Melissa O’Connor, MS, RAC, CTBS on the Importance of Healthcare Quality in Ensuring Optimal Patient Outcomes

This week is Healthcare Quality Week. Healthcare Quality Week was established by the National Association for Healthcare Quality and is a dedicated time to acknowledge the progress made by healthcare and quality professionals toward improving patient outcomes.1

StimLabs’ Take on Healthcare Quality

Here at StimLabs, we believe that product safety and quality are paramount when striving for optimal patient outcomes. As Vice President of Quality Assurance and Regulatory Affairs, it is my utmost goal to ensure the products StimLabs distributes are free from communicable disease and safe for transplant. Our team follows rigorous procedures to ensure donor tissue safety and that final products are free from contamination that could potentially lead to adverse outcomes. Even in the midst of a global pandemic, with all the challenges we face both professionally and personally, our teams’ commitment to quality and safety for patients remains at the forefront of everything we do. Healthcare Quality Week celebrates the contributions professionals have made to improve healthcare quality. My team of quality professionals includes quality assurance specialists, quality control technicians, donor services staff, regulatory affairs specialists and a strong management team that orchestrates the delicate dance our team performs each day to ensure StimLabs’ success in delivering high quality, safe products that adhere to or exceed the strictest regulatory standards.

Why Regulatory Compliance in Healthcare Matters

Recently, I gave a virtual presentation at the 8th Annual Medical Device Regulations conference co-sponsored by the US Food and Drug Administration (FDA) and the University of Georgia’s International Biomedical Regulatory Sciences program where I discussed the evolution of the FDA’s regulatory framework for human cells, tissues and cellular and tissue-based products (HCT/Ps). In this presentation I provided an overview of the regulations companies like StimLabs follow in order to ensure our products are safe and free from communicable disease agents that could cause adverse outcomes for patients. As a leader in the development and supply of regenerative medicine products, StimLabs appreciates the events that led to the development of this important regulatory framework and places the highest emphasis on regulatory compliance. A key component of the regulations I discussed at the conference is donor screening and eligibility determination. The process my team follows to determine donor eligibility includes a comprehensive screening process that exceeds minimum requirements outlined by the FDA; this process not only demonstrates our commitment to regulatory compliance, but also ensures our patients receive only the highest quality and safest products available on the market. The performance of the donor screening team is measured by quality, not quantity, and team members are celebrated, incentivized and rewarded based on the quality of their work.

In the ever changing and evolving regulatory landscape of medical products, it is StimLabs’ belief that it is the responsibility of product manufacturers to ensure that they are adhering to the latest guidelines and regulations put forth by governing agencies to ensure optimal product quality and patient safety. I applaud my entire department, my colleagues, and the StimLabs’ leadership team for their hard work and dedication to the field not only this week, but every week. Thank you for all you do!

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1. National Association for Healthcare Quality. Healthcare Quality Week October 17 – October 23. https://nahq.org/event/healthcare-quality-week/. Accessed 31 August 2021.

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