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LESSON 1 Types of Services offers in different Regions

2006 Version 1 2015 discontinuance 2017 Version 2 2019 Version 5

United States of America (USA) dollars ancestry 119 ancestry + health service 229 23andme + Premium 229 23andme Total Health 99/month 5 US Territories included (Puerto Rico, Guam, Northern Mariana Islands American Samoa, US Virgin Islands)

Canada (CA) dollars ancestry 149 ancestry + health service 299 23andme + Premium 299

United Kingdom (UK) Pound ancestry 99 ancestry + health service 179 23andme + Premium 179

Europe (EU) Euro only FINDS (Finland, Ireland, Netherlands, Denmark and Sweden) ancestry 109 ancestry + health service 219

International (ROW/ Rest of the World) Ancestry 129+

LESSON 2 ZENDESK - tools to receive and reply cx concerns

4 boxes > Guide > IHC (Zendesk Navigation Overview) Home or Views OPEN - you have to reply or to take action PENDING - waiting for reply or customers response (Tier 1 Concerns) ON HOLD - waiting for 3rd party before we reply

TICKET - All customers email QUEUE - For tier 2 agent CATEGORY - fall in certain category (buying or shipping) SOLVED - Accomplish cx concerns

WORKFLOW FOR SENDING A TICKET *Step 1 - Check Previous Correspondence *Step 2 - Use admin to investigate inquiry *Step 3 - Draft a ticket response *Step 4 - Select appropriate Zendesk ticket fields

(if having a 2 ticket with different concern that's the time to merge the ticket)

MESSAGING

INTERNAL NOTE - for documentation (cx can't see this note) Yellow PUBLIC REPLY - for cx reply (White)

MERGING - merging 2 tickets with same concern and email (uncheck the requesters eme) LINKING - connecting to another ticket or another email

LOCALE - Country Existing Account - must be "Loaded"

Reason of Escalation Macro : Title of Macro

Internal notes>check correction>public reply

IHC > Style Guide Customer Care Drafting a Response *Step 1 - Greetings (Hi, Hello) *Step 2 - Opening Statement (thank you for contacting/ interest) *Step 3 - address all questions, most important question first (thank you for doing that...) acknowledging the concern first *Step 4 - Remove unnecessary information *Step 5 - Closing Statement ( Is there anything that I can help you? ) *Step 6 - Best Regards/Bye for now

REMEMBER!! sympathy - sorry for your loss empathetic - ex: I do really understand, I'm sorry for what happened I also lost my grandmother ex; I can only imagine how you're going through

HOW TO EDIT YOUR NICKNAME Picture> View Profile> Alias

IHC > Macros

REMEMBER!! *Never Include brackets, curly bracket and capitalized text in your response *If ticket requires additional information escalate to the team

Macros Cont'd

TONE Professional - No typos, emoticons or colloquial language Helpful - Do not discourage further questions or make the customer feel stupid Empathetic - Be sensitive to customer disappointment and life circumstances, and respond appropriately Match Tone - Avoid riling customer up - never be rude

Just to highlight regarding your concern.../ Upon checking here...

*Non-Customer Facing Terminologies Sample Swap Unclaimed User- initiated widget erroneously, mistakenly

NOTE: always select the appropriate queue and category (very important especially when or before escalating the ticket)

Select Appropriate Ticket Fields Locale - Country Existing Customer - Loaded / Processing etc. Product Are

NOTE: You will not be able to submit a ticket until all * ticket fields are selected.

Macros will autofill ticket fields but always double check Merging Oldest ticket to Newest Ticket Request approval for your team manager before merging

IHC > Zendesk Workflow Ticket

Copy Ticket of Older Tix and click the Newer Tix click the 3 dots> Merging - paste - Older Ticket Don't Merge Ticket to New Ticket

Linking Ticket

Check out the linking to a problem ticket in Zendesk article

Problem ticket TYPE: used if there is incident/problem Linked Locked accounts following CIRT Setting a task:::::: Type> Task

Zendesk Compromised

ESCALATIONS Step 1 - Select the queue the ticket fits into before escalating Step 2 - Put internal note why escalation is necessary Step 3 - Press Submit

categories buy ship sample

9 boxes>5 most recent> existing account read concerns admin tool macro edit proofread select appropriate queue and category and existing account

Ticket Fields Queues locale category existing (right side to the left side) assignee

REMINDERS!!

  1. check 5 most recent
  2. remove brackets
  3. apply proper spacing and indentation
  4. remove unnecessary text and hyperlinks to admin 2
  5. Dates must be March 3, 2001 / 03 March 2001
  6. Observe proper grammar
  7. don't forget to check the training to the left side before sending
  8. If you are initiating ticket to a customer, don't thank them for contacting
  9. submit as new/open/pending/on-hold/solved

Use of I (closing statement, empathy and acknowledgement statement) I sincerely apologize for any I would be happy to assist you with updating your account please let me know if you have additional questions

Use of We Our records indicate that.... Our Terms and conditions require that... we are working to resolve issue as soon as possible

*Consistency use between I and we: please let us know if we are

*Greetings: Hello is more formal than Hi

*Opening Statement: Thank you for contacting for your interest for your follow up for calling / bringing this to our attention

assurance but don't use rest assured (I will do my best to help you)

*Body of a response I am sorry to hear that you are having difficulty updating the email address associated with your 23andme account I understand that you would like to update your email address

Can be used:::::::::::::::::::::::: However Alternatively additionally Unfortunately

do not include the name of an article (https://:customercare.23andme.com/1234567888-DNA-Relatives-How-it-work) (For more information about the DNA Relatives features visit the following help article:)

Send Section *open escalated or replied by the cx

*pending (waiting for the reply) I look forward to your reply I will await your response Please reply to this message with [[requested information]]

*on hold (Waiting for the verification or response of mostly 3rd party) I am escalating [[describe issue]] to our relevant team

*solved Please feel let me know if you have additional questions

Best regards,

Cid 23andme

*Bug This bug should be resolved soon We will look into the behavior(issue) you reported

don't use shortcut don't wouldn't shouldn't Events - what happened to tickets

LESSON 3 PROTECTING DATA PRIVACY!!

maintaining a high level of customer satisfaction and protecting privacy We must not compromise the privacy of our customers We must protect our customer's data We will adhere to all FDA regulations in every communication We do not provide Medical advice/diagnosis/opinion

Identity Verification Need to know that they are the holder/right person *Order information/actions - provided to the order email *Account information/actions - provided to the account email *Sample information/actions - depends on registration status

Talks about the 23andme Kit *Unregistered - falls under Order information/actions *Registered - falls under Account information/actions

*ORDER Email Address - Address that uses to order *ACCOUNT Email Address - successful account creation for 23andme.com Exceptions Apply - this will be covered in the ID Verification Document discussion

IDENTITY VERIFICATION PROCESS *Account Level Account Inquiry Account Email Address Email (T1 only) They must use their Account Email to (Email that is used for successfully registering the Kit) Phone and Chat - chat via email (T1 only) We can provide info through phone calls The customer must log in real time to check their account If they can't log-in, they need to contact us via email listed on their account

*Order Level Order Email Address

confirm 3 order details thru email confirm 3 order details thru phone call (can't disclose any information and must send additional info thru email) before we continue assistance

Order Details -Order ID -Order Email Address -Billing Address -Phone Number -Last 4 Digits of the purchasing card

(Phone Call Only) We will send follow-up email to order email address

*Sample Level (Verification) If customer provide info or barcode via email If customer provide info via phone We can only provide if their account is registered or not We can't disclose Information whether your account is registered or not

If there is a name registered If clear then not registered

Order Information: General Guideline Emailing from correct order email correct email must provide order information

Emailing from incorrect order email if cx is writing emails from an email that is not listed on order 3 order details must be provided

For Phones/ Chat (T1 only) • 3 order details must be confirmed before providing order or unregistered sample information/actions

outbound - going to the cx inbound - going back to lab

Order Information • Provide order status and information • Provide tracking information for unregistered kits • Issue a refund for unregistered kits • Ship a replacement order if the order is lost outbound (to customer) • Ship a replacement kit for unregistered kits that are mishandled, lost, or damaged

Order Details

If a customer is inquiring about an order, but writing from an incorrect email, we can provide some information after confirming three order details. See Identity Verification article for details on what information we can provide after details are confirmed. Order details include:

If necessary, the kit barcode can be requested in addition to three order details Macro: Confirm Order Details

Three order details + Barcode We can provide all of information listed in the prior slide. We can ship a replacement for unregistered to any address the cx choose

Barcode Only If the cx provides only barcode, we can only provide that the barcode is registered or not (can not disclose info)

Email not found

Different Line of Business Tier 1 ops Tier 1 advanced ops Tier 1 product Tier 1 advanced product Tier 2 ops Tier 2 advanced ops

Email not found for order If we can locate the order we can continue the assistance but if not then we can escalate

Email not found for sample

once a sample is registered, verification process is account level

Account Verification: Email Correct Email We can only provide account or registered sample status information

Incorrect account email: ask them to write to us directly from that email or create a follow up by creating a ticket on their behalf

Phones/ Chat

Log-in Log-out Log-in

If they can't Log-in they need to email us using the account email address

Account Information/Actions: Overview Information

At the request of the correct account email, we can provide the following information and perform the following actions:

-Information-

● Confirm any visible account information. Examples include:

○ Number of profiles and profile names ○ Email confirmation status ○ Account deletion status ○ Google Signed In/Apple Signed In/2Sample Verification info ○ Sample status ○ Consent options

-Actions-

● Password Reset ● Issue replacement for registered kit ● Hide demo profile ● Demo account deletion ● Issue refund for registered kit*

*Order email can request a refund for a kit with a double sample failure, but we cannot give further details on the sample.

Registered - provide for Account email Unregistered - provide to order account only

Email not found Workflow for account

if email is given create new ticket by using account email address and link to the ticket

if not, request for additional details and if not escalate to tier 1 advance ops

Sample Information Unregistered Samples Information and actions regarding that kit fall under ORDER Information

Registered Samples Information and actions fall under Account information

*Personal Identifying Information (PII) Names Email Address Shipping Information, Billing Information etc.

Important: Agent should still check previous correspondence to help inform them on how to handle a call. However, it should not be discussed with the customer.

We're gonna continue the assistance via email.

Never provide Information: Ask for their information This is for your security purposes so we couldn't provide information however, what we can do is send you a follow up- email

Requesters CC's and Third Party Commenters Merging Copy/ Pasting Admin Info and Multiple Zendesk Tabs

Maintaining Privacy Via Zendesk

Avoid adding customer PII in your public responses whenever possible! ● Do not add a customer’s personal identifying information unless it is absolutely required to assist a customer with their inquiry. This includes the following: ○ Customer’s full name ○ Customer’s shipping address ○ Customer’s payment details ○ Customer’s full barcode ○ Customer’s email address

● Macros that require you enter PII will specifically instruct you to include it. Examples below: Internal Note for PII Approval of supervisor and if approved is the time to send to the cx ○ Full barcode if customer needs it to register ○ Last 4 digits of customer’s barcode if we’re just confirming registration status

● Avoiding PII in our responses help ensure that private info isn’t accidentally sent to another customer. ○ If you’re unsure whether PII should be included in your response, please ask your supervisor. ○ If you feel that a certain macro requires PII, please submit feedback within the Internal Help Center, or notify your supervisor.

Escalation to T1 Advanced Ops If a customer is not able to complete identity verification steps for their order, account or sample inquiry.

Escalate to Tier 2 (Privacy Queue): If a customer’s Personal Identifying Information (PII) was provided to another customer. This can happen either due to agent error or from the customer receiving someone else’s PII from an email, label on a kit, or any other type of communication. These issues should also be marked as potential quality complaints.

IHC> search bar Identity Verification Process Email Not Found Workflow Emails Forwarded to Customer Care Zendesk Navigation Overview Tickets with CC'd users

Zendesk::Email Not Found::Account Inquiry::Request Additional Details to Locate Account

Call account log out log in Call order 3 order Details

*copy of a receipt if cannot provide 3 order details when the customer bought the kit to the amazon

*if cx still have access to Account email address and is located that's the time we gonna be issued a password reset via admin

Order Details by Payment Method

For Credit Card Orders •Order confirmation number •Order email address •Order phone number •Shipping address •Billing address (if different from the shipping address) •Last 4 digits of the credit card number

For PayPal Orders •Order confirmation number •Order phone number •Order email address •PayPal Transaction ID •Email address associated with the PayPal account (if different from order email) •Shipping address

For Retail Orders •Lab fee order ID •Order email address •Last 4 digits of credit card •Billing address Note that billing information is not stored for orders placed by 3rd party sites (excluding Amazon). If the customer has questions specific to billing and/or refund status, they must contact the site they purchased the kit through.

Lesson 4: Placing an Order

General: One Address per order We do not take phone order All orders are through online store, they can purchased in authorized online reseller which is Amazon

Discount: A. Seasonal Discount During Holidays Kit that expires a certain date Ongoing email campaign discount Non-23andme Discounts Discount: Multi-kit discounts

Product and Shipping Chart

IHC> Product and Shipping Chart

Distribution Center (courier)

3 Different types of Outbound Shipping

Inbound Shipping - 2-4 weeks

ROW before they order ( they will be noticed that they will only get ancestry service)

Address Verification: Verified or unverified cx will place and receive order

Macro>Shipping Address Verification

Payment Options American Express (AMEX)), Visa, Mastercard, Pay pal Pay pal Credit and Discover card are also accepted in US Store Apple pay is available in the US store for IOS users that uses safari browser

Macros>

Payment Declined

if a Pay pal transact declined, a pop-up message will appear let them know to check their billing information or try again with a different credit card Site Error or still continues to experience difficulty must escalate to Tier 1 Advanced Ops for further investigations

Order Confirm cx are taken to a confirmation page that includes their M order Number

still receives order (email order email address)

Order Confirmation Email If cx cancel their kit order within 60 minutes by clicking on the link provided on the order confirmation page or in the confirmation email

Shipping Confirmation Email If US CA or ROW Ship US order, email will include a tracking number/info If UK EU or ROW Ship EU email will not receive a tracking number/info

Packing Slip

cx receive packing slip. This does not show billing information cost

Referral Program cx can receive 20$ Amazon gift card of a relative or friend purchases our Health + Ancestry kit or a $10 gift card if the purchase is for an Ancestry + Traits Kit. If order is mixed we will default to 20$ gift card. Only one i

emails escalate to tier 1

refer 23andme account can enter email

FSA Flexible Spending Account HSA Health Savings Account Only in the US

In general the health component of the health +ancestry service should be eligible as medical care covered by FSA/HSA benefits

Lesson 5: SHIPPING

Outbound shipping (can be located at the top) the shipment of the kit from warehouse to the customer the status of the shipment tracking details shipping method warehouse carrier order details(service type, number of kits shipping address)

Shipment tab where you can locate your tracking details

shipping options can be located in the Product and Shipping Chart

Inbound Shipping (can be located at the bottom) the shipment of the kit from the customer going back to the lab Note: Tracking details are not available for order mailed with PostNL

Return (Inbound) Shipping NOTE: they can see the process or where is the customers kit

IHC > Product and shipping Chart > regarding shipping prices

Status will say "waiting to receive your kit" as soon as kit is registered

Shipping Options All five Regions have standard and express outbound shipping options The US also has an expedited outbound shipping options Canada UK EU and ROW ship EU have a two-step delivery - Kits are first sent to the distribution center then forwarded to the lab in bulk

Territory Shipping We also ship the US product to these 5 US territories (Puerto Rico, Guam, Northern Mariana Islands American Samoa, US Virgin Islands) Same shipping cost and method as normal US orders

Military Addresses We ship the US product to valid APO/FPO military addresses in international locations Army Post Office Macro>APO/FPO Address

Shipping Warehouses ( Distribution Centers)::::::::::::: ALOM Located in Fremont CA and Indianapolis, IN NOTE: Ship kits ordered through US Store

Think Logistics Located in Ontario, Canada NOTE: ship kits ordered through Canadian Store

Movianto Located in Oss, Netherlands NOTE: Ship kits ordered through UK store and EU Kits and through International stores

Common Questions:::::::: When will my order get here? Macro> In transit to customer

I think my order is lost. Macro> Lost Outbound

My kit has not been delivered to the lab. Macro> Lost Inbound

NOTE: Once the kit is replaced, the original kit will be invalidated in Admin

Always ask for the shipping address of the customer

Twice is the only times for the replacement

Carton Delays Occasionally, some pieces of the carton may be delivered later than the rest. Delays are from the DISTRIBUTION CENTER. This results in a carton delay

If a kit is a part of Carton delay, it does not mean the kit is lost

Clearance Delay Occasionally, CA/UK/ EU/ ROW ship Europe cx will notice there is a FedEx clearance delay on the carton containing their sample. Delays are from CUSTOMS offices.

US and ROW customers are eligible to receive replacement shipping material OR a full replacement kit. CA/UK/EU customers are NOT eligible to receive replacement shipping material. We can only offer them a full replacement kit. If a customer would like replacement shipping materials, escalate to Tier 2.

Quarantined Samples When a customer places an order for shipment to a country and USE and/or RETURNS the sample kit from a different country, we are required to invalidate these kits to comply with our Terms of Service.

*We will cover the following scenarios: ● Amazon Samples ● Shippable Countries ● Non Shippable Countries

Amazon (Order Receipt) Scenario: Sample kits that were purchased from Amazon.com (United States), Amazon.ca (Canada), Amazon.uk (United Kingdom)

Customers are not eligible to receive a replacement kit. We need to request the Amazon invoice and provide a refund

Shippable Countries Scenario: Sample kits that were purchased from the 23andMe online store and used and/or returned form a country that we ship to.

Customers are eligible to receive a replacement kit for use in and return from within the country the sample kit was originally shipped OR the country in which they used and/or returned their sample from. If the customer declines the replacement or free kit link, we can provide a full refund.

Non-Shippable Countries Scenario: Sample kits that were purchased from the 23andMe online store and used and/or returned form a country that we do not ship to.

Customers are not eligible to receive a replacement kit. We can only refund these kits.

Restricted Countries (Quarantine Samples) NOTE: If a sample is returned to the lab from a different country than where it was originally shipped, the kit will be quarantined at our laboratory. You can see the quarantined kit status on the sample page in Admin. Quarantined kits should be escalated to Tier 1 Advanced Ops.

NOTE: >no payments for replacement of kits *USPS (United States Postal Service) and FedEx are the courier used in Standard and Express shipping

IHC > International ROW Shipping

Lesson 6: Refunds Replacements and Upgrade

Refund Policy (US, CA, EU, ROW):::::::::::::::::::::::::::::::::::::::::

The customer can cancel their order prior 60 minutes only including shipping fee for refund Customers are eligible for refund IF

order was placed within the last 30 days Their sample has not yet been received by our laboratory for processing

UK Refund ONLY::::::::::::::::::::::::::::::::::::: will receive a full refund (including shipping fees) within the last 30 days

Online Refund Form::::::::::::::::::::::::::::::::: Help Center> Refund and Cancellation Form (includes order information) NOTE: This form only applies for refunds on an entire order They must reach out to us if one out of 3 kits wants to be refunded

US Refund Policy - Extra Step :::::::::::::::::::::::::::::::::::::: -cx must return the kit using its own box to the lab using the prepaid box within 30 days for the refund request -Refund will be mark as pending in admin until the kits are received by the lab -Once received, the customer will automatically receive the refund (minus shipping). The refund will be marked as “Completed” in Admin.

admin account> order number> shipments > If pending admin> order number> payment and refunds stab> pending successful

Retail Kits:::::::::::::::::::::::::::::::: While 23andMe no longer sells kits at retailers (CVS, Target, Walgreens, etc), customers may still reach out to Customer Care about receiving a refund for their sample failure.

Split-payment kits: T1 ● We will refund the $69 or $169 lab fee paid by the customer. ● We will not refund the $29.99 retail kit fee since the customer paid this fee to the retailer. Refund is only for the payment for the lab and not for the kit

Single-payment kits: ● T1AO will be able to issue the customer a credit. The customer will not be required to provide a receipt for their retail purchase. The credit amount will be based on the kit type and the retailer (both can be found on the sample page in Admin 2). ● Credit amounts can be found in List of Retailers and Payment Methods.

Replacement Policy If a kit is LOST, DAMAGED, or EXPIRED, we can typically offer a free replacement kit* Replacement kits can only be shipped to the SAME SHIPPING COUNTRY listed on the original order.

Resources on Refunds::::::::::::::::::::::::::::::::::

Help Center: Refund Policy Refund & Cancellation Form

Internal Help Center: Issuing Refunds in Admin Refund Flowchart and Policy Overview

Verification:::::::::::::::: Before shipping a replacement, proper identity verification and confirmation is needed.

If the kit that needs replacing is UNREGISTERED, the kit is associated with the ORDER level

If the kit that needs replacing is REGISTERED, the kit is associated with the ACCOUNT level

Once we have verified the identity, we ask the customer for the best shipping address for their replacement.

Assigned Replacements:::::::::::::::::::: Re-registration However, as of June 23, 2020, ALL REPLACEMENT KITS NEED TO BE REGISTERED by the customer in order for the lab to process the sample. (ASSIGNED REPLACEMENT KIT are kits need to be Re-register)

If the kit that needs replacing is registered, the replacement will be ASSIGNED to the profile of which the original sample was registered. The kit is not yet registered. The customer will need to re-register (or "activate") their replacement barcode for the lab to process the sample.

(cx will only choose Upgrade/Replacement Kit: Example Profile)

Retail Kits While 23andMe no longer sells kits at retailers (CVS, Target, Walgreens, etc), customers may still reach out to Customer Care about receiving a REPLACEMENT. This can be for reasons such as sample failure or kit expired. Split-payment kits: ● This kit type is discontinued so we cannot easily replace these within Admin. ● Instead, T1AO agents will send the customer either a $30 off link or free kit link (depending on if the lab fee is paid) to order a new kit from the online store. Single-payment kits: ● These kits can simply be replaced within Admin per the ISSUING REPLACEMENT KITS workflow

Help Center: 23andMe DNA Test Kit Replacement Policy

Internal Help Center: Issuing Replacement Kits Replacement & Chip Upgrade Kit Registration Damaged/Lost/Mishandled Kits Flowchart Expired Kits Flowchart Lost Outbound Flowchart

Health Upgrade::::::::::::::: US and CUE (Canada, UK, Europe) customers who purchased the Ancestry + Traits Service available in their country have the ability to upgrade to the Health + Ancestry Service.

This upgrade does NOT require a new sample as the reports are generated using the existing raw data from the customer's Ancestry + Traits kit.

Important Note: The health upgrade fee is NON-REFUNDABLE for profiles with data. However, we can refund the health upgrade fee for a profile that has not received data (either because of sample failure or pre-data buyer's remorse).

How to Purchase a Health Upgrade::::::::::::::::::::::::::::::::::::::::: After completing registration, Ancestry + Traits customers may see an offer for a health upgrade at a discounted price. The discounted price may vary.

Once the Ancestry + Traits kit is registered, the customer can purchase a health upgrade from within their account. If the customer receives an email offer for a health upgrade, they will be able to purchase it without signing in to the account. Customers can also purchase an upgrade to the Health + Ancestry service on the 23andMe iOS mobile app (the Android app does not have this feature).

Chip Upgrade 23andMe periodically updates its DNA analysis platform, or genotyping chip. We are currently on VERSION 5 of the chip, known as V5, which was released in August 2017.

Customers on outdated platforms are able to purchase a chip upgrade and PROVIDE A NEW SAMPLE in order to access the newest reports and 23andMe experience. (If Health, don't need to provide new sample)

If eligible, customers must log in to their account to purchase a chip upgrade.

Assigned Chip Upgrade Kits::::::::::::::::::::::::::::::: Like with registered replacements, all chip upgrade kits purchased after June 23, 2020 are assigned to the original profile. (ASSIGNED CHIP UPGRADE KIT are kits need to be re register)

However, they need to be registered (or “activated”) by the user before the lab can analyze the sample.

This looks the same as registering a replacement kit. Once the chip upgrade barcode has been registered, the lab can analyze the sample normally.

Chip Upgrade vs New Kit:::::::::::::::::::::::::::::::::::: Customers may ask why they should purchase a chip upgrade rather than a new kit to get the most current reports. We want to push customers to purchase a chip upgrade rather than a new kit.

Why? Here are the main reasons: ● If the customer uses the new kit, they will have DUPLICATE RESULTS. ● This gets messy for both Customer Care and the customer (ex. they answer research questions in both profiles, they show up as their own twin, they don’t know which profile has the archive or has the new results, etc.)

*All other chip upgrade inquiries should be escalated to Tier 1 Product *Same inclusion if *It's not advisable for the old cx to buy new kit but to chip upgrade *customers have old versions are able to avail chip upgrade

Lesson 7

23andme Kit Includes Saliva Collection Kit Specimen bag Step by step Instructions tube container Funnel lid (inside are the stabilization buffer - months) Saliva collection tube (5 seconds of shaking the tube) tube cap

Do not eat, drink*, smoke, chew gum, brush your teeth, or use mouthwash for at least 30 minutes prior to providing your sample. *Includes water

The recommended volume of saliva to provide is 2ML, or about 1⁄2 teaspoon. Your saliva sample should be just above the fill line.

Provide your sample and add the STABILIZATION BUFFER within 30 minutes. Waiting longer than 30 minutes may DECREASE the yield and quality of your DNA. Cap securely before shipping.

Q: I can’t find the cap!!!! A: It’s inside the clamshell. (Still can’t find it? See later slide about mishandled kits.)

Q: I lost the biohazard bag. What do I do? A: You can use a plastic bag with a piece of paper towel. Macro: Biospecimen Bag / Absorbent Pad

Q: I thought you covered shipping to the lab. A: The shipping label is on the bottom of the box for US/CUE customers.

Q: I received the kit and it was leaking everywhere. A: Report to your team lead, and send the customer a free replacement. Leads should report the defect on the Kit Manufacturing Defects form.

Q: I ate within 30 minutes of spitting! Or There was a piece of peanut in my sample! Or There’s lipstick in my sample! A: If you’ve already sent it back, just see if processing works. Macro: Usage Error (Contaminated/Clamshell/Forgot to Shake/Buffer Released)

Q: My sample is all bubbles. A: Try to make sure it’s liquid to the fill line.

Q: I accidentally released the buffer solution into the tube, but I haven’t spit yet. A: You can provide your sample on top of the buffer solution. Just make sure to spit all the way to the top of the tube. Macro: Usage Error (Contaminated/Clamshell/Forgot to Shake/Buffer Released)

Q: Can I spit when I’m sick? A: Yes, but makes sure it’s spit and not mucus

Q: Can I provide a sample if I’m pregnant? A: Yes, pregnancy will not affect the sample

Q: Can I provide a sample if I’m undergoing chemotherapy? A: Yes, but we can’t specifically say what the effect of the chemotherapy drugs will be on the amount of DNA in saliva. We recommend waiting at least a week until after the last chemo treatment, or until white blood cell count returns to normal.

Macro for all questions above: Test Eligibility (Cold/Pregnancy/Chemotherapy)

Q: I’m having trouble getting enough spit. A: Try rubbing the outside of your cheeks, or thinking about sour foods such as lemons. Macros: Tips for Providing a Good Sample Difficulty Providing a Good Sample (Ex. Elderly/Dry Mouth)

Q: Will this medication I’m on affect my sample? A: As long as it does not lower your white blood cell count, it should not have an impact Macro: Medicine/Drugs Effect on DNA Q: How much spit do you need? A: 1⁄2 teaspoon (~2 mL) Macro: Alternate Sample (Basic, Deceased Person, Do Not Add Tissue)

Q: I didn’t release the liquid from the funnel lid or I left the funnel lid on when I mailed it or I lost/couldn’t find the cap but I already spit A: You’ll need a replacement kit. (These are considered “mishandled” replacements) Macro: Damaged/Lost/Mishandled Kit

Q: I messed up the first time and need to spit again. Can I rinse the tube and reuse it? A: No. You’ll need a replacement kit. (These are considered “mishandled” replacements) Macro: Damaged/Lost/Mishandled Kit

Q: My collection tube is missing the bottom! A: Your collection tube does have a bottom, but it is not visible unless you look directly in the bottom of the tube.

Reproductive Age

● For older instructions kit inserts, there is a section with the following information: “Special conditions for use: DNA carrier screening is intended for adults of reproductive age”

● This is referring specifically to the Carrier Status reports, which are intended to tell you the risks of passing variants down to your children. However, the kit can be used by anyone as long as they can provide a sample.

Macro: Reproductive Age (Kit Insert)

Bone Marrow Transplants If a customer has received a bone marrow transplant, it WILL affect the DNA sample. We CANNOT recommend that these customers use the 23andMe service. For presales customers, use the following macro: Bone Marrow Transplant (Presales)

NOTE: Tier 1 instructions: For post-sales customers who indicate they have received a bone marrow transplant, please escalate to Tier 2

Alternate Collection Kits

The only kit we have available is the Standard Collection Kit which requires ~2ml or 1⁄2 tsp of saliva. We don’t offer any other type of collection method. We previously offered saliva collection swabs called Assisted Collection Kits (ACKs), but these are NO LONGER AVAILABLE. Our sample collection method isn’t great for people who can’t spit (infants, elderly, disabled, dry mouth). • Infants - our kits should not be used by infants or small children who cannot spit. We recommend parents wait to collect a sample from their child UNTIL THEY ARE ABLE TO SPIT, for example, spitting toothpaste. Drool is not adequate due to low concentration of DNA. • Elderly or disabled Macros: Providing a Good Sample Difficulty Providing a Good Sample (Ex. Elderly/Dry Mouth) Sample for Infants / Young Children

NON SALIVA SAMPLES We DON'T ACCEPT AYTHING BESIDES SALIVA.

To respond, use the Alternate Sample (Basic, Deceased Person, Do Not Add Tissue) macro: Thank you for your interest in 23andMe. The analysis that we provide can only be performed using a saliva sample collected using the saliva kit that we include with your order. The saliva sample collected is ~2 ml. Unfortunately, we are unable to analyze any other type of sample.

Additional information is provided in the macro for less common questions related to deceased individuals or adding material to the sample other than saliva.

manufacture smudged barcode delivered spilled delivered kulang di masara ang takip

Lesson 8: Account Creation and Registration

if the kit is registered it will fall under Account Email Address A sample will not be processed until it has been registered. Register kit (upper right corner of the website)

Registering to an Existing Account If the customer already has an account, they can register by clicking Register Kit from the main 23andMe website and then clicking the blue Sign In

NEW ACCOUNT There are two ways to set up an account:

  1. Fill out everything (we’ll refer to this as regular sign up)
  2. Third party account -Google or Apple (we’ll refer to this as third party sign up).

Under 13 Restriction ● Must have guardian - children under the age of 13. A parent or guardian may order and set up an account for our services on behalf of their child. ● Parent must register their child’s sample collection tube under the child’s own profile.

Account (parents) > profile under account (different from parent's account)

If a child under 13 tries to set up an account, the following message will appear, ""Sorry, we are not able to accept your registration at this time.""

REGULAR SIGN UP Account Already Created :::::::::::::::::::::::::::::: ● If a customer has already created a 23andMe account with their email, we will notify them in a follow-up that an account already exists. This email will be titled ""Account Creation Attempt Made."" ● Direct the customer to the “Sign In” button at the bottom of the Register Your Kit box (see Register to Existing Account slide) to register to their existing account. ● If the customer has forgotten their account password, they can RESET it by following the prompts in the email.

Email Verification ::::::::::::::::::::::::::::::::::::::::: ● If a customer signs up with their email, they need to verify their email address to finish setting up an account and be able to register a kit. ● Until the email address has been confirmed, the account will be Activated but have an Unconfirmed (or Pending) email address in Admin. Additionally, a Resend Confirmation Email button will be visible.

Macro: Account Not Confirmed

THIRD PARTY SIGN UP Account Already Created::::::::::::::::::::::::::::::::::::::::: • If a customer has already created a 23andMe account with their email and then attempts to create an account with Google or Apple Sign in, they will be asked whether they would like to link their existing account to their Google or Apple account. • If they proceed, they will need to sign in with Google or Apple for all future login attempts. • They will receive an email titled, Your first Google/Apple sign in.

Account verification::::::::::::::::::::::::::::::::::: ● Accounts created using third party sign up (Google or Apple) skip the email confirmation step! ● As soon as the user gives permission for 23andMe to access their Google/Apple information, their account is created, and they can proceed with entering their barcode. ● They’ll receive an account creation email titled “Success! Your 23andMe account is ready”.

Order vs Account Creation ● Some customers will think that they automatically have an account after placing an order. Unless the customer has created an account - either from the store page or by clicking REGISTER KIT on the main site, an account will not exist. ● The customer will not receive a unique error message if they try to log in with their order email address; they will simply be notified that their email and/or password is not recognized. If they click Forgot Your Password?, they will NOT receive a reset email.

Macro: Order vs Account Creation

Account Verification Issues ● If the customer contacts us and has not confirmed their account email address, send the Account Not Confirmed macro. The customer will be prompted to search for the confirmation email, and reset their password to confirm their email and access their account if they cannot.

● If the customer is unable to confirm their account email address and has not requested a password reset (check the Event Log), send the password reset message through Admin 2 and send the Password Reset in Admin macro.

Macro > Account not confirmed Macro > Password Reset in Admin

Account Verification Issues::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

● If the customer has more than 10 login failures (you can see this at the top of the account page) and they do NOT have third party sign in, this means their account is LOCKED. ● They won’t be able to confirm their account normally – you’ll need to send them a manual password reset instead through Admin2 (Password Reset in Admin).

Registration: Barcode and Profile::::::::::::::::::::::::::::::::::::::::::::::::::::::

Entering the Barcode and Personal Information

  1. Enter the kit barcode and indicate who will be using the kit (I will be using this kit if you're the one Someone else will be using this kit if it's someone else)
  2. Fill out the personal information of the person using the kit
  3. Click Continue to get to the next step

Registration: Barcode and Profile ● If registering an Ancestry Service kit, customers will see a message after clicking CONTINUE where they will need to acknowledge that they will only be receiving ancestry reports. This message reads: ""This kit is for the Ancestry service and will not receive health-related reports.""

Barcode Issues

• If the customer says the barcode they entered was invalid or already in use, ask for the barcode. (We can search in ADMIN 2) • Once you have the barcode, you can check the status in admin to see why they’re having trouble. • We have a great internal help article for how to proceed in each case (Difficulty Registering Barcode).

Invalid Barcode- double check this barcode has already been used. Barcodes only need to be entered once

Barcode Issues Assigned replacement kits: ● If a replacement kit is sent for a previously registered kit, the replacement will be automatically assigned to the original profile, and it can only be registered by that individual (they need to sign into their account first). ● If a customer is logged into the wrong account and enters the barcode of an unregistered assigned replacement kit, they will receive an error message.

Macro: Assigned Kit, Registration Error (Wrong Account)

This barcode is assigned to a profile that does not belong to this account. Please contact customer Care

Terms of Service and Privacy Statement:::::::::::::::::::::: ● There is only the option to accept at the bottom of the document.

Consent to the Use and Transfer of Sensitive Information:::::::::::: ● This consent is only shown to customers who purchased a kit to an EU address (EU Service or ROW country in the EU). ● Customers have the ability to decline consent, but will not be able to participate in 23andMe Services.

***I CONSENT to the processing of my sensitive personal information ***I DO NOT CONSENT """""""

Research Consent ● Customers should scroll and read to the bottom of the document to choose their consent preference. ● Customers in Canada and the EU (EU Service country) cannot participate in research and will not see this consent.

Consenting for adults: -I am this person, I have read this document and -I am legally authorized to give consent for this and -I DO GIVE CONSENT -I DO NOT GIVE CONSENT

Consenting for Minors (Under 18) -I am this child's parent or legal guardian, this child GIVES ASSENT to participate, and -I DO AUTHORIZE -I DON"T AUTHORIZE

Individual Data Sharing Consent ● Only customers who have consented to participate in research in the previous step will see this consent. ● Like research consent, this preference can be changed at any time. -I am this person, I have read this document and -I am legally authorized to give consent for this and -I DO GIVE CONSENT -I DO NOT GIVE CONSENT

Research Opportunities Based on Your Unreported DNA Variants ● Only customers who have consented to participate in research will see this consent. ● Like research consent, this preference can be changed at any time. -Yes, you may contact -No, do not contact

Sample Storage ● Customer should select whether or not they want to store their sample at our lab. ● If a customer stores their sample, they can choose to discard it after they have received results. Discarding a sample is irreversible. ● If a customer discards their sample, they can only change this by contacting Customer Care to unregister their kit.

Note: kits can only be UNREGISTERED before the sample has reached the lab.

Registration Review and Submit:::::::::::::::::: ● The customer will be given the chance to review registration details before submitting. ● Registration is not complete until they click the Complete Registration button.

Registration: Confirmation::::::::::: ● Upon clicking COMPLETE REGISTRATION, a confirmation page will be shown. The customer will also receive a confirmation email. ● Clicking GET STARTED will direct the customer to opt-in and surveys.

Post Registration::::::::::::::: If the customer clicks Get Started on the confirmation page, they will be directed through the following steps:

Step 1: The customer will first confirm their profile name, date of birth, biological sex, and country of residence. Step 2: Opt-in to Health Reports (if customer purchased Health + Ancestry Service) ● Customers can choose to include or exclude Carrier Status and Genetic Health Risk (GHR) reports. Post Registration ○ There are also several locked GHRs that require an additional opt in. ○ There is not an opt-out option for Traits or Wellness reports. ● The selection can be updated anytime from within the Account Settings.

Step 3: Configure your reports ● This includes an ethnicity questionnaire that will help to highlight health reports that are relevant for your ethnicity. ● This section is optional, but Carrier Status reports will not be generated UNLESS THE ETHNICITY QUESTIONNAIRE IS COMPLETED

Step 4: Health Profile Survey ● This survey completely optional, and no data is generated based on the answers. ● It is a bit longer - it generally takes ~20 minutes, so if you’re walking someone through registration, you can let them finish this on their own.

-Complete last step -Take me to the Home page instead

OTHER ISSUES:::::::::::::::::::::::::::::::::: Split-fee payment kits If the customer's kit is a split payment retail kit (requires a lab fee before the kit can be processed), they will be prompted to select a service and pay the lab fee for their kit.

We don’t sell these types of kits anymore so these inquiries are rare

Difficulty Registering If a customer is having trouble registering, provide registration instructions using the following macros based on the scenario:

● Incomplete Registration, Existing Account ● Incomplete Registration, Existing Account (Breakdown) ● Incomplete Registration, New Account (create account before registration)

Customers can also register using the mobile app (iPhone and Android). There are specific macros for the mobile app and mobile site, so make sure you select the right one based on the device they’re using!

Sample Sent to the Lab Unregistered::::::::::::::::::::::::::::::: Some samples are sent to the lab unregistered. Most often, the customer started the registration process but did not finish all the steps so it was not completed. ● When the lab receives an unregistered sample, an Action Required: Unregistered Kit at Lab email is automatically sent to order email address for orders placed at the 23andMe online store. (Note that we are unable to track the barcodes for unregistered retail kits purchased from authorized sellers.) ● An unregistered kit at the lab will be highlighted in red in Admin 2. To see date it was received, click on the barcode. ○ If unregistered kit received within the last 2 years, provide registration instructions and include the sample barcode. ○ If unregistered kit received at lab more than 2 years ago, send a replacement kit.

Multiple Samples in Same Order Sent to the Lab Unregistered

If multiple samples in the same order are sent to the lab unregistered: ● Send Unregistered Kit Received at Lab, Multi Kit Order macro. ● This macro is sent to prevent the customers from registering the wrong samples.

Lesson 9: Existing Account Experience

Account Menu and Features Profile Page Account Settings Printable Features

Profile Page:::::::::::::::::::::::::::::::::: Name in the Upper right side of their screen/top right > View Your Profile ● You can access your profile page by clicking on your profile name in the top right corner, then “VIEW YOUR PROFILE” ● This page shows an overview of your personal information, family background, as well as ancestry, trait, and health reports (if applicable). ● This page is not available on the mobile app.

Account Settings::::::::::::::::::::::::::::: Name in the Upper right side of their screen/top right> Settings ● On the website, you can locate Account Settings on desktop by clicking on your profile name, and selecting Settings from the dropdown. ● On the mobile app, you can click on your profile photo/initials or the gear icon in the top right corner.

There are 6 sections in Account Settings::::::::::::::::::::::::::: ● Account Information

● Personal Information Edit profile photo

This section includes a link through which you can edit your enhanced profile (visible to DNA Relatives and Connections).

● Privacy/Sharing Here, you can do the following:

● Preferences Here, you can do the following:

● Research and Product Consents Here, you can do the following:

● 23andMe Data Here, you can do the following:

Printable Features:::::::::::::::::::::::::::::

Printable Features::::::::::::::::::::::::::::::::::::::::::::::

Sharing and Messaging::::::::::::::::::::::::::::::::::::: ● All Sharing and Messaging inquiries should be directed to the Existing Account Experience queue. (Tier 1 Product) ● Most of these inquiries will be addressed by product agents. ● We go into this in more detail during Product training, but we’ll provide a quick background here!

Sharing::::::::::::::::::::::::::::::::::::::::

Messaging Overview::::::::

Profile Management::::::::::::::::::::::::::::::::::::::

Profile Management: Demo Profiles:::::::::::::::::::::::::::::::::

Profile Management: Profile Transfers:::::::::::::::::::::::::::::::::::::::::: ● Users are able to transfer profiles between accounts through the profile transfer process ● A destination account must exist to accept the transferred profile. ● Both accounts need to confirm the transfer through an email sent from donotreply@23andme.com. Macros: Account::Settings::Profile Transfer (LM) Account::Settings::Profile Transfer Breakdown Account::Settings::Accept/Reject Profile Transfer (Destination Account) Account::Settings::Cancel Profile Transfer (Initiating Account)

Account Deletion:::::::::::::::::::::::::::::::::::::::::::::: ● Users are able to request deletion of their account through the 23andMe Data section of their Settings. ● They will need to confirm their deletion request via email within 24 hours. ● Once confirmed, account deletion is irreversible, and deleting an account will delete all profiles under the account. Macros: Account Access::Closure::Account Deletion Account Access::Closure::Data Account Deletion Steps Account Access::Closure::Data Account Deletion Confirmation Account Access::Closure::Data Account Deletion Irreversible Account Access::Closure::Data Account Deletion for Multiple Profiles

Account Deletion - Demo Accounts:::::::::::::::::::::::::::::::::::::::::: ● It is possible for demo accounts to be deleted from within the Account Settings but we can also offer to do it for them. ● Once the customer confirms that they’d like to proceed, you can delete the demo account within Admin. Macros: Account Access::Closure::Demo Account Deletion Steps Account Access::Demo Account Closure Confirmation Account Access::Closure::Demo Account Closure Request Account Access::Manual Demo Account Closure Confirmation

Lesson 10: Mobile App

The 23andMe Mobile App is a mobile application which provides the 23andMe experience to customers on their smartphones and devices. This means customers do not have to use a web browser navigate to 23andMe.com to access their account. Note, the mobile app is different from a mobile browser. If a customer is using a mobile browser, they are required to type in the 23andMe web address to access the 23andMe service on their phone. Once a customer downloads the app, they can simply click the app within their smartphone, sign in, and view their 23andMe account!

Who can use the App?::::::::::::::::::::::::::::::::::

The app is available for download in countries where we offer our services. The app is free to download on:

NOTE: This means a customer located in the US/CA/EU/UK or ROW country with an iOS or Android device can download and use the app!

Downloading: iOS:::::::::::::::::::::::::::::::::::: Customers with an iPhone can download the app through the App Store. -AppStore If they are having trouble finding the 23andMe app, you can link them to the APP LANDING PAGE.

Important note: The app is compatible with iOS 12.0 or later. Customers with versions lower than 12.0 will not be able to install or update the app.

Downloading: Android:::::::::::::::::::::::::::::::: Customers with an Android device can download the app through the Google Play Store. If they are having trouble finding the 23andMe app, you can link them to the app landing page. -Google Play

Important note: The app is compatible with Android 7.0 or later. Customers with versions older than Android 7.0 will not be able to install or update the app.

Existing Accounts:::::::::::::::::::::::::::::::::::::::: Once the app is installed, customers with existing 23andMe accounts and can simply sign in using their email address and password.

Customers also have the option to sign in using Google, Apple, and 2-Step Verification (if previously enabled)

If a customer forgets their password, they can click Forgot password? to be taken to the 23andMe website on their mobile web browser. They can then reset their password through the website.

Register a Kit:::::::::::::::::::::::::::::::::::::::

If you need to register a kit, you can click the green Register a Kit button. Customers are able to create a new account or register to an existing account. Macros Incomplete Registration, New Account (Mobile App) Incomplete Registration, Existing account (Mobile App)

Registration, New Account:::::::::::::::::::::::::::::::::::::::::::::::

Creating a new account and registering a kit to that account is similar to this process on the website. Customers will walk through the following steps:

● ACCOUNT CREATION: customers will enter their name, email address, birthdate, and password and will then be required to confirm their email address. ● BARCODE ENTRY: customers can either enter their barcode manually or scan it using their device’s camera. ● PROFILE ENTRY: customers will enter the profile name, birthdate, and sex ● CONSENTS: depending on the customer’s country, they will walk through the applicable consent documents ● COMPLETE REGISTRATION: review the registration information and submit to complete the process. need to confirm email address Note: the order of these steps may change with updates to the mobile app. For the most up-to-date information, refer to the Mobile App tab of the REGISTRATION WALKTHROUGH article.

Registration, Existing Account::::::::::::::::::::::::::::::::::::::::

Registering a kit to an existing account is also similar to registering on the website. Customers will walk through the following steps:

● LOG IN: customers log into their existing account before moving to the next step. Note: if the customer is already logged in, they will need to log out and click on Register a Kit to walk through registration; there is no way to navigate to registration once logged in. ● BARCODE ENTRY: customers can either enter their barcode manually or scan it using their device’s camera. ● PROFILE ENTRY: customers will enter the profile name, birthdate, and sex ● CONSENTS: depending on the customer’s country, they will walk through the applicable consent documents ● Complete registration: review the registration information and submit to complete the process.

Note: the order of these steps may change with updates to the mobile app. For the most up-to-date information, refer to the Mobile App tab of the Registration Walkthrough article.

SAMPLE STATUS:::::::::::::::::::::::::::::::::::::::::::::::: You can check the status of your sample once registration is complete. When a step is reached, it will be highlighted.

Just like the website, if you have the H+A service, you can configure your reports while waiting for your results

The NAVIGATION BAR:::::::::::::::::::::::::::::::::: Located at the bottom of the app, this navigation bar allows customers to view their Ancestry features, Health features, Research, Connections, and Notifications.

Note that customers may see different icons here depending on the service type of their kit. New customers with the Ancestry + Traits service will see an eye icon.

Profile settings can be accessed by clicking the profile photo (or gear icon for Android users) in the upper right-hand corner of the screen.

The mobile app changes nearly every week! For the most up-to-date screenshots, go to the Mobile App IHC article. Navigation can be found at the bottom

Account Settings Not all account settings in the website are available in the mobile app and may vary for iOS vs Android users.

Things you CAN do: ● Switch profiles (if the customer has more than one profile with data) ● Update profile information (name, birthdate, sex) ● View genotyping chip version and service type* ● Change password ● Purchase a new kit ● Refer a friend ● Discard your sample ● Change research consent(s) ● Opt in/out of health reports ● View 23andMe data (raw data) ● Update report sharing settings ● Enable/disable nearby sharing invitations ● Enable/disable biometric login ● View legal documents ● Contact Customer Care ● Send app feedback ● Log out

Things you CAN’T do (but can on the website): ● Delete account ● Download data ● Update email address ● Update email notification preferences ● DNA Relatives opt-in (customers can opt in/out by going to the Connections section of the app) ● Transfer profiles ● Become a Beta tester ● Review ethnicity information ● 2SV - customers cannot enable or disable 2SV from the mobile app

Ancestry::::::::::::::::::::::::::

-Each report or feature is presented as a different tile. -Click the tiles to see the report or feature! -You can scroll vertically to see the rest of the tiles. -Some tiles allow you to swipe horizontally to see more. -You can always click the Ancestry Composition wheel icon on the bottom left corner of the screen to return to your Ancestry reports.

Health:::::::::::::::::::::::::::::::::::::

-Health reports are listed in their categories. Click on each category to see the list of reports in that category. -Click on a report to see more information about your result -Scroll down through the report to read more. Scientific Details can also be clicked on. -If the customer is in the US or CUE and has the Ancestry + Traits Service, they will see a lock icon on the heart. Customers can now purchase Health + Ancestry Service upgrades by clicking on the Locked Heart icon. NOTE: Keep in mind that this Health section is only available for customers with the Health + Ancestry Service. You can also click the Upgrade me now.

Research::::::::::::::::::::::::::::::::::::::::::

-Screenshots on this slide are from the iOS app version 8.23.0 You can currently answer survey questions*, view Discoveries and participate in Research Insights like Sleep and Caffeine tracking** within the app. -Customers can click See and edit past responses to search for a survey or question of interest. However, surveys that have already been completed cannot currently be accessed on the app. In this case, you will need to go through the website. NOTE: Keep in mind that Discoveries are no longer available on the 23andMe website, and this will likely be phased out of the app in the future. *Website supports all question types, but some versions of the app don’t support certain question types. For this reason, customers may not see some questions in the app. **Only available for iOS

Connections::::::::::::::::::::::::::::::::::::::::::: -Connections in the app is similar to Family & Friends on the website. Connections may be renamed in future updates.

-Click on a sharing connection to view your comparison page with them!

In Connections, you can: ● Visit DNA Relatives ● Send messages ● Extend sharing invitations and accept sharing requests

Notifications:::::::::::::::::::::::::::::::::::::::::: In Notifications, you can:

● Check for sample status updates ● See general account updates (like when new DNA Relatives matches are added) ● See announcements about new reports and features ● Access messages received from relatives and sharing connections. Clicking on the notification will route you directly the the new message!

Unavailable Features *Not all 23andMe features accessible on our website are available in our app. Here are a list of commonly asked features that are available on our website, but not yet available within the mobile app: • Browse Raw Data • Forums • Reports Archive (if applicable to the account)

Keep in mind that this is not a comprehensive list and will change. We are working to expand the features in the mobile app. For an up-to-date list of limitations of the mobile app, check out the Mobile App IHC article.

Trouble Shooting::::::::::::::::::::::::: -If a customer is experiencing difficulty downloading the mobile app, it typically means that their device is incompatible. -If the customer has stated that they are using the mobile app, DO NOT tell them we are not optimized for mobile devices. -If a customer is experiencing difficulty signing in to their account on the mobile app, they probably need to update the app or are entering the incorrect email address and/or password. -In general, you can follow the checklist on the right to troubleshoot the issue.

Checklist

  1. Is their iOS or Android device compatible?
  2. Is the feature/tool available on the mobile app?
  3. Have they updated the app to the newest version? You can check the app version the customer has downloaded in the EVENT LOG of Admin!

Common Questions::::::::::::::::::::::: Q: I’m located outside of the US. Can I download the app? A: Yes, as long as you’re located in one of our shipping countries.

Q: It’s not letting me sign in on the app, but I can on the website. Help! A: They probably need to update their app version. You can check what version of the 23andMe mobile app is current in the IHC article.

Q: Why can’t I find my Raw Data on the app? A: It’s not available on the app. The customer would need to go on a web browser.

Lesson 11: Sample Status

Our Laboratories::::::::::::::::::::::::::::::::: All samples are mailed in the pre-paid return shipping material to our laboratories in the United States.

We have two laboratories in the following locations: ● Burlington, North Carolina ● Los Angeles, California

Privacy First!::::::::::::::::::::::::::::::::::::::: ● Once a sample has been registered to an account, we can only verify sample status information with the email address used to register the kit. ● Encourage self-service!

Sample Status Timeline::::::::::::::::::::::::::::::::::::::::::::::::::: When customers log in to their accounts, they will see the following “While-You-Wait” timeline display.

When a step is completed, the timeline will be a solid green color. When the step is in process, the timeline will be dotted.

Receiving

  1. Registered
  2. Arrived at Lab
  3. Prepped

Analyzing 4) Extracting your DNA 5) Genotyping

Interpreting 7) Reviewing 8) Computation 9) Results Ready

Users can hover their cursor over each step in the timeline to see more information and when it was completed.

Quarantine Status:::::::::::::::::::::::::::::::::::::::::::: If a sample is returned to the lab from a different country than where it was originally shipped, the kit will be QUARANTINED at our laboratory. This is usually apparent because the shipping material used is different than what we provide.

Customers will often contact us to ask about the delivery status of their sample or they may report that their sample was lost in transit to our laboratory.

Before shipping a replacement for a kit that may be lost in transit to the lab, please check their quarantine status on the sample detail page.

If a kit is in quarantine, please escalate immediately to Tier 1 Advanced Ops and do not ship a replacement.

Sample Processing Time::::::::::::::::::::::::::::::::::::::::::::::::::::: ● Sample processing time begins when the barcode of the registered kit is scanned at the laboratory.

NOTE: Sample processing take approximately 2-3 weeks the time after the sample received at the lab. NOTE: Unregistered kit will start Processing when registered. NOTE: Retail Split payment sample begins process once the lab fee has been paid.

● Samples are processed in the order they are received (some exceptions apply) ● Due to biological variability, sample processing times range. So even if two samples are received at the same time, they may not receive data on the same date. Some samples may require additional steps to be processed successfully. Macros: Sample Status > Lab Processing Time Sample Status > Variable Processing Time Sample Status > Fast processing, results still accurate

Sample Processing Time::::::::::::::::::::::::::::::::::: ● Sample processing time begins when the barcode of the registered kit is scanned at the laboratory.

Sample Processing Time:::::::::::::::::::::::::::::::::::::::::::::::::::: This is an example of a sample that was not processed until the customer registered it after it arrived at the lab. Their sample was received on January 9, 2018 and was not registered until July 1, 2018. Macro: Sample Status > Processing Delay >Sample originally received Unregistered

NOTE: Missing Instruction File means the sample receive at lab but still not registered.

On the right is an example of a sample that arrived at the lab registered but with an unpaid lab fee. On the Sample page, If you see that a registered sample has not been processed or says “missing instruction” check under the Details section to check the following:

  1. Is this a retail kit? (true or false)
  2. Has the customer paid the lab fee? a) This will be noted as “Unpaid” or give a date for when the lab fee was paid

Macro: Lab Fee Unpaid, Registered Kit

NOTE: Retail Kit: True Lab fee UNPAID or PAID on (DATE) problem - DATE - Missing Instruction

Sample Processing Steps: DNA Quantification:::::::::::::::::::::::::::::::::::::::::: Once a sample is received by our lab, it enters DNA Quantification. The date next to the ACCESSIONED entry is the date the sample was received.

Extracted During this process the sample is: IEA • Visually inspected • DNA is extracted • The extracted DNA is amplified

NOTE: If the sample does not yield sufficient quantities of DNA, this step may be repeated.

DNA EXTRACTION:::::::::::::::::::::::::::::

View in Admin: READY TO EXTRACT and CONDENSING

View in Customer's Account: IN QUEUE FOR DNA EXTRACTION "WE'RE EXTRACTING THE DNA FROM THE CELLS IN YOUR SALIVA SAMPLE. THIS STEP USUALLY TAKES 1-2 WEEKS"

Sample Processing Steps: DNA Analysis::::::::::::::::::::::::::::::::::::::

After the DNA is successfully extracted and amplified, it enters DNA Analysis. During this process the sample is: • Genotyped on our Microarray Chip (genotyping chip) • Data returned from the genotyping process undergoes quality review

NOTE: If your sample does not yield a call rate that meets our standards, this step may be repeated.

DNA Analysis in Admin and Customer Account:::::::::::::::::::::::::::::

View in Admin: DNA ANALYSIS

View in Customer's Account: GENOTYPING YOUR DNA "WE ARE READING ABOUT 600,000 LOCATIONS ON YOUR EXTRACTED DNA. THIS STEP USUALLY TAKES 3-10 DAYS."

Quality Review::::::::::::::::::::::::::: The final step before data is computed. You will see a status of “Data Received” but the Genotype will be “Claimed” on the Sample Info page in Admin:

All samples go through this step and it’s often very brief. Occasionally, sets or batches of samples are flagged for additional quality review for extended periods of time. Doesn’t reflect on quality or viability of a particular sample, but simply overall set of data.

Macros:

  1. Lab Processing Time macro should be used if the sample is within our processing estimates
  2. Additional quality review macro should be used if the customer specifically mentions quality review and/or it is outside of our expected processing estimate.

Pending Release::::::::::::::::::::::::::::::::::::::::::::::::::: As soon as analysis is completed by the lab, the data is sent to 23andMe. The sample status will update to show that the reports are currently being “computed” using the raw genetic data. In Admin, you will see “Pending Release”. Macro: Pending Release

View in Admin: Pending Release

View in Customer's Account: Reviewing "Our scientists are reviewing your genetic data. This step usually takes 1-3 days."

Results Ready:::::::::::::::::::::::::::::::::: **Data computation times vary. However, completed results are typically returned within the current estimated processing time.

View in admin: Loaded

customer will receive an email: Marlon, welcome to you! VIEW YOUR REPORTS

Summary: Admin vs. Sample Status Timeline:::::::::::::::::::::::::::::::::::

• Admin: Ready_to_Extract and Condensing Timeline: In queue for DNA Extraction

• Admin: DNA Analysis Timeline: Genotyping

• Admin: “Claimed” under genotype status, and “Data Reported” on sample status log Timeline: Reviewing/Genotyping

• Admin: “Pending Release” under genotype status Timeline: Computation, which includes initial Raw Data processing and computation and report generation

Sample Reanalysis:::::::::::::::::::::::::::::::::::::::::::::::::: Occasionally, samples do not meet our quality standards during the first analysis attempt, so we will repeat that analysis step a second time. This is called Reanalysis, and does NOT mean that the sample has failed analysis.

DNA Quantification Reanalysis in Admin: "RETEST" Macro: Low DNA (first attempt), repeating extraction

DNA Re-analysis in Admin: Macro: Analysis Failure, Re-extract (Reanalysis Delay) "RETEST"

Sample Failures:::::::::::::::::::::::::::::::::::::::: Samples may fail analysis for the following reasons:

  1. Low volume - macro: Low volume due to customer error a. The customer didn’t provide enough volume of saliva b. The customer left the funnel lid attached and it leaked in transit c. The customer did not screw the small cap on tightly enough and it leaked in transit

  2. Insufficient DNA - macro: Low DNA / insufficient DNA (explanation) a. Last step in Admin before invalidation is DNA Quantification b. There was not enough DNA for us to analyze. This could be due to a number of reasons, including not following directions or just not having enough DNA in their saliva naturally

  3. Analysis Failure (low call rate) - macro: Analysis failure (explanation) a. Last step in Admin before invalidation is DNA Analysis b. Samples must have a 98.5% call rate or higher for us to provide results i. Out of all the SNPs we analyze, 1.5% or less should result in a “not deter mined” result. If more than 1.5%, will result in Analysis Failure

Per Section 5 of our Terms of Service: The laboratory may not be able to process your sample up to 5% of the time Up to 065% of all samples fail the second attempt at testing according to 23andMe data obtained in 2019 for all genotype testing

First Failure:::::::::::::::::::::::::::::: • Customers are entitled to a free replacement kit if their sample fails analysis. In this case, they will receive a notification email prompting them to order a replacement • A banner will also appear at the top of their 23andMe account.

• If a customer would like a refund, they will need to contact Customer Care directly. In this case, we can go ahead and process a refund per our policy. Macro: Sample Status > Sample Failure > 1st Sample Failure > Refund Requested, First Failed Analysis

NOTE: Preparation was unsuccessful: Your sample analysis failed Order a replacement kit If they need a refund they need to contact us first

You will know that the lab failed a sample if it says Invalid as the sample status. If the customer still needs to request a replacement or refund from within their account, it will display a Needs Action status next to Replacement Status. We will need to direct to request a replacement within their account.

Macro: Sample Status > Sample Failure > 1st Sample Failure > Request a replacement

Replacement Status - Needs Action Sample Status Log - Invalid

You will know that the customer requested a replacement when you see that the Replacement Status is updated to Reshipped. Once the replacement has been fulfilled, another sample will appear on the sample page. Replacement Status - Reshipped Invalidation Reason - Analysis Failed

Second Failure::::::::::::::::::::::::::::::::::::::: • After two hard sample failures (any combination of low DNA or analysis failure), customers are only provided with the option of receiving a refund. • We can provide them with the 2nd Sample Failure > No Replacement macro. If the customer comes back, escalate the inquiry to Tier 1 Advanced Ops.

Sample Processing (Priority) Samples can be priority processed

Only used for special cases and should be escalated to Tier 1 Advanced Ops. Special cases include: ● Customer’s first sample failed analysis and they are pushing back on having the second sample to be expedited ● Customer says that are in contact with 23andMe employee and were promised expedited processing ● Customer’s first sample was lost inbound and they want the second sample to be expedited ● Expedite sample requests for terminally ill individuals

**Once the sample has been received by the lab, we are unable to prioritize it.

Lesson 12: Privacy

Customer Care and Privacy::::::::::::::::::::::::: Customer Care receives and handles privacy concerns and inquiries through a number of channels: ● Submit a request/customercare@ Many privacy questions and concerns come through our submit a request form, are follow ups, or are included in inquiries that also address other areas ● HPA – Human Protections Administrator (HPA@) Problems with consent status (e.g. changing consent) Research related complaints ● Privacy@ 23andMe’s Privacy Administrator General Privacy questions about our privacy policies ● Letters – infrequently – addressed to Privacy Administrator and are sent to HQ address in Mountain View

Privacy 101:::::::::::::::::::::::::::: 23andMe receives a lot of personal information in many different ways: ● Order/Registration Information: Information a customer provides about themselves when registering and/or purchasing our Services. Examples include: Name, email/phone, Date of Birth, payment info ● Genetic Information: information regarding a customer’s genotype. ● Self Reported Information (SRI): Information about a customer entered into surveys, forms, or features. Examples include: information about conditions, health related info, personal traits, ethnicity, family history etc. ● User Content: Information, other than Genetic Information and SRI, generated by users of 23andMe and transmitted to or through 23andMe. Such as a post or message on our community forums. Examples include: data, text, photographs, messages, or other materials ● Web Behavior Info: Information on how you use the 23andMe website. Collected through cookies, web beacons etc. Examples include: IP address, Browser type, Operating system, clickstreams, and page views ● Sensitive Information: information about a customer’s health, Genetic Information, and certain Self-Reported Information such as as racial and ethnic origin and sexual orientation.

Privacy 102::::::::::::::::::::::::::::::::::::::::::::::::::::::::: How is this data collected? ● Information Customers provide to 23andMe Order, Registration, Self-Reported Information (surveys), User Content, and CC inquiries. ● Processing and Genetic Testing Services Sample storage and Genetic Information generated through our Services. ● Collection through Tracking Tech (Cookies, web beacons, and similar technologies) Web Behavior Information (IP, browser, Internet Service provider, Clickstreams etc.) ● Other New products and features may require new or additional types of information in the future. In this case the Privacy Statement will be updated to reflect new types of data.

Data Protection:::::::::::::::::::::::::::::::::::::: How does 23andMe protect data? ● 23andMe measures are in accordance with current technological standards and best practices in the industry. We use physical, technical and administrative measures to safeguard our customers’ information. ● Accessing our Services: Each page on our website can only be accessed through secure web pages (https) and connections are encrypted. ● Data storage and protection: ■ All 23andMe servers are maintained in secure locations. ■ Strictly monitored and protected from outside access ■ Restricted Internet access and Firewall protection ■ Backup data is encrypted and stored in a secure location ● Personally identifying information is stored separately from genetic and self-reported data. ○Segmenting the data across database systems in this way prevents re-identifiability. ● Disclosing the details of all of our security plans and practices is a security concern, so we do not disclose all of that information.

GDPR and CCPA:::::::::::::::::::::::::: How does 23andMe honor customers’ privacy rights? ● The GDPR (General Data Protection Regulation) is a data protection law that governs the processing of personal data of EU residents. 23andMe complies with its obligations to data subjects in the EU with the GDPR. ● The California Consumer Privacy Act of 2018 (CCPA) is a new California privacy law that secures data protection rights for consumers within the state of California. 23andMe is also committed to complying with the CCPA and empowering our customers to make informed decisions about how their information is used and shared. Overview Macros: GDPR>GDPR 101>What is the GDPR? Privacy>CCPA>What is the CCPA? If you receive pushback from someone who is not able to exercise their GDPR or CCPA rights from within their account, escalate to Tier 1 Advanced Ops.

HIPAA:::::::::::::::::::::::::::::::::::: (Health Insurance Portability and Accountability Act 1996) Example Customer Question: "Is 23andMe subject to HIPAA rules and restrictions? If not, how do I protect the results from public dissemination?"

23andMe customer care is not a COVERED ENTITY as defined under HIPAA, so personally identifying information provided by a user on our site is not subject to HIPAA regulations. We have developed our practices to protect customer information in compliance with all applicable laws and industry standards. Macro: Privacy> HIPAA Compliance

Pre-sales and Registration:::::::::::::::::::::::::::::: Can I purchase or participate anonymously? ● Ordering: Customers can do a number of things to limit the amount of personal information they provide such as order using prepaid card, ship to corporate address or PO Box, enter fake information such as name/email/phone number. We do not instruct customers on how to do so. ● Registration: We require true Registration Information during the account creation and registration process. ○ Purchaser and Registrant must agree to TOS Section 6 Account Creation,
Customer Account, Password, and Security Obligations

Macros: Ops>Order>Pre>Purchase Anonymously Registration>Privacy >Register as Pseudonym/Anonymous Registration>Privacy >Register as Pseudonym/Anonymous (pushback) FAQ: Can I be genotyped anonymously?

Example Inquiries: Hi there, just wondering if someone can submit for testing anonymously? Has there been any thought of offering anonymous testing? It would be great to have the ability to register an account using any name I choose.

Who Can Participate/Register::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Ordering and Registration • You must be of legal age to form a binding contract in order to accept TOS • Must not be barred from receiving our services due to laws of the jurisdiction in which you have residency, or from which you use our services

Important ages: “Sorry, we are not able to accept your registration at this time.” This message will only be displayed for DOB under 13 • 13 – Must be 13 to create an account and use our services WITHOUT submitting a sample or genetic information and accept our TOS • 18 – Must be 18 if submitting your own genetic information and agree to TOS for yourself, or for those you have legal authority to agree

Macro: Account Access>Account Setup error, Under 13 Example Tickets: 832705, 835722

Registering for Others:::::::::::::::::::::::::::::::::::::::::::::::::::: A parent or guardian may register for their child (<18) • Parent assumes full responsibility for information provided on behalf of their child • Accounts must be created in the parent’s name and DOB for <13 • 13< child <18 - Child may create account(profile) but guardian must register to the account on their behalf. • In both scenarios, the kit is registered using child’s info.

someone else will be using this kit

Registering for an individual over 18 • Registering on behalf of an individual who is 18+ requires their authorization, (verbal or can be in the room) no need for their parents

Research Consent is Optional::::::::::::::::::::::::::::::::::::::

Customers must make a consent selection when registering (with the exception of EU/CA customers). They can choose to give consent or not give consent.

Choosing to not participate in research will NOT have any impact on the customer’s results. Choosing not to participate will not affect access to the customer’s genetic data or their use of the Personal Genome Service.

Consent Document, section 6: “Choosing not to give consent or withdrawing from 23andMe Research will not affect your access to your Genetic Information or to the Personal Genome Service®.”

Macros: Research>Surveys>Other> Surveys are Optional Research>Surveys>Restrictions>Canadian Customers Can't Participate in Research/Surveys Research>Surveys>Restrictions>EU Customers Can't Participate in Research/Surveys Research>General>Other> Data Is Not Generated From Survey Answers FAQ: Research Example Tickets: 825578, 768751

2 Types of Research Consent::::::::::::::::::::::::::::::::::::::::::

  1. Type of Information Shared by Consenting to the Individual Data Sharing Consent Document
  1. Type of Information Shared by Consenting to the Research Consent Document

Consenting for Another Person When registering for someone who is 18 or older, they NEED that individual’s authorization (verbal or they can be in the room).

If parents are registering for a minor (under 18) ONE parent must authorize the child to participate in research AND the child must also give ASSENT (affirmative agreement to participate).

Domestic disputes between parents or guardians concerning a minor’s participation should be escalated to Tier 2. (544016)

Consent Document: Your child may take part in 23andMe Research if he or she gives assent to participate and a parent authorizes 23andMe to use his or her Genetic & Self-Reported Information for research.

Privacy Statement: Section 4f: Children’s privacy.

-I am this person, I have read this document and -I am legally authorized to give consent for this and -I DO GIVE CONSENT -I DO NOT GIVE CONSENT

Sample Storage:::::::::::::::::::::::::::::::::::::::::::::: What is Sample Storage? ● Sample storage (bio-banking) is an option for customers to store their sample at the lab. Biobanking is completely optional. What are they consenting to? ● Consent to store and perform additional genetic analyses (including genotyping or more advances sequencing etc.) Why store my sample? ● If 23andMe changes our technology (e.g. genotyping chips) or the laboratory needs to retest the sample again, customers may benefit from the ability to be reanalyzed without having to provide another sample. This document does not however address the cost of upgrades

Macros: Sample Storage>Overview Sample Storage>Overview (breakdown) Sample Storage>Biobank, Not At Lab Sample Storage>Biobank, Received at Lab or Has Data Sample Storage>Discard Sample

Privacy Statement: section 1b1: Saliva sample and bio-banking

Sample Storage::::::::::::::::::::::::::::::::::::::::::::: Sample Storage Options • Yes, Store this Sample - will be stored at the lab for a min. of 1 year, max. of 10 years. Consent for additional analyses. • No, DO NOT Store this Sample - Customer’s sample will be discarded 6 months after being fully processed or sooner as required by applicable laws.

If stored, the customer can later choose to discard the sample once the results are ready, but this is irreversible.

How to Change Consent::::::::::::::::::::::::::::::: From the Consent Document, section 6: Do I have any alternatives? Can I withdraw from this study?

Customers can change their selection at anytime. The choice to opt out is effective beginning 30 days after 23andMe receives their request. Any data that was previously to that point that has been used for Research purposes won’t be removed or withdrawn.

Exceptions: Customers who were not required to review a Consent Document and/or cannot participate.

Customers with Demo Accounts cannot opt out of research, because they never registered a sample and therefore were never required to make a Consent decision. EU and CA residents do not have a research consent selection, at this time, and do not see this page during the registration.

How to Change Consent:::::::::::::::::::::::::::::::::: Macro: Account::Settings::Change Research Consent How to edit your Research Consent Profile>Settings>Change Research Content> Edit>View Consent Options

Research Consent and Internal R&D::::::::::::::::::::::::::::::::: If a customer does not consent to participate in 23andMe Research, their information will not be used for 23andMe Research. 23andMe Research activities do not include R&D (Research & Development also referred to as Product Development). ● 23andMe may still perform internal R&D with de-identified user data if a customer has not given consent for 23andMe Research.

Product Development - research and development activities and analyses performed by 23andMe on de-identified user data with the goals of: ● Monitoring and improving our Services and/or developing new products or services ● Performing quality control activities

Privacy Statement 4.a. - Describes how we use information to operate, provide, analyze and improve our Services

Do you share or sell my data?::::::::::::::::::::::::::::::::: Many customers have questions about if and how 23andMe shares their personal information. There are several frequently asked about scenarios: ● General “Do you sell my information to anyone?” requests ( sometimes about pharmaceutical companies) ● Law Enforcement Requests ● Insurance General Requests: Many times customers are misinformed and/or have not read our policies. “I noticed in the news that you plan to sell all our DNA data to pharma companies…”

Macros: Privacy>Golden Privacy (US/UK) and Privacy>Golden Privacy (CA/EU) We DO NOT SELL, LEASE, or RENT, or otherwise disclose our customer’s individual-level Personal Information without asking for and receiving their explicit consent to do so. ● Our policies are clearly stated in our legal documents. The Golden Privacy macro also directs the customer to review our docs. By participating in our service they are allowing us to process their information as stated in our Privacy Statement, Terms of Service, and Consent Document.

Law Enforcement Requests:::::::::::::::::::::::::::::::::::::::::::::::: Law Enforcement or “legal requests” for customer information may include subpoenas, court orders or search warrants. ● When we receive such a request, our legal team reviews the request to see if it satisfies legal requirements and our policies. ● We use all legal measures to resist any and all requests. ● To date, we have successfully challenged these requests and have not re leased any information to law enforcement. ● Our Transparency Report shows the number of law enforcement agency requests we've received and the percentage of requests that we complied with (0%): https://www.23andme.com/transparency-report/

Macros: Privacy> Law Enforcement Requests / Transparency Report Privacy> Law Enforcement Requests / Transparency Report (CUE/ROW) Example Tickets: 789553, 601165, 453245

If you receive a request from someone identifying themselves as a law enforcement agent escalate to Tier 2 immediately. Example: I'm a police detective wondering if a sample could be submitted from a 35 year old cold case homicide to try and locate possible suspect relatives.

Insurance:::::::::::::::::::::::::::::::::::::::::::::::::::::: Given the nature of our service, many customers have concerns about participating due to fear of genetic discrimination, particularly in insurance decisions. Most requests come from US and Canadian customers. ● Laws protecting customers are specific to their jurisdictions. The laws protecting some customers may not apply to others. Be sure you understand where the customer is before providing information to be sure it is relevant to them. 23andMe will not provide any person’s data (genetic or non-genetic) to an insurance company or employer. ● 23andMe has been a long-time supporter of legislative efforts intended to prevent genetic discrimination and to safeguard individuals' genetic privacy. US Customers - The Genetic Information Nondiscrimination Act, or GINA, is U.S. federal legislation that protects Americans from discrimination, in health insurance and employment decisions, on the basis of genetic information. ● GINA does not cover long term, life, or disability insurance providers. ● Some states have their own statutes protecting against genetic discrimination

Canadian Customers - In May 2017, Canadian Bill S-201, the Genetic Non-Discrimination Act, received Royal Assent and became law. This law offers protections to Canadians from genetic discrimination. However, recent developments suggest the constitutionality of this law may be challenged. While the law will remain in effect, our language during this time may be limited. Macro: Privacy>Insurance>Canadian Insurance (S-201)

Keep In Mind:::::::::::::::::::::::::::::::::::::: 23andMe takes privacy and security concerns very seriously. As a direct to consumer company processing and storing sensitive information about our customers, it is imperative that we earn the trust of our customers by handling and addressing privacy concerns appropriately.

If you are unsure how to handle a request, do not hesitate to escalate the call or email to Tier 2. Certain scenarios should always be escalated: ● I think my account has been hacked ● Consent issues - “I cannot change my research consent/You changed my research consent!” ● Request from a Law Enforcement Agent/Police or Insurance Company

How to handle Privacy ● Be confident 23andMe’s dedication to privacy ● Be confident in our policies and Legal Team ● Know the policies ● Be confident in your knowledge ● Refer to our documents ● Take the call to email or let the customer know they can contact our Privacy Team directly, by emailing Privacy@23andme.com

Important Resources and Macros Resources: Terms of Service: https://www.23andme.com/about/tos/ Privacy Statement: https://www.23andme.com/about/privacy/ Research Consent Document: https://www.23andme.com/about/consent/ Transparency Report: https://www.23andme.com/transparency-report/ Biobanking Consent: https://www.23andme.com/legal/biobanking/

Macros: ●We do not share or sell data without your consent + Legal docs - Accounts>Privacy>Golden Privacy Macro ●Links to our legal docs - Privacy>Legal Links (Snippet) ●How we protect your data - Privacy>Data Security/Hacking Overview ●Cannot participate anonymously - Registration>Privacy >Register as Pseudonym/Anonymous ●Participation in Research is optional - Research>Surveys>Other> Surveys are Optional ●What is Sample storage? - Account>Setting>Sample Storage>Overview ●Law Enforcement Requests - Privacy> Law Enforcement Requests / Transparency Report ●Do you share with Insurance Companies? - Privacy>Insurance>Data Not Shared with Insurance/Employers ●US protections against Genetic Discrimination - Privacy>Insurance>GINA (US) ●Canadian Protections - Privacy> Insurance>Canadian Insurance (S-201)

Lesson 13: Surveys and 23andMe Research

cx has the option to answer the survey of 23andMe

23andMe Research Aims:::::::::::::::::::::::::::::::: 23andMe aims to make and support scientific discoveries and publish those discoveries in scientific journals. 23andMe Research was formerly known as >“23andWe” All customers are encouraged to take part in this research, but are not required in order to receive data. A customer’s participation (or lack thereof) in 23andMe Research will not impact their use of the service or the results that they receive.

Consent Documents:::::::::::::::::::::::::: General Research Consent Document v Individual Level Research Consent Document v Research Opportunities Based on Your Unreported Genetics

General Research Consent Document:::::::::::::::::::::::: • In order to participate in 23andMe research, customers must agree to the full terms in our Consent Document during kit registration • This applies to US, UK and ROW customers *You can learn about which consents are available for which customers in this IHC article

Individual Level Research Consent Document:::::::::::::::::::::::: • Customers that agree to the Individual Data Sharing Consent Document are giving 23andMe permission to share their de-identified, individual-level data with qualified research collaborators outside of 23andMe (US only) registration • If customers have specific questions about this consent document,

escalate to Tier 2

Research Opportunities Based on Your Unreported Genetics::::::::::::::::::: • Customers that agree to research opportunities based on your unreported genetics (GDR) consent, are giving 23andMe permission to reach out to them about DNA variants that are not included in our current reports • This applies ONLY to US, UK and ROW customers If a customers are comparing their account to other account from diff country MACRO: Account::Settings::Change Research Consent (CA/EU) • If customers have specific questions about this consent document, escalate to Tier 2 if the customer are having hard time changing consent escalate to tier 2 Queue is Research and Category is 23andMe Research

Editing Research Consent:::::::::::::::::::::::::::::::: Customers may change their consent selections at anytime from within their profile settings:

  1. Click on Profile Name in the upper right-hand corner.
  2. Select “Settings”
  3. Scroll down to “Preferences”
  4. Click “Change Consent” to revisit document
  5. Scroll to bottom to view consent options.

Customers can click See and edit past responses to search for a survey or question of interest. However, surveys that have already been completed cannot currently be accessed on the app. In this case, you will need to go through the website.

Editing Research Consent:::::::::::::::: You can use the following macros for customers requesting they be opted out of research: Account::Settings::Change Research Consent Account::Settings::Change Research Consent (CA/EU)

If a customer is having trouble changing their consent, escalate to Tier 2

EU Customers: (Denmark, Finland, Ireland, the Netherlands, and Sweden)

Restricted Research Locales 23andMe Research Experience is dependent on the locale of the customer due to regulatory and IRB restrictions currently in place US, UK, and ROW customers: • Are given a US locale, and fall under our US IRB protocol. They will have access to all surveys and Quick Questions. *UK customers may see less surveys than US/ROW customers

Canadian customers: • Not eligible to participate in Research. They will see limited surveys, including the health profile survey, and quick questions

EU Customers: (Denmark, Finland, Ireland, the Netherlands, and Sweden) • Not eligible to participate in Research. They will see limited surveys, including the health profile survey, and quick questions

*Customers will see only limited questions in the Health Profile.

Surveys & Quick Questions::::::::::::::::::::::::::::: Customers can access surveys and quick questions within their accounts by clicking on the Research tab at the top of their account homepage, or on the light bulb icon in the 23andMe mobile app.

From here, customers can see and edit past survey responses*, view untaken surveys, and current studies and research publications Account>Research> Edit Answers *Surveys that have already been completed cannot currently be accessed on the app

Quick Questions & Surveys:::::::::::::::::::::::::::: Quick Question: When you're n the mood for a snack, what kind of snack do you usually reach for? Sweet Salty or savory Both Neither

Survey: Vocabulary Test

Surveys: Admin In Admin 2 you can see all the surveys a customer has taken, and is eligible to take

Your General Health NEW> Indicates the customer has not yet taken the survey Recent Dietary Habits SKIPPED> Indicates the customer skipped the survey COVID-19 Complete 2020-04-10 11:367> Confirms the customer completed the survey

Publications Customers can view what papers 23andMe has published based on 23andMe Research within this section of their account. Customers can also see which publications they have directly contributed to, and what surveys were used for the publication

ALL PUBLICATIONS

Note - if you contributed to a publication, that does not mean you have the condition it referenced. It just means your data was used when doing the study for any number of reasons (ie; control data)

Users can filter publications by their areas of interest or by contribution

Macros: Research::Other::Share Research Findings/Publications Research::Other::Publication Contribution

Common Survey Questions::::::::::::::::::::::::::::::::::::::::::: Q: I answered a question wrong. How can I go back to the survey and change it? Macro: Research::Surveys::Specific Survey::Edit/Update Survey Answers (LM)

Q: How can I edit specific survey? I answered these questions incorrectly Macro: Research::Surveys::Specific Survey::Edit/Update Survey Answers (LM) Macro: Research::Surveys::Specific Survey::How to Edit Family Origins Survey

Keep in mind that you can find a specific survey and copy that survey link by using site search (better functionality than search/edit)

Q: What am I getting out of this? We should receive some sort of payment or a free upgrade for answering questions Macro: Research::General::Other::Will I Be Compensated for Research?

Q: I’ve been answering so many questions. How many more surveys are there? Macro: Research::Surveys::Edit::Have I Completed All Surveys? Profile > Surveys

Q: Do I have to take all these surveys? Macro: Research::Surveys::Other::Surveys Are Optional

Q: Will my survey answers affect my data/results? Macro: Research::General::Other::Data Is Not Generated From Survey Answers We only get DNA result not their survey answers

Common Survey Questions: Suggestions::::::::::::::::::::::::::::::::::::::: Customers frequently share feedback, or make suggestions for how we can improve research. You can address inquires of this nature with the following macros:

Research::Surveys::Suggestion::Survey Feedback - General Can be used when a customer provides general feedback about a survey

Research::Surveys::Suggestion::Survey Feedback - Best of Your Ability Can be used for customers who report there was not a response selection applicable to them

Research::Surveys::Suggestion::Survey Feedback - Suggestion Can be used when a customer provides a suggestion for a topic we do not currently have a survey on

Research::General::Suggestion::Research Initiative Suggestion Can be used when a customer provides a suggestion for an area not currently a topic of research

Research::Surveys::Suggestion::Survey Feedback - Adopted Can be used for customers frustrated about survey questions asking about their family history

Common Survey Questions: Troubleshooting:::::::::::::::::::::::::::::::::::: Customers may sometimes report that they are experiencing issues completing a survey, or that surveys are freezing (this is a known issue on Internet Explorer and Edge). The following macros can be used in these cases:

Research::Surveys::Troubleshooting::Cannot Complete Survey on IE11/Microsoft Edge

General::Website::Browser Requirements

Other Survey Questions::::::::::::::::::::::::::::::::::::::::::::::::: Customers sometimes contact us to share additional information about their medical background. Users are usually prompted to provide this information if there was not a survey question which asked about it.

“I have just been diagnosed with autoimmune disease, and put on medication. Is this something the research team is interested in?”

Within the Health Profile there is a write-in option which allows customers to share other conditions they may have been diagnosed with, or are being treated for. We can direct customers to add information here. It is important to note that information the customer shares can only be used in research if entered into a survey.

Macro: Research::General::Other::Add Additional Symptoms to File (TMI) (LM)

Cognitive Games::::::::::::::::::::::::::::::::::::::::::: Cognitive games are games customer’s can participate in within their account. From time to time, they do not load properly.

If a customer reports an issue with the following games: The Balloon Inflating Challenge, Pointing Speed, The Sustained Attention Test, feel free to use: Research::Surveys::Troubleshooting::Intific Cog Games Won't Load (The Balloon Inflating Challenge, Pointing Speed, The Sustained Attention Test)

If a customer reports that one of these games, Matching Speed and Spot the Difference, isn’t working, please use the following: Research::Surveys::Specific Survey::Native Cog Games Won’t Load (Matching Speed and Spot the Difference)

If a customer says that they want the score to their game once it’s already been completed, use the following: Research::Surveys::Specific Survey::No Cog Games Score Displayed If customer pushback, escalate to tier 2

Resources:::::::::::::::::::::::::::::::::::::::::: Research Communities: • Customer Care does not directly provide support for these communities. Each research community has its own support email address. • You can read more about each research community in the IHC here • Answering questions from research community participants is slightly different than answering regular customer inquiries. You can find more information here

Research Communities: • If you get a question from a customer asking about a Research Community which you cannot answer, you can move it to the appropriate research community queue (eg. Fertility, Global Genetics Project) using Zendesk::Escalate::Move To Research Communities (No Response to Customer) • Move the ticket to the appropriate research community using the dropdown menu. Detailed instructions can be found in the IHC here Research Community> N?A IBD PD Lupus

Help Center: • Customers can read about research communities in our Help Center Macros: Research::Surveys::Other::Navigation Research::Surveys::Other::Surveys Are Optional Research::Surveys::Other::How We Select Questions/Topics Research::Surveys::Specific Survey::Vocabulary Survey Results Research::Surveys::Specific Survey::Understanding Other People Survey Results Research::Surveys::Specific Survey::Edit/Update Survey Answers (LM) Research::Surveys::Specific Survey::How to Edit Family Origins Survey Research::Surveys::Edit::Have I Completed All Surveys? Research::Surveys::Edit::Survey Completed in Wrong Profile (LM) Research::Surveys::Suggestion::Survey Feedback - Suggestion Research::Surveys::Suggestion::Survey Feedback - General Research::Surveys::Suggestion::Survey Feedback - Best of Your Ability Research::Surveys::Troubleshooting::Intific Cog Games Won't Load (The Balloon Inflating Challenge, Pointing Speed, The Sustained Attention Test) Research::Surveys::Specific Survey::Native Cog Games Won’t Load (Matching Speed and Spot the Difference) Research::Surveys::Specific Survey::No Cog Games Score Displayed Research::General::Suggestion::Research Initiative Suggestion Research:: General:: Suggestion::Wondering If There Is a Research Initiative Research::Surveys::Restrictions::Canadian Customers Can't Participate in Research/Surveys Research::Surveys::Restrictions::EU Customers Can't Participate in Research/Surveys Research::General::Other::Data Is Not Generated From Survey Answers Research::General::Other::Add Additional Symptoms to File (TMI) (LM) Research::General::Other::Is There a Genetic Link? Zendesk::Escalate::Move To Research Communities (No Response to Customer) Research::General::Other::Will I Be Compensated for Research?

Common Escalations • A customer reporting a survey is taking them to a “page not found” • Customer is unable to update/change their research consent selection • Conference speaker or exhibition requests (any non research collaboration request) • Inquiries about Individual Level Research Consent • Inquiries about Research Opportunities Based on Your Unreported Genetic Variants • Refer to this article for what to escalate when it comes to research community participants

Lesson 14: Customer Care Quality Complaint Escalations and MDR

Customer Inquiry Received > Inquiry regarding Health or Ancestry

Yes > Move to Tier 1 Product

Inquiry Regarding Health or Ancestry > No > Potential QA Complaint per Tier 1 Ops Training? > Yes > Escalate as a potential QA Complaint > Select box next to "Flag ticket as potential quality complaint" in Zendesk > Select the type of potential complaint in the required drop down menu > Escalate to Tier 2 Immediately: Ticket transfer via Zendesk

Potential QA complaint per Tier 1 Ops training > No > Other inquiry that needs to be transferred to a another team/tier 2 > Yes > Transfer to another team or Tier 2 > Refer to the Escalation Topics help article to determine proper escalation macro > Provide reason for escalation in internal note and apply appropriate escalation macro before submitting updates to the ticket

Other Inquiry that needs to be transferred to another team/ tier 2 > No > Respond to customer inquiry For kit defects, report them to the Kit Manufacturing Defect Form.

Kit Manufacturing Defects::::::::::::::::::::::::::::::::::::::::::: These typically do not require escalation as potential quality complaints (PQCs), but they do require an escalation via the kit manufacturing defect form (instructions to follow). Kit Manufacturing Defects

What would be considered a defect that does not require PQC escalation? • Missing kit components (with the exception of missing welcome booklet see slide 21 for instructions regarding missing welcome booklet ) • Kit box arrived without a small cap • Kit box arrived without a funnel lid • Kit box arrived without a plastic biohazard bag • Cap manufactured incorrectly • Customer is unable to screw the small cap onto the tube (ticket #1015518) • Funnel manufactured incorrectly • Plastic lining on the funnel cap arrived ripped, which caused buffer to leak (Ticket #868037 & 974498) • There was no buffer fluid in the funnel (Ticket #510561) • Tube manufactured incorrectly • Tube came without a barcode sticker, barcode sticker faded / unreadable • Substance in the tube aside from buffer liquid (be sure to get more details)

What is NOT considered a manufacturing defect: • The kit box arrived damaged (courier error), and as a result it caused damage to other components within the kit. • Customer lost the small cap or any other component within the kit • Any other damage caused after the kit arrived intact at the customer’s address. If you are unsure whether the damage was caused after the customer received the kit, ask for additional details.

How do I report a manufacturing defect? • Report directly through the Kit Manufacturing Defects Form • If you do not have access to the form, please contact a supervisor. • Include the following information: • Kit barcode • Zendesk ticket number • Type of defect (be very specific) • Ex. Missing kit component, kit box arrived without a funnel lid • Our Supplier Quality team routinely checks reported defects and provides feedback to our kit manufacturer, DNA Genotek. We need your help to ensure that all incidents are reported!

Typical Escalations vs Quality Complaints:::::::::::::::::::::::::::::::::::::::::::: TYPICAL ESCALATION TOPICS are inquiries that require escalation to Tier 2 or to another team with Customer Care. These are not considered quality complaints. (handled or assisted by tier 1before escalating to the right department) QUALITY COMPLAINTS are inquiries that will require specialized handling by Tier 2 Leads. These need to be escalated immediately to Tier 2 and cannot be handled by Tier 1. We will discuss how to identify and escalate potential quality complaints in the next slides. (immediately transfer to tier 2)

Identifying Typical Escalation Topics:::::::::::::::::::::::::::::::::::::::::::: The internal help article Escalation Topics contains a list of topics that need to be escalated to different teams within Customer Care. Please review to ensure you are directing the customer’s inquiry to the appropriate channel.

Health and Ancestry Inquiries::::::::::::::::::::::::::::::::::::::::::::::: General Guidelines • Keep in mind that any questions specific to a customer’s Health and Ancestry results need to be transferred immediately to a Product-trained agent. Product agents are trained to identify potential complaints concerning our Health & Ancestry features. Please do not respond to these inquiries until you have received training to prevent potential complaints from being missed or improperly escalated. • Check with a supervisor if you are unsure whether an inquiry should be transferred to Tier 1 Product. • Example scenarios to be on alert for escalation to Tier 1 Product: • Customer alleging that their Health or Ancestry report is wrong. • Customer reporting that they cannot see a close relative on the DNA Relatives feature or that they have an unexpected close relative. • Customer reporting that their Health or Ancestry report(s) changed.

What is a Quality Complaint?:::::::::::::::::::::::::::::: Regulatory definitions: Quality Complaint if the customers have complaint about product or performance of kit 21 CFR 820.3(b) Quality System Regulation “Complaint means any written, electronic, or oral communication that alleges deficiencies in the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is released for distribution.”

ISO 13485 (3.4) Customer Complaint Any “written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety or performance of a medical device that has been placed on the market.”

 • Let’s think of this in the simplest terms: Is it possible that 23andMe
 provided incorrect results? Does it sound like someone’s results or the kit
 itself may have negatively impacted or harmed them?
      • If the answer to either of those questions is yes this is a POTENTIAL 
      QUALITY COMPLAINT.

 • It is important that potential quality complaints are identified and
 immediately escalated. If they are incidents that need to be reported to
 the US FDA as a Medical Device Report (MDR) or to the EU Competent
 Authority as an Incident Report or Field Safety Corrective Action (FSCA),
 these are TIME SENSITIVE

Who is responsible?::::::::::::::::::::::::::::::::::::::::::::::::::::::::: Tier 1 Customer Care Agents and all other 23andMe personnel must acknowledge any and all potential quality complaints and provide all pertinent information to Tier 2 Customer Care immediately. The following slides will cover potential quality complaint categories that you will likely encounter

Types of Potential Quality Complaints:::::::::::::::::::::::::::::::::::::::::::: Sex Mismatches and Sample Swaps (Genotype Exceptions*)

Escalate the following scenarios if data is LOADED: • “I am male but you’re saying I’m genetically female” • “I am a woman but my results say I’m a man” • “I provided a sample in the wrong kit” • “My results appear to be mixed up with my husband”

Note: It is not a POTENTIAL COMPLAINT if the customer has a HELD genotype status. Simply escalate to the Tier 1 Advanced Operations, but no need to follow the process for a potential complaint. Tier 1 Advanced Operations should follow the workflow in the IHC article for Genotype Exceptions. *Genotype Exceptions is an internal term only.

Types of Potential Quality Complaints:::::::::::::::::::::::::::::::::::::::::::::: Changes in medical behavior due to interpretation/anticipation of 23andMe results. (It AFFECTS or HARM customer will consider Potential Complaint) • Customer stopped taking their medication because of their result in a health report without consulting their doctor • Customer reported that they stopped taking medication while they waited for their 23andMe results without consulting their doctor • Example: “I haven't receive my reports yet. I have brain cancer and I need the results ASAP in order to proceed with my medical treatment.” (Ticket # 481886)

Types of Potential Quality Complaints:::::::::::::::::::::::::::::::::::::::::: Contact with Kit Materials or Harm from Results Customer came into contact with the buffer fluid in any way or reports that they experienced physical harm/side effect from use of 23andMe kit materials. ALWAYS ask for the kit barcode in question when escalating as a quality complaint.

 • Customer reports that the buffer fluid spilled onto their skin or they other 
 wise came into contact with the buffer fluid in any manner
 • Customer reports an adverse physical reaction (respiratory issues, rash, 
 burning, itching, etc.) caused by kit materials
 • Customer cut their lip with the funnel cap while spitting
 • Customer was hospitalized or had to see doctor as a result of reaction to kit 
 materials
 • Experienced any other harm from the kit or 23andMe reports

Types of Quality Complaints:::::::::::::::::::::::::::::::::::: Distress or Anxiety Caused by Reports Mental distress (or psychological distress) is a term used, both by some mental health practitioners and users of mental health services, to describe a range of symptoms and experiences of a person's internal life that are commonly held to be troubling, confusing or out of the ordinary.

What are the signs of emotional distress? ●Depression or general unhappiness ●Stress or panic ●Suicidal Ideation (follow the specific email and phone protocol for responding to these inquiries) ●Anxiety and agitation ●Moodiness, irritability, or anger ●Feeling overwhelmed ●Loneliness and isolation ●Other mental or emotional health problems ●Disruption of a person’s ability to conduct normal life functions that affected quality of life

Privacy Breaches

  1. Customer reported receiving another person’s personal information or reports that they believe their information was released to another person. Always ask for a screenshot of the email or breach before escalating the ticket. Example: A customer receives an email from donotreply@23andme.com that is addressed to an individual that is not listed in their account

  2. A customer’s 23andMe account email address or registered barcode was released to another individual Example: A customer is unable to register a kit that they purchased from Amazon because the kit was already registered to another account

    Example: An agent accidentally copy/pasted the wrong email address into the correspondence with another customer

Other discrepancies that should also be escalated as a potential quality complaint: • Potential fulfillment errors - The customer received a kit with a different barcode than the barcode on file in their order page in admin. This can result in someone’s data being loaded into another customer’s account.

 • Missing Welcome Booklet - This is because the welcome booklet includes 
 important disclaimers and information regarding the medical device

 • Customers or medical professionals alleging that the information specified 
 in our reports or scientific details are incorrect - This is because each of 
 these cases must be reviewed by the appropriate 23andMe teams

What is NOT a Quality Complaint?:::::::::::::::::::::::::::::::::::::::::::: • Web store-related issues • No results reported to customers • Kit manufacturing defects • Customer misuse of kit • Sample failures • Genotype exceptions where sample is Held

Keep in mind that the above topics may be considered a QUALITY COMPLAINT IF THE CUSTOMER REPORTED PHYSICAL HARM, DISTRESS OR ANXIETY reported physical harm, distress or anxiety as a result of the issue. Escalate to Tier 2 in the event this occurs.

How to Escalate Potential Complaints to Tier 2 Customer Care Leads::::::::::::::::::::::::::::::::::::::::::::::::::::::::::

Once identified, all potential quality complaints must be escalated to Tier 2 Team Leads immediately.

  1. To escalate, select the box next to Flag ticket as a potential quality complaint.
  2. In the drop down menu, select the appropriate complaint category. Examples: • If customer burned their hand with the buffer fluid, select Kit Usage > Kit Issue • If customer is reporting that they have stopped taking their medication select Change in medical behavior
  3. After you have selected the appropriate complaint category, completed all other Zendesk fields, and entered the necessary internal notes in the ticket, escalate the ticket using the Move to Customer Care (Tier 2) macro. (Tier 2 No Response to the Customer)

Following the above steps allows Tier 2 to be notified of the incident.

Tier 2 Team Leads are responsible::::::::::::::::::::::::::::::::: • To notify QA of any potential complaint or any new information obtained during follow up that could reclassify an inquiry as a complaint. • To interact with the customer to ensure that their concerns are properly understood and communicated within the company and that their needs are met.

RA/QA Responsibility::::::::::::::::::::::::::::::::::::::: QA is responsible... • For administration, investigation and management of the complaint process. • For ensuring closure to any corrective action reports initiated, providing trend analysis reports to management RA is responsible... • For assessing whether a complaint is reportable to regulatory authorities. • To ensure that reportable events are properly documented and submitted according to regulatory guidelines

What is an MDR, Incident Report or FSCA?::::::::::::::::::::::::::::::: A report submitted to the FDA or EU Competent Authority (dependant on customer local) when 23andMe becomes aware of an event that reasonably suggests that our device has or may have caused or contributed to a death or serious injury; OR When 23andMe BECOMES AWARE of an event that reasonably suggests that our device has malfunctioned and that our device or a similar device would be likely to CAUSE or CONTRIBUTE to a death or SERIOUS INJURY if the malfunction were to occur again.

“Becomes aware” What does “becomes aware” mean? This is when a 23andMe employee acquires information that reasonably suggests a reportable adverse event has occurred.

This information can be acquired through a Customer Care interaction (phone call, chat, or email), or event outside of work. When you receive a report of an adverse event, you must treat it as a potential quality complaint and escalate the incident to Customer Care Team Leads through the channels discussed in the previous slides.

Customer Care Team leads are then responsible for reviewing the potential quality complaint and escalating it to QA.

“Serious Injury” An injury or illness that:

  1. Is life-threatening
  2. Results in permanent impairment of a body function or permanent damage to a body structure
  3. Necessitates medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure

MDR Reporting Timeframe

Regulatory Body RA needs to report when.. Timeframe: FDA When unreasonable risk 5 working days (United States) of substantial harm to public health requires remedial action

FDA May have caused or Within 30 calendar days (United States) contributed to a death from date of awareness or serious injury

FDA A device has malfunctioned Within 30 calendar days (United States) and the device or similar from date of awareness device would be likely to to cause or contribute to a death or serious injury if the malfunction were to recur

As you can see in the table above, 23andMe’s RA team has a limited number of days to report an adverse event to the FDA. This is why we need to ensure that all potential complaints are escalated appropriately to Tier 2 Customer Care immediately.

A- Answer R- Reason of the Answer E- Example of the Answer M- Message