b. Testing of interventions -- likely establishment of at least two new protocols would be put in place; 1) heightened diligence and/or special considerations for certain pharmaceutical combinations with concurrent educational seminars and/or training sessions; 2) additional monitoring criteria based on patient history, combination of symptoms, severity of treatment. Impossible to do double blind studies on these implications, because a repeat of the action is not wanted; but using case analysis and review, potential negative outcomes could still be tested appropriately.

c. Pre-Steps for FMEA Preparation:

a. Collection and analysis of patient records during ER visit.

b. Collection and analysis of patient file from GP or previous hospital visits.

c. Log of staff, patients, and responsibilities for shift (Resource log allocation study).

d. Notarized statements from all involved in the case.

e. Any test results done white in the ER; if autopsied, any quantitative test results.

f. Physicians and Nurses from ER meet to fill out a FMEA worksheet to help guide committee through longitudinal/chronological issues:, ex:

Function

Failure

Mode

Effects

S

(Severity

Rating)

Causes

O

(Occurrence

Rating)

Current

Controls

D

(Detection Rating)

RPN

(Risk

Priority

Number)

Reccom.

Actions

Res.

Target

Completion Date

Action Taken

What was done for patient, details and time?

What failed? When?

What effects.

Scale 1-10, 10 highest

Identification

How often?

Steps in place now

How are issues detected?

Overall risk priority in similar cases

Step-by-Step recomm.

Who is Resp.

Tactics

(Bluvband and Grabov, 2010)

d. FMEA Steps:

1. Severity -- Determine failure modes based on functional requirements and effects. Severity in this case was drug combination and lack of proper monitoring based on history. Use quantifiable methods, not qualitative. Let facts speak, not...

Occurrence -- Based on a chronological timeline, when did the issues seem to occur that caused the failure; was this a small window (less than 10 minutes) in which patient might have recovered had appropriate monitoring happened? If ER had not been busy, would a nurse have caught issue sooner?
3. Detection -- Appropriate actions regarding monitoring and drug interactions have been put in place; but design verification needed. Historical literature review using a professional medical database would provide RPN (risk priority numbers) that might make it easier to note efficacy of change processes (Joint Commission Resources Inc., 2005)

Part 4 - Nurses Role - Actually, the nursing role in this situation was critical. Not only could one of the nurses reminded the physician privately that there was a significant risk for pharmaceutical interaction, but since it was the nurse that brought the oxycodone issue to Dr. T., ample opportunity could have been given to a dialog. Further, in two ways the nurse could have been more proactive: 1) when seeing that there was a past history more severe than originally thought, combined with the drug interaction, a more stringent monitoring system could have been implemented; 2) as the ER became busier, the nurse should have called in additional resources for help with Mr. B. However, all this predicates particular hosptial policy and span of control, as well as level of experience, for the nursing staff. Nurses have a key role in situations like this; they are at the forefront of the tactical situation, and do have the ability to often delve deeper into the issues than an attending, particularly in an ER.

REFERENCES

Drug Interactions Between Oxycodone and Diazapam. (2011, January). Retrieved January 2011, from Drugs.com: http://www.drugs.com/drug-interactions/oxycodone-with-valium-1770-0-862-441.html

Bluvband and Grabov. (2010, March). Failure Analysis of FMEA. Retrieved January 2011, from Advanced Logistics Department: http://www.aldservice.com/en/articles/failure-analysis-of-fmea.html

Joint Commission Resources Inc. (2005). Failure Mode and Effectgs Analysis in Health Care. Oakbrook Terrace, IL: Joint Commissions Resource.

Latino, R. (2006). Root Cause Analysis. Boca Raton, FL: CRC Press.

Tiffany and Lutjens. (1998). Planned Change Theories for Nursing. Thousand Oaks: SAGE.