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Compliance Policy

Policy Information

Policy Number: 04.13
Issued Date: 07/01/2006

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Policy Statement

Duke requires its staff, medical staff, and contractors to comply with all applicable federal, state and/or local laws and the related Duke policies and procedures.  Any intentional violation of such laws, policies and procedures will result in corrective action.  Corrective action steps may vary, depending on circumstances and the severity of the violation, and can range from a verbal warning up to and including termination. Duke also requires the prompt reporting of situations in which individuals suspect that violations of such laws, policies and procedures may have occurred.

  • In addition to these general requirements, staff, medical staff and contractors related to Duke Health have additional responsibilities and requirements which are included in Integrity in Action, the DUHS Corporate Compliance & Code of Conduct.

Policy Details

Speak-up Statement and Reporting Concerns

Duke wants you to speak up when words, behaviors or actions are not consistent with our values.  Concerns that should be reported include, but are not limited to:  criminal activity, harassment, suspected fraud, compliance violations, research misconduct or other violations of Duke’s Statement on Values and Culture, the institutional Code of Conduct or Duke Health’s statement on Integrity in Action.

It takes courage to come forward.  Retaliation for reporting your concerns is strictly prohibited.

If you witness or are asked to participate in actions that are not consistent with our values or with policies, standards or laws, tell someone.  Ask your supervisor or department head for advice.  If that is not possible, contact 800.843.9793 to discuss your question or report your concern.  The toll-free number is a confidential, and anonymous if you choose, service provided 24 hours per day, 365 days per year.  A third party administers the toll-free line and refers the information to the appropriate audit or compliance office for follow-up action. 

Duke commits to conducting a fair and expeditious inquiry and to use any information to correct errors, make improvements and ensure accountability.  Should illegal activity be suspected or confirmed, Duke has a duty to report those facts to the appropriate authorities.

Staff, faculty and students may also directly contact Duke’s Office of General Counsel, Duke Human Resources or the Office of Audit, Risk and Compliance.  These resources are available during normal business hours for confidential advice and consultation.

If any member of the Duke community has concerns about a Duke student’s behavior or health, resources and assistance are available through the DukeReach program.

Research Integrity and Misconduct

Research at Duke University occurs in many forms and includes (but is not limited to) laboratory research, field research, research with animals or human subjects, student or trainee-led research, surveys, questionnaires, community-based research, and many types of data analyses.  Duke University has implemented multiple programs/initiatives to support a culture of rigor, reproducibility, and responsible conduct of research.  These programs are intended to support a culture of research integrity at all levels and are described on the Duke Office of Scientific Integrity website.

A subset of problems that can occur in research are defined as Research Misconduct under the federal regulations.  Research Misconduct means fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.  Fabrication is making up data or research and recording or reporting them.  Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.  Plagiarism is the appropriation of another person’s ideas, processes, results, or words without giving appropriate credit. 

Problems that may represent potential research misconduct are reviewed under the Duke University Policies and Procedures Governing Misconduct in Research, which can be found at this link:

Any questions about Research Integrity, Misconduct in Research, or the policy above can be referred to Duke Office of Scientific Integrity.

Reporting Concerns Related to Research Misconduct

It is the responsibility of all Duke staff to bring potential research misconduct or other research compliance concerns or violations to the attention of management so that they can be properly addressed. These issues should be reported immediately using any of the following means:

  • Report directly to a supervisor, business manager, department head, or dean.
  • Report to the subject-specific compliance office which deals with the issue involved (e.g. the Occupational and Environmental Safety Office for laboratory safety concerns, the Duke Office of Scientific Integrity/Misconduct in Research Office for problems in research, or the Research Costing Compliance Office (RCC) for research cost compliance issues).
  • Contact the Office of Audit, Risk and Compliance (OARC). OARC can be reached by phone at 919-613-7630 or via email at OARC@duke.edu. OARC will coordinate with the appropriate compliance office(s) and operational units to address all concerns raised.
  • Contact 800.843.9793 to discuss your question or report your concern.  The toll-free number is a confidential, and anonymous if you choose, service provided 24 hours per day, 365 days per year.  A third party administers the toll-free line and refers the information to the appropriate audit or compliance office for follow-up action. 

All concerns reported to any Duke compliance office are taken seriously and will be reviewed to determine the appropriate course of action. The confidentiality of individuals assisting Duke by providing contact information will be protected to the extent allowed by law or policy. Duke policy, and in many cases federal law, protects individuals bringing such concerns forward in good faith from any retaliation and/or retribution.

Integrity in Action - Duke University Health System Corporate Compliance Program & Code of Conduct

Compliance is individuals' understanding of their job responsibilities and following the laws, regulations, and internal policies that apply to their work. The DUHS Compliance Program creates the framework to ensure that the workforce is properly trained to follow all the laws, regulations, and policies that relate to the operations and provides a way for the workforce to raise compliance concerns and ask questions.

The Compliance Office oversees the program and addresses such activities as:

  • Honoring patients' rights
  • Maintaining and retaining records
  • Billing and coding for services
  • Protecting the health and safety of human and animal subjects in research
  • Reviewing Conflict of Interest
  • Providing a safe working environment free from disruptive and inappropriate behavior
  • Protecting the confidentiality of patient, business, and personal information
  • Complying with all the laws governing federal- and state-funded health care programs and the requirements of insurance companies

All DUHS staff, medical staff, volunteers, contractors, vendors and others with whom we do business are required to comply with federal, state and local laws and regulations, the DUHS Compliance Program, the Duke Health Code of Conduct and other Duke policies and procedures

Anyone who violates applicable policies, laws, regulations such as the False Claims Act, or the Code of Conduct may be disciplined. Individuals may also be disciplined if they do not report a compliance violation. Disciplinary action may include being terminated or having a contract revoked.

It is a violation of the Federal and North Carolina False Claims Act for anyone to knowingly submit, or cause another person or entity to submit, false claims for payment of government funds. Examples of actions that could violate the False Claims Act include:

  • Filing a claim for services that were not provided.
  • Filing a claim for services that were provided but were not medically necessary.
  • Submitting a claim containing information known to be false.

Penalties for such action(s) may be three times the government's damages plus civil penalties of $5,500 to $11,000 per false claim and in criminal cases may include imprisonment. Healthcare organizations also can be excluded from participation in federal health care programs.

The False Claims Act contains provisions that allow employees with actual knowledge of alleged false claims to sue on behalf of the government. These individuals will be protected from retaliation, e.g., harassment, demotion, and wrongful termination, as a result of the employee's lawful acts in furtherance of a false claims action.

Anyone who has a question or suspects a violation of the False Claims Act or any other federal or state law, the DUHS Compliance Program, the Duke Health Code of Conduct, or other policies or procedures has a duty to report the issue. The following reporting channels may be used to inform Duke management officials of questionable activities:

  • Report directly to the supervisor, department head or chair, facility compliance officer or to the DUHS Chief Compliance Officer (668-2573). Click here for a list of compliance contacts.
  • Call the toll-free Duke Health Compliance Program Integrity Line (1-800-826-8109). Reports may be made anonymously and all calls are not recorded or traced.
  • Email the DUHS Compliance Office at compliance@dm.duke.edu

No one who in good faith reports an actual or suspected violation of a law or DUHS policy will experience any retaliation or retribution as a result of such reporting, regardless of whether or not, after the investigation, a violation is found to have occurred.

DUHS Reporting Channels

Staff who have compliance questions or concerns should report questionable activities to their supervisor, department head or chair, their facility compliance officer, or to the DUHS Chief Compliance Officer. A list of compliance contacts may be found at intranet.dh.duke.edu/compliance. Alternatively, staff can call the toll-free "Compliance Program Integrity Line" at 1-800-826-8109 to report such information. This hotline is operated by an outside company and is available 24 hours a day, 365 days a year. Staff can call this hotline to report compliance concerns anonymously, and calls will not be recorded or traced.

DUHS maintains a "zero tolerance" policy toward violations of applicable laws or for other wrongdoing. Anyone who violates applicable policies, laws, regulations, or the Duke Health Code of Conduct may be disciplined. Staff, medical staff, and contractors may also be disciplined if they do not report a compliance violation. Corrective action may result in the revoking of a contract or in full termination.

Accuracy, Retention and Disposal of Records

Duke staff are responsible for the integrity and accuracy of our organization’s documents and records. No one may alter or falsify information on any record or document. Medical and business documents and records will be retained in accordance with the law and our record retention policies.

During a government inspection, employees must never conceal, destroy or alter any documents, lie or make misleading statements to government representatives.

Compliance and Fraud-Reporting Hotlines

Duke staff, medical staff, students or contractors can call either of the toll-free compliance hotlines to report information related to suspected fraud activities or compliance violations. These hotlines are operated by an outside company and are available 24 hours a day, 365 days a year. Calls can be made anonymously and will not be recorded or traced.  Follow up contact with individuals making reports will only be made with their permission. 

  • For DUHS and the Duke Health Integrity Line, please call 1-800-826-8109.
  • For the Duke University Compliance and Fraud Hotline, please call 1-800-849-9793.

False Claims Act

It is a violation of the Federal or North Carolina False Claims Act for anyone to knowingly submit, or cause another person or entity to submit false claims for payment of government funds. Examples of actions that could violate the False Claims Act include:

  • Filing a claim for services that were not provided.
  • Filing a claim for services that were provided but were not medically necessary.
  • Submitting a claim containing information known to be false.
  • Using federal research funds for purposes unrelated to the grant.

Penalties for such action(s) may be three times the government's damages plus civil penalties of $5,500 to $11,000 per false claim and in criminal cases may include imprisonment. Healthcare organizations also can be excluded from participation in federal health care programs.

The False Claims Act contains provisions that allow employees with actual knowledge of alleged false claims to sue on behalf of the government. These individuals will be protected from retaliation, e.g., harassment, demotion, and wrongful termination, as a result of the employee's lawful acts in furtherance of a false claims action.

Anyone who has a question or suspects a violation of the False Claims Act has a duty to report the issue. The following reporting channels may be used to inform Duke management officials of questionable activities:

  • For DUHS, reports should be made to the DUHS Compliance Office (668-2573) or the Integrity Hotline (1-800-826-8109) or to other approved DUHS Reporting Channels.
  • For Duke University, reports should be made to the Institutional Ethics & Compliance Office (613-7691) or the Compliance & Fraud Hotline (1-800-849-7691).

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