COMPLIANCE

UNIVERSITY OF OKLAHOMA

COMPLIANCE AND QUALITY IMPROVEMENT PROGRAM

I. Adoption of Compliance and Quality Improvement Program.

1.01 Purpose of the Program.

The University of Oklahoma (the “University”) is committed to the highest standards of ethics~~, honesty, and integrity~~ and to compliance with all applicable laws and regulations. The ~~purpose~~ goals of this Compliance and Quality Improvement Program (the “Program”) is are to: call the attention of persons associated with the University to some of the laws and regulations applicable to academic institutions. The Program is intended to (a) promote legal and ethical behavior in the academic context and (b) prevent and detect violations of law. The Program is intended to provide for more effective and efficient compliance efforts and oversight.

(a) protect research subjects, patients and employees through more effective and efficient compliance efforts and oversight; and (b) assist faculty and staff with the myriad of complicated laws and regulations to which they are subject in a way that facilitates the University’s critical missions. Training and education will be the key mechanisms for achieving these goals.

1.02 Action by Board of Regents.

This Program was originally adopted on the 30^th day of January 2002 by resolution of the University’s Board of Regents (the “Board”). It was revised on December 3, 2002.

1.03 Pre-existing Standards and Procedures.

In addition to this document, the University has established and maintains various practices, policies and procedures ~~which~~ that are incorporated into the Program. This Program does not supercede or diminish any other policy or program of the University that, in whole or in part, also addresses compliance issues, unless such other policies or programs are inconsistent with this Program.

1.04 Compliance with Other Laws.

University employees are required to comply with all applicable laws and regulation, whether or not specifically addressed in the Program. The standards of conduct set forth in this Program cannot cover every legal situation. It is the responsibility of each University employee to act honestly and with integrity in all dealings and to seek appropriate guidance when necessary.

1.05 Modification of the Program.

This Program, and any attachments hereto, will be periodically updated or otherwise modified by the Board as necessary. In addition to this document, the University will periodically distribute memoranda or other policies, which supplement the Program.

1.06 General Application.

This Program applies to all University colleges, departments and employees that: (i) submit claims for reimbursement of medical services; (ii) perform human and/or animal research; and/or (iii) handle or work with or around hazardous and/or radioactive materials.

II. Duties of University Leadership.

2.01 Board of Regents.

The Board has the responsibility for (a) implementing; and (b) overseeing the Program and related compliance activities. Functions of the Board will include, but not be limited to the following:

1. Authorization for the University to implement the Program.

2. Approval of the structure for management oversight and reporting of compliance activities.

3. Review of periodic reports concerning the Program and compliance activities.

4. Review of any special reports on any compliance activity.

2.02 University Officers and Other Management Personnel.

The Director of Compliance must have the support of all University officers, Department chairs and other management personnel to effectively implement and manage the Program. Employees in leadership positions must pay special attention to the laws and regulations applicable to his/her college or department and should bring areas of concern to the attention of the Director of Compliance.

III. Office of Compliance.

3.01 General Purpose.

The University’s Office of Compliance, under the direction of the Director of Compliance, is responsible for overseeing, monitoring, and assisting the University in its efforts to (i) raise awareness regarding legal and ethical issues; (ii) improve compliance training and quality improvement and review functions; and (iii) ensure adherence to the highest standards of conduct.

3.02 Specific Purpose.

In addition to the general purpose stated above, the Office of Compliance will coordinate the University’s efforts to:

a. Inform applicable University employees about the Standards of Conduct ~~and Improvement~~;

b. Implement and conduct training programs where needed, and/or monitor existing training programs;

c. Perform and/or arrange periodic compliance/quality improvement reviews;

d. Conduct investigations of compliance complaints in coordination with the applicable University department and/or officer;

e. Maintain a reporting and question hotline for compliance matters;

f. Serve as a resource to the University on matters of compliance;

g. Assist with the correction of compliance concerns; and

h. Draft and implement, in coordination with the applicable department, any necessary policies and procedures.

3.03 Structure.

The Office of Compliance will report to the University’s General Counsel. However, the Director of Compliance may present compliance issues or concerns directly to the President of the University or the Board in the event the General Counsel does not respond to such issues or concerns in a timely manner.

IV. Director of Compliance

4.01 Appointment.

The Director of Compliance will administer the Program ~~will be overseen by a Director of Compliance~~. The specific duties of the Director of Compliance are set forth in Section 4.03.

4.02 Selection Criteria

The Director of Compliance will administer ~~oversee~~ and monitor the University’s compliance activities. The day-to-day decisions related to the Program will be made by the Director of Compliance. The Director of Compliance will coordinate the Program and identify and build on existing University policies and procedures. The Director of Compliance should be an individual who has the following characteristics:

a. High integrity and a thorough understanding of the operations of the University.

b. Effective analytical skills required to direct regulatory monitoring.

c. Effective public speaking skills and the ability to articulate complex regulatory information in understandable terms.

d. Effective interpersonal skills required to work with University officers and employees as well as ~~third party vendors and~~ government representatives.

e. Effective organizational and planning skills as well as the ability to handle multiple tasks simultaneously.

f. Effective writing skills.

g. Thorough understanding of the laws and regulations which apply to the areas covered by this Program, and the ability to identify the legal issues and refer them to the Office of Legal Counsel.

4.03 Responsibilities of the Director of Compliance.

~~It is the responsibility of~~ The Director of Compliance is responsible for to ensuring that the Program is implemented and monitored. Coordination and communication are key functions of the Director of Compliance. It is not the duty of the Director of Compliance to perform all compliance related tasks. Rather, the role of the Director of Compliance is to coordinate compliance activities. The Director of Compliance will have authority to review documents and records relevant to compliance activity. The duties of the Director of Compliance will include, but not be limited to, the following activities:

a. Oversee implementation of the Program in all areas designated by the Board and President pursuant to the time line established in consultation with the General Counsel.

b. Work with University officers, Department chairs and employees to prevent, detect and respond appropriately to compliance issues.

c. Identify University functions and routine business practices and activities requiring compliance training and monitoring.

d. Establish procedures to make available the appropriate portions of this Program and any amendments thereto to all affected University employees.

e. Establish a reporting system with University employees who have compliance responsibilities.

f. Serve as a resource for the University on matters of Compliance.

g. Perform routine, periodic compliance reviews, or arrange for such reviews, of high-risk areas.

h. Monitor (in conjunction with the Office of Legal Counsel) developments and changes in statutes, court rulings, rules and regulations that affect compliance requirements, bring them to the attention of the appropriate officers and employees, and assist with remedial activities when appropriate.

i. Make recommendations, as needed, to University departments regarding their compliance efforts.

j. Implement systems to ensure that all University employees are adequately informed of their responsibilities under the Program.

k. Establish a 24-hour a day hotline through which University employees can make anonymous and confidential reports and inquiries about areas covered by this Program.

l. Maintain records related to the Program.

m. Review and periodically propose revisions to the Program to meet changes in the University’s needs and in the business and regulatory environment.

n. Submit periodic reports to the General Counsel and Advisory Committee regarding compliance activities.

o. Conduct investigations in coordination with the applicable department or University officer as needed and act on compliance related matters. The Director of Compliance will notify the appropriate University officer, in addition to the General Counsel, prior to initiating any investigation.

p. Monitor and respond to any questions, concerns and reports of possible violations reported through any means.

q. Hire or retain, with the approval of the General Counsel and President and in a manner that is consistent with University policies, any employees or independent contractors necessary to implement the Program and perform the compliance review and training functions.

V. Advisory Committee

5.01 Establishment of Committee

The members of the Advisory Committee will be: (i) the Senior Vice President and Provost – Norman Campus; (ii) the Senior Vice President and Provost – Health Sciences Center; (iii) the Vice President for Health Affairs and Associate Provost – Health Sciences Center; (iv) the Vice President for Research – Norman Campus; (v) the Vice President for Research – Health Sciences Center; (vi) the Associate Vice President for Clinical Research; (vii) the Vice Presidents for Administrative Affairs; and (viii) any other University employees designated from time to time by the General Counsel.

5.02 Purpose of Committee

The Advisory Committee will meet on a periodic basis to (i) provide advice and assistance to the Director of Compliance; (ii) discuss matters of policy applicable to the areas covered by the Program; and (iii) receive reports from the Director of Compliance regarding the activities of the Office of Compliance and developments regarding compliance issues.

VI. Standards of Conduct.

6.01 Introduction.

The Standards of Conduct (“Standards”) are a non-exclusive compilation of guidelines regarding ethical and legal standards that all University employees are expected to follow when performing services for or on behalf of the University that are related to the areas covered by this Program. The Standards will be made available to all University employees in the Office of Compliance and on the University’s website ~~under the section dedicated to the Office of Compliance.~~ www.ouhsc.edu/compliance.

6.02 Hiring and Retention

The University will not hire or retain as an employee, independent contractor or agent, a health care professional it knows to have been convicted of a criminal offices related to health care or who is debarred by the General Services Administration or is excluded, or otherwise ineligible for participation in Federal Health Care Programs. All health care professionals seeking employment and/or credentials ~~will be required to~~ must provide information concerning: (a) criminal convictions; (b) exclusions from any Federal Health Care Program; and (c) sanctions by any Federal Health Care Program. Health care professionals must notify the University of any changes in this information. Each College providing health care services will do a criminal background check prior to a decision to offer employment or credentials to a health care professional. When credentialing physicians, the College of Medicine, Oklahoma City and Tulsa, will consult with the National Practitioner Data Bank as well.

6.03 Coding and Billing Standards and Procedures.

6.03.1 Billing in General.

Honesty and accuracy in billing and in the making of claims for payment by a Federal Health Care Program, or payment by any third party payer, is vital. Each health care professional employed by the University is expected to monitor compliance with applicable billing rules. No University employee shall submit, authorize or sign a false claim for reimbursement in violation of applicable laws and regulations. Claims for the provision of services and/or supplies should only be submitted by the University department or college that generated the charges unless an alternative billing arrangement has been approved ~~by the Director of Compliance and the Vice President for Health Affairs and Associate Provost – Health Sciences Center~~.

6.03.2 Billing and Coding Specifics.

University employed health care professionals will refrain from any of the following practices and work to identify and correct instances in which mistakes have occurred in the following areas:

A. Billing for items or services not rendered or not provided as claimed;

B. Submitting claims for equipment, medical supplies and services that are not reasonable and necessary;

C. Double billing resulting in duplicate payment;

D. Billing for non-covered services as if covered;

E. Knowingly misusing provider identification numbers, resulting in improper billing;

F. Unbundling (billing for each component of the service instead of billing or using an all-inclusive code);

G. Failure to properly use coding modifiers;

H. Falsely indicating that a particular health care professional attended a procedure or that services were otherwise rendered in a manner they were not;

I. Clustering (billing all patients using a few middle levels of service codes, under the assumption that it will average out to the appropriate level of reimbursement);

J. Failing to refund credit balances; and

K. Upcoding the level of service provided.

~~6.03.3. Billing to Receive a Denial.~~

A University department or college may bill Medicare in order to receive a denial for services, but only if the denial is needed for reimbursement from a secondary payer. The Medicare claim submission should indicate that the claim is being submitted for the purpose of receiving a denial in order to bill a secondary insurance carrier.

~~6.03.4. Waiver of Copayments and Deductibles.~~

University employed health care professionals will not waive copayments or deductibles except to the extent consistent with applicable laws, regulations and guidance issued by the Office of Inspector General. Permissible waivers include, but are not necessarily limited to, waiver based on indigency and contractual write-offs and discounts.

6.03.3 Write-Offs.

University employed health care professionals are not permitted to write –off charges for their services, unless the write-off is consistent with applicable State and Federal laws and regulations and any guidance issued by the DHHS Office of Inspector General. Examples of impermissible write-offs include, but are not limited to, (1) the routine waiver of co-payments and deductibles (or “insurance only” arrangements) and (2) the provision of professional courtesies to referral sources. Permissible waivers include, but are not limited to, waiver based on indigency and contractual write-offs and discounts. Waivers of payment are permitted in order preserve State and/or University assets.

~~6.03.5. Billing and Coding Queries.~~

Billing and coding staff shall be able to communicate with and receive communications from University employed healthcare professionals at all times. Billing and coding staff will not submit claims for reimbursement until all coding questions have been satisfactorily answered and appropriated documentation has been submitted by the appropriate health care professional.

~~6.03.6. Use of Consultants.~~

From time to time, the University may retain consultants to provide reimbursement and/or coding assistance. Such consultants may not be paid on a percentage based upon the increase in reimbursement to the University or one of its departments or colleges (i.e., a contingent fee contract).

6.03.4. Documentation.

Claims for payment will be coded and billed based on the documentation contained in the patient’s medical record. University employed health care professionals will appropriately document the services and supplies provided to, or the diagnosis and treatment of, each patient and will complete medical records in a timely manner. Medical record documentation must be complete and legible.

6.04 Anti-Kickback Statute and Self-Referral Proscriptions.

6.04.1 Anti-Kickback Statute.

No University employee, ~~department or college~~ may pay or accept a payment ~~or the referral of a patient~~ to induce the referral of a patient in violation of the federal or state anti-kickback statutes. No one acting on behalf of the University, or one of its departments or colleges, may offer gifts of more than nominal value, loans, rebates, services, or payment of any kind to a referral source or to a patient without consulting the director of compliance. Gifts of nominal value (not to exceed $300 in a calendar year) may be provided to a referral source if made without intent to induce a referral.

6.04.2. Self-Referral Proscription.

No University employee may have an ownership or compensation relationship that violates the Physician Self-Referral Statute, more commonly known as “Stark II” ~~prohibits a physician’s referral of a patient for a designated health service to an entity with which the physician has a financial relationship unless an exception is met.~~ Compensation and ownership relationships with physicians, including physician employment and independent contractor arrangements, must satisfy an exception to Stark II. Analysis of whether an exception is met depends upon a number of specific facts. University employees should not make a unilateral judgment on the availability of an exception. The responsibility for evaluating the availability of an exception lies with the University’s Office of Legal Counsel.

~~6.04.3. Physician Recruitment.~~

The recruitment and retention of physicians require special care to comply with applicable laws and regulations. Each recruitment package or commitment must be in writing and consistent with applicable laws and regulations. New or unique recruitment arrangements must be reviewed by the Director of Compliance in consultation with the University’s Office of Legal Counsel.

6.05 Gifts and Gratuities.

6.05.1. Gifts from Patients.

University employed health care professionals are prohibited from soliciting tips, personal gratuities or gifts from patients and from accepting monetary tips or gratuities. Health care professional may accept non-monetary gratuities and gifts of nominal value from patients. If a patient or another individual wishes to present a monetary gift, he/she should be referred to the University Development Office. When an employee receives a gift that violates this policy, the gift should be returned to the donor and reported to the Director of Compliance.

6.05.2. Gifts Influencing Decision-Making.

University employed health care professionals shall not accept gifts, favors, services, entertainment or other things of value to the extent that decision-making or actions affecting such employee may be influenced. ~~Gifts may be received by University employed health care professionals~~ Employees may accept gifts when they are of such limited value that they could not reasonably be perceived as an attempt to affect the judgment of the recipient. For example, token promotional gratuities from suppliers, such as advertising novelties and food are not prohibited under this policy. The offer or giving of money, services or other things of value with the expectation of influencing the judgment or decision making process of any purchaser, supplier, customer, government official or other individual by University employee, department or college is prohibited.

~~6.05.3. Gifts to Referral Sources.~~

Gifts of nominal value may be provided to a referral source if made without intent to induce a referral. If a gift is to be made to a referral source which will result in that individual receiving gifts valuing over $300.00 in a calendar year, that gift must be approved in advance by the Director of Compliance. Cash gifts to referral sources are prohibited. Non-cash gifts are permissible only if made without regard to the volume of business received from the referral source.

~~6.06 Unlawful Advertising.~~

Neither the University, one of its departments or colleges of an employed health care professional will use the names, abbreviations, symbols, or emblems of the Social Security Administration, Center for Medicare Services (formerly the Health Care Financing Administration), Department of Health and Human Services, Medicare, Medicaid, or any combination or variation of such words, abbreviations, symbols or emblems in a manner that conveys the false impression that the advertised item or service is endorsed by such government agencies.

6.07 Confidentiality of Patient Information.

All University employees have an obligation to protect the ~~conduct themselves in accordance with the principle of maintaining the~~ confidentiality of individually identifiable health information in accordance with the HIPAA Privacy Regulations and all other applicable laws and regulations and to adhere to the University’s policies and procedures implementing such laws and regulations.

6.08 Environmental Health and Safety/Radiation Safety

6.08.1. Workplace Health and Safety.

The University is committed to providing a safe and healthy environment for the entire University community and to complying with all applicable Federal and State laws and regulations pertaining to occupational, environmental, and radiation health and safety ~~wants all employees to work in a safe environment~~. All University employees must perform their jobs in compliance with all applicable laws and institutional policies ~~and State and Federal laws and regulations relating to the protection of workers’ safety~~. In addition, all employees must ensure that they have received all required safety training and have been authorized to perform a job before undertaking it. ~~Employees must become familiar with the worker safety laws and regulations which apply to their jobs.~~ Employees should seek advice regarding workplace safety and compliance issues from their supervisors or the Environmental Health and Safety Office or the Radiation Safety Office. Each employee is responsible for advising the employee’s supervisor or the Environmental Health and Safety Office or the Radiation Safety Office of any serious situation presenting a danger of exposure or injury so that timely corrective action may be taken.

6.08.2 Use of Radioactive and Biological Materials.

No use of radioactive materials or radiation producing devices is permitted without the permission of one of the University’s Radiation Safety Committees (“RSC”). No use of microorganisms, recombinant DNA or biological toxins is permitted without first obtaining the approval of one of the University’s Institutional Biosafety Committees (“IBC”), if such approval is required by University policies. Employees must comply with all applicable RSC and IBC policies, procedures, decisions, conditions and requirements.

6.08.3 Protection of the Work Environment.

All University employees must manage and dispose of hazardous chemical, radioactive, and other wastes in a way that maximizes protection of human health and the work environment and is in accordance with all applicable ~~local, State and Federal~~ laws and institutional policies ~~regulations~~. All employees must be trained to perform their duties and conduct their activities in an environmentally responsible manner in accordance with applicable University policies.

6.09 Standards Relating to Research.

~~6.09.1 Protection of Human and Animal Subjects.~~

The University is committed to dealing ethically with the human and animal subjects participating in research projects conducted by faculty, staff and students and research involving University property. Employees involved in human subject or animal research must comply with all federal and state statutes and regulations for research and must adhere to all University policies and procedures regarding research.

6.09.1 Protection of Human Subjects. In order to protect human subjects, each investigator must:

a. Design and implement ethical research consistent with the three ethical principles delineated in The Belmont Report. The three principles are: justice, beneficence and respect for persons.

b. Comply with all applicable Federal regulations impacting the protection of human subjects (e.g., 45 C.F.R. § 46 and 21 C.F.R. § 50 and 56).

c. Ensure that all research involving human subjects is submitted to and approved by one of the University’s institutional review boards (“IRB”) prior to subject recruitment and data collection, as required by the policies and procedures of the IRB of the respective campus.

d. Comply with all applicable IRB policies, procedures, decisions, conditions and requirements.

e. Implement research as approved by the IRB and obtain prior IRB approval for any changes to the research protocol prior to implementation.

f. Obtain informed consent and assent in accord with Federal regulations and as approved by the IRB.

g. Document informed consent and assent in accord with Federal regulations and as approved by the IRB.

h. Report progress of approved research to the IRB, as often and in the manner prescribed by the IRB.

i. Report to the IRB any injuries, adverse events/effects, or other unanticipated problems involving risks to subjects or others.

j. Retain signed consent documents and IRB research records for at least three years past completion of the research activity.

6.09.2 Protection of Animal Subjects. In order to protect animal subjects, each investigator must:

a. Comply with all applicable Federal laws and regulations impacting the protection of animal subjects (e.g., the Animal Welfare Act and the Public Health Service Policy on Humane Care and Use of Laboratory Animals).

b. Ensure that all research involving animal subjects is submitted to and approved by one of the University’s institutional animal care and use committees (“IACUC”).

c. Comply with all applicable IACUC policies, procedures, decisions, conditions and requirements.

d. Implement research as approved by the IACUC and obtain prior IACUC approval for any changes to the research protocol.

e. Choose a species for study that is well suited for investigation of the issues posed.

f. Use the smallest number of animals necessary and sufficient to accomplish the research goals.

g. If procedures used in research or teaching involve exposure to painful, stressful or noxious stimuli, consider whether the knowledge that may be gained is justified.

h. Use only reputable suppliers for the procurement of animals.

i. Ensure that caging conditions and husbandry practices meet applicable standards.

j. Dispose of animals in accordance with applicable laws and standards.

6.09.3 Scientific Misconduct.

The University will not tolerate scientific misconduct ~~which~~ that includes, but is not limited to: (i) plagiarism; (ii) falsification; (iii) fabrication; and (iv) other unethical scientific practices. Scientific misconduct is further defined in and governed by other University policies.

6.09.4. Research Financial Issues.

Research costs and budgets must be prepared and submitted accurately and in accordance with (i) generally accepted accounting principles; (ii) OMB Circular A-21; and/or (iii) the terms set forth in an industry-sponsored or government grant or contract, whichever is applicable, in addition to applicable statutes and regulations. Financial conflicts of interest will be reported in accordance with University policy.

VII. Administration of the Program.

7.01 Adherence to the Program.

It is intended that all University employees subject to this Program carry out their duties for the University in a manner that is consistent with this Program. Conduct that does not comply with the Program (i) is not authorized by the University; and (ii) may subject the employee to corrective action pursuant to Section 7.03. Such corrective actions also may apply to an employee’s supervisor or department chair, as applicable, who (i) directs or approves the employee’s improper actions; (ii) is aware of the improper actions, but does not appropriately correct such actions; or (iii) otherwise fails to exercise appropriate supervision.

7.02 Questions About the Program.

If any question arises as to (i) the existence of, interpretation of or application of any law or regulation which applies to an area or matter that is covered by this Program; or (ii) whether any action complies with the Program, a University employee should present that question to such employee’s immediate supervisor. If the question cannot be addressed in that manner because the supervisor is absent, does not know the answer or does not respond in a timely manner, or is suspected of being involved in or condoning the activity, the question should be addressed to the Director of Compliance. Legal issues should be referred to the Office of Legal Counsel. The University encourages employees not to guess, but to ask for clarification from the Director of Compliance if there is confusion or a question with regard to the Program, the law, or a policy or procedure.

7.03 Corrective Action.

The Program includes the possibility of corrective action for University employees who have failed to comply with (i) the Program; (ii) other University policies and procedures; and (iii) applicable Federal and State laws and regulations. Corrective action also may be appropriate where an employee should have, but failed, to detect a violation. Any violation of applicable Federal or State laws or regulations or deviation from the appropriate standards of conduct as set forth in this Program will subject an employee to corrective action, which may include, but is not limited to, any of the following:

1. Mandatory training;

2. Counseling session;

3. Corrective action;

4. Required leave;

5. Reduction in salary;

6. Demotion;

7. Suspension;

8. Abrogation of tenure;

9. Suspension of billing privileges, if a health care provider; and/or

10. Termination of employment or contractual relationship.

Mandatory training and/or counseling will be the preferred corrective action and will be used whenever appropriate.

~~7.04 Exit Interviews.~~

The University shall attempt to conduct an exit interview for all employees performing services for the University that are covered by this Program who terminate employment for any reason using the exit interview form attached hereto as Exhibit B. The employee’s supervisor should notify Human Resources when an employee notifies him/her of the employee’s termination. Upon receipt of such notice, Human Resources should send the employee the Exit Interview Questionnaire attached hereto as Exhibit B which should also be returned to Human Resources. Exit interview forms which raise compliance issues should be copied and routed to the Director of Compliance.

7.05 Self-Reporting.

To be effective, the Program depends to some extent upon self-reporting and acceptance of responsibility by University employees who may have made mistakes out of lack of knowledge or inattention. To the extent a University employee self-reports a potential wrongdoing, both the self-reporting and the acceptance of responsibility will be taken into account by the University as a mitigating factor in determining the form of action taken. University employees can use the Hotline described in Section 10.02.4 of this Program to self-report or they may contact the Director of Compliance directly.

VIII. Training and Education.

8.01 Generally

Education and training is a critical part of the Program and is the primary mechanism for preventing and correcting compliance issues. Education and training will involve not only new employees, but all existing employees as needed. The University will require participation by all employees in appropriate training programs. University officers, department chairs and other management personnel will be involved in the educational process by ~~assisting in~~ (i) identifying areas that require training; and (ii) supporting the training process. The Director of Compliance will be actively involved in the design and implementation of training and educational programs. A Training Program relating to the areas covered by this Program will be developed and incorporated into this Program by reference the training process.

8.02 Mandatory Training.

An employee’s failure to attend a mandatory training session will subject that employee to corrective action as discussed in Section 7.03 above. The supervisor or management employee responsible for conducting the training will maintain attendance records and will forward copies of such records to the Director of Compliance.

8.03 Dissemination of Information.

~~Upon the adoption of this Program by the Board,~~ The University will distribute to employees: (i) a letter from the University’s President discussing the University support of the Program; and (ii) the Standards of Conduct summarizing the Program. ~~From that point forward,~~ Human Resources will help coordinate the distribution of the Standards of Conduct to new and existing employees. and the affected Departments will provide a copy of the President’s letter and the Standard’s of Conduct to persons at the same time an offer of employment is made and such individuals will be required to Employees will be required, as a condition of employment, to acknowledge receipt of the Standards of Conduct by executing a Certification and Agreement of Compliance as attached hereto as Exhibit C B ~~as a condition of employment~~. On at least an annual basis, employees will be reminded of their obligations under this Program and their duty to report suspected violations of the Program and applicable statutes and regulations through a written or electronic communication from the Office of Compliance.

IX. Monitoring and Compliance Review.

9.01 Generally.

Regular monitoring and review of compliance activities is a feature of the Program. There will be regular reporting to University management, the President and the General Counsel.

9.02 Monitoring Techniques.

The University will utilize regular and periodic compliance reviews. The compliance reviews will focus on those areas within the University which have substantive exposure and which otherwise put the University at risk. If it is determined that any error or deviation is caused by improper procedures, misunderstanding of the rules, including fraud or other systematic problems, the Director of Compliance, in consultation with the General Counsel should take immediate steps to correct the problem. To the extent that monitoring and auditing discloses that variations or deviations were not detected in a timely manner due to deficiencies in the Program, the Program will be modified.

Monitoring techniques can take a variety of forms, including, but not limited to: (i) onsite visits; (ii) document reviews; (iii) personal interviews. The Director of Compliance will have access to (i) any pertinent records and (ii) relevant personnel. Cooperation with the Director of Compliance is mandatory.

9.03 Advice from the Government and its Agents.

To the extent the University requests advice, or receives advice, from the government or its agents, the University will document and retain a record of such request and response or unsolicited advice received. Each employee receiving such advice will be responsible for providing a copy of the advice, if written, or a memorandum describing the advice, if oral, to the Director of Compliance. Every effort should be made to obtain such advice in written form. The Director of Compliance will maintain a log of advice received.

X. Response and Prevention.

10.01 Reports of Wrongdoing.

All University employees have a duty under this Program to report possible wrongdoing or suspected violations of applicable federal and state laws and regulations. The University has an open door policy available to all employees acting in good faith to encourage communication, dialogue and the reporting of incidents of potential wrongdoing or suspected violations. A “suspected violation” occurs when an employee has reasonable cause to believe that a violation of a law regulation applicable to an area covered by this Program, or a violation of this Program, has occurred or will occur. The University will not retaliate or discriminate against any employee who makes a good faith report of a suspected violation regarding the observed conduct or actions by another person by reason of such a report being made. While the University will strive to maintain the confidentiality of an employee’s identity, it may become necessary for such employee’s identity to become known or revealed during the investigation process. It will be a violation of this Program to make a report of a suspected violation which is knowingly false.

The reporting methods set forth below apply to reports of suspected violations of law which apply to areas and matters covered by this Program or to suspected violations of this Program. Other issues should be reported through the University’s normal reporting structure.

10.02 Methods of Reporting.

10.02.1 Immediate Supervisor.

The first option for reporting suspected violations of law is to make the report to the employee’s immediate supervisor who can in turn, work with the Director of Compliance to investigate and rectify any problems. If reporting to the supervisor is inappropriate because the supervisor is absent, does no know the answer or does not respond in a timely manner, or because the supervisor is suspected of condoning the activity, reports can be made pursuant to one of the other options set forth below.

10.02.2 Director of Compliance.

The University desires to establish an open line of communication between all employees and the Director of Compliance to provide for the successful implementation and operation of the Program. The Director of Compliance can be reached by telephone at (405) 271-2511 or during ordinary office hours in Room 175D of the Bird Library. A message may also be sent to the Director of Compliance via regular or electronic mail.

10.02.3 Hotline.

If an employee wishes to remain anonymous while reporting potential wrongdoing, an employee may call the Helpline, which will be available 24 hours a day, at (405) 271-2223 or toll free at (866) 836-3150. The call will not be traced and the person need not give his/her name.

10.03 Responding to Reports.

When a report of a suspected violation is received on a matter that does not concern compliance issues, that report will be referred to the appropriate University department. Whenever the Director of Compliance receives a report of a suspected violation, from any source, which allegation may reasonably constitute a criminal or civil offense, the Director of Compliance will promptly conduct a preliminary review of such allegation. Advice from the Office of Legal Counsel may be sought to determine the seriousness of the allegation. The preliminary review should be completed within a reasonable time of the receipt of the report. If the Director of Compliance reasonably determines that it is necessary to conduct an internal investigation of the alleged misconduct, the Director of Compliance will conduct such an internal investigation in coordination with the applicable Department or University officer. The Director of Compliance will notify the appropriate University officer, in addition to the General Counsel, prior to initiating any investigation. The internal investigation should be completed within a reasonable time of the initial report. When circumstances so require, the Director of Compliance will proceed more quickly than the time standards set forth herein or authorize additional time to complete the investigations. All internal investigations and their results will be reported to the General Counsel.

Employees under investigation may be removed from their current work activity and put on administrative leave pending completion of an investigation or preliminary review upon action of the Director of Compliance or the General Counsel, to the extent permitted by applicable University policies and procedures.

The Director of Compliance should take appropriate steps to secure or prevent the destruction of documents and other evidence relevant to the investigation. Advice from the Office of Legal Counsel regarding any such investigation may be obtained if necessary. Once an investigation is completed, if corrective action is warranted, it should be immediate and imposed in accordance with the University’s Employee and Faculty Handbooks.

1. Introduction

The University is committed to the highest standards of ethics and to compliance with all applicable laws and regulations. To promote legal and ethical behavior and to prevent and detect violations of law, the Board of Regents approved the adoption of the Compliance and Quality Improvement Program. The goals of the Program are to: (1) protect research subjects, patients and employees; and (2) assist faculty and staff with the myriad of complicated laws and regulations to which they are subject in a way that facilitates the University’s critical missions. Training and education will be the key mechanisms for achieving these goals.

The program includes Standards of Conduct, set forth below, which are a non-exclusive compilation of guidelines regarding ethical and legal standards that all University employees are expected to follow when performing services for or on behalf of the University that are related to the areas covered by the program. A complete copy of the program is posted on the University’s Web site at: www.ouhsc.edu/compliance.

In addition to the Standards, this booklet includes general information about the program in order to educate employees about their responsibilities.

4. 2. Standards Relating to Research

~~Protection of Human and Animal Subjects.~~ The University is committed to dealing ethically with the human and animal subjects participating in research projects conducted by faculty, staff and students and research involving University property. Employees involved in human subject or animal research must comply with all federal and state statutes and regulations for research and must adhere to all University policies and procedures regarding research.

Protection of Human Subjects. In order to protect human subjects, each investigator must:

a. Design and implement ethical research consistent with the three ethical principles delineated in The Belmont Report. The three principles are: justice, beneficence and respect for persons.

b. Comply with all applicable Federal regulations impacting the protection of human subjects (e.g., 45 C.F.R. § 46 and 21 C.F.R. § 50 and 56).

c. Ensure that all research involving human subjects is submitted to and approved by one of the University’s institutional review boards (“IRB”).

d. Comply with all applicable IRB policies, procedures, decisions, conditions and requirements.

e. Implement research as approved by the IRB and obtain prior IRB approval for any changes to the research protocol.

f. Obtain informed consent and assent in accord with Federal regulations and as approved by the IRB.

g. Document informed consent and assent in accord with Federal regulations and as approved by the IRB.

h. Report progress of approved research to the IRB, as often and in the manner prescribed by the IRB.

i. Report to the IRB any injuries, adverse events, or other unanticipated problems involving risks to subjects or others.

j. Retain signed consent documents and IRB research records for at least three years past completion of the research activity.

Protection of Animal Subjects. In order to protect animal subjects, each investigator must: