Spotlight Case June 2005

1. Spotlight Case June 2005 Getting to the Root of the Matter

2. Source and Credits • This presentation is based on the June 2005 AHRQ WebM&M Spotlight Case • See the full article at http://webmm.ahrq.gov • CME credit is available through the Web site • Commentary by: Scott Flanders, MD; Sanjay Saint, MD, MPH • Editor, AHRQ WebM&M: Robert Wachter, MD • Spotlight Editor: Tracy Minichiello, MD • Managing Editor: Erin Hartman, MS

3. Objectives At the conclusion of this educational activity, participants should be able to: • Appreciate the goals and limitations of root cause analysis • Outline the steps to conduct root cause analysis

4. Case: Getting to the Root of the Matter A 65-year-old man with atrial fibrillation, lung cancer, and chronic renal insufficiency presented to ED with shortness of breath. Vitals signs were significant for respiratory rate of 32, temperature of 102.4°F, oxygen saturation of 87% on 100% non-rebreather. Chest X-ray showed a right middle lobe infiltrate. Due to respiratory distress, the patient was intubated.

5. Case: cont. The patient became hypotensive with a systolic blood pressure (BP) of 65 mm Hg. While continuing fluid resuscitation, BP was supported with phenylephrine and vasopressin. Phenylephrine was changed to norepinephrine. After 8 hours, arterial blood gas revealed pH 7.23, PCO2 23 mm Hg, PO2 161 mm Hg, BE –16, lactate 6.2 mmol/L (normal 0.5 – 2.2 mmol/L).

6. Case: cont. A pulmonary artery catheter was placed, and initial numbers were—surprisingly—more consistent with cardiogenic shock than septic shock. Central venous pressure was 13-17 mm Hg, pulmonary capillary wedge pressure 19 mm Hg, cardiac index (CI) 1.8 L/min/m2, and systemic vascular resistance (SVR)1500 dynes/sec x cm-5.

7. Case: cont. Norepinephrine was weaned rapidly. The patient remained on vasopressin. An ECG showed global decrease in contractility, with an ejection fraction of 45% and mild right ventricular dilatation. Shortly thereafter, it was discovered that the patient had been receiving 0.4 units/min of vasopressin, rather than the intended dose of 0.04 units/min. Vasopressin was discontinued.

8. Case: cont. Within the next few hours, the patient’s condition improved. The CI and mixed venous oxygen saturation increased to 3.8 L/min/m2 and 75%, respectively, and the SVR decreased to 586 dynes/sec x cm-5. A creatine kinase (CK) peaked at 7236 U/L, CKMB at 37 U/L. The patient was treated with fluids and antibiotics, and had an uneventful recovery.

9. Root Cause Analysis • Investigation of a serious adverse event or close call • Performed by a team with expertise in the area whose members were not directly involved with the error • Team typically organized by patient safety or quality improvement program

10. Goals of Root Cause Analysis • What happened • Why did it happen • What can be done to prevent it from happening again

11. Root Cause Analysis • Assess environment of the error and identify system vulnerabilities rather than individual culpability • Observe work environment • Interview staff involved • Review incident reports of similar errors • Propose realistic suggestions for change Bagian JP. Jt Comm J Qual Improv. 2002;28:531-545.

12. Performing Root Cause Analysis • How would you do it? • What would you be likely to find in this case? • What solutions could be implemented?

13. Performing Root Cause Analysis • Establish the team • Leader from patient safety • ICU physician • ICU nursing (manager and staff) • Pharmacist • ER physician • Trainees (resident and fellow)

14. Performing Root Cause Analysis • Step # 1—Develop timeline of events • All provider contact with the patient (from physician to patient transport) • All orders • All tests, test results • Step #2—Generate a differential diagnosis for systems factors that may have contributed to the error

15. RCA—Timeline • Fellow tells resident to start patient on vasopressin • Resident uses computerized order entry system. Multiple doses of vasopressin are available. He orders vasopressin 0.4 units/min instead of 0.04 units/min • Nurses deliver the medication for 16 hours

16. RCA—Timeline • Team rounds on patient next morning, including attending, pharmacist, nurses, and trainees • During an orientation tour, nurse informs nursing students that patient is receiving vasopressin at a dose of 0.4 units/minute • ICU fellow overhears this and realizes the patient is receiving the wrong dose

17. RCA—Differential Diagnosis • No ICU protocols for high-risk procedures or for the use of high-risk drugs • Poor staff / trainee teamwork skills • No systematic process in the ICU for reviewing key aspects of patient care during daily rounds

18. RCA—Differential Diagnosis • No nursing guidelines or protocols for use of vasopressor medications • No process in pharmacy to highlight medications used in differing doses for different indications

19. RCA—Analyzing Contributing Factors • No ICU protocols for high-risk procedures or for the use of high-risk drugs • Preventable adverse drug events common in ICU • Vasopressin, given narrow therapeutic window and serious adverse cardiovascular effects, should be flagged as a high-risk medication • Protocols should be developed for high-risk medications Bates DW. JAMA. 1995;274:29-34.Mutlu GM, Factor P. Intensive Care Med. 2004;30:1276-1291.see Notes for complete references

20. RCA—Differential Diagnosis • Poor staff / trainee teamwork skills • Vasopressin order incorrectly written by resident after receiving a verbal order from his supervising critical care fellow • Unlikely that the fellow asked the resident whether he understood the order or had used vasopressin previously in patients with septic shock • Unlikely that verbal order was followed by a “read back” by trainee

21. RCA—Differential Diagnosis • No systematic process in the ICU for reviewing key aspects of patient care during daily rounds • ICU physician rounding process rarely includes a regular assessment of medication doses, drug interactions, or key error prevention and patient safety steps • Pharmacists not always included Saint S. Ann Intern Med. 2002;137:125-127.

22. RCA—Differential Diagnosis • No nursing guidelines or protocols for use of vasopressor medications • Nursing in this ICU did not follow set protocols related to the use of vasopressors • No systematic review of medication doses during nursing sign-out • No regular process of “double-checking” whether the right drug is being given to right patient at the right dose

23. RCA—Differential Diagnosis • No process in pharmacy to highlight medications used in differing doses for different indications • CPOE in place, but merely implementing CPOEor a barcoding system will not eliminate medication errors • CPOE system did not ask for the indication, nor flag the order for pharmacist to review Kaushal R. Arch Intern Med. 2003;163:1409-1416. Nebeker JR. Arch Intern Med. 2005;165:1111-1116.

24. RCA—System Solutions • Most institutions respond to such errors by patching “small leaks” in systems that have created the error • Most long-lasting changes result from complete system redesign • Most institutions are reluctant to commit the resources and effort required for such changes Bates DW. Ann Intern Med. 2002;137:110-116.

25. RCA—System Solutions • Redesign medication delivery process employing multidisciplinary approach • Reconcile all medications on admission and discharge from ICU • ICU safety officer rounds with team reviewing all medication • At minimum, team, including pharmacist, reviews all medications on rounds Pronovost P. J Crit Care. 2003;18:201-205. Leape LL. JAMA. 1999;282:267-270. Keely JL. Ann Intern Med. 2002;136:79-85.

26. RCA—System Solutions • High-risk medications need to be treated similarly to high-risk procedures • “Time outs” before administration • Program standard dosing scales into IV pumps • Implement teamwork training for all ICU staff, physicians, nurses, and trainees • Include role-playing and simulations to improve team dynamics and communication

27. RCA—System Solutions • Create a forum that allows residents, fellows, and other team members to openly discuss errors • Morning report or morbidity and mortality conference Wu AW. JAMA. 1991;265:2089-2094.

28. RCA—System Solutions • CPOE system should remind physician that a drug like vasopressin has more than one indication; then query the indication and provide suggested dose • Overridden computer-generated recommendations ideally would be flagged for immediate pharmacist review • Smart systems could include admitting diagnoses, and by combining that with patient location (ICU or ward) flag a drug or dose as potentially incorrect

29. RCA—Caveats and Limitations • Works best in reducing rare events • Proposed system solutions must be feasible • All changes should be re-evaluated periodically to ensure the process is indeed safer and achieving the desired outcomes

30. Take-Home Points • RCA is an important tool for reducing serious, rare adverse events • Multidisciplinary approach and commitment of resources is necessary to employ successful solutions • Changes should be evaluated regularly to assure efficacy Wu AW. JAMA. 1991;265:2089-2094.