Non-Technical SOP

Non-Technical SOP

TABLE OF CONTENTS

1.PURPOSE......

2.SCOPE......

3.RESPONSIBILITY......

4.DEFINITIONS......

5.PROCEDURE......

6.RECORDS MAINTENANCE......

7.RELATED DOCUMENTS......

8.REFERENCES......

9.REVISION HISTORY......

10.PROCEDURE RETIREMENT......

11.ADDENDA AND APPENDICES......

1.PURPOSE

To outline the standard procedure for data entry on client communications for IntelliTest Manager™.

2.SCOPE

This SOP is intended for use by those Database Management personnel with authorized access to the Administration Main Menu of IntelliTest Manager™ and who are responsible for the maintenance of this SOP.

3.RESPONSIBILITY

• The Department Supervisor is responsible for:
• Ensuring compliance with this policy or process or procedure in his/her department.
• Periodic review of records as specified.

• The Technical Supervisor is responsible for implementing this policy or process or procedure in the department for which he/she is responsible.

• The Laboratory Director is responsible for the approval of the initial document and any subsequent revisions.

• The Laboratory Director or Designee is responsible for the annual review of this document.

4.DEFINITIONS

• Bolding= a test change or new test information
• Blue entries = information in Master Communications for Business Unit (BU) use only
• Ctrl C = Copy
• Ctrl X = Cut
• Ctrl V = Paste
• Ctrl Z = Undo last entry
• Italic = Former test code, Former test name, Genus and Species name
• ITM = IntelliTest Manager™
• Section Tag = a place holder to format the order of data
• Message Tag = manually created verbiage to attach with header
• Test Name Sort = html stripped data to allow for alphabetizing of test names
• Utilization code= local code tied to billing and usage
• Master Tab= Approved and public communications
• Published Tab= Communications to be copied from and if you have rights you can unpublish to edit
• Pending Tab= Work in process communications that you have rights to edit

5.PROCEDURE

5.1 LOG ON GUIDELINES

5.1.1Log on to

5.1.2 Username is your Quest Diagnostics log-in user name (xxxx.x.xxxxx)

5.1.3Enter your password is

5.2.4Click on Log-In button

CREATE A MASTER COMMUNICATION

5.2.1 Select the Pending tab

5.2.2Select Add New +

5.2.3 Choose Master from the Business Unit drop down box

5.2.4 Choose the type of Communication (refer to Communication Guidelines for additional details on communication types)

5.2.5Choose a Publication Date:

5.2.6 Make sure all 3 fields are correctly entered and select Save

5.2.7 Description Template Formatting

5.2.7.1 Communications will auto populate with description template formatting..

5.2.8 Once all applicable edits have been added to the Description Template select Save to save your edits.

5.2.9 Add Items to Communication

5.2.10Select Add+

5.2.11Choose the Type from drop down box

5.2.12 Choose the Clinical Franchise from drop down box

5.2.13 Choose the Article Owner from drop down box

5.2.14 Enter eDBR case number

5.2.14Save

5.2.15 Perform data entry on applicable side. EBUs enter data on Non-QLS (left) side. NSDB enters data on QLS (right) side

5.2.16The “Copy all” option at the top will copy all data between sides, with the exception of Specimen Stability, Reference Range, Interface Maping and Tests Affected sections

5.2.17The single Copy buttons in the middle will copy only the selected section

5.2.18Alert Message- refer to section 5.8

5.2.19 If Immediate Action select reason from drop down box

• Test Name – select copy for Test Name Sort
• Message (ex: New York message, Tests included in group code)
• Clinical Significance
• Effective Date

• Former Test Name –automatically formats to italics in previews & exports Former Test Code –automatically formats to italics in preview & exports Test Code
• Utilization Code- local code populated for Master QLS side only

• CPT Code(s)

• Specimen Requirements
• Reject Criteria
• Instructions (Collection Instructions)
• Transport Temperature
• Specimen Stability-
• Add New button opens a dialog box to enter stability
• If only 1 sample type, ok to leave blank . Fill out the temperature and stability sections as appropriate
• The temperature has a drop down box that allows you to select a temperature instead of manually entering it
• Selecting ADD will wipe out previously entered data so all fields are clear to enter the next temperature.
• SAVE AND CLOSE add the last data and close out of editor
• CLOSE applies/saves no changes, and closes out of editor
• As stability is added the rows will appear in test update.
• Edit any row by clicking Edit or specific Sample Type
• Copy any row between QLS and Non-QLS sides by selecting the copy icon to the right of the row
• Remove any row on one side be selecting the trash can icon
• Set-up/Analytic Time
• Reference Range
• Add New button opens a dialog box to enter Reference Ranges
• The expanded dialog box contains areas to enter; result code, result name, age, gender, reference range, unit of measure, LOINC Code, and Component Name
• Enter the result code from the analtye that has a reference range
• Enter the result name from the analyte that has a reference range
• Enter Age or age range if applicable. Leave blank if not needed.
• Enter Gender if applicable. Leave blank if not needed.
• Enter Reference Range
• Enter Unit of Measure if applicable. Leave blank if not needed.
• Enter LOINC code. Add “Pending assignment” if unavailable * if TSO to outside vendor, leave blank*
• Enter Component name. Leave blank if unavailable or is TSO to outside vendor
• Selecting ADD keeps all data previously added to minimize rework for mulitple ages, or gender.
• If you need to enter new information simply highlight existing data in editor and delete. All your newly entered data is ready to ADD.
• SAVE AND CLOSE adds the last data and close out of editor
• CLOSE applies/saves no changes, and closes out of editor
• As reference ranges are added the rows will appear in test update.
• Edit any row by clicking result code
• Copy any row between QLS and Non-QLS sides by selecting the copy icon to the right of the row
• Remove any row on one side be selecting the trash can icon
• Units of Measure
• Always Message
• Methodology
• Assay Category - The Type is a drop down box for choosing the assay category, you may also manually enter data

• Performing Site- The Type is a drop down box for choosing the performing site, you may also manually enter data

• Interface Mapping
• Manage button opens a dialog box to enter Interface Mapping
• The dialog box opens and presents the ability to check which sites the mapping is going to be created for. If mapping is standard for all sites, check Standard box.
• When Chantilly is checked a new box displays (Show Table Message) that will auto add a message specifically to CHY mapping when checked.
• Once appropriate sites are selected, choose ADD NEW MAPPING button
• A green header displays the site(s) and gives the ability to add mapping
• If the mapping is for a panel, profile or reflexfill in test code information for the first componet, otherwise select SAVE
• Once the save is selcted a preview on the right side autopopulates with data being entered on left.
• You now have the ability to add mapping or copy from reference range table. Choose ADD RC (result code) button after each data entry. The binocular icon will allow you to copy one row at a time from the reference range table.
• The right side will continously autoppoulate with your data entries from the left.
• You can bold any section in this row by highlighting the entry and a small B box will appear. Select it and after you move to another section the right side will automatically update your bolded/edited information.
• If mapping is for panel, profile or reflex, select the next component by clicking ADD NEXT TC (test code) button
• Format the data as needed and when ready to add, click SAVE
• Follow the same process to enter the result code rows as needed.
• You can copy the created mapping to another non-used site. There is a “Copy To” with a drop down box. Please note only one site can be copied to at a time.
• A confirm copy pop-up box will appear. Choose either COPY or CANCEL to proceed.
• Scroll down on the left to reach the site you just coped and apply any necessary edits.
• There is also a section to add any free text message to the mapping on the bottom left.
• Once all mapping is entered and confirmed the CLOSE button will take you back to the edit test update page.
• BU Update Items- a field in Master communications to announce BU only changes in a Lab Update for business units. Does not show to clients.

• Additional Information

5.2.20Add tests or panels affected by test change by clicking on Add New

5.2.20.1A pop-up box appears

5.2.20.2Enter the test code(s), test name.

5.2.20.3 Add- enables you to add multiple entries, one at a time.

5.2.20.4 Save and Close- enables you to add/modify one entry and will return you to test update edit.

5.2.20.5Edits can be made by selecting the underlined test code

5.2.20.5.1Delete an entry by selecting the trash can icon on far right

5.2.20.5.2 Copy individual Test or Panels Affected between Non-QLS & QLS sides by using the Copy Icon on each row

5.2.21Click on SAVE to preview data entry. Non-QLS preview displays first, scroll down to view the QLS article

5.2.22Once previewed table is acceptable with no new edits, select CLOSE

5.2.23When all items have been added to communication select SAVE under Description Template. (Recommendation: saving update multiple times throughout will ensure no lost data)

5.2.23.1.1Any changes to communication require SAVE for the changes to be implemented.

5.2.24Two preview windows; one for non-QLS and another for QLS populates with the communication in its entirety. You may export the communication in WORD, PDF or EXCEL. IM check box applies to both preview windows

6From Pending tab check the Approved and Public boxes to publish a communication.

6.2CREATE COPY OF A TABLE

5.3.1Select communication where test update is tied

5.3.2Locate test in the Items in Update section

5.3.3Select Copy to right of selected test code

5.3.4Confirm Copy pop-up box will display, choose the BU/Version of the communication you wish to copy into. Select “Copy”

5.3.5Choose the Communication. You may also make any edits to the fields at this time. Select SAVE for preview. CLOSE for item to be added to communication. Note: You will remain in the communication you copied from.

5.4CREATE A LOCAL COMMUNICATION

5.4.1There are two scenarios for localized communications:

5.4.1.1Creating a copy from a Master Communication for your local site

5.4.1.1.1Go to Published Tab

5.4.1.1.2Select Copyof existing communication

5.4.1.1.3Confirm Copy pop-up will appear, choose Business Unit from drop down box and Copy

5.4.1.1.4Edit Items in Communication by removing blue items, also remove any changes that are not applicable.

5.4.1.1.5Add Utilization Code under Test Code and in the Tests Affected area

5.4.1.1.6Remove an entire article from the communication by selecting Remove this test update? after the Save buttons

5.4.1.1.7If entire section is removed from communication you must also remove the section header and tag from the Description Template

5.4.1.1.8Once all changes have been made to communication select SAVE under Description Template

5.4.1.1.9Obtain local approvals, then select Approved and Public boxes to make the communication available for clients to view

5.4.1.1.10See section 5.9 for instructions on how to distribute to clients via IntelliTest Manager

5.4.1.2 Creating a new communication for your local site

5.4.1.2.1 Select the Pending Tab

5.7.1.2.2 Select Add New+

5.7.1.2.3 Choose your Business Unit, Communication Type and Publication Date.

5.7.1.2.4To add Items in Update select Add+

5.7.1.2.5Alert Message- refer to section 5.8

5.7.1.2.6Follow steps outlined in 5.2.15 for entering data in this test update

5.7.1.2.7For new interface mapping, select the MANAGE button

5.7.1.2.8Check “Standard” and select ADD NEW MAPPING

5.7.1.2.9If panel, profile or reflex fill in test code information, otherwise select SAVE

5.8Enter result code and all other applicable information, or copy from reference range table using the binocular icon one row at a time and then select ADD RC (result code)

5.8.1.2.4Once all appliable mapping is entered select SAVE AND CLOSE

5.8.1.2.5Tests or Panels Affected

5.8.1.2.6Select Add New

5.7.1.2.9 Enter information in boxes that appear (Test Codes, Utilization Code, Test Name, Client/Account number(s) if applicable) and select ADD to add more or SAVE AND CLOSE to go back to test update editor

5.7.1.1.10Select SAVE to preview data entry.

5.7.1.1.10.1Once previewed table is acceptable, select SAVE & CLOSE

5.7.1.1.10.2When all items have been added to communication select SAVE under Description Template.

5.8REVISION OR IMPORTANT MESSAGE

5.8.1To apply a correction to a published communication, unpublish the update by removing check in Approved and Public box

5.8.2Select the unpublished communication in the pending tab

5.8.3Edit Communication box has a “Choose” drop down

5.8.3.1Choose Revision Message!

5.8.3.2In HTML editor directly below, enter message in following format: “Please note: (enter date change will be made) communication revision for test code (enter test code) – (enter test name), list section that is changing. Example: Please note: 9/2/11 communication revision for test code 123- Peppermint Bark, specimen stability.

5.8.3.3Start a new line in HTML editor box for each table revised.

5.8.4Important Message! is to be used when emphasis is needed to the communication

5.8.5Select Save at the communication level and under Description Template before editing test update

5.8.6Select the Test Table for revision. A similar “Choose” drop down exists

5.8.6.1Choose Revision Message!

5.8.6.2In HTML editor directly below, enter message in the following format: “Please note: (List section that is changing) was updated to (new information) effective (date when change will be made). Example: Please note: Specimen stability was updated to Room temperature: 7 days Refrigerated: 7 days Frozen: 7 days effective 9/2/11.

5.8.7Obtain local approvals, then select Approved and Public boxes to make the communication available for clients to view

5.8.8Email clients to inform them that a revision has been made to a published communication. Refer to section 5.9 for client distribution via IntelliTest Manager™ .

5.9Distributing Communications to Clients via IntelliTest Manager

5.9.1Select Published tab

5.9.2Select the Send Email button

5.9.3Select Business Unit from drop down

5.9.4Select Template type from drop down menu

5.9.4.1Lab Update- for every distribution unless a revision is involved

5.9.4.2Lab Revision- use for communciations previously sent and now require a reissue

5.9.4.2.10Can combine more than one communication when sending a revision. Example: The Immediate Action is being revised and the monthly update needs to go for the first time. Send both communciations together and add custom text.

5.9.5Subject line autopopulates once template selected. Text may be modified if required

5.9.6Select the corresponding communication checkbox(es). Your selection will be reflected on the right.

5.9.7Choose Email List drop down to select recipients for email

5.9.7.1Business Unit List- email all clients which are associated with your business unit

5.9.7.1.10View or download BU email lists by going into Admin tab Email Lists and choosing a BU from drop down list & submitting

5.9.7.2Specific Client Numbers- email only the clients that you have chosen. Please note client numbers must already exist in ITM and are within your primary business unit.