Focus on Compliance

Risk Management:
A Tool for Quality Improvement and Business
Growth

Jeremy Hart, MD, MA, FCAP August 17, 2022

© College of American Pathologists.

Disclosure
The following speakers/planners have no financial interests/relationships
to disclose:
• Jeremy Hart, MD, MBA, FCAP
• Rich Becker, MSEd, CQIA
• Sara Lieske, MPH, CLS(ASCP)
• Shelley Martire, MLS(ASCP)
• Stacy Meyer, MLS(ASCP), CPP(AACC)
• Joan Rose, MT (ASCP) SH

© College of American Pathologists. All rights reserved.

Accreditation
The College of American Pathologists (CAP) is accredited by the Accreditation Council for Continuing
Medical Education (ACCME) to provide continuing medical education for physicians.

CME Category 1 (Continuing Education for Physicians)

The CAP designates this live educational activity for a maximum of 1.00 AMA PRA Category 1
Credit. Physicians should claim only the credit commensurate with the extent of their participation in
the activity.

CE (Continuing Education for Nonphysicians)

The CAP designates this educational activity for a maximum of 1.00 credit/hour of continuing
education. Each participant should only claim those credits/hours he/she spent in the activity.

ASCP Statement
The American Society for Clinical Pathology (ASCP) Board of Certification (BOC) Certification
Maintenance Program (CMP) accepts this activity to meet the continuing education requirements.

California and Florida Statement

This activity is approved for continuing education credit in the states of California and Florida.
© College of American Pathologists. 3
 Today’s Presenter
Dr. Hart is the medical director of clinical
laboratories at St. Elizabeth Healthcare in
Edgewood, Kentucky.
He received his medical degree from the
University of Kentucky in Lexington,
Kentucky, and completed his fellowship at
Vanderbilt University in Nashville, Tennessee.
Dr. Hart is board certified in anatomic and
clinical pathology and hematology.
He is a member of the CAP 15189 Committee,
which oversees the CAP’s ISO 15189
accreditation program and associated Jeremy Hart, MD, MBA, FCAP
education.
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Objectives

• Describe how to identify, prioritize, and mitigate risks.

• Recognize how your quality system helps you manage risks.
• Identify tools and practices that help you implement risk
management.
• Describe the role of quality culture in risk management.

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 Risk Management is Relevant to Everyone…

Sourcing critical reagents

Small laboratory
Staffing challenges
Large laboratory
Health care system
Independent laboratory
Preventing and minimizing problems

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With and Without Risk Management…

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1)Your Existing Quality Routines are Fantastic
“Identifiers” of Risk

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2) Risk Management is a Good Thing

Being aware of and managing risks expands your opportunities

for success.

With every critical risk you identify and control, you improve
your process effectiveness and increase trust in your laboratory
services.

© College of American Pathologists.

3) Risk Management is not a Set of Formal
Methodologies or Tools, Rather it’s About…
• Asking key questions
o What could go wrong?
o Where else might this be happening?

• Maintaining key attitudes

o Vigilance
o Curiosity
o Situational awareness

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IQCP: Framing QC in
Terms of Risk
• Intended clinical use – what could
go wrong?
• Phases and components – where
could something go wrong?
• What checks are needed to monitor
these risks?

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CAP Checklist GEN.20310

“…the QMS includes a process to define the scope and extent of the
investigation required.”

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Agenda
• The risk management model and process
• How quality routines – including communication structures and routines –
can help you with risk management
• What risk management looks like in the real world – cases and examples
• Some key tools
• How to develop a culture that supports risk management

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 What is a Risk?

• A risk is a potential harm,

including the downstream
effects on patient care and
laboratory operations.
o Potential can be
expressed in terms of
probability.
o Harm can be expressed in
terms of severity.

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Risk Matrix/Heat Map

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The Model
• Analyze the system or process
Identify Risks
• Ask: What could go wrong?

• Assess based on probability and

Evaluate Risks severity

• Mitigate significant risks

Control Risks
• Choose indicators

• Follow indicator data

Monitor Risks
• Bring down until you hit constraints

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 Continuous Different Forms of
A continuous assessment based on
daily events and observation
Risk
Management…
Periodic
An internal audit to find risks,
opportunities for improvement, and
deviations from procedure

Proactive
A project to evaluate weaknesses in a
new, revised, or complex process

Reactive
A project triggered by an occurrence
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or audit finding 17
 Quality Routines and Identifying Risks
Quality Routine How it Can Help Identify Risks
PT and QC review Looking for patterns that indicate weaknesses and risks

Following up on occurrences; tracking and trending

Occurrence management
Finding root cause, and looking for similar risks

Process development/
Planning out processes, their interactions, and handoffs
change management

Communication Setting up channels to detect and escalate risks

Tracking, analyzing, and trending data – and being

Metrics/data analysis
curious about it – can reveal patterns

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Importance of Communication Structures
• Not enough to say, “Our team communicates well…”
• Must have structures like huddles and shift reports
• These structures can facilitate risk identification as well as subsequent
phases:
o Evaluation, control, monitoring

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Daily Huddles
• Establish a regular cadence
• Train leaders to focus communication
• Can be formed based on specific needs
o Eg, supply chain issues

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Shift Reports

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Quality Routines and Controlling Risks
• Process improvement projects (eg, mistake proofing, lean)
• Documentation – especially for risk prone steps – providing information at
the point of need (eg, bench aids)
o Address issue of procedural drift
o Make sure only current documents are available

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Quality Routines and Monitoring Risks
(eg, Management Review Meetings)

• Consider all inputs…feedback, quality indicator data, nonconformities, PT

data…
• Is there a signal?

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Cases and Examples

© College of American Pathologists.

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Occurrence Management Example: Uncovering
Variation
07/08/22 13:11
Measured Values for Quality Control

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Reviewing PT and PTT QC Results in HemoHub
Reviewing PT and PTT QC results in HemoHub
Condition Action Repeat Condition Action

2 Controls IN
Enter initials/date in
Both Normal and Abnormal
HemoHub.
Control are Acceptable (Within +/-
Click submit to exit.
3 SD)

Repeated Control(s) IN Enter initials in HemoHub.

Control is Acceptable Type "Reran same QC vial."
Error Condition Exists
(Within +/- 3 SD) Click submit to exit.
STOP reporting patient results
Any Control OUT Check QC material and
Either/Both Control(s) exceed 3 reagent (bubbles, expiry
SD dates)
Repeat out of control level(s)
using same vial(s) only ONCE Repeated Control(s) Error Condition Still Exists
OUT exceeds 3 SD Use Troubleshooting Guide
1 August
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2022
 Troubleshooting Guide (Toolbox)
Required
Patient Investigation
Documentation in
Since Last Good QC
Action When to Consider HemoHub Retesting Prior Patient Samples
(may require repeat
(all notations as
patient testing)
appropriate)

Trouble- 1. Make fresh

Try this after re-running
same vial of QC has not
Not Required

Shooting
"Made new QC" Problem with QC Not Required
QC rectified the out-of-control
material itself.
situation.

Guide Try this if new QC has not

rectified the out-of-control
situation. Consider as
initial step if both levels of
2. Make fresh control are out. Also
"Made new reagent"
Reagent consider early if LJ plot
indicates a QC trend in
same direction over
multiple days (aging
reagent onboard).
Always be aware. Confirm
Check that maintenance
maintenance prescribed by procedure
was performed as part
Records has been performed and is
current.
Try this after all other tools
Call IL
have failed to resolve the
Technical
situation. Document in shift
Support
report.
© College of American Pathologists.
Required
Unstable/expired
1. Retest patient samples since last
reagent could have
good QC.
impacted patient test
A. If small number, retest all.
results.
B. If large number, retest in
batches of 10 working backwards.
C. If samples past stability, do not
retest.
2. Record data in "Patient Retest"
Excel template.
Required 3. % difference for each sample will be
Document what
Malfunctioning calculated.
maintenance, if any,
instrument could have 4. Compare % difference to critical
impacted patient test threshold(s).
of troubleshooting.
results. 5. If any of the individual % differences
exceed the critical threshold, must
immediately notify supervisor
(includes 2nd or 3rd shift).
6. Supervisor will determine (with
input from medical director) the
Required clinical significance and whether prior
Multiple variables results need to be corrected or
"Contacted IL tech
could have invalidated.
support"
impacted patient test
results.
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28
2022
Process Summary: Uncovering Variation

Identify Risks • Incorrect test results

Evaluate Risks • Medium to high risk – widespread

• Process workflow, visual aids

Control Risks
• Standardized work

• Monthly QC reports, review of

Monitor Risks
documentation

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Occurrence Management Example: Strep Test
Complaint
• Started with complaints from ambulatory practices – increase in invalid
molecular tests
• Risks of invalid results
o Kid with sore throat coming into pediatrician
o Delays in testing have potential negative clinical impact
o Customer perceptions impact long-term trust in lab test provider

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Driving Risk Out of the System…

Perform
Find
root cause
occurrence
analysis

Mistake
Likely cause proof the
Generalize: process
Where else might
this be happening?

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Strep Test Complaint: Key Features of Case
Regular communication channels with joint venture partners
• Rapid risk identification and evaluation
• Time-sensitive root cause analysis and execution of plan of risk control
• Access to data reporting tools for monitoring ongoing risk

© College of American Pathologists. 32

New Process Development/Change Management
Example: Joint Venture
• Joint ventures fail at a rate of 60%-70%
• Possible risk areas:
o Test methodology changes
o Reference interval alignment
o Logistics of specimen handling and transportation

• Risk controls
o Virtual workspace
o Real-time troubleshooting logs

1 August
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2022
 New Process Development/Change Management
Example: Post-Launch Quality Monitoring
RISKS

JV Partner 1
Differences in
rate of high
potassium
values JV Partner 2
between joint
venture
partners

© College of American Pathologists.

Post-Launch Quality Monitoring: Risks and
Controls
RISKS
• Risk evaluation
o High risk of declines in provider and patient satisfaction

• Risk controls
• Use both health systems’ quality departments
• Use auditors from both organizations

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Process Development/Change Management Example:
Proactive Project for New Urine Collection Process

• Creatively sourcing products

• Shortage of gray top urine collection tubes

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Reprinted from St. Elizabeth Hospital Laboratory-Microbiology

Data Analysis/Metrics Example: JAK2 Test Utilization

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Investigation
• Various types of JAK2
Utilization testing
pattern • Who’s ordering exon 12
• Why not V617F

• Primary
Clinician care
doctors
data ordering
exon 12

• Often
Patient V617F
would have
charts been more
appropriate
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EMR Alert

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Occurrence Management Example: Near Miss
on Diagnosis of APL

• Near miss: something went wrong,

but no downstream consequences
• Near miss = risk

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Driving Risk Out of the System…

Near miss Perform root

on APL cause analysis

Automated review
Limited
queue in LIS
experience of
generalists on
Digital image
challenging
technology for
morphologic
real-time peer
cases
consultation
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Near Miss on Diagnosis of APL

Patient name
MRN #
Patient name DOB
Patient name

Patient name

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Key Tools

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Change Management Checklist

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FMEA (Failure Mode and Effects Analysis)

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Risk Register

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SWOT (Strengths, Weaknesses, Opportunities and
Threats)

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Developing a Culture That Supports Risk
Management

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Culture Elements That are Critical to Risk
Management
• Speaking up
• Transparency
• Process orientation – Fixing the process rather than blaming a person

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Leadership Drives Culture

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Leader Response – and Language – is Important

“Retrain employee.” “Let’s look at the work

process, paying attention to
risk points.”
- or -

“Let’s look at how we train

employees and how we
support them with bench aids
in the work environment.”

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Takeaways

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Six Things You can do to Implement Risk
Management
1. Use your collected data to find risks and make changes.
2. Next time you see a problem, ask the question, “If it happened here,
where else might it be happening?”
3. Reward people for speaking up about risks, mistakes, and near misses.
4. Focus on the process and not the person.
o Aim to never again say, “Retrain employee.” Look for the process cause.

5. Put energy into a huddles and other communication channels.

6. Develop expertise in root cause analysis and mistake proofing.

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More Information

© College of American Pathologists.

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Resources
• QMEd Courses
o Risk Management
o Root Cause Analysis
o Mistake Proofing
– Path: cap.org / Shop / Learning / Quality Management Education (QMEd)

• FOC Webinar Toolbox

o Risk Management course poster
o Risk Essentials document
o Mistake Proofing course poster
o Root Cause Analysis Toolkit (Excel)

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© College of American Pathologists.