# Presentation: 512721

## Spotlight Case June 2005

**Getting to the Root of the Matter**

## 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](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

## 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

## 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. *

## 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**2** 161 mm Hg, BE –16, lactate 6.2 mmol/L (normal 0.5 – 2.2 mmol/L). *

## 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/m**2**, and systemic vascular resistance (SVR)**1500 dynes/sec x cm**-5**. *

## 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. *

## 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. *

## 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

## Goals of Root Cause Analysis

- What happened
- Why did it happen
- What can be done to prevent it from happening again

## 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.*

**Notes:**
2. Bagian JP, Gosbee J, Lee CZ, Williams L, McKnight SD, Mannos DM. The Veterans Affairs root cause analysis system in action. Jt Comm J Qual Improv. 2002;28:531-545. 

## Performing Root Cause Analysis

- How would you do it?
- What would you be likely to find in this case?
- What solutions could be implemented?

## 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)

## 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

## 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

## 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

## 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

**Notes:**
Instead of slide 17 and 18 it would be better to include a chopped up version of the table scott included. If you broke it up over 5 slides or so that would be ideal.

## 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

## 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   *

**Notes:**
3. Bates DW, Cullen DJ, Laird N, et al. Incidence of adverse drug events and potential adverse drug events. Implications for prevention. ADE Prevention Study Group. JAMA. 1995;274:29-34. 
4. Bates DW. Unexpected hypoglycemia in a critically ill patient. Ann Intern Med. 2002;137:110-116. 
5. Leape LL, Bates DW, Cullen DJ, et al. Systems analysis of adverse drug events. ADE Prevention Study Group. JAMA. 1995;274:35-43. 
6. Pronovost PJ, Wu AW, Sexton JB. Acute decompensation after removing a central line: practical approaches to increasing safety in the intensive care unit. Ann Intern Med. 2004;140:1025-1033. 
7. Landrigan CP, Rothschild JM, Cronin JW, et al. Effect of reducing interns' work hours on serious medical errors in intensive care units. N Engl J Med. 2004;351:1838-1848. 
8. Mutlu GM, Factor P. Role of vasopressin in the management of septic shock. Intensive Care Med. 2004;30:1276-1291. 
9. Malay MB, Ashton JL, Dahl K, et al. Heterogeneity of the vasoconstrictor effect of vasopressin in septic shock. Crit Care Med. 2004;32:1327-1331. 

## 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

## 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. *

**Notes:**
11. Saint S, Lipsky BA, Goold SD. Indwelling urinary catheters: a one-point restraint? Ann Intern Med. 2002;137:125-127.

## 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

## 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. *

**Notes:**
12. Kaushal R, Shojania KG, Bates DW. Effects of computerized physician order entry and clinical decision support systems on medication safety: a systematic review. Arch Intern Med. 2003;163:1409-1416. 
Nebeker JR, Hoffman JM, Weir CR, Bennett CL, Hurdle JF. High rates of adverse drug events in a highly computerized hospital. Arch Intern Med. 2005;165:1111-1116.

## 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.*

**Notes:**
4. Bates DW. Unexpected hypoglycemia in a critically ill patient. Ann Intern Med. 2002;137:110-116. 

## 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.  *

**Notes:**
13. Pronovost P, Weast B, Schwarz M, et al. Medication reconciliation: a practical tool to reduce the risk of medication errors. J Crit Care. 2003;18:201-205. 
14. Leape LL, Cullen DJ, Clapp MD, et al. Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA. 1999;282:267-270. 
15. Keely JL, for the American College of Physicians-American Society of Internal Medicine. Pharmacist scope of practice. Ann Intern Med. 2002;136:79-85. 

## 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

## 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. *

**Notes:**
16. Wu AW, Folkman S, McPhee SJ, Lo B. Do house officers learn from their mistakes? JAMA. 1991;265:2089-2094. 

## 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

## 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

## 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. *

**Notes:**
16. Wu AW, Folkman S, McPhee SJ, Lo B. Do house officers learn from their mistakes? JAMA. 1991;265:2089-2094.