1. Laboratory Compliance Coordinator

    1. Kelley Suskie, Administrator of the Department of Pathology and Laboratory Services has been appointed as the Department's Compliance Coordinator and is a member of the Compliance Operational Sub-committee.

    2. Duties of the Laboratory Compliance Coordinator shall include the following in addition to the standard duties laid forth in Appendix A to the Corporate Compliance Program:

      1. Co-chair the Laboratory Compliance Committee;

      2. Ensure that all physicians who order services from the Department are informed of the Plan and the compliance standards with respect to test ordering, test panels, coding, billing, and marketing.

  2. Laboratory Compliance Committee

    1. Membership of the Committee will be made up of employees representing all divisions within the Department (Clinical Laboratory, Anatomic Pathology, and Blood Bank), along with a representative from the Hospital Compliance Office.

    2. The Hospital Compliance Committee has approved a policy detailing the structure and purpose of the laboratory compliance Committee.

    3. The Laboratory Compliance Committee will work to encourage and support an environment within the Department whereby all employees may report suspected compliance violations without fear of retaliation.

  3. Laboratory Compliance Policies and Standards

    1. The Hospital Code of Conduct establishes the standards of conduct for all Hospital employees. The Department is committed to high standards of conduct for its employees, and hereby incorporates the Hospital's Code of Conduct into its Plan. All departmental employees are expected to follow the Code of Conduct and to adhere to all laws, statutes, regulations, and other program requirements governing the operations of the Department or Federal, State, and Private Health Plans.

    2. The Laboratory Compliance Committee will develop policies to address compliance issues in the Department. In developing the policies, the committee will follow guidance from Federal and State Authorities including the Office of Inspector General's Compliance Program Guidance for Clinical Laboratories.

    3. The policies will be reviewed and approved by the Hospital Compliance Operational Sub-committee prior to implementation.

    4. The Laboratory Compliance Committee will review the policies on an annual basis, or as needed due to regulatory revisions or changes in the guidance from Federal and State Authorities

    5. Policies that have been developed and approved include the following:

      1. Laboratory Compliance Committee

      2. Billing for Laboratory Only Visits

      3. Laboratory Billing Compliance

      4. Notice to Medical Staff: Tests Requiring Pathologist Interpretation

      5. Outpatient Laboratory Test Orders

      6. Physician Customization Profile
        Physician Customization Profile Request Form

      7. Reflex Testing

    6. The Department will follow the more stringent of the Hospital's policy or Federal and State regulation (such as CMLA, CLIA, FDA, etc.) regarding the retention of records. All records required by Federal and State Law will be created and maintained for the time period specified.

    7. All Departmental employees will be trained periodically on new compliance regulations, policies and procedures. New employees will be trained early in their employment. Attendance of the training sessions will be mandatory for all Departmental employees. The training should emphasize the Department's commitment to compliance and reiterate that compliance with the regulations, policies and procedures is a condition of employment. Non-compliance will result in disciplinary action up to and including termination. Additionally, compliance will be an element of employee performance in the annual evaluation process.

      updated 6/18/2013

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