Client Business Situation
AFHCAN (Alaska Federal Health Care Access Network), an organizational unit of the Alaska Native Tribal Health Consortium (ANTHC) is an organization dedicated to improving the healthcare delivery of the native Alaskan population through a diversified healthcare delivery model. AFHCAN, as part of its overall mission, has developed innovative and proprietary medical device data systems (MDDS) that facilitate the delivery of medical assessment, diagnosis and treatment at remote, rural locations at the fringes of Alaska’s populated regions.
The MDDS systems aggregate medical data (measurements from instruments, data from patient interviews, etc.) for review and assessment at regional, urban medical centers that have greater access to medical specialties and personnel. The MDDS systems also provide qualified non-physician treatment professionals with the ability to perform “tele-health” delivery through real-time interaction with actual physicians and specialists located at an urban hospital setting in Anchorage, AK. Since the formation of the ANTHC in the late 1990s, the development and implementation of the MDDS systems, and the ability to deliver healthcare services to such a remote population had been nothing less than transformative for the native Alaskan population. The AFHCAN MDDS systems had become essential in keeping costs in control, and improving healthcare outcomes.
In early 2013, AFHCAN contacted Compliance Architects® due to uncertainties with FDA’s regulatory treatment of MDDS systems at the time of the engagement. The FDA local office had considered the MDDS systems to be “in interstate commerce” and therefore subject to FDA jurisdiction. The client was concerned that their quality system may not conform to the requirements of 21 CFR 820 and corresponding FDA expectations. They were concerned with their ability to successfully host an FDA inspection and therefore, potential impact to their ability to deliver services to their native Alaskan constituency.
Client Business Pain
In this engagement, the client was acting proactively to ensure continued ability of its constituency to receive quality healthcare despite their remote geographic locations. The client did not possess extensive experience in FDA regulatory requirements and expectations for MDDS systems. In addition, due to the nature of the organization as a public-service non-profit, it was important that solutions and recommendations be prioritized for significance, and that approaches for remediation be cost-conscious.
Solutions Provided/Services Delivered
- A three day onsite audit, along with full delineation and explanation of observations;
- Inspection readiness training;
- Remediation activity planning and resource capability discussions.
The assessment was conducted in accordance with accepted industry practices. Compliance Architects® reviewed and verified provided information against contemporary FDA requirements and expectations. The audit portion focused on, among other things: 21 CFR 820 quality system readiness and robustness; product and software release practices; organizational readiness; validation and commercialization certification activities; design and functional performance capability assessments; and other areas related to FDA inspection readiness. A final audit report, encompassing assessment of ANTHC quality system practices, organizational capability and FDA inspection readiness was prepared.
AFHCAN received a number of benefits from the consulting engagement that will help to advance their ability to continue development and delivery of essential healthcare solutions, with a reduced FDA enforcement risk profile:
- The AFHCAN organization was exposed to a rigorous approach to assessing the adequacy of individual quality system areas, providing important experience for the quality and operational teams in advance of a potential FDA Inspection;
- The organization received a comprehensive, prioritized report with a thorough listing of observations that will help them to prioritize and address deficiencies in a risk-based, cost-effective manner; and
- AFHCAN Senior Management became aware of the need to make appropriate investments in personnel and infrastructure that will reduce exposure from potential enforcement actions during an FDA inspection.