May 2021 CHANGE REQUEST COVID-19 Biorepository Information Sheet

B-6b. National ALS Biorepository COVID-19 Safety Information Sheet

This document will provide general information to participants that would like to take part in the ALS Biorepository and get samples safely collected during the COVID-19 pandemic. This document will be included in the information packet along with other information that is sent to participants.

Introduction

On March 11, 2020, the Registry paused Biorepository specimen collections to protect the health of those taking part in the Biorepository and members of their households. We are now restarting Biorepository collections and have added precautions to ensure that staff, participants, and their caretakers/household members are protected from COVID-19. This is based on CDC guidance for non-COVID public health activities that require face-to-face interaction during the COVID-19 pandemic.

What you need to know

Changes in the Biorepository procedures have been made to;

• Minimize risk of exposure, illness, and spread of disease among staff working with the Biorepository;

• Minimize risk of exposure, illness, and spread of disease among those taking part in the Biorepository and members of their households; and

• Maintain essential functions of the Biorepository.

COVID-19 Safety

Face coverings are required and meant to protect others in case you are infected. Phlebotomists will wear a disposable surgical mask. The Biorepository staff will include at least two disposable face masks in each collection kit that is shipped to your home. Phlebotomists will go through training and all personal protective equipment will be provided before collections.

COVID-19 Screening

Before each appointment, participants, household members, and phlebotomists will be asked if they have experienced any COVID-19 symptoms in the past 14 days.

When appointments are scheduled, those taking part and household members will be told about the screening procedures. They will also be instructed to notify Biorepository staff to cancel their appointment if they are experiencing COVID-19 symptoms. Participants will be asked again about symptoms in a reminder call the day before their scheduled appointment.

Before entering the home, phlebotomists will be screened for symptoms associated with COVID-19. Phlebotomist will not be assigned to any collections if they answer yes to having any of the COVID-19 symptoms or traveled in violation of any federal, state, or local guidance or orders.

Feel free to contact a member of the National ALS Biorepository by phone at 1-855-874-6912 or by email at alsbiorepository@secure.mcking.com if you have any questions or concerns.