Sandra ThompsonAdministrator, Quality Resources/ComplianceLaurens County Health Care SystemClinton, SCThursday, May 31, 2012

Discuss establishing a “Culture of Safety”

Describe the linkage between and importance of FMEA to RM

Identify the TJC FMEA requirements

Discuss the basics of failure mode and effects analysis

Identify tools and resources for further information & study

1995: “The year that medicine went to Hell in a handbasket” - Dennis O’Leary, JCAHO President, 9/01 Tampa: Wrong site surgery Dana Farber: Chemo event Martin Memorial: Anesthesia event

These events helped drive a consensus for change

Imperative driven by IOM reports “To Err is Human” – 1999 “Crossing the Quality Chasm” – 2000

Culture of Safety is owned by ALL Not physicians, Administration, or a single

department

Requires new tools, new thinking, new information not traditionally utilized in healthcare FMEA, RCA, Six Sigma, Lean, Systems

Engineering, ????

Root cause analysis

Lean Forcing functions (poke yoke) Standardization (5S) Customer focus (value stream mapping) Front-line staff involvement (observation – “going

to the gemba”, spaghetti diagrams) Push/pull systems (patient flow)

High-reliability organizations “Going for Zero”

Electronic health record

Proactive risk assessment Healthcare FMEA!

Least Effecti

ve

Most Effecti

ve

Forcing Function

s

Automation, Computerizati

on

Protocols, Pre-Printed Orders

Standardization

Checklists

Information

Education

Rules & Double-

Checking

Effectiveness Scale

Inspection

Auditing

Proactive

Reactive

HFMEA is a proactive means of assessing &

decreasing risk in your

organization!

Proactive Risk Assessment (FMEA,

HFMEA)

FMEA Failure Mode & Effect Analysis Traditionally used in industry Looks at a device or a component

HFMEA Healthcare Failure Mode & Effect

Analysis Looks at a process

Process developed by VA Pt. Safety Center

Online tutorial at: http://www.patientsafety.gov/

CogAids/HFMEA/index.html#page=page-1

Do you take actions to prevent yourself from being late to work? Yes or No

Do you “take the shortcut” when you see traffic building up in a familiar place?

Yes or No

Do you try to distinguish “big problems” from “little problems”? Yes or No

Do you see the possibility of eliminating some problems, but need a better way to show that to people?

Yes or No

Failure When process begins to produce

undesired results/effects

Failure Mode Weakness/vulnerability in any part of

process Chain of events that has potential to

cause safety problem

Assists RMs to favorably impact the patient care environment

Another tool in the box of RM strategies to understand and reduce medical error

Assists RMs & others in driving change before it can do harm

Proactively forecasts potential failures

Applies risk /loss control techniques to those potential failures

What philosophy ? “Blame free” vs. “Just Culture”

Do we see systems or individuals?

Are the right tools & resources available for the job?

What is an incident to be reported at your facility? Close call/near miss/”good catches”? Only adverse events (e.g., “harm”)? Sentinel events? Where do willfully unsafe acts fit in? Disruptive

behavior?

Design/redesign incident reporting systems to capture near misses Predictive – show patterns around a process

– 100:10:1 Rich source of information Reward/encourage near miss reporting Follow up on near misses and trend Don’t forget the narrative! Important details

found here Close the loop – report back to staff on

trends, patterns noted, solicit suggestions for improvement

Must filter the tidal wave!

Assign Severity

CatastrophicFailure could cause death or

serious injury (Sentinel Events)

MajorPermanent lessening of bodily

functioning, disfigurement, surgical intervention required,

additional treatment required (3 or more patients)

ModerateIncreased LOS, increased level

of care (1-2 patients)

MinorNo injury, no increased LOS, no

increased level of care

For each reported incident:

Assign Frequency:

Frequent: Likely to occur immediately or within a short period (may happen several times in one year)

Occasional: Probably will occur (may happen several times in 1-2 years)

Uncommon: Possible to occur (may happen sometime in 2-5 years)

Remote: Unlikely to occur (may happen sometime in 5-30 years)

Apply the risk management equation Severity x Frequency = RISK What resources per level of risk? Examine trends/patterns

Sources: Your incident report data Loss runs/claims data Brainstorm list of HR processes for your

organization Consider physical resources, environment, staffing, etc.

Worker’s Compensation reports Literature Sentinel Event Alerts Infection Control data IHI Joint Commission Organizational strategic quality goals/objectives

Multidisciplinary group who have hands-on experience with the selected process/procedure Include physicians!

RM role May be multifaceted CAUTION: Leader/Facilitator

ABSOLUTE MUST: Direct observation of process (Lean)

Tools: “Process Mapping” vs. Flowcharting Fishbone (Cause & Effect Diagram) Current State Stream Maps (Lean)

Differentiate - need TWO maps! “The way things were intended to work” “The way things are actually working”

Medication ordered

Auto electronic transfer to Pharmacy

system

Pharmacy fills scipt; sends to

floor

Nurse administer

s

Process Step

Process Step

Process Step

Process Step

Sub-Processes

Sub-Processes

Sub-Processes

Sub-Processes

A. Dummy terminal

B. PCs

A. Check drug allergies

B. Check drug interactions

C. Check proper dosages

D. Orders labsE. Order sent to

auto dispensing

A. Automatically fills orders checked

B. Drugs pulled and script filled

C. Med cart filled

D. Cart sent to floor

A. Log on to laptop

B. MedcartC. Medications

scannedD. Patient band

scannedE. Medication

given to pt.F. Pt. record

updated

1 2 3 4

Sub-Processes

A. Dummy terminal

B. PCs

Compare “ideal” vs. “reality”

May be multiple failure modes – list all

Each failure mode can have multiple possible effects

Tool: Brainstorming

Ask: What could fail with this step? (i.e., failure modes) Why would this failure occur? (i.d., causes) What could happen if this failure occurred? (i.e.,

effects)

Assess risk – severity/probability

Tools: Fishbone (C&E) Diagram Hazard Scoring Matrix (HFMEA)

Decision (proceed or stop) If score 8 or higher & decision to stop,

document rationale Tools:

Decision Tree (HFMEA) HFMEA Worksheet

Develop action plan for change Include outcome measures,

management concurrence

Concerns re: discoverability

Could provide potent evidence for plaintiff if all potential failures not addressed & mishap occurs involving that failure point

Follow current procedures under state law relative to peer review protection Must be produced under guidance of medical

staff & reviewed in “medical staff committee” Include “disclaimer” on document Seek guidance from legal counsel

Seek support from senior leadership Executive/Administrative Sponsor?

Include physicians Physician Champion

Seek out trained facilitator OR get training in facilitation Important to open communication

Involve front-line staff; give them ownership

Look for best practices already identified for the process being assessed

VA Center for Patient Safety HFMEA Toolkit http://www.patientsafety.gov/CogAids/HFMEA/

index.html#page=page-1

Institute for Healthcare Improvement Online tool for conducting FMEA; can be

shared Tutorials, journal articles Completed examples http://www.ihi.org/knowledge/Pages/Tools/

FailureModesandEffectsAnalysisTool.aspx

http://www.patientsafety.gov/SafetyTopics/HFMEA/FMEA2.pdf

http://psnet.ahrq.gov/resource.aspx?resourceID=1531 http://www.patientsafety.gov/SafetyTopics/HFMEA/HFMEAIntro.pdf

http://intranet.uchicago.edu/quality/FailureModesandEffectsAnalysis_FMEA_1.pdf

http://www.patientsafety.gov/SafetyTopics/HFMEA/HFMEA_JQI.pdf