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    labguy46@gmail.com      972/983-­‐1946      Valerie  Ng  vang@alamedahealthsystem.org      510/437-­‐4671    Terri  Wolek    terese_wolek@bio-­‐rad.com    510/741-­‐6893      Steve  Halasey    shalasey@allied360.com  626/219-­‐0199    

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