Download presentation
Presentation is loading. Please wait.
1
Failure Modes and Effects Analysis (FMEA) for Compounder Practices
Joel Melroy, PharmD, MS, BCPS Director, Adult Pharmacy Services
2
Objectives Recognize the utility of a systems based approach constructing a Failure Modes and Effects Analysis (FMEA) Demonstrate techniques to effectively build an FMEA through a consensus based, interprofessional approach Apply a systematic approach for reducing errors in a complex system or organization
3
MUSC Pharmacy Overview
310 people (~290 FTEs) Locations spread throughout campus to optimize delivery of clinical care Three 24-hour inpatient pharmacies Infusion centers, OR pharmacies, IOP, Support Services Four retail pharmacies + mail order Education Partnership with College of Pharmacy – over 200 student rotations One of the largest Pharmacy Residency programs in the nation
4
Connect to Purpose MD order for 3% Sodium Acetate
Medication comes from Pharmacy and starts to infuse Patient’s symptoms do not improve Hours later, a second bag is needed. Discovery that the initial bag did not contain sodium acetate. The new bag contains the correct ingredients and is sent. Patient’s symptoms improve
5
Background Medication safety event occurred involving an error in compounding 3% Sodium Acetate Root Cause Analysis completed that identified multiple points of failure (Swiss cheese) Problems were identified and solutions implemented; however, possible risks with the current processes still existed A proposal to conduct an FMEA was approved by the IMPROVE/Quality Operations group Team included: Performance Improvement facilitator, directors, coordinators, pharmacists and technicians Focus: Compounding processes involving the automated compounder in the pharmacy
6
Compounder
8
What is an FMEA? Failure Modes and Effects Analysis
A systematic analysis of a process used to identify potential failures and to prevent their occurrence Developed in the 1950s and used by organizations such as NASA and Ford Motor Company Must evaluate the ACTUAL process – not what we think is happening! Failure Mode The manner in which the process could potentially fail to meet the process requirements (intended outcomes)
9
Constructing the Team Objective care team members with a systematic focus who are detail oriented and connected to the process Technicians and Pharmacists involved in error Pharmacy Management/Leadership Medication Safety and Use Policy Pharmacists Pharmacy Residents IS Human Factors Facilitator
10
Prioritization and Rules of Engagement
Importance of ensuring high priority of attending meetings or discussions Understanding the reason behind what we are doing Judgment stops at the door – ensure a trusting environment for differences in process to be discussed Identified as a “system problem” so we are not going to discuss individual shortcomings Employees are the key to understanding and improving process Watch for leaders speaking over employees as to “what should happen”
11
FMEA Process Construct a detailed process map
Identify process steps with highest risk of error Evaluate each process step for potential causes, effects of failure, and process controls Score severity, occurrence, and detection to obtain a Risk Priority Number Prioritize RPN and develop actions to proactively mitigate failures Risk Prioritization Number
12
Process Mapping….
13
Process mapping….
18
Lessons Learned from Process Mapping
Management's view WILL BE different than what actually happens. Just accept it! Discussions about potential failure modes will start to occur during process mapping Utilize the opportunity to gain information and potentially follow up data/feedback needed prior to the FMEA scoring If needed, take a field trip! Perspective of Human Factors Engineer – asks questions that most of the SME just assumed
19
Potential Effects of Failure Recommended Action(s)
FMEA (Failure Mode and Effects Analysis) Process Step Potential Failure Mode Potential Effects of Failure Potential Cause(s) Current Process Controls SEV OCC DET RPN Recommended Action(s) Abacus templates Templates are not built with the correct ingredients Formulation made incorrectly Unable to identify templates to modify Visual check 10 7 490 Investigate further integration of EPIC templates and software with the compounder to reduce the reliance on Abacus. Ingredient omission Template does not match what is on the compounder 4 280 Delay in therapy Extra time spent making corrections 1 16 Abacus templates are not modifiable Could end up working with a template that you know is incorrect Limited administrator rights Could end up working with a template that you don't know is incorrect 700 No Abacus template Delay in therapy and have to go manual Low use item New product Disconnect with operational needs
20
Potential Effects of Failure Recommended Action(s)
Process Step Potential Failure Mode Potential Effects of Failure Potential Cause(s) Current Process Controls SEV OCC DET RPN Recommended Action(s) Verify order in EPIC The order build is not correct in EPIC Formulation made incorrectly Incorrect ingredients Visual check 7 343 Build a robust process to validate, maintain and update all templates in EPIC. Build a reliable process to communicate drug shortages or any ingredient changes to all compounder stakeholders. The order build is outdated 4 196 Formulation made incorrectly or the formulation can not be made at all Product changes do not get updated into EPIC None 10 490 Unable to verify ingredients that are available Lack of knowledge available ingredients 280 Changes in product availability are not communicated well
21
Potential Effects of Failure Recommended Action(s)
Process Step Potential Failure Mode Potential Effects of Failure Potential Cause(s) Current Process Controls SEV OCC DET RPN Recommended Action(s) Check the mix check report Miss a manual add is required No manual add performed Don't check report Visual check 10 4 160 No hand off communication between techs None 7 700 Use the wrong drug Formulation made incorrectly Misread the mix check report 1 28 Chose the wrong drug Does not always go through Dose Edge 280 Expand use of Dose Edge varification software Prepare for Incorrect amount Formulation Injected too to allow the validation of a manual add. checking using made incorrectly much or too little Create the following SOPs: the vial and 400 A technician that starts a prep, finishes the prep pull back One prep at a time from start to finish method Represented the incorrect amount on the pull back 112 Incorrect drug Selected the wrong drug
22
Potential Effects of Failure Recommended Action(s)
Process Step Potential Failure Mode Potential Effects of Failure Potential Cause(s) Current Process Controls SEV OCC DET RPN Recommended Action(s) Place bag, Incorrect Mix Wrong report Multiple preps Visual check syringe, vial Check Report in with wrong bag being done at and Mix Check Report in basket the same time 1 4 Product omission Formulation made incorrectly Multiple preps being done at the same time 7 10 280 Too small of volume 28 Incorrect other items in basket Wrong product selection by technician 160 Dose Edge preparation Bar code scanning error System is set up incorrectly Visual check in Dose Edge System doesn't recognize ingredient Software hard stop Tech scans bar code different than one used in preparation Scan wrong bar code resulting in incorrect formulation To avoid removing item from sterile area and returning it Visual 49 Pharmacist verification The wrong formulation is dispensed Unverified formulation is dispensed Pharmacist doesn't perform verification Visual check of label Patient receives wrong formulation Pharmacist didn't detect error 100 Pharmacist doesn't correct error
23
Lessons Learned from the FMEA
It takes committed time, effort, and staff buy-in to be effective Scoring may not be perfect, but it should be consistent Refer back to a ground rule document when everything becomes a “10” Establish a rule for consensus on scoring Make sure everyone has a voice – elicit comments/feedback from those who have “quieter” voices Follow through – cannot lose positive momentum Organize similar process steps for more substantive resolutions Have patience
24
Questions? Team Members Jeff Brittain Colleen Scherer Deanna Kidwell
Drew McCormick Eric Smathers Jennifer Carter Bill Medovic Ken Catchpole Lindsay Wallace Shelby Stricklin Dominic Ragucci Matt Van Cuyk Joel Melroy
Similar presentations
![Presented to [Date] By [Insert Name] The Application of FMEA to a Medication Reconciliation Process.](/33/6551852/big_thumb.jpg "Presented to [Date] By [Insert Name] The Application of FMEA to a Medication Reconciliation Process.>")
