oneworld accuracy user guide · 2014. 3. 14. · oneworld accuracy user guide routine programs v...

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Oneworld Accuracy User Guide Routine Programs

ON EWORLD A CCURA CY USER GU IDE

ROUT IN E P ROGRA MS V 2 .2 | 20 14

TA BLE OF CON TEN TS

PART 1 – ONEWORLD ACCURACY SUPPORT ............................................................................................ 3

PART 2 – OASYS OVERVIEW ...................................................................................................................... 6

PART 3 – SUBSCRIBING TO ONEWORLD ACCURACY ............................................................................... 8

PART 4 – GETTING STARTED ....................................................................................................................... 9

PART 5 – TEST EVENT CALENDAR ............................................................................................................. 12

PART 6 – MANAGING LABORATORY PROFILES ...................................................................................... 13

PART 7 – SUBMITTING EQA RESULTS ........................................................................................................ 23

PART 8 – EQA PERFORMANCE REPORTS | GRAPHS .............................................................................. 30

PART 9 – POLICIES .................................................................................................................................... 33

APPENDIX 1A | 1B – LABORATORY RESULTS SUMMARY INTERPRETATION

APPENDIX 2 – INTERPRETING YOUR GRAPH

APPENDIX 3 – CMS SCORING REPORT INTERPRETATION



P A RT 1 – ON EWORLD A CCURA CY SUPP ORT

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WHAT IS ONEWORLD ACCURACY SUPPORT?

Oneworld Accuracy Support refers to the customer support provided by your EQA Provider as a member of the Oneworld Accuracy Collaboration.

HOW DO I CONTACT ONEWORLD ACCURACY SUPPORT?

You can contact Oneworld Accuracy Support for your EQA Provider by email, phone and fax as follows:

Location EQA Provider Email Phone Fax

Antigua & Barbuda

Ministry of Health, Antigua and Barbuda

[email protected] 268 462 5685 268 462 9333

Australia + New Zealand

National Serology Reference Laboratory, Australia (NRL)

[email protected] 61 3 9418-1112 61 3 9418-1155

Bahamas Ministry of Health, Bahamas

[email protected] +1.604.222.3900 +1.604.222.3901

Barbados Barbados EQA Project [email protected]

246-426-3870 246-436-1495

Belize Ministry of Health, Belize [email protected] +1.604.222.3900 +1.604.222.3901

Canada Oneworld Accuracy Canada

[email protected] 800-665-2575 604-222-3900

800-665-5949 604-222-3901 Canada NLHRS National Laboratory for

HIV Reference Services (NLHRS)

[email protected] 800-665-2575 604-222-3900

800-665-5949 604-222-3901

China China International Transfusion Infection Control

[email protected] 86-21-6219-1867 86-21-6208-8495

Costa Rica PROMED S.A. [email protected] 506 2253-1480 +506 2253-1495

Dominica Ministry of Health, Dominica

[email protected] +1.604.222.3900 +1.604.222.3901

El Salvador PROMED S.A. de C.V. [email protected] +503 2200-9700 -

Ethiopia Ethiopian Health and Nutrition Research Institute

[email protected] +251-11-275-15-22 +251-11-275-34-70

251(0)11-275-47-44

Grenada Ministry of Health, Grenada

[email protected] +1.604.222.3900 +1.604.222.3901

Guatemala PROMED S.A. [email protected] +502 2223-8600 -

Guyana Ministry of Health, Guyana

[email protected] 592-227-5262 592-226-5118

Haiti Laboratoire National de Santé Publique Haïti

[email protected] +509 3644 8013 -

Hondurus PROMED S.A. [email protected] 504 2232-1191 -

India Span Diagnostics Ltd. [email protected] +91-22-2852-6937 +91-22-2852-6938




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Italy Oneworld Accuracy Italia

[email protected] 090.9023290 090.9023315

Italy | CRQ Centro Regionale Qualità Laboratori

[email protected] 091.6553167 / 3170 091.6553168

Ivory Coast Projet Retro-CI, Ministère de la Santé Public du Cote d’Ivoire

[email protected] 225 21 21 43 22 225 21 24 29 69

Jamaica Ministry of Health Jamaica

[email protected] 9672\234-6, 9227708

8769670169

Kenya + East Africa

Human Quality Assessment Services (HuQAS)

[email protected] 254 20 354-2483 254 20 375-5132

Panama PROMED S.A. [email protected] +507 303-3100 -

Philippines NRL - SACCL [email protected] 309-9528 711-4117

Portugal Oneworld Accuracy Portugal

[email protected] +351.226004800 +351.226004801

Romania Sanimed International Impex

[email protected] +40729.039.838 +40314.274.127

Rwanda National Reference Laboratory Rwanda

[email protected] 252 570 414/ 400 -

Saint Kitts and Nevis

Ministry of Health, Saint Kitts and Nevis

[email protected] (869)465 2551 x 163 -

Saint Lucia Ministry of Health Saint Lucia

[email protected] 758 456 8233 758 452 1688

Saint Vincent & the Grenadines

Ministry of Health, Saint Vincent & the Grenadines

[email protected] +1.604.222.3900 +1.604.222.3901

Saudi Arabia Alinfrad Trading Establishment

[email protected] 966 11 2120606 966 11 2120099

Senegal AfriQuaLab [email protected] (221)776403082 (221)338216442

South Africa Thistle QA [email protected] +27 11 463 3260/1/2

+27 11 463 3036

Spain Oneworld Accuracy Spain

[email protected] +34. 917265000 +34.913612306

Suriname Ministry of Health Suriname

[email protected] 597-410-441 ext 242

597-473-923

Taiwan Medicare Products Inc. [email protected] 886-2-29180011 886-2-29152447

Trinidad &Tobago

Trinidad & Tobago EQA Project

[email protected] 868-662-8827 868-663-4335

Turkey Oneworld Accuracy Turklab

[email protected] +90 800 211 00 12 +90 212 230 07 76

United Arab Emirates

Oneworld Accuracy UAE

[email protected] 00971508035951 97165340255

United States AccuTest [email protected] 800-665-2575 604-222-3900

800-665-5949 604-222-3901

All other countries

Oneworld Accuracy International

[email protected] 604-222-3900 604-222-3901




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WHAT ARE ONEWORLD ACCURACY SUPPORT HOURS OF OPERATION?

Oneworld Accuracy Support for all EQA Providers is available during normal local business hours. Please contact your local EQA Provider for their current hours of operation.

HOW DO I SEND COMMENTS?

Your feedback is important to us and helps us improve Oneworld Accuracy System (OASYS). You can send comments as follows:

� Via internet: Go to www.oneworldaccuracy.com. Select ‘Member’ from the dropdown menu and click "LOGIN". Enter the username and password and login to the system by clicking on .

� Click on ‘Launch OASYS’ .

� Click "SESSION" and select "Feedback". Type your comments and then click <Send> .

� Via email | phone | fax as noted in the table of the EQA provider information.



P A RT 2 – OA SY S OVERVIEW

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WHAT IS OASYS?

OASYS (Oneworld Accuracy System) is the world’s most advanced EQA informatics system and is developed and managed by Oneworld Accuracy Inc. as a shared resource for all members of

the Oneworld Accuracy Collaboration. The system manages many elements of EQA such as:

� Shipment and registration notices, which include the necessary information (method and reagent/instrument information) for correct evaluation of results

� Result submission

� Generation of reminders for missing results

� Statistical analysis

� Publication of laboratory reports

� Access to historical results

WHAT IS THE ONEWORLD ACCURACY COLLABORATION?

The Oneworld Accuracy Collaboration was conceived as a new model upon which proficiency testing could serve as the foundation to build a global network of laboratories providing

accurate and reliable diagnostic testing to international standards.

The underlying objective is to empower national groups to assume responsibility for managing the quality of testing in their own countries via proficiency testing (and accreditation). Healthcare is ultimately a matter of local concern – and pride. The underlying informatics system (OASYS) make it possible to leverage and transfer collective experience to local stakeholders. OASYS supports proficiency testing and standardization initiatives.

The collaboration now encompasses many countries worldwide – all using a common informatics system to advance proficiency testing as a meaningful process to standardize and improve the quality of laboratory testing.

WHAT LANGUAGES ARE SUPPORTED BY OASYS?

OASYS currently supports English, French and Italian.



P A RT 2 – OA SY S OVERVIEW

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HOW DOES OASYS MANAGE THE EQA PROCESS?

Here is an overview of OASYS processes:

Here's how we acknowledge your commitment to testing quality

For EQA Programs, we provide an annual Certificate of Participation listing the disciplines of all Programs you participated in. For Standardization Programs, we provide an annual Certificate of Performance for each Program in which you met the performance goal.



P A RT 3 – SUBSCR IB IN G TO ON EWORLD A CCURA CY

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HOW TO SUBSCRIBE TO ONEWORLD ACCURACY PROGRAMS?

1. Go to www.oneworldaccuracy.com. Select and click your “Member” location from the drop-down menu.

2. Click "PROGRAMS".

a) Click on the drop down menu of ‘Select Catalog section’ and select "Order Form" or

"Request for Quote".

b) Click <View section> . Print and complete the selected form.

c) Send your completed form to your EQA provider.



P A RT 4 – GETT IN G STARTED

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SOFTWARE REQUIREMENTS

� To use the website, you need Windows 98 or higher with Internet Explorer 7.0 or higher or Firefox 3.6 or higher.

� To view Oneworld Accuracy reports, you need Adobe Acrobat Reader 9.0 or higher.

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

TIPS FOR USING OASYS

� If you are using a networked computer and have problems accessing your laboratory information on our website, please clear your Temporary Internet files and cookies from your computer. Cookies stored in your computer can sometimes interfere with accessing information on websites. The Temporary Internet Files (or cache) permits Internet Explorer

or MSN Explorer to download only the content that has changed since you last viewed a Web page, instead of downloading all the content for a page every time it is displayed.

To remove Temporary Internet Files and cookies follow these instructions:

1. Click on Start on your Active Desktop; select “Settings” and then “Control Panel”.

2. Double click “Internet Options” and click on the “General” tab. Locate the Temporary Internet files. Click on “Delete Cookies” and click OK to delete all cookies in the Temporary Internet files folder. Click on “Delete files” and click to

select the Delete all offline content check box, and then click OK.

� Use the <Next> or <Back> buttons on the public website and OASYS to access information.

� Submit Results for an Active Test Event before the Result Deadline listed on the worksheets. Do not leave data submission until the last minute as accessing the website may be limited due to the high rate of usage.

HOW DO I LOGIN TO OASYS?

1. Go to www.oneworldaccuracy.com.

2. Click "LOGIN"




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3. Enter your Username and Password (previously received by email if you had initially provided your email address) and then select <Login to OASYS Account > .

HOW DO I GET A USERNAME AND PASSWORD?

A Username and Password are assigned to all registered contacts. An email will automatically be sent to the email address provided when you initially subscribed with your username and also

a link to reset your password.

If you have an email address but did not receive your account information, you can request them from the Oneworld Accuracy website:

1. Go to www.oneworldaccuracy.com. Click "LOGIN”.

2. Click “Forgot username | password?”.

3. Enter your email address and click <Submit account request> .

4. Your Username and Password will be emailed to you.




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If you do not have an email address, contact Oneworld Accuracy Support to get your Username and Password.

WHAT HAPPENS IF I LOSE MY USERNAME OR PASSWORD?

1. Go to www.oneworldaccuracy.com.

2. Click “Forgot username | password?”.

3. Enter your email address and click <Submit account request> .

4. Your Username will be emailed to you along with a link to reset your password.

If you did not receive your account information, contact Oneworld Accuracy Support.

HOW CAN I FAMILIARIZE MYSELF WITH OASYS PRIOR TO SUBMITTING MY FIRST EQA RESULTS?

You can take a test drive of OASYS on the Internet. A ‘Demo’ account is available for you to get hands-on experience with OASYS.

1. Go to www.oneworldaccuracy.com. Select "Demo".

2. Click “Get demo account information”.

3. 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.

4. Your Demo Username and Password will be emailed to you. If you do not have email access, call Oneworld Accuracy Support to get your Username and Password.

5. Once you receive your Username and Password, go to www.oneworldaccuracy.com and click "Demo". Enter your Username and Password and click <Login to OASYS Demo> .

6. Click any header to view details about OASYS and how to submit EQA results.

Note: Please remember this is a demo account and it may not represent the programs for which

you are enrolled.



P A RT 5 – TES T EVEN T CA LEN DA R

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HOW CAN I GET A COPY OF THE TEST EVENT CALENDAR?

Test Event Calendar is available online at www.oneworldaccuracy.com.

1. Select and click your “Member” location from the drop-down menu at the top right hand corner of the page.

2. Click on "PROGRAMS".

3. Click on the drop-down menu (Select catalog section).

4. Scroll through the list and select “Calendar” and click <View section> . This will display a PDF file that you can save or print.

Alternatively, if you have an account, log in to your account, then select “Access Worksheets & Calendar”. The Calendar for a specific program can be obtained by clicking on the icon <Test event> located toward the end of the line of each program.

WHEN DO I EXPECT TO RECEIVE THE SAMPLES?

Two weeks prior to the shipment, 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. (shipping contact is the lab contact to whom samples will be shipped). The ASN lists the programs you should expect to receive and your registration information. Please inform all personnel of the upcoming shipment to avoid problems in the delivery to your laboratory.

Along with your ASN, you will receive the “lab paperwork” which is the handling instructions and

worksheets.

These documents are also available online. To access these documents, log on to your account;

• On the home page click on the “Access Worksheets and Calendar”

• Under the heading 'Test Event Paperwork' you will see <Lab paperwork> this is the handling instructions. Use the drop-down menu to select the “Test Event Opening Date” and then click on the ‘page’ icon. A PDF document will open. You may then print or

save the document. • Under the same heading you will also see <Data Submission Forms/ Worksheets> which

includes your results sheets. Use the drop-down menu to select the test event opening date then click on the ‘page’ icon.



P A RT 6 – MA NA GIN G LABORA TORY PROF I LES

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HOW DO I MANAGE MY LABORATORY PROFILES?

Depending upon the level of authority assigned to a user, many aspects of OASYS relating to your account can be modified. This user guide will detail Level 1 access.

After logging onto OASYS, choose the appropriate option from the Profile option.

1. PERSONAL

The Personal option allows the authorized user to modify, add or delete his/her personal

information in regard to address, contact type, and user information. A user can only change his/her own profile.

• From the “User Details” page click the <Modify Users Details> icon to modify the user’s information, including name and Report Unit Preference and also to reset the Password.

Please note that a “Report Unit Preference” can be either “Resulting Unit” or “Recommended Unit”. If a user's Report Unit Preference is Resulting Unit, then when viewing reports, results and statistics will be displayed in the unit the Analyte was resulted in. If a lab user's Report Unit Preference is Recommended Unit, then when viewing reports, results and statistics will be displayed in the “Recommended Unit” of the lab's Oversight Organization. By default, a lab user's Report Unit Preference will

be set to Resulting Unit.




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• From “Personal Profile” click the <Subscription Assignment> icon to modify a subscription contact.

• Click the <Modify Profile> icon to change email, phone or fax number and

address.

• Click the <Delete Profile> to delete a contact and his/her own details.

2. LABORATORY USERS

The Laboratory Users option provides a summary of all users associated with that laboratory, their Username, authority Level and Status. Click the <View user details> icon adjacent to each user to return to their Personal page.

3. LABORATORY PROFILE

The Laboratory Profile indicates the Oneworld Accuracy ID and information regarding the organization’s regulatory agencies.

HOW DO I COMPLETE MY REGISTRATION INFORMATION?

In order to submit the results each participant must submit detailed information about their analytical systems. Please submit data only for those analytes you will be measuring at your laboratory. A laboratory may add new analytes at anytime during the year.

Review the (Advance Shipment Notice) sent prior to every shipment carefully to be sure that

we have your most current registration information necessary for a correct evaluation.

You can update your instrument/reagent/analyte changes via Internet. Please refer to the instructions below. All changes to instrument/reagent/analyte must be done before you are able to submit results via the web. If you need assistance in updating your registration information please contact your EQA provider support team. In case of any Instrument changes

consult our online catalog for program-instrument compatibility and inform your EQA provider as

soon as possible.

HOW DO I ADD, MODIFY OR REPLACE AN INSTRUMENT?

1. OASYS requires an instrument for most programs. If you are not using an instrument for your testing you still need to add <Manual Determination> as an instrument, as this is a required field.

2. To add a new instrument:

a) Log on to your account, select < Update Instruments> from the homepage. On the Registered Instrument page click on <Add> at the bottom of the page. The following screen will appear.




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b) Click on the “Select a Manufacturer” drop down menu, scroll and select the manufacturer of the instrument. For tests that are manual and are performed using a

kit, select “not applicable” from the drop down menu.

c) Click on the “Select an instrument” drop down menu, scroll and select the instrument model. For tests that are manual and are performed using a kit, select “Manual

determination” from the drop down menu.

d) Enter Nickname and Serial Number if necessary. Click <Submit> .

We advise you to indicate the “Nickname” and the serial number of the instrument if

the program you are subscribing allows you to check more than one instrument for the same measurement. This can also be useful for other programs if you have more than one instrument that can do the same measurement and you want to identify one in particular.

3. If the instrument used is not present in the list click on <Instrument Not Listed> . Complete the mandatory fields (marked by *) as much as possible and click on the <Send> icon. This data will be sent to Oneworld Accuracy and the instrument will

be added to the system. You may be contacted by Oneworld Accuracy Support to request further information to ensure the instrument is set up correctly. An email message will confirm the successful submission of the inserted information.




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4. To modify instrument information – It is possible to modify only the Nickname and Serial

Number of an instrument:

a) From the list of instruments select the instrument and click <Modify Registered Instruments> .

b) Click on the field beside Nickname or Serial Number, Modify the contents and click

<Submit> .

5. To replace an instrument:

a) In order to replace an instrument associated to a subscription in OASYS, refer to the section “HOW DO I MODIFY INSTRUMENT | REAGENT OR KIT INFORMATION TO A SUBSCRIPTION?”

b) If you are replacing the instrument with an instrument not present in the proposed list you must first add the new instrument to the system as indicated in point 2 and then proceed with the change. We recommend that labs do not delete the old

instrument from the list of instruments for that lab.

HOW DO I VERIFY THE PROGRAMS WE ARE SUBSCRIBED TO?

The Subscription option gives access to the programs to which the lab is subscribed. Click

“PROFILE” and select “Subscriptions”.




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• Test Events button gives information about the status of each Test event for the

program selected, More precisely it reports:

The number of test events, the shipment dates, the test event open date, the status of the test event (e.g. shipped or closed) and the date when the web pages for data submission will be closed.

• View / Modify button Allows access to some preferences in report and shipping details.

Please contact your EQA provider before changing these settings.

• Maintain Subscription Contacts button There are several possible contact types available in OASYS including Billing, Shipping and Reporting. The contacts are program specific; therefore, different people may be indicated as contacts for different programs.

o Billing Contact: Indicates the person who will receive the invoices. Only one billing contact is allowed per subscription.

o Shipping Contact: Indicates the person who will receive the samples for that

subscription. All shipping documentation and deliveries are forwarded to this person. Only one Shipping Contact is allowed per subscription

o Reporting Contact: Indicates the person who can enter results and also has the option of receiving Oneworld Accuracy reports by email or fax. There may be multiple Reporting Contacts for each subscription.

In addition to the above contacts is the Primary Contact. A user is not allowed access to the Primary Contact details. Only one Primary Contact is allowed for each institution. Contact the Oneworld Accuracy Support to obtain more information about your Primary Contact.

• Historical Subscription Contacts: Provides an audit trail on the changes made to Contacts

• Registered analytes / procedures: Each laboratory can add, modify, or delete analytes associated with each subscription.

HOW DO I ADD INSTRUMENT | REAGENT OR KIT INFORMATION TO A NEW SUBSCRIPTION?

1. On the homepage select <Update Reagents & Assays>, under subscriptions for the

current year click on <Registered analytes | procedures> for the program/subscription in question.

2. The Registered Analytes/Procedures page with the list of analytes / procedures (and units for

Quantitative analytes) will be shown on the screen.

3. Locate the first analyte you want to add information to and click <Modify registered analytes/procedures> .




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4. On the “Analyte/Procedure Details” page for Quantitative analyes, click on the drop down menu beside “Units”, select the unit that your lab reports in for that analyte.

5. Click on the drop down menu beside “Registered Instrument”, then select and click the

instrument from the drop down menu.

6. For some of the EQA providers, “Designated for Regulatory PT” will be listed as one of the Analyte/Procedure Details for analytes that are designated for regulatory purposes. Click on the box if you want to send results to your regulatory agencies.

7. Click on the drop down menu beside “Reagent Manufacturer”, then select and click the manufacturer of your reagent from the drop down menu.




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8. Click on the drop down menu beside “Reagent Catalog #”, then select and click the corresponding catalog number from the drop down menu.

9. Click on the drop down menu beside “Reagent Submethod”. Most reagents have only

one method however some clinical chemistry, immunology, and coagulation reagents have more than one method. Select and click on the corresponding method.

10. Click <Submit> to save the information. Repeat the steps above for all the remaining analytes you are reporting.

11. Fields marked with an asterisk (*) are mandatory and therefore must be filled before proceeding.

12. If the reagent used by your laboratory is not present in the dropdown menu, click the <Reagent Not Listed> icon. On this page, include information about the reagent.

Complete the mandatory details (marked with an *) as completely as possible and click < Send> icon. This data will be sent to Oneworld Accuracy and the reagent will be added to the system. You may be contacted by Oneworld Accuracy Support to provide further information to ensure the reagent is set up correctly. An email message will confirm that the inserted information has been transmitted successfully.




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HOW DO I MODIFY INSTRUMENT | REAGENT | REPORTING UNITS OR KIT INFORMATION TO A

SUBSCRIPTION?

1. Select <Update Reagents and Assays> on the homepage, then click the <Registered

analytes | procedures> for the program | subscription you want to modify.

2. The “Registered Analytes / Procedures” page with the list of analytes / procedures will be shown on the screen.

3. Locate the analyte you want to modify the instrument | reagent Information | reporting units for then click <Modify registered analytes/procedures> .

4. Modify all the necessary information from the drop down menu on the “Analyte / Procedure Details” page.

5. If the units for a Subscribed Analyte are changed, the system will, after a warning,

remove any results submitted for current Test Event for that Analyte. Click <Submit> to save the information.




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HOW DO I ADD OR DELETE AN ANALYTE TO A SUBSCRIPTION?

1. To add a new analyte:

a) Click <Add> at the bottom of the “Registered Analytes / Procedures” page to display the list of available analytes:

b) Locate the analyte and click <Add Analyte/Procedure> on the right hand side.




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c) Enter the mandatory information (Instrument, Reagent) then Click <Submit>

2. To delete an analyte:

a) Check the box on the left hand side of the analyte name.

b) Click the symbol at the bottom of the page to remove the analyte from the subscription profile. Note: If there is only one analyte remaining for the subscription,

the analyte cannot be removed. You must contact Oneworld Accuracy support to cancel the subscription.

c) If the analyte you are deleting is designated for regulatory purposes, a message will appear on your screen notifying you of this. If you are reporting results for the same analyte in another subscription, you will need to designate the analyte for regulatory purposes in the other subscription.



P A RT 7 – SUBMI T T IN G EQA RESULTS

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HOW CAN I SUBMIT EQA RESULTS?

1. Go to www.oneworldaccuracy.com and log on to your account.

2. Select “ Submit Results” on the homepage.

This will display a list of all subscribed EQA programs for which the results can be submitted.

Red sample icons indicate that EQA results have not been submitted yet.

Blue sample icons indicate that EQA results have been submitted.

3. To submit EQA results for the corresponding program click the red sample box for which you want to submit the data.




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4. For some programs after clicking on submit results you will see a yellow arrow in a red box

under ‘Select Sample/Assay’.

5. Click on this red box with the yellow arrow and complete the information required under ‘Sample Conditions’.

6. After completing the requested information go to Background Info.




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7. Once the background information is entered you can now enter the results.

8. Once the results are entered you have the option to print them by clicking on ‘Print Results’.

9. The red box that was there before result submission will now turn blue indicating that the results are submitted.




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10. If the information for methods, reagents and instruments is missing for a subscription, the following message will appear; “Please update analyte information before submitting results”. To update the analyte information go to HOW DO I ADD INSTRUMENT/REAGENT

OR KIT INFORMATION FOR A NEW SUBSCRIPTION?

For each subscription, you will be requested to confirm the instrument and analyte/reagent information. If the information is not accurate or you want to view the detailed information, click either <Modify Registered Instrument> or <Modify registered Analyte | Procedure> . Make the modifications and then click <Submit> for this page.

For quantitative results, make sure the reporting units are correct for your laboratory. If not,

change the units prior to proceeding to next page.

11. If you agree to the indicated modifications or if the presented information is accurate, click <Confirm> at the bottom of the Review Registration page.

12. You cannot delete analytes in the Active Test Event screen. You must delete analyte(s) from

the Profile Subscriptions section. Please refer to the section <HOW DO I ADD OR DELETE AN

ANALYTE TO A SUBSCRIPTION?>

13. Enter the results for the selected sample. The Laboratory Analyst and Laboratory Director information can be entered if preferred (not mandatory) then click on at the bottom on that page to submit.

a) For quantitative results; enter your result in the blank box.




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b) For qualitative results, select and click on the corresponding result from the drop down menu.




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c) For some qualitative programs such as CELL435 and USED432, you must first select a category from the drop down menu and then select the corresponding result from the Result drop down menu.

14. Once you have clicked on the system will take you to the next screen, where you can review your results. Then you need to click on the at the bottom of the second page again to submit your results. By doing this, the system will take you back to the original page to enter results for other samples.

15. If you cannot enter a result, indicate the reason by selecting it from the Problem | Reason Code list. Enter either a result or a Problem | Reason Code, but not both.

� If your result is less than or greater than the sensitivity limit of your instrument or kit, select

Problem | Reason Code 11 or 22 .

� If you are not performing testing due to an instrument being out of service etc., select Problem | Reason Code 33 or 88.




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16. If you need to make changes to the results, you can do so by simply clicking on the sample box for which you need to change the results and re-enter the results and resubmit.

17. Once you have entered results for all the samples, you will find that all red results boxes have turned blue.

18. To view/print submitted EQA 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 EQA results you submitted for the subscription. You can print or save this PDF document.

19. To email submitted EQA results to a colleague or responsible person for the laboratory, 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 must not be used to email results to Oneworld Accuracy.



P A RT 8 – EQA P ERFORMAN CE REP ORTS | GRAP H S

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HOW DO I ACCESS REPORTS AND GRAPHS ONLINE?

You will need Adobe Acrobat Reader 9.0+ to view Reports.

1. Go to www.oneworldaccuracy.com and click “LOGIN”, then log on to your account.

2. Select <Access Performance Reports> on the homepage for quick access to your past performance reports (from the previous two years).

3. Or click “REPORTS” on the toolbar and then select the report you wish to generate, from the list.

“Current Failed Results”

This report shows unsuccessful 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.

“CLIA Results” – ONLY This report shows the Centers for Medicare and




31 31

AVAILABLE FOR US PARTICIPANTS

Medicaid Services (CMS) designated analyte scoring performance by analyte and cycle for

the past 3 testing events.

“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 (quantitative analytes only).

4. Locate the program you wish to view, and the Results Deadline | Test Event from the drop-down menu. The “All” option, if available, will give you the results for all the programs that have the same Results Deadline | Test Event date you have selected.

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




32 32

6. Click <View/Print reports> , to display the report in PDF that can be printed or saved.

7. To email the report to a colleague or other laboratory responsible person, click <Email reports> .

HOW DO I ACCESS REPORTS GENERATED IN THE LAST 7 DAYS

Reports you have generated in OASYS are stored in your Profile for one week.

1. To access these reports, go to www.oneworldaccuracy.com and click “LOGIN”.

2. Enter your username and password and log in to the system.

3. Click “PROFILE” and select “Report Log”.

4. Click on the report you want to view located under the “Report” header. A PDF file is

generated which can be viewed, printed or saved.

WHERE CAN I FIND THE REFERENCE METHODS AND EVALUATION CRITERIA FOR ANALYTES?

To view the Reference Methods

1. Go to www.oneworldaccuracy.com and select your Oneworld Accuracy Worldwide location from the drop down menu.

2. Click “PROGRAMS” and then click on the drop down menu < Select catalog section>.

3. Scroll down the menu and click on “CEQAL Reference Methods”, then select <View section> . A pdf file is generated which can be viewed, printed or saved.

To view the Evaluation Criteria – not available for all EQA providers

1. Go to www.oneworldaccuracy.com and select your Oneworld Accuracy Worldwide

location from the drop down menu.

2. Click “User Guides” and select “Evaluation Criteria”. A pdf file is generated which can be viewed, printed or saved.



P A RT 9 – P OL IC IES

33

1. SHIPMENTS

Two weeks prior to a EQA shipment, the person designated as shipping contact will receive an <Advance Shipment Notice>. The Advance shipment notice contains information on

programs to be received and demographic information of the lab together with all the information relative to methods, reagents and instruments that you have provided to Oneworld Accuracy.

It is the responsibility of the laboratory to ensure this data is current and to notify their EQA

provider Support team of any changes prior to date of sample shipment.

Shipment dates of the samples cannot be changed. Extensions or excused status will not be

granted due to routing/receiving problems within an institution causing non-delivery of samples.

Although shipment dates cannot be changed, programs may be ordered at any time and the price is prorated to the number of remaining test events.

Samples stored refrigerated or frozen are sent via next day delivery. If samples are not received by test event opening date, contact Oneworld Accuracy Support for tracking.

Samples that require storage at room temperature are shipped for delivery within 7 working days. If samples are not received within this time frame, contact Oneworld Accuracy Support for tracking.

2. ORDERS

Changes to purchased programs should be directed to your EQA provider via email, fax or telephone. Changes to programs are dependant on availability of product.

All communication should include

� Your Oneworld Accuracy ID.

� Laboratory name, address, email and telephone number.

� Contact name.

� Information on programs added or cancelled.

� Billing information.

All prices will be prorated by the number of test events/year.

3. WAIVED TEST PROCEDURES – FOR US PARTICIPANTS ONLY

If for a regulated analyte your laboratory changes mid-year from a non-waived to a waived method or if the manufacturer is granted waived status, you must maintain enrolment in a 5 sample program for any remaining non-waived tests in the

subspecialty as per CMS regulations.

4. SAMPLES

All shipments should immediately be opened upon receipt and contents checked for the following:

� Damaged samples

� Missing samples




34

� Incorrect samples

For replacements, contact Oneworld Accuracy support.

Store samples at the appropriate temperature and follow all sample handling protocols

indicated in the “Handling & Reporting Instructions”.

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

EQA samples should be analyzed as soon as possible and results submitted on OASYS.

5. RESULTS SUBMISSION

Please follow the instructions in Part 7 to submit your results.

DO NOT MAIL RESULTS TO ONEWORLD ACCURACY

Participants will receive a reminder 2-3 business days prior to the Results Deadline that their

results are due. Late results will not be evaluated.

6. EQA PERFORMANCE

Results evaluation is performed using criteria approved by the relevant regulatory agencies or oversight bodies.

All reports are emailed (or faxed in some cases) to participants within approximately 10

business days of the Results Deadline. Reports consist 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”.

� CMS scoring report (only available for US participants) - all Centers for Medicare and Medicaid Services (CMS) regulated analytes and their performance over 3 cycles.

A guide to interpreting your report is included in Appendices.

7. CORRECTIONS

EQA Performance reports are also sent to accrediting | regulatory agencies. Therefore, it is critical that you review your reports immediately and report any errors on our part to Oneworld Accuracy Support. A corrected report will be sent to you as soon as possible.

Errors on the part of the lab, e.g., results entered from incorrect instrument, wrong units or incorrect order would not be corrected.

8. EQA FAILURES

Before contacting Oneworld Accuracy Support, participants should follow their protocols for troubleshooting samples, instrument or reagent problems. Oneworld Accuracy Support can




35

provide suggestions and other resources to assist participants. Samples for remedial EQA are available on a limited basis and there is a cost associated with the samples.

9. REPORTS

It is the responsibility of the participant to keep all records of participation in proficiency testing for two years. Participants can access all reports and graphs including archived reports from previous test events in the “REPORTS” Section online at www.oneworldaccuracy.com. Refer to Appendices for instructions on interpreting reports.

10. ACCREDITATION AGENCIES AND REPORTS

Participation in an approved EQA program is part of your laboratory’s Quality Assurance requirements. Reports are sent to laboratory oversight bodies | regulatory agencies. As an approved EQA provider we will report EQA results in a manner that meets the laboratory oversight bodies | regulatory agencies requirements. It is the responsibility of the participating laboratory to notify the EQA provider which agencies should receive EQA performance

reports. It is also the responsibility of the laboratory to notify the EQA provider of their current status on an annual basis. (An authorization form is sent at the beginning of each year along with the yearly order confirmation).

Laboratory Results Summary Interpretation Guidelines

Laboratory Lab ID # Facility: Page

Test Event XXXXX Print Date

Program Lipids (LIPDxxx) Results Deadline

Peer Group Statistics Evaluation Criteria

Subscription ID Result AP Code Actual Results

Count Statistical

Count Mean SD

CV (%)

SDI Peer Group

Code: Description

Flag Statistical

Count PI Targets Range Description

Cholesterol- Total

mmol/L A

4.74 357 28 4.463 0.12 2.7 2.3

ID: Beckman LX-20

257 0.7 4.45 4.04 – 4.86

Reference Value ± 9%

2100 B

5.39 357 27 5.002 0.085 1.7 4.6

ID: Beckman LX-20

257 0.7 5.07 4.61 – 5.53


C

6.50 357 28 6.23 0.163 2.6 1.7

ID: Beckman LX-20

257 0.3 6.35 5.77 – 6.93


*please note that there are SD, CV(%) and SDI also under Evaluation Criteria

DEFINITIONS:

Individual analyte and unit of measure. Identification code of each sample. The test result submitted by your laboratory. Total number of participants measuring that analyte. Number of participants in peer group. The mean of the peer group. The standard deviation of the peer group. The coefficient of variation of the peer group data. Standard Deviation Index. The SDI is an expression of the distance your result is from the group mean. The value calculated is the number of SDs your result is from the group mean.

SDI = Your Result – Peer Group Mean Peer Group SD

Analyte peer group description. The number of participating labs evaluated with this evaluation criteria. Performance Index PI = (lab Result – Target Value)

Accreditation Limit

A value of zero indicates the result exactly equals the evaluation group mean or target value. A value between -1 and 1 indicates the result is within the evaluation range. Target against which lab results are evaluated and are dependent on evaluation criteria used for that analyte. The range within which results must fall for acceptable performance. Criteria for acceptable performance are defined by your regulatory agency. Description of the evaluation criteria used to evaluate analyte performance.

Evaluation Flags � AP - This symbol indicates results submitted with an analytical problem code. � NE - This symbol indicates results not evaluated. � This symbol indicates results that have exceeded evaluation criteria. � This symbol indicates results that are statistical outliers and have been excluded from the peer group statistics (Tukey’s Outlier Test). Analytical Problem (AP) Codes 11 This indicates that you have submitted a below linear

/detection limit problem code instead of a result.

22 This indicates that you have submitted an above linear /detection limit problem code instead of a result.

33 This indicates that you have submitted an analyzer out of service problem code instead of a result.

44 This indicates that you have submitted an insufficient volume problem code instead of a result.

66 This indicates that you have submitted an specimen not appropriate problem code instead of a result.

77 This indicates no result has been submitted.

Peer Group (PG) Codes AR (All Results group): Encompasses all results for a particular analyte. ME (Method group): This group defines basic methodological principles, for example immunoassay, kinetic/rate. SM (Submethod group): This group further defines a particular methodological principle, e.g. immunoassay – enzymatic, immunoassay – chemiluminescent. RM (Reagent Manufacturer group): Results for reagents using similar method/submethod from the same reagent manufacturer. RG (Reagent Group): Results for reagents using similar method/submethod and reagent technology from the same reagent manufacturer. RE (Reagent): Results for reagents having the same catalog number. IM (Instrument Manufacturer group): Results for a particular instrument manufacturer. IG (Instrument group): Results for a particular instrument series. ID (Instrument Model group): Results for a particular instrument model.

Appendix 1A – not applicable to all participants

Laboratory Results Summary Interpretation Guidelines

Laboratory Lab ID # Facility: Page

Test Event XXXXX Print Date

Blood Gas Electrolytes – Performance Report

Subscription ID # Instrument Model: CLIA # Cycle: Accreditation # Result Deadline: State ID #

YOUR LAB’S DATA COMPARATIVE GROUP DATA

Analyte Sample Result Reason Code

SDI Grade Statistical

count Mean SD CV(%)

Peer Group Code: Description

Acceptable Results

>> Potassium

mmol/L A 4.4 0.70 ACC 196 4.20 0.30 7.1 ID: Beckman CX7 3.7 – 4.7

B 2.9 1.00 ACC 190 2.50 0.10 16.0 ID: Beckman CX7 2.0 – 3.0

C 6.1 0.20 ACC 196 6.00 0.60 10.0 ID: Beckman CX7 5.5 – 6.5

D 3.8 1.70 ACC 194 3.30 0.30 9.0 ID: Beckman CX7 2.8 – 3.8

E 3.4 1.30 ACC 194 3.00 0.30 10.0 ID: Beckman CX7 2.5 – 3.5

Analyte Score: 100% Percentile: 78.2%

DEFINITIONS:

Analyte/Unit Individual analyte and unit of measure.

Analyte Score (see note below). The percentage of test results which fall within the Acceptable Range. This is calculated by:

Sample Identification code of each sample.

Number of acceptable responses for analyte x 100

Total number of analyte samples

Result The test result submitted by your laboratory.

Statistical count The number of participants in the peer group.

Reason Codes

1 failure to participate (0% score)

8 Excused participation – natural disaster

11 Below linear/detection limit

22 Above linear/detection limit

88 testing suspended during test event

Mean The mean of the Comparative Group Data, used to determine the Acceptable Range and SDI. SD The standard deviation of the Comparative Group Data.

SDI SDI = Your Result – Peer Group Mean Peer Group SD

CV% The coefficient of variation of the Comparative Group Data.

Standard Deviation Index. The SDI is an expression of the distance your result is from the group mean. The value calculated is the number of SDs your results is from the group mean.

CV% = SD x 100 Mean Peer Group Code: Description The peer group at which the analyte was evaluated.

Grade ACC Acceptable Actual result submitted falls within

the Acceptable Range. UNACC Unacceptable Actual result submitted falls

outside the Acceptable Range. *ACC/*UNACC Not applicable to all laboratories.

Upgradeable Group results were not gradable due to lack of consensus (less than 80%). See NOTE below.

Acceptable Range The range within which test results must fall for acceptable performance. Criteria for acceptable performance are defined CMS, and are published in the Federal Register, February 28, 1992, 42 CFR Part 405, CLIA '88. Percentile Percentile rankings are based on your overall SDI for the analyte, as compared to your peer group. Higher percentile = better performance.

Instrument/Method The instrument or method your laboratory indicated as the procedure used to perform the analysis.

IMPORTANT NOTES:

Analyte Scores that are designed for regulatory purpose (“>>”) are reported to accrediting agencies to fulfill proficiency testing requirements. Grades with an asterisk (*) indicate challenges that demonstrated a lack of consensus (<80%) of participating laboratories, referee laboratories, or both. Since such challenges are automatically graded "acceptable" and assigned a 100% score, these scores do not reflect a true evaluation of the laboratory's performance. If a laboratory has received an unsatisfactory score (<80%) on a test, or analyte, subspecialty, or specialty, then a second unsatisfactory score in one of the next two testing events for the same test or analyte, subspecialty or specialty will result in unsuccessful performance.

Appendix 1B – not applicable to all participants

Interpreting Your Graph

Cholesterol - Total

Performance Evaluation Criteria : Peer Group Mean ± 10.0% Desirable Performance Goal : All Results Mean ± 9.0%

Cholesterol Oxidase/Peroxidase - Dade Dimension RxL

Method(ME) SubMethod(SM) Reagent Manufacturer(RM) Instrument Manufacturer(IM) Instrument Model Group(IG) Instrument Model(ID)

Enzymatic Cholesterol Oxidase/Peroxidase

Siemens (Dade Behring Products)

Siemens (Dade Behring Products)

Dade Behring Dimension Series

Dade Dimension RxL

Analyte reference range

SDI = Your Result – Peer Group Mean

Peer Group SD

Bias % = (Your Result – Reference Value or All Result Mean) x 100

Reference Value or All Result Mean

Cumulative summary of your results

Your cumulative results relative to the all result group or reference value

Your cumulative results relative your peer group

The shape of the symbol denotes concentration according to your laboratory’s reference range Current test event results: ◊ - results within reference range – results below the lower reference range limit - results above the upper reference range limit

Solid symbols ◆ results are outside the acceptable evaluation range

A cross through a solid – result is an outliner A circle around a solid symbol – result off the axis

Appendix 2

2nd

box represents peer group category at which peer group “stopped” and the

n value in brackets

• - Previous test event result

Results Deadline date

1st box represents the all result

group, the ends of the box equals 2SD, and the n value in brackets

Symbols represent your results

The dashed line indicates your bias

Vials ordered alphabetically

Your results Data expressed relative to all result mean or reference

value

Method and instrument registration

Analyte desirable performance goal

Desirable performance goal

Desirable performance goal

Performance evaluation upper limit

Performance evaluation target

Performance evaluation lower limit

Routine Chemistry – CMS Scoring Report Interpretation Guidelines Page 1 of 1

Print Date

Attn: Lab ID XX1234 Cycle: 02 - YYYY

CLIA Number Cycle Date: May – August YYYY

Results for your CMS designated instrument(s):

PT Number

Analyte Cycle 03 – 2006

Score Cycle 01 – 2007

Score Cycle 02 – 2007

Score CLIA

Status

315 Ph U(40%) S(100%) S(100%) Successful

325 pO2 S(80%) S(100%) S(100%) Successful 335 pCO2 U(40%) S(100%) S(100%) Successful

Overall Score: U(53%) S(100%) S(100%) Successful

DEFINITIONS:

PT Number CMS designated analyte number Analyte Analyte description Cycle XX First test event Cycle XX Second test event Cycle XX Current test event CLIA Status Current performance status Overall Score Specialty Score for last 3 test event

Reviewed by:

Review Date:

S = Analyte test event score equal to or more than 80% (4 of 5 values which CMS range): Satisfactory

U = Analyte test event score less than 80%: Unsatisfactory

Attention All Participants:

If a lab has an unsatisfactory score (<80%) on an analyte, then a second unsatisfactory score in one of the next two test events for the same analyte will result in unsuccessful performance. Such a CLIA score may trigger CMS or state sanctions.

Any unsatisfactory performance for a designated PT instrument requires specific remedial action and document (see CFR 42 Sec. 493.841 for details).

Analytes that are not federally monitored are not scored for purposes of CLIA compliance.

Oneworld Accuracy Support: [email protected] fax: 800-665-5949 phone: 800-665-2575

Appendix 3 – not applicable to all participants

mailto:[email protected]

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