AccuTrak - Werfen/media/IL/Docs/Product/AccuTrak... · Lab Coordinator Report This report is designed for use by individuals who oversee a number of laboratories that report to the

AccuTrak ®

Quality Control Program Procedures Manual

Contents

Introduction………………………………………………….………………………………. 1

Data Entry

Data Input Form (bubble form)……………………………………………………. 3 In-House Computer Data (ICD) Summary Form……………………………….. 5 IMPACT ™…………………………………………….………………………………. 7 On-Line Data Entry for Summarized Data

Output Reports

Individual Laboratory Report……………………………………………………… 9 Data Description Report………………………………….………………………… 11 Message/Exception Summary Report……………..…………………………. 13 Laboratory Summary Report……………………………….………….………….. 15 All Methods Summary Report…………..………………………….……………… 17 Condensed All Methods Summary Report……………………………………… 19 Condensed Laboratory Summary………………………………………………… 21 Instrument Performance Plots…………………………………………………….. 23 Lab Coordinator Report…………………………………………………………….. 25

Quality Control Concepts

Levey-Jennings Interpretation……………………………………………………. 27 Discussion of Statistical Terms………………………………………………….. 28 Mail Monthly Data Input forms to: IL AccuTrak Center Instrumentation Laboratory 180 Hartwell Rd Bedford, MA 01730

In House Computer Data Summary Form and the AccuTrak Summary Report from the Impact Data Management System may be faxed to the AccuTrak Center at 781-861-4588. ***Data Input Forms (bubble sheets) are optically scanned and the originals must be mailed. For AccuTrak ® inquiries and to request additional preprinted mailing envelopes or input forms call the AccuTrak Center at 800-678-0710 (option 7) or visit our website at www.ilus.com and select:

Products and Services

AccuTrak

Data Entry Supplies Complete the appropriate information and send your request to the AccuTrak Center for prompt delivery. July 2010

Introduction

The AccuTrak Quality Control Program provides participants with ongoing peer comparisons for managing laboratory quality.

Our Commitment Confidence in a clinical laboratory’s test results demands a continuing, systematic evaluation of their precision and accuracy. Two factors are essential to an effective Quality Control program:

Reliable control materials for assay.

Competent statistical analysis of laboratory data. Instrumentation Laboratory (IL) is committed to supplying both of these requirements with a dependability that merits your confidence.

IL Clinical Controls We offer a comprehensive selection of controls for Critical Care and Coagulation product lines as the basis of a total Quality Control System that can serve virtually all the needs of clinical laboratories.

Quality Control Service The IL AccuTrak QC program provides a data system convenient for statistical comparison of the user’s own results with those of other labs performing the same (and/or related) methods. Preprinted data entry forms with mailing envelopes or on-line data entry are available to make your reporting of data as quick and trouble-free as possible. For on-line data entry, register today by visiting our website at www.ilus.com . From E-business Portal (lower right corner) select “Click here to access AccuTrak and your other IL e-business solutions”. Peer comparison reports excellent for reviewing instrument performance and satisfying inspectors requirements are sent to you promptly and are also available on-line to registered users.

Data Entry IL provides a choice of input forms to facilitate your monthly submission of data. Each form satisfies state and federal regulatory requirements and is described in detail in the Data Entry section of this manual.

Data Input Form (Bubble Form) This form permits optical scanning by our AccuTrak Center for fast, accurate transfer of your data to our computer system. A form will be provided for each of your test-system-method combinations; each page accommodating one or two control levels, according to your preference. Entering a data value is a simple matter of filling in an ellipse and can be done in either of two formats to generate a Levey-Jennings wall chart or histogram. In addition to provisions for notifying us of changes in your instruments or methods and for requesting various options, there is a column on the portion that you retain for notation of any corrective action taken by your lab during the month.

In-House Computer Data Form (ICD) Summary Form Available to program participants who computer process their own data for quality control. The ICD form provides the means of submitting the pre-computed data for incorporation in peer group comparison reports.

IMPACT™ For program participants using the IMPACT Data Management System. The AccuTrak Summary Report is printed directly from your IMPACT System and submitted for incorporation in peer group comparison reports.

On-Line Data Entry for Summarized Data Summarized monthly QC data can be submitted on-line quickly and efficiently for incorporation in peer group comparison reports.

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http://www.ilus.com/

Introduction (cont.)

Output Reports A variety of monthly reports to select from based on your needs and the needs and requirements of your laboratory are detailed below. All of these are explained in detail in the Output Reports section of this manual.

Individual Laboratory Report A monthly compilation of your statistics for each test, system, and method, together with a synopsis of your lab’s cumulative statistics (past performance). This report is generated and sent to you immediately after receipt of your data, prior to processing of group comparison reports.

Data Description Report A tabular presentation of the raw data for each respective test-system-method combination submitted by your lab via Data Input Forms for the last reporting period. For each test it shows the number of times each specific value occurred and which values (if any) were excluded as outliers.

Message/Exception Summary Report Prepared individually for each participating lab, this report notifies you systematically of exceptional program considerations in two categories:

Occurrences of general interest such as lot expiration, instances of insufficient data for processing and history deletions per your request.

ALERT messages regarding possible data-related problems that may need your attention.

Laboratory Summary Report Provides a month-by-month tabulation of summarized data (up to a full 12-month display on each report) from your lab and from the group using your test/system/method/lot combination together with cumulative individual and group statistics. The report is useful for detecting shifts and trends and is an excellent record keeping tool to satisfy all state and federal regulations.

All Method Summary Report and Condensed AMS This report is useful for comparing methods in terms of accuracy and precision. It contains statistics for the monthly reporting period from each participating lab reporting to your test /system/method/lot combination as well as year-to-date statistics for each lab. Also provided is a Condensed All Methods Summary Report, which is a summary of statistics for all methods for the reporting period.

Condensed Laboratory Summary Report This report allows you to view your Current Month, Cumulative and Peer Group Statistics for a specific analyzer in a simple and concise monthly report. This report is excellent for quick review of an instrument’s performance and satisfies the requirements of inspectors and other key individuals in your organization.

Instrument Performance Plots Graphic presentations provide an overall view of your accuracy and precision as compared to the peer group.

Lab Coordinator Report This report is designed for use by individuals who oversee a number of laboratories that report to the AccuTrak® QC Program. This report includes statistics for the individual laboratories in the laboratory group, your specific laboratory group, and your peer group.

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DATA ENTRY

Data Input Form In-House Computer Data Form IMPACT™

On-Line Data Entry for Summarized Data Register today by visiting our website at www.ilus.com.

(From E-business Portal (lower right corner) select “Click here to access AccuTrak

and your other IL e-business solutions”)

http://www.ilus.com/

DATA INPUT FORM – (Bubble Form)

The following information is preprinted on your Data Input Form and should not be altered.

1 General Laboratory Information - This information includes your Test/System/Sys#/Method, your Control Code and

Lot Number(s), your Facility Name and Lab Code Number.

2 Current Mean, 2SD and CV values - Calculated from your lab’s last reporting period.

3 Preprinted Value Scale - The range expected to accommodate data from your method and control level(s). The

Critical Care and Coagulation programs will reflect a cumulative scale after the first month’s data is reported. (If your test values fall outside this scale, write them in the spaces provided on the right hand margin. See #8, Off Scale Values.)

4 Asterisks (*) - Indicates your group’s 2SD range. This value is for comparison purposes. It is derived from data

reported by all labs using your lot of control on the same system and type of reagent (method). (Shown on both sides of the form.)

5 + and - - Indicates your lab’s 2 and 3 SD range, based on cumulative data. (Shown on both sides of the form.)

6 Mean (M) - Shows your lab’s mean for the given level, based on your cumulative data.

Data can be plotted daily on the form by filling in the ellipse for the value it represents based on the preprinted scale on the left side. Use a No. 2 pencil only.

7 Changes - You may indicate any changes in system, system number, method (reagent type) and temperature. Always

indicate system/system number together and method/temperature together, even if only one of these is being changed. This form can then be used to submit data for the new system/method indicated.

8 Off Scale Values - Use spaces provided to write in any values that fall outside the preprinted range. Mark the ellipse

only if you want the off scale values included in your monthly statistical analysis. Please do not write dates in these boxes (keep dates to the side in the Corrective Action Notes area).

9 Corrective Action Notes - For your records only.

10 Freeze Scale and Mean - Mark U or L ellipse to freeze the preprinted scale and mean for Upper or Lower control

values. This option allows you to readily identify data shifts.

11 Remove Freeze - Mark U or L ellipse to remove freeze from the level indicated.

12 Delete History - Mark U or L ellipse to have data on this form supersede all previous data for the control level

indicated. To delete data for certain months, please call the AccuTrak Center with your request.

13 Number of Forms - Indicate number of additional forms you wish to receive back from this submission.

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DATA INPUT FORM – (Bubble Form)

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In-House Computer Data (ICD) – Summary Form

This form provides an efficient means for labs to submit pre-computed QC data. It is intended for labs that regularly computer process their own data and wish to obtain peer group comparison reports. The ICD form is preprinted with identifying information, names and code numbers of your tests, systems and methods (reagents). You simply write in your pre-computed mean, 1 standard deviation, and number of occurrences for each control/level/lot. You can also use the ICD to notify us of any changes in your program such as the addition of new tests/systems/methods (reagents) or new lots of controls and/or reagents by handwriting the new data on the lower portion of the form if space permits. The ICD form may be faxed to the AccuTrak Center (fax: 781-861-4588). AccuTrak will return to you an Individual Report documenting the processed data along with a preprinted ICD form for your next reporting period. Peer comparison reports follow shortly thereafter. The following information is preprinted on your In-House Computer Data Form. This information covers all Test/System/Method combinations and the control levels for which you submit data. 1 Facility Name, Contact and Address information

2 Lab Code Number

3 Date of the data for the period being submitted.

4 Control Code and Description

5 Level and Lot

6 Test / System / System # / Method Descriptions (Sys.# identifies multiple systems or shifts used by your lab) Method reflects

reagent.

7 Test / System / # / Method Codes used by AccuTrak for grouping purposes.

The following information must be entered for your lab. Make entries on the proper line with respect to Test / System / Method and Control Lot /Level. 8 Occ(N) / Mean / 1SD

Occ/N - Occurrences or the number of measurements that were used in your computations for the given Test/System/Method. Mean - Your computer-derived mean value for the given Test/System/Method. Observe decimal point.

1 SD - Your lab’s computer-derived 1 Standard Deviation for the given Test/System/Method. Observe decimal point.

*D (Delete History) - Check here to have the data on the indicated line - the specific Test/System/Method and control level - supersede your corresponding previously submitted data. (EX: when changing lots of reagent) To delete data for specific months, please call the AccuTrak Center. If changes need to be made to the pre-printed form, such as lot or system changes or additions, simply cross out and update right on the form. Any new items may be added directly to the lower portion of the form if space is available.

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In-House Computer Data (ICD) – Summary Form

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IMPACT™ for Critical Care

The IMPACT Data Management System allows you to manage and document the operation of one or multiple critical care testing stations. IMPACT monitors QC as well as the calibration, maintenance and patient results of all connected analyzers. It provides an AccuTrak Summary Report that can be printed and sent to AccuTrak monthly for processing and incorporation into the group for peer comparison reports. This report includes:

1 Facility Name and address information.

2 Lab Code, Model, Analyzer # and Date range of data submitted.

3 Control, Level and Lot number.

4 AccuTrak Test, System and Method Codes that are programmed in during your initial set up of controls.

5 Occ(N) - Number of values submitted and acceptable for the specific method, your calculated Mean and

1SD. For technical support regarding IMPACT call IL’s Technical Support Hotline at 1-800-678-0710. For information on the IMPACT™ Data Management system contact your sales representative or call 1-800-955-9525.

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IMPACT™ for Critical Care

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Output Reports

Individual Laboratory Report Data Description Report AccuLert Message/Exception Summary Report Laboratory Summary Report All Methods Summary Report

Condensed All Methods Summary Report Condensed Laboratory Summary Report

Instrument Performance Plot Laboratory Coordinator Report

Individual Laboratory Report

This report is a compilation of statistics for each of your lab’s tests, systems and methods for the last reporting period. It is the basic evaluation of your lab’s performance. It also includes a lab history - a summary of your lab’s cumulative statistics (past performance). The Individual Laboratory Report is generated immediately after receipt of your monthly data. It is sent to you promptly as documentation of data received in addition to the preprinted forms of your choice (if applicable). The statistical terms used in the explanations below are defined in the Quality Control Concepts section. Each report contains the following information:

1 Reporting Period covered in this report, your Lab Code Number, Control Code and Description submitted.

2 Test/System/System #/Method, Level and Lot numbers.

Your Laboratory’s Data for the Monthly Reporting Period 3 N - Number of values submitted and acceptable for the specific method.

4 Asterisk(*) - Indicates exclusion of outlier values from that method’s data calculations. A footnote indicating this

appears at the bottom of the report. Excluded values are also summarized in the Data Description Report for the corresponding month.

5 Mean - Average of all values reported for a particular method. Outlier values are not included.

6 1 SD - Your lab’s 1 Standard Deviation. This is a measure of the variance of your method values from their mean. It is

a measure of precision.

7 - 2 SD/ + 2 SD - (Statistical Bounds or Confidence Limits). These values are the limits of the range from 2 standard

deviations below, to 2 standard deviations above, your lab’s mean.

8 CV - (Coefficient of Variation) refers to the reproducibility of your results. It describes the variation around the mean and

is expressed as a percentage of the mean. Your Laboratory’s History This is your lab’s cumulative year-to-date historical data for each specific method.

9 N - Cumulative number of values submitted for the lot/system/method.

10 Mean – Weighted average of means for preceding reporting periods.

11 PSD - (Pooled Standard Deviation) Weighted average of Standard Deviations for preceding reporting periods.

12 CV - Average of Coefficients of Variation for preceding reporting periods.

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Individual Laboratory Report

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PAGE: 1

** ACCUTRAK CENTER **

INSTRUMENTATION LABORATORY

DATA FOR PERIOD ENDING - 06/15/2002 180 HARTWELL RD

BEDFORD MA 01730 UNIVERSITY HOSPITAL

LAB 0000040071 1 DR. JOHN SMITH

123 CLINIC DRIVE

CONTROL 0750 CONTRIL 7 LEXINGTON, MA 02421

* * INDIVIDUAL LABORATORY REPORT * *

---------------STATISTICAL BOUNDS---------------- ----------LAB HISTORY----------

2 3 5 6 7 8 9 10 11 12 TEST SYSTEM # METHOD N MEAN 1SD -2SD +2SD CV N MEAN PSD CV

ION CA++ MMO PREMIER 3000 1 IL

LEVEL 1 LOT L703 LOW 32*4 1.609 0.024 1.561 1.657 1.492 155 1.616 0.020 1.215

LEVEL 2 LOT N703 NORMAL 32 1.118 0.012 1.094 1.142 1.073 149 1.127 0.013 1.125

LEVEL 3 LOT H703 HIGH 32 0.563 0.009 0.545 0.581 1.599 151 0.569 0.011 1.991

PC02 mmHg PREMIER 3000 1 IL

LEVEL 1 LOT L703 LOW 32 67.344 1.807 63.730 70.958 2.683 155 67.239 1.614 2.401


LEVEL 3 LOT H703 HIGH 32 17.531 0.621 16.289 18.773 3.542 151 17.596 0.524 2.977

PH pH PREMIER 3000 1 IL

LEVEL 1 LOT L703 LOW 32 7.142 0.007 7.128 7.156 0.098 155 7.144 0.007 0.099


LEVEL 3 LOT H703 HIGH 32 7.648 0.005 7.638 7.658 0.065 151 7.650 0.004 0.058

POTASSIUM BG PREMIER 3000 1 IL

LEVEL 1 LOT L703 LOW 32 5.853 0.076 5.701 6.005 1.298 155 5.881 0.065 1.110


LEVEL 3 LOT H703 HIGH 32 2.516 0.037 2.442 2.590 1.471 151 2.506 0.045 1.797

PO2 mmHg PREMIER 3000 1 IL

LEVEL 1 LOT L703 LOW 32 67.625 2.225 63.175 72.075 3.290 155 68.968 2.812 4.077


LEVEL 3 LOT H703 HIGH 32 162.875 1.773 159.329 166.421 1.089 151 164.106 2.763 1.684

SODIUM BG mm PREMIER 3000 1 IL

LEVEL 1 LOT L703 LOW 32 157.625 1.561 154.503 160.747 0.990 155 157.865 1.417 0.898


LEVEL 3 LOT H703 HIGH 32 117.844 1.462 114.920 120.768 1.241 151 117.973 1.519 1.288

4 (*)Measurement accepted after the exclusion of outliers.

Data Description Report

This report is a tabular presentation of the raw data for each respective Test/System/Method combination submitted by your lab via Data Input Forms (bubble sheets) for the last reporting period. For each test, it shows the number of incidences of every specific data value reported by your lab for the respective control level. It also indicates which data were excluded from calculations as illogical or as statistical outliers. The Data Description Report is generated immediately after receipt of your monthly data. It is sent to you promptly, together with your Individual Laboratory Report in addition to the preprinted forms of your choice (if applicable). Each report contains the following information:

1 Reporting Period covered in this report, your Lab Code Number and Control Code and Description of Control submitted.

2 Test/System/Method - The first line of each section of data in the table specifies the test/test code, system/system code and

method/method code for which data is shown.

3 Level - Control level and lot number to which the tabular data below pertains.

4 Data Values listed, consists of a data point (in decimal form) followed by the frequency of occurrence indicating the number of

times that value was submitted.

5 Y - Signifies exclusion of the corresponding data value(s) from statistical computations as outliers, that is outside your lab’s 3 SD

range.

6 X - Signifies exclusion of the corresponding data value(s) as illogical, that is, outside the gross screen of the particular test.

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Data Description Report

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DATA FOR PERIOD ENDING - 05/15/2002 180 HARTWELL RD DR. JOHN SMITH


LAB 0000030431 1 123 CLINIC DRIVE CRITICAL CARE LEXINGTON, MA 02421

CONTROL 0750 CONTRIL 7 * * DATA DESCRIPTION REPORT * *

2 TEST CODE SYSTEM CODE METHOD CODE X = MEASUREMENT OMITTED AS ILLOGICAL

---------------------- ---------------------- --------------------------- Y = MEASUREMENT OMITTED AS OUTLIER

PC02 2040 IL 1610/20 5131 IL 2030

LEVEL 1 LOT L707 LVL 1

66.7000 : 1 Y 70.3000 : 1 70.9000 : 3 71.2000 : 3

3 71.8000 : 1 72.1000 : 1 72.4000 : 4 72.7000 : 1

73.0000 : 1 73.3000 : 3 73.6000 : 2 74.2000 : 1

74.5000 : 1 74.8000 : 1 75.4000 : 1

LEVEL 2 LOT N707 LVL 2

39.5000 : 1 39.7000 : 1 4 39.9000 : 1 40.1000 : 1

40.5000 : 1 40.7000 : 3 40.9000 : 2 41.1000 : 4

41.3000 : 2 41.5000 : 1 41.7000 : 1 41.9000 : 1

LEVEL 3 LOT H707 LVL 3

21.9000 : 2 22.0000 : 2 22.1000 : 1 22.2000 : 2

22.3000 : 2 22.4000 : 3 22.5000 : 2 22.6000 : 3

22.7000 : 3 22.8000 : 3 22.9000 : 1

PC02 2040 IL 1610/20 5132 IL 2030

LEVEL 1 LOT L707 LVL 1

69.6000 : 1 Y 5 70.5000 : 1 71.7000 : 1 72.0000 : 2

72.3000 : 3 72.9000 : 3 73.2000 : 6 73.5000 : 4

73.8000 : 2 74.1000 : 5 74.4000 : 10 74.7000 : 7

LEVEL 2 LOT N707 LVL 2

39.7000 : 1 Y 41.1000 : 1 41.3000 : 3 41.5000 : 5

41.7000 : 5 41.9000 : 6 42.1000 : 10 42.3000 : 10

42.5000 : 11 42.7000 : 14 42.9000 : 7 43.1000 : 5

LEVEL 3 LOT H707 LVL 3

21.4000 : 1 21.5000 : 3 21.6000 : 1 21.8000 : 1

21.9000 : 3 22.0000 : 3 22.1000 : 7 22.2000 : 9

22.3000 : 12 22.4000 : 16 2.5000 : 12 X6 22.6000 : 5

AccuLert Message/Exception Summary Report

This report notifies you systematically of exceptional program considerations in two categories: 1. (Standard and received by all participants) - General information related to your lab’s monthly submission such as:

a. Lot expiration (the expiration date for your currently used lot of control material will appear in the report 3 months prior to expiration).

b. Submission by your lab of less than the 2 valid data points per test required for processing your data for that test. c. Historical data deleted per your request. (generally due to new reagent lot.) 2. (Optional at participant’s request) - “ALERT” messages calling your attention to possible problems relating to your data, such as: a. Incidence of outlier data values. b. Unusual data variations reflected in your lab’s mean values in comparison to group mean values (Standard Deviation

Interval or Z score), or messages about your SD range in relation to the groups’ SD range. The AccuLert Report is mailed to you monthly, along with any other optional peer group comparison reports you have requested. If no exceptional considerations of the types described above apply to your program for a given month, you will receive a message stating such. (Please note that even though you have chosen not to receive the Alert messages for the Optional report based on statistical data comparisons, you will receive this report based on the Standard messages only.) Statistical terms used below and in the sample report are defined in the Quality Control Concepts section.

The following information appears on your report: (Messages are grouped by Control, Test/System/Method, Level/Lot.)

1 Reporting period to which this report pertains.

2 Technical Support telephone numbers for assistance in interpreting Acculert messages.

3 Control – Code and description.

4 Test/System/Method for which messages are noted below.

5 Messages pertaining to the specific Test, System, Method, Level and Lot of control.

Alert - Indicates a data exception message related to the statistics derived from your laboratory’s data submission. We suggest that you review such messages with reference to statistics for the pertinent Test/System/Method in your various output reports. For help interpreting alert messages call Technical Support: In USA In Canada Critical Care call (800) 678-0710 Critical Care (800) 387-9643 Coagulation call (800) 526-7694 Coagulation (800) 526-7694

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AccuLert Message/Exception Summary Report

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180 HARTWELL RD

BEDFORD MA 01730

DR. JOHN SMITH

UNIVERSITY HOSPITAL

123 CLINIC DRIVE

LEXINGTON, MA 02421

LAB 0000040124 * * MESSAGE/EXCEPTION SUMMARY * *

1

ATTACHED ARE YOUR ACCUTRAK QC REPORTS FOR 04/15/2002 TO 05/15/2002.

WE HAVE LISTED ANY "EXCEPTIONAL" OCCURRENCES IN YOUR PROGRAM THIS MONTH

FOR ASSISTANCE IN INTERPRETING ACCULERT MESSAGES, PLEASE CALL TECHNICAL SUPPORT:

IN USA 2 IN CANADA

CRITICAL CARE (800) 678-0710 CRITICAL CARE (800) 387-9643

COAGULATION (800) 526-7694 COAGULATION (800) 526-7694

3 CONTROL 0750 CONTRIL 7

4 TEST - PC02 mmHg SYSTEM - PREMIER 3000 2 METHOD - IL

ALERT: LEVEL 1 - LOT L704 , Your Z-Score (SDI) indicates your mean was greater than 2 SD from the group mean.

TEST - PH pH SYSTEM - PREMIER 3000 2 METHOD - IL

5ALERT: LEVEL 1 - LOT L704 , Your Z-Score (SDI) indicates your mean was greater than 2 SD from the group mean.

ALERT: LEVEL 3 - LOT H704 , Measurements excluded as group outliers.

TEST - POTASSIUM BG mmol/L SYSTEM - PREMIER 3000 2 METHOD - IL

ALERT: LEVEL 1 - LOT L704 , Measurements excluded as group outliers.

ALERT: LEVEL 2 - LOT N704 , Measurements excluded as group outliers.

TEST - PO2 mmHg SYSTEM - PREMIER 3000 1 METHOD - IL

ALERT: LEVEL 1 - LOT L704 , Your Z-Score (SDI) indicates your mean was greater than 2 SD from the group mean.

ALERT: LEVEL 2 - LOT N704 , Your Z-Score (SDI) indicates your mean was greater than 2 SD from the group mean.

ALERT: LEVEL 3 - LOT H704 , Your Lab`s Two SD range is wider than the Group`s Three SD range.

ALERT: LEVEL 3 - LOT H704 , Your Z-Score (SDI) indicates your mean was greater than 2 SD from the group mean.

Laboratory Summary Report

Provides a month-by-month tabulation of summarized data (up to a full 12-month display on each report) from your lab and from the group using your method, together with cumulative individual and group statistics. Includes your Standard Deviation Interval (SDI or Z Score) comparing your lab mean with the group mean. This report is useful for detecting shifts and trends, and is excellent for satisfying inspectors by verifying instrument performance.

The statistical terms used in the explanations that follow are defined in the Quality Control Concepts section.

Report contains the following information:

1 The Reporting Period covered in this report, your Lab Code Number, Control Code and Description of Control submitted.

Lab and group YTD values represent cumulative data for each respective control level, including all data submitted year-to-date (YTD).

2 Mean (Lab YTD) - Your laboratory’s cumulative mean.

3 Mean (Group YTD) - Cumulative mean (mean of means) of all laboratories using the same method for the given test.

4 PSD (Lab YTD) - Your laboratory’s pooled 1 Standard Deviation. The PSD (Lab YTD) is a weighted average of the monthly SD values.

5 PSD (Group YTD) - Cumulative pooled 1 Standard Deviation for all laboratories using the same Lot/System/Method for the given test. The

PSD is a weighted average of the monthly PSD.

Monthly Data for each control level, for each year-to-date (YTD) reporting period indicated.

6 Month - Lists each (YTD) monthly reporting period, with latest month first.

7 N - The total number of data (excluding outliers) submitted for the specific System/Method combination. An asterisk (N*) indicates outlier data

were excluded from your lab’s calculated statistics. A footnote stating this appears at the bottom of reports on which this occurs.

8 Lab Mean - The average of all values (excluding outliers) reported by your lab for the specific method during month indicated. An asterisk next

to your lab mean indicates your data was excluded from the group. A footnote stating this appears at the bottom of reports on which this occurs.

9 Group Mean – The weighted average of the means of all labs using your Lot/System/Method for the given test.

10 SDI (Standard Deviation Interval or Z Score) –Indicates the position of your lab’s mean in the distribution of all means calculated for that

method. (An SDI value of ± 2.0 indicates your lab’s mean is more than 2SD’s from the group mean.) Factors to consider when your SDI is > ± 2.0: Are there a small number of labs reporting to the group, and is the range of values within the group relatively small?

11 Number of Labs - The number of laboratories reporting results determined by your Lot/System/Method for a given test.

12 Lab 1SD - One Standard Deviation as determined by the results your lab submitted for the month indicated.

13 Group PSD - Weighted average 1 Standard Deviation for all labs using your method for the given test for the month indicated.

14 Lab CV - Your lab’s Coefficient of Variation as computed from your data for the month indicated.

15 Group CV - Average Coefficient of Variation of all labs using your method for the given test computed for the month indicated.

16 Test/System/Method for which data are tabulated on the lines following.

17 Level and Lot of control for which data are shown.

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Laboratory Summary Report

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DATA FOR - 04/15/2002 to 05/15/2002 180 HARTWELL RD DR. JOHN SMITH


LAB 0000026486 1 123 CLINIC DRIVE

COAGULATION LEXINGTON, MA 02421

CONTROL 0450 ROUTINE UNASSAYED (8HR)

* * LABORATORY SUMMARY REPORT * *

TEST SYSTEM # METHOD

2 3 4 5 6 7 8 9 10 11 12 13 14 15

------M E A N------ ------P S D------- LAB GROUP SDI NO. LAB GROUP LAB GROUP

LAB-YTD GROUP-YTD LAB-YTD GROUP-YTD MON N MEAN MEAN (Z) LABS 1 S.D. P.S.D C.V. C.V.

16 APTT Seconds ACL 1 IL

17 LEVEL 1 LOT N1013172 7

29.024 28.035 1.135 0.876 MAY 91* 28.700 28.096 0.821 61 1.000 0.899 3.484 3.198

APR 96 29.000 27.847 1.095 62 1.130 0.881 3.897 3.165

MAR 83 29.500 28.177 1.897 44 1.300 0.857 4.407 3.042

FEB 85 28.900 28.152 1.027 25 1.100 0.826 3.806 2.934

JAN 12 29.250 28.361 1.277 4 1.160 0.794 3.966 2.798

LEVEL 3 LOT N1012541 8

60.192 59.271 3.696 1.881 MAY 94 51.300* 58.952 3.552 34 6.200 2.183 10.455 3.703

APR 97 59.900 59.474 0.404 36 1.830 1.663 3.055 2.796

MAR 91 60.700 59.556 0.900 28 3.100 1.825 5.107 3.064

FEB 83 60.800 58.955 1.280 19 1.850 1.773 3.043 3.007

JAN 12 61.480 59.878 1.294 4 1.880 1.332 3.058 2.224

PT Seconds ACL 1 IL

LEVEL 1 LOT N1013172

12.418 12.047 0.301 0.352 MAY 95 12.400 12.019 1.651 69 0.300 0.276 2.419 2.295

APR 98 12.500 12.050 1.732 65 0.330 0.191 2.640 1.585

MAR 84 12.500 12.074 1.525 49 0.300 0.443 2.400 3.671

FEB 90 12.300 12.058 0.733 30 0.270 0.555 2.195 4.602

JAN 14 12.240 12.021 0.776 4 0.280 0.179 2.288 1.490


28.711 27.187 0.922 0.830 MAY 94 28.600 27.537 1.604 34 1.000 0.786 3.497 2.856

APR 98 28.700 27.142 1.655 37 1.000 0.788 3.484 2.902

MAR 84 29.100 26.941 2.018 27 0.900 0.796 3.093 2.956

FEB 84 28.500 27.150 0.993 18 0.780 1.015 2.737 3.737

JAN 12 28.430 27.460 0.665 4 0.600 0.810 2.110 2.950

7 (N *) Measurement accepted after the exclusion of outliers.

8 (Mean *) Measurements excluded as group outlier.

All-Methods Summary Report

Provides each participating laboratory’s statistics for the last month reporting to your Test/System/Method combination. Also included are year-to-date statistics for each lab. For more in depth interpretation of peer group data, this report allows you to view each laboratory’s data submitted to the group and compare for accuracy and precision.

The statistical terms used in the explanations that follow are defined in the Quality Control Concepts section. Report contains the following information: 1 The Reporting Period summarized in this report, your Lab Code Number, Control Code and Description of Control submitted.

2 Lab - Lab Code Numbers for each participating laboratory. A “T” after the lab code indicates the lab’s own computed statistics (submitted on

the In-House Computer Data Summary Form or Impact). The identity of each lab remains confidential.

3 System - The system and it’s designation (system #1, 2 etc.) reported.

4 Method for which data are shown.

Data for last reporting period for all labs included with the peer group 5 N - The total number of data (excluding outliers) submitted during the last reporting period by that lab, for that specific System/Method

combination. An asterisk next to a number in the N column indicates outlier data were excluded from that lab’s calculated statistics. Footnote stating this appears at the bottom of the page.

6 Mean - The average of all reported values for that respective lab. (A mean value marked with an asterisk indicates the mean has been excluded

from the group as an outlier.) Footnote stating this appears at the bottom of the page.

7 SDI (Standard Deviation Interval or Z Score) - Indicator of the position of each individual lab’s mean in the distribution of all means calculated

for that method. (An SDI value of ± 2.0 indicates the lab’s mean is more than 2SD’s from the group mean.) Factors to consider when your SDI is > ± 2.0: Are there a small number of labs reporting to the group, and is the range of values within the group relatively small?

8 1 SD - One Standard Deviation is derived from that lab’s data for the reporting period.

9 - 2 SD/ +2 SD Confidence Limits (Stat Bounds) - The values in these two adjacent columns are the limits of the range from two Standard

Deviations below to two Standard Deviations above the mean.

10 CV - Coefficient of Variation describes the variation around the mean and is expressed as a percentage of the mean.

Cumulative Data Reporting periods prior to the last month are summarized in the last three columns under Lab History

11 Mean (in each individual lab’s data line) - The mean is the cumulative mean for that lab.

12 PSD - The Pooled Standard Deviation is the cumulative weighted average YTD of cumulative 1SD values for that lab.

13 CV - The Coefficient of Variation is derived from the YTD means and pooled SD values for that lab.

Information for specific test, level and lot of control:

14 Test - The test for which data below are shown.

15 Level and lot number of control for which data are shown.

16 Peer Group Data provides the weighted average group mean, 1SD, ± 2SD range and CV.

17 Standard Deviation of Means is a 1SD performed on the means submitted to the group for the reporting period.

17

All-Methods Summary Report

18



DATA FOR - 04/15/2002 to 05/15/2002 180 HARTWELL RD DR JOHN SMITH



COAGULATION LEXINGTON, MA 02421

CONTROL 0450 ROUTINE UNASSAYED (8HR)

* ALL METHODS SUMMARY * *

7 8 9 10 11 12 13

2 3 4 5 6 SDI --CONF. LIMITS-- ------ LAB HISTORY -------

LAB SYSTEM METHOD N MEAN (Z) 1S.D. -2S.D. +2S.D. C.V. MEAN P.S.D. C.V.

14 METHOD SUMMARY FOR TEST - APTT Seconds

15 LEVEL 1 LOT N0616766

0000025890T ACL IL 60 29.650 0.084- 0.884 27.882 31.418 2.981 29.486 0.808 2.741

0000025923T ACL IL 93 29.480 0.312- 1.000 27.480 31.480 3.392 29.361 1.000 3.406

0000025987T ACL IL 55 29.470 0.325- 0.962 27.546 31.394 3.264 29.731 0.870 2.926

0000026033 ACL IL 22 29.845 0.177 0.751 28.343 31.347 2.516 29.401 0.895 3.045

0000026043 ACL 1 IL 14 28.157 2.081- 0.744 26.669 29.645 2.642 28.037 0.718 2.563

0000026093T ACL IL 22 30.000 0.384 0.610 28.780 31.220 2.033 29.840 0.502 1.683

0000026151 ACL 1 IL 60 31.043 1.779 1.164 28.715 33.371 3.750 31.474 1.097 3.487

0000026156T ACL 1 IL 63 29.030 0.913- 0.600 27.830 30.230 2.067 29.008 0.595 2.053

0000026260T ACL 2 IL 74 29.760 0.063 3.300 23.160 36.360 11.089 29.668 2.806 9.458

0000026276 ACL 1 IL 13 30.246 0.713 0.669 28.908 31.584 2.212 30.395 0.859 2.826

0000026290 ACL 1 IL 44*5 29.100 0.820- 0.942 27.216 30.984 3.237 29.205 1.001 3.428 0000026312 ACL 1 IL 86 29.765 0.070 0.960 27.845 31.685 3.225 29.812 0.852 2.858

0000026414 ACL IL 35 30.480 1.026 1.023 28.434 32.526 3.356 30.262 1.086 3.587

0000026421 ACL 1 IL 54* 29.730 0.022 0.562 28.606 30.854 1.890 30.400 0.793 2.608

0000026455T ACL 1 IL 92 29.200 0.686- 0.600 28.000 30.400 2.055 29.268 0.568 1.941

0000026455T ACL 2 IL 22 28.700 1.355- 0.500 27.700 29.700 1.742 28.790 0.632 2.195

0000026467 ACL 1 IL 48 29.310 0.538- 0.719 27.872 30.748 2.453 29.318 0.672 2.291

0000026559 ACL 1 IL 4 31.850 2.858 2.294 27.262 36.438 7.203 29.807 1.968 6.601

0000026562T ACL 1 IL 86 29.990 0.371 0.820 28.350 31.630 2.734 29.990 0.820 2.734

0000026567T ACL 1 IL 64 30.340 0.839 0.843 28.654 32.026 2.779 30.099 0.717 2.382

0000026584T ACL 1 IL 24 30.750 1.387 0.510 29.730 31.770 1.659 30.489 6.309 20.693

0000026592T ACL 1 IL 82 30.020 0.411 1.250 27.520 32.520 4.164 30.029 1.127 3.755

0000026602T ACL 1 IL 23 30.130 0.558 0.260 29.610 30.650 0.863 29.970 0.395 1.317

0000026819T ACL 1 IL 23 28.387 1.773- 0.560 27.267 29.507 1.973 28.375 0.520 1.832

0000026821 ACL 1 IL 23 29.670 0.058- 0.824 28.022 31.318 2.777 29.670 0.824 2.776

0000026834 ACL 1 IL 19 29.011 0.940- 0.658 27.695 30.327 2.268 28.600 0.637 2.226

0000026842T ACL 1 IL 33 30.680 1.293 0.780 29.120 32.240 2.542 30.531 0.912 2.988

0000026872T ACL 1 IL 92 28.748 1.291- 0.544 27.660 29.836 1.892 28.530 0.587 2.059

0000026872T ACL 2 IL 31 28.913 1.070- 0.488 27.937 29.889 1.688 28.611 0.502 1.756

0000026873T ACL 1 IL 119 29.150 0.753- 1.015 27.120 31.180 3.482 28.996 0.988 3.406

0000026873T ACL 2 IL 88 30.300 0.785 1.147 28.006 32.594 3.785 29.912 1.003 3.353

0000026964T ACL 1 IL 26 25.000*6 6.303- 1.240 22.520 27.480 4.960 25.000 1.240 4.960

16 * * PEER GROUP DATA * * 78 29.713 1.087 27.539 31.887 3.658

17* * * STANDARD DEVIATION OF MEANS * * * 0.748

5 (N *) Measurements accepted after the exclusion of outliers.

6 (MEAN *) Measurements excluded as a group outlier.

All-Methods Summary Condensed Report

This report is a condensed version of peer group comparison for All Systems and Methods reporting to your Test/System/Method combination, level and lot of control(s) reported. This report is useful in comparing data for other methodologies. The statistical terms used in the explanations that follow are defined in the Quality Control Concepts section. Report contains the following information for the Reporting Period:

1 The Reporting Period summarized in this report, your Lab Code Number, Control Code and Description of Control

submitted.

2 Test/System/Method for which peer comparison data is provided on the lines following.

3 #Labs – The number of labs reporting results to your Test/System/Method, control level and lot number indicated for the

reporting period.

4 Group Mean – The weighted average of the means for labs of all Systems and Methods reporting to your control levels and

lots.

5 PSD – Pooled Standard Deviation is the weighted average 1 Standard Deviation for the group.

6 - 2 SD/ +2 SD Confidence Limits - The values in these two adjacent columns represent 2 Standard Deviations below to 2

Standard Deviations above the group mean.

7 CV - Coefficient of Variation describes the variation around the group mean and is expressed as a percentage of the mean.

8 Level and lot number of control for which data are shown.

19

All-Methods Summary Condensed Report

20



DATA FOR - 04/15/2002 to 05/15/2002 180 HARTWELL RD DR JOHN SMITH



CRITICAL CARE LEXINGTON, MA 02421

CONTROL 0650 CONTRIL SPECTRUM

* * ALL METHODS SUMMARY * *

CONDENSED

**************** 2 **************** 3 4 5 6 7 --CONF. LIMITS--

TEST SYSTEM METHOD #LABS MEAN PSD -2SD +2SD C.V.

PC02 mmHg

8 LEVEL 1 LOT N0718628

IL 1710 IL 2 62.567 2.038 58.491 66.643 3.257

IL 1610/20 IL 1 63.700 2.000 59.700 67.700 3.140

IL 1715 IL 47 63.205 1.557 60.091 66.319 2.463

IL 1720-35 IL 24 62.892 1.681 59.530 66.254 2.673


IL 1710 IL 2 35.593 2.091 31.411 39.775 5.876

IL 1610/20 IL 1 35.500 0.900 33.700 37.300 2.535

IL 1715 IL 45 36.104 0.626 34.852 37.356 1.733

IL 1720-35 IL 24 36.158 0.803 34.552 37.764 2.221


IL 1710 IL 2 18.575 1.283 16.009 21.141 6.908

IL 1610/20 IL 1 18.500 0.900 16.700 20.300 4.865

IL 1715 IL 47 18.836 0.542 17.752 19.920 2.876

IL 1720-35 IL 23 18.893 0.636 17.621 20.165 3.368

PH pH


IL 1710 IL 2 7.150 0.012 7.126 7.174 0.162

IL 1610/20 IL 1 7.148 0.005 7.138 7.158 0.070

IL 1715 IL 48 7.150 0.005 7.140 7.160 0.069

IL 1720-35 IL 23 7.152 0.005 7.142 7.162 0.071


IL 1710 IL 2 7.419 0.013 7.393 7.445 0.173

IL 1610/20 IL 1 7.419 0.004 7.411 7.427 0.054

IL 1715 IL 45 7.420 0.006 7.408 7.432 0.084

IL 1720-35 IL 24 7.420 0.006 7.408 7.432 0.077


IL 1710 IL 2 7.628 0.013 7.602 7.654 0.167

IL 1610/20 IL 1 7.637 0.006 7.625 7.649 0.079

IL 1715 IL 47 7.637 0.007 7.623 7.651 0.097

IL 1720-35 IL 24 7.636 0.006 7.624 7.648 0.075

Condensed Laboratory Summary Report

This report allows you to view your Current Month, Cumulative and Peer Group Statistics for a specific analyzer in a simple and concise monthly report. This report is excellent for quick review of an instrument’s performance and satisfies the requirements of inspectors and other key individuals in your organization.

The statistical terms used in the explanations that follow are defined in the Quality Control Concepts section.

Report contains the following information:

1 Your Lab Code Number, Facility Name and Contact.

2 Control Code and Description.

3 Reporting Period, Business Unit, System and it’s designation (System # 1, 2 etc).

4 Method (reagent), Test, Level and Lot number of control.

5 Current Month Statistics N - The total number of data (excluding outliers) submitted for the specific System/Method combination. An asterisk (N*) indicates outlier data were excluded from your lab’s calculated statistics. A footnote stating this appears at the bottom of reports on which this occurs. Lab Mean - The average of all values (excluding outliers) reported by your lab for the specific method during month indicated. An asterisk next to your lab mean indicates your data was excluded from the group. A footnote stating this appears at the bottom of reports on which this occurs. Lab 1SD - One Standard Deviation as determined by the results your lab submitted for the month indicated. - 2 SD/ +2 SD Confidence Limits (Stat Bounds) - The values in these two adjacent columns are the limits of the range from two Standard Deviations below to two Standard Deviations above the mean.

CV - Coefficient of Variation describes the variation around the mean and is expressed as a percentage of the mean. SDI (Standard Deviation Interval or Z Score) – Indicator of the position of your lab’s mean in the distribution of all means calculated for your

method, an estimate of accuracy. (An SDI value of ± 2.0 indicates your lab’s mean is more than 2SD’s from the group mean.) Factors to consider when your SDI is > ± 2.0: Are there a small number of labs reporting to the group, and is the range of values within the group relatively small?

CVI (Coefficient of Variation Index) - An indicator of precision that allows you to compare your precision to that of your peers.

6 Cumulative Statistics N – Total number of data submitted to date for the Lot/System/Method combination noted. Mean - The mean is the cumulative mean for your lab. PSD - The Pooled Standard Deviation is the cumulative weighted average YTD of cumulative 1SD values for your lab. CV - The Coefficient of Variation is derived from the YTD means and pooled SD values for your lab.

7 Peer Group Statistics Labs - The number of laboratories reporting results determined by your Lot/System/Method for a given test. Mean - The weighted average of the means of all labs using your Lot/System/Method for the given test. PSD - Weighted average 1 Standard Deviation for all labs using your Lot/System/Method for the given test. CV - Average Coefficient of Variation of all labs using your Lot/System/Method for the given test. SD of Means is a 1SD performed on the means submitted to the group for the reporting period.

21

Condensed Laboratory Summary Report

2 3

1 LABORATORY: 0000012345

DR. JOHN SMITH

UNIVERSITY HOSPITAL 123 CLINIC DR

LEXINGTON, MA 02421

Current Month Statistics Cumulative Statistics Peer Group Statistics

Method 4 5 6 7 Test

Level/Lot N Mean 1 SD -2SD +2SD CV% SDI CVI N Mean PSD CV% Labs Mean PSD CV% SD of Means

IL

APTT Seconds

1 N0774393 34 29.000 0.800 27.400 30.600 2.759 -0.808 0.728 497 28.904 0.853 2.950 18 29.978 1.136 3.790 1.210

3 N0674248 34 49.000 1.000 47.000 51.000 2.041 -2.150 0.648 493 52.785 1.046 1.983 19 55.023 1.732 3.148 2.802

PT Seconds

1 N0774393 34 13.000* 0.250 12.500 13.500 1.923 3.973 0.932 514 12.295 0.198 1.610 22 12.416 0.256 2.062 0.147

3 N0674248 34 30.000 0.600 28.800 31.200 2.000 -0.570 0.679 500 30.353 0.779 2.568 22 30.572 0.900 2.944 1.003

(MEAN *) Measurements excluded as a group outlier.

INSTRUMENTATION LABORATORY, ** ACCUTRAK CENTER **, 180 HARTWELL ROAD, BEDFORD MA, 01730

22

Report Period : 01/15/2009 - 02/15/2009

Business Unit : COAGULATION

System : ACL 100 – 7000

Sys. # : 1

Instrument Performance Plot

This report provides you with an overview of your laboratory’s precision and accuracy as compared to the peer group. The statistical terms used in the explanations that follow are defined in the Quality Control Concepts section. Report contains the following information:

1 Your Lab Code Number, Facility Name and Contact.

2 Control Code and Description.

3 Reporting Period, Business Unit, System and it’s designation (System # 1, 2 etc).

4 Method (reagent) and Test.

Plot

5 Level and Lot # of control.

6 Lab SDI (Standard Deviation Index) is an estimate of accuracy as it compares your mean to the peer group mean.

CVI (Coefficient of Index) is an estimate of precision as it compares your CV to the peer group CV. Based on 3 SDI and 3 CVI

7 The x-axis represents the coefficient of variation index (CVI) indicating precision.

8 The y-axis represents the standard deviation index (SDI) indicating accuracy.

Represents your lab co-ordinates for SDI and CVI. Interpretation Please note these interpretations are strictly statistical in nature and should be used as guidelines only. It is the responsibility of each laboratory to determine clinical significance and whether corrective action is necessary.

9 0.0 - ± 2.0 is Typical Peer Group Performance (95% of peer population).

± 2.0 – ± 3.0 is Borderline Peer Group Performance (5% of peer population).

23

9

Instrument Performance Plot

24

LABORATORY: 0000012345

DR. JOHN SMITH

UNIVERSITY HOSPITAL

123 CLINIC DR LEXINGTON, MA 02421

1 2

3

4

5

6

8

7

9

Lab Coordinator Report

This report is designed for use by individuals who oversee a number of laboratories that report to the AccuTrak® QC Program. This report includes statistics for the individual laboratories in the laboratory group, your specific laboratory group, and your peer group. Please call the AccuTrak Center if you wish to set up a Coordinator Report for your group of laboratories. The statistical terms used in the explanations that follow are defined in the Quality Control Concepts section. Report contains the following information:

1 The Reporting Period summarized in this report, your System, Control Code and Description of Control submitted.

2 The Lab Coordinator ID, contact name and address information.

3 Lab ID (Lab Code).

4 Facility Name.

5 System # (identifies multiple systems i.e. Sys #1, 2 etc.).

6 N - The total number of data (excluding outliers) submitted for that specific System/Method combination.

7 Mean - The average of all reported values for each lab. (A mean value marked with an asterisk indicates the lab’s mean has been

excluded from the group as an outlier.)

8 1SD - One Standard Deviation derived from each lab’s data for the reporting period.

9 CV - Coefficient of Variation describes the variation around the mean and is expressed as a percentage of the mean.

10 SDI (Standard Deviation Interval or Z Score) - Indicator of the position of each individual lab’s mean in the distribution of all

means calculated for that method. (An SDI value of ± 2.0 indicates the lab’s mean is more than 2SD’s from the group mean.)

11 Test , Method(Reagent), Level and Lot of control.

12 Laboratory Group represents the average statistics for the above laboratories listed in the group for the specific System/Method.

13 Peer Group represents the weighted average statistics for all labs for the specific System/Method.

25

Lab Coordinator Report

** ACCUTRAK CENTER ** PAGE: 4


180 HARTWELL ROAD BEDFORD MA 01730

DATA FOR - 01/15/2009 TO 02/15/2009 COORD. ID: 12

1

SYSTEM : 565 FUTURA/ADV 2 ATTENTION: DR. JOHN SMITH - QUALITY MGMT

CONTROL : 0420 UNASSAYED (24HR) LABORATORY: UNIVERSITY HEALTH SYS. LAB 123 CLINIC DR

LEXINGTON, MA 02421

COAGULATION

* * LAB COORDINATOR REPORT * *

3 4 5 6 7 8 9 10 LAB ID NAME SYSTEM # N MEAN 1SD CV SDI

_______________________________________________________________________________________________________________________________________ TEST : PT

11 METHOD : 2G RECOMBIPLASTIN

LEVEL : 1

LOT : N1275459 NORMAL

0000050362 HUNTSVILE HOSP 1 54 11.822 0.353 2.986 -0.846 0000050362 HUNTSVILLE HOSP 2 61 11.861 0.494 4.165 -0.708

0000050482 SOUTHSEA HOSPITAL LAB 2 53 12.000 0.300 2.500 -0.218

0000050483 SOUTHSEA HOSPITAL LAB 1 61 12.000 0.300 2.500 -0.218 0000050603 NORTHVIEW HOSP 1 40 12.356 0.221 1.789 1.037

0000050603 NORTHVIEW HOSP 2 45 12.395 0.147 1.186 1.175

0000050841 NORTH UNIV HOSP 1 67 12.124 0.317 2.615 0.219 0000050841 NORTH UNIV HOSP 2 57 12.293 0.321 2.611 0.815

0000051014 NEW CITY HOSPITAL 1 98 11.920 0.230 1.930 -0.500

0000051273 FRANKLIN GENERAL HOSPITAL 1 72 12.000 0.220 1.833 -0.218 0000051273 FRANKLIN GENERAL HOSPITAL 2 70 11.960 0.190 1.589 -0.359

LABORATORY GROUP AVERAGES 678 12.066 0.281 2.337 0.016

PEER GROUP DATA No. Labs 40 12.062 0.272 2.252 LEVEL : 2

LOT : N0386068 LO ABN

0000050362 HUNTSVILLE HOSP 1 38 22.668 0.460 2.029 -0.533 0000050362 HUNTSVILLE HOSP 2 43 22.712 0.610 2.686 -0.450

0000050482 SOUTHSEA HOSPITAL LAB 2 41 22.600 0.500 2.212 -0.662

0000050483 SOUTHSEA HOSPITAL LAB 1 46 22.500 0.500 2.222 -0.851 0000050603 NORTHVIEW HOSP 1 60 23.745 0.630 2.653 1.503

0000050603 NORTHVIEW HOSP 2 52 23.738 0.635 2.675 1.489

0000050841 NORTH UNIV HOSP 1 49 22.692 0.513 2.261 -0.488 0000050841 NORTH UNIV HOSP 2 37 22.909 0.400 1.746 -0.078

0000051014 NEW CITY HOSPITAL 1 91 22.560 0.580 2.571 -0.738

0000051273 FRANKLIN GENERAL HOSPITAL 1 65 22.820 0.560 2.454 -0.246 0000051273 FRANKLIN GENERAL HOSPITAL 2 69 22.800 0.570 2.500 -0.284

12 LABORATORY GROUP AVERAGES 591 22.886 0.542 2.365 -0.122

13 PEER GROUP DATA No. Labs 16 22.950 0.603 2.629

26

QUALITY CONTROL CONCEPTS

Levey-Jennings Interpretation

Discussion of Statistical Terms

Levey-Jennings Interpretation

In interpreting the plot made on the Levey-Jennings Chart (Data Input Form), it is important to keep in mind the statistical significance of the ± 2 SD lines. Once a method has been evaluated and found to be acceptable, values assayed for a single lot number of control should show a normal distribution about the mean with points falling above and below the mean value with relatively even frequency. The ± 2 SD lines delineate the area of the normal distribution in which 95.5% of the points should fall. Approximately once in every 20 tests, the value will fall outside these limits (mainly between 2 and 3 SD). This will occur by chance and thus cannot be said to indicate a definite “out of control” situation. Points falling outside the ± 2 SD limits must be interpreted in the light of preceding values. Repeating the determination will often result in a value falling within the statistical bounds. Frequently, a single outlier reflects a random error resulting from, e.g., a dirty piece of glassware. If the frequency of points falling outside the ± 2 SD limits is greater than 1 in 20, or if there are 2 successive points outside the same limiting line, an investigation should be made to determine the cause of the bias. When six successive points fall on the same side of the mean line (even though within ± 2 SD), the situation is considered to be “out of control.” The procedure should be evaluated and the problem corrected. See Shifts and Trends.

When carefully prepared and evaluated, the Levey-Jennings quality control charts are an extremely useful tool in the laboratory’s maintenance of high standards of performance.

Shifts and Trends A shift is said to have occurred when the six successive values (falling on the same side of the mean line) are observed to be consistent, not normally distributed above and below the mean line. Shifts may be caused by such factors as a change in diluter calibration, a change in the concentration of a reagent, or a change in a reference sample.

+ 4.7

* 4.6

+ 4.5 _________

4.4

4.3

M 4.2 4.1 4.0— 3.9 3.8

3.7— 3.6

A trend differs from a shift in that the six successive control values are not consistent; rather, the test results keep increasing or decreasing

relative to the mean. This situation may be attributed to a gradual change in a reagent, reference control, or instrument. + 12.9

12.8

* 12.7

12.6

+ 12.5

12.4

M 12.3 12.2 12.1

12.0 11.9

11.8

27

Discussion of Statistical Terms

Accuracy is the degree of closeness of a measurement to its “true” (accepted) value. AccuTrak output reports enable evaluation of

accuracy in terms of the closeness of a lab’s mean values to the respective group (method) means.

Precision is a measure of the reproducibility (or repeatability) of multiple measurements of the sample (how close the measured values

are to each other). Precision does not necessarily correlate with accuracy. That is, it is possible for a group of measured values to show excellent precision without being accurate. Reliability of measured values requires that both the accuracy and the precision be within acceptable limits.

Errors - If the measured values deviate from the accepted value beyond a certain magnitude, the measurements are considered

unreliable. In statistics, errors are differentiated into two types:

A. Random errors occur in no set pattern. They can be positive or negative in a given group of results, or may

fluctuate in a random manner. Random errors can be caused by incidental variations such as a lapse in technique or equipment performance.

B. Systematic errors are produced by variations that influence results consistently in one direction or the other (i.e., yielding all positive or all negative errors). The many possible causes of systematic errors include the analyst or laboratory bias and reagent deterioration.

Mean Value is an average of the control values submitted by a laboratory for a particular test (excluding outlier values).

Calculation: X = x

N

Significance: Used to show a central tendency of a group of data. It can be used for evaluating accuracy if a reference to which it can

be compared is available (e.g. as in method group reports). The mean value for a given constituent depends on method, instrumentation, and standards used. (Should have at least 20 pieces of data in the calculation. Significance declines as fewer pieces of data are used. The fewer the numbers, the more effect extreme values will have on the result.)

Group Mean ( x ) is the peer group’s mean (also called “mean of means” or “Grand Mean”). It is “weighted” by the number of results each

lab has reported. “Weighting” is using the weight or number of determinations to properly influence the end statistics. (EX: A lab submitting 30 data points has more influence on the group than a lab submitting 10 data points.)

Calculation: w

ww

x = x

(where w is the number of observations made by the laboratory, and x is the individual mean value.)

Significance: Used to evaluate inter-laboratory “accuracy” by serving as the reference to which individual means can be compared.

Standard Deviation (SD) is an expression of the spread or scatter of values around the mean. It is used as an indication of precision.

Calculation: SD = X X

N 1

2

Significance: 1. The interval from 1SD above to 1SD below a test’s mean (called a 1SD range) will contain approximately 68% of all results determined on a given control. A 2SD range above and below the mean will include approximately 95.5% of all results. A 3SD range will contain approximately 99.7% of all results. 2. Confidence Limits: Most laboratories attempt to work within 2SD of the mean value (95% confidence limits). A single value falling between 2 and 3SD may be an indication of error and should be investigated. The occurrence of two consecutive values in this interval is considered to be an “out of control” situation. A value of more than 3SD from the mean is always considered “out of control”.

28

Discussion of Statistical Terms (cont .)

Pooled Standard Deviation (PSD) as applied to group data represents the “average” Standard Deviation of the method

(group) irrespective of variations in means between laboratories. It is “weighted” by the number of results each lab has reported.

Calculation: PSD =

N 1 SD + N 1 SD + N 1 SD +...+ N 1 SD

N 1 N 1 N 1 +...+ N 1

1 1

2

2 2

2

3 3

2

X X

2

1 2 3 X

(where N X is the number of observations made by laboratory x; SD X is the SD of laboratory x’s values.)

Pooled Standard Deviation (PSD) as applied to individual laboratory cumulative Standard Deviation. This is an analogous

to the group’s PSD but is the individual lab’s average SD from month to month irrespective of variation in the monthly means.

Calculation: same as for group PSD above, but where N X is the number of pieces of data reported for month x; SD X is

the SD of the data reported for month x.

Standard Deviation Interval (SDI) is an indicator of accuracy by showing how well your lab mean compares to the peer group

mean qualitatively (+ or -) and quantitatively. The term SDI, as used in CAP-QAS, is known as “Z-Score.”

Calculation using monthly data: SDI = Lab Mean – Group (Method) Mean

SD of Group Means

SDI = X X

SD NOTE: The SD of group means is calculated from the means listed for a particular test, system, method, level and lot.

Calculation: SD of means = X X

N 1

2

Significance: SDI is generally used to demonstrate bias, e.g. if it is always negative, it could indicate your method is recovering low.

If your SDI is –1, it means your X was one method SD below X . An SDI of ± 3 indicates your mean is more than 3 SD from the group. It is indicative of large bias and should be investigated thoroughly.

Factors to consider when your SDI is > ± 2.0: Are there a small number of labs reporting to the group? Is the range of values within the group relatively small?

**Screening for outliers within a small, tight group, can result in the exclusion of labs with values that are not clinically different from the majority. This process is strictly statistical in nature and it is the laboratory’s responsibility to determine clinical significance.

Coefficient of Variation (CV%) measures variability around the mean. It is an indicator of precision expressing the standard

deviation as a percentage of the mean.

Calculation: CV = SD x 100%

x Significance: The CV allows you to compare and measure precision at different levels. However, raw numbers should be examined to establish the CV’s significance.

Coefficient of Variation Index (CVI) allows you to compare your precision to that of your peers.

Calculation: CVI = Lab CV

Group CV 29

Documents

AccuTrak - Werfen/media/IL/Docs/Product/AccuTrak... · Lab Coordinator Report This report is designed for use by individuals who oversee a number of laboratories that report to the