Blog Post

Effective Compliance Records Management Program

Richard P. Kusserow | February 2020

Compliance Record Management Tips to Consider

All effective healthcare compliance programs should implement some type of compliance records management system. The primary purpose of a compliance records management system is to ensure that all documents, including healthcare compliance policies and procedures, necessary for protecting the integrity of the organization, are current with applicable laws, regulations and requirements and are properly maintained.

A well-managed compliance records management system also evidences the effectiveness of the compliance program. Compliance Officers need to ensure that their records management policy is being followed and is compliant with any retention schedules required by law. If a government entity audits the organization, one of the items that will be verified is whether there is compliance with appropriate laws. A Compliance Office’s records management system should include:

  • Documentation that employees were adequately trained;
  • Reports from the compliance hotline;
  • Tracking logs of compliance investigations;
  • Documentation that shows modifications to the compliance program;
  • Self-disclosures to government agencies;
  • Compliance audit checklists;
  • Results of auditing and monitoring efforts;
  • Healthcare compliance policies and procedures; and
  • Records management compliance checklists.

A well-structured compliance records management program will ensure regulatory compliance mandates are met, documents evidencing compliance program effectiveness are available, and exposure to liabilities are reduced. The following are tips to consider:

  1. Records Management System. Develop a compliance records management and healthcare records management system to track, administer and store compliance related documents and healthcare compliance policies and procedures.
  2. Set-up a Records Retention Schedule. The schedule should outline how long records should be kept from an operational and legal standpoint, and that outdated records should be disposed of in a timely, systematic manner. When determining the retention period for records, it’s important to, (a) perform a record inventory of all physical and electronic records; (b) establish a standardized record classification system; and (c) conduct research on all federal, state, and local records retention requirements.
  3. Policies and Procedures. Develop and implement policies and procedures for the creation, distribution, retention, storage, retrieval and destruction of compliance related documents and healthcare compliance policies and procedures. Ensure that the compliance records management policy addresses the protection of patients’ protected health information.
  4. Accessibility and Location. The records management program must include the ability to find and access information, when needed. It is advisable to index records by date, subject matter, creator, and location of the record.
  5. Ongoing Monitoring and Auditing. It is important to have ongoing monitoring of the records management system to ensure compliance with policies and procedures. There should also be periodic independent audits of compliance to ensure that retention schedules are being followed, timely reviews are being made to keep documents current, destruction of documents are in accordance with policies, etc.
  6. Records Disposal/Destruction. There are times when documents are no longer needed and should be destroyed. Maintaining records longer than necessary increases exposure to possible breaches. Disposing or destroying records must closely follow the written policy and procedure guidance. It is also important to keep a record of all disposals.

About the Author

Richard P. Kusserow established Strategic Management Services, LLC, after retiring from being the DHHS Inspector General, and has assisted over 3,000 health care organizations and entities in developing, implementing and assessing compliance programs.

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