California Comprehensive Compliance Program and Compliance Declaration

Radiometer America. INC. is providing this information pursuant to the requirements of California Health and Safety Codes §§119400-119402 (the "Statute"), which requires certain medical device companies doing business in California to make available their Compliance Program and annual written Declaration of compliance with the Compliance Program.

 

The Description and Declaration below covers Radiometer America and HemoCue. ("Radiometer").

Introduction

Radiometer America Inc. is committed to doing business in accordance with the highest standards of business conduct and ethics, and we consider our reputation for ethical and compliant behavior to be a valuable corporate asset. Accordingly, Radiometer has established a Compliance Program ("CP") in accordance with California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 119400?119402 (the "Statute"), based on our good faith understanding of the requirements of the Statute as it may apply to a medical device manufacturer, and the Compliance Program Guidance for Pharmaceutical Manufacturers ("OIG Guidance") published by the Office of Inspector General, U.S. Department of Health and Human Services. 

Our Compliance Program, applied in conjunction with our MedTech Healthcare Professional Engagement Policy ("MedTech Policy"), is tailored to Radiometer’s size, organizational structure, available resources, and the nature of our business as a medical device manufacturer. The medical device industry has established, and Radiometer’s Compliance Program is designed in accordance with, the AdvaMed Code of Ethics on Interactions with Healthcare Professionals (the "AdvaMed Code"). The AdvaMed Code is a voluntary ethical code substantially similar to the Pharmaceutical Research and Manufacturers of America Code on Interactions with Healthcare Professionals (the "PhRMA Code") but was developed with a primary focus on the unique interactions between medical device manufacturers and healthcare professionals and is thus more uniquely suited to Beckman's compliance needs. 

This is a description of Radiometer’s Compliance Program. It reflects the plan and policies we have implemented, but the Compliance network is a dynamic and continuously developing entity requiring coordination between multiple policies and programs as well as the commitment of our management team and associates. While adoption and implementation of appropriate policies cannot guarantee complete elimination of improper conduct, it is Radiometer’s expectation that all associates will comply with our Compliance Program and all applicable laws, rules, and regulations. Radiometer’s passion for continuous improvement in all areas of our business dictates that we regularly review and enhance our Compliance Program to adapt to our evolving compliance needs.

Overview of Compliance Program

1. Leadership and Structure.

   Our Compliance Program has been developed by Radiometer’s Compliance leadership and is managed by its desginated Compliance Officer. Company Management works with the Compliance team to ensure Radiometer  effectively prevents, detects, and reacts to instances of non-compliance.
   
   

2. Policies and Procedures.

   Radiometer America Inc.’s Code of Conduct is our statement of ethical and compliance principles that guide our daily operations.  The Code establishes that we expect management, employees, and agents of the Company to act in accordance with law and applicable Company policy.

   The Code articulates our fundamental principles, values and framework for action within our organization.

   As required by the California Health & Safety Code 119400-119402, we also have established an annual spending limit of $1,500 for certain promotional activities directed toward healthcare professionals in California.
   
   

3. Education and Training. 

   A critical element of our Compliance Program is the education and training of our employees on their legal and ethical obligations under applicable federal health care program requirements.  Radiometer America Inc. is committed to taking all necessary steps to effectively communicate our standards and procedures to all affected personnel.  Moreover, Radiometer America Inc. will regularly review and update its training programs, as well as identify additional areas of training on an “as needed” basis.
   
   

4. Internal Lines of Communication. 

   Radiometer America Inc. is committed to fostering dialogue between management and employees.  Our goal is that all employees, when seeking answers to questions or reporting potential instances of fraud and abuse, should know who to turn to for a meaningful response and should be able to do so without fear of retribution.  Radiometer America Inc. has established a Compliance Hotline to allow for anonymous reporting of potential violations of law or Company policy.
   
   

5. Auditing and Monitoring. 

   Radiometer America Inc.’s Compliance Program includes efforts to monitor, audit, and evaluate compliance with the Company’s compliance policies and procedures.  We note that in accordance with the HHSOIG Guidance, the nature of our reviews as well as the extent and frequency of our compliance monitoring and auditing varies according to a variety of factors, including new regulatory requirements, changes in business practices, and other considerations.
   
   

6. Investigating and Responding to Potential Violations. 
   Our Compliance Department monitors company functions and activities for potential violations of law, regulation, industry codes, the Code of Conduct and company policies. Potential violations are promptly and thoroughly investigated and appropriate corrective action taken.
   

7. Corrective Action Procedures. 

   In determining the appropriate response to an established violation, our Company considers various options for corrective action. These options include remediation to evaluate current practices and close any gaps in policies, practices or training that may have led or contributed to the violation, as well as the imposition of disciplinary action up to and including termination.

 

STATE OF CALIFORNIA

COMPREHENSIVE COMPLIANCE PROGRAM DECLARATION

July 1, 2022

To the best of our knowledge, Radiometer America Inc. has established a Compliance Program in accordance with California Health and Safety Code, Division 104, Part 15, Chapter 8, Sections 1 19400-1 19402 (the “Statute”), based on our good faith understanding of the requirements of the Statute as it may apply to medical device manufacturers.  Radiometer America Inc. has developed a Compliance Program consistent with the Compliance Program Guidance for Pharmaceutical Manufacturers (which is expressly applicable to medical device manufacturers) published by the Office of Inspector General of the U.S. Department of Health and Human Services.  Our Compliance Program is tailored to the size, organizational structure, nature of our business as a medical device manufacturer, and resources of our Company.  The medical device industry has established, and Radiometer America Inc.’s Compliance Program is designed in accordance with, the AdvaMed Code of Ethics on Interactions with Health Care Professionals (the “AdvaMed Code”).  The AdvaMed Code is a voluntary ethical code established by the medical device industry.  It is substantially similar to the Pharmaceutical Research and Manufacturers of America Code on lnteractions with Healthcare Professionals, but reflects the unique interactions between medical device manufacturers and health care professionals.

While adoption of appropriate policies does not necessarily guarantee that improper employee conduct will be entirely eliminated, it is Radiometer America Inc.’s expectation that employees will comply with our Code of Conduct, healthcare compliance policies and other policies adopted in support of the Code.  Furthermore, our Compliance Program has been designed to prevent and detect violations.  In the event Radiometer America Inc. becomes aware of potential violations of law or Company policy, the Company will, where appropriate, investigate the matter, take disciplinary action, and/or implement corrective measures to prevent future violations.  This description of our Compliance Program reflects the plan we have implemented.  We will periodically reassess the program to improve it, and may refine the elements as necessary.  Radiometer America Inc. is committed to upholding the highest standards of business conduct and ethics in its relationships with customers, employees, shareholders, the business community, and state and federal governments.

A copy of Radiometer America Inc.’s Compliance Program and this declaration may be obtained by calling 800-736-0600 extension 51056.