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 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, PCO 2 23 mm Hg, PO 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 mm Hg, pulmonary capillary wedge pressure 19 mm Hg, cardiac index (CI) 1.8 L/min/m 2, 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/m 2 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:

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: Mutlu GM, Factor P. Intensive Care Med. 2004;30: 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:

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 CPOE or 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: Nebeker JR. Arch Intern Med. 2005;165:

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:

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: Leape LL. JAMA. 1999;282: 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:

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: