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User Guide – Routine Programs - DigitalPT

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DIGITALPT   User Guide
             Routine Programs
  T AB L E O F C O N T E N T S




PART 1 – DIGITALPT SUPPORT .............................................................................................................. 3


PART 2 – DIGITALPT OVERVIEW ............................................................................................................ 5


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


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


PART 5 – TEST EVENT CALENDAR ...................................................................................................... 11


PART 6 – MANAGING LABORATORY PROFILES ................................................................................ 12


PART 7 – SUBMITTING PT RESULTS ................................................................................................... 21


PART 8 – PT PERFORMANCE REPORTS | GRAPHS .......................................................................... 26


PART 9 – POLICIES ................................................................................................................................. 29



APPENDIX 1A | 1B – LABORATORY RESULTS SUMMARY INTERPRETATION


APPENDIX 2 – INTERPRETING YOUR GRAPH


APPENDIX 3 – CMS SCORING REPORT INTERPRETATION




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WHAT IS DIGITALPT SUPPORT?
DigitalPT Support refers to the customer support provided by your PT Provider as a member of the
DigitalPT International EQA Collaboration.
HOW DO I CONTACT DIGITALPT SUPPORT?
You can contact DigitalPT Support for your PT Provider by email, phone and fax as follows:


 Location               PT Provider                  Email                    Phone                 Fax


 Antigua & Barbuda Ministry Of Health, Antigua healthinfo@antigua.gov.ag      268 462 5685          268 462 9333
                   and Barbuda
 Australia     +   New National          Serology digitalpt@nrl.gov.au        61 3 9418-1118        61 3 9418-1155
 Zealand               Reference       Laboratory,
                       Australia (NRL)
 Barbados               Barbados EQA Project         hadynr@hotmail.com       246-426-3870          246-436-1495


 Canada                 HealthMetrx                  support@digitalpt.com    800-665-7436          800-665-5949
                                                                              604-222-3900          604-222-3901

 Canada NLHRS           National Laboratory for HIV support@digitalpt.com     800-665-7436          800-665-5949
                        Reference         Services
                        (NLHRS)                                               604-222-3900          604-222-3901
                        Canadian External Quality support@digitalpt.com       800-665-7436          800-665-5949
 Canada                 Assessment      Laboratory
                        (CEQAL)                                               604-222-3900          604-222-3901
 Ethiopia               Ethiopian    Health      and EHNRI@ethionet.et        +251-11-275-15-22     251(0)11-275-47-44
                        Nutrition Research Institute
                                                                              +251-11-275-34-70

 Guyana                 Ministry of Health, Guyana guyana@digitalpt.com       592-226-5118          592-226-5118


 Italy                  Valutazione Esterna      di veq@aosp.bo.it            51.347207             51.6361444
                        Qualità (VEQ)
                                                                              51.4296822
 Jamaica                Ministry of Health Jamaica   florisgordon@yahoo.com   9672\234-6, 9227708 8769670169


 Kenya       +     East Human              Quality huqas@huqas.org            254 20 354-2483       254 20 375-5132
 Africa                 Assessment        Services
                        (HuQAS)
 Philippines            NRL - SACCL                  nrl_saccl@yahoo.com.ph   309-9528              711-4117


 Saint Lucia            Ministry of Health Saint ezra_longlab@yahoo.com       758 456 8233          758 452 1688
                        Lucia

 Senegal                AfriQuaLab                   momar_bakhoum@yahoo.fr   (221)776403082        (221)338216442


 South Africa           Thistle QA                   mail@thistle.co.za       +27 11 463 3260/1/2   +27 11 463 3036


 Suriname               Ministry of Health Suriname phlabsur@yahoo.com        597-410-441 ext 242   597-473-923

 Trinidad &Tobago       Trinidad & Tobago EQA lab.accreditation@ttbs.org.tt   868-662-8827          868-663-4335
                        Project
 United States          AccuTest                     support@digitalpt.com    800-665-2575          800-665-5949
                                                                              604-222-3900          604-222-3901




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 West Africa (Ivory Projet Retro-CI, Ministère Tehea@ci.cdc.gov          225 21 21 42 22   225 21 24 29 69
 Coast)              de la Santé Public du Cote
                     d’Ivoire
 All other countries AccuTest                   support@digitalpt.com    604-222-3900      604-222-3901



WHAT ARE DIGITALPT SUPPORT HOURS OF OPERATION?
DigitalPT Support for all PT Providers is available during normal local business hours. Please contact
your local PT Provider for their current hours of operation.


HOW DO I SEND COMMENTS?
Your feedback is important to us and helps us improve DigitalPT. You can send comments as follows:
         Via internet: Go to www.digitalpt.com and click "LOGIN". Select "DigitalPT Account" and login to the
          system. Click "SESSION" and select "Feedback". Type your comments and then click <Send>         .
         Via email | phone | fax as noted in the table of the PT provider information..




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WHAT IS DIGITALPT?
DigitalPT (www.digitalpt.com) is the world’s most advanced PT informatics system and is developed and
managed by HealthMetrx as a shared resource for all members of the DigitalPT International EQA
Collaboration. The system manages many elements of PT 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 DIGITALPT INTERNATIONAL EQA COLLABORATION?
The DigitalPT International EQA 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 systems (DigitalPT and DigitalAP) make it
possible to leverage and transfer collective experience to local stakeholders. DigitalPT supports
proficiency testing and standardization initiatives and DigitalAP supports effective licensing, accreditation
and self-assessment.
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 THE DIGITALPT SYSTEM?
DigitalPT currently supports English, French, Italian and Spanish and Chinese.




HOW DOES DIGITALPT MANAGE THE PT PROCESS?


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Here is an overview of DigitalPT.




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HOW TO SUBSCRIBE TO DIGITALPT PROGRAMS?
     1. Go to www.digitalpt.com. Select and click your “DigitalPT Worldwide” location from the drop-down
        menu.
     2.    Click "PROGRAMS" and then select the corresponding program from the drop-down menu.
          PT Programs (Proficiency Testing 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) Fax your completed form to your PT provider.


          Standardization (Standardization Programs) – not available for all PT providers
          If you would like to participate in an online presentation
          a) Click on the drop down menu of ‘Select Catalog section’ and select "Presentation
             Form" and click <View section> .
          b) Print and complete the selected form.
          c) Fax your completed form to your PT provider.


          If you would like to place an order
          a) Select "Order Form" and click <View section>            .
          b) Print and complete the selected form.
          c) Fax your completed form to your PT provider.




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SOFTWARE REQUIREMENTS
         To use the website, you need Windows 98 or higher with Internet Explorer 5.0 or higher.
         To view DigitalPT reports, you need Adobe Acrobat Reader 8.0 or higher.

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


TIPS FOR USING THE DIGITALPT SYSTEM
         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 DigitalPT website 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 DIGITALPT?
     1. Go to www.digitalpt.com.
     2. Click "LOGIN" and select "DigitalPT Account".




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




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


HOW DO I GET A USERNAME AND PASSWORD?
A Username and Password are assigned to all registered DigitalPT contacts. Your account information
will automatically be sent to the email address provided when you initially subscribed.
If you have an email address but did not receive your account information, you can request them from
thDigitalPT website:
     1. Go to www.digitalpt.com. Click "LOGIN" and select "DigitalPT Account".
     2. Click “Get account information”.
     3. Enter the requested information and click <Submit account request>       .
     4. Your Username and Password will be emailed to you.
If you do not have an email address, contact DigitalPT Support to get your Username and Password.

WHAT HAPPENS IF I LOSE MY USERNAME OR PASSWORD?
     1. Go to www.digitalpt.com and click "LOGIN" and select "DigitalPT Account".
     2. Click “Lost your Username | Password?”.
     3. Enter the requested information and click <Submit account request>       .


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     4. Your Username and Password will be emailed to you.
If you have not received your account information, contact DigitalPT Support.



HOW CAN I FAMILIARIZE MYSELF WITH DIGITALPT PRIOR TO SUBMITTING MY FIRST PT
RESULTS?
You can take a test drive of the DigitalPT system on the Internet. A ‘Demo’ account is available for you to
get hands-on experience with the DigitalPT system.

     1. Go to www.digitalpt.com. Click "LOGIN" and select "Demo Account".
     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
        DigitalPT Support to get your Username and Password.
     5. Once you receive your Username and Password, go to www.digitalpt.com and click "LOGIN" and
        select "Demo Account". Enter your Username and Password and click <Login to DigitalPT
        Demo> .
     6. Click any header to view details about DigitalPT and how to submit PT results.
Note: Please remember this is a demo account and it may not represent the programs for which you are
       enrolled




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HOW CAN I GET A COPY OF THE TEST EVENT CALENDAR?
The Test Event Calendar is available online at www.digitalpt.com.
     1. Select and click your “DigitalPT Worldwide” location from the drop-down menu at the top right
        hand corner of the page.
     2. Click "PROGRAMS" and select "PT Programs".
     3. Select the corresponding year on the top left side.
     4. Click on the drop-down menu (Select catalog section).
     5. Scroll through the list and select Test Event Calendar and click <View section>         . This will
        display a PDF file that you can save or print.
If you do not have Internet access, contact DigitalPT Support.

WHEN DO I EXPECT TO RECEIVE THE SAMPLES?
Three 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 your <lab paperwork> which includes the handling instruction and
result sheets.
These documents are also available on line.To access these documents,log in to your DigitalPT account;

     •    Select "Active Test Event Reports" from the Results drop-down menu.
     •    Under the heading 'Shipment Reports', you will see <Lab paperwork>.Use the drop-down menu
          to select the shipment date and then click on the ‘page’ icon. A PDF document will open. You
          may then print or save the document.
     •    Under same heading you will also see < Data Submission Forms> which includes only your
          results sheets.Use the drop-down menu to select the shipment date then click on the ‘page’ icon.

The samples are sent by courier to each laboratory. If the courier for your shipment is FedEx (by air) or
Purolator or Canada Express Post, you will receive an email notification directly from the courier on the
day the package leaves our facility. The email will include a tracking number and link that will enable you
to track your shipment in real time. If you do not receive the package when expected, contact DigitalPT
support immediately so we can track the package for you.




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HOW DO I MANAGE MY LABORATORY PROFILES?
Depending upon the level of authority assigned to a user, many aspects of the DigitalPT database
relating to your laboratory can be modified. This user guide will detail the lowest level only.
After logging onto DigitalPT, choose the appropriate option from the Profile option.




         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/herown profile. From the “User Details” page click the <Modify Users Details>    icon to
          modify the user’s information, including Password,name, measurement system preference and
          reporting unit preference.

          1.Measurement System/Report Unit Preference
          A Report Unit Preference can be either Resulting Unit or Recommended Unit.

          •.If a lab 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.
          You can change the Report Unit Preference on the Modify User Details page.




          2.From “Profile” click the <Subscription Assignment>           icon to modify a subscription contact.
          3. Click the <Modify Profile>            icon to change email, phone or fax number and address.


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




         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.


         LABORATORY PROFILE
          The Laboratory Profile indicates the DigitalPT 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 registration report sent upon enrollment and with every shipment notification (Advance
Shipment Notice) 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 the Internet or fax. If you have access to
the Internet and prefer to do the changes online, please refer to the instructions below. All changes to
instrument/reagent/analyte must be done before you are able to submit results via the web. If you do not
have access to the Internet, contact DigitalPT Support to update your instrument/reagent/analyte
information or write the changes on the Registration Notice or Advance Shipment Notice and fax it to your
PT provider. All changes to instrument/reagent/analyte registration must be received three days before
the shipment date of the samples.


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HOW DO I ADD, MODIFY OR REPLACE AN INSTRUMENT?
     1. Click “PROFILE” and then select “Instruments”. The DigitalPT system requires an instrument for
        most programs. If you are not using an instrument for your testing you must add a manual
        instrument, as it is a required field.
     2. To add a new instrument:
          a) Go to the bottom of the Registered Instrument page and click <Add> . The following screen
             will appear.




          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 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 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 to
                keep it under control.
     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 DigitalPT and the instrument will be added to the system. You may be
        contacted by DigitalPT Support to provide 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:
          In order to modify an instrument in the DigitalPT system, refer to the section “HOW DO I MODIFY
          INSTRUMENT | REAGENT OR KIT INFORMATION TO A SUBSCRIPTION?” If it is an
          instrument not present in the proposed list you must first add the new instrument to the system as
          indicated in point 1 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”.




         Test Events button       gives information about the status of each Test event for the program
          selected, More precisely it reports:




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          The number of test events, the shipment dates, the anticipated dates when the samples will be
          received (which coincide with the opening of the web pages), 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 PT provider before changing these settings.
         Maintain Subscription Contacts button There are several possible contact types available in
          DigitalPT 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 DigitalPT 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
          DigitalPT 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. Go to “PROFILE” and select “Subscription” then click <Registered analytes | procedures> for the
         interested program | subscription.The Registered Analytes / Procedures page with the list of analytes /
         procedure and units for Quantitative analytes will be shown on the screen.
     2. Locate the first analyte you want to add information to and click <Modify registered
         analytes/procedures> .




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   3. In 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.




     4. Click on the drop down menu beside “Registered Instrument”,then select and click the instrument
         from the drop down menu.
     5. For some of the PT 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.
     6. Click on the drop down menu beside “Reagent Manufacturer”,then select and click the
         manufacturer of your reagent from the drop down menu.
     7. Click on the drop down menu beside “Reagent Catalog #”,then select and click the corresponding
         catalog number from the drop down menu.
     8. 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.
     9. Click <Submit>         to save the information. Repeat the steps above for all the remaining
         analytes you are reporting.
     10. Fields marked with an asterisk (*) are mandatory and therefore must be filled before proceeding.
     11. 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 DigitalPT and the reagent will be added to the system. You may be contacted by
           DigitalPT 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. Go to “PROFILE” and select “Subscription” then click the <Registered analytes | procedures> for
        the program | subscription you want to modify.The Registered Analytes / Procedures page with the
        list of analytes / procedure will be shown on the screen.
     2. Locate the analyte you want to modify the instrument | reagent Information | reporting units for
        then click <Modify registered analytes/procedures> .




     3. Modify all the necessary information from the drop down menu in the Analyte / Procedure Details
        page.



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     4. 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.




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) Select the analyte and click <Add Analyte/Procedure>    .
          c) Enter the mandatory information (Instrument, Reagent) then Click <Submit>       .
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     2.    To delete an analyte:
          a) Click <Delete registered analyte/procedure> . Note: If there is only one analyte remaining
             for the subscription, the analyte cannot be removed. You must contact DigitalPT support to
             cancel the subscription.
          b) If the analyte you are deleting is designated for regulatory purposes, a message will appear
             on your screen notifying you of this. Click <Submit>          to delete the analyte. 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.




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HOW CAN I SUBMIT PT RESULTS?
         Online via www.digitalpt.com.

HOW DO I SUBMIT PT RESULTS USING THE INTERNET?
     1. Go to www.digitalpt.com and click “LOGIN”. Select “DigitalPT Account” and login to the system.
        A screen will appear containing the following information.




     2. Click “RESULTS” and select “Active Test Events”. This will display a list of all subscribed PT
        programs for which the pages for the result submission are available. Red sample icons indicate
        that PT results have not been submitted yet. Blue sample icons indicate that PT results have
        been submitted.




     3.    To submit PT results for the corresponding program click the red sample of the sample for which
          you want to submit the data. 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?
     4.    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


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          <Modify Registered Instrument>                   or <Modify registered Analyte | Procedure>   .   Make the
          modifications and then click <Submit>               for this page.
     5.    If you agree to the indicated modifications or if the presented information is accurate, click <Confirm>
          at the bottom of the Review Registration page.




     6.    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?>
     7.    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.




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     a) For quantitative results, make sure the reporting units are correct for your laboratory. If not, change the
         units prior to entering any results.




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




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




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     8.    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.




     9.    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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  10.     If you need to make changes to the results, you can do so by simply click on the box of the
            sample for which you need to change the results for and re-enter the results.
   11.     Once you have entered results for all the sample, you will find that all red results boxes have
           turned blue.
   12.     To view/print submitted PT 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 PT results you submitted for the
           subscription. You can print or save this PDF document.
   13.     To email submitted PT 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 DigitalPT.




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HOW DO I ACCESS REPORTS AND GRAPHS ONLINE?
You will need Adobe Acrobat Reader to view Reports.
     1. Go to www.digitalpt.com and click “LOGIN”. Select “DigitalPT Account” and login to the system.
     2. Click “REPORTS” and then select the report you want to generate from the list.




                                                           This report shows unsuccessful performance by
             “Current Failed Results”                      subscription for each sample for the most recent test
                                                           event using the applicable evaluation criteria.
                                                           This report shows performance by subscription for a selected
             “All Results”
                                                           test event.
                                                           This report shows instrument performance for a selected
                                                           test event (quantitative analytes only). Multiple
             “Results by Instrument”
                                                           subscriptions of the same program are shown in one
                                                           report.
                                                           This report shows performance by analyte/procedure for a
                                                           selected test event and the two prior test events
             “Historical Results”
                                                           (quantitative analytes only). Multiple subscriptions of the
                                                           same program are shown in one report.
                                                           This report shows the Centers for Medicare and Medicaid
             “CLIA Results” – ONLY AVAILABLE
                                                           Services (CMS) designated analyte scoring performance
             FOR US PARTICIPANTS
                                                           by analyte and cycle for the past 3 testing events.
                                                           This report shows performance by analyte/procedure for a
             “Results by Analyte/Procedure”                selected test event. Multiple subscriptions of the same
                                                           program are shown in one report.
                                                           This report shows the peer group statistics
             “Participation Statistics (Quant)”            (quantitative analytes only) by analyte| procedure for
                                                           a selected test event.
                                                           This report shows the peer group statistics
             “Participation Statistics (Qual)”             (qualitative analytes only) by analyte| procedure for
                                                           a selected test event.
                                                           This report graphically depicts performance by
             “Graphs”                                      analyte/procedure over multiple test events
                                                           (quantitative analytes only).




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     3. 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.




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




     5. Click <View/Print reports>             , to display the report in PDF that can be printed or saved.
     6. 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 the Digital PT system are stored in your Profile for one week.
     1. To access these reports, go to www.digitalpt.com and click “LOGIN”.
     2. Select “DigitalPT Account” and login 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.




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WHERE CAN I FIND THE REFERENCE METHODS AND EVALUATION CRITERIA FOR ANALYTES?
To view the Reference Methods
     1. Go to www.digitalpt.com and select your DigitalPT Worldwide location from the drop down menu.
     2. Click “PROGRAMS” and select “PT Programs”. Select the corresponding year and then click on
        the drop down menu.
     3. Scroll down the menu and click on “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 PT providers
     1. Go to www.digitalpt.com and select your DigitalPT Worldwide location from the drop down menu.
     2. Click “DOCUMENTS” and select “Evaluation Criteria”. A pdf file is generated which can be
        viewed, printed or saved.




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1. SHIPMENTS
      Three weeks prior to a PT 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 DigitalPT.
     It is the responsibility of the laboratory to ensure that this data is current and to notify DigitalPT
     Support 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 within
     3 days of shipping date, contact DigitalPT 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 DigitalPT Support for tracking.


2. ORDERS
     Changes to purchased programs should be directed to your PT provider via email, fax or telephone.
     Changes to programs are dependant on availability of product.
     All communication should include
         Your DigitalPT 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
     samples 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
         Incorrect samples
     For replacements, contact DigitalPT support.
     Store samples at the appropriate temperature and follow all sample handling protocols indicated in
     the “Handling & Reporting Instructions”.

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     All PT samples should be considered as potentially hazardous and laboratories should follow their
     protocols for handling biohazard materials when processing or discarding samples.
     PT samples should be analyzed as soon as possible and results submitted to DigitalPT.


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

     DO NOT MAIL RESULTS TO DIGITALPT
     Participants will receive a reminder 2 days prior to the Results Deadline that their results are due.
     Late results will not be evaluated.


6. PT PERFORMANCE
     Results evaluation is performed using criteria approved by the relevant regulatory agencies or
     oversight bodies.
     All results are emailed or faxed to participants within approximately 5 working 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 Appendixes.

7. CORRECTIONS
     PT 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 DigitalPT 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. PT FAILURES
     Before contacting DigitalPT Support, participants should follow their protocols for troubleshooting
     samples, instrument or reagent problems. DigitalPT Support can provide suggestions and other
     resources to assist participants. Samples for remedial PT 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.digitalpt.com. Refer to Appendixes for instructions
     on interpreting reports.




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10. ACCREDITATION AGENCIES AND REPORTS
     Participation in an approved PT program is part of your laboratory’s Quality Assurance requirements.
     Reports are sent to laboratory oversight bodies | regulatory agencies. As an approved PT provider we
     will report PT results in a manner that meets the laboratory oversight bodies | regulatory agencies
     requirements. It is the responsibility of the participating laboratory to notify the PT provider which
     agencies should receive PT performance reports. It is also the responsibility of the laboratory to notify
     the PT provider of their current status on an annual basis. (An authorization form is sent at the
     beginning of each year along with the registration package).




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                                                                                               Appendix 1A – not applicable to all participants


 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
                                                                                       Peer Group
                                    Actual Results Statistical             CV                                 Statistical
Subscription ID Result    AP Code                              Mean SD           SDI     Code:        Flag                   PI Targets   Range       Description
                                        Count       Count                  (%)                                  Count
                                                                                       Description




Cholesterol- Total
   mmol/L
                 A
                                          357        28       4.463 0.12   2.7   2.3
                                                                                       ID: Beckman
                                                                                                                 257         0.7   4.45
                                                                                                                                          4.04 –   Reference Value ±
                4.74                                                                       LX-20                                           4.86           9%
     2100
                 B
                                          357        27       5.002 0.085 1.7    4.6
                                                                                       ID: Beckman
                                                                                                                 257         0.7   5.07
                                                                                                                                          4.61 –   Reference Value ±
                5.39                                                                       LX-20                                           5.53           9%
                 C
                                          357        28       6.23 0.163 2.6     1.7
                                                                                       ID: Beckman
                                                                                                                 257         0.3   6.35
                                                                                                                                          5.77 –   Reference Value ±
                6.50                                                                       LX-20                                           6.93           9%
 *please note that there are SD, CV(%) and SDI also under Evaluation Criteria


 DEFINITIONS:
       Individual analyte and unit of measure.                                               Analyte peer group description.
    
    Identification code of each sample.                                                     The number of participating labs evaluated with this evaluation
                                                                                             criteria.
    The test result submitted by your laboratory.
                                                                                             Performance Index PI = (lab Result – Target Value)
    Total number of participants measuring that analyte.                                                                 Accreditation Limit

    Number of participants in peer group.                                                   A value of zero indicates the result exactly equals the evaluation
                                                                                             group mean or target value. A value between -1 and 1 indicates
    The mean of the peer group.                                                             the result is within the evaluation range.

    The standard deviation of the peer group.                                               Target against which lab results are evaluated and are
                                                                                             dependent on evaluation criteria used for that analyte.
       The coefficient of variation of the peer group data.
                                                                                             The range within which results must fall for acceptable
       Standard Deviation Index. The SDI is an expression of the distance                    performance. Criteria for acceptable performance are defined by
       your result is from the group mean. The value calculated is the                       your regulatory agency.
       number of SDs your result is from the group mean.
                                                                                             Description of the evaluation criteria used to evaluate analyte
                      SDI =      Your Result – Peer Group Mean                               performance.
                                     Peer Group SD
       Evaluation Flags                                                                      Peer Group (PG) Codes

        AP - This symbol indicates results submitted with an analytical                     AR (All Results group): Encompasses all results for a
       problem code.                                                                         particular analyte.

        NE - This symbol indicates results not evaluated.                                   ME (Method group): This group defines basic methodological
                                                                                             principles, for example immunoassay, kinetic/rate.
        This symbol indicates results that have exceeded evaluation
       criteria.                                                                             SM (Submethod group): This group further defines a particular
                                                                                             methodological principle, e.g. immunoassay – enzymatic,
        This symbol indicates results that are statistical outliers and have                immunoassay – chemiluminescent.
       been excluded from the peer group statistics (Tukey’s Outlier Test).
                                                                                             RM (Reagent Manufacturer group): Results for reagents using
       Analytical Problem (AP) Codes                                                         similar method/submethod from the same reagent manufacturer.

       11            This indicates that you have submitted a below linear                   RG (Reagent Group): Results for reagents using similar
                     /detection limit problem code instead of a result.                      method/submethod and reagent technology from the same
                                                                                             reagent manufacturer.
       22            This indicates that you have submitted an above linear
                     /detection limit problem code instead of a result.                      RE (Reagent): Results for reagents having the same catalog
                                                                                             number.
       33            This indicates that you have submitted an analyzer out
                     of service problem code instead of a result.                            IM (Instrument Manufacturer group): Results for a particular
                                                                                             instrument manufacturer.
       44            This indicates that you have submitted an insufficient
                     volume problem code instead of a result.                                IG (Instrument group): Results for a particular instrument
                                                                                             series.
       66            This indicates that you have submitted an specimen
                     not appropriate problem code instead of a result.                       ID (Instrument Model group): Results for a particular
                                                                                             instrument model.
       77            This indicates no result has been submitted.
                                                                                                           Appendix 1B – 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
                                            Reason                               Statistical                                             Peer Group Code:            Acceptable
Analyte             Sample       Result                  SDI        Grade                        Mean           SD         CV(%)
                                             Code                                  count                                                    Description               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                                                                                   Analyte Score (see note below).
    Individual analyte and unit of measure.                                                             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                                                                                         Statistical count
          The test result submitted by your laboratory.                                                  The number of participants in the peer group.

          Reason Codes                                                                                   Mean
          1       failure to participate (0% score)                                                      The mean of the Comparative Group Data, used to determine
          8       Excused participation – natural disaster                                               the Acceptable Range and SDI.
          11      Below linear/detection limit
                                                                                                         SD
          22      Above linear/detection limit                                                           The standard deviation of the Comparative Group Data.
          88      testing suspended during test event

          SDI                                                                                            CV%
                     SDI =        Your Result – Peer Group Mean                                          The coefficient of variation of the Comparative Group Data.
                                        Peer Group SD
                                                                                                                                CV% =         SD       x 100
          Standard Deviation Index. The SDI is an expression of the distance                                                                 Mean
          your result is from the group mean. The value calculated is the
          number of SDs your results is from the group mean.                                             Peer Group Code: Description
                                                                                                         The peer group at which the analyte was evaluated.

          Grade                                                                                          Acceptable Range
                                                                                                         The range within which test results must fall for acceptable
          ACC                     Acceptable Actual result submitted falls within                        performance.
                                  the Acceptable Range.
                                                                                                         Criteria for acceptable performance are defined CMS, and are
          UNACC                   Unacceptable Actual result submitted falls                             published in the Federal Register, February 28, 1992, 42 CFR
                                  outside the Acceptable Range.                                          Part 405, CLIA '88.

          *ACC/*UNACC             Not applicable to all laboratories.                                    Percentile
                                  Upgradeable Group results were not gradable                            Percentile rankings are based on your overall SDI for the
                                  due to lack of consensus (less than 80%).                              analyte, as compared to your peer group.
                                  See NOTE below.                                                        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 2
                                                                          Interpreting Your Graph

                                                                     Cholesterol - Total
    Method and instrument registration
                                            Performance Evaluation Criteria : Peer Group Mean ± 10.0%
                                               Desirable Performance Goal : All Results Mean ± 9.0%                                          Analyte desirable performance goal

                                            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              Siemens (Dade Behring                    Siemens (Dade Behring               Dade Behring Dimension          Dade Dimension RxL
                      Oxidase/Peroxidase                  Products)                                Products)                            Series

      Vials ordered alphabetically


      Data expressed relative to
                                                                         Your results
     all result mean or reference
                 value                                                                                                                                           Performance evaluation
                                                                                                                                                                       upper limit


                                                                                                                                                                 Desirable performance goal



                                                                                                                                                                  Performance evaluation
                                                                                                                                                                          target
 1st box represents the all result
group, the ends of the box equals                                                                                                                                 Performance evaluation
2SD, and the n value in brackets                                                                                                                                        lower limit


                       Bias % =                                                                              2nd box represents peer group category                    SDI =
(Your Result – Reference Value or All Result Mean) x 100          Symbols represent your results             at which peer group “stopped” and the        Your Result – Peer Group Mean
          Reference Value or All Result Mean                                                                           n value in brackets                       Peer Group SD



                                                                                   Cumulative summary of your results




                                                                                                                                                                   Desirable performance goal




          Results Deadline date

                                                                                   Analyte reference range                                                   • - Previous test event result


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




                                                                                    The dashed line indicates your bias


                               The shape of the symbol denotes concentration according to your laboratory’s reference range
                               Current test event results:
                                        ◊ - results within reference range  – 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 3 – not applicable to all participants


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                                                   Cycle 03 – 2006          Cycle 01 – 2007          Cycle 02 – 2007                   CLIA
                                           Analyte
           Number                                                      Score                    Score                    Score                       Status
              315                            Ph                        U(40%)                   S(100%)                  S(100%)                  Successful
              325                            pO 2                      S(80%)                   S(100%)                  S(100%)                  Successful
              335                           pCO 2                      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

    Status
     CLIA
         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.



                    DigitalPT Support: support@digitalpt.com                         fax: 800-665-5949                             phone: 800-665-2575

				
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