California Comprehensive Compliance Program Declaration

 

Quanta Dialysis Technologies Inc. (“Quanta”) believes that adherence to all applicable laws, regulations, and industry standards is critical to our operations and success. Consistent with the guidance of the Department of Health and Human Services Office of the Inspector General (“HHS‐OIG”), Quanta has developed and implemented a Comprehensive Compliance Program (“CCP”) that is designed to prevent and detect violations of applicable law, compliance standards, and other Quanta policies.  Quanta’s CCP has been tailored to the nature of its business as a medical device manufacturer, but has been designed to incorporate and address the OIG’s seven fundamental elements of an effective compliance program.

 

Every Quanta employee is required to understand and comply with the obligations of the CCP. Quanta holds its representatives and vendors to the same standards of applicable laws and regulations as its employees.

 

California Spend Limit

 

Quanta has implemented an annual spending limit[1] of $2,500 on promotional materials, or items or promotional activities that Quanta may provide to California-licensed health care professionals. All interactions with health care professionals are subject to further restrictions as set forth in our CCP, AdvaMed’s Code of Ethics on Interactions with Healthcare Professionals (“AdvaMed Code”), and any other applicable policies.

 

Annual Declaration of Compliance

 

To the best of our knowledge, as of June 1, 2022, Quanta’s comprehensive compliance program addresses California’s statutory requirements for inclusion of policies addressing the OIG Guidance and limiting gifts and incentives to healthcare professionals. Accordingly, and subject to the above, Quanta declares that it is, in all material respects, in compliance with California Health & Safety Code §§ 119400-119402.

 

Please contact Quanta’s Legal Department at legal@quantadt.com for a copy of this summary and declaration document, or if you are aware of any activity that violates this policy and would like to discuss that activity anonymously.

 

 

[1] Consistent with the California statute and the AdvaMed Code, this dollar limit does not include: (a) product samples of our medical devices or disposables intended for free distribution to patients that are provided to hospitals and other medical institutions; (b) financial support for continuing medical education forums or health educational scholarships; (c) educational materials that directly benefit patients or are intended for patient use; (d) payments made for legitimate professional services provided by a California medical or health care professional; (e) travel and meal expenses for attendance at medial education and product training meetings; (f) training on the safe and effective uses of our medical devices consistent with approved uses; or (g) grants made to support bona fide research, fellowship programs and/or charitable initiatives of a California-licensed health care professional.

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