Course Content

0 - Workshop Introduction

Overview

Purpose

Participants are provided with an overview of how this workshop integrates quality control (QC) into their laboratory to support their accreditation efforts. Additionally, workshop expectations are presented to participants.

Key Message

The workshop targets primarily quantitative QC and method evaluation.
Linkages between QC workshop training and ISO 15189 will be made throughout the workshop.
Where are we, where do we expect to be, and where do we want to be are three questions that will be used throughout the workshop to assist with data analysis and evaluation.

Self Assessment

Can you:

Understand how the QC workshop supports the SLMTA process?
Understand the workshop’s scope, targeting quantitative QC?
Understand expectations during and after the workshop?

Resources

1 - Let's Examine the Basics

Overview

Purpose

In this activity, the pre-requisite reading’s Final Examination on basic QC and Measures of Central Tendency worksheet will be reviewed with participants. Tools to calculate mean, standard deviation (SD), and coefficient of variation (CV) will be introduced and used throughout the workshop.

Key Message

The mean, SD, and %CV are foundational statistics used with QC
Given a data set, the mean, SD, and %CV can be calculated.
Calculators, spreadsheets, and online resources are available tools sites can use with their QC data.

Self Assessment

Can you:

Calculate the mean, SD and %CV from a given data set?
Utilize the tools introduced to obtain a mean, SD, and %CV from their site’s data set?
Calculate the measures of central tendency?

Resources

2 - Gaussian is the key

Overview

Purpose

Stable analytical systems will produce the same Gaussian distribution of data. When a system undergoes a change, an unexpected data point will be produced. In this activity, participants will demonstrate the foundational principles of statistical QC (SQC).

Key Message

The accuracy and precision of an analytical system describes WHERE WE ARE.
The basis of SQC is knowing WHERE WE ARE and WHERE WE EXPECT TO BE.
If WHERE WE ARE with our current observed value is not WHERE WE EXPECT TO BE, then a change has occurred.

Self Assessment

Can you:

List the performance specifications that describe WHERE WE ARE with an analytical system?
Define SQC and how it applies to monitoring their analytical system?
Define the criteria required for SQC to monitor change?

Resources

2.1 Gaussian is key

Video length: 8:43

Then complete: Worksheet 1: Definition of Terms Quiz (203v2) and Worksheet: Terms and Concepts – Gaussian.

2.2 Measures of Central Tendency

Video length: 3:27

Then complete: Worksheet 1: Definition of Terms Quiz (203v2) and Worksheet: Terms and Concepts – Gaussian.

2.3 Gaussian distribution

Video length: 3:51

Then complete: Worksheet 1: Definition of Terms Quiz (203v2) and Worksheet: Terms and Concepts – Gaussian.

2.4 Gaussian demonstration

Video length: 2:29

Then complete: Worksheet 1: Definition of Terms Quiz (203v2) and Worksheet: Terms and Concepts – Gaussian.

2.5 Levey-Jennings Chart

Video length: 4:02

Then complete: Worksheet 1: Definition of Terms Quiz (203v2) and Worksheet: Terms and Concepts – Gaussian.

2.6 Data populations

Video length: 3:02

Then complete: Worksheet 1: Definition of Terms Quiz (203v2) and Worksheet: Terms and Concepts – Gaussian.

2.7 SQC recap

Video length: 2:43

Then complete: Worksheet 1: Definition of Terms Quiz (203v2) and Worksheet: Terms and Concepts – Gaussian.

3 - Match it up

Overview

Purpose

QC rules alert laboratorians to a change in the analytical system (measurement procedure). In this activity, participants match charts to the correct QC rule violation and identify the type of error.

Key Message

Results of QC samples are analyzed to assess and alert us to changes in accuracy and precision (method performance).
The nomenclature for rule violations includes the number of data points involved and the applied control limits usually expressed as the mean ± a multiple of the SD.
Different rules indicate if the change is random or systematic. This information is used to assist with troubleshooting an out-of-control run.

Self Assessment

Can you:

Analyze L-J charts and Gaussian distributions and identify the rule violation?
Determine if the rule indicates a systematic or random error?
Understand how SE and RE assists with troubleshooting?

Resources

3.1 Match it up Introduction

Video length: 4:38

Then complete: Part I of the Rule Violation Answer Sheet (306). Do not watch 3.4.1 or 3.4.2 until Part I is done.

3.2 Common QC terms

Video length: 3:21

Then complete: Part I of the Rule Violation Answer Sheet (306). Do not watch 3.4.1 or 3.4.2 until Part I is done.

3.3 Homework Part 1 Match it up

Video length: 4:27

Then complete: Part I of the Rule Violation Answer Sheet (306). Do not watch 3.4.1 or 3.4.2 until Part I is done.

3.4.1 Homework Part II Introduction Match it up

Video length: 9:08

Before watching: Complete Part I of the Rule Violation Answer Sheet (306).

Then complete: Part II of the Rule Violation Answer Sheet (306) and Worksheet: Terms and Concepts – Match It Up.

3.4.2 Homework Part II Match it up

Video length: 2:28

Before watching: Complete Part I of the Rule Violation Answer Sheet (306).

Then complete: Part II of the Rule Violation Answer Sheet (306) and Worksheet: Terms and Concepts – Match It Up.

4 - The Front line worker

Overview

Purpose

Front-line workers assess whether or not an analytical run is acceptable. QC protocols developed by laboratory management must standardize the decision criteria used by the workers. In this activity, participants are provided with QC charts and a Westgard Multirule algorithm and must apply the decision-making process to determine acceptability of the analytical run.

Key Message

Multirules provide a high level of error detection capability while at the same time keeping false rejection rates low.
Laboratory management must provide clear instructions to the front-line workers regarding QC decision criteria.
The 1:2s warning rule is a scanning tool that can save time and effort in manual QC applications.

Self Assessment

Can you:

Determine whether an analytical run is acceptable or not based upon a given QC protocol?
Recognize how the 1:2s warning rule can be used as a scanning tool?
Understand when a multirule should be applied to a measurement procedure?

Resources

4.1 Introduction to The Front line worker

Video length: 6:42

Then complete: Worksheets 1–3: Scenarios 1–3 (404–406).

4.2 Homework The Front line worker

Video length: 3:37

Then complete: Worksheets 1–3: Scenarios 1–3 (404–406).

5 - It Begins with the Right Chart

Overview

Purpose

Using the QC tool, L-J Chart, one can visually inspect a quantitative method’s current accuracy and precision to quickly assess if a change is occurring within the system. In this activity, participants learn how to correctly create this tool, how to visually assess it, and how to avoid pitfalls commonly encountered with its set-up.

Key Message

One of the most widely used tools with QC is the L-J chart. This tool allows one to visually assess for a change in a method’s current performance.
When L-J charts are regularly examined, a small change may be recognized long before a QC rule violation occurs.
If the assigned values used on the chart do not reflect the observed values of the current performance, then the QC rules are unable to function properly to detect errors. The data will no longer appear normally distributed.

Self Assessment

Can you:

Create a properly prepared L-J chart?
Visually assess a chart to see if there has been a change in the method’s performance?
Recognize common pitfalls when the assigned values do not equal the observed values of a stable system?

Resources

5.1 Introduction - It Begins with the Right Chart

Video length: 4:15

Then complete: Part I: Worksheets 1–3, L-J Charts 1–3 (504–506).

5.2 True and False Accepts and Rejects

Video length: 8:30

Then complete: Part I: Worksheets 1–3, L-J Charts 1–3 (504–506).

5.3 LJ Chart set up

Video length: 3:13

Then complete: Part I: Worksheets 1–3, L-J Charts 1–3 (504–506).

5.4 Homework Part I - Assigned = Observed

Video length: 2:53

Then complete: Part I: Worksheets 1–3, L-J Charts 1–3 (504–506).

5.5 Homework - Introduction to Part II - Assigned ≠ Observed

Video length: 6:35

Before watching: Complete Part I: Worksheets 1–3 (504–506).

5.6 Homework Part II - Assigned ≠ Observed

Video length: 3:42

Before watching: Watch 5.5.

Then complete: Part II: Worksheets 4–6, L-J Charts 4–6 (507–509).

6 - Parallel Testing

Overview

Purpose

Only when the system is known to be stable can data be collected to calculate the observed mean and SD of a new lot number of QC material. % CV is introduced and used in the SD computation of short shelf-life control materials.

Key Message

New lot numbers of control material should be tested in parallel with the currently in-use control material.
Parallel testing is only performed when the instrument is operationally stable.
Package inserts serve as a guideline only and should not be used when creating the L-J chart for the new control.  %CV tells us WHERE WE ARE in terms of precision.

Self Assessment

Can you:

Understand the importance of parallel testing?
Identify the steps to perform parallel testing at their site?
Calculate the %CV?

Resources

6.1 Parallel Testing QC Material

Video length: 9:04

Then complete: Part I: Applying %CV (605) and Part II: The Great Equaliser.

6.2 Homework CV%

Video length: 7:44

Then complete: Part I: Applying %CV (605) and Part II: The Great Equaliser.

7 - Total Error

Overview

Purpose

Total error (TE) combines bias and imprecision to quantify the largest variation from the true (target) value. In this activity, participants are introduced to bias and true value. Using the information supplied by 3 key numbers, participants calculate the TE in units and percent. Additionally, participants explore the impact that bias and imprecision can have on TE and relate site-specific processes that affect TE to checklist items.

Key Message

3 key numbers are required to calculate TE – mean, SD, and true value.
The target value is our best estimate using sources that each has its own limitation.
TE is the total variation of our value from the true value.

Self Assessment

Can you:

Calculate bias and absolute bias?
Calculate TE in units and percent?
Identify ways to reduce bias and imprecision at their site?

Resources

7.1 Introduction to Total Error

Video length: 3:59

Then complete: Worksheet 1: Calculate TE (703), Worksheet 2: Impact of Bias and Imprecision on TE (704) and Worksheet: Terms and Concepts – IBWRC and TE.

7.2 Bias equation TE

Video length: 4:34

Then complete: Worksheet 1: Calculate TE (703), Worksheet 2: Impact of Bias and Imprecision on TE (704) and Worksheet: Terms and Concepts – IBWRC and TE.

7.3 TE Calculation Part I

Video length: 3:59

Then complete: Worksheet 1: Calculate TE (703), Worksheet 2: Impact of Bias and Imprecision on TE (704) and Worksheet: Terms and Concepts – IBWRC and TE.

7.4 TE Calculation Part II

Video length: 4:06

Then complete: Worksheet 1: Calculate TE (703), Worksheet 2: Impact of Bias and Imprecision on TE (704) and Worksheet: Terms and Concepts – IBWRC and TE.

7.5 Homework Calculating Total Error

Video length: 3:56

Then complete: Worksheet 1: Calculate TE (703), Worksheet 2: Impact of Bias and Imprecision on TE (704) and Worksheet: Terms and Concepts – IBWRC and TE.

8 - Putting TEa into Quality

Overview

Purpose

To control quality, one must first determine what quality is needed for a test. In this activity, participants will explore what information the fourth key number must provide to define the quality required. Additionally, participants will use a laboratory scenario to assess if the method remains acceptable for the intended clinical use of the test result.

Key Message

TE_A defines the quality specifications specific to the analyte being tested to make the analytical result clinically meaningful.
QC statistics can effectively reflect method performance if acceptable performance limits are defined and applied.
For clinically meaningful results, the TE should be less than the TE_A for that analyte.

Self Assessment

Can you:

Identify the four key numbers needed for quality?
Calculate error limits if given the Target Value and TE_A?
Compare TE to TE_A to determine if the method still performs within acceptable limits?

Resources

8.1 Homework Intended use Putting TEa into Quality

Video length: 3:42

Then complete: Worksheet 1: Intended Use (805) and Worksheets 2A–4: Intended Use (806–810).

8.2 Using Total Allowable Error

Video length: 8:45

Before watching: Complete the intended use worksheets (805–810).

Then complete: Worksheet 5: Calculating TEa Error Limits (811).

8.3 Calculating TEa Limits

Video length: 6:42

Before watching: Complete the intended use worksheets (805–810).

Then complete: Worksheet 5: Calculating TEa Error Limits (811).

8.4 Homework TEa Calculations and Reagent lot number changes

Video length: 3:56

Before watching: Complete Worksheet 5 (811).

Then complete: Worksheet 6: Reagent Lot Number Change (812).

9 - How Far can Your Mean Shift

Overview

Purpose

Benchmarking measurement procedures using TE_A and the current method’s performance allows a laboratory to identify which methods are meeting quality specifications and which are not. In this activity, Sigma-metric and Critical Systematic Error (ΔSEc) are introduced. Participants will review a site’s monthly summary report and perform an investigational analysis using instrument records and QC charts.

Key Message

SEc indicates how far the mean can shift before quality performance requirements are exceeded.
Benchmarking methods using a Sigma scale allows a laboratory to use their resources wisely.
Good recordkeeping is essential in resolving QC problems.

Self Assessment

Can you:

Describe how SEc and Sigma indicate method performance relative to quality performance goals?
Calculate SEc and Sigma?
Use information gleaned from records to troubleshoot a QC issue?

Resource

9.1 Introduction to How Far can Your Mean Shift

Video length: 8:04

Then complete: Worksheet 1: Calculating SEc and Sigma (906), Worksheet 2: QC Investigation (907), Worksheet 3: Case Scenario (908) and Worksheet: Terms and Concepts – TEa and HFCYMS.

9.2 Introduction to SEc

Video length: 3:40

Then complete: Worksheet 1: Calculating SEc and Sigma (906), Worksheet 2: QC Investigation (907), Worksheet 3: Case Scenario (908) and Worksheet: Terms and Concepts – TEa and HFCYMS.

9.3 Calculating SEc

Video length: 8:56

Then complete: Worksheet 1: Calculating SEc and Sigma (906), Worksheet 2: QC Investigation (907), Worksheet 3: Case Scenario (908) and Worksheet: Terms and Concepts – TEa and HFCYMS.

9.4 Introduction to Sigma metrics

Video length: 6:14

Then complete: Worksheet 1: Calculating SEc and Sigma (906), Worksheet 2: QC Investigation (907), Worksheet 3: Case Scenario (908) and Worksheet: Terms and Concepts – TEa and HFCYMS.

9.5 Homework Calculating SEc and Sigma

Video length: 2:03

Then complete: Worksheet 1: Calculating SEc and Sigma (906), Worksheet 2: QC Investigation (907), Worksheet 3: Case Scenario (908) and Worksheet: Terms and Concepts – TEa and HFCYMS.

9.6 Homework Review and investigate

Video length: 6:23

Then complete: Worksheet 1: Calculating SEc and Sigma (906), Worksheet 2: QC Investigation (907), Worksheet 3: Case Scenario (908) and Worksheet: Terms and Concepts – TEa and HFCYMS.

10 - How to Select Control Rules

Overview

Purpose

Laboratories must select appropriate QC rules based on the quality required for a test and the method’s observed accuracy and precision. In this activity, participants are introduced to the Sigma-metrics QC Selection Tool, available at Westgard.com. Using a case scenario, participants will select appropriate QC rules and design a QC strategy for a workstation.

Key Message

The measurement procedure’s quality requirement and the accuracy and precision must be considered in the selection of appropriate QC rules.
The control rule selected should alert the laboratorian to a significant change before wrong results are reported.
Selected control rules should maximize the error detection (P_ed ≥ 90%) and minimize the false rejection (P_fr ≤ 5%) while using the lowest number of control measurements possible.

Self Assessment

Can you:

Select appropriate QC rules using the Sigma-metrics QC Selection Tool from the Westgard internet site?
Select a TE_A% using the Westgard internet site?
Design an effective QC strategy for a workstation?

Resources

10.1 Introduction to How to Select Control Rules

Video length: 7:58

Then complete: Worksheet 1: Predicting Ped Capabilities (1006) and Worksheet 2: Candidate QC Rules (1007 v2).

10.2 QC selection tool introduction Part I

Video length: 8:19

Then complete: Worksheet 1: Predicting Ped Capabilities (1006) and Worksheet 2: Candidate QC Rules (1007 v2).

10.3 QC selection tool introduction Part II

Video length: 6:45

Then complete: Worksheet 1: Predicting Ped Capabilities (1006) and Worksheet 2: Candidate QC Rules (1007 v2).

10.4 Homework Predicting Probabilities

Video length: 3:55

Then complete: Worksheet 1: Predicting Ped Capabilities (1006) and Worksheet 2: Candidate QC Rules (1007 v2).

10.5 Homework Workstation activity

Video length: 3:51

Then complete: Worksheet 1: Predicting Ped Capabilities (1006) and Worksheet 2: Candidate QC Rules (1007 v2).

11 - How Proficient Are We

Overview

Purpose

External Quality Assessment Schemes (EQAS) enable the laboratory to assess on-going accuracy by comparing its method’s performance to external sources. In this activity, participants are introduced to standard deviation index (SDI) and z-score and will review a proficiency test (PT) report.

Key Message

Proficiency testing (PT) programs provide a way to verify long-term accuracy of a method.
SDI is a quick indicator of how well our mean compares to the method peer mean.
All PT failures must be investigated and documented by the laboratory.

Self Assessment

Can you:

Recognize the common elements found in a PT report and their significance?
Calculate SDI and use that information to assess the accuracy of the method?
Recognize that PT results, both acceptable and unacceptable, should be evaluated?

Resources

11.1 Why EQA Part 1

Video length: 3:13

Before watching: Phase 1: read Job Aids 1–3 (1107–1109), Handout: PT Examples (1105) and Handout: PT EQA Implementation, then answer the PT Reading Assignment Quiz.

Then complete: Worksheet: PT Calculations (1106).

11.2 Why EQA Part 2

Video length: 6:05

Before watching: Phase 1: read Job Aids 1–3 (1107–1109), Handout: PT Examples (1105) and Handout: PT EQA Implementation, then answer the PT Reading Assignment Quiz.

Then complete: Worksheet: PT Calculations (1106).

11.3 PT Programs Part 1

Video length: 4:20

Before watching: Phase 1: read Job Aids 1–3 (1107–1109), Handout: PT Examples (1105) and Handout: PT EQA Implementation, then answer the PT Reading Assignment Quiz.

Then complete: Worksheet: PT Calculations (1106).

11.4 PT Programs Part 2

Video length: 6:21

Before watching: Phase 1: read Job Aids 1–3 (1107–1109), Handout: PT Examples (1105) and Handout: PT EQA Implementation, then answer the PT Reading Assignment Quiz.

Then complete: Worksheet: PT Calculations (1106).

11.5 PT Programs Part 3

Video length: 3:26

Before watching: Phase 1: read Job Aids 1–3 (1107–1109), Handout: PT Examples (1105) and Handout: PT EQA Implementation, then answer the PT Reading Assignment Quiz.

Then complete: Worksheet: PT Calculations (1106).

11.6 PT Programs Part 4

Video length: 8:00

Before watching: Phase 1: read Job Aids 1–3 (1107–1109), Handout: PT Examples (1105) and Handout: PT EQA Implementation, then answer the PT Reading Assignment Quiz.

Then complete: Worksheet: PT Calculations (1106).

11.7 PT Programs Part 5

Video length: 5:56

Before watching: Phase 1: read Job Aids 1–3 (1107–1109), Handout: PT Examples (1105) and Handout: PT EQA Implementation, then answer the PT Reading Assignment Quiz.

Then complete: Worksheet: PT Calculations (1106).

11.8 Introduce the Activity

Video length: 3:33

Before watching: Phase 1: read Job Aids 1–3 (1107–1109), Handout: PT Examples (1105) and Handout: PT EQA Implementation, then answer the PT Reading Assignment Quiz.

Then complete: Worksheet: PT Calculations (1106).

12 - Understanding Interlab Comparison

Overview

Purpose

Laboratories using the same measurement procedure and analyzing the same control material will generate similar means and SDs. This information is a valuable source to determine the target value of the QC material for a laboratory and compare their method’s performance to their peers.

In this activity, participants are introduced to coefficient of variation index (CVI). Based on the information supplied from the inter-laboratory comparison report, participants will investigate a QC problem.

Key Message

Inter-laboratory peer comparisons can help identify method and PT problems.
The peer mean is an excellent source of the true (target) value for each control.
Coefficient of Variation Index is a peer-based metric of imprecision.

Self Assessment

Can you:

Calculate the SDI and CVI?
Verify the 4 key numbers used to monitor and evaluate performance?
Perform an investigational analysis regarding a summary statistic flag?

Resources

12.1 Introduce

Video length: 4:27

Before watching: Phase 1: read Job Aids 1–2 (1214–1215), then answer the Inter-laboratory Reading Assignment Quiz.

Then complete: Worksheet 1A: Calculating SDI and CVI.

12.2 Comparison

Video length: 5:44

Before watching: Phase 1: read Job Aids 1–2 (1214–1215), then answer the Inter-laboratory Reading Assignment Quiz.

Then complete: Worksheet 1A: Calculating SDI and CVI.

12.3 QC Materials

Video length: 5:39

Before watching: Phase 1: read Job Aids 1–2 (1214–1215), then answer the Inter-laboratory Reading Assignment Quiz.

Then complete: Worksheet 1A: Calculating SDI and CVI.

12.4 How It Works

Video length: 3:25

Before watching: Phase 1: read Job Aids 1–2 (1214–1215), then answer the Inter-laboratory Reading Assignment Quiz.

Then complete: Worksheet 1A: Calculating SDI and CVI.

12.5 CVI Part 1

Video length: 2:08

Before watching: Phase 1: read Job Aids 1–2 (1214–1215), then answer the Inter-laboratory Reading Assignment Quiz.

Then complete: Worksheet 1A: Calculating SDI and CVI.

12.6 CVI Part 2

Video length: 3:38

Before watching: Phase 1: read Job Aids 1–2 (1214–1215), then answer the Inter-laboratory Reading Assignment Quiz.

Then complete: Worksheet 1A: Calculating SDI and CVI.

12.7 CVI Part 3

Video length: 4:41

Before watching: Phase 1: read Job Aids 1–2 (1214–1215), then answer the Inter-laboratory Reading Assignment Quiz.

Then complete: Worksheet 1A: Calculating SDI and CVI.

12.8 Introduce the Activity

Video length: 5:22

Before watching: Phase 1: read Job Aids 1–2 (1214–1215), then answer the Inter-laboratory Reading Assignment Quiz.

Then complete: Worksheet 1A: Calculating SDI and CVI.

13 - Introduction to Method Validation and Verification

Overview

Purpose

Before a method can be placed into routine service, it must be evaluated to ensure that the measurement procedure meets defined criteria, such as sensitivity, specificity, precision, accuracy, and linearity. In this activity, participants will perform method verification experiments and assess data to determine if the method is acceptable or not.

Key Message

Even though manufacturers test their methods extensively, there are many factors in an individual laboratory that can affect the actual precision and accuracy of the method.
Method evaluation is performed to reveal the amount of error present in the new method.
Once the performance of the method has been judged to be acceptable from method evaluation studies, then statistical QC procedures need to be selected that can detect medically important errors.

Self Assessment

Can you:

List the steps required to introduce a new method?
Collect and analyze the experimental data needed to quantify the error present?
Judge if the method meets pre-defined quality requirements?
Verify a reference interval?

Resources

13.1 Introduction Part 1

Video length: 3:06

Before watching: Phase 1: read Handouts 1–3 (1403–1405), then answer the MV Reading Assignment Quiz.

Then complete: Part 1: Worksheet – Method Validation & Verification Flowchart.

13.2 Introduction Part 2

Video length: 5:00

Before watching: Phase 1: read Handouts 1–3 (1403–1405), then answer the MV Reading Assignment Quiz.

Then complete: Part 1: Worksheet – Method Validation & Verification Flowchart.

13.3 ISO Requirements

Video length: 5:00

Before watching: Phase 1: read Handouts 1–3 (1403–1405), then answer the MV Reading Assignment Quiz.

Then complete: Part 1: Worksheet – Method Validation & Verification Flowchart.

13.4 Intro Summary

Video length: 3:07

Before watching: Phase 1: read Handouts 1–3 (1403–1405), then answer the MV Reading Assignment Quiz.

Then complete: Part 1: Worksheet – Method Validation & Verification Flowchart.

13.5 Performance Characteristics 1

Video length: 4:23

Before watching: Phase 1: read Handouts 1–3 (1403–1405), then answer the MV Reading Assignment Quiz.

Then complete: Part 1: Worksheet – Method Validation & Verification Flowchart.

13.6 Performance Characteristics 2

Video length: 3:28

Before watching: Phase 1: read Handouts 1–3 (1403–1405), then answer the MV Reading Assignment Quiz.

Then complete: Part 1: Worksheet – Method Validation & Verification Flowchart.

13.7 Performance Characteristics 3

Video length: 4:08

Before watching: Phase 1: read Handouts 1–3 (1403–1405), then answer the MV Reading Assignment Quiz.

Then complete: Part 1: Worksheet – Method Validation & Verification Flowchart.

13.8 Performance Characteristics 4

Video length: 7:07

Before watching: Phase 1: read Handouts 1–3 (1403–1405), then answer the MV Reading Assignment Quiz.

Then complete: Part 1: Worksheet – Method Validation & Verification Flowchart.

13.9 Performance Characteristics 5

Video length: 2:24

Before watching: Phase 1: read Handouts 1–3 (1403–1405), then answer the MV Reading Assignment Quiz.

Then complete: Part 1: Worksheet – Method Validation & Verification Flowchart.

13.10 Validation and Verification Summary

Video length: 1:16

Before watching: Phase 1: read Handouts 1–3 (1403–1405), then answer the MV Reading Assignment Quiz.

Then complete: Part 1: Worksheet – Method Validation & Verification Flowchart.

13.11 Introduce the Activity - Decision Tree

Video length: 1:20

Before watching: Phase 1: read Handouts 1–3 (1403–1405), then answer the MV Reading Assignment Quiz.

Then complete: Part 1: Worksheet – Method Validation & Verification Flowchart.

13.12 MV Overview Part 1

Video length: 3:21

Then complete: Part 2: Precision Experiment Worksheets – Long V2 and Short V2.

13.13 MV Overview Part 2

Video length: 4:46

Then complete: Part 2: Precision Experiment Worksheets – Long V2 and Short V2.

13.14 MV Overview Part 3

Video length: 3:24

Then complete: Part 2: Precision Experiment Worksheets – Long V2 and Short V2.

13.15 Precision Experiment 1

Video length: 6:38

Then complete: Part 2: Precision Experiment Worksheets – Long V2 and Short V2.

13.16 Precision Experiment 2

Video length: 3:35

Then complete: Part 2: Precision Experiment Worksheets – Long V2 and Short V2.

13.17 Intro the Activity - Precision

Video length: 5:11

Then complete: Part 2: Precision Experiment Worksheets – Long V2 and Short V2.

13.18 Linearity Experiment 1

Video length: 2:22

Then complete: Part 3: Linearity Experiment Worksheet (14A03).

13.19 Linearity Experiment 2

Video length: 4:56

Then complete: Part 3: Linearity Experiment Worksheet (14A03).

13.20 Linearity Experiment 3

Video length: 3:40

Then complete: Part 3: Linearity Experiment Worksheet (14A03).

13.21 Linearity Experiment 4

Video length: 4:53

Then complete: Part 3: Linearity Experiment Worksheet (14A03).

13.22 Linearity Experiment 5

Video length: 6:56

Then complete: Part 3: Linearity Experiment Worksheet (14A03).

13.23 Linearity Experiment 6

Video length: 2:36

Then complete: Part 3: Linearity Experiment Worksheet (14A03).

13.24 Linearity Experiment 7

Video length: 6:06

Then complete: Part 3: Linearity Experiment Worksheet (14A03).

13.25 Intro the Activity-Linearity

Video length: 4:10

Then complete: Part 3: Linearity Experiment Worksheet (14A03).

13.26 Accuracy Experiment 1

Video length: 2:11

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.27 Accuracy Experiment 2

Video length: 3:51

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.28 Accuracy Experiment 3

Video length: 5:19

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.29 Accuracy Experiment 4

Video length: 3:47

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.30 Accuracy Experiment 5

Video length: 4:28

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.31 Accuracy Experiment 6

Video length: 5:19

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.32 Accuracy Experiment 7

Video length: 2:35

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.33 Accuracy Experiment 8

Video length: 4:32

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.34 Accuracy Experiment 9

Video length: 4:47

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.35 Accuracy Experiment 10

Video length: 6:25

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.36 Accuracy Experiment 11

Video length: 5:03

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.37 Introduce the Activity - Accuracy

Video length: 12:20

Then complete: Part 4: Comparison of Methods Worksheet V2 (14C04) and Judging Acceptability Worksheet (14C05).

13.38 Reference Interval Experiment 1

Video length: 2:02

Then complete: Part 5: Reference Interval Worksheet (14D03).

13.39 Reference Interval Experiment 2

Video length: 4:18

Then complete: Part 5: Reference Interval Worksheet (14D03).

13.40 Reference Interval Experiment 3

Video length: 3:55

Then complete: Part 5: Reference Interval Worksheet (14D03).

13.41 Reference Interval Experiment 4

Video length: 3:32

Then complete: Part 5: Reference Interval Worksheet (14D03).

13.42 Introduce the Activity - Ref Interval

Video length: 4:58

Then complete: Part 5: Reference Interval Worksheet (14D03).

14 - Measurement of Uncertainty

Overview

Purpose

Every result has some degree of uncertainty that comes from the calibration of the method and the analysis itself. In this activity, participants learn how to determine measurement uncertainty using a top-down approach and how to apply measurement uncertainty in an advisory capacity for their clients.

Key Message

The uncertainty gives the limits of the range in which the true value of the measurand is estimated to be at a given probability.
The long-term %CV or SD data gained through the laboratory’s IQC is sufficient for satisfying the minimal criteria for MU determination.
The MU is helpful in differentiating whether a change in a serial test result is due to analytical variation or a true physiological change.

Self Assessment

Can you:

Recognize the need for hospital management support and analytical staff adherence when planning a QC program?
Identify the steps needed during the planning phase to successfully implement a QC program?
Further refine the process plan to identify what happens, who’s responsible, and by when?