Annual Declaration of Compliance with California Law
KARL STORZ Endoscopy-America Inc. is the leading endoscope manufacturer that offers systems for human and veterinary medicine, as well as for industrial applications. Endoscopes, instruments, devices, and camera systems from KARL STORZ have stood for tradition, advanced technology, and quality for more than 75 years. Integrity in the form of trust, compliance, commitment, and accountability is an essential element of our corporate values and culture that shapes KARL STORZ’s business practices. To further this pledge, KARL STORZ has established and is maintaining a comprehensive compliance program to help us prevent and detect violations of our business standards, which is in accordance with California Health and Safety Code § 119402 (S.B. 1765).
The compliance program at KARL STORZ’s confirms our adoption of policies and procedures appropriate to our company, including compliance with the AdvaMed Code of Ethics on Interactions with Healthcare Professionals. Substantially like the PhRMA Code referenced in California Health and Safety Code § 119402, the AdvaMed Code addresses potential risk areas that apply to the unique environment of the medical device industry. Therefore, consistent with the OIG Guidance, the KARL STORZ’S compliance program includes policies for compliance with the AdvaMed Code.
Written Policies and Procedures
KARL STORZ Endoscopy-America, Inc. has written policies and procedures that state the company’s highest-level principles, to ensure compliance with applicable laws and regulations and support good business practices. KARL STORZ Endoscopy-America’s Code of Conduct translates our corporate values as well as laws, internal policies, and other guidelines into practical instructions that help KARL STORZ’s management, employees, contractors, and agents make responsible decisions. To emphasize the importance of the Code, we require each of our employees to certify annually that they agree to abide by it. Additionally, KARL STORZ, issues policies and guidance on a variety of other matters, including policies on evaluation products, educational grants, meal and travel reimbursements, sponsorships, and exhibits, and on interactions with health care professionals. All such policies and guidance require strict adherence to applicable laws and regulations.
Annual Spending Limit
Our company has established an annual limit of $2,500, as the aggregate value for meals, promotional materials, and educational items that may be provided to California healthcare professionals pursuant to the requirements of California Health & Safety Code § 119402 (S.B. 1765). This dollar limit represents a spending cap and doesn’t reflect the actual amount spent per physician annually, which is anticipated to be substantially less than this maximum amount.
Leadership and Structure
The Chief Compliance Officer is responsible for overseeing implementation and oversight of the Comprehensive Compliance Program, responding promptly to compliance-related issues, and taking corrective or disciplinary action necessary to resolve or remediate the compliance-related issue.
Training and Education
Education and training are essential to effectively communicating our standards and requirements to our personnel and enabling them to perform in accordance. KARL STORZ Endoscopy America has an annual Ethics and Compliance training process that includes testing and annual certification of appropriate employees. Employees are also trained on the company’s disciplinary policy that highlights the consequences of non-compliance with the requirements of the company’s Ethics and Compliance program.
KARL STORZ Endoscopy-America, Inc. promotes prompt reporting of any known or suspected violations of the Code of Conduct, KARL STORZ policies, procedures or guidelines, or any applicable law or regulation to supervisors, Human Resources (on HR matters), Compliance and Legal. Additionally, it also supports confidential reporting via online forum at https://go.karlstorz.com/ComplianceHotline and by phone at 1 (844) 348-5244 (toll free number). As with all questions and inquiries, the information given on the hotline is treated as confidential to the extent possible. KARL STORZ does not permit retaliatory action and will not tolerate any reprisals against employees who express concerns in good faith.
Auditing and Monitoring
The Compliance department at KARL STORZ have the authority and resources available to them to audit matters they deem necessary and periodically audits the organization’s compliance with its policies and procedures.
Enforcement and Disciplinary Measures
All reports of alleged violations are investigated by KARL STORZ. If the results of an investigation indicate that corrective action is required, the Company will decide the appropriate steps to take, including disciplinary action up to and including termination of employment. If appropriate, at its discretion, KARL STORZ may turn over an investigation to applicable outside authorities for assistance with the inquiry.
Responses To Detected Problems and Actions to Correct Issues
KARL STORZ requires a detailed analysis and diligent response to potential violations of the Company’s Ethics and Compliance program. Actions in response to detected problems may result in continuous improvements to policies, procedures, training, communication, and monitoring or may require disciplinary action to prevent future violations.
As of the date of this declaration, KARL STORZ Endoscopy-America, Inc. declares that, to the best of its knowledge, and based on a good faith understanding of the statutory requirements of California’s Health & Safety Code §§ 119400 – 119402 (S.B. 1765), KARL STORZ Endoscopy-America, Inc. is in compliance with its Compliance Program in all material respects. Last update: December 9, 2022.
Copies of this declaration and the Compliance Program may be obtained by calling corporate headquarters at 800 421-0837 (toll free).