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CLINICAL LAB PRODUCTS Webcast
IQCP: From First Principles to First Steps
24 June 2014
Steve Halasey Chief Editor Clinical Lab Products
SPONSOR
www.bio-‐rad.com
Individualized Quality Control Plan
• New guidelines from the Centers for Medicare and Medicaid Services permit CLIA-registered laboratories to implement an IQCP program.
• Rarely formalized in clinical lab settings in the past, risk management principles provide the foundation of IQCP.
• On a practical level, labs are already performing many of the tasks required to develop and operate an IQCP program.
TODAY’S WEBCAST
TODAY’S WEBCAST
Objectives for Today’s Webcast
• Identify methods for handling subjective metrics related to risk management
• Understand the elements required to plan and execute a risk assessment
• Evaluate options for monitoring the effectiveness of an IQCP
How would you rate the likelihood that your clinical laboratory will implement an individualized quality control plan (IQCP) when the CMS program is fully effective on January 1, 2016? (n = 870)
IQCP SURVEY
10%
16% 29%
23% 14%
8%
Not very likely
Possible
Not sure
Likely
Very likely
Certain
What types of facilities and instruments will be included in your IQCP? (n = 836)
IQCP SURVEY
55%
12%
19%
6% 8%
Hospital or other inpa>ent lab
POL or other outpa>ent lab
POC instruments
Reference lab
Other
What is your lab currently doing to implement an IQCP program? (n = 810)
IQCP SURVEY
65% 7% 2%
8%
5% 4%
9%
Making early inquiries
Acquiring materials and scheduling staff training
Comple>ng staff training
Performing risk assessments
Formalizing IQCP details
Implemen>ng IQCP and ongoing monitoring ac>vi>es
Other (please specify)
What do you consider your lab's biggest obstacle to implementing an IQCP program? (n = 798)
IQCP SURVEY
10% 30%
3% 26%
1%
19%
4% 7%
Costs for training and implementa>on
Time for training and planning
Staff resistance
Unfamiliarity with risk management
Geographic dispersion of instruments
Complexity across varied tests types
Ongoing monitoring and repor>ng
Other
Greg Cooper, CLS, MHA, CQA Principal W. Gregory Cooper LLC
SPEAKER
The Road to Risk Management:
From Paper to Practice
Brief History
Need for QC frequency rationale led to CLSI guideline EP23
• Focus on failure mode and effects analysis (FMEA) CMS responded with individualized quality control plan (IQCP)
What is IQCP intended to be?
Uncomplicated Critical and honest Review and evaluation of known and potential risks in the lab Planned Well-documented
When is an IQCP needed?
Totally voluntary unless:
• You want to reduce QC for a test or a device to less than 2 times per day
• The manufacturer (product insert) recommends less than 2 times per day
What about just using an IQCP prepared by the manufacturer?
Not allowed
Provides a good baseline though
So how do we identify risks in the lab?
Form a small group
Start small
Brainstorm
Map the process
• Look for hazards (potential failures that could cause harm)
• Assess the associated risk (next slide)
Assessing the risk
How probable is it that the failure will occur?
What degree of harm would come to the patient if a bad result were reported and acted upon?
How many patients might be affected?
Then what?
Establish causes of the potential failures (hazards)
• Use a cause and effect analysis o Ishigawa chart, fishbone diagram
Cause and effect
Classic IQCP Method Specimen Measurement — Man Testing personnel Materials Reagents Machine Test system Environment Environment
FISHBONE
Text
Text
Text
Text
Text
Text
Text
Text
Text
Text
Text
Text
Text
Text
Text
Personnel Reagents Specimen
Test System Environment
Then . . .
Prioritize risks using FMEA
Identify and put controls into place that will: • Eliminate the cause of the failure (and/or) • Reduce the potential the failure will happen (and) • Effectively detect the failure should it occur
Follow-up six months later • Evaluate effectiveness • Document
Summary
Keep it simple
Do the work
Ask the hard questions
Be able to accept results you don’t expect
Perform an honest assessment
References Medical devices – Application of risk management to medical devices (ISO 14971: 2007). Medical laboratories – Requirements for quality and competence (ISO 15189: 2012). Laboratory Quality Control Based on Risk Management, CLSI Guideline EP23. Wayne PA: Clinical and Laboratory Standards Institute, 2011. “Individualized Quality Control Plan (IQCP).” CMS microsite, available at: www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html
Valerie Ng, MD, PhD Chair of Laboratory Medicine and Pathology Alameda County Medical Center
SPEAKER
Challenges at the Starting Gate: How to Hit the Ground Running
Valerie Ng, MD, PhD Chair, Laboratory Medicine and Pathology
Learning Objectives
Explain why you will develop IQCP for certain tests and not for others
Describe how you will develop your IQCP
List what evidence you already have to support and justify your IQCP
When to do an IQCP
“If it ain’t broke, don’t fix it” • Virtually all testing performed within the clinical laboratory
o CLIA ’88
Consider IQCP when • Assay is very stable and CLIA QC frequency seems
excessive o Rare to nonexistent QC failures
• When traditional QC is either excessive or doesn’t provide adequate quality assurance
New Technology: How Much QC?
Unit-use devices
CLSI Guideline EP23
Risk Assessment: Must Include
Testing personnel
Environment
Specimens
Reagents
Test system
Risk Evaluation per ISO 14971
Negligible Minor Serious Critical Catastrophic
Frequent not ok not ok not ok not ok not ok
Probable ok not ok not ok not ok not ok
Occasional ok ok ok not ok not ok
Remote ok ok ok ok not ok
Inconceivable ok ok ok ok ok
Severity of harm
Prob
abili
ty
Probability • Frequent: once a week • Probable: once a month • Occasional: once a year • Remote: once every few years • Inconceivable: should never happen
(once a career)
Severity • Negligible: Inconvenience or temporary discomfort • Minor: Temporary injury or impairment not requiring
professional medical intervention • Serious: Injury or impairment requiring professional
medical intervention • Critical: Permanent impairment or life-threatening injury • Catastrophic: Results in patient death
Tools
IQCP Template
CLSI EP23-A
ACT IQCP (2 pages)
ACT IQCP
ACT: QC Plan Monitoring
72 total tests since go-live in September 2011 • 33 months
o 19 tests/8 patients o 4 tests: reagent lot-to-lot comparison o 9 tests: proficiency testing (PT) o 40 tests: QC o Medical record review: no adverse patient outcomes
Ratio of QC or PT:patient test = 2.6:1
IQCP_CLP_Jun 24 2014_Ng
CLIA 2003
EQC options ALL
SOME
NONE
Learning Objectives
Explain why you will develop IQCP for certain tests and not for others
Describe how you will develop your IQCP
List what evidence you already have to support and justify your IQCP
Terri Wolek, MT(ASCP) US Quality Control Product Manager Bio-Rad Laboratories QSD
SPEAKER
Monitoring Effectiveness
Terri Wolek, MT(ASCP)
Objective
After this presentation, the attendee will be able to:
• Evaluate options for monitoring the effectiveness of an IQCP
IQCP Requirements
All IQCP quality assessment monitoring must be part of the laboratory’s overall quality assessment plan.
• The laboratory must establish a review system for ongoing monitoring of the effectiveness of its IQCP
• Monitoring should include, but is not limited to, testing personnel, environment, specimens, reagents, and test systems
• Reevaluation of the QCP should be considered when changes occur in any of the above components
CMS Survey and Cer>fica>on Memorandum 13-‐54-‐CLIA, p. 10.
CLIA Probes
Has the laboratory established a review system for the ongoing monitoring of the QCP and evaluation of its effectiveness?
In the event of a testing process failure, has the laboratory evaluated all patient test results since the last acceptable quality control?
CMS Survey and Cer>fica>on Memorandum 13-‐54-‐CLIA, pp. 10, 11.
What is a Review System?
A clear list of requirements to be employed when the IQCP is reviewed, revealing how the IQCP is working
Existing Monitors
Quality control data reviews
Competency assessment reviews
Storage condition logs (temperature, humidity)
Failure investigation protocols and standard operating procedures
Complaint logs
When?
System reviews should be conducted:
• Semi-annually during the first year
• If no issues arise, annually from the second year onward
• When changes are made in: o Instructions for use or the package insert o Expansion of types of users
• When any of the following occur: o Proficiency tes>ng failures o Competency assessment failures o Inspec>on findings o Complaints
More on Complaints
Can one assume that if there have been no complaints, IQCP is fine?
• In many instances, medical staff do not regularly review and comment on lab performance.
• Through their own monitoring, laboratory staff may often identify issues that have not been brought to their attention through a clinical staff complaint.
Evaluating Effectiveness
How do I know my IQCP is effective?
• Are systematic errors being caught before results are released?
• Are quality issues the same or lower than in the last review?
• Are QC failures appropriately assessed, and their cause determined (e.g., rules, QC materials, reagents, instruments)?
QC Failure Assessment
In the event of a testing process failure, has the laboratory evaluated all patient test results since the last acceptable quality control?
• How should a lab determine whether a patient sample needs to be retested?
• Is there an established policy?
• Is it followed?
• Does the point-of-care testing staff ignore QC failures (retest, retest, retest)?
Quality Assessment
One of the required components of an IQCP
Labs must have requirements and must maintain records to demonstrate that each required assessment (review) has been completed
Q&A
Audience Q&A
To type in a ques>on, navigate to the Q&A sec>on of the event panel. If your ques>on is for a specific speaker, please name them at the beginning of your entry.
SPONSOR
www.bio-‐rad.com
CONTACTS
Greg Cooper [email protected] 972/983-‐1946 Valerie Ng [email protected] 510/437-‐4671 Terri Wolek terese_wolek@bio-‐rad.com 510/741-‐6893 Steve Halasey [email protected] 626/219-‐0199
ARCHIVE
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Thanks for Attending!