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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.

Emergency Preparedness

Welcome to the most boring section of the revised Conditions of Participation.  Coincidentally, it may very well be the most important part of the CoPs.  Having lived through Andrew, Katrina, Rita, Gustav and the recent summer flooding, I assure you that nothing will go according to plan.  However, if you do not have a plan, you will lose your true North and risk not knowing what to do next.  There is nothing worse than seeing devastation all around you and not knowing what to do.

Write your plan and practice until you know it inside out.  This is not an exercise to appease surveyors.  This is how you will ensure your patients’ get through an emergency.

All agencies must have their plan reviewed at least annually.  Plan must:

  • Be based on and include a documented, facility-based and community-based risk assessment, utilizing an all-hazards approach.
  • Include strategies for addressing emergency events identified by the risk assessment.
  • Address patient population, including, but not limited to, the type of services the HHA has the ability to provide in an emergency; and continuity of operations, including delegations of authority and succession plans.
  • Include a process for cooperation and collaboration with local, tribal, regional, State, and Federal emergency preparedness officials’ efforts to maintain an integrated response during a disaster or emergency situation, including documentation of the HHA’s efforts to contact such officials and, when applicable, of its participation in collaborative and cooperative planning efforts.

Policies to be developed for:

  • Patients during a natural or man made disaster
  • Individual plans must be included as part of comprehensive assessment
  • Procedures to inform state and local emergency preparedness officials about patients in need of evacuation based on medical or psychiatric need
  • Follow-up procedures to determine services that are needed in the event of an interruption of services or due to emergency. Agency must notify state/local officials of any on-duty staff or patients that cannot be located.
  • A system of accessible documentation that preserves both the content of the record and patient confidentiality.
  • Use of volunteers including State or Federally designated healthcare professionals to address surge needs.

A communication plan must be developed as part of the Emergency Preparedness plan.  It will include:

  • Names and contact information for the following:
  • Entities providing services under arrangement.
  • Patients’ physicians.
  • Contact information for the following:
  • Federal, State, tribal, regional, or local emergency preparedness staff.
  • Other sources of assistance.
  • Primary and alternate means for communicating with the HHA’s staff,
  • Federal, State, tribal, regional, and local emergency management agencies.
  • A method for sharing information and medical documentation for patients under the HHA’s care, as necessary, with other health care providers to maintain the continuity of care.
  • A means of providing information about the general condition and location of patients under the facility’s care as permitted under 45 CFR 164.510(b)(4). (HIPAA Disclosures that require an opportunity for the patient to refuse).
  • A means of providing information about the HHA’s needs, and its ability to provide assistance, to the authority having jurisdiction, the Incident Command Center, or designee.

If an agency is part of a larger healthcare system consisting of multiple certified providers, the agency may participate in a unified plan encompassing all providers under the parent umbrella.




  1. Assign one person to implement with an understudy so nobody is left wondering who was supposed to do this when a tornado or hurricane hits.
  2. Many states have Emergency Preparedness requirements. Be sure your agency meets both sets of guidance.
  3. The decision to leave one’s family to go tend to patients is very hard. Encourage your staff to think about how they will provide for their children and elderly relatives in the event of an emergency so that they are not overly anxious being away from them.
  4. The section on communications is useful only if phones are working. If phones go down, how will your staff proceed?
  5. Find out where the high acuity shelters are planned before anything happens. If you wind up admitting patients to the hospital because of ventilators, IV’s, etc., you may create an artificially high hospitalization rate.
  6. If a disaster occurs where there is advance warning such as hurricane or flood, assign someone to keep up with when the restrictions on Medicaid drugs is lifted.  You may have patients who will not have enough medications and cannot buy more until 30 days passes from their last prescription pick-up date.

If your agency has been through a disaster, please share with the rest of us anything you learned that got you through or thwarted your efforts.

Revised Conditions of Participation – Part 4

Two More Conditions of Participation

The next two conditions apply to the people who visit patients on behalf of your agency regardless of whether they are directly employed or contract personnel.

Skilled Professionals

Skilled professionals include nurses, therapists (Physical, Occupational and Speech) and Social workers.  The qualifications are expanded upon under another Condition of Participation, §484.115 Personnel qualifications.  So, this standard is as follows:

484.75 Condition of participation: Skilled professional services

Services are authorized, delivered, and supervised only by health care professionals who meet the appropriate qualifications.

Responsible for:

  • Ongoing interdisciplinary assessment of the patient;
  • Development and evaluation of the plan of care in partnership with the patient, representative (if any), and caregiver(s);
  • Providing services that are ordered by the physician as indicated in the plan of care;
  • Patient, caregiver, and family counseling;
  • Patient and caregiver education;
  • Preparing clinical notes;
  • Communication with all physicians involved in the plan of care and other health care practitioners (as appropriate) related to the current plan of care;
  • Participation in the HHA’s QAPI program; and
  • Participation in HHA-sponsored in-service training.


  • Rehabilitative therapy services are provided under the supervision of an occupational therapist or physical therapist
  • Medical social services are provided under the supervision of a social worker


  • Ensure that all employees are aware of responsibilities to QA program.
  • Begin involving entire agency now.
  • Clarify care coordination roles for nursing and therapists
  • Review recent charts for evidence of communication, patient teaching and collaboration. If unable to identify these elements, revise policies and educate staff.
  • When the above elements are identified, share the documentation with staff as examples of what is expected.

484.80 Condition of participation: Home health aide services

The requirements for home health aide services are  extensive.  The first section reviews what is to be included for agencies that train their home health aides.  Most agencies I work with hire home health aides who have a certificate from a trade school or hospital, etc.  Since the training requirements and competency requirements are very similar, I made you a short list of all the required elements.  home-health-aide-training.

This section is for the rest of you that hire qualified home health aides.  Your responsibility is to assess competency and supervise these valuable employees.

As an aside, you won’t find anything about criminal history background checks here.  This does not mean you do not have to run a background check that meets your state’s standards.  My go to guy for over 15 years Ernie of EF Research.  He pretty much knows everything about background checks and can run them faster than the state police in most cases.   If you know of any other resources, please post in comments.

Back to home health aide competency which is to be assessed before an aide is assigned patients.

Competency must include:

  • Communication skills, including the ability to read, write, and verbally report clinical information to patients, representatives, and caregivers, as well as to other HHA staff.
  • Observation, reporting, and documentation of patient status and the care or service furnished.
  • Reading and recording temperature, pulse, and respiration.
  • Basic infection prevention and control procedures.
  • Basic elements of body functioning and changes in body function that must be reported to an aide’s supervisor.
  • Maintenance of a clean, safe, and healthy environment.
  • Recognizing emergencies and the knowledge of instituting emergency procedures and their application.
  • The physical, emotional, and developmental needs of and ways to work with the populations served by the HHA, including the need for respect for the patient, his or her privacy, and his or her property.
  • Appropriate and safe techniques in performing personal hygiene and grooming tasks that include –
    • Bed bath;
    • Sponge, tub, and shower bath;
    • Hair shampooing in sink, tub, and bed;
    • Nail and skin care;
    • Oral hygiene;
    • Toileting and elimination;
    • Safe transfer techniques and ambulation;
    • Normal range of motion and positioning;
    • Adequate nutrition and fluid intake;
    • Recognizing and reporting changes in skin condition; and
  • Any other task that the HHA may choose to have an aide perform as permitted under state law.

Underlined tasks must be performed by observation of the aide with a patient.  The remaining tasks may be observed directly or competency may be assessed through oral or written exam.


If home health aide services are provided to a patient who is receiving skilled nursing or therapies, a registered nurse or other appropriate skilled professional makes a visit no less than every 14 days.  The supervision visit must be made by a skilled professional who is familiar with:

  • the patient,
  • the patient’s plan of care,
  • and the written patient care instructions

If an area of concern in aide services is noted by the supervising registered nurse or other appropriate skilled professional, then the supervising individual must make an on-site visit to the patient’s home in order to observe and assess the aide while he or she is performing care. (Present Supervisory Visit).

If the deficiency in aide services is verified during an on-site visit, then the agency must conduct, and the home health aide must complete a full competency evaluation.   That’s three things.  Here they are again.  I like lists.

  1. A deficiency is observed during a supervisory visit
  2. The Supervising nurse or other skilled professional will perform a present supervisory visit, and if a deficiency is observed;
  3. The aide’s competency is assessed again.

For agencies providing home health aide services paid for by Medicaid, (waived services), the aide’s competency may be abbreviated to include only those tasks that are specific to the patient.


  • Verify competency now
  • Educate nurses and therapists regarding elements of competency defined by new CoPs.
  • Determine how your staff becomes familiar with the patient and commit it to policy.
  • Improve your hiring process to exclude candidates who do not have the dedication required to meet and exceed your standards.
  • Double up on education.  It will be less expensive to improve your home health aide services than investigating multiple complaints and your patients will appreciate excellent home health aide services as opposed to merely adequate.

None of this will be difficult for most agencies but when considering the patient rights condition which includes complaints together with the supervisory requirements in the home health aide services condition, a bad hire could be costly.  I’ve known agencies to skimp on competency because of a sudden need for a new aide.  This can’t happen anymore.  It shouldn’t have happened in the past.

Stay tuned.  The best is yet to come.

Condition of Participation Part 3

Quality Assessment Performance Improvement

Here’s some good news.  This provision replaces the former conditions at §484.16, “Group of professional personnel,” and §484.52, “Evaluation of an agency’s program.”  Those annual meeting minutes are now going to look suspiciously like QA reports.  I will miss being a community representative at all those dinners and want to point out that there is nothing in the CoP’s prohibiting agencies from taking their favorite consultant to dinner.

Agencies are free to design their own QA plans and formats as long as they include the following elements plus the infection control component below.

  1. Use of objective measures to demonstrate improved performance (Julianne’s note: Whenever possible, use data that is already being collected like OASIS or HHCAPS)
  2. Tracking performance to ensure that improvements are sustained over time
  3. Setting priorities considering prevalence, severity of identified problems; giving priority to activities affecting clinical outcomes
  4. Reflect the scope, complexity and past performance of the agency and documentation of projects.

Many agencies are already doing this and many are not.  Agencies that are accredited by the JCAHO, CHAP and ACHC and adhere to their standards are probably compliant but there are also agencies who choose to focus on dumb stuff that never actually happens to avoid looking bad.  Surveyors are not generally impressed when you show that 100 percent of your nurses now wear agency approved socks to match scrubs in the home environment.  The point is to make the focus of your work matter to your patients.

To determine what matters to your patients, have a meeting with all the visiting staff.  Where are the cracks and what is falling through them?  Examine all hospitalizations in the past quarter.  Ask patients and their caregivers.

Quality Assurance is not only about reading notes as they come into the agency.  It does not require an advanced degree and elaborate diagrams, either.  Somewhere in between these two extremes lies the sweet spot for an effective QA plan.  As you design or re-design your plan and implement it, avoid comparing it to someone else’s.  The only criteria are that it contains these elements and that it works to measure the improvements your agency make’s in patient care.


  • Determine if your agency’s plan incorporates all four requirements
  • Have meeting with a simple agenda so leadership knows what activities are currently being undertaken and determine how to expand upon them so that your plan meets these guidelines.
  • Use OASIS data or other assessment elements if appropriate to avoid additional data collection.
  • Chose projects that focus on patient care.
  • Call computer vendor to determine what reports may be used.
  • Learn to make pretty charts in Excel or Word and then post them for your staff to see.


Infection prevention and control

I was surprised to find that Infection control was a new addition to the Conditions of Participation.  There are state standards and OSHA standards that apply to home health.  The CDC does not have authority to ‘mandate’ actions but OASIS typically defers to the CDC’s extensive research to determine their course of actions.  But the conditions of participation have been silent all these years.  So, just in case you were not doing it right for other regulatory bodies, here’s some instructions on how to do right within the confines of the CoP’s.

The agency must maintain a coordinated agency-wide program for the surveillance, identification, prevention, control, and investigation of infectious and communicable diseases that is an integral part of the HHA’s QAPI program.

Infection Control must include:

  • The use of accepted standards of practice, including standard precautions, to prevent the transmission of infections and communicable diseases;
  • A method for identifying infectious and communicable disease problems;
  • A plan for the appropriate actions that are expected to result in improvement and provide infection control education to staff, patients, and caregivers.

That’s all for today.  Questions and comments may be posted below.

.  Stay tuned for more.

More Conditions of Participation

484.55 Condition of participation: Comprehensive assessment of patients.

Most agencies will not find it difficult to comply with the requirements in the Comprehensive Assessment because they are already assessing these areas.  The fact that ‘Cognitive Status’ which is already included in the OASIS data set and ‘Patient Goals’ are now mentioned in the Conditions of Participation may be an indicator of exactly how serious Medicare is about changing their focus to a patient centered approach to care and outcomes as opposed to the more punitive approach of hunting for agencies that disregard regulations.

The biggest change regarding the Initial Assessment that I see is that the Occupational Therapist is now able to complete the initial visit if OT is the only service ordered by the MD and if the need for OT establishes Medicare Eligibility.  Welcome to the world of Admits, OT’s.

Content of Comprehensive Assessment

  • Current health; functional and cognitive status
  • strengths, goals and care preferences
  • Continuing need for home care
  • Review of all medications (Identify potential adverse reactions, ineffective drug therapy, side effects, significant drug reactions, duplication and noncompliance with meds.
  • Patients primary caregiver and other available support
    • Willingness to provide care
    • Availability and schedules
    • Patients representative if any
  • Incorporation of OASIS data

Recertification visits are still done within the same time frame (days 56 through 60 of episode).  Resumption of care visits are done within 48 hours of the patient’s return to home OR on physician ordered ROC date.

Plan of Care

Patients are accepted for treatment on the reasonable expectation that the agency can meet medical, nursing, rehab and social needs in the home.  Care plan must specify the care and services to meet specific needs identified in the comprehensive assessment.

Plan of Care contents

  • All pertinent diagnoses
  • Mental, psychosocial and cognitive status
  • Types of services, supplies and equipment required
  • Frequency and duration of visits to be made
  • Prognosis
  • Rehab potential
  • Functional limitations
  • Activities permitted
  • Nutritional requirements
  • All Medications and Treatments
  • Safety Measures
  • Risk for Emergency dept visits and rehospitalizations
  • Measures to mitigate risk of above
  • Patient and caregiver education
  • Specific interventions and education
  • Measurable outcomes and goals mutually identified by the patient and agency
  • Advance directives
  • All orders

Each patient must receive a copy of their plan of care.

Additionally, each patient is to receive written instructions that include:

  • Visit schedule
  • Med list with names, dosages and any meds to be administered by agency
  • Any treatments including those administered by agency or persons acting on behalf of agency including therapy.
  • Any other pertinent instructions specific to the patient’s care needs
  • Name and contact information of the agency clinical manager.

Revision of POC

There is nothing new here but something has been removed.  There is no requirement that a 60 day summary be sent to the physician.  It shouldn’t be needed if agencies abide by the following.

  • The plan of care must be reviewed and revised by the physician responsible for the home health plan of care at least every 60 days .
  • Agency MUST promptly alert relevant physicians to any changes in the patient condition or needs that suggest that outcomes are not being achieved and/or that the plan of care should be altered.
  • Revised plan must reflect current information from updated OASIS and contain information about progress to goals.
  • Revisions must be communicated to the patient, representative (if any), caregiver and all physicians issuing orders for the plan of care.
  • Revisions related to discharge planning must be communicated with all of the above plus the patient’s primary care practitioner or other healthcare professional who be providing care for the patient in the community.

Conformance with MD Orders

  • Drugs, services and treatments are administered only upon the order of a physician.
  • Influenza and pneumococcal vaccines may be administered per agency policy developed in consultation with a physician, and after assessing for contraindications.


  • Review the way your agency handles plans of care and ensure your process includes a mechanism for dissemination of information to all physicians writing orders for a patient.  Review or develop a vaccine policy that allows for administration of flu and pneumonia vaccines according to a well-written protocol developed in conjunction with a physician.
  • Most agencies will have to expand the collection of information related to caregivers and availability.
  • Begin now to audit admissions for the requirements set forth in the CoPs.
  • Begin reviewing admissions using a tool based on the new requirements.  admission-review-tool.pdf  Modify to fit the needs of your agency.
  • Educate your staff.

More Later.  And to think, we haven’t even looked at Quality Assurance, yet.

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