Every Department of Health and Human Services (HHS) Office of Inspector General (OIG) compliance document stresses the importance of the development and distribution of written policies and procedures to ensure compliance with all applicable laws and regulations. There are many challenges in carrying this out. A good starting point is to ensure that there is a formalized process for policy development. It should address the form, format, and process for development and implementation of new and revised policy documents. Daniel Peake of the Compliance Resource Center (CRC) works with clients in developing compliance-related documents. He notes that when developing policy documents, it is important to understand what policy statements are and how they differ from procedures. The former conveys officially-approved guiding principles and serves as a general guide toward accepted strategies and objectives. Procedures convey a means by which a policy can be accomplished by defining and outlining officially approved processes and standard practices. In short, they provide a description of how a policy is to be carried out. Developing a standardized format of presenting policies is important to ensuring the work force will be able to easily understand what is required of them. It has the benefit of making the policies immediately recognizable to everyone and assists in including all key elements in the document. The CRC Policy Development Center uses the following framework for developing all of its compliance-related policy and procedure document templates:
- Header Block. The header block should include: (a) a title identifying the policy topic; (b) the identity of the party responsible for drafting the document; (c) the policy number; (d) the date of the document; (e) the identity of approval authority; (f) whether it replaces or modifies an existing policy; and (g) the number of pages inclusive in the document.
- Background. The background section can be used to give context to the document, such as changes in the laws, regulations, standards, compliance guidance, etc. It can also be used to relate and/or differentiate the particular policy document to other written guidance.
- Purpose/Objective. This section defines the intent and objectives of the policy. It should be relatively short and direct.
- Definitions. Key terms used in the document should be defined. It is advisable to cite the authority for the definitions being used.
- Scope. This section explains the range of application of the document in terms of covered persons, facilities, sites, etc.
- Policy. This section includes statements of the general guiding principles or rules relating to the top of the document.
- Procedures. This section includes statements that provide detailed procedural requirements, methods, and guidance on how covered persons are expected to act in accordance with the policy.
- Related Policies. It is important that policies addressing similar or related issues be linked to ensure that they are consistent.
- References/Citations. This section can be used for legal and regulatory citations.
Daniel Peake can be reached for more information on compliance document templates at (email@example.com or (703)-236-9854)
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