1. 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

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

3. 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

4. ISO15189 Requirement
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.”

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

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

7. 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

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

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

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

11. 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

12. Testing Personnel Sources of Risk
Education
Training
Competency
Staffing levels

13. 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

14. Process Map

15. Fishbone Diagram

16. 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

17. 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)

18. 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

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

20. 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.

21. 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.

22. FMEA

23. 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.

24. 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.

25. References
Hammerling JA. A review of medical errors in laboratory diagnostics and where we are today. LabMed. 2012;43(2):
CLSI EP23-A.
CAP 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):
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:

26. Thank You