1 What s New in Statistical Quality Control Guidance: CLSI s C24 Updates August 2, 2016
CLSI C24-4 th Edition Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions Curtis A. Parvin, PhD Nils B. Person, PhD, FACB Nikola Baumann, PhD Lili Duan, PhD A. Paul Durham Valerio M. Genta, MD Jeremie Gras, MD Greg Miller, PhD Megan E. Sawchuk, MT(ASCP) 2
CLSI C24-4 th Edition Document Status Project Phase Activities Dates Proposed Draft Voting Delegates and Committee Dec 1, 2015 Feb 1, 2016 members vote on Proposed Draft Comment Resolution Committee resolves February, 2016 April, 2016 comments and updates draft Preparation for Final Draft Voting Editing, Final approval from chairholder May, 2016 August, 2016 Final Draft Vote Preparation for Publication Consensus Council Approves Publication Editors prepare publication format Aug 26 Sep 15, 2016 September, 2016 Publish September, 2016 3
What s New? Notable changes and additions Alignment with principles introduced in CLSI EP23: Laboratory Quality Control Based on Risk Management Additional performance measures related to patient risk Expanded guidance on setting target values and SDs Greater focus on QC frequency and QC schedules More emphasis on recovering from an out-of-control condition 4
Patient Risk Sequence of Events Creating Risk of Harm for a Patient (Example) Hazardous Situation P1 P2 P3 P4 P5 P6 Initiating cause Testing process failure generated reported Misdiagnosis Hazardous medical action Patient harmed CLSI EP23, Figure 6 5
Managing Patient Risk CLSI EP23, Table 3. Risk Acceptability Matrix Severity of Harm Probability of Harm Negligible Minor Serious Critical Catastrophic Frequent unacceptable unacceptable unacceptable unacceptable unacceptable Probable acceptable unacceptable unacceptable unacceptable unacceptable Occasional acceptable acceptable acceptable unacceptable unacceptable Remote acceptable acceptable acceptable acceptable unacceptable Improbable acceptable acceptable acceptable acceptable acceptable 6
Patient Risk Sequence of Events Creating Risk of Harm for a Patient (Example) Hazardous Situation P1 P2 P3 P4 P5 P6 Initiating cause Testing process failure generated reported Misdiagnosis Hazardous medical action Patient harmed CLSI EP23, Figure 6 7
Patient Risk Sequence of Events Creating Risk of Harm for a Patient (Example) Hazardous Situation P1 P2 P3 P4 P5 P6 Initiating cause Testing process failure generated reported Misdiagnosis Hazardous medical action Patient harmed CLSI EP23, Figure 6 Laboratory QC 78
Patient Risk Sequence of Events Creating Risk of Harm for a Patient (Example) Hazardous Situation P1 P2 P3 P4 P5 P6 Initiating cause Testing process failure generated reported Misdiagnosis Hazardous medical action Patient harmed CLSI EP23, Figure 6 Probability of detecting a testing process failure 79
Patient Risk Sequence of Events Creating Risk of Harm for a Patient (Example) Hazardous Situation P1 P2 P3 P4 P5 P6 Initiating cause Testing process failure generated reported Misdiagnosis Hazardous medical action Patient harmed CLSI EP23, Figure 6 Probability (number) of incorrect patient s reported before the testing process failure is detected 710
Patient Risk Sequence of Events Creating Risk of Harm for a Patient (Example) Hazardous Situation P1 P2 P3 P4 P5 P6 Initiating cause Testing process failure generated reported Misdiagnosis Hazardous medical action Patient harmed CLSI EP23, Figure 6 Probability (number) of incorrect patient s identified and corrected before misdiagnosis or hazardous action 711
Patient Risk Sequence of Events Creating Risk of Harm for a Patient (Example) Hazardous Situation P1 P2 P3 P4 P5 P6 Initiating cause Testing process failure generated reported Misdiagnosis Hazardous medical action Patient harmed CLSI EP23, Figure 6 Focus on the measurement procedure 712
Patient Risk Sequence of Events Creating Risk of Harm for a Patient (Example) Hazardous Situation P1 P2 P3 P4 P5 P6 Initiating cause Testing process failure generated reported Misdiagnosis Hazardous medical action Patient harmed CLSI EP23, Figure 6 Focus on risk of harm to patients 713
Patient Risk Based QC Performance Measures Number of erroneous patient s generated before detecting an out-of-control condition Depends on Magnitude of out-of-control condition QC Strategy # of QCs evaluated QC rule(s) Frequency of QC evaluations (QC schedule) Allowable total error for the analyte 814
Patient Risk Based QC Performance Measures Number of erroneous final patient s reported before detecting an out-of-control condition Depends on When patient s are reported What recovery strategy the laboratory employs for identifying and correcting erroneous patient s 915
CLSI C24-4 th Edition Main Chapters (Draft) 3. Purpose of Statistical Quality Control 4. Assessing Quality Control Performance 5. Planning a Statistical Quality Control Strategy 6. Recovering from an Out-of-Control Condition 7. Ongoing Assessment of Quality Control Programs 8. Worked Examples 10 16
CLSI C24-4 th Edition Main Chapters (Draft) 3. Purpose of Statistical Quality Control 4. Assessing Quality Control Performance 5. Planning a Statistical Quality Control Strategy 6. Recovering from an Out-of-Control Condition 7. Ongoing Assessment of Quality Control Programs 8. Worked Examples 10 17
CLSI C24-4 th Edition Main Chapters (Draft) 3. Purpose of Statistical Quality Control 4. Assessing Quality Control Performance 5. Planning a Statistical Quality Control Strategy 6. Recovering from an Out-of-Control Condition 7. Ongoing Assessment of Quality Control Programs 8. Worked Examples Greg Miller: Planning a Statistical Quality Control Strategy 10 18
CLSI C24-4 th Edition Main Chapters (Draft) 3. Purpose of Statistical Quality Control 4. Assessing Quality Control Performance 5. Planning a Statistical Quality Control Strategy 6. Recovering from an Out-of-Control Condition 7. Ongoing Assessment of Quality Control Programs 8. Worked Examples Niki Baumann: Recovery From Out of Control Conditions 10 19
Our Speakers Nikola Baumann, PhD, DABCC PhD from University of Wisconsin in Madison Postdoc in Clinical Chemistry at Washington University Asst. Prof. of Lab Medicine and Pathology, Mayo Clinic Co-Director Central Clinical Laboratory, Director of Central Processing, Director of the Clinical Chemistry Fellowship Program Active in AACC at both the regional and national level An influential contributor to the topic of preparing for and recovering from large-scale testing errors 11 20
Our Speakers Greg Miller, PhD PhD from University of Arizona in Tucson Postdoc in Clinical Chemistry at Ohio State University Professor of Pathology, Virginia Commonwealth Director of Clinical Chemistry and Pathology Information Systems Past President of AACC (2012) and CLSI (2015) Key contributor to committees and working groups for several professional organizations involved with standardization, harmonization, quality control, and external quality assessment 12 21