SUMMARY OF PROPOSED HOME HEALTH COPs
ADMINISTRATION AND AGENCY ORGANIZATION
Maintain requirements for disclosing the names and addresses of all persons with an ownership or controlling interest, officers, directors, board members, agents, or managing employees and add that they include the residential address for such persons. Title 22 is different.
Proposed new definitions for “managing employee” specifying that the individual includes a general manager, business manager, administrator, or director, who exercises operational or managerial control over the entity, or who directly or indirectly conducts the day-to-day operations of the entity. Title 22 does not include a definition for this position.
Proposed new definition for “director” would refer to a corporate director and not a medical director or nursing director. Title 22 does not include a definition for this position.
Proposed new definition for an “agent” defined as any person who has been delegated the authority to obligate or act on behalf of a provider. Title 22 does not include a definition for this position.
Proposed new definition for “Officer” defined as any person who is responsible for the overall management of the operation of the agency and requires that information on all individuals who are officers of the agency as defined under state law in which the agency is incorporated. Title 22 does not include a definition for this position.
Proposed §484.100 would cited agencies when the violation of federal, state, local laws or regulations could potentially affect the health and safety of the agency’s patients, and the rights and well-being of patients. Title 22, section 74683 has similar requirements.
Relocate current §484.14(g), “Coordination of patient services,” and revise requirements under proposed §484.60. Not applicable to Title 22.
Proposed §484.105 relocates current §484.38, “Qualifying to furnish outpatient physical therapy or speech pathology services.” Not applicable to Title 22.
Current §484.14(b), which requires the governing body should be able to assess the agency’s financial needs and assume responsibility for effectively managing its financial resources is retained and relocated to proposed §484.105(a), which expands the responsibilities of the governing body to assume full legal authority and responsibility for the agency’s overall management and operation, the provision of all home health services, the review of the budget and operational plans, and the agency’s quality assessment and performance improvement program. Title 22 section 74717 has fewer requirements.
Proposed §484.105(b), “Administrator,” describes the role of the administrator and sets provisions for when the administrator is not available. Proposed personnel requirements for the administrator are relocated to §484.115(a). Title 22, section 74718 contains similar requirements.
Proposed §484.105(b) requires that the administrator be appointed by the governing body, be responsible for all day to day operations of the agency, and be responsible for ensuring that a skilled professional as described in §484.75 is available during all operating hours Title 22, section 74718 contains similar requirements.
Proposed 484.105 requires that any time when the administrator is not available, a pre-designated person, who is authorized in writing by the administrator and governing body, would assume the same responsibilities and obligations as the administrator, including the responsibility to be available during all operating hours. Title 22, section 74718 has different requirements.
Propose a new clinical manager role at §484.105(c) who would be a qualified licensed physician or registered nurse, identified by the agency, who is responsible for the oversight of all personnel and all patient care services provided by the agency, whether directly or under arrangement, to meet patient care needs. Title 22, section 74703 does not provide as many options.
Proposed §484.105(d), adds a new standard for parent-branch relationship. Revises definition of “branch” in §484.2 to define a branch office as a location or site from which an agency provides services within a portion of the total geographic area served by the parent agency. Deletes part of the requirements for branch locations by removing the language that the branch location be “sufficiently close” to the parent agency. Time and distance from parent location will still be considered as factors in conjunction with other considerations. Title 22, section 74609 is different.
The parent location should be aware of the staffing, patient census and any issues/matters affecting the operation of the branch and must be able to monitor branch activities: clinical, administrative, management of services, personnel and administrative issues, including providing ongoing in-service training to ensure that all staff is competent to provide care and services. The parent location is responsible for any contracted arrangements with other individuals or organizations, even when the contracted services are used exclusively by the branch. Title 22, section 74719 is different.
Proposed an additional requirement that agencies report their branch locations to the state survey agency at the time of an initial certification request, at each survey, and at the time any proposed additions or deletions are made. Title 22, section 74661(3) already has this requirement.
Retain current §484.14(h) in proposed §484.105(e), Services under arrangement. Require that the primary agency have a written agreement with another agency, with an organization, or with an individual, that it has contracted with to provide services to its patients, which stipulates that the primary agency would maintain overall responsibility for all care provided to a patient in accordance with the patient’s plan of care, whether the care is provided directly or under arrangement. Title 22, section 74719 already has this requirement.
Proposed §484.105(f)(1), retains the requirement that skilled nursing and one of the therapeutic services must be made available on a visiting basis in the patient’s home and at least one service would be required to be provided directly by the agency. Title 22 does not have this requirement.
Proposes an additional requirement that all home health services be provided in accordance with current clinical practice guidelines. Title 22, section 74742(E) already has this requirement.
CLINICAL RECORD
Proposed 484.110 adds a requirement that the information contained in the clinical record would need to be accurate, adhere to current clinical record documentation standards of practice, and be available to the physician who is responsible for the home health plan of care and appropriate agency staff. The information could be maintained electronically. The clinical record must exhibit consistency between the diagnosed condition, the plan of care, and the actual care furnished to the patient. Consistency would be reflected in the appropriate link between patient assessment information and the services and treatments ordered and furnished in the plan of care. Title 22, section 74735 has different requirements.
Removes requirement that the name of the physician and drug, dietary, treatment, and activity orders be included in a dedicated part of the clinical record, since these items are already part of the plan of care and should already be in the clinical record. Title 22, section 74735 has different requirements.
Proposed §484.110(a), requires that the clinical record include: the patient's current comprehensive assessment, including all of the assessments from the most recent home health admission, clinical visit notes, and individualized plans of care; all interventions, including medication administration, treatments, services, and responses to those interventions, which would be dated and timed in accordance with the requirements of proposed §484.110(b); goals in the patient’s plan of care and the progress toward achieving the goals; contact information for the patient and representative (if any); contact information for the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the agency; and a discharge or transfer summary note that would be sent to the patient’s primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the agency within 7 calendar days, or, if the patient is discharged to a facility for further care, to the receiving facility within 2 calendar days of the patient’s discharge or transfer. Title 22, section 7475 has different requirements.
Proposes to add a new standard at §484.110(b) which requires authentication of clinical records. Requires that all entries be legible, clear, complete, and appropriately authenticated, dated, and timed. Title 22, section 74735 has different requirements.
Authentication for every entry would be required to include a signature and a title, or a secured computer entry by a unique identifier, of a primary author who had reviewed and approved the entry. Title 22 does not have this requirement.
In cases where the original clinician is unable to correct their entry, require documentation of communication with the original clinician regarding modifications to the original entry. Title 22 does not have this requirement.
Require that clinical records be retained for 5 years after the discharge of the patient, unless state law stipulates a longer period of time. Title 22, section 74731 requires 7 year retention period.
Continues to require, in §484.110(c)(2), that the agency’s policies provide for retention of records even if the agency discontinues operations. Title 22, section 74731 already has this requirement.
Proposes that the agency be required to notify the state agency as to where the agency’s clinical records would be maintained. Title 22, section 74731 already has this requirement.
Proposed §484.110(d), requires that clinical records, their contents, and the information contained therein, be safeguarded against loss or unauthorized use. Title 22, section 74731 already has this requirement.
Adds a new standard at §484.110(e), retrieval of clinical records which requires that a patient’s clinical records (whether hard copy or electronic) be made readily available to a patient or appropriately authorized individuals or entities upon request. Title 22, section 74731 already has this requirement.
COMPLAINTS
Proposed §484.50(e), “Investigation of complaints,” would expand upon the current complaint investigation requirements at §484.10(b)(5). Proposed §484.50(e)(1)(i) would require the agency to investigate complaints made by patients, representatives, caregivers, and families regarding treatment or care that is (or fails to be) furnished, is furnished inconsistently, or is furnished inappropriately. Title 22 already requires under section 74743(5).
Proposed requirements are added that require agencies to investigate allegations of mistreatment, neglect, or verbal, mental, psychosocial, sexual, and physical abuse, including injuries of unknown source, and/or misappropriation of patient property by anyone furnishing services on behalf of the agency. This requirement would clarify that all patient complaints should be investigated by the agency. Title 22 already requires under section 74743.
Proposed §484.50(e)(2) requires any agency staff, regardless of whether they are employed directly or obtained under arrangements with another entity, to immediately report to the agency’s administrator or other appropriate authorities any incidences of mistreatment, neglect, or abuse, and/or any misappropriation of patient property, which they have noticed during the normal course of providing services to patients. Title 22, section 74719 (5) addresses differently.
Proposed §484.50(f), “Accessibility” requires that information provided to patients would be provided in plain language, and in a manner that is both accessible and timely to the individual. For people with disabilities, providing access includes the use of accessible websites and the provision of auxiliary aids and services, such as qualified interpreters and alternate formats. For persons with LEP, providing access includes providing oral interpretation and written translations. Title 22, section 74743(b) is different.
COMPREHENSIVE ASSESSMENTS
Retains the current requirements at §484.55, Comprehensive assessment of patients. Title 22 does not address comprehensive assessments.
Proposes removal of the requirements that the agency send a summary of care to the attending physician at least once every 60 days, that the agency have a group of professional personnel to advise its operation, and that the agency conduct a quarterly evaluation of its program via chart reviews. Proposed is contrary to Title 22 section 74697(4) and section 74742.
Proposed 484.55 requires that the comprehensive assessment must accurately reflect the patient’s status, and would assess or identify the following: Title 22 does not address comprehensive assessments.
• The patient’s current health, psychosocial, functional, and cognitive status;
• The patient’s strengths, goals, and care preferences, including the patient's progress toward
achievement of the goals identified by the patient and the measurable outcomes identified by the
agency;
• The patient's continuing need for home care;
• The patient's medical, nursing, rehabilitative, social, and discharge planning needs;
• A review of all medications the patient is currently using;
• The patient’s primary caregiver(s), if any, and other available supports; and
• The patient’s representative (if any).
Proposed §484.55(d)(2) allows for a physician-ordered resumption of care date as an alternative to the fixed 48 hour time frame. Title 22 does not have this requirement.
DEFINITIONS AND REORGANIZATION OF SECTIONS
Reorganizes §484.1 which would set out the statutory authority for the proposed regulations and deletes §484.1(a)(3). Not applicable to Title 22.
Proposes elimination of current definitions for the terms “bylaws” and “supervision.” Title 22 does not address.
Proposes elimination of the definition for “home health agency” because it is already defined in Section 1861(o) of the Act. Title 22 has requirements under section 74600.
Proposes deletion of the term “progress notes” because notations in the clinical record are more typically referred to as “clinical notes,” a term that is well defined and understood in the industry. Title 22 does not address.
Proposes deletion of the term “subunit” because the distinction between the requirements that the parent location and a subunit must meet are minor. Title 22 defines under section 74605.
Proposes deletion of the requirements for the group of professional personnel. This deletion is contrary to Title 22 which has detailed requirements under section 74742.
Proposes adding definitions for the terms “in advance,” “quality indicator,” “representative,” “supervised practical training,” and “verbal order.” Title 22 does not define all of these terms.
Proposes definition for “representative” and enables patients to choose their representatives, if they wish to do so. Title 22 does not define the term.
Proposes to explicitly recognize legal guardians in situations where the patient has one. CA law defines under Probate Codes 1500-1543.
Proposes definition for “verbal orders” to mean those physician orders that are delivered verbally (meaning spoken), by the physician, to a nurse or other qualified medical personnel, and recorded in the plan of care. Title 22, section 74701 is different.