Part No. J04498 Cat No. 680 0325 Performance...

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Performance Verifiers Training Module

Part No. J04498 Cat No. 680 0325

2Performance VerifiersVITROS® Chemistry Systems

Part No. J044982018-06-15

IMPORTANT

The information contained herein is based on the experience and knowledge relating to the subject matter gained by Ortho Clinical Diagnostics prior to publication. Always consult the current Product Instructions for Use (IFU). Ortho Clinical Diagnostics reserves the right to change this information without notice.

All product and company names are trademarks™ or registered® trademarks of their respective holders.

VITROS® is a trademark of Ortho Clinical Diagnostics, Inc.

Ortho Clinical Diagnostics, Inc., 1997-2018. All rights reserved.

Export authorized under general license GTDA (General Technical Data Available)

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Performance VerifiersVITROS® Chemistry Systems

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Revision History

Revision Description

2018-06-15 Company name changed to Ortho Clinical Diagnostics.Updated to reflect current analyzers. Removed Table 17 in Appendix 2.Added Table for Validation Calculations and Calculation of Control Means in Appendix 3.

2007-06-25 Added all MicroTip Drugs of Abuse Testing (DAT) Assays.

2006-03-31 Added all MicroTip and MicroSlide Assays and Performance Verifiers that have become available since last release.

1999-08-01 Company name changed to Ortho-Clinical Diagnostics, Inc., a Johnson & Johnson Company.


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Revision Date Chapter Page

2018-06-15 All Chapters All




List of Revised Pages

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About This Training Manual

Purpose

The purpose of this module is to provide information on how VITROS® Performance Verifiers can be used to monitor performance of VITROS® Chemistry Systems.

For setting up Quality Control files on your VITROS® Chemistry System, refer to the V-DOCs or Quality Control section of the VITROS® 350, 4600, 5600 and XT 7600 Operator’s Guide.

Audience

How This Module is Organized

Additional Training Modules

This module is intended for use by customers of Ortho Clinical Diagnostics using VITROS® 350, 4600, 5600 and XT 7600 Chemistry Systems.

This module describes Performance Verifiers, how the range of means and within-lab standard deviations are established, and how Performance Verifiers can be used with VITROS® Chemistry Systems.

Statistical Tools of Quality Control

Part No. 7B6006 CAT No. 184 9017

Additional training modules are available on orthoclinical.com. For ordering information, please contact your Ortho Clinical Diagnostics Laboratory Specialist.


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About This Training Manual

ContentsPurpose ..................................................................................................................................................... 5Audience .................................................................................................................................................... 5How This Module is Organized .................................................................................................................. 5Additional Training Modules ...................................................................................................................... 5

Introduction ................................................................................................................................................... 7Objectives .................................................................................................................................................. 8

Definitions ..................................................................................................................................................... 9

What are Performance Verifiers? ................................................................................................................ 12How the Range of Means (ROM) is Established ....................................................................................... 13How the Range of Means (ROM) is Used ................................................................................................. 13How the Within-lab Standard Deviation (Within-lab SD) is Established ................................................................................................................... 14How the Within-lab Standard Deviation is Used ........................................................................................ 14

Using Performance Verifiers? ..................................................................................................................... 15Verifying a New Calibration ....................................................................................................................... 16Establishing Baseline Means for Performance Verifiers ............................................................................ 18Monitoring System Performance on a Periodic (Monthly) Basis ............................................................... 20Verifying a Previous Calibration When System Performance May Have Changed ................................... 22Verifying a Previous Calibration When No Valid Baseline Mean for Performance Verifiers Has Been Established ............................................................................................................................... 24

Appendix 1: Performance Verifier Assay Sheets ...................................................................................... 26

Appendix 2: Delta Tables ............................................................................................................................. 27

Appendix 3: Quality Control Worksheets ................................................................................................... 36VITROS® Chemistry System QC Worksheet ............................................................................................. 38VITROS® Chemistry System QC Worksheet ............................................................................................. 39

Exercises ....................................................................................................................................................... 41

Answer Key ................................................................................................................................................... 51

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Introduction

The purpose of this module is to provide you with recommendations for using Performance Verifiers to monitor the performance of the VITROS® Chemistry System in your laboratory. These recommendations do not,however, exclude alternative approaches to monitoring your system’s performance.

Prerequisites for this module are:

• Ability to calculate a mean and standard deviation.• Ability to define and apply the 12S, 22S, and 13S quality control multi-rules.

If you have not fulfilled these prerequisites, you must complete the following module:

— Statistical Tools of Quality Control Module 7B6006.


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Introduction

ObjectivesUpon completion of this module, you will be able to:

• Explain what Performance Verifiers are and how to use them. • Describe how to establish a mean for each level of Performance Verifier.

• Explain the information found on the assay sheets which accompany the Performance Verifiers. • Understand Range of Means and Within-lab standard deviation.

• Perform daily quality control using Performance Verifiers.

• Perform calibration verification on a new slide/reagent lot using Performance Verifiers.

• Use Performance Verifiers to monitor your system’s performance periodically.

• Verify pre-existing calibration when there are no valid baseline means available for Performance Verifiers.

This module will take approximately two hours to complete. You will need the following items:

• Pencil

• Calculator

This module contains practice exercises to help you apply the concepts learned. The answer key for the practice exercises is provided.

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DefinitionsGeneration (Gen) is a term used to describe those slide lots that can use the same Supplemen-tary Assigned Values (SAVs) for calibration. Supplementary Assigned Value refers to the value each calibrator is assigned of equivalent concentration (in the units appropriate for the assay) by predicting the concentration that would be present at the measured response if the test fluid were a patient sample. Slide lots from the same generation have the same Range of Means on the assay sheet. The Gen number for each lot of slides is found on the packaging as well as on the side and top labels ofindividual slide cartridges.

Performance Verifier Range of Means (ROM) is a term used to describe the lowest and highest mean values your VITROS® Chemistry System should produce for your slide lot. These ranges are specific for a particular Gen of slides. These ranges define the acceptable mean values for any generation of slides. On the assay sheet for Performance Verifiers, each Gen of a particular analyte is listed with its corresponding ROM.

A Baseline SD is the value the VITROS® Chemistry System QC software uses in combination with the mean to calculate the 12s, 22s and 13s control rule limits that should be used for your daily quality control decisions.

The Baseline SD that is used to calculate control limits in the VITROS® Chemistry System software may be a fixed criteria, such as the within-lab SD from the Perfor-mance Verifier assay sheets. This is a calculated SD determined from the laboratory’s experience with the VITROS® Chemistry Systems, or your laboratory’s medically useful limits. Adopting an SD wider than the Performance Verifier assay sheet is not suggested.

The Within-lab SDs on the Performance Verifiers assay sheets were established using monthly within-lab SD for VITROS® Chemistry System users participating in a commercial quality control service. These values are representative of the performance of properly operating VITROS® Chemistry Systems. These values are representative of the performance of properly operating VITROS® Chemistry Systems in multiple laboratories using multiple Performance Verifier lots. Additionally, each SD was compared to USA and European proficiency testing goals and adjust-ed accordingly.


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The published within-lab SD includes the variability associated with performing replicate measurements within a day and measurements from one day to the next. The day-to-day variability includes the small variation introduced by different slide cartridges, different vials of control material, multiple calibration events, environmental influences, and preventive maintenance events. These values do not include the variability due to using different slide lot numbers.

A within-lab SD can be calculated from your daily quality control results and compared to the Performance Verifier assay sheets within-lab SD. A calculated laboratory SD larger than the Performance Verifier assay sheets within-lab SD indicates that system troubleshooting may be necessary. If the calculated SD is much smaller than the Performance Verifier assay sheets within-lab SD, you may not have included all of the expected sources of variability or valid QC results may have been excluded from the calcula-tion. If you use this calculated SD as your baseline SD, valid data points may be rejected and troubleshooting may be performed more frequently than needed.

Calibration Verification is a means of assessing whether a calibration is acceptable by using results from each level of Performance Verifiers. At a minimum, these results should be within the ROM for that control.

A Preliminary Baseline Mean is the average of two values run sequentially (two replicates from one cup) immediately after the system is calibrated. This should be done using a fresh vial of PV. This mean is used to verify this calibration. This value should be used as the base-line mean in the VITROS® Chemistry System QC software until a more robust estimate of the mean is available (refer to your analyzer Operator’s Guide).

If you are not using PVs as your daily QC materials, then record the preliminary baseline mean as a Calibration Verification Mean for use in troubleshooting and verification of a pre-existing calibration.

A Baseline Mean is the average of QC results observed over 20–30 days, and this mean should replace the preliminary baseline mean in VITROS® Chemistry System software. It is a better estimate of the true mean than the 2-point preliminary baseline mean (refer to your analyzer Operator’s Guide).

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Definitions

A Current Mean is the mean value you should use to periodically evaluate the VITROS® Chemistry System after you have established a baseline mean and when there is no evidence that anything has happened to alter your system’s performance. The Current Mean will typically be your calculated monthly mean (refer to your analyzer Operator’s Guide).

A Current SD is the standard deviation calculated along with your monthly Current Mean (refer to your analyzer Operator’s Guide).

A Delta is the absolute difference between any two means. If the Delta is greater than the values in the Delta Tables in Appendix 2, then the two means are different. Depending on your laboratory’s policy and the magnitude of the difference, troubleshooting may be necessary if this is the case.

The values in the Delta tables for n = 2 should also be used as guidelines for acceptable replication of Performance Verifiers in any evaluation.

The delta values in the tables were calculated using standard statistical techniques for the com-parison of two means. We used the Performance Verifier assay sheet SD as the basis for this comparison. For small sample sizes (n=2), the calculated deltas assure that the probability of concluding that the means are not different when they truly are, is small. For sample sizes of 20 or more, the calculated deltas assure that the likelihood of saying that the means are different when they are truly not, is small. These choices give laboratory personnel a good balance be-tween the risk of making a certain type of error and the effect that increasing sample size has on the quality of the estimate of the difference between the two means.


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What are Performance Verifiers?Performance Verifiers (PVs) are assayed controls designed for use asquality control tools. PVs provide you with a way to assess the calibration of your analyzer, monitor the daily performance of the system, and assist you in troubleshooting out-of-control conditions indicated by your daily quality control results.

The following Performance Verifiers are currently available:

• AAT/HPT Performance Verifier Level I, II and III• ApoA1 Performance Verifier Level I• ApoB Performance Verifier Level I• ASO/RF Performance Verifier Level I and II• CRP Performance Verifier Level I and II• DAT Performance Verifier Level I, II, III, IV and V• dTIBC Performance Verifier Level I and II• HCY Performance Verifier Level I, II and III• hsCRP Performance Verifier Level I, II and III• Isoenzyme Performance Verifier Level I and II• Liquid Performance Verifier Level I and II

• mALB Performance Verifier Level I and II• PALB Performance Verifier Level I and II• Performance Verifier Level I and II• Protein Performance Verifier Level I, II and III• TDM Performance Verifier Level I, II and III• UPRO Performance Verifier Level I and II

The assay sheet which accompanies these fluids includes the followinginformation for each analyte:

• A generation (Gen-) specific range of means (ROM).• A recommended within-lab standard deviation (SD). Appendix 1 shows

an example of an assay sheet.

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How the Range of Means (ROM) is EstablishedThe width of the ROM (highest mean value minus the lowest mean value) is a fixed parameter. The ROM reflects the performance of properly operating VITROS® Chem-istry Systems as monitored with Performance Verifiers. The ROM width for each analyte was compared to USA and European proficiency testing goals and adjusted as appropriate. The numerical values that define the ROM for each slide generation are established by collecting data from internal testing performed on multiple analyzers and among different slide lot numbers within the slide generation.

How the Range of Means (ROM) is Used

When evaluating the performance of a VITROS® Chemistry System using Performance Verifiers, the mean based on two or more replicate measurements of these fluids must be within the ROM to be acceptable.

Since Performance Verifiers are manufactured fluids, they do not have the same physical and chemical characteristics or “matrix” as fresh patient specimens. These differences may cause the results on different slide lots to vary. The term “matrix effects” is commonly used to describe this phenomenon. Matrix effects result in wider ROM than would otherwise be observed.

• The mean of two or more measurements can fall anywhere in the ROM (not necessarily in the center) for that particular slide Gen.

• For calibration verification, the mean of 2 or more replicate measurements of Performance Verifiers (called a Preliminary Baseline Mean) should fall within the ROM listed on the assay sheet.

• When using Performance Verifiers for routinely monitoring a properly operating system, all calculated means should be within the ROM. Each estimate of the mean should be statistically the same as all other estimates of the mean. The assessment of any two means will be discussed later on in this module.

• It is not expected that all individual daily QC values will fall within the ROM even if the system is showing acceptable performance. However, the mean of a distribution of daily QC values for properly operating systems should always fall within the ROM.


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How the Within-lab Standard Deviation (Within-lab SD) is Established

The published within-lab SD on the Performance Verifier assay sheets was established using monthly within-lab SD for VITROS® Chemistry System users participating in a commercial quali-ty control service. These values are representative of the performance of properly operating VITROS® Chemistry Systems in multiple laboratories using multiple Performance Verifier lots. Additionally, each SD was compared to USA and European proficien-cy testing goals and adjusted as appropriate.

The published within-lab SD on the Performance Verifier assay sheets normally does not change from one lot of Performance Verifiers to another. However, it may be adjusted if the analyte concentration changes significantly. This should not occur very often.

How the Within-lab Standard Deviation is Used

The baseline SD that is used to calculate control limits in the VITROS® Chemistry System software may be a fixed criteria, such as the within-lab SD from the Performance Verifier assay sheets, a calculated SD determined from the laborato-ry’s experience with the VITROS® Chemistry Systems, or your laboratory’s medically useful limits.

We recommend that you use the within-lab SD from the PV assay sheets for your baseline SD and your daily quality control decisions.

Some laboratories also calculate the actual SD for the VITROS® Chemistry System.

– A calculated laboratory SD larger than the PV assay sheet within-lab SD indicates that system troubleshooting may be necessary. – If the calculated SD is much smaller than the PV assay sheet within-lab SD, you may not have included all of the expected sources of variability or valid QC results may have been excluded from the calculation. If you use this calculated SD as your baseline, you may be rejecting valid data points and be troubleshooting more frequently than needed.

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Using Performance Verifiers?Performance Verifiers (PVs) can be used:

• To verify calibration.• As daily quality control materials.• As tools for troubleshooting.

The flowcharts described below illustrate how to use Performance Verifiers to address circumstances.

Flowchart 1: Verifying a new calibration.

Flowchart 2: Establishing Baseline Means for PVs (Using PVs as daily QC materials).

Flowchart 3: Monitoring System performance on a periodic (monthly) basis.

Flowchart 4: Verifying a previous calibration when system performance may have changed.

Flowchart 5: Verifying a previous calibration when no valid Baseline Means for Performance Verifiers have been established.

Those laboratories not using PVs as daily QCmaterials do not need to use flowchart 2. However, it is as-sumed that these laboratories will have PVs on hand to assist in troubleshooting and calibration verification. IMPORTANT: To verify a previous calibration when using Per-formance Verifiers as daily QC, you should always being with Flowchart 3.

Some abbreviated language has been used to keep the flow-charts short and simple. Refer to the Definitions section of this module to find explanations for the some terms you will find in the flowcharts that follow.

Calibrate Slide/Fluid Lot

Run fresh vials of PVs in

duplicate.


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Verifying a New CalibrationWhenever the means of two or more measurements of Performance Verifiers, made after a new calibration, are within the ROM, these results reflect the distribution of acceptable calibrations for VITROS® Chemistry Systems. The mean for a given combination of analyzer, slide lot, and Performance Verifier lot is not expected to fall in the middle of the ROM for that particular generation of slides.

For verifying calibration immediately following a new calibration, follow these steps (see Flowchart 1):

1. After calibration, measure in duplicate the PV fluid (from the same cup) from freshly reconstituted vials of PV Level I and PV Level II (also PV Level III, if applicable).

2. Calculate the mean for two replicates of each PV fluid. These are the preliminary baseline means.

3. If the preliminary baseline mean values of all Performance Verifiers fall within the range of means, calibration is verified.

Note: In addition, you may prefer to evaluate the performance of the newly calibrated slide lot by comparing it with a previous slide lot or another method. Compare the results of 5 – 10 patient samples run on the current and new slide lots with your laboratory’s analyte-specific evaluation criteria.

4. Input these preliminary baseline means in the analyzer software or record these mean values in your QC system. Appendix 3 contains a Calibration Verification worksheet that can be used to record these values and document your other QC records.

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Flowchart 1. Verifying a New Calibration Using Performance Verifiers (PVs)


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Establishing Baseline Means for Performance Verifiers

If you intend to use Performance Verifiers as your daily quality control materials, you need to establish a baseline mean. This is necessary because the baseline mean established using additional data points is a better estimate of the true mean than the 2-point preliminary baseline mean. The more data collected to calculate the baseline mean, the more confidence you will have that your calculated mean approaches the true mean.

• To calculate a baseline mean you must run Performance Verifiers for a minimum of 20 days. This length of time will help ensure that multiple vials of Performance Verifiers and multiple slide cartridges are included in this estimate. During this period, you must change the slide cartridges and control fluid vials at least twice.

• We recommend that you establish the baseline mean for a new lot of Performance Verifiers while still using your current lot of Performance Verifiers to make daily QC decisions. • If you need to use a new lot of Performance Verifiers for daily QC decisions while establishing the baseline mean, use the preliminary baseline mean established during calibration verification and the Within- lab SD as the criteria for making your QC decisions. Also use the 13S rule (only react to the F3 QC flags from the VITROS® Chemistry System software) during this period.

• The baseline mean should not differ from the preliminary baseline mean by more than the Delta for n = 2 from Appendix 2. Appendix 3 contains a Baseline Mean Evaluation worksheet to record these values.

See Flowchart 2 for an outline of this process.

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Flowchart 2. Establishing Baseline Means for Performance Verifiers


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Monitoring System Performance on a Periodic (Monthly) Basis

If you use Performance Verifiers as your daily control materials the results can be used to assess the performance of the VITROS® Chemistry System on a periodic basis. This assessment might be done to detect drift or to verify a previous calibration.

• We recommend that this assessment be done on a monthly basis.

• Evaluate both the current (monthly) means and the calculated SDs. The monthly means are evaluated both for being within the ROM and whether or not the current mean is statistically the same as the baseline mean. The calculated standard deviations are evaluated for being larger than the PV assay sheet Within-lab SD. • In order to evaluate whether the current mean is statistically different from the baseline mean, you need to calculate the difference (delta) between the current mean and the baseline mean. This difference is evaluated using the Delta table in Appendix 2.

• The number of data points (n) included in this monthly assessment should match the number used to calculate the baseline mean (20-30). If the two (n)s are not the same, use the following guideline:

– If either the baseline mean or the current mean has n < 30 data points, use n = 20 from the Delta table in Appendix 2.– If both the baseline mean and the current mean have n ≥ 30 data points, use n = 30 from the Delta table in Appendix 2.

Use the steps outlined in Flowchart 3 to assess the performance of a VITROS® Chemistry System on a periodic basis. In order to use this flowchart, you must use PVs as your daily control materials. Appendix 3 contains a worksheet that can be used to document the period-ic monitoring of system performance.

This procedure determines whether or not there is a statistically significant difference between your current mean and the baseline mean. A statistically significant difference may not be clinically significant. When you have a statistically significant difference, an investigation may be required, depending on your laboratory’s action limit for monthly mean variation.

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Monitoring System Performance on a Periodic (Monthly) Basis

Flowchart 3. Monitoring System Performance on a Periodic (Monthly) Basis


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Verifying a Previous Calibration When System Performance May Have Changed

Performance Verifiers should also be used to verify an existing calibration when the perfor-mance of the VITROS® Chemistry System may have changed. The following situations may alter the performance of the VITROS® Chemistry System to the extent that you should use Flowchart 4 to verify calibration:

• Major maintenance

• Environmental changes

If you suspect that system performance has changed, use the mean results of duplicate measurements of fresh vials of Performance Verifiers to assess the current performance of the system. The calibration is still acceptable if the mean of two or more measurements of fresh vials of Performance Verifiers is within the ROM and these results are comparable to the baseline means.

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Flowchart 4. Verifying a Previous Calibration When System Performance May Have Changed


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Verifying a Previous Calibration When No Valid Baseline Mean for Performance Verifiers Has Been Established

If you have not established a valid baseline mean for Performance Verifiers, and you need to verify a previous calibration, follow the steps outlined in Flowchart 5. There are several reasons for not having a valid baseline mean established. The two most common reasons are:

• You do not use Performance Verifiers as your daily QC material.• There has not been enough time to establish the baseline mean (less than 20-30 days).

If you are verifying a previous calibration or you would like to assess the performance of the VITROS® Chemistry System on a periodic basis and do not use PVs as a daily control you need to calculate the difference (delta) between your calibration verification mean (established at initial calibration) and today’s 2-replicate mean on fresh vials of PVs. This difference is evaluated using the Delta table in Appendix 2.

If you are using PVs as your daily control and you need to verify a previous calibration but have not yet established a baseline mean, follow the steps outlined in Flowchart 5. You need to calculate the difference (delta) between your preliminary baseline mean (established at initial calibration) and today’s 2-replicate mean on fresh vials of PVs. This difference is evaluated using the Delta table in Appendix 2.

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Flowchart 5. Verifying a Previous Calibration When No Valid Baseline Mean for Performance Verifiers (PVs) Has Been Established


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Appendix 1: Performance Verifier Assay SheetsThis Appendix contains a sample of the Performance Verifier assay sheets.

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Appendix 2: Delta TablesThe use of Delta Tables as an additional statistical tool is determined by individual laboratories.

The Delta Tables in this Appendix are used to evaluate system drift or performance shifts. Data in the tables were developed using the within-lab SD found on the Performance Verifier assay sheets.

Table 1: VITROS® Performance Verifiers I and II

Conventional Units SI Units

Chemistry PV Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

ALB 1 g/dL 0.18 0.10 0.08 g/L 1.8 1.0 0.8ALB 2 g/dL 0.22 0.12 0.10 g/L 2.2 1.2 1.0

ALKP 1 U/L 6.8 3.8 3.1 U/L 6.8 3.8 3.1ALKP 2 U/L 31.4 17.6 14.4 U/L 31.4 17.6 14.4ALT 1 U/L 5.3 3.0 2.4 U/L 5.3 3.0 2.4ALT 2 U/L 9.8 5.5 4.5 U/L 9.8 5.5 4.5

AMYL 1 U/L 8.2 4.6 3.8 U/L 8.2 4.6 3.8AMYL 2 U/L 20.5 11.5 9.4 U/L 20.5 11.5 9.4AST 1 U/L 2.9 1.7 1.3 U/L 2.9 1.7 1.3AST 2 U/L 9.8 5.5 4.5 U/L 9.8 5.5 4.5Bc 1 mg/dL 0.20 0.11 0.09 μmol/L 3.4 1.9 1.5Bc 2 mg/dL 0.49 0.28 0.22 μmol/L 8.4 4.7 3.8


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Table 1: VITROS® Performance Verifiers I and II (Continued)

Conventional Units SI UnitsChemistry PV

Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

Bu 1 mg/dL 0.12 0.07 0.05 µmol/L 2.0 1.1 0.9Bu 2 mg/dL 0.59 0.33 0.27 µmol/L 10.1 5.6 4.6

BUN 1 mg/dL 1.2 0.7 0.5 mmol/L 0.4 0.2 0.2BUN 2 mg/dL 2.7 1.5 1.3 mmol/L 1.0 0.5 0.4Ca 1 mg/dL 0.43 0.24 0.20 mmol/L 0.11 0.06 0.05Ca 2 mg/dL 0.51 0.29 0.23 mmol/L 0.13 0.07 0.06

CHE 1 U/mL 0.24 0.13 0.11 U/L 240 130 110CHE 2 U/mL 0.33 0.19 0.15 U/L 330 190 150

CHOL 1 mg/dL 8.5 4.8 3.9 mmol/L 0.22 0.12 0.10CHOL 2 mg/dL 11.7 6.6 5.4 mmol/L 0.30 0.17 0.14

CK 1 U/L 28.8 16.2 13.2 U/L 28.8 16.2 13.2CK 2 U/L 81.7 45.9 37.5 U/L 81.7 45.9 37.5Cl- 1 mmol/L 2.2 1.2 1.0 mmol/L 2.2 1.2 1.0Cl- 2 mmol/L 2.7 1.5 1.3 mmol/L 2.7 1.5 0.3

CREA 1 mg/dL 0.16 0.09 0.07 µmol/L 13.9 7.8 6.4CREA 2 mg/dL 0.27 0.15 0.13 µmol/L 24.3 13.6 11.1DGXN 1 ng/mL 0.24 0.13 0.11 nmol/L 0.30 0.17 0.14DGXN 2 ng/mL 0.33 0.19 0.15 nmol/L 0.43 0.24 0.20dHDLC 1 mg/dL 3.06 1.72 1.40 mmol/L 0.079 0.044 0.036dHDLC 2 mg/dL 4.61 2.59 2.11 mmol/L 0.119 0.067 0.055dLDL 1 mg/dL 6.27 3.52 2.88 mmol/L 0.163 0.091 0.075dLDL 2 mg/dL 10.98 6.16 5.03 mmol/L 0.284 0.160 0.130ECO2 1 mmol/L 2.5 1.4 1.2 mmol/L 2.5 1.4 1.2ECO2 2 mmol/L 2.0 1.1 0.9 mmol/L 2.0 1.1 0.9

Fe 1 µg/dL 8.5 4.8 3.9 µmol/L 1.52 0.85 0.70Fe 2 µg/dL 16.4 9.2 7.5 µmol/L 2.94 1.65 1.35

GGT 1 U/L 3.4 1.9 1.6 U/L 3.4 1.9 1.6GGT 2 U/L 17.3 9.7 7.9 U/L 17.3 9.7 7.9GLU 1 mg/dL 4.1 2.3 1.9 mmol/L 0.23 0.13 0.10GLU 2 mg/dL 9.3 5.2 4.2 mmol/L 0.51 0.29 0.24

HDLC 1 mg/dL 3.9 2.2 1.8 mmol/L 0.10 0.06 0.05HDLC 2 mg/dL 8.5 4.8 3.9 mmol/L 0.22 0.12 0.10

K+ 1 mmol/L 0.20 0.11 0.09 mmol/L 0.20 0.11 0.09K+ 2 mmol/L 0.31 0.18 0.14 mmol/L 0.31 0.18 0.14

LAC 1 mmol/L 0.15 0.09 0.07 mmol/L 0.15 0.09 0.07LAC 2 mmol/L 0.41 0.23 0.19 mmol/L 0.41 0.23 0.19

Appendix 2: Delta Tables

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Table 1: VITROS® Performance Verifiers I and II (Continued)

Conventional Units SI Units Chemistry PV Level Units

Delta n=2

Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

LDH 1 U/L 31.4 17.6 14.4 U/L 31.4 17.6 14.4LDH 2 U/L 61.4 34.5 28.1 U/L 61.4 34.5 28.1Li 1 mmol/L 0.12 0.07 0.05 mmol/L 0.12 0.07 0.05Li 2 mmol/L 0.16 0.09 0.07 mmol/L 0.16 0.09 0.07LIPA 1 U/L 14.9 8.4 6.8 U/L 14.9 8.4 6.8LIPA 2 U/L 27.8 15.6 12.8 U/L 27.8 15.6 12.8Mg 1 mg/dL 0.14 0.08 0.06 mmol/L 0.06 0.03 0.03Mg 2 mg/dL 0.20 0.11 0.09 mmol/L 0.08 0.05 0.04Na+ 1 mmol/L 2.7 1.5 1.3 mmol/L 2.7 1.5 1.3Na+ 2 mmol/L 2.7 1.5 1.3 mmol/L 2.7 1.5 1.3PHOS 1 mg/dL 0.27 0.15 0.13 mmol/L 0.09 0.05 0.04PHOS 2 mg/dL 0.45 0.25 0.21 mmol/L 0.15 0.08 0.07PHYT 1 µg/mL 2.0 1.1 0.98 µmol/L 7.9 4.4 3.6PHYT 2 µg/mL 2.9 1.7 1.36 µmol/L 11.6 6.5 5.4TBIL 1 mg/dL 0.16 0.09 0.07 µmol/L 2.7 1.5 1.2TBIL 2 mg/dL 0.90 0.51 0.41 µmol/L 15.4 8.7 7.1THEO 1 µg/mL 1.3 0.8 0.6 µmol/L 7.4 4.2 3.4THEO 2 µg/mL 1.7 1.0 0.8 µmol/L 9.6 5.4 4.4TIBC 1 µg/dL 43.1 24.2 19.8 µmol/L 7.7 4.3 3.5TIBC 2 µg/dL 54.5 30.6 25.0 µmol/L 9.8 5.5 4.5TP 1 g/dL 0.29 0.17 0.13 g/L 2.9 1.7 1.3TP 2 g/dL 0.33 0.19 0.15 g/L 3.3 1.9 1.5TRIG 1 mg/dL 5.9 3.3 2.7 mmol/L 0.07 0.04 0.03TRIG 2 mg/dL 12.3 6.9 5.7 mmol/L 0.14 0.08 0.06URIC 1 mg/dL 0.18 0.10 0.08 µmol/L 10.5 5.9 4.8URIC 2 mg/dL 0.43 0.24 0.20 µmol/L 25.6 14.4 11.8



Part No. J044982018-06-15

Table 2: VITROS® Liquid Performance Verifiers I and II

Table 3: VITROS® Isoenzyme Performance Verifiers I and II


Conventional Units SI UnitsChemistry PV Level Units

Deltan=2

Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

ALC 1 mg/dL 19.6 11.0 9.0 mmol/L 4.26 2.39 1.95ALC 2 mg/dL 26.1 14.6 12.0 mmol/L 5.7 3.2 2.6

AMON 1 µmol/L 6.2 3.5 2.9 µmol/L 6.2 3.5 2.9AMON 2 µmol/L 9.0 5.0 4.1 µmol/L 9.0 5.0 4.1

GLU (CSF) 1 mg/dL 2.7 1.5 1.3 mmol/L 0.15 0.09 0.07GLU (CSF) 2 mg/dL 5.9 3.3 2.7 mmol/L 0.33 0.18 0.15

K+ (ur) 1 mmol/L 0.57 0.32 0.26 mmol/L 0.57 0.32 0.26K+ (ur) 2 mmol/L 3.18 1.78 1.46 mmol/L 3.18 1.78 1.46

Na+ (ur) 1 mmol/L 2.0 1.1 0.9 mmol/L 2.0 1.1 0.9Na+ (ur) 2 mmol/L 3.7 2.1 1.7 mmol/L 3.7 2.1 1.7PROT (CSF) 1

mg/dL 9.2 5.2 4.2 mg/L 92 52 42

PROT (CSF) 2

mg/dL 22.7 12.8 10.4 mg/L 227 128 104

SALI 1 mg/dL 0.9 0.5 0.4 mmol/L 0.07 0.04 0.03SALI 2 mg/dL 2.2 1.2 1.0 mmol/L 0.16 0.09 0.07


Chemistry PV Level Units

Delta n=2

Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

CKMB 1 U/L 4.3 2.4 2.0 U/L 4.3 2.4 2.0CKMB 2 U/L 10.0 5.6 4.6 U/L 10.0 5.6 4.6

CK 1 U/L 29.0 16.3 13.3 U/L 29.0 16.3 13.3CK 2 U/L 36.3 20.4 16.6 U/L 36.3 20.4 16.6

Part No. J044982018-06-15


31

Table 4: VITROS® TDM Performance Verifiers I, II and III



Delta n=2

Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

ACET 1 µg/mL 2.3 1.3 1.1 µmol/L 14.17 8.60 7.28ACET 2 µg/mL 3.6 2.0 1.7 µmol/L 23.82 13.23 11.25ACET 3 µg/mL 9.5 5.3 4.4 µmol/L 62.85 35.06 29.11

CAFFN 1 µg/mL 0.43 0.24 0.20 µmol/L 2.201 1.236 1.009CAFFN 2 µg/mL 1.94 1.09 0.89 µmol/L 9.982 5.605 4.576CAFFN 3 µg/mL 3.45 1.93 1.58 µmol/L 17.746 9.964 8.135CRBM 1 µg/mL 0.78 0.44 0.36 µmol/L 3.31 1.86 1.52CRBM 2 µg/mL 1.37 0.77 0.63 µmol/L 5.80 3.26 2.66CRBM 3 µg/mL 1.96 1.10 0.90 µmol/L 8.29 4.65 3.80DGXN 1 µg/mL 0.25 0.14 0.12 µmol/L 0.325 0.183 0.149DGXN 2 µg/mL 0.25 0.14 0.12 µmol/L 0.325 0.183 0.149DGXN 3 µg/mL 0.37 0.21 0.17 µmol/L 0.476 0.267 0.218GENT 1 µg/mL 0.11 0.06 0.05 µmol/L 0.237 0.133 0.109GENT 2 µg/mL 0.24 0.13 0.11 µmol/L 0.508 0.285 0.233GENT 3 µg/mL 0.55 0.31 0.25 µmol/L 1.194 0.670 0.547PHBR 1 µg/mL 2.23 1.25 1.02 µmol/L 9.60 5.39 4.40PHBR 2 µg/mL 2.88 1.62 1.32 µmol/L 12.42 6.97 5.69PHBR 3 µg/mL 5.76 3.24 2.64 µmol/L 24.84 13.94 11.39PHYT 1 µg/mL 0.78 0.44 0.36 µmol/L 3.09 1.74 1.43PHYT 2 µg/mL 1.37 0.77 0.63 µmol/L 5.43 3.05 2.50PHYT 3 µg/mL 2.35 1.32 1.08 µmol/L 9.31 5.23 4.28

TOBRA 1 µg/mL 0.13 0.07 0.06 µmol/L 0.280 0.157 0.128TOBRA 2 µg/mL 0.22 0.12 0.10 µmol/L 0.474 0.266 0.217TOBRA 3 µg/mL 0.40 0.22 0.18 µmol/L 0.857 0.481 0.393VALP 1 µg/mL 4.39 2.47 2.01 µmol/L 30.38 17.06 13.93VALP 2 µg/mL 7.15 4.02 3.28 µmol/L 49.59 27.84 22.73VALP 3 µg/mL 11.25 6.32 5.16 µmol/L 78.01 43.80 35.76VANC 1 µg/mL 0.65 0.36 0.30 µmol/L 0.43 0.24 0.20VANC 2 µg/mL 1.65 0.92 0.75 µmol/L 1.10 0.62 0.50VANC 3 µg/mL 2.94 1.65 1.35 µmol/L 1.98 1.11 0.91



Part No. J044982018-06-15

Table 5: VITROS® CRP Performance Verifiers I and II

Table 6: VITROS® UPRO Performance Verifiers I and II

Table 7: VITROS® AAT/HPT Performance Verifiers I, II and III

Table 8: VITROS® dTIBC Performance Verifiers I and II

Table 9: VITROS® HCY Performance Verifiers I, II and III


Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

CRP 1 mg/dL 0.38 0.21 0.17 mg/L 3.8 2.1 1.7CRP 2 mg/dL 0.66 0.37 0.30 mg/L 6.6 3.7 3.0



Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

UPRO 1 mg/dL 6.3 3.5 2.9 g/L 0.06 0.04 0.03UPRO 2 mg/dL 15.3 8.6 7.0 g/L 0.15 0.09 0.07


Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

AAT 1 mg/dL 2.55 1.43 1.17 g/L 0.0255 0.0143 0.0117AAT 2 mg/dL 4.70 2.64 2.16 g/L 0.047 0.0264 0.0216AAT 3 mg/dL 12.54 7.04 5.75 g/L 0.1254 0.0704 0.0575HPT 1 mg/dL 2.74 1.54 1.26 g/L 0.0274 0.0154 0.0126HPT 2 mg/dL 4.9 2.75 2.25 g/L 0.049 0.0275 0.0225HPT 3 mg/dL 9.6 5.39 4.4 g/L 0.096 0.0539 0.044


Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

dTIBC 1 ug/dL 18.03 10.12 8.27 umol/L 3.23 1.81 1.48dTIBC 2 ug/dL 22.34 12.55 10.24 umol/L 4.00 2.25 1.83


Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

HCY 1 umol/L 0.63 0.35 0.29 umol/L 0.63 0.35 0.29HCY 2 umol/L 0.82 0.46 0.38 umol/L 0.82 0.46 0.38HCY 3 umol/L 1.45 0.81 0.66 umol/L 1.45 0.81 0.66

Part No. J044982018-06-15


33



Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

ApoA1 1 mg/dL 6.41 3.60 2.94 g/L 0.065 0.036 0.030

Table 10: VITROS® ApoA1 Performance Verifier I

Table 11: VITROS® ApoB Performance Verifier I


Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

ApoB 1 mg/dL 6.27 3.52 2.88 g/L 0.063 0.035 0.029

Table 12: VITROS® ASO/RF Performance Verifiers I and II


Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

ASO 1 IU/mL 10.58 5.94 4.85 IU/mL 10.58 5.94 4.85ASO 2 IU/mL 15.88 8.91 7.28 IU/mL 15.88 8.91 7.28RF 1 IU/mL 2.43 1.36 1.11 IU/mL 2.43 1.36 1.11RF 2 IU/mL 2.74 1.54 1.26 IU/mL 2.74 1.54 1.26

Table 13: VITROS® hsCRP Performance Verifiers I, II and III


Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

hsCRP 1 mg/dL 0.11 0.06 0.05 mg/L 0.106 0.059 0.049hsCRP 2 mg/dL 0.14 0.08 0.07 mg/L 0.143 0.080 0.066hsCRP 3 mg/dL 0.43 0.24 0.20 mg/L 0.431 0.242 0.198

Table 14: VITROS® mALB Performance Verifiers I and II


Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

mALB 1 mg/dL 0.60 0.34 0.27 mg/L 6.00 3.37 2.75mALB 2 mg/dL 0.66 0.37 0.30 mg/L 6.62 3.72 3.04


Part No. J044982018-06-15

Table 15: VITROS® PALB Performance Verifier I and II



Level UnitsDelta

n=2Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

PALB 1 mg/dL 0.64 0.36 0.30 mg/L 6.45 3.62 2.96PALB 2 mg/dL 1.87 1.05 0.86 mg/L 18.68 10.49 8.56

Table 16: VITROS® Protein Performance Verifiers I, II and III



Delta n=2

Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

C3 1 mg/dL 2.94 1.65 1.35 mg/L 29.4 16.5 13.5C3 2 mg/dL 6.27 3.52 2.88 mg/L 62.7 35.2 28.8C3 3 mg/dL 16.46 9.24 7.55 mg/L 164.6 92.4 75.5C4 1 mg/dL 0.61 0.34 0.28 mg/L 6.1 3.4 2.8C4 2 mg/dL 1.00 0.56 0.46 mg/L 10.0 5.6 4.6C4 3 mg/dL 1.78 1.00 0.82 mg/L 17.8 10.0 8.2IgA 1 mg/dL 7.45 4.18 3.41 g/L 0.074 0.042 0.034IgA 2 mg/dL 10.78 6.05 4.94 g/L 0.108 0.061 0.049IgA 3 mg/dL 19.60 11.00 8.99 g/L 0.196 0.110 0.090IgG 1 mg/dL 29.99 16.84 13.75 g/L 0.300 0.168 0.137IgG 2 mg/dL 54.68 30.70 25.07 g/L 0.547 0.307 0.251IgG 3 mg/dL 112.11 62.95 51.40 g/L 1.121 0.629 0.514IgM 1 mg/dL 3.92 2.20 1.80 g/L 0.039 0.022 0.018IgM 2 mg/dL 5.29 2.97 2.43 g/L 0.053 0.030 0.024IgM 3 mg/dL 7.84 4.40 3.59 g/L 0.078 0.044 0.036

TRFRN 1 mg/dL 8.43 4.73 3.86 g/L 0.084 0.047 0.039 TRFRN 2 mg/dL 15.48 8.69 7.10 g/L 0.155 0.087 0.071 TRFRN 3 mg/dL 35.48 19.92 16.26 g/L 0.355 0.199 0.163

Part No. J044982018-06-15


35

Appendix 2: Delta TablesTable 18: VITROS® DAT Performance Verifiers I, II, III, IV, and V



Delta n=2

Delta n=20

Delta n=30 Units

Delta n=2

Delta n=20

Delta n=30

AMPH 1 ng/mL 35.28 19.81 16.17 ug/L 35.28 19.81 16.17AMPH 2 ng/mL 38.02 21.35 17.43 ug/L 38.02 21.35 17.43AMPH 3 ng/mL 37.44 21.02 17.16 ug/L 37.44 21.02 17.16AMPH 4 ng/mL 91.73 51.5 42.05 ug/L 91.73 51.5 42.05AMPH 5 ng/mL 37.44 21.02 17.16 ug/L 37.44 21.02 17.16BARB 1 ng/mL 11.31 6.35 5.18 ug/L 11.31 6.35 5.18BARB 2 ng/mL 12.62 7.09 5.79 ug/L 12.62 7.09 5.79BARB 3 ng/mL 11.88 6.67 5.45 ug/L 11.88 6.67 5.45BARB 4 ng/mL 16.09 9.03 7.38 ug/L 16.09 9.03 7.38BARB 5 ng/mL 26.09 14.65 11.96 ug/L 26.09 14.65 11.96BENZ 1 ng/mL 29.26 16.43 13.42 ug/L 29.26 16.43 13.42BENZ 2 ng/mL 39.81 22.35 18.25 ug/L 39.81 22.35 18.25BENZ 3 ng/mL 33.5 18.81 15.36 ug/L 33.5 18.81 15.36BENZ 4 ng/mL 48.86 27.43 22.4 ug/L 48.86 27.43 22.4BENZ 5 ng/mL 108.04 60.66 49.53 ug/L 108.04 60.66 49.53COCM 1 ng/mL 11.37 6.38 5.21 ug/L 11.37 6.38 5.21COCM 2 ng/mL 15.68 8.8 7.19 ug/L 15.68 8.8 7.19COCM 3 ng/mL 16.66 9.35 7.64 ug/L 16.66 9.35 7.64COCM 4 ng/mL 28.81 16.18 13.21 ug/L 28.81 16.18 13.21COCM 5 ng/mL 57.23 32.13 26.24 ug/L 57.23 32.13 26.24METD 1 ng/mL 13.33 7.48 6.11 ug/L 13.33 7.48 6.11METD 2 ng/mL 10.58 5.94 4.85 ug/L 10.58 5.94 4.85METD 3 ng/mL 9.02 5.06 4.13 ug/L 9.02 5.06 4.13METD 4 ng/mL 11.17 6.27 5.12 ug/L 11.17 6.27 5.12METD 5 ng/mL 45.67 25.64 20.94 ug/L 45.67 25.64 20.94

OP 1 ng/mL 18.62 10.45 8.54 ug/L 18.62 10.45 8.54OP 2 ng/mL 19.6 11 8.99 ug/L 19.6 11 8.99OP 3 ng/mL 77.22 43.36 35.4 ug/L 77.22 43.36 35.4OP 4 ng/mL 160.13 89.91 73.41 ug/L 160.13 89.91 73.41OP 5 ng/mL 220.5 123.8 101.08 ug/L 220.5 123.8 101.08

PCP 1 ng/mL 2.2 1.23 1.01 ug/L 2.2 1.23 1.01PCP 2 ng/mL 2.57 1.44 1.18 ug/L 2.57 1.44 1.18PCP 3 ng/mL 4.29 2.41 1.97 ug/L 4.29 2.41 1.97

THC 1 ng/mL 1.88 1.06 0.86 ug/L 1.88 1.06 0.86 THC 2 ng/mL 1.71 0.96 0.78 ug/L 1.71 0.96 0.78

THC 3 ng/mL 2.14 1.2 0.98 ug/L 2.14 1.2 0.98THC 4 ng/mL 2.39 1.34 1.1 ug/L 2.39 1.34 1.1


Part No. J044982018-06-15

Appendix 3: Quality Control Worksheets

This Appendix contains the following Quality Control worksheets:

• Calibration Verification

• Baseline Mean Evaluation

• Periodic Monitoring of System Performance

Part No. J044982018-06-15


37

VITROS® Chemistry System QC Worksheet

Calibration Verification (Preliminary Baseline Mean)

Chemistry: Body Fluid:

Performance Verifier I Lot # Expires:

Performance Verifier II Lot #: Expires:

Performance Verifier III Lot #: Expires:

MicroSlide/MicroTip Reagent Lot #: Expires:

NOTE: MicroSlide Lot is 12 digits MicroTip Reagent Lot is 10 digits

Date of Calibration: Calibrated by:

Check the appropriate box

If the average for each Performance Verifier is within its ROM, then CALIBRATION IS VERIFIED.

If the average of any Performance Verifier is NOT within its ROM, then CALIBRATION IS NOT VERIFIED. Reviewed by: Date:

Performance Verifier I

ROM:Is the Average

within the ROM?

Replicate 1: Yes No

Replicate 2:

Average:

Performance Verifier II

ROM:Is the Average

within the ROM?

Replicate 1: Yes No

Replicate 2:

Average:

Performance Verifier III

ROM:Is the Average

within the ROM?

Replicate 1: Yes No

Replicate 2:

Average:

Attach the calibration report printout to this worksheet for future reference.


Part No. J044982018-06-15

VITROS® Chemistry System QC WorksheetBaseline Mean Evaluation

Chemistry: Body Fluid:

MicroSlide/MicroTip Reagent Lot #: Expires:

NOTE: MicroSlide Lot is 12 digits. MicroTip Reagent Lot is 10 digits

Date of Calibration:

Performance Verifier I, Lot #ROM:

Is the Baseline Mean within the ROM?

Preliminary Baseline Mean**

Is the difference between the Baseline Mean and the Preliminary Baseline mean less than or equal to the Calculated Delta*?

Delta Value*:

Baseline Mean: Yes No Delta Value Yes No

N=:

Performance Verifier II, Lot #ROM:




Delta Value*:


N=:

Performance Verifier III, Lot #ROM:




Delta Value*:


N=:

*Use the Calculated Delta for n=2 to verify that the differences between the Preliminary Baseline Means and the Baseline Means are not significant. The Calculated Delta is equal to the absolute value of the difference between the current mean and the baseline mean.** The Preliminary Baseline Mean is recorded in the Calibration Verification Worksheet.

If the answers to all questions were YES, then the Baseline means are acceptable.

If the answer to any question was NO, then an investigation is required.

Check the appropriate box.

Reviewed by: Date:


Part No. J044982018-06-15

Appendix 3: Quality Control WorksheetsVI

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Part No. J044982018-06-15

Appendix 3: Quality Control WorksheetsTable for Validation Calculations and Calculation of Control Means

Chemistry Gen # Range of Means (ROM)

Initial Mean

Standard Deviation

ReferenceMean

VITROS® Standard Deviation

Preliminary Baseline

Part No. J044982018-06-15


41

Exercises

1. What are Performance Verifier Fluids? What are the three ways they can be used?

2. What information is provided on the Performance Verifier (PV) assay sheets?


Part No. J044982018-06-15

3. Explain what is meant by the term Range of Means (ROM?

Exercises

4. What information is provided by the Within-lab standard deviation on the PV assay sheets?

5. Explain the difference between a Preliminary Baseline mean and a Baseline mean.

Part No. J044982018-06-15


43

Exercises

6. Describe how to use Performance Verifiers to monitor performance of the VITROS® Chemistry System.

7. What are Delta tables and how are they used?

8. Describe how you would assess the performance of the VITROS® Chemistry System if you do not intend to use Performance Verifiers as daily quality control materials.


Part No. J044982018-06-15

Exercises


PVI Replicate 1: 8.95 mg/dL (2.23 mmol/L)Replicate 2: 9.21 mg/dL (2.30 mmol/L)

Assay Sheet ROM: 8.3–9.32 mg/dL (2.07–2.33 mmol/L)

PVIIReplicate 1: 12.87 mg/dL (3.21 mmol/L) Replicate 2: 12.96 mg/dL (3.23 mmol/L)


a. Which flowchart should the laboratory use to assist in verifying a new calibration?

b. What performance characteristics should the laboratory evaluate?

c. Is the above calibration verified? Explain your reasoning.

Part No. J044982018-06-15


45

Exercises

10. Laboratory B is assessing the performance of the VITROS® Chemistry System on a monthly basis.

a. Which flowchart should be used to assist in this process?

b. What performance characteristics should this laboratory evaluate?

c. Laboratory B obtained the following quality control data for Glucose:

Baseline QC Data (January) QC Data (March)

n Mean SD Units n Mean SD Units

PV I20

80.0 2.1 mg/dL31

84.3 1.8 mg/dL4.43 0.12 mmol/L 4.67 0.10 mmol/L

PV II30

280.3 4.7 mg/dL31

281.4 4.0 mg/dL15.54 0.26 mmol/L 15.60 0.22 mmol/L

Range of Means on PV Assay Sheet

PV I 74.3–85.1 mg/dL4.12–4.72 mmol/L

PV II 269.8–295.7 mg/dL14.98–16.41 mmol/L

Has the performance of the VITROS® Chemistry System changed during the current month (March)? Explain your reasoning.


Part No. J044982018-06-15

Exercises

d. Are the calculated within-lab standard deviations for March acceptable? Explain your reasoning?

11. Laboratory C has just experienced major repair of the VITROS® Chemistry System and needs to verify TP calibration. This laboratory uses PVs on a routine basis and has established Baseline means.



Part No. J044982018-06-15


47

Exercises

c. Laboratory C obtained the following quality control data for TP:

Results on a fresh PV vial of PV (Today)Replicate # Result

PV I 1 4.56 g/dL (45.6 g/L)2 4.48 g/dL (44.8 g/L)

PV II 1 6.20 g/dL (62.0 g/L)2 6.30 g/dL (63.0 g/L)

Baseline MeansPV I 4.15 g/dL (41.5 g/L) n = 20PV II 6.41 g/dL (64.1 g/L) n = 31

Range of Means on PV Assay SheetPV I 3.89–4.79 g/dL (38.9–47.9 g/L)PVII 6.10–7.10 g/dL (61.0–71.0 g/L)

Is the existing calibration for TP still valid? Has the performance of the VITROS® Chemistry System changed as a result of the repair? Explain your reasoning.


Part No. J044982018-06-15

Exercises

12. Laboratory D is concerned that the extremely warm conditions in the lab may be affecting the performance of ALKP. The laboratory does not use PVs on a routine basis but has available a supply of the same lot number of PV fluids used to verify the initial calibration.



c. Laboratory D obtained the following quality control data for ALKP:

Results on a fresh PV vial of PV (Today)Replicate # Result Units

PV I 1 99 U/L2 94 U/L

PV II 1 393 U/L2 380 U/L

Range of Means on PV Assay SheetPV I 4.15 g/dL (41.5 g/L) n = 20PV II 6.41 g/dL (64.1 g/L) n = 31

Calibration Verification MeansPV I 92.5 U/LPVII 375.5 U/L


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Is calibration verified for ALKP?

13. Laboratory E is evaluating monthly QC data for ECO2. This lot of slides was put into use at the beginning of the month and the data are being evaluated to establish a Baseline mean:




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Exercises

c. Laboratory E obtained the following quality control data for ECO2. The data for the Baseline Means were calculated using the VITROS® Chemistry System software (see the Operator’s Guide):

Preliminary Baseline QC Data (November)

Baseline QC Data (December)

Mean Units n Mean Units SD n

PV I 24.5 mmol/L 2 25.5 mmol/L 2.2 30

PV II mmol/L 2 13.2 mmol/L 2.0 30


PV I 23.2–28.2 mmol/L SD: 1.3 U/L

PV II 13.4-20.1 mmol/L SD: 1.0 U/L

Should the laboratory use these calculated Baseline data for routine QC decisions? Explain your reasoning.

d. Are the calculated SDs for the current month acceptable? Explain your reasoning.

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1. What are Performance Verifier Fluids? What are the three ways they can be used?

2. What information is provided on the Performance Verifier (PV) assay sheets?

3. Explain what is meant by the term Range of Means (ROM).

4. What information is provided by the Within-lab standard deviation on the PV assay sheets?

Performance Verifiers are assayed controls which can be used as follows:

• To verify calibration of VITROS® Chemistry Systems. • As daily quality control materials.• As tools for troubleshooting VITROS® Chemistry Systems.

Generation-specific range of means.Recommended within-laboratory standard deviation.

Performance Verifier ROM is a term used to describe the lowest and highest mean values your VITROS® Chemistry System should produce for your slide lot. These ranges are specific for a particular generation of slides.

Performance Verifier assay sheet Within-lab SD is the recommended value for the Base-line SD in the VITROS® Chemistry System quality control software. The PV assay sheet Within-lab SD includes the variability associated with replicate PV measurements within a day and from one day to the next. It does not include the variability associated with using different slide lot numbers or multiple calibration events.


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5. Explain the difference between a Preliminary Baseline mean and a Baseline mean.

A Preliminary Baseline mean is the average of two values for Performance Verifiers run sequentially (two replicates from one cup) immediately after the system is calibrated. This mean is used to verify calibration and is replaced by the Baseline mean when more QC data are available.The Baseline mean is the average of PV results obtained over a 20–30 day period. It is a better estimate of the true mean than the Preliminary Baseline mean.

6. Describe how to use Performance Verifiers to monitor performance of the VITROS® Chemistry System.

7. What are Delta tables and how are they used?

You should use the Baseline mean, the recommended Within-lab SD on the PV assay sheet, and your laboratory-specific QC procedures to make routine QC decisions on the VITROS® Chemis-try System (source of QC procedures can be Statistical Tools of Quality Control: Training Module or your own QC procedures).You should also assess the performance of your VITROS® Chemistry System on a periodic (monthly) basis. This assessment requires evaluation of both the current (monthly) mean and calculated (monthly) within-lab SD (Flowchart 3).The monthly mean is evaluated for being within the PV assay sheet ROM and whether or not it is statistically different from the baseline mean. The calculated within-lab standard deviation is evaluated for being larger than the PV assay sheet Within-lab SD.

A Delta is the absolute difference between any two means. If the difference (delta) between two means is greater than the values in the delta tables in Appendix 2, these two means are statistically not the same.

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You should maintain a supply of Performance Verifiers for verifying calibration and for use as tools in troubleshooting. To verify a new calibration follow the guidelines outlined in Flowchart 1 and record the Calibration Verification Means for future use. For verification of an existing calibration or for troubleshooting follow the guidelines outlined in Flowchart 5.

If you use other manufacturer’s materials for your daily quality control, you also need to establish a Baseline mean for these controls. This Baseline mean, the recommended Within-lab SD on the PV assay sheet, and your laboratory-specific QC procedures should be used to make routine QC decisions on the VITROS® Chemistry System.

You should also assess the performance of your VITROS® Chemistry System on a periodic (monthly) basis. This assessment requires evaluation of both the current (monthly) mean and calculated (monthly) within-lab SD.


a. Which flowchart should the laboratory use to assist in verifying a new calibration?

b. What performance characteristics should the laboratory evaluate?

PVI Replicate 1: 8.95 mg/dL (2.23 mmol/L)Replicate 2: 9.21 mg/dL (2.30 mmol/L)


PVIIReplicate 1: 12.87 mg/dL (3.21 mmol/L) Replicate 2: 12.96 mg/dL (3.23 mmol/L)


Flowchart 1

The laboratory should evaluate the average of the two replicates for each PV fluid to de-termine if they fall within the range of means.These averages are also used to establish Preliminary Baseline means.


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c. Is the above calibration verified? Explain your reasoning.

YES; this calibration is verified. The reasoning is as follows:

The mean of the 2 replicates of PV I is 9.08 mg/dL (2.27 mmol/L) . The mean of the 2 replicates of PV II is 12.54 mg/dL (3.22 mmol/L). Both values fall within the range of means, therefore, the calibration is verified.

10. Laboratory B is assessing the performance of the VITROS® Chemistry System on a monthly basis.



c. Laboratory B obtained the following quality control data for Glucose:

Baseline QC Data (January) QC Data (March)

n Mean SD Units n Mean SD Units

PV I20

80.0 2.1 mg/dL31

84.3 1.8 mg/dL

4.43 0.12 mmol/L 4.67 0.10 mmol/L

PV II30

280.3 4.7 mg/dL31

281.4 4.0 mg/dL

15.54 0.26 mmol/L 15.60 0.22 mmol/LRange of Means on PV Assay Sheet

PV I 74.3–85.1 mg/dL

4.12–4.72 mmol/L

PV II 269.8–295.7 mg/dL

14.98–16.41 mmol/L

Flowchart 3

The laboratory should evaluate both the calculated current (monthly) means and the calcu-lated within-lab standard deviations. The monthly means are evaluated for being within the ROM and whether or not the current monthly mean is statistically the same as the Baseline mean. The calculated within-lab standard deviations are evaluated for being larger than the PV assay sheet Within-lab SD. Each level of Performance Verifiers should be evaluated.

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YES; the performance of the VITROS® Chemistry System has changed. The reasoning is as follows: Both PV I and PV II must be evaluated. Use the worksheet from Appendix 3 to record the data.

PV I: Is the Current Mean within the ROM?

YES; 84.3 mg/dL (4.67 mmol/L) is within the PV I ROM 74.3–85.1 mg/dL (4.12–4.72 mmol/L).

Is the calculated delta* less than or equal to the delta value**? NO; 4.3 mg/dL (0.24 mmol/L) > 2.3 mg/dL (0.13 mmol/L).

Calculated delta* for PV1 = | current monthly mean – Baseline mean |= (84.3 – 80.0) = 4.3 mg/dL= (4.67 – 4.43) = 0.24 mmol/L

Note: PV I Baseline mean (n = 20); PV I: Current Mean (n = 31); therefore use the delta value** for n = 20 from the Delta table (Appendix 2)Delta Value**, n = 20: = 2.3 mg/dL: (0.13 mmol/L) (Appendix 2)

The calculated delta* is greater than the delta value ** from the Delta table; there is a statisti-cally significant difference between the current monthly mean and the Baseline mean for PV I. An investigation may be required.

PV II: Is the Current Mean within the ROM?

YES; 281.4 mg/dL (15.60 mmol/L) is within the PV II ROM 269.8–295.7 mg/dL (14.98 - 16.41 mmol/L).

Is the calculated delta* less than or equal to the delta value**? YES; 1.1 mg/dL (0.06 mmol/L) < 4.2 mg/dL (0.24 mmol/L).

Calculated delta* for PV II = | current monthly mean – Baseline mean |= (281.4 - 280.3) = 1.1 mg/dL= (15.60- 15.54) = 0.06 mmol/L

Note: PV II Baseline mean (n = 30); PV II Current Mean (n = 31); therefore use the delta value** for n = 30 from the Delta table (Appendix 2).Delta Value** = = 4.2 mg/dL (0.24 mmol/L)


Part No. J044982018-06-15

Answer Key

The calculated delta is less than the delta value from the Delta Table; there is no statistically significant difference between the current monthly mean and the Baseline mean for PV II.

NOTE: Although the performance of PV II is acceptable, an investigation may be required. Each PV must meet all of the evaluation criteria. The current mean for PV I is within the ROM.

However, there is a statistically significant difference between the current PV I mean and the Baseline mean.

d. Are the calculated within-lab standard deviations for March acceptable? Explain your reasoning?

YES; the calculated within-lab standard deviations for March are within the expected ranges. The reasoning is as follows:

The Baseline standard deviations were established using the recommended PV assay sheet Within-lab standard deviations.

PV I: Calculated within-lab SD 1.8 mg/dL (0.10 mmol/L) < Baseline SD 2.1 mg/dL (0.12 mmol/L).

PV II: Calculated within-lab SD 4.0 mg/dL (0.22 mmol/L) < Baseline SD 4.7 mg/dL (0.26

11. Laboratory C has just experienced major repair of the VITROS® Chemistry System and needs to verify TP calibration. This laboratory uses PVs on a routine basis and has established Baseline means.



Flowchart 4. The laboratory is verifying calibration following an occurrence that may have al-tered system performance. Since the laboratory routinely uses PVs, valid Baseline means for PVs have been established. The laboratory should evaluate whether PV results obtained after the event are statistically the same as the established Baseline means.

The laboratory should evaluate the average of the two replicates for each PV. The average of the two replicates for each PV fluid is evaluated for falling within the range of means and whether today’s two-replicate averages (performed on fresh vial of PV fluids) and the Baseline Means are statistically the same.

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c. Laboratory C obtained the following quality control data for TP:

Results on a fresh PV vial of PV (Today)Replicate # Result

PV I 1 4.56 g/dL (45.6 g/L)2 4.48 g/dL (44.8 g/L)

PV II 1 6.20 g/dL (62.0 g/L)2 6.30 g/dL (63.0 g/L)

Baseline MeansPV I 4.15 g/dL (41.5 g/L) n = 20PV II 6.41 g/dL (64.1 g/L) n = 31

Range of Means on PV Assay SheetPV I 3.89–4.79 g/dL (38.9–47.9 g/L)PVII 6.10–7.10 g/dL (61.0–71.0 g/L)

Is the existing calibration for TP still valid? Has the performance of the VITROS® Chemistry System changed as a result of the repair? Explain your reasoning.

NO; Calibration is not verified. The performance of the VITROS® Chemistry System has changed. The reasoning is as follows:

Both PV I and PV II must be evaluated. Use the worksheet from Appendix 3 to record the data.

PV IIs today’s 2-replicate average of PV I within the ROM?

YES; 4.52 g/dL (45.2 g/L) is within the PV I ROM 3.89 - 4.79 g/dL (38.9 - 47.9 g/L)

Is today’s 2-replicate average for PV I statistically the same as the Baseline Mean? i.e. Is the calculated delta* (today’s 2-replicate average for PV I - Baseline Mean) less than or equal to the delta value** (n=2) from the Delta table in Appendix 2.NO; (0.37 g/dL (3.7 g/L) > 0.29 g/dL (2.9 g/L)


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Answer Key

Calculated delta* for PV I = | current monthly mean – Baseline mean | = (4.52 - 4.15) = 0.37 g/dL

= (45.2 - 41.5) = 3.7 g/LNote: PV I; Use the delta value** for n = 2 from the Delta table in Appendix 2 (see Flowchart 4).Delta Value **, n = 2: = 0.29 g/dL (2.9 g/L) (Appendix 2)

The calculated delta* is greater than the delta value ** from the Delta table; there is a statistically significant difference between the today’s 2-replicate average for PV I and the Baseline mean for PV I. Calibration is not verified. Investigation is required. The most likely solu-tion would be to re-calibrate TP.

PV IIIs today’s 2-replicate average of PV II within the ROM?YES; 6.25 g/dL (62.5 g/L) is within the PV II ROM 6.10 - 7.10 g/dL (61.0 - 71.0 g/L)

Is today’s 2-replicate average for PV II statistically the same as the Baseline Mean? i.e. is the cal-culated delta* (today’s 2-replicate average for PV II - Baseline Mean) less than or equal to the delta value** (n=2) from the Delta table in Appendix 2).YES; 0.16 g/dL (1.6 g/L) < 0.33 g/dL (3.3 g/L)

Calculated delta* for PV II =| today’s 2-replicate average - Baseline mean | = (6.25 - 6.41) = 0.16 g/dL = (62.5 - 64.1) = 1.6 g/LNote: PV I; Use the delta value** for n = 2 from the Delta table in Appendix 2 (see Flowchart 4).Delta Value **, n = 2: = 0.33 g/dL (3.3 g/L) (Appendix 2)

The calculated delta* is less than the delta value ** from the Delta table; there is no statistically significant difference between the today’s 2-replicate average for PV II and the Baseline mean for PV II.

NOTE: Calibration is not verified even though the performance of PV II is acceptable. Although today’s 2-replicate average for PV I is within the ROM, there is a statistically significant difference between this average and the Baseline mean.

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12. Laboratory D is concerned that the extremely warm conditions in the lab may be affecting the performance of ALKP. The laboratory does not use PVs on a routine basis but has available a supply of the same lot number of PV fluids used to verify the initial calibration.



c. Laboratory D obtained the following quality control data for ALKP:

Results on a fresh PV vial of PV (Today)Replicate # Result Units

PV I 1 99 U/L2 94 U/L

PV II 1 393 U/L2 380 U/L

Range of Means on PV Assay SheetPV I 4.15 g/dL (41.5 g/L) n = 20PV II 6.41 g/dL (64.1 g/L) n = 31

Calibration Verification MeansPV I 92.5 U/LPVII 375.5 U/L

Has the performance of the VITROS® Chemistry System changed during the current month (March)? Explain your reasoning. Is calibration verified for ALKP?

Flowchart 5. The laboratory is verifying calibration following an occurrence that may have altered system performance. Since the laboratory does not routinely run PVs, no valid Baseline mean for PVs has been established.

The laboratory needs to evaluate whether today’s 2-replicate averages on PVs are statistically the same as the established Calibration Verification Means.

In addition, the average of the two replicates for each PV fluid is evaluated for falling within the range of means and whether today’s two-replicate average and the Calibration Verifi-cation Mean are statistically the same.


Part No. J044982018-06-15

Answer Key

YES; There is no statistical evidence that the performance of the VITROS® Chemistry System has changed. Calibration is verified. The reasoning is as follows:

Both PV I and PV II must again be evaluated. Use the worksheet from Appendix 3 to record the data.

Is today’s 2-replicate average of PV I within the ROM? YES; 96.5 U/L is within the PV I ROM (67.3 - 106.3 U/L)

Is today’s 2-replicate average for PV I statistically the same as the Calibration Verification Mean? i.e. Is the calculated delta* (today’s 2-replicate average for PV I - Calibration Verification Mean) less than or equal to the delta value** (n=2) from the Delta table in Appendix 2)?

YES

Calculated delta* for PV I = | today’s 2-replicate average – Calibration Verification Mean | = (96.5 - 92.5)= 4.0 U/LNote: PV I Use the delta value** for n = 2 from the Delta table (Appendix 2) see Flowchart 5. Delta Value**, n = 2: = 6.8 U/L (Appendix 2)

The calculated delta* is less than the delta value ** from the Delta table (4.0 U/L < 6.8 U/L); there is no statistically significant difference between the today’s 2-replicate average for PV I and the Calibration Verification mean for PV I.

Is today’s 2-replicate average of PV II within the ROM? YES; 386.5 U/L is within the PV II ROM (356.8 - 559.1 U/L)

Is today’s 2-replicate average for PV II statistically the same as the Calibration Verification Mean? i.e. Is the calculated delta* (today’s 2- replicate average for PV I - Calibration Verification Mean) less than or equal to the delta value** (n=2) from the Delta table in Appendix 2)?

YES

Calculated delta* for PV I = today’s 2-replicate average – Calibration Verification Mean = (386.5 - 375.5) = 11 U/LNote: PV I Use the delta value** for n = 2 from the Delta table (Appendix 2) see Flowchart 5. Delta Value**, n = 2: = 31.4 U/L (Appendix 2)

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The calculated delta* is less than the delta value ** from the Delta table (11 U/L < 31.4 U/L); there is no statistically significant difference between the today’s 2-replicate average for PV II.

Calibration is verified. There is no statistical evidence that the VITROS® Chemistry System performance has changed.

NOTE: Calibration is verified only when each PV meets all of the evaluation criteria.

13. Laboratory E is evaluating monthly QC data for ECO2. This lot of slides was put into use at the beginning of the month and the data are being evaluated to establish a Baseline mean:



c. Laboratory E obtained the following quality control data for ECO2. The data for the Baseline Means were calculated using the VITROS® Chemistry System software (see the Operator’s Guide):

Preliminary Baseline QC Data (November)

Baseline QC Data (December)

Mean Units n Mean Units SD n

PV I 24.5 mmol/L 2 25.5 mmol/L 2.2 30

PV II mmol/L 2 13.2 mmol/L 2.0 30


PV I 23.2–28.2 mmol/L SD: 1.3 U/L

PV II 13.4-20.1 mmol/L SD: 1.0 U/L

Flowchart 2.

The laboratory should evaluate both the calculated current (monthly) means and the calcu-lated SDs. The monthly means are evaluated for being within the ROM and whether or not the current monthly means are statistically the same as the Preliminary Baseline means. The calculated standard deviations are evaluated for being larger than the PV assay sheet Within-lab SD. Each level of Performance Verifiers should be evaluated.


Part No. J044982018-06-15

Answer Key

Should the laboratory use these calculated Baseline data for routine QC decisions? Explain your reasoning.

NO; These Baseline data are not acceptable for routine use. Investigation Required.The reasoning is as follows:Both PV I and PV II must be evaluated. Use the worksheet from Appendix 3 (Baseline Mean Evalu-ation) to record the data.

PV IIs the Baseline mean within the ROM?YES; 25.5 mmol/L is within the PV I ROM (23.2 - 28.2 mmol/L).

Is the calculated delta* less than or equal to the delta value**? YES; (1.0 mmol/L < 2.5 mmol/L).

Calculated delta* for PV I = | Baseline mean – Preliminary Baseline mean | = (25.5 - 24.5)= 1.0 mmol/L

Note: Use the delta value** for n = 2 from the Delta table (Appendix 2).

Delta Value**, n = 2: = 2.5 mmol/L (Appendix 2)

The calculated delta* is less than the delta value ** from the Delta table; (1.0 mmol/L < 2.5 mmol/L) there is no statistically significant difference between the current monthly mean and the baseline mean for PV I.

PV II:Is the Baseline Mean within the ROM?NO; 13.2 mmol/L is outside the PV II ROM (13.4 - 20.1 mmol/L)

Is the calculated delta* less than or equal to the delta value**? YES; calculated delta (2.0 mmol/L) = delta value (2.0 mmol/L).

Calculated delta* for PV II = | Baseline mean – Preliminary Baseline mean | = (13.2 - 15.2) = 2.0 mmol/L

Note: Use the delta value** for n = 2 from the Delta table (Appendix 2).

Delta Value**, n = 2: = 2.0 mmol/L

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The calculated delta* is equal to the delta value ** from the Delta table; there is no statistically significant difference between the Preliminary Baseline mean and the Baseline mean for PV II.

NOTE: The laboratory should not, however, use these Baseline data for routine QC decisions. Although the performance of PV I is acceptable and there is no statistically significant difference between the PV II Baseline mean and Preliminary Baseline mean, the PV II Baseline mean is outside the ROM. Calibration is verified only when each PV meets all of the evaluation criteria. Investigation is required. Following successful troubleshoot-ing of the System, the laboratory would need to establish a new Baseline mean from 20 -30 days of additional QC data.

d. Are the calculated SDs for the current month acceptable? Explain your reasoning.

NO; The reasoning is as follows:The Baseline SDs were established using the recommended PV assay sheets SDs. PV I: the Current SD 2.2 mmol/L > Baseline SD 1.3 mmol/L. PV II: the Current SD 2.0 mmol/L > Baseline SD 1.0 mmol/L.

There may be a link between the higher SD and the bias or drift seen in PV II. The investigation should focus on determining this link.

Ortho Clinical Diagnostics, Inc. 100 Indigo Creek Drive Rochester, New York 14626-5101

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