Risk Management 5- 6 November 2017 Regency Hotel, Kuwait Carlo Kaabar Carlo Kaabar BAppSc, BTheol, AFCHSM,CMI Director, Laboratory Services and Outreach American Hospital Dubai Dubai, UAE Carlo Kaabar Director, Laboratory Services and Outreach American Hospital Dubai Dubai, UAE

Objectives Risk Management Principles Methods Used in Risk Assessment Measures to Minimize Pre-Analytical, Analytical and Post-Analytical Laboratory Risk

Some Key Definitions TERM DEFINITION Risk Combination of the probability of occurrence of harm and the severity of harm (ISO 14971) Hazard Potential source of harm (ISO/IEC Guide 51) Harm Physical injury or damage to the health of people (ISO/IEC Guide 51) Severity Measure of the possible consequences of a hazard (ISO14971) Risk Analysis Systematic use of available information to identify hazards and to estimate the risk (ISO/IEC Guide 51) Risk Assessment Overall process comprising a risk analysis and a risk evaluation (ISO/IEC Guide 51) Risk Estimation Process used to assign values to the probability of occurrence of harm and the severity of that harm (ISO14971) Risk Evaluation Process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk (ISO14971) -Failure Mode and Effects Analysis (FMEA) Some Key Definitions

ISO15189 Requirement 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 and document decisions and actions taken.”

Risk Management Systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk (ISO 14971)

Processes PRE ANALYTIC ANALYTIC POST ANALYTIC Test Ordering Testing Result Reporting Specimen Collection Result Review Specimen Archiving Specimen Transport Interpretation Specimen Receipt

Where to get information for Risk Assessment Package insert and operator manual Troubleshooting guide Manufacturer alerts and bulletins Verification of performance specifications Personnel qualifications, training, competency QC and PT data QA information including corrective action Scientific publications Complaints Other sources as appropriate

Specimen Sources of Risk Patient preparation Specimen collection, labeling, storage, preservation, stability, transportation Specimen accessioning and processing Specimen acceptability and rejection Specimen referral

Environment Sources of Risk Temperature, humidity, dust, utilities Airflow/ventilation Light intensity Noise and vibration Altitude Water quality Adequate space

Reagent Sources of Risk Shipping/receiving Storage conditions Expiry date Preparation

Test System Sources of Risk Sampling Clot detection Detection of interfering substances Calibration issues Mechanical failures Failure of system controls and function checks Software/hardware Transmission of test result

Testing Personnel Sources of Risk Education Training Competency Staffing levels

QC Material Sources of Risk Electronic Embedded Controls Liquid external controls ELECTRONIC Black box function checks Often do not challenge the entire testing process Usually only check the electronic/electronic circuitry and software Usually do not check any mechanical/physical processes EMBEDDED Some blood gas analyzers have built-in on board liquid controls (optimized to work on the device) May not challenge the entire testing process DEPENDENT CONTROL (First Party) Optimized, Same formulation as calibrators SEMI DEPENDENT (Second Party) CONTROL Exclusive for a device, specific formulation, may mimic calibrators INDEPENDENT CONTROLS (Third party) Absolutely independent of calibrator, can be used across multiple platforms, often a human based material

Process Map

Fishbone Diagram

Risk Identification Table Element Pre Analytical Analytical Post Analytical Specimen Insufficient sample Interfering substances Clotted Personnel Lack of training Competency assessment not performed Inadequate training in how to report critical values Lab Environment Heavy traffic in specimen reception area Temperature fluctuates Test system Calibration overdue No mechanism for error detection Reagents No inventory control Improper reagent mixing Post analytical activity LIS not verified after recent update

Available Standards ISO 14971:2007 Medical devices -- Application of risk management to medical devices ISO/TS 22367:2008 Medical laboratories -- Reduction of error through risk management and continual improvement ISO 31000:2009 Risk management -- Principles and guidelines ISO/IEC 31010:2009 Risk management – Risk assessment techniques ISO Guide 73Risk management — Vocabulary (CLSI EP23-A)Laboratory Quality Control Based on Risk Management (2011)

Risk management aims to identify sources of error and match up these hazards with appropriate controls. It begins with creating a map of each lab process, such as performing a particular test, then considering how the process could fail at each step. Risk estimation follows, which included assessing the likelihood of a given failure, as well as the severity of patient harm resulting from the failure. Third, risk evaluation compares the results of risk estimation to the lab’s risk controls. Risk monitoring and failure investigation complete the loop. Source: CLSI EP23A

Process to develop and continually improve a quality control plan. Source: CLSI EP23A Laboratory Quality Control based on Risk Management; Approved Guideline. www.clsi.org

Individualized Quality Control Plan (IQCP) IQCP implementation requires a plan for all three phases of testing (pre-analytical, analytical, post- analytical) and must include three basic steps: Risk Assessment. Quality Control Plan. Quality Assessment.

CAP Risk Management Guideline Analyze the process-Understand it (typically through process mapping) and identify risk points. Evaluate risk points- Assess each issue based on probability and severity/impact. Typically this takes the form of a matrix, in which a value is assigned to the risk. Example: Control risks–Pick the highest risks, and decide how to mitigate them by modifying the process. Document the results of this stage. Monitor risks.

FMEA

Summary Risk Management includes: Risk identification: Identifying potential sources of error. Risk assessment: evaluating errors to determine their impact on patient test results. Risk mitigation: controlling errors in such a way that residual risk is manageable. Any risk not prevented or detected 100% of the time is considered residual risk.

Messages Risk analysis, assessment and management is not new to medical laboratories Formal risk analysis, assessment and management is relatively new No guarantee of complete elimination of risk by developing a risk management process Implementation of a comprehensive risk management process will lead to risk reduction What is best for the PATIENT? Outcome is continued delivery of quality patient care Risk is a mathematical concept but cannot be SOLVED by statistics. Modern mathematical theory indicates that the best strategies are those that reduce the opportunities for worst outcomes.

References Hammerling JA. A review of medical errors in laboratory diagnostics and where we are today. LabMed. 2012;43(2): 41-44. CLSI EP23-A. CAP 15189 Risk Management Guideline for Laboratories.2014. Eliza DR & Minodora D, Risk Management in Clinical Laboratory: from Theory to Practice.Acta Medica Marisiensis 2015;61(4):372-377. Pullan P & Murray-Webster R. A short guide to facilitating risk management: engaging people to identify, own and manage risk. Routledge, 2016. Njoroge SW and Nichols JH. Risk management in the clinical laboratory. Annals of Laboratory Medicine. 2014;34:274-278.

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