Risk Management: Why It Is Part of ISO 15189 and How It Relates to CLIA's IQCP Megan Staudenmaier A2LA Accreditation Officer II [email protected]
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Risk Management: Why It Is Part of ISO 15189 and How It
Relates to CLIA's IQCP
Megan Staudenmaier A2LA
Accreditation Officer II [email protected]
Key Learning Objectives
• Learn what risk management is and what it encompasses
• Learn what ISO 15189 requires concerning risk management
• Learn what IQCP entails and why risk management is so important to IQCP
Background - IQCP
• Announced with Survey & Cert 13-54 • New quality control option based on
risk management • Replaces EQC • Transition period 01/01/14-01/01/16
What is Risk Management?
• Need to understand risk first ! The effect of uncertainty on objectives
(ISO 31000:2009)
• How you monitor, assess, and treat risk • Organization-wide effort
Important Terms to Know
• Risk Assessment: Overall process of risk identification, risk analysis, and risk evaluation
• Risk Analysis: Process to comprehend the nature of risk and to determine the level of risk
• Risk Criteria: Terms of reference against which the significance of risk is evaluated
• Risk Evaluation: Process of comparing results of risk analysis with risk criteria to determine whether the risk is acceptable or tolerable
• Residual Risk: Risk remaining after risk treatment
Why is Risk Management Important?
• Ethical duty • Potential consequences • Improve operational efficiency • Confidence in results (staff and public) • Required activity for ISO/IEC 15189 and
for IQCP in CLIA
Risk Management in ISO 15189
• Section 4.14.6: Risk management
“The laboratory shall evaluate the impact of work processes and potential failures on
examination results as they affect patient safety, and shall modify processes to reduce
or eliminate the identified risks and document decisions and actions taken.”
• Multi-faceted ! Internal Audit ! Management Review
• Core component of management system ! Needs to be done routinely, not as a one-
time event
Significance of Section 4.14.6
Risk Management in ISO 15189
• Section 4.12: Continual Improvement
“ Improvement activities shall be directed at areas of highest priority
based on risk assessments.”
How Can You Maintain Continual Improvement?
• Feed back into Internal Audit and Management Review
• Preventative/Corrective Actions
Risk Management in ISO 15189
• Section 4.13: Control of records
“Records shall include, at least, the following: n) risk management records”
Risk Management in ISO 15189
• Section 4.15.2: Review Input
“The input to management review shall include information from the results of evaluations of at least the following:
e) risk management”
Management Reviews
• Conducted by top management • Gives opportunity to look at the
“bigger picture” • Ensures risk management is
incorporated throughout the entire organization and allows trends in risk to be analyzed
Risk Management in ISO 15189
• Section 5.6.2.2: Quality control materials
“Quality control materials shall be periodically examined with a frequency
that is based on the stability of the procedure and the risk of harm to the
patient from an erroneous result.”
Why is Risk Management Important in IQCP?
• IQCP is risk management • Assessing risk to determine individual
QC frequency requirements (RA) • Treating/controlling that risk (QCP) • Monitoring your risk (QA)
A Closer Look at IQCP: Risk Assessment
• Identifying, analyzing, and evaluating potential sources of risk/error
• Must include at least five components: ! Specimen ! Test System ! Reagent ! Environment ! Testing Personnel
• Should include entire testing process (preanalytic, analytic, postanalytic)
Methods of Risk Identification
• Process Mapping ! Breaking down all steps in testing process
• Fishbone Diagram ! Cause and effect associated with
different aspects of the testing process
• Risk Identification Table ! Lists possible risks in element v. testing
phase table
A Closer Look at IQCP: Quality Control Plan
• Methods of reducing your risk • Creation can be delegated, but must
be approved, signed, and dated by laboratory director
• Cannot be less stringent then manufacturer procedures
• Must allow for immediate detection of errors
A Closer Look at IQCP: Quality Control Plan
• Plan must include number, type, frequency, and acceptance criteria
• Possible practices to include: ! Internal/External Controls ! Training/Continuing Education ! Proficiency Testing ! Calibration/Verification
A Closer Look at IQCP: Quality Assessment
• Monitoring potential risk and how well your QCP is working
• Should include monitoring of all aspects required by RA and all parts of QCP
• Have written QA plan that includes a schedule
A Closer Look at IQCP: Quality Assessment
• Possible ways to monitor: ! Review of internal records
• PT results, CARs, QC results, etc.
• May need to consider doing another RA and updating QCP depending on results of quality assessment
A2LA’s IQCP Requirements
• Plan must be provided with application
• Must complete checklist C622 • Must comply with S&C: 13-54-CLIA
What to Expect During Your Assessment
• Assessors will… ! Interview key IQCP staff ! Review the IQCP Plan ! Review IQCP evaluation records ! Ensure risk is being monitored ! Review training records
• Will also want to see risk management incorporated into other aspects of the lab (internal audit, management review, etc.)
How to Ensure Risk Management Works for You
• Incorporate risk management objectives into the organizational objectives – get top management committed
• Write a risk management policy into your quality system
• Assign risk management responsibilities • Set risk management performance
indicators • Ensure it is a continuous process • Train your staff
References and Further Guides
• ISO 15189:2012 (Medical laboratoires – Requirements for quality and competence
• ISO 31000:2009 (Risk management – Principles and guidelines)
• CMS IQCP Webpage: https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html
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