userGuide Standardization 1.3 - Oneworld Accuracy · 2007-11-08 · STANDARDIZATION USER GUIDE V1.4...

www.digitalpt.com

[email protected]

800.665.2575 (US) | 800.665.7436 (Canada) phone

800.665.5949 fax

TM

DigitalPT

Standardization User Guide

ST AND ARD I ZA T I ON USE R GUID E V1 . 4 | FEB RU A RY 20 06

TABLE OF CONTENTS

TM

DigitalPT

PART 1 – OVERVIEW...............................................................................................................................................3

PART 2 – DIGITALPT SUPPORT.............................................................................................................................6

PART 3 – SUBSCRIBING TO DIGITALPT...............................................................................................................7

PART 4 – GETTING STARTED ................................................................................................................................8

PART 5 – TEST EVENT CALENDAR ......................................................................................................................10

PART 6 – UPDATING REGISTRATION ...................................................................................................................11

PART 7 – SUBMITTING STANDARDIZATION RESULTS ......................................................................................12

PART 8 – STANDARDIZATION PERFORMANCE REPORTS | GRAPHS ..............................................................13

PART 9 – POLICIES.................................................................................................................................................14

APPENDIX 1 – SAMPLE REPORTS (IMPERIAL UNITS)

APPENDIX 2 – SAMPLE REPORTS (SI UNITS)

APPENDIX 3 – INTERPRETING YOUR GRAPH

ST AND ARD I ZA T I ON USE R GUID E V1 . 4 | FEB RU A RY 20 06 TM

DigitalPT

PART 1 – OVERVIEW

3

INTRODUCTION

The accuracy (trueness) of creatinine test results varies from laboratory to laboratory. Without the standardization of creatinine, patients will be at risk of being incorrectly classified and misdiagnosed on the basis of their reported estimation of glomerular filtraton rate (eGFR). The National Kidney Disease Education Program (NKDEP) has recognized the importance of this issue and has established a Laboratory Working Group that is working with National Institute of Standards and Technology (NIST), the Center for Disease Control and Prevention (CDC) and manufacturers on introducing a national program to standardize the measurement of creatinine. Standardization of creatinine is a difficult problem and it will take a number of years before a national program can be fully implemented.

The DigitalPT Laboratory Standardization program has been designed to provide an immediate solution for standardizing creatinine and the estimation of GFR at the lab level, within a network of labs and across networks. By participating in the program, each laboratory will receive a custom Bias Correction Formula specific for the instrument it uses to measure creatinine. The laboratory will use the Bias Correction Formula to correct the instrument generated creatinine test result prior to using it in calculating the eGFR from the Modification of Diet in Renal Disease (MDRD) equation. In most, if not all, situations, the laboratory information system (LIS) will calculate the corrected creatinine and the eGFR. This creatinine standardization program does not require you to change the calibration settings on your analyzer. Your analyzer should be operated as always and monitored on the basis of your current Internal Quality Control (IQC) program.

The DigitalPT Laboratory Standardization program for the early detection of kidney disease consists of three separate components – eGFR Baseline, eGFR Calculation and eGFR Monitoring. Although each of these components may stand alone they have been designed to compliment each other.

Lipid disorders and diabetes are prevalent in patients with kidney disease. Risk factor reduction in this population often requires a comprehensive management program for lipids and diabetes. There are well-recognized national treatment guidelines for these disorders. The uniform application of these guidelines requires that your lipid and A1c testing systems be standardized. Standardizing lipid and hemoglobin A1c testing with creatinine represents a more comprehensive approach for standardizing key analytes that are used in managing the risk factors in patients with early stage renal disease. Hemoglobin A1c and lipids standardization monitoring programs are also available.

eGFR Baseline (GFRB716)

EGFR Baseline provides an assessment of the total error, calibration bias and precision of your creatinine method. From these data, a custom Bias Correction Formula is determined for your laboratory that has been optimized for the standardization of creatinine test results that are critical for the assignment of stage 3 renal disease. This formula is applied post-analytically to your creatinine test results. The corrected (standardized) creatinine result is then used in calculating the patient’s GFR. The standardized creatinine result is not reported to the physician. It is only used for calculating GFR. The calibration of your creatinine method should not be altered unless you are directed to so by the manufacturer of your analyzer. Your laboratory should continue to monitor its creatinine method as always and to report its creatinine test results without change.

You will receive three sets of three samples A-C (1 mL each). There is one set of samples for each day of testing. On each of 3 days one set of these three samples is to be measured in triplicate. Thus for each of these three samples you will be submitting 9 results. In addition to your three baseline test samples, you will receive three blind check samples (samples D-F). One of the check samples is to be measured on each of the three days in which your baseline samples are measured. Thus you will submit one test result for samples D-F.The results of your check samples will be used to check the appropriateness of your custom Bias Correction Formula and to confirm the % Total Error (TE) for your laboratory following correction. In addition, you are asked to submit your laboratory’s current adult reference intervals for creatinine.

eGFR Calculation (GFRC715)

EGFR calculation provides an arithmetic challenge to your laboratory in the form of 5 case studies and as such there is no testing of samples required. Each patient case comes with age, gender, ethnicity and an uncorrected creatinine test result. You are asked to apply the custom Bias Correction Formula that has been assigned to your laboratory in calculating the GFR for each case. The eGFR calculation component allows us to confirm that you are correctly using the assigned custom Bias Correction Formula for your laboratory and are applying it correctly in the MDRD formula for the calculation of GFR.


DigitalPT

PART 1 – OVERVIEW

4

eGFR Monitoring (GFRM733)

EGFR Monitoring consists of three samples (1 mL) shipped three times a year. Each sample (A-C) comes with a case history. You are asked to measure the creatinine in the sample (uncorrected), the corrected creatinine (using the Bias Correction Formula that was previously supplied), to calculate the GFR for each sample based on the case history and to record the comment that you would report with each GFR result.


DigitalPT

PART 1 – OVERVIEW

5

WHO IS ACCUTEST?

AccuTest, founded in 1992, is a leading provider of quality assurance programs to US laboratories and a fully credentialed Proficiency Testing Provider by the Centers of Medicare and Medicaid Services. AccuTest offers regulatory and accreditation programs approved by CMS, CAP, COLA, AOA, JCAHO, and most state agencies.

WHO IS HEALTHMETRX?

HealthMetrx is the principal Proficiency Testing Provider for Canadian laboratories and a leader internationally in developing information technologies for clinical laboratories. The DigitalPT Standardization Program is provided by AccuTest to US laboratories and by HealthMetrx to Canadian and international laboratories.

WHO IS CEQAL?

CEQAL is a Reference Method laboratory that is a member of the Cholesterol Reference Method Laboratory Network operated by the CDC. CEQAL serves as an accuracy resource for the Standardization Program.

WHAT LANGUAGES DOES DIGITALPT SUPPORT?

DigitalPT currently supports English, French and Spanish. Chinese is being added shortly.

WHAT IS DIGITAL MANAGEMENT OF STANDARDIZATION?

Here is an overview of DigitalPT.


DigitalPT

PART 2 – D IG ITALPT SUPPORT

6

HOW DO I CONTACT DIGITALPT SUPPORT? You can contact DigitalPT Support as follows:

Email at [email protected]

Toll-free phone at 800.665.2575 (US) or 800.665.7436 (Canada)

Toll-free fax at 800.665.5949

HOW DO I PROVIDE FEEDBACK ON DIGITALPT?

Your feedback is important and helps us improve DigitalPT. You can provide feedback as follows:

Via internet: Go to www.digitalpt.com and click "LOGIN". Select "DigitalPT Account" and login to the system. Click "SESSION" and select "Feedback". Type your feedback and then click <Send> . All comments are automatically forwarded to our Vice President, Operations for review.

Via email | phone | fax as noted above.

WHAT ARE DIGITALPT SUPPORT HOURS OF OPERATION?

The DigitalPT Support phone center is open Monday through Friday from 7:00 am to 4:30 pm (Pacific Standard Time). Outside these hours please leave a message on our voice mail system and we will return your call the following business day.


DigitalPT

PART 3 – SUBSCRIB ING TO D IG ITALPT

7

HOW DO I SUBSCRIBE TO DIGITALPT STANDARDIZATION PROGRAMS?

You can subscribe to DigitalPT as follows:

Go to www.digitalpt.com. Select and click your "DigitalPT Worldwide" location from the drop-down menu.

Click "PROGRAMS" and then select “Standardization” from the drop-down menu.

If you would like to participate in an online presentation, select "Presentation Form" and click <View section> . If you would like to place an order, select "Order Form" and click <View section> . Download, print and complete the Order Form. Fax your completed form toll-free: 800.665.5949.

HOW DO I SET UP A STANDARDIZATION NETWORK ON DIGITALPT? Simply let DigitalPT Support know the participants and programs within your network so that individual and aggregated performance data can be shared.


DigitalPT

PART 4 – GETTING STARTED

8

WHAT DO I NEED TO GET STARTED ON DIGITALPT?

To run DigitalPT, you need Windows 98 or higher with Internet Explorer 5.0 or higher.

To view DigitalPT reports, you need Adobe Acrobat Reader 5.0 or higher.

Go to www.digitalpt.com for links to the latest versions of these free software packages.

HOW DO I LOGIN TO DIGITALPT?

Go to www.digitalpt.com. Click "LOGIN" and select "DigitalPT Account".

Enter your Username and Password. Click <Login to DigitalPT Account > .

IMPORTANT: Please ensure that you do not use your Demo Account Username and Password to login. The Demo Username and Password will only work on the Demo Account.

HOW DO I GET A USERNAME AND PASSWORD?

A Username and Password is automatically assigned to all registered DigitalPT contacts. If you have supplied a valid email address, your account information will automatically be sent to you at that address.

If you have a valid email address but did not receive your account information, your Username and Password is available from the DigitalPT website:


Click “Get account information”.

Enter the requested information and click <Submit account request> .

Your Username and Password will be emailed to you.

If you do not have an email address, contact DigitalPT Support toll-free at 800.665.2575 (US) or 800.665.7436 (Canada)

WHAT HAPPENS IF I LOSE MY USERNAME OR PASSWORD?


Click “Lost your Username | Password?”.

Enter the requested information and click <Submit account request> .

Your Username and Password will be emailed to you.

If you have not received your account information, contact DigitalPT Support at 800.665.2575 (US) or 800.665.7436 (Canada).


DigitalPT

PART 4 – GETTING STARTED

9

HOW CAN I GET FAMILIARIZED WITH DIGITALPT PRIOR TO SUBMITTING MY FIRST STANDARDIZATION RESULTS?

You can take a test drive of the DigitalPT system on the Internet.

A ‘Demo’ is available for participants that will be submitting data using the web. The ‘Demo’ gives you hands-on experience with the online DigitalPT system.

Go to www.digitalpt.com. Click "LOGIN" and select "Demo Account".

Click “Get demo account information”.

Enter all requested information and click <Submit account request> . The system will automatically log you into the Demo database at this point. If you would like to access the Demo account at a later time, please review the information below.

Your Demo Username and Password will be emailed to you. If you do not have email access, call DigitalPT Support at 800.665.2575 (US) or 800.665.7436 (Canada) to get your Username and Password.

Once you receive your Username and Password, go to www.digitalpt.com and click "LOGIN" and select "Demo Account". Enter your Username and Password and click <Login to DigitalPT Demo> .

Click any header to view details about DigitalPT and how to submit Standardization results.


DigitalPT

PART 5 – TEST EVENT CALENDAR

10

WHEN DO I EXPECT TO RECEIVE THE SHIPMENT?

Two weeks before the samples are shipped, each laboratory receives an Advance Shipment Notice (ASN) of the upcoming shipment by fax or email. The ASN is sent to the designated shipping contact for the samples. The ASN lists the programs you should expect to receive and your registration information. Please inform your shipping department of upcoming shipments to ensure prompt delivery to your laboratory.

Shipments are sent directly by courier to each laboratory. You will become familiar with the courier schedule after a few shipments. If you do not receive the package when expected, contact customer support immediately so that we may track the package for you.


DigitalPT

PART 6 – UPDATING REGISTRATION

11

HOW DO I COMPLETE MY REGISTRATION INFORMATION In order to provide peer group results evaluations, we require that each subscriber submit detailed information about their analytical systems. Review the registration package sent upon enrollment and with every shipment notification (Advance Shipment Notice) carefully to be sure that we have your most current method registration information.

You can update your instrument/reagent/analyte changes via the internet or fax. If you have access to internet and prefer to do the changes online, please refer to the instructions below. All changes to instrument/reagent/analyte must be done before you are able to submit results via web. If you do not have access to the Internet, contact DigitalPT Support to update your instrument/reagent/analyte information or write the changes on the Registration Notice or Advance Shipment Notice and fax it to 800.665.5949. All changes to instrument/reagent/analyte registration must be received three days before the shipment date.

HOW DO I ADD, MODIFY OR REPLACE AN INSTRUMENT ONLINE?

Go to www.digitalpt.com and click “LOGIN”. Select “DigitalPT Account” and login to the system.

Click “PROFILE” and then select “Instruments”. Follow the corresponding steps below.

To add an instrument:

Once in the Instruments section, scroll to the bottom of the current instrument information and click <Add> . Click on the “Select a Manufacturer” drop down menu, scroll and select the manufacturer of the

instrument. Click on the “Select an instrument” drop down menu, scroll and select the instrument model. Enter Nickname and Serial Number if necessary. Click <Submit> .

To modify an instrument:

You are only able to modify the Nickname and Serial Number of an instrument. Once in the Instruments section, locate the instrument from the list and click <Modify registered instruments> . Click on the field beside Nickname or Serial Number, Modify the contents and click <Submit> .

To replace an instrument:

In order to replace an instrument in the DigitalPT system, the instrument cannot be linked to a subscription. If it is linked to a subscription, the instrument must be replaced with a new instrument or another existing one before inactivating it. Add new instrument as instructed in the previous section.

Click “PROFILE” and select “Subscriptions”. Locate the subscription ID for the program that contains the instrument, which is being replaced. Click <View registered analytes/procedures> . Locate the first analyte which is linked to the instrument to be replaced and click <Modify registered analytes/procedures>

. Click on the drop down menu beside “Registered Instrument”, select and click the new or existing instrument from the drop down menu. Review and make changes to the reagent information at this time if required. Click <Submit> . Modify the instrument information for the remaining analytes linked to the instrument to be replaced.

HOW DO I ADD, DELETE OR MODIFY AN ANALYTE | PROCEDURE ONLINE?


Click “PROFILE” and select “Subscriptions”.

Once in the Subscriptions section, click <View registered analytes | procedures> , located beside the subscription you want to modify.

This will display the “Registered Analytes | Procedures” screen.

To add a new analyte (if available): click <Add> , to display a list of available analytes. Select the analyte and click <Add Analyte/Procedure> . Enter the mandatory information. Click <Submit> .

To delete an analyte, click <Delete registered analyte/procedure> .

To modify an analyte, click <Modify registered analyte/procedure> . Enter the modifications and then click <Submit> .


DigitalPT

PART 7 – SUBMITT ING STANDARDIZATION RESULTS

12

HOW CAN I SUBMIT STANDARDIZATION RESULTS?

By the web at www.digitalpt.com.

Submit all results after all data have been collected for 3 days for GFR Baseline program.

There is also a fax system for those laboratories that do not have Internet access. The fax system is not preferred because it does not handle information digitally which contributes to transcription errors and delays in statistical results and performance reports | graphs. If necessary, fax results toll free 800.665.5949.

HOW DO I SUBMIT STANDARDIZATION RESULTS USING THE DIGITALPT SYSTEM? Go to www.digitalpt.com and click “LOGIN”. Select “DigitalPT Account” and login to the system.

Click “RESULTS” and select “Active Test Events”.

This will generate a list of all subscribed Standardization programs for which Standardization results are due. Red sample icons are for un-submitted results. Blue sample icons are for submitted results.

Submit results for your sample by clicking the red sample icon.

For each subscription, you will be requested to confirm the analyte/instrument/reagent information.

If the information is accurate, click <Confirm> . If not, click <Modify registered Analyte | Procedure> , make the appropriate modifications and then click the <Submit> for this page . If you agree to the modifications, click the final <Confirm> .

Enter the results for the selected sample. If you cannot provide a result, select a Reason (Problem) Code from the drop-down menu. Enter either a result or a Reason (Problem) Code, but not both.

Once you have entered results for the sample, click <Next> . This displays the Confirmation Screen.

If you need to make changes to the results, click <Revise> , make the changes and then click <Next> . Review the changes in the Confirmation screen.

If you agree with the results, click <Submit> .

PLEASE NOTE: Once you click <Submit> , you cannot make changes to the results.

To enter results for the next sample, go to the drop-down menu at the bottom of the screen and select <to >> Enter Next Sample>, click < Next> . Follow the directions to enter the results for the next sample.

Once you have entered results for all samples, use the drop-down menu at the bottom of the screen and select <to Active Test Events>, click < Next> . The sample icons for that subscription will appear in blue and the subscription will be indicated as “SUBMITTED” under the “Results Deadline” header.

To view/print submitted results, click “Active Test Events”. Locate the subscription you want to view, click the corresponding <View | Print all submitted results> . A PDF-formatted Data Confirmation Report will be generated, containing the results you submitted for the subscription. You can print or save this PDF document.

To email submitted results to a colleague or lab manager, click “Active Test Events” in the main menu. Locate the subscription you want to email, click the corresponding <Email submitted results> . An email will be displayed with your address. Fill in the address of the recipient(s) and add any message to the email. Click <Send> . This functionality is not used to email results to DigitalPT.

CAN I CHANGE MY STANDARDIZATION RESULTS AFTER SUBMISSION? Results may not be revised after submission. If you believe that extraordinary circumstances pertain, contact DigitalPT Support via phone 800.665.2575 (US) or 800.665.7436 (Canada) or email [email protected].


DigitalPT

PART 8 – STANDARDIZATION PERFORMANCE REPORTS | GRAPHS

13

HOW DO I ACCESS REPORTS AND GRAPHS ONLINE FOR MONITORING PROGRAMS (BASELINE REPORT WILL BE AVAILABLE SHORTLY)?

You will need Adobe Acrobat Reader to view Reports.


Click “REPORTS” and then select from the list the report that you wish to generate:

“Current Failed | Flagged Results” This report shows successful performance by subscription for each sample for the most recent test event using the applicable evaluation criteria.

“All Results” This report shows performance by subscription for a selected test event.

“Results by Instrument” This report shows instrument performance for a selected test event (quantitative analytes only). Multiple subscriptions of the same program are shown in one report.

“Historical Results” This report shows performance by analyte| procedure for a selected test event and the two prior test events (quantitative analytes only). Multiple subscriptions of the same program are shown in one report.

“Results by Analyte | Procedure”

This report shows performance by analyte| procedure for a selected test event. Multiple subscriptions of the same program are shown in one report.

“Participation Statistics (Quant)” This report shows the peer group statistics (quantitative analytes only) by analyte| procedure for a selected test event.

“Participation Statistics (Qual)”

This report shows the peer group statistics (qualitative analytes only) by analyte| procedure for a selected test event.

“Graphs” This report graphically depicts performance by analyte/procedure over multiple test events.

Locate the subscription you wish to query, select the Results Deadline | Test Event from the drop-down

menu. The “All” option, if available, will give you all results for the Results Deadline | Test Event date you have selected.

If the “Analyte | Procedure” header is present, click the drop-down menu to view specific results for analytes | procedures.

Click <View/Print reports> , to display the selected report and graph.

To email report to a colleague or lab manager, click <Email reports> .

HOW DO I ACCESS REPORTS GENERATED IN THE LAST 7 DAYS

Reports you have generated in the Digital PT system from the past seven days are stored in your Profile. To access these reports, go to www.digitalpt.com and click “LOGIN”. Select “DigitalPT Account” and login to the system. Click “PROFILE” and select “Report Log”. Click on the corresponding report located under the “Report” header. A pdf file is generated which can be viewed, printed or saved.


DigitalPT

PART 9 – POLIC IES

14

SAMPLES

All packages should be immediately opened upon receipt and contents checked for

Damaged samples

Missing samples

Wrong programs

For replacements, contact DigitalPT support. A “Request for Replacement Samples Form” will be sent to you for completion. Fax back the completed and signed form to DigitalPT Support.

Store samples at the appropriate temperature and follow all sample handling protocols indicated in the accompanying ‘Handling & Reporting Instructions”.

All Standardization samples should be considered as potentially hazardous and laboratories should follow their protocols for handling biohazard materials when processing or discarding samples.

Standardization samples should be analyzed as soon as possible and results submitted to DigitalPT.

RESULTS SUBMISSION

For participants submitting via the WEB – shipment package includes custom worksheets for all subscribed programs. Complete the worksheet, login to www.digitalpt.com using your Username | Password and submit results. Follow the instructions in Part 7 – “How do I submit Standardization results using the DIGITALPT System?”

DO NOT MAIL RESULTS TO DIGITALPT.

STANDARDIZATION PERFORMANCE

All results are emailed or faxed to participants within 5 working days of Results Deadline. Report consists of:

Program performance report – all analyte results performance in a given test event.

Alert report (if applicable) - highlights analytes/vials that did not meet “acceptable criteria”.

A sample program performance report with interpretation is included in Appendix 1 (Imperial unit) and 2 (SI unit).

2 7 February 6

IMPERIAL

Appendix 1

Test Event

Results Deadline

3 2 4

7

3

RH1100 Regional Hospital

175

Your Custom Bias Correction Formula

Test Event

Results Deadline

Cholesterol Reference Method Laboratory Network (CRMLN) Clinical Laboratory Comparison

Analyte: Total Cholesterol Comparison date: 2004 Oct 29, 30 Method: Data analysis date: 2004 Nov 30, Dec 1, 2Reagent & Lot #: Roche Chol 14314000Calibrator & Lot #: Roche cfas 163 004-01 Instrument Model: Roche Hitachi 717Precision % Limit: 3% CRMLN Lab: CEQAL Inc.Accuracy % Limit: 3% Clinical Lab Name:

I.D. MD1029Number of samples 6

ABELL-KENDALL TEST METHOD Bias % Bias Within-Sample Results Mean Results Mean versus AK versus sample

ID 1 2 mg/dL run 1 2 mg/dL mg/dL AK CV (%) A 161.0 161.7 161.4 1 155 163 168.7 7.3 4.5% 5.2%

2 167 1773 173 177

B 293.5 290.9 292.2 1 285 288 299.3 7.1 2.4% 3.7%2 303 3103 298 312

C 231.65 229.9 230.8 1 234 223 236.8 6.1 2.6% 4.0%2 233 2503 245 236

D 204.7 204.2 204.5 1 207 203 202.5 -1.9 -1.0% 1.2%2 201 2023 201 201

E 187.8 187.7 187.8 1 187 191 196.5 8.8 4.7% 3.2%2 203 2023 199 197

F 253.1 253.4 253.3 1 256 255 262.7 9.4 3.7% 2.5%2 268 2613 272 264

Report format Copyright © 2005 Centers for Disease Control and Prevention. All rights reserved.Report contents Copyright © 2005 HealthMetrx, Inc. All rights reserved.

Page 1

Certification - Total Cholesterol Performance Report (format dictated by the Centers for Disease Control and Prevention)

Data in BLUE submitted by participant

Cholesterol Reference Method Laboratory Network (CRMLN)Clinical Laboratory Comparison

Analyte: Total Cholesterol Comparison date: 2004 Oct 29, 30Method: 0 Data analysis date: 2004 Nov 30, Dec 1, 2Reagent & Lot #: Roche Chol 14314000Calibrator & Lot #: Roche cfas 163 004-01 Instrument Model: Roche Hitachi 717Precision % Limit: 3% CRMLN Lab: CEQAL Inc.Accuracy % Limit: 3% Clinical Lab Name: 0

Regression of Clinical Lab Values on Abell-Kendall Values:RESULT

Slope 1.01Intercept 3.09R-square 0.99 OK

Regression Prediction: Predicted % AbsoluteConcentration Bias % Bias Bias

mg/dL --------versus AK method-------- RESULTPredicted at 200 mg/dL: 205.8 5.8 2.9% 2.9% OK

Predicted at 240 mg/dL: 246.4 6.4 2.7% 2.7% OK

Statistical Summary: bias & precision: RESULTAverage % Bias 2.8% OKAverage Bias, mg/dL 6.1Average % Absolute Bias 3.2% FailAverage within-sample CV 3.3% Fail

t-test for Mean Percent Bias between Test Method and AK resultt-value (absolute value) 1.84 2.10 1.84

based on CV = 3% & allowable difference of 3% assuming 35 degrees of freedom

significance for t-value t-testalpha critical t* Result10.0% 1.69 Significant:bias >3%5.0% 2.03 Not significant: Bias < 3%2.5% 2.34 Not significant: Bias < 3%1.0% 2.72 Not significant: Bias < 3%

* Critical t values for 35 degrees of freedom

Outliers:Within-method outliers: Number RESULT

Phase 1 0Phase 2 0Fail both 0 OK

Between-method outliers:Phase 1 0Phase 2 0Fail both 0 OK

Concentration Range Check of test method meansRange 100 to 200 >200 to 240 >240Number in Range 2 2 2Criterion 2 2 2

Page 2

Report format Copyright © 2005 Centers for Disease Control and Prevention. All rights Reserved.

Report Contents Copyright © 2005 HealthMetrx, Inc. All rights reserved.

2 7 February 6

Appendix 2

Test Event

Results Deadline

3 2 4

9

3

eGFR (mL/min/1.73 m ) = 30849.22

RH1100 Regional Hospital

Your Custom Bias Correction Formula

Test Event

Results Deadline


Analyte: Cholesterol Comparison date: 2004 Oct 29, 30 Method: Data analysis date: 2004 Nov 24, 25, 26Reagent Used: Roche Chol 2 (Gen2) 658617Calibrator Source Roche CFAS 161779 Instrument: Roche Integra 800Precision % Limit: 3% CRMLN Lab: CEQAL Inc. Accuracy % Limit: 3% Clinical Lab:

Number of samples 6

ABELL-KENDALL TEST METHOD Bias % Bias Within-Sample Results Mean Results Mean versus AK versus sample

ID 1 2 mmol/l run 1 2 mmol/l mmol/l AK CV (%) A 4.16 4.18 4.17 1 4.40 4.30 4.43 0.3 6.3% 1.8%

2 4.50 4.503 4.50 4.40

B 7.59 7.52 7.56 1 8.00 7.90 8.02 0.5 6.1% 1.5%2 8.10 8.203 8.00 7.90

C 5.99 5.95 5.97 1 6.10 6.20 6.25 0.3 4.7% 1.3%2 6.30 6.303 6.30 6.30

D 5.29 5.28 5.29 1 5.50 5.50 5.60 0.3 6.0% 1.6%2 5.70 5.603 5.70 5.60

E 4.86 4.85 4.86 1 5.00 5.10 5.12 0.3 5.4% 1.5%2 5.10 5.203 5.10 5.20

F 6.54 6.55 6.55 1 6.70 7.10 6.97 0.4 6.4% 2.2%2 7.00 7.003 6.90 7.10

Report format Copyright © 2005 Centers for Disease Control and Prevention. All rights reserved.Report contents Copyright © 2005 HealthMetrx, Inc. All rights reserved.

Page 1


Data in BLUE submitted by participant

0.13 3.81


Analyte: Cholesterol Comparison date: 2004 Oct 29, 30 Method: 0 Data analysis date: 2004 Nov 24, 25, 26 Reagent Used: Roche Chol 2 (Gen2) 658617 Calibrator Source Roche CFAS 161779 Instrument: Roche Integra 800 Precision % Limit: 3% CRMLN Lab: CEQAL Inc. Accuracy % Limit: 3% Clinical Lab: 0

Regression of Clinical Lab Values on Abell-Kendall Values: RESULT

Slope 1.06Intercept -0.03R-square 1.00 OK

Regression Prediction: Predicted % Absolute Concentration Bias % Bias Bias

mmol/l --------versus AK method-------- RESULTPredicted at 5.17 mg/dL: 5.47 0.3 5.8% 5.8% Fail

Predicted at 6.21 mg/dL: 6.57 0.4 5.9% 5.9% Fail

Statistical Summary: bias & precision: RESULTAverage % Bias 5.8% FailAverage Bias, mg/dL 0.3Average % Absolute Bias 5.8% FailAverage within-sample CV 1.6% OK

t-test for Mean Percent Bias between Test Method and AK result t-value (absolute value) 3.81

based on CV = 3% & allowable difference of 3% assuming 35 degrees of freedom

significance for t-value t-testalpha critical t* Result10.0% 1.69 Significant:bias >3% 5.0% 2.03 Significant:bias >3% 2.5% 2.34 Significant:bias >3% 1.0% 2.72 Significant:bias >3%

* Critical t values for 35 degrees of freedom

Outliers:Within-method outliers: Number RESULT

Phase 1 1Phase 2 0Fail both 0 OK

Between-method outliers: Phase 1 0Phase 2 0Fail both 0 OK

Concentration Range Check of test method means Range 2.59 to 5.17 > 5.18 to 6.21 >6.21Number in Range 2 1 3Criterion 2 2 2

Report format Copyright © 2005 Centers for Disease Control and Prevention. All rights reserved. Report content Copyright © 2005 HealthMetrx, Inc. All rights reserved.

Page 2


Interpreting Your Graph Appendix 3

Creatinine - Corrected Performance Goal: Reference Value ± 10.0%

Creatinine Iminohydrolase - Bayer Advia 1650

Method (ME)

Enzymatic

SubMethod (SM)

Creatinine Iminohydrolase

Reagent Manufacturer (RM)

Roche Diagnostics

Instrument Manufacturer (IM)

Bayer Diagnostics

Instrument Model Group (IG)

Bayer Advia Chemistry Series

Instrument Model (ID)

Bayer Advia 1650

Tota

l Err

or(%

)

-50-40-30-20-10

01020304050

AM ME EV AM ME EV AM ME EV

A B C

(117) (63) (119) (63) (118) (62)

Tota

l Err

or(%

)

-10-20-30-40-50

01020304050

Mar 2005 Nov 2004

Tota

l Err

or(%

)

Concentration (μmol/L)

-10-20-30-40-50

01020304050

0 50 100 150

0 62 13300

SDI

Concentration (μmol/L)

-1

-2

-3

-4

0

1

2

3

4

0 50 100 150

0 62 13300

Method and instrument registration Analyte performance goal

Vials ordered alphabetically

Data expressed relative to all method mean or reference value

1st box represents the all method group, the ends of the box equals 2SD, and the n value in brackets

Total Error % = (Your Result - Reference Value or All Method Mean) x 100

Reference Value or All Method Mean

Your Results

Evaluation Target and acceptable limits

Symbols represent your results

2nd box represents peer group category at which peer group “stopped” and the n value in brackets

SDI = Your Result - Peer Group Mean

Peer Group SD

Cumulative summary of your results

Goal

Results Deadline Date Analyte reference range - previous test event result

Your cumulative results relative to the all method group or reference value Your cumulative results relative to your peer group

The dashed line indicates your bias

The shape of the symbol denotes concentration according to your laboratory’s reference range

Current test event results: ’ - results within reference range i - results below the lower reference range limit h- results above the upper reference range limit Solid symbols �� results are outside the acceptable evaluation rangeA cross through a solid symbol - result is an outlierA circle around a solid symbol - result is off the y axis

userGuide Standardization 1.3 - Oneworld Accuracy · 2007-11-08 · STANDARDIZATION USER GUIDE V1.4...

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Transcript of userGuide Standardization 1.3 - Oneworld Accuracy · 2007-11-08 · STANDARDIZATION USER GUIDE V1.4...