors/resuscitation equipment with nerve block

•Speeding on the highway•Not fully stopping at a stop sign•Wearing scrubs outside the hospital•Texting/internet surfing while driving•Not always wearing gloves (airway, IV)•Reading / texting / internet surfing during cases•Careless “aseptic” technique with respect to stopcocks•Drawing up drugs for the next case during the current case•Abbreviating the preanesthetic workup in “healthy” patients•Performing an incomplete apparatus checkout prior to its use

“Hi, I’m Capt Sullenberger, your pilot . We’re running late and havea very busy day ahead. We’ve not fully checked out the plane. But noworries! Things hardly ever go wrong! So sit back, relax, enjoy!!”Let’s just do thequick one todayYeah, just the oddnumbered ones

Improving anesthesia safety" Technology: U/S for lines and nerve blocksBetter equipment, monitors, alarms" Ergonomics: Appreciation for human factorsWork-hour limits (?) / Drug testing (?)" Protocols: “Time out”, MH, ACLS, 2 people check bloodCommunication “call outs”, Difficult airway" Checklists: FDA machine checkout / Hand-offsWHO pre-surgical checklist / Bundles (CVC)" Education: Better curricula, focused symposia, read!

Individual accountability vs dysfunctional systemBut what about: not doing a time out?not washing your hands?not doing a quality ‘hand-off’?not checking out your equipment?Blame the systemIf pilot refuses to do checkout---fired!!Blame the personYet we engage in behaviors threatening patients without penalty

Gotta get gas for my carWhoa, that guy has a nice ---Birthday card for JoanOh! Work report due TuesdayRemember to renew licenseChecklists have value……………but…..Technical solutions rarely solve adaptive problems

Multidisciplinary checklistMulticenter, prospective studyPreop, Periop & Postop steps--Rx, Mark Site, Postop InstructionsComplications significantly decreasedNEJM2010;363:1928Qual Saf Health Care2009;18:121

We too often rationalize ‘at risk’ behaviorsAs long as the mole doesn’t pop out, we’re OKBut when a “harm” occurs: WE WHACK IT!We will make mistakesAnticipatory design can reap rewardsLearn from them (don’t WHACK ‘em!)

Humans are easily distracted!Simple solutions to complex problemsThe Red TowelIf occupied:Do not enter!Do not talk to!Do not bother!Do not talk to!

1 AANA NewsBulletinMay 2011. 12-152 CDC Guidelineswww.edc/gov/hicpac/pdf/isolation3 MMWR 2010;59:65-69Solution complexity is dwarfed by complication potentialWearing a mask is a quick, painless and cheap solution that mayhelp prevent a huge problem: post-dural puncture meningitis

How Safe (Really) is Anesthesia in 2011?It all depends…..Modern surgery and anesthesiaHarlem Hospital wall muralPaint on plasterAlfred Crimi 1936…..on the human factor

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