A key responsibility for compliance officers is maintaining records related to the healthcare compliance program. The U.S. Department of Health and Human Services Office of Inspector General state that written policies and procedures and other compliance related documents are a key element of an effective compliance program. So I am often asked, what types of documents must be maintained and how can I manage it?
In general, compliance officers should implement compliance related documents that protect the integrity of the organization’s compliance program and evidence that the organization is compliant with applicable laws, regulations and program requirements. Specifically, this means that, the organization must implement compliance related guidance in the form of policies and procedures, documentation that evidences employees receive adequate annual compliance training, compliance hotline reports and results of investigations, documentation of modifications and updates to the compliance program, self-disclosure documents for overpayments and/or wrong doing and results of ongoing monitoring and auditing efforts by the compliance office.
The compliance office’s obligations for document management extends to ensuring operational records are properly maintained. For example, compliance office personnel should audit patient medical records, billing information and cost reports to determine whether it is carried out in accordance with the policies and procedures and other compliance related documents that govern these areas. Healthcare organization must be able to provide documentation, such as patients’ medical records and physician orders, to support medical necessity. Additionally, the creation, dissemination and retention of documents that include protected health information (PHI) should be a particular priority of the compliance office and the privacy officer to ensure that PHI is handled in compliance with the applicable policies and procedures. Many areas in healthcare compliance are governed by specific laws and regulations. Therefore, the compliance officer should ensure proper ongoing monitoring and auditing of those policies and procedures.
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10 Tips for Compliance Document Management
- Standardize the format used for policies and procedures to avoid missing key elements in the document. Policies and procedures should include a background section, along with a purpose statement and scope, to provide context to the policy.
- Insert a header block at the top of the policy document. The header block includes critical information to ensure proper management of the policy. It should include at a minimum: (1) Policy title; (2) Department responsible for managing the policy; (3) Effective date; (4) Approval date; (5) Department or committee that approved the policy; (6) Internal policy tracking number; (7) Date of last update; (8) Number of pages.
- Include a list of related documents for cross reference to ensure consistency and to avoid conflicting procedures, guidance or information.
- Cite applicable laws, regulations, program rules or requirements in the document. Make sure these citations stay up-to-date.
- Maintain records related to employee compliance training, including attendance logs from annual and new hire compliance training, copies of the material distributed during the training sessions and attestations signed by employees that completed the training.
- Maintain records related to the compliance hotline, including a log of reports made via the phone line, web-report and in-person. The logs should include date the report was received, how the report was handled and the status of the report (i.e., resolved, in progress).
- Maintain a database of all business contracts with clients, vendors and contractors and agreements with referral sources. The database will act as a repository for all contract and agreements and help manage the latest versions.
- Conduct ongoing monitoring and auditing to ensure that managers and employees are complying with applicable compliance documents.
- Develop policy and procedures for creating, implementing, storing and rescinding compliance related documents. Always maintain as part of the permanent record old policy documents that have been revised or rescinded. If challenged about a policy, the issue will be what the policy was at the time of the issue under consideration.
- Maintain a document management system that can track and notify you when documents need to be updated. There are vendors that offer such document management software designed for healthcare organizations. For smaller organization, the use of a MS Access database or Excel spreadsheet would be sufficient.
Management of compliance policies and documents will always be a key responsibility for compliance officers and the compliance office staff. Implementation of an effective process to manage documents is essential to keeping up-to-date with changing rules, regulations and requirements.