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Conditions of Participation Part -5

This is it – the last post we offer on the revised Conditions of Participation.  Pay attention as there are some important changes here including the introduction of the new Position of Clinical Manager.

484.105 Condition of participation: Organization and administration of services

Agencies may not delegate administrative and supervisory functions to another agency or organization.  Julianne’s note:  Management companies are not forbidden but owners are still liable for any decisions made by the management company.  Authority cannot be delegated.

Must have a clearly identified ‘governing body’.  The GB assumes full legal authority for operations, care provided, financial operations, review of budget and plans and QA program.


  • Must be appointed by and report to the Governing Body
  • Be responsible for all day to day operations
  • Ensure that clinical manager is available during operating hours
  • Must have back up for times when unavailable – may be clinical manager
  • Must be available during all operating hours

Clinical Manager

  • One or more qualified individuals must oversee all care and services and personnel.
  • Create patient and personnel assignments
  • Coordinates patient care
  • Coordinates referrals
  • Assures patients are continually assessed
  • Assures development, implementation and updates to Plan of care


  • All branches must be reported to state before initial survey and all surveys following or at the time the parent agency proposes to delete or add a branch.
  • The parent agency provides support to branches and maintains administrative control.

Services under arrangement:

Any person or organization providing services to patients of the agency who is not a direct employee of the agency must have a written contract.  The agency always maintains control of the services.

Contractors must not have been:

  • Denied Medicare or Medicaid enrollment
  • Been excluded from or terminated from any federal health care program or Medicaid
  • Had Medicare or Medicaid privileges revoked
  • Been debarred from participating in any government program

 Services Furnished

Skilled nursing services and at least one other therapeutic service (physical therapy, speech-language pathology, or occupational therapy; medical social services; or home health aide services) are provided in a patient home.

One of these must be provided directly by the agency but others can be provided under arrangement.

All services must meet current practice standards

There are instructions that the average clinician might not ever consult for:

  • An annual operating budget
  • A capital expenditure plan for any purchases exceeding $600,000.00 – more than the most expensive wound care supplies.
  • An annual review of the operating budget and capital expenditure plan.


  1. Place signed appointment of administrator in front of your policy manual. Make a note to re-sign annually.
  2. The clinical manager will likely be the same person as the current DON.
  3. Consider using a third party to run all your employees and physicians through necessary databases monthly.
  4. Review contracts to ensure compliance to the requirements for services provided under arrangement.

Condition:  Clinical Records

  • Include comprehensive assessment, including all the assessments from the most recent home health admission, clinical notes and plans of care, and orders.
  • All interventions – med administration, treatments and services
  • Responses to above interventions
  • Goals and progress towards goals
  • Contact information for patient, patient representative, and primary caregiver.]
  • Completed discharge summary to healthcare professional caring for patient post discharge (within 5 days).
  • Completed transfer summary sent within 2 days of transfer or awareness of transfer


Signature, title and date OR computerized unique identifier that is secure and specific to primary author who has reviewed and approved the entry.


  • All records must be retained for 5 years for Medicare Beneficiaries unless your state requires more.
  • Records are maintained for 5 years even when agency goes out of business – must inform state of location of records.

Retrieval of records

Upon request, clinical records are made available to patients at the next home visit but no later than 4 days.


  • If you didn’t catch on about discharge summaries and patient requests for records, re-read this section.
  • Begin sending discharge summaries now so that your process is smooth by July.  Agencies who are accredited by Accrediting bodies other than CMS are already doing this.
  • Review and edit as necessary your policy regarding electronic signatures.
  • Create written policy regarding record retention.

484.115 Condition of participation: Personnel qualifications

This is the last condition and it is long and tedious.   As such, it has been sidelined to a separate document.  These requirements are straight out of the conditions of participation where many disciplines have qualifications changed with employees grandfathered in resulting in multiple sets of requirements.


And we’re done.  Although the CoP’s are more extensive than this set of posts, you will be ahead of the game if you read, understand and act on this abbreviated version.  If you start now, you can eliminate a lot of drama when July rolls around.  There will be questions and agencies will have time to find answers if implementation starts now.  Even if you only tackle one or two conditions at a time, the effective date in July will pass without much fanfare.

If you need additional inservicing, we are available to come to your office to teach and assist in implementation.  Or, if you know better ways of getting things done, share with us in the comments.

If you don’t know if you need help, take our quiz and see if you missed anything.

4 Comments Post a comment
  1. Kyandra #

    I disagree with “2.The clinical manager will likely be the same person as the current DON”
    In most agencies I have worked in, the day to day clinical management was the role of the next person down, whatever their title. In many cases the DON and administrator are the same. I know I do none of that in my job. I think it depends on size, and organizational structure. “may be” would be a better word choice.

    February 24, 2017

    • I appreciate your insight.

      I am going to try to change the answer. Sometimes after publishing the quiz it is a bit difficult.

      Thanks for your response.

      February 24, 2017
  2. Anita #

    Thanks so much for all your work on this series. As always, you did a beautiful job!

    February 26, 2017

    • Thank you for taking time out of your day to offer such kind words. It means the world to me.

      February 27, 2017

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