California 2013 Compliance Policy

INTRODUCTION

LifeCell™ has established a program, in accordance with the AdvaMed Code of Ethics on Interactions with Health Care Professionals, designed to materially comply with applicable federal and state laws and industry standards relating to the marketing and promotion of its products.  The AdvaMed code advocates seven elements for an effective compliance program.

Overview of Compliance Program

1. Written Policies and Procedures

LifeCell™ has written policies to assure substantial compliance with the applicable laws and regulations and standards governing the marketing and promotion of our products. LifeCell™ has established written policies that govern activities involving interactions with our customers regarding the appropriate use of our products including appropriate instruction, education, training, and technical support required for the safe and effective use of our products. LifeCell™ also has policies governing activities involving the advancement of scientific and educational activities supporting medical research and education. 

It is our policy not to provide Entertainment such as sporting events or golf outings to customers. LifeCell™ has established an annual limit of $2,000.00 for meals and educational items as the aggregate value of the items or activities that may be provided to California health care professionals.

2. Assigned Compliance Officer

LifeCell™ has appointed a Chief Compliance Officer, who has been empowered with appropriate authority to exercise independent judgment and has free and unencumbered access to senior management.

In addition, a Compliance Committee has been formed. This committee is comprised of the company's Chief Compliance Officer and members of the company's management team.

3. Training

LifeCell™ has an annual Health Care Compliance training process that is mandated for all employees. New associates received training at the time of hire and annually thereafter. The training covers applicable guidelines governing our compliance program.

4. Communication

LifeCell™ encourages open and candid discussion between management and employees regarding any compliance concerns. LifeCell™ employees are encouraged to report their concerns to their manager, to the Human Resources Department, or to the company's Compliance Officer. Associates also have the option to report potential violations by calling the LifeCell™ AlertLine at (800) 279-3239.

5. Auditing and Monitoring

LifeCell™ self-assesses and audits its compliance programs and reviews policies and procedures periodically. Audit observations are tracked to ensure timely closure of any identified items.

6. Enforcement and Disciplinary Guidelines

LifeCell™ will take disciplinary actions in response to violation of the company's compliance policies or procedures. An investigation of any matter that is brought to the company's attention will occur and will be brought to closure in a timely manner.

7. Responses to Detected Problems and Actions to Correct Issues

LifecCell™ responds promptly to any potential violations of the company’s compliance program.  Reponses may include additional training, enhanced communications, refinement of policies, or possible disciplinary actions.