Red Cross regulatory compliance programs
Our credibility as an organization, is deeply rooted in the trust of the American
public. To earn and maintain this trust, Red Crossers must comply with applicable federal,
state, and local laws and regulations, as well as with Red Cross policies. Regulatory
compliance touches many parts of our work; however, as the nation’s largest supplier of
bloodproducts,themostsignicantareaofregulatorycompliancefortheRedCrossis
related to our Biomedical Services mission.
Red Cross staff and volunteers comply with quality and regulatory standards to provide
blood products and services that meet the expectations of donors, recipients, health
care professionals and the American public. To ensure our adherence to Red Cross and
external standards, our Audit and Risk Management Committee provides oversight for
Biomedical Services quality and regulatory compliance.
The Red Cross is licensed by the U.S. Food and Drug Administration (FDA) and adheres
toadditionalguidanceandregulationsprovidedforbloodcenteroperations—such
as AABB, U.S. Centers for Disease Control and Prevention, and Clinical Laboratory
Improvement Amendments (CLIA). The FDA conducts regular inspections of Biomedical
Services facilities, and the Red Cross responds to all FDA observations from these audits.
In FY 2022, no FDA inspections resulted in Form 483 observational issues and there
were no nes or sanctions levied against the Red Cross by a regulatory agency.
To support our efforts to ensure a safe, adequate blood supply and regulatory compliance,
Red Cross Biomedical Services maintains a Quality Management System which monitors
performance, including facility and systems operations and donor and patient safety.
Additionally, we have an internal quality audit team that aims to promptly identify issues
so that we can address and implement solutions as soon as possible. Our rigorous
measures and processes led us to receiving International Standards Organization
(ISO) certication in May 2022, signifying our ability to provide high quality products
and services to our customers.
Concern Connection Line
A24-hour,condential,toll-freehotlinethatanyone
can use to report complaints or allegations of fraud,
waste, abuse, misappropriation, illegal or unethical
conduct, violations of safety standards or violations of
the Code or any Red Cross policy. Reports may be made
anonymously either online or by calling 1-888-309-9679.
In FY 2022, there were 303 total reports made to the
Concern Connection Line.
Biomedical Regulatory Hotline
A24-hour,condential,toll-freehotlineforreporting
concerns about the collection, manufacturing, processing,
distribution or utilization of blood and blood components.
Reports may include violations of regulations (FDA,
OSHA,etc.),falsication,trainingissues,qualityfailures
and computer and equipment issues. Reports may
be made by calling 1-800-741-4738. In FY 2022,
there were 26 total reports made to the Biomedical
Regulatory Hotline.
Ofce of the Corporate Ombuds
TheOmbudsisacondential,neutral,independent,
informal and impartial resource that can help identify and
discuss options for addressing or resolving concerns.
This service is available to all employees, volunteers and
members of the public by calling 1-866-667-9331 or by
email.TheOmbudsofceaveragesapproximately800
contacts per year.
The Red Cross also has multiple channels through which employees, volunteers, recipients of Red Cross services or members of the public can report concerns.
GOVERNANCE APPENDIXGOVERNANCESOCIAL — WORKPLACESOCIAL — MISSIONENVIRONMENT ESG REPORT 2022 | 20SOCIAL — MISSION APPENDIXGOVERNANCESOCIAL — WORKPLACEENVIRONMENT