Aligning Clinical Program Strategy with Regulatory Documentation Control: A Guide to Compliance

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In healthcare leadership strategic planning, we often attempt to develop new clinical programs derived from operational goals that are out of alignment with the organization’s current capabilities.  One of the most important but often neglected operational directives associated with new clinical program implementations are validation documents such as policies, standard operating procedures, and associated reference forms required and available for surveyors during the certification and accreditation phase of the implementation.   

The mandatory documentation control procedures are clear directives from regulatory agencies such as CMS which provide oversight of patient safety, standard operating procedures for treatment, and clinical services.  The association is critical because documents validate clinical services to surveyors and ensure the platform of the organization’s practice is in alignment with policies, procedures, protocols, and reference forms.  In the State Operations Manual Appendix A-Survey Protocol, Regulations and Interpretive Guidelines for Hospitals, there is language throughout discussing the need for review of policies, procedures, and contracted services while the surveyor is on-site to assure the organization is equipped to perform the services to be rendered appropriately.  

There are also regulatory directives regarding what should be represented on the policy template header, especially multi-system organizations.  It is required to determine specifically which hospitals are to be named on the policy template by the governing body.  Hospitals are also required to have system governing body policies represented with the provider assignment applied.  If hospitals are run separately and not a multi-campus structure, each facility should maintain their own documents and not operationally integrated.  In other words, the template has only the name of provider assignment and the governing body for that specific organization is responsible for the approval and upkeep of the documents. 

If you struggle to align your operational strategy with the document control regulatory requirements, I have a solution!  My resource guide, Guidance for Developing an Effective & Compliant Document Control Practice in Healthcare Organizations is available to you as a roadmap to be compliant in your regulatory requirements surrounding policies, procedures, and reference forms.  

In my guide, you will have access to a host of templates such as the Document Control Plan, a sample agenda for a Document Control Committee, and insight on how the regulatory agencies view document control, detailing the requirements healthcare organizations are required to follow.  

And, as always, I would love to help you through your journey to achieve regulatory compliance or assist in detangling your current document control process!

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