CASE STUDY IN SYSTEMS FAILURE

1. CASE STUDY IN SYSTEMS FAILURE Ethan Cumbler M.D. Assistant Professor of Medicine Hospitalist Section University of Colorado Hospital 2007 Case represents an example based on real case. Some details have been changed and case de-identified to preserve patient confidentiality

2. Case-Background • 78 y/o with multiple comorbidities including afib, DM II, CHF and CAD • Pt was taken off warfarin 2 months before admission due to falls. • Underwent gallbladder removal for symptomatic gallstones one month PTA. • Two days PTA left lower extremity swelling begins. Pt c/o pain from left knee to groin.

3. What Diagnosis Do You Suspect?

4. Case- PMH • Afib • DM II with proteinurea • CAD with stent in 2007 • CHF • HTN • COPD • Overactive bladder with indwelling cath • Hyperlipidemia • Osteoporosis • Macular degeneration • Hx shingles • PSH • Choly 1 month PTA • Cataract removal • Social History • 25 pack yr smoking hx. • No ETOH • No drug use • Widowed • Lives alone

5. CASE-MEDS • MEDS: • Esomeprazole • Aspirin • Digoxin • Atorvastatin • Furosamide • Lorazepam • Fiber • Norethindione • Ranitidine • Alendronate • Diltiazem XT • O2 5L • MEDS: • Nitrofurantion • B12 • Fluticasone/salmeterol • Prochlorperazine prn • Meclizine prn • Vaginal Estrogen supp. • Brimonidine opth • Latanoprost opth • Oxybutinin • Pregabalin • Fluconazole • Glyburide

6. What About This Case Already Creates Higher Than Average Risk for Adverse Events and Medical Error?

7. SET-UP • Multiple Interacting Co-morbidities • Polypharmacy- Multiple opportunities for drug-drug interactions • Annual risk of Adverse drug event in the elderly: • <5 med4% risk • 6-10 meds10% risk • 11-15 meds30% risk • >15 meds55% risk

8. CASE-EXAM • Vitals 150/60 37.2 76 18 98% on 5L • Irregular Heart Rate. Grade 3/6 SEM • Abdomen- mildly tender RUE • 3+ edema in left lower extremity (1+ on right)

9. CASE-LABS+IMAGING • Na 133, K 4.2, Cl 98, CO2 23, BUN 25, Gluc 80 • Cr 2.0 • WBC 13.2, HB 11.2, Plt 330 • INR 1.2 • U/S DVT extending from the common femoral vein to the distal femoral vein

10. CASE- Initial Assessment • #1- DVT, over wt limit for LMWH. Start Heparin drip (used custom 18 U/kg/hr following 80 U/kg bolus). Warfarin 5mg qd 1st dose tonight. Stool for occult blood. Malignancy w/u as outpt • Increased WBC. ? Due to UTI. Bactrim. • Afib- Check Digoxin level • DM- hold oral agents SSI • CAD- continue Aspirin • COPD- O2 • HTN- Continue home meds • Proph- Heparin drip. Change H2B to PPI

11. Potential Issues • Overall plan is reasonable- Medical team seems to recognize increased risk of bleeding. • Use of custom higher than average dose of heparin in setting of renal failure. • Increased risk for bleeding with combination aspirin/warfarin/heparin • Multiple drug-drug interactions (warfarin and antibiotic). Levels will need close monitoring.

12. CASE-HOSPITAL COURSE • Day 1+2- initiated plan • Day 4- blood pressure noted to be relatively low. Anemia discussed. Aspirin held

13. CASE-HOSPITAL COURSE • Day 5- Hb drops to 7.8. • Assessment notes drop in Hb. Attributes to likely acute/subacute bleed. CT abdomen ordered • (Note later in day comments on CT finding of rectus sheath hematoma)

14. CASE-HOSPITAL COURSE • 0815- order to transfuse 2 U PRBCs • 0835- nursing notes “MD will write for T+C for possible transfusion” • 1859- type and cross completed • 2055- transfusion started • 0200 the following morning transfusion completed

15. Analysis of Case • Use (Systematic Analysis of a Medical Error form to guide discussion)

16. Step 1Adverse event, Medical error, Causation • Was there an adverse event? Yes- the bleed represented an adverse drug event. • Was there a medical error? Yes- 17 hour 45 min delay between ordering a transfusion and the completion of the transfusion • Significant delay in transfusion represents a delay between intent and outcome • (Remember that the definition of medical error does not require harm to occur) • Did the medical error cause the adverse event- No. In this case there is an adverse drug event but the medical error occurred during the treatment of the adverse event and was not a causal factor.

17. Step 2Did system errors contribute to medical error?Which types? • Type and Cross blood sample was lost • No feedback mechanism to trigger investigation when blood did not arrive • This error represents both problems with information management and with communication • To determine exactly what in the system failed, a more detailed process map was required.

18. Failure Analysis • Process Mapping • Between Order and Transfusion > 20 nodes • Where did things go wrong? • Failure at Nodes • Tech drawing multiple blood samples before sending • Blood sent by tube system to wrong location by nurse • Lack of Nodes • No feedback mechanism, when blood has not arrived • Lack of Communication • Pt sent for CT Scan before type and cross drawn

19. Step 3List Individual Errors + Type • Individual error included nurse sending type and cross to wrong location via intra-hospital tube system • This represented a Skill-based Error on the part of the nurse who accidentally sent the blood to the wrong location. • Looking back there was probably also opportunity for earlier recognition of the adverse drug event (bleeding) by the physicians with the drop in blood counts on day #3

20. Step 4List Heuristic Failures Leading to Individual Judgment Error • None related directly to the medical error which was the delay between ordering the transfusion and the blood being transfused

21. Step 5What Level Harm Occurred As a Result of The Adverse Event? • Rectus sheath bleed in patient on heparin/coumadin/and aspirin is an adverse drug event • Harm occurred- major temporary harm • The adverse event was probably not directly related to the medical error in this case. • No evidence that harm was worsened by delay in transfusion

22. Step 6What Would You Disclose? • In a case such as this where the process has broken down but no harm is occurring it is appropriate to keep the patient informed that the transfusion is still planned but has been delayed by difficulty processing the blood. • A simple apology for the delay is usually sufficient when no harm is occurring. • A commitment to keep the patient updated is important.

23. Step 7What Could Be Done To Prevent This In The Future?

24. What Could Be Done To Prevent This In The Future? • Involve risk management to assist in creating new feedback nodes between the floor nurses and the laboratory. • This involves change in system of care and requires multi-disciplinary approach to creating a solution • Follow-up by physician to assure that ordered events are occurring (active step which is significantly less reliable then the system solution described above)

25. References • Pierluissi E, Fischer MA, Campbell AR, Landefeld CS. Discussion of Medical Errors in Morbidity and Mortality Conferences. JAMA 2003;290:2838-2842 • C.K. Hofling et al. An Experimental Study in Nurse-Physician Relationships. Journal of Nervous and Mental Disease 143; 1966:171-80 (as quoted in The Lucifer Effect. Understanding how Good People turn Evil. Philip Zimbardo Random House New York 2007) • Blumenthal D, Ferris TG. Safety in the Academic Medical Center: Transforming Challenges Into Ingredients For Improvement. Academic Medicine 2006;81:817-822 • Murayama KM, Derossis AM, DaRosa DA, Sherman HB, Fryer JP. A Critical Evaluation of the Morbidity and Mortality Conference. Am J Surg 2002; 183:246-250 • Spencer FC. Human Error in Hospitals and Industrial Accidents: Current Concepts. J Am Coll Surg 2000:191:410-418

26. References • Buetow S, Elwyn G. Patient Safety and Patient Error. Lancet 2007;369:158-161 • Jagsi R, Kitch BT, Weinstein DF, Campbell EG, Hutter M, Weissman JS. Residents Report on Adverse Events and Their Causes. Arch Intern Med 2005;165:2607-2613 • Patient Safety: Past, Present, and Future. Clinical Orthopaedics and Related Research 2005;440:P242-250 • James Reason. Human Error. Cambridge University Press. Cambridge. 1990