CASE STUDY IN CASE STUDY IN SYSTEMS FAILURESYSTEMS FAILURE

Case represents an example based on Case represents an example based on real case. Some details have been real case. Some details have been changed and case de-identified to changed and case de-identified to

preserve patient confidentialitypreserve patient confidentiality

Ethan Cumbler M.D.Assistant Professor of Medicine

Hospitalist SectionUniversity of Colorado Hospital

2007

Case-BackgroundCase-Background

78 y/o with multiple comorbidities including 78 y/o with multiple comorbidities including afib, DM II, CHF and CAD afib, DM II, CHF and CAD

Pt was taken off warfarin 2 months before Pt was taken off warfarin 2 months before admission due to falls.admission due to falls.

Underwent gallbladder removal for Underwent gallbladder removal for symptomatic gallstones one month PTA.symptomatic gallstones one month PTA.

Two days PTA left lower extremity swelling Two days PTA left lower extremity swelling begins. Pt c/o pain from left knee to groin.begins. Pt c/o pain from left knee to groin.

What Diagnosis Do You Suspect?What Diagnosis Do You Suspect?

Case- PMHCase- PMH AfibAfib DM II with proteinureaDM II with proteinurea CAD with stent in 2007CAD with stent in 2007 CHFCHF HTNHTN COPDCOPD Overactive bladder with Overactive bladder with

indwelling cathindwelling cath HyperlipidemiaHyperlipidemia OsteoporosisOsteoporosis Macular degenerationMacular degeneration Hx shinglesHx shingles

PSHPSH Choly 1 month PTACholy 1 month PTA Cataract removalCataract removal

Social HistorySocial History 25 pack yr smoking hx.25 pack yr smoking hx. No ETOHNo ETOH No drug useNo drug use WidowedWidowed Lives aloneLives alone

CASE-MEDSCASE-MEDS MEDSMEDS:: EsomeprazoleEsomeprazole AspirinAspirin DigoxinDigoxin AtorvastatinAtorvastatin FurosamideFurosamide LorazepamLorazepam FiberFiber NorethindioneNorethindione RanitidineRanitidine AlendronateAlendronate Diltiazem XTDiltiazem XT O2 5LO2 5L

MEDS:MEDS: NitrofurantionNitrofurantion B12B12 Fluticasone/salmeterolFluticasone/salmeterol Prochlorperazine prnProchlorperazine prn Meclizine prnMeclizine prn Vaginal Estrogen supp.Vaginal Estrogen supp. Brimonidine opthBrimonidine opth Latanoprost opthLatanoprost opth OxybutininOxybutinin PregabalinPregabalin FluconazoleFluconazole GlyburideGlyburide

What About This Case What About This Case Already Creates Higher Already Creates Higher Than Average Risk for Than Average Risk for Adverse Events and Adverse Events and

Medical Error?Medical Error?

SET-UPSET-UP

Multiple Interacting Co-Multiple Interacting Co-morbiditiesmorbidities

Polypharmacy- Polypharmacy- Multiple opportunities Multiple opportunities for drug-drug for drug-drug interactionsinteractions

Annual risk of Adverse Annual risk of Adverse drug event in the drug event in the elderly:elderly:

<5 med<5 med4% risk4% risk 6-10 meds6-10 meds10% risk10% risk 11-15 meds11-15 meds30% risk30% risk >15 meds>15 meds55% risk55% risk

CASE-EXAMCASE-EXAM

Vitals 150/60 37.2 76 18 98% on 5LVitals 150/60 37.2 76 18 98% on 5L

Irregular Heart Rate. Grade 3/6 SEMIrregular Heart Rate. Grade 3/6 SEM Abdomen- mildly tender RUEAbdomen- mildly tender RUE 3+ edema in left lower extremity (1+ on 3+ edema in left lower extremity (1+ on

right)right)

CASE-LABS+IMAGINGCASE-LABS+IMAGING

Na 133, K 4.2, Cl 98, CO2 23, BUN 25, Gluc 80Na 133, K 4.2, Cl 98, CO2 23, BUN 25, Gluc 80 Cr 2.0 Cr 2.0 WBC 13.2, HB 11.2, Plt 330WBC 13.2, HB 11.2, Plt 330 INR 1.2INR 1.2 U/S DVT extending from the common U/S DVT extending from the common

femoral vein to the distal femoral veinfemoral vein to the distal femoral vein

CASE- Initial AssessmentCASE- Initial Assessment

#1- DVT, over wt limit for LMWH. Start Heparin drip (used #1- DVT, over wt limit for LMWH. Start Heparin drip (used custom 18 U/kg/hr following 80 U/kg bolus). Warfarin 5mg custom 18 U/kg/hr following 80 U/kg bolus). Warfarin 5mg qd 1qd 1stst dose tonight. Stool for occult blood. Malignancy w/u dose tonight. Stool for occult blood. Malignancy w/u as outptas outpt

Increased WBC. ? Due to UTI. Bactrim.Increased WBC. ? Due to UTI. Bactrim. Afib- Check Digoxin levelAfib- Check Digoxin level DM- hold oral agents SSIDM- hold oral agents SSI CAD- continue AspirinCAD- continue Aspirin COPD- O2COPD- O2 HTN- Continue home medsHTN- Continue home meds Proph- Heparin drip. Change H2B to PPIProph- Heparin drip. Change H2B to PPI

Potential IssuesPotential Issues

Overall plan is reasonable- Medical team Overall plan is reasonable- Medical team seems to recognize increased risk of bleeding.seems to recognize increased risk of bleeding.

Use of custom higher than average dose of Use of custom higher than average dose of heparin in setting of renal failure.heparin in setting of renal failure.

Increased risk for bleeding with combination Increased risk for bleeding with combination aspirin/warfarin/heparinaspirin/warfarin/heparin

Multiple drug-drug interactions (warfarin and Multiple drug-drug interactions (warfarin and antibiotic). Levels will need close monitoring.antibiotic). Levels will need close monitoring.

CASE-HOSPITAL COURSECASE-HOSPITAL COURSE

Day 1+2- initiated planDay 1+2- initiated plan Day 4- blood pressure Day 4- blood pressure

noted to be relatively noted to be relatively low. Anemia low. Anemia discussed. Aspirin discussed. Aspirin heldheld

DayDay HbHb INRINR PttPtt

11 11.211.2 1.21.2 3232

22 10.910.9 5858

153153

171171

33 8.98.9 1.31.3 72-7372-73

44 8.78.7 1.51.5 6464

CASE-HOSPITAL COURSECASE-HOSPITAL COURSE

Day 5- Hb drops to 7.8.Day 5- Hb drops to 7.8. Assessment notes drop in Hb. Attributes to Assessment notes drop in Hb. Attributes to

likely acute/subacute bleed. CT abdomen likely acute/subacute bleed. CT abdomen orderedordered

(Note later in day comments on CT finding (Note later in day comments on CT finding of rectus sheath hematoma)of rectus sheath hematoma)

CASE-HOSPITAL COURSECASE-HOSPITAL COURSE

0815- order to transfuse 2 U PRBCs0815- order to transfuse 2 U PRBCs 0835- nursing notes “MD will write for T+C for 0835- nursing notes “MD will write for T+C for

possible transfusion”possible transfusion”

1859- type and cross completed1859- type and cross completed 2055- transfusion started 2055- transfusion started 0200 the following morning transfusion completed0200 the following morning transfusion completed

Analysis of CaseAnalysis of Case

Use (Use (Systematic Analysis of a Medical Error form to Systematic Analysis of a Medical Error form to guide discussion)guide discussion)

Step 1Step 1

Adverse event, Medical error, CausationAdverse event, Medical error, Causation

Was there an adverse event? Yes- the bleed Was there an adverse event? Yes- the bleed represented an adverse drug event.represented an adverse drug event.

Was there a medical error? Yes- 17 hour 45 min delay Was there a medical error? Yes- 17 hour 45 min delay between ordering a transfusion and the completion of the between ordering a transfusion and the completion of the transfusiontransfusion

Significant delay in transfusion represents a delay Significant delay in transfusion represents a delay between intent and outcomebetween intent and outcome

(Remember that the definition of medical error does not (Remember that the definition of medical error does not require harm to occur)require harm to occur)

Did the medical error cause the adverse event- No. In Did the medical error cause the adverse event- No. In this case there is an adverse drug event but the medical this case there is an adverse drug event but the medical error occurred during the treatment of the adverse event error occurred during the treatment of the adverse event and was not a causal factor.and was not a causal factor.

Step 2Step 2

Did system errors contribute to medical error?Did system errors contribute to medical error?Which types? Which types?

Type and Cross blood sample was lostType and Cross blood sample was lost No feedback mechanism to trigger No feedback mechanism to trigger

investigation when blood did not arriveinvestigation when blood did not arrive This error represents both problems with This error represents both problems with

information management and with information management and with communicationcommunication

To determine exactly what in the system To determine exactly what in the system failed, a more detailed process map was failed, a more detailed process map was required.required.

Failure AnalysisFailure Analysis

Process MappingProcess Mapping Between Order and Transfusion > 20 nodesBetween Order and Transfusion > 20 nodes Where did things go wrong?Where did things go wrong?

• Failure at NodesFailure at Nodes Tech drawing multiple blood samples before sendingTech drawing multiple blood samples before sending Blood sent by tube system to wrong location by nurseBlood sent by tube system to wrong location by nurse

• Lack of NodesLack of Nodes No feedback mechanism, when blood has not arrivedNo feedback mechanism, when blood has not arrived

• Lack of CommunicationLack of Communication Pt sent for CT Scan before type and cross drawnPt sent for CT Scan before type and cross drawn

Step 3Step 3

List Individual Errors + TypeList Individual Errors + Type

Individual error included nurse sending type and Individual error included nurse sending type and cross to wrong location via intra-hospital tube cross to wrong location via intra-hospital tube systemsystem

This represented a Skill-based Error on the part This represented a Skill-based Error on the part of the nurse who accidentally sent the blood to of the nurse who accidentally sent the blood to the wrong location.the wrong location.

Looking back there was probably also Looking back there was probably also opportunity for earlier recognition of the adverse opportunity for earlier recognition of the adverse drug event (bleeding) by the physicians with the drug event (bleeding) by the physicians with the drop in blood counts on day #3drop in blood counts on day #3

Step 4Step 4

List Heuristic Failures Leading to List Heuristic Failures Leading to Individual Judgment ErrorIndividual Judgment Error

None related directly to the medical error None related directly to the medical error which was the delay between ordering the which was the delay between ordering the transfusion and the blood being transfusedtransfusion and the blood being transfused

Step 5Step 5

What Level Harm Occurred As a Result of What Level Harm Occurred As a Result of The Adverse Event?The Adverse Event?

Rectus sheath bleed in patient on Rectus sheath bleed in patient on heparin/coumadin/and aspirin is an adverse heparin/coumadin/and aspirin is an adverse drug eventdrug event

Harm occurred- major temporary harmHarm occurred- major temporary harm The adverse event was probably not directly The adverse event was probably not directly

related to the medical error in this case.related to the medical error in this case. No evidence that harm was worsened by No evidence that harm was worsened by

delay in transfusiondelay in transfusion

Step 6Step 6

What Would You Disclose?What Would You Disclose? In a case such as this where the process has In a case such as this where the process has

broken down but no harm is occurring it is broken down but no harm is occurring it is appropriate to keep the patient informed that the appropriate to keep the patient informed that the transfusion is still planned but has been delayed transfusion is still planned but has been delayed by difficulty processing the blood.by difficulty processing the blood.

A simple apology for the delay is usually A simple apology for the delay is usually sufficient when no harm is occurring.sufficient when no harm is occurring.

A commitment to keep the patient updated is A commitment to keep the patient updated is important.important.

Step 7Step 7

What Could Be Done To What Could Be Done To Prevent This In The Prevent This In The

Future?Future?

What Could Be Done To Prevent What Could Be Done To Prevent This In The Future?This In The Future?

Involve risk management to assist in creating Involve risk management to assist in creating new feedback nodes between the floor nurses new feedback nodes between the floor nurses and the laboratory.and the laboratory.

This involves change in system of care and This involves change in system of care and requires multi-disciplinary approach to creating a requires multi-disciplinary approach to creating a solutionsolution

Follow-up by physician to assure that ordered Follow-up by physician to assure that ordered events are occurring (active step which is events are occurring (active step which is significantly less reliable then the system significantly less reliable then the system solution described above)solution described above)

ReferencesReferences

1.1. Pierluissi E, Fischer MA, Campbell AR, Landefeld CS. Discussion Pierluissi E, Fischer MA, Campbell AR, Landefeld CS. Discussion of Medical Errors in Morbidity and Mortality Conferences. JAMA of Medical Errors in Morbidity and Mortality Conferences. JAMA 2003;290:2838-28422003;290:2838-2842

2.2. C.K. Hofling et al. An Experimental Study in Nurse-Physician C.K. Hofling et al. An Experimental Study in Nurse-Physician Relationships. Journal of Nervous and Mental Disease 143; Relationships. Journal of Nervous and Mental Disease 143; 1966:171-80 (as quoted in The Lucifer Effect. Understanding how 1966:171-80 (as quoted in The Lucifer Effect. Understanding how Good People turn Evil. Philip Zimbardo Random House New York Good People turn Evil. Philip Zimbardo Random House New York 2007)2007)

3.3. Blumenthal D, Ferris TG. Safety in the Academic Medical Center: Blumenthal D, Ferris TG. Safety in the Academic Medical Center: Transforming Challenges Into Ingredients For Improvement. Transforming Challenges Into Ingredients For Improvement. Academic Medicine 2006;81:817-822Academic Medicine 2006;81:817-822

4.4. Murayama KM, Derossis AM, DaRosa DA, Sherman HB, Fryer Murayama KM, Derossis AM, DaRosa DA, Sherman HB, Fryer JP. A Critical Evaluation of the Morbidity and Mortality JP. A Critical Evaluation of the Morbidity and Mortality Conference. Am J Surg 2002; 183:246-250Conference. Am J Surg 2002; 183:246-250

5.5. Spencer FC. Human Error in Hospitals and Industrial Accidents: Spencer FC. Human Error in Hospitals and Industrial Accidents: Current Concepts. J Am Coll Surg 2000:191:410-418Current Concepts. J Am Coll Surg 2000:191:410-418

ReferencesReferences

6.6. Buetow S, Elwyn G. Patient Safety and Patient Error. Lancet Buetow S, Elwyn G. Patient Safety and Patient Error. Lancet 2007;369:158-1612007;369:158-161

7.7. Jagsi R, Kitch BT, Weinstein DF, Campbell EG, Hutter M, Jagsi R, Kitch BT, Weinstein DF, Campbell EG, Hutter M, Weissman JS. Residents Report on Adverse Events and Their Weissman JS. Residents Report on Adverse Events and Their Causes. Arch Intern Med 2005;165:2607-2613Causes. Arch Intern Med 2005;165:2607-2613

8.8. Patient Safety: Past, Present, and Future. Clinical Orthopaedics Patient Safety: Past, Present, and Future. Clinical Orthopaedics and Related Research 2005;440:P242-250and Related Research 2005;440:P242-250

9.9. James Reason. Human Error. Cambridge University Press. James Reason. Human Error. Cambridge University Press. Cambridge. 1990Cambridge. 1990