quick start guide monitored rapid tests

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Proprietary and Confidential — Not for distribution. Updated August 2021 1 Monitored rapid tests: Quick start guide

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Proprietary and Confidential — Not for distribution.

Updated August 2021

1

Monitored rapid tests: Quick start guide

Proprietary and Confidential — Not for distribution.Proprietary and Confidential — Not for distribution. 2

Proprietary and Confidential — Not for distribution. 3

Color is excited to be partnering with [customer] to expand access to COVID-19 testing. Our goal is to provide a program that meets your needs while simultaneously providing you with a high level overview of the process from now until your program launches.

In this partnership, Color will prioritize your experience and support you in each step of creating a seamless COVID-19 testing system for your population. Strong ongoing communication will be critical to the success of this program.

Your Color Customer Success Manager [Name, email] and Program Operations Lead [Name, email] will be ready to assist you along the way.

How we work

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Getting started

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To get started preparing for your program, there is some information we need to collect from you. To this end, you will receive a separate email with a link to a form, requesting you to fill out key information. It is critical that you fill out the form at least 14 days before the target start date of your program.

The following pages provide an overview of the information we’re requesting as well as key reference materials to help you prepare for you testing program.

There are 3 main sections to this document:

Preparing to test and set up the testing site

01 02Preparing to communicate results

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Preparing to set up the testing site

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01

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Contact information (name, title, email, phone #) for key roles (e.g., project magr., IT, etc.)

Information to collect Why this is important NotesTo be able to work out the details of your program and know who to go to for certain patient-specific questions

More details on this page

01 Information we will collect through form

Shipping address, and contact name, email, phone # for receiving the kits and supplies

We need to know where to send the test kits and who to address them to

If you have multiple sites, you have the option of filling out the form several times or filling out a template for batch upload

Testing schedule (days and hours) Common question our support team gets

Registration method (unique URL or participant pre-registration list)

Need to know whether patients will need to register or if info of eligible patients will be provided in advance

More details on this page

More details on this page

Estimated # of people to test / wk Helps us plan for # of kits to ship each week

Ordering physician and practicing institution information

Color tests are physician ordered; if you don’t have an ordering provider we can help you secure one

More details on this page

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To work out the details in setting up your program, and to be able to consult on patient-specific questions, we need names and contact information from key representatives in your organization in the following areas

Key contacts information

Project manager The person who will be responsible for overall coordination and day-to-day management of the testing program for the organization. This person will also assign access to PHI and aggregate dashboards.

Site managerPerson who will be onsite and responsible for assigning roles to other onsite staff.

IT/TechSomeone in the organization who we can talk to for any technical issues, including domain, email addresses, and onsite tech tools (e.g., APIs, SFTP).

Note: It is ok to have the same person be the representative for different roles.

Operations and logisticsOur main point of contact for site set-up, supply needs and day-to-day operations.

Customer supportWe’ll take care of all Color-specific questions but we need a contact that we can direct partner-specific questions to (e.g., testing locations, pick-up / drop-off times, compliance). This can also be a website.

Eligibility supportSomeone in the organization that we can go to for eligibility-specific questions.

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In order to test participants, we need to gather some information from them (e.g., first and last name, date of birth, email, etc.) which we will confirm at the moment of check in.

Unique URL or QR code:We will provide you with a unique URL that you can share with the participants in your testing program so they can register for testing.

Participants must register in advance prior to walking up to testing stations.

⚙ Pre-registration through data file: You will provide Color with a participant data file that contains key information on the people you are testing.

In this option, participants do not need to register in advance and can just walk up to the testing stations.

Registration method

We have two options for this:

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You will need to provide a file (.xlsx or .csv) listing all the participants who are eligible for testing with the following fields as columns:

You can use the template on this link as a base for your participant data file. To ensure this information is shared in a secure way, you will need to share it via secure email or SFTP. Please reach out to your CSM to get guidance on this.

Field(column header)

Description(participant’s…)

Required / Optional Example

First_Name First name Required JohnLast_Name Last name Required Smithbirthday Date of birth Required 09/13/1989sex Female, Male, non-binary Optional* group1wEmail_work Work email address Optional* [email protected]_personal Personal email address Optional [email protected]_mobile Mobile phone # Optional* 999-999-9999Phone_work Work phone # Optional 888-888-8888

Uploading a participant data file

Field(column header)

Description(participant’s…)

Required / Optional Example

Street Home address line 1 Optional* 123 Main St.Street_2 Home address line 2 Optional Apt. 101City Home city Optional* BurlingameState Home state Optional* California

Zip_code Home zip code Optional* 94010

Ethnicity Hispanic, Not hispanic Optional* Hispanic

RaceAmerican Indian, Asian, Black or African American, Native Hawaiian, White, Unknown

Optional* White

*Must be provided during check in process

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We understand you might need to track results at different levels or view the data in different ways.

By using Populations you can disaggregate results by location and/or group. This can be particularly useful for contact tracing, outbreak management, and compliance tracking.

How to use populations (optional)

Note that this is an optional feature. You will still have access to aggregate results if you choose not to use this. If you do, we will create different URLs for each population.

● San Francisco employees and San Francisco contractors ● Atlanta office, Chicago office, Memphis office, New Orleans factory,

and Tulsa warehouse● New York office staff and New York field staff● Building 1, Building 2, Building 3, and Floaters

Populations can be created for different test sites, staff functions, or other parameters, for example:

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Participant handoutsImportant reminder

As you hand tests out to participants, it is important to remind them to carefully review and follow the instructions provided by the kit manufacturer.

We have created this handout that should be given out to each person along with the rapid test kit being used.

Please reach out to your CSM if you would like Color to provide printed out copies for your organization.

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Station 1: Check in Station 2: Sample collection

Site setup

Check in station enables technology access to those who might not have own mobile device / tablet/ laptop

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Link to all signage templatesSignage Templates

Proprietary and Confidential — Not for distribution.

[Company]

We have developed an email template to make it easy for you to share the news of the Color testing program with your population.

You can access the template on the link below:

● Email for new program launch

Announcing the program

[Company] COVID-19 Testing AnnouncementEmail template

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These tests require a blanket order signed by a physician. If you don’t have an ordering physician, we can assist you by connecting you with one of our partner providers.

We will require the following information which we will collect through the form emailed to you.

● Provider first and last name● Role/specialty (e.g. OB/GYN, NP)● NPI Number● Phone number (may be same as institution) ● Fax number (may be same as institution)● Email

● Name of institution where the provider practices

● Institution address● Institution phone● Institution fax

Note that all these fields are required. Please make sure to provide them all to avoid delays.

Ordering physician

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Preparing to communicate results

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02

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As part of our partnership, Color can send emails to your participants. In order to ensure these emails are delivered to your participants, please have your IT department whitelist [email protected] or preferably the @color.com domain.

Whitelist @color.com domain

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We want to provide you with updated program metrics. You will have visibility into the number of tests administered, the positive and inconclusive result rate, sample processing and appointment data. This dashboard is intended for program administrators / program leads.

Program aggregate dashboard

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This dashboard contains Protected Health Information (PHI) as it is a complete view of all testing participants and relevant information including participant first and last name, birthdate, result type and date the result was released. This dashboard is intended for program administrators / campus health services who need to know individual-level information about all testing participants and would be following up with anybody who tested positive and running the contact tracing protocols.

Individual PHI dashboard

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Information accessible via the PHI dashboard is a high-level summary of patient data from Color’s clinical results. By accessing the dashboard, you understand and acknowledge the following: Color's Clinical Provider Portal (CPP) is the means by which Color returns validated, clinical results as required under CLIA and CAP; the information you access via the dashboard has not been compiled as part of Color’s standard clinical reporting process, nor has it been validated or signed out in accordance with CLIA or CAP requirements; and information accessed through the dashboard does not constitute clinical reporting or results. You acknowledge and agree that you will only access and share data from the dashboard consistent with the forgoing, as permitted under applicable federal and state law (including HIPAA), rule, and regulation, and that, by accessing this dashboard, you expressly accept liability for any breach thereof.

Important notice re: PHI dashboard

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We are excited to partner with you and committed to support you in every way possible. If you have any other questions, please don’t hesitate to reach out to your Customer Success Manager or Program Operations Lead.

We also encourage you to visit our knowledge base (https://docs.color.com/docs) for detailed reference materials and how-to guides for each of our different tools.

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[Name, email]Customer Success Manager

Questions and additional resources

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[Name, email]Program Operations Lead

© 2021 Color Genomics, Inc. CLIA #05D2081492 - CAP #8975161

color.com

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