Breaking Down the New Home Health Conditions of Participation: Personnel Qualifications, Emergency Preparedness, Compliance with Regulations, Administration of Services, and Clinical Records

Update: On Friday, July 7, 2017, CMS issued a final rule to change the new Home Health Conditions of Participation effective date from July 13, 2017 to January 13, 2018. Despite this delay, home health agencies should not cease or postpone preparation for the new Home Health CoPs.

To help you prepare for the new Home Health CoPs, HEALTHCAREfirst has partnered with home health care consultant and regulatory expert, Mary St. Pierre, RN, BSN, MGA, for a series of blog articles regarding the regulatory changes to the Home Health CoPs that will likely require amended policies, procedures, and forms.

In parts one through four of our blog series on the Home Health Conditions of Participation (CoPs), we discussed QAPI, infection control, care, planning and coordination, as well as patient rights requirements. Additionally we talked about comprehensive assessments, skilled professional services, and home health aide services. In this article, we will cover personnel qualification requirements, emergency preparedness, compliance with Federal, State & Local laws/regulations, organization/administration of services, and maintenance of clinical records. Please note that this is only a summary of many of the CoP changes and you should refer to the revised Conditions of Participation for complete details.

Personnel Qualifications
Some changes have been made to the qualifications and responsibilities of home health personnel as follows.

Standard: Administrator
The Home Health Administrator must ensure that a clinical manager is available during all operating hours. Additionally, s/he must ensure the agency employs qualified personnel as well as development of personnel qualifications and policies.
The Administrator must be or have a pre-designated person who acts when s/he is not available. This person:

  • Must be qualified
  • Is authorized in writing by the administering and governing body
  • Assumes responsibility and obligations of the Administrator
  • May be the Clinical Manager

Additionally, for Administrators who begin employment with a home health agency on or after July 13, 2017, s/he must:

  • Be a licensed physician, a registered nurse, or hold an undergraduate degree, and
  • Has experience in health service administration, with at least one year of supervisory or administrative experience in home health care or a related health care program

Standard: Clinical Manager
The standard states that a Clinical Manager is a person who is a licensed physician, physical therapist, speech-language pathologist, occupational therapist, audiologist, social worker, or a registered nurse.

  • Can be one or more qualified individuals
  • Provides oversight of all patient care services and personnel
  • Oversight must include the following :
    • Making patient and personnel assignments
    • Coordinating patient care
    • Coordinating referrals
    • Assuring that patient needs are continually assessed
    • Assuring the development, implementation, and updates of the individualized plan of care


Emergency Preparedness

This CoP consists of four elements that must be in place (including completed training and testing) by November 15, 2017. They must be reviewed and updated at least annually, with annual drills and exercises to test the emergency plan.

Risk Assessment and Planning
Develop an emergency plan based on a risk assessment.

  • Perform risk assessment using an “all-hazards” approach, focusing on capacities and capabilities.

Policies and Procedures
Develop and implement policies and procedures based on the emergency plan and risk assessment.

  • Policies and procedures must address a range of issues including subsistence needs, evacuation plans, procedures for sheltering in place, tracking patients and staff during an emergency.

Communications Plan
Develop a communication plan that  complies with both Federal and State laws.

  • Coordinate  patient care within the facility, across health care providers, and with state and local public health departments and emergency management systems.

Training and Testing
Develop and maintain training and testing programs, including initial training in policies and procedures.

  • Demonstrate knowledge of emergency procedures and provide training at least annually.

Compliance with Federal, State & Local Laws/Regulations
Standard: Laboratory Services
This standard states that a home health agency may not substitute its equipment for a patient’s equipment when assisting with self-administered tests. This is likely related to glucose monitoring, however pertains to all self-administered testing equipment.


Organization/Administration of Services
This CoP outlines the responsibilities of the governing body, the parent-branch relationship, and services under arrangement.

Standard: Governing Body
This standard states that the governing body assumes full legal authority and responsibility for:

  • Overall management and operation
  • Provision of all home health services
  • Fiscal operations
  • Review of agency’s budget, operational plans
  • QAPI program

Standard: Parent-Branch Relationship
This standard clarifies that the parent is responsible for reporting each branch to the state agency at time of survey and each time the parent proposes to add or delete a branch, as well as providing direct support and administrative control over the branch.

Standard: Services Under Arrangement
This standard details what types of organizations a home health agency may not contract with, including those that have been denied Medicare or Medicaid enrollment, been excluded or terminated from any federal health program, had its Medicare or Medicaid billing privileges revoked, or been debarred from participating in any government program.


Maintenance of Clinical Records
This CoP addresses the maintenance, content, and retrieval requirements of clinical records.
It states that the home health agency must maintain a clinical record:

  • Containing past and current information
  • Information contained in the clinical record must be accurate, adhere to current clinical record documentation standards of practice
  • Be available to the physician(s) issuing orders for the home health plan of care, and appropriate agency staff

Summary report and progress note have been deleted from the clinical records.

Standard: Contents of Clinical Record
There are a few additions to this standard, including a requirement that the clinical record contain all of the assessments from the most recent home health admission, as well as responses to interventions. Additionally, the clinical record should have contact information for the patient, the patient’s representative (if any), and the patient’s primary caregiver(s) in addition to contact information for the primary care practitioner or other health care professional responsible care and services after discharge.

CMS added that the clinical record must contain a completed discharge summary that is sent to the primary care practitioner or other health care professional who will be responsible after discharge:

  • Within 5 business days of the patient’s discharge; or
  • A completed transfer summary that is sent within 2 business days of a planned transfer, if the patient’s care will be immediately continued in a health care facility; or
  • A completed transfer summary that is sent within 2 business days of becoming aware of an unplanned transfer, if the patient is still receiving care in a health care facility at the time when the HHA becomes aware of the transfer.

(Note: Required content to be determined in a separate rule)

Standard: Authentication
All entries must be legible, clear, complete, and appropriately authenticated, dated, and timed. Authentication must include a signature and a title (occupation), or a secured computer entry by a unique identifier, of a primary author who has reviewed and approved the entry.

Standard: Retention of Clinical Records
Clinical records must be retained until five years after discharge.

Standard: Retrieval of Clinical Records
A patient’s clinical record (whether hard copy or electronic form) must be made available to a patient, free of charge, upon request at the next home visit, or within four business days (whichever comes first).

In the next blog article in this series, Mary will discuss what HHAs should be doing now to prepare for the updated Home Health CoPs. Be sure to subscribe to our blog  to get notifications when new articles in this series are posted!

Have questions about the new Home Health CoPs? Read our FAQ that addresses home health agencies’ most common questions and concerns. You can also register for a webinar on May 18th where we will provide an in-depth discussion of the new Home Health CoPs and what you should be doing now to prepare.

About Mary St. Pierre, RN, BSN, MGA

Mary St. Pierre worked was employed as a registered nurse by the Visiting Nurse Association of Trenton and St. Francis Hospital in New Jersey, followed by 24 years as a home care nurse, clinical supervisor and branch manager with the Visiting Nurse Association of Washington, DC (now MedStar VNA).

Before retiring in 2013 she oversaw the operations of the Regulatory Affairs Department of the National Association for Home Care & Hospice (NAHC) for 20 years, tracking regulations and influencing regulatory bodies (e.g. CMS, FDA, OSHA). She wrote articles, prepared educational programs, presented speeches and programs and kept the NAHC membership abreast of regulatory, Medicare coverage, quality, and clinical information.

Since retirement, Mary has served as a consultant, providing clinical, operational, and regulatory guidance to the home health industry. She currently provides services exclusively to HEALTHCAREfirst.

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