2024 CAP Staff Outstanding Achievement Award

The College of American Pathologists (CAP) established the CAP Staff Outstanding Achievement Award in 2015 to recognize employees whose contributions during their career have greatly impacted and supported the growth and improvement of the CAP, including its staff, its members, and patients.

The College of American Pathologists presents Helena L. Duncan, MJ, with the 2024 CAP Staff Outstanding Achievement Award in recognition of her exceptional contributions to the CAP, demonstrated by her excellent political acumen in the regulatory, legislative, and political arenas.

As an accomplished advocacy professional dedicated to the CAP, Helena has achieved success on many policy objectives over the last 15 years. From Washington, DC, Helena is the staff director who bridges health care policy and science as the CAP’s advocacy liaison between the Council on Government and Professional Affairs (CGPA), Council on Scientific Affairs (CSA), Council on Accreditation (COA), and the Council on Informatics and Pathology Innovation (CIPI). Recently, Helena has taken on regulatory efforts related to next-generation sequencing, artificial intelligence, and health data standards to keep up with new health policy issues.

During the COVID-19 pandemic, Helena focused on public health measures, specifically, advocating for emergency use authorizations pathologists and laboratories needed to develop new tests and remote sign-out capabilities, allowing for continuity of patient care.

A prime example is Helena’s exemplary work on the regulation of laboratory-developed tests (LDTs). The oversight of LDTs has challenged all interested stakeholders for more than a decade to find the right balance between safeguarding patients without overburdening laboratories. Anytime a new regulation is proposed, or new legislation is released on LDTs, Helena reliably provides near-instant analysis on how it will affect CAP members and align with long-held policy. Having worked with leading members to define principles for LDT oversight, Helena has expertly executed leadership’s directions and represented CAP policy positions in numerous meetings with the FDA, patient advocacy groups, industry, and other laboratory organizations. Helena has forged credibility not only for herself but also the CAP on this issue, which ensures the pathologist’s voice is well represented in all arenas where regulatory policy is debated.

To her colleagues, Helena is a pleasure to work with. She knows all things FDA and offers direct lines of communication with the CMS CLIA frontline. Despite her enormous portfolio and numerous projects, Helena is always ready to spend time educating a colleague on an issue or stepping up to help with a project, no matter how large or small. Helena’s knowledge of the FDA and LDTs is one of her tremendous gifts to the CAP, in addition to her knowledge of the scientific structure and member relationships within the CSA. She is also a leader in the CAP staff community, where she actively pursues various volunteer opportunities and chairs the employee resource group Black Opportunities Recognized Now (BORN).

Helena is an invaluable partner to the CAP as she is proactively engaged with the staff, identifying current and potential future issues and opportunities with government and regulatory bodies.

Helena Duncan is the senior director of quality at the College of American Pathologists’ advocacy office in Washington, DC.

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