Celltrion

Logging into TaskSuite

⦁ Navigate to https://celltrion.tasksuite.com/
⦁ Click “Sign in” on the upper right hand corner
⦁ Enter your Username & Password
⦁ Click “Sign In”
⦁ Verify that you are in the “available” status for inbound phone calls by making sure the phone icon in the upper left corner is green. If it is anything other than green, click it and select “online”.

Check for emails/VMs

⦁ Log into Tasksuite (see the login process).
⦁ Select the tile menu in the upper left hand corner of the page
⦁ Select/click on the “Helpdesk” icon.
⦁ Adjust the filters by clicking the “x” so you are looking for any “open” tickets.
⦁ Click on the ticket to view notes and take action.

Handling inbound calls.

⦁ Accept the call by clicking on the green answer button on the left hand side of Tasksuite.
⦁ Greet the caller
⦁ “Thank you for contacting the Celltrion Diatrust Covid-19 Test kit Support team, my name is <your name>. How may I be of assistance?”
⦁ Listen to the caller’s complaint/question/comment.
⦁ You do not need to ask for a name unless the caller is reporting an issue. See the appropriate escalation process for each issue type.
⦁ Respond to the caller appropriately by utilizing the Question and Answer guide (Q&A Guide).
⦁ In the event the inquiry/comment/question is not covered by any existing responses in the Q&A guide DO NOT provide an off the cuff (winged) response.
⦁ Respond to the individual letting them know we do not have an answer for that inquiry currently but we will bring it to the escalation team’s attention and follow up with an answer. Do not make promises we cannot keep. Timelines for follow up should be 48-72 business hours.
⦁ Urgent escalations need to be brought to George Barbour’s attention so additional guidance or assistance can be rendered as necessary.
⦁ Disposition the call in TaskSuite by selecting the appropriate call disposition and add notes regarding the call.
⦁ Escalations will require additional information to be gathered. You should have a template pop-up once the appropriate escalation type has been selected from the call disposition list.
⦁ In the event you are filing out an escalation, follow the escalation process specific to the type of escalation you are filing.
⦁ Ask if the caller has any other inquiries that we can assist with.
⦁ Thank the customer for calling.
⦁ If the caller does not disconnect the call click the end call button on Tasksuite.
⦁ You’re ready for the next call!

Outbound Calls

Currently support requests will be generated by inbound contacts though at time we might need to place an outbound call to respond to an inbound request. Outbound calls should be handled essentially the same as an inbound call, except you are initiating it instead of the customer calling in to initiate it.

⦁ Review the Helpdesk request in its entirety.
⦁ Compose your answer prior to reaching out to the customer.
⦁ Place the outbound call.
⦁ Introduce yourself once you reach the customer or their VM.
⦁ In the event you reach the individual’s VM leave a short simple message as appropriate. Use best judgement to decide if you should leave the full answer or a brief response & encourage to contact us back. The majority of responses can be left in the VM. Inquiries that will lead to an escalation should be encouraged to respond/call us back.
⦁ Respond to the individuals request appropriately utilizing the Q&A guide.
⦁ Confirm resolution and no further inquiries.

Handling Email & Fax Requests

Email, Fax, and Voicemail requests will all be handled under the “Helpdesk” module in Tasksuite. Most of the time you will want to just stay on the Helpdesk module as calls can be answered from any module.
⦁ Navigate to the Helpdesk section of Tasksuite. (See the Check for Emails/Fax/VM process)
⦁ Verify your filters are correctly looking for any open issue (remove the “mine” default filter by clicking the “x” next to it).
⦁ Click on an open email request.
⦁ (image pending)
⦁ Scroll down and read through the request.
⦁ To respond click “Send message”, compose your response using the Q&A guide, then click “send”.
⦁ If the question/inquiry has been answered in its entirety mark the ticket as complete/closed.
Fax
If a fax needs to have a fax based response you will need to log into the Efax system and process.
For now, if one is required please see George. Fax’s will be visible in the Helpdesk module. They are sent into the system as email’s. Fax responses must be sent via the Efax system.

No answer available for customer question

In rare cases we might receive a question that we do not have a defined response to in the Q&A list. In the event this occurs take the following steps to reach a resolution.
⦁ Double check the Q&A list to verify no existing response fits the inquiry.
⦁ Fully document the inquiry.
⦁ Verify the inquiry with the customer.
⦁ Verify contact information for follow up once an answer is identified.
⦁ Make a note of the preferred contact method and any time constraints if applicable.
⦁ Set proper expectations with the customer.
⦁ Customers should expect follow up after 48 business hours.
⦁ TEMPORARY STEP: Email George Barbour with the escalation.
⦁ Assign the system generated ticket (Helpdesk module) to George Barbour.
⦁ George will be a second validation point prior to escalation of questions/complaints that do not fit the pre-defined “expected” escalations. (Adverse report/Device report escalations).
⦁ George will forward the inquiry to the product team after verifying no existing answer is available for the request.
⦁ After a response is received from the escalation team, or after the timeframe for follow up has elapsed, follow up with the original requestor to provide the answer or update expectations as to when an answer will be provided.
⦁ Update the ticket with any appropriate notes.
⦁ If no further contact is required to answer the inquiry close out the ticket via the helpdesk Module.

Escalation – Device Problem/Defective Device – Manufacturer at Fault

If a customer contacts support to report an issue with the device that is related to manufacturing follow this process. This type of escalation would be used in the event that a customer reports any of the following: Missing testing components (no swab, no buffer solution, no IFU, etc.), aluminum test pouches were not sealed, test pouches do not contain all expected components, test kits are missing from the package, incorrect number of test kits were in the package, wrong components, etc.
⦁ Apologize to the customer for the issue they’ve experienced and for any inconvenience it has caused them.
⦁ Ask probing questions to verify this is a manufacturer’s issue.
⦁ Select the correct disposition on tasksuite.
⦁ Work In Progress
⦁ Currently we will need to fill out the adverse event report form manually. Once it has been filled out get a copy to George to escalate to the appropriate team(s).
⦁ In the next iteration of Tasksuite the system will screen pop an email template with the form for us to fill out. Once complete it will auto send to the appropriate individuals. Until then this needs to be done manually.
⦁ Fill out the Device Problem Form (example form is available on the Q&A guide)
⦁ Capture information for all requested fields.
⦁ Apologize again for the issue that had been experienced.
⦁ Inform the caller we’ll work to get an exchange to replace the defective product.
⦁ Capture shipping information and note this in Tasksuite in the call notes section.
⦁ Set expectation for follow up of 48-72 hours with an update with next steps.
⦁ Notify George Barbour of the incident.
⦁ Thank the caller for their report and ask if we can assist with anything else at this time.
⦁ Close out the call.

Escalation – Device Problem/Defective Device – Distributor/Customer at fault.

This type of escalation will occur in the event we receive a report/complaint about a defective device and we’ve determined while probing that the issue occurred due to the Distributor or Customer. Some examples include, but are not limited to: Wrong product was delivered, Wrong Test Count was delivered (ordered a 2 test kit box but received a 5 count), damage to the packaging, over filled the sample well, spilled the buffer solution, broke the swab, etc.

⦁ Apologize to the customer for the issue they’ve experienced and for any inconvenience it has caused them.
⦁ Ask probing questions to verify this is not a manufacturer issue.
⦁ Select the correct disposition on tasksuite.
⦁ Work In Progress
⦁ Currently we will need to fill out the adverse event report form manually. Once it has been filled out get a copy to George to escalate to the appropriate team(s).
⦁ In the next iteration of Tasksuite the system will screen pop an email template with the form for us to fill out. Once complete it will auto send to the appropriate individuals. Until then this needs to be done manually.
⦁ Fill out the Device Problem Form (example form is available on the Q&A guide)
⦁ Capture information for all requested fields.
⦁ Determine next steps.
⦁ If this was a distributor issue refer the customer back to the distributor to discuss a potential replacement.
⦁ If the issue was customer caused (Over filled sample well, spilled the buffer solution, etc.) politely inform the customer they’ll need to re-test to get a valid result. If asked to provide a replacement kit politely inform the customer that we’re unable to facilitate a replacement for improperly performed tests.
⦁ Offer to assist with any other questions or concerns.
⦁ Close out the interaction.

Escalation – Device Problem/Defective Device – Unknown cause.

In the event we cannot identify the cause for the device issue. Its unclear who would be at fault we’ll want to escalate for additional investigation. Real world examples TBD.
⦁ Apologize to the customer for the issue they’ve experienced and for any inconvenience it has caused them.
⦁ Ask probing questions to verify this is was not manufacturer, distributor, or customer caused.
⦁ Select the correct disposition on tasksuite.
⦁ Work In Progress
⦁ Currently we will need to fill out the adverse event report form manually. Once it has been filled out get a copy to George to escalate to the appropriate team(s).
⦁ In the next iteration of Tasksuite the system will screen pop an email template with the form for us to fill out. Once complete it will auto send to the appropriate individuals. Until then this needs to be done manually.
⦁ Fill out the Device Problem Form (example form is available on the Q&A guide)
⦁ Capture information for all requested fields.
⦁ Apologize again for the issue that had been experienced.
⦁ Set expectation for follow up of 48-72 hours with an update with next steps (If applicable)
⦁ Customers may not always want a follow up in these cases. They might just be reporting an issue that occurred. Use best judgement and clearly document if a follow up is required.
⦁ Notify George Barbour of the incident if a follow up is necessary.
⦁ Thank the caller for their report and ask if we can assist with anything else at this time.
⦁ Close out the call.

Escalation – Adverse Event Report

While unlikely it is possible we’ll receive a report from a consumer or healthcare practitioner that an adverse event has occurred. These events include, but are not limited to: Injuries caused by the device(s), adverse effects caused by the test, events impacting others in the household (E.g., Child drank buffer solution), etc.
⦁ Use an empathy statement relevant to the situation.
⦁ Apologize to the customer for the issue that has occurred.
⦁ Ask probing questions to understand the event.
⦁ Select the correct disposition on tasksuite.
⦁ Work In Progress
⦁ Currently we will need to fill out the adverse event report form manually. Once it has been filled out get a copy to George to escalate to the appropriate team(s).
⦁ In the next iteration of Tasksuite the system will screen pop an email template with the form for us to fill out. Once complete it will auto send to the appropriate individuals. Until then this needs to be done manually.
⦁ Fill out the Adverse Event Report Form (example form is available on the Q&A guide)
⦁ Capture information for all requested fields.
⦁ Apologize again for the issue that had been experienced.
⦁ Let the customer know we’ll be escalating the report internally and also submitting a report to the FDA of the event.
⦁ Thank the caller for their report and ask if we can assist with anything else at this time.
⦁ Close out the call.
⦁ Notify George Barbour of the incident.

Escalation – False Result (False Positive/Negative)

If contacted about incorrect results we’ll need to escalate a report. False Positives/Negatives should be verified with a lab based report. If a customer has reason to believe they are receiving a false result but has not verified it they should re-test.
⦁ Apologize to the customer for the issue they’ve experienced and for any inconvenience it has caused them.
⦁ Ask probing questions to identify if the customer is reporting a verified false result or if they are reporting a potential false result.
⦁ In the event it is not a confirmed false result ask the customer to re-test. If they are non-symptomatic and believe they are incorrectly receiving a negative result verify that the caller has properly serial tested.
⦁ If the customer has not taken any steps to validate their suspicions do not submit a false result report until the customer has taken validation steps.
⦁ Serial testing, re-testing, lab verified.
⦁ Select the correct disposition on tasksuite.
⦁ Work In Progress
⦁ Currently we will need to fill out the adverse event report form manually. Once it has been filled out get a copy to George to escalate to the appropriate team(s).
⦁ In the next iteration of Tasksuite the system will screen pop an email template with the form for us to fill out. Once complete it will auto send to the appropriate individuals. Until then this needs to be done manually.
⦁ Fill out the Adverse Event Report (example form is available on the Q&A guide)
⦁ Capture information for all requested fields.
⦁ Apologize again for the issue that had been experienced.
⦁ Thank the caller for their report and ask if we can assist with anything else at this time.
⦁ Close out the call.
⦁ Notify George Barbour of the incident.

Escalation – Invalid Result

Invalid results are tests that do not have a visible control line and all proper testing steps have been verified. If a customer did not take proper testing steps they need to re-test. Only submit an escalation if the customer verifies (via check list) that they did take all necessary steps.

⦁ Apologize to the customer for the issue they’ve experienced and for any inconvenience it has caused them.
⦁ Utilize the Invalid Result Checklist to verify that the caller did take all appropriate testing steps to receive a valid result.
⦁ In the event testing instructions were not properly followed inform the customer they will need to re-test following the IFU instructions fully.
⦁ No escalation required if the customer did not properly test.
⦁ Select the correct disposition on tasksuite.
⦁ Work In Progress
⦁ Currently we will need to fill out the adverse event report form manually. Once it has been filled out get a copy to George to escalate to the appropriate team(s).
⦁ In the next iteration of Tasksuite the system will screen pop an email template with the form for us to fill out. Once complete it will auto send to the appropriate individuals. Until then this needs to be done manually.
⦁ Fill out the Adverse Event Report (example form is available on the Q&A guide)
⦁ Capture information for all requested fields.
⦁ Apologize again for the issue that had been experienced.
⦁ Thank the caller for their report and ask if we can assist with anything else at this time.
⦁ Close out the call.
⦁ Notify George Barbour of the incident.

Purchasing bulk lab kit orders

If contacted about bulk ordering for lab test kits or arranging periodic shipments, please direct the caller to email Celltrion directly at diatrust@celltrion.com