Analytical quality control based

on risk management
Adriana Unić
Department of medical biochemistry and analytical toxicology
Department of Clinical Chemistry
Sestre milosrdnice University Hospital Center

15th BELGRADE SYMPOSIUM FOR BALKAN REGION

 Risk managment

1. What can go wrong?

2.

What we can do about it?

Use of procedures designed to minimize the occurence of patient harm due to

an incorrect test result

15th BELGRADE SYMPOSIUM FOR BALKAN REGION

 Risk
managment
HFMEATM -
the Health Care Failure
Mode Effects Analysis

15th BELGRADE SYMPOSIUM FOR BALKAN REGION

 Verification of test specifications

• Demonstrate that method can obtain performance specifications comparable to

those established by the manufacturer (accuracy, precision, reportable range)

• Verify reference intervals (normal values)

Sigma value =(TEa-bias)/CV

Sigma Acceptable
performance

>5 Excellent
4-5 Good

3.5-4 Marginal

< 3.5 Poor

15th BELGRADE SYMPOSIUM FOR BALKAN REGION

 Risk management- Identify risk

1 2 4
Samples Operator Laboratory Environment
Sample Integrity Atmospheric Environment
- Lipemia Operator Capacity - Dust
- Hemolysis - Training - Temperature
- Interfering subtances - Competency - Humidity
- Clotting
- Incorrect tube
Utility Environment
Sample Presentation Operator staffing - Electrical
- Bubbles - Short staffing - Water quality
- Inadequate volume - Correct staffing - Pressure
Identify Potential Hazards Incorrect Test Result
Reagent Degradation
- Shipping Instrument Failure
- Software failure
- Storage
- Optics drift
- Used past expiration Calibrator Degradation - Electronic instability
- Preparation - Shipping
Quality Control Material Degradation - Storage
- Used past expiration Inadequate Instrument Maintenance
- Shipping
- Preparation - Dirty optics
- Storage
- Contamination
- Used past expiration
- Scratches
- Preparation
3 5
Reagents Measuring
System

CLSI EP23: Laboratory Quality Control Based on Risk Management; Approved Guideline

15th BELGRADE SYMPOSIUM FOR BALKAN REGION

 Risk management - Assess risk
SEVERITY

Negligible Minor Serious Critical Catastrophic

Score OCC Severity Frequent Low Moderate High Unacceptable Unacceptable

5 10 15 20 25

5 Frequent Catastrophic - patient

(10-3) death
Probable Low Moderate High Unacceptable Unacceptable

PROBABILITY
4 Probable Critical - permanent 4 8 12 16 20
(10-3 – 10-4) impairment of life
threating injury
Occasional Low Moderate Moderate High High
3 Occasional Serious - injury or 3 6 9 12 15
(10-4 – 10-5) impairment not
requiring medical
intervention Remote Low Low Moderate Moderate Moderate
2 4 6 8 10
2 Remote Minor - temporary
(10-5 – 10-6) injury or impairment
not requiring medical Improbable Low Low Low Low Low
intervention 1 2 3 4 5

1 Improbable/ Negligible –
theoretical inconvenience or
(< 10-6) temporary discomfort

RPN = OCC * SEV

15th BELGRADE SYMPOSIUM FOR BALKAN REGION

 RPN RISK
ASSESMENT
> 50 HIGH
25-50 MODERATE

15th BELGRADE SYMPOSIUM FOR BALKAN REGION

≤ 25 LOW
15th BELGRADE SYMPOSIUM FOR BALKAN REGION
 Risk management - Control risk
• Optimize the detection of medically
important errors

• Reduce the risk of harm to a patient:

• prevent the error from occurring

which averts harm to the patient
(calibration, maintenance,
environmental factors changes…)

• detect the error before it can harm

the patient
15th BELGRADE SYMPOSIUM FOR BALKAN REGION
 Risk management - Control risk

Specify Specify the quality required of a patient result

Determine the magnitude of “critical” out-of-control

Determine conditions with unacceptably high probability of
producing patient results that fail to meet the
required quality

Design QC procedures with adequate power to

Design detect “critical” out-of-control conditions

15th BELGRADE SYMPOSIUM FOR BALKAN REGION

 Risk management - Control risk

• Quality Control Product (s)

1. • Number of controls

• Control limits
2.

• Size of the analytical run

3. • Frequency of QC

• Monitoring and analysis

4.

 Corrective actions
5.

15th BELGRADE SYMPOSIUM FOR BALKAN REGION

Implement QC strategies that minimize the number of incorrect patient results that are
reported when a failure mode does occur
Sigma

ΔSEcrit = (TEa-Bias/CV ) – 1,65 Z = value for 1-sided confidence limit

Sigma SQC Selection Tool

15th BELGRADE SYMPOSIUM FOR BALKAN REGION
Westgard S, Bayat H, Westgard JO. Analytical
Sigma metrics: A review of Six Sigma
implementation tools for medical laboratories.
Biochem Med 2018;28(2): 020502.

• MR6 - 6 control measurements (either 6

controls run at once, or 3 controls run with 2
measurements being made on each control)
• SRN2 - represents a set of single wide control
limits (3 SD) with 2 control measurements
• MR2 - represents a standard set of “Westgard
Rules” (multirule QC procedure) with 4 control
measurements
• MR4 - represents a standard set of “Westgard
Rules” (multirule QC procedure) with 2 control
measurements
• SR4 - represents a set of single wide control
limits (3 SD) with 4 control measurements
15th BELGRADE SYMPOSIUM FOR BALKAN REGION
 Defining goals for intended use

Critical decision level

Shortcomings Bias

Detecting random errors

Practicality and cost of implementation

 Level U/L TE (%, BV) CV (%) Bias (%) Sigma
1 39 14,6 1,1 5 8,2
2 110 14,6 2,1 0,9 6,5
3 335 14,6 7,1 0,8 2

N = 180 15th BELGRADE SYMPOSIUM FOR BALKAN

REGION
15th BELGRADE SYMPOSIUM FOR BALKAN REGION
Thank You!
15th BELGRADE SYMPOSIUM FOR BALKAN REGION