N.Y. Comp. Codes R. & Regs. tit. 10 § 766.9 : DEPARTMENT OF HEALTH — Medical Facilities — State Hospital Code — Certified Home Health Agencies and Licensed Home Care Services Agencies — Licensed Home Care Services Agencies-minimum Standards — Governing authority

The governing authority or operator, as defined in Part 700 of this Title, of a licensed home care services agency shall:

(a) be responsible for the management and operation of the agency;

(b) ensure compliance of the home care services agency with all applicable Federal, State and local statutes, rules and regulations;

(c) ensure the development of a written emergency plan which is current and includes procedures to be followed to assure health care needs of patients continue to be met in emergencies that interfere with delivery of services, and orientation of all employees to their responsibilities in carrying out such a plan;

(d) adopt and approve amendments to written policies regarding the management and operation of the home care services agency and the provision of health care services;

(e) make available to the public information concerning the services which it offers, the geographic area in which these services are made available, the charges for the various types of service and the payment mechanisms which may be available for such services;

(f) provide an office facility or facilities equipped and sufficient in size to permit the efficient conduct of business including access to patient records by all professional staff providing care and prompt telephone contact to and from patients, referral agencies or facilities, and other home care services agencies;

(g) employ or contract for a sufficient number of staff to coordinate, direct and deliver services to patients accepted for care in accordance with prevailing standards of professional practice;

(h) employ at least one licensed and currently registered professional nurse whose educational and experiential qualifications are deemed appropriate by the employing agency for the duties assigned, to be responsible for the direction and supervision of all patient care services and other health care activities of the agency;

(i) accept and retain for services only those persons whose health care needs can be safely and adequately met by the agency according to criteria specified in written agency policies;

(j) ensure the development and implementation of a patient complaint procedure to include:

(1) documentation of receipt, investigation and resolution of any complaint, including the maintenance of a complaint log indicating the dates of receipt and resolution of all complaints received by the agency;

(2) review of each complaint with a written response to all written complaints and to oral complaints, if requested by the individuals making the oral complaint:

(i) explaining the complaint investigation findings and the decisions rendered to date by the agency within 15 days of receipt of such complaint; and

(ii) advising the complainant of the right to appeal the outcome of the agency's complaint investigation and the appeal procedure to be followed;

(3) an appeals process with review by a member or committee of the governing authority within 30 days of receipt of the appeal; and

(4) notification to the patient or his or her designee that if the patient is not satisfied by the agency's response, the patient may complain to the Department of Health's Office of Health Systems Management;

(k) ensure continuous quality improvement initiatives, by establishing and maintaining a coordinated quality assessment and improvement program which integrates the review activities of all home care programs and services to enhance the quality of care and treatment. Quality improvement shall be the responsibility of all staff, at every level, at all times. Supervisory personnel alone cannot ensure quality of care and services. Such quality must be part of each individual's approach to his or her daily responsibilities;

(l) appoint a quality improvement committee to establish and oversee standards of care. The quality improvement committee shall consist of a consumer and appropriate health professional persons. The committee shall meet at least four times a year to:

(1) review policies pertaining to the delivery of the health care services provided by the agency and recommend changes in such policies to the governing authority for adoption;

(2) conduct a clinical record review of the safety, adequacy, type and quality of services provided which includes:

(i) random selection of records of patients currently receiving services and patients discharged from the agency within the past three months; and

(ii) all cases with identified patient complaints as specified in subdivision (j) of this section;

(3) prepare and submit a written summary of review findings to the governing authority for necessary action; and

(4) assist the agency in maintaining liaison with other health care providers in the community;

(m) ensure that any management contract complies with the following:

(1) for purposes of this section, a management contract is an agreement between a licensed home care services agency's governing authority and a managing authority for the purpose of managing the day-to-day activities of the agency or any portion thereof. The following shall not be considered management contracts:

(i) a contract solely for the provision of professional or other health care services;

(ii) an employment contract; or

(iii) a contract for the provision of administrative, consulting or support services if all of the following factors are present:

(a) the agency's governing authority retains responsibility for the day-to-day operations of the home care agency;

(b) the contracting entity has no authority to hire or fire any agency personnel;

(c) the contracting entity does not maintain and control the books and records of the agency;

(d) the contracting entity has no authority to dispose of assets or to incur any liability on behalf of the agency; and

(e) the contracting entity has no authority to adopt or enforce policies regarding the operation of the agency;

(2) a governing authority may enter into a management contract if the requirements of this subdivision are met. A management contract which has been approved by the department prior to the effective date of this subdivision need not be amended further in order to meet the specific requirements of this subdivision. A management contract entered into on or after the effective date of this subdivision shall be effective only with the prior written consent of the commissioner. Management contracts shall include the following:

(i) a description of the proposed roles of the governing authority and managing authority during the period of the proposed management contract. The description shall clearly reflect retention by the governing authority of ongoing responsibility for compliance with all statutory and regulatory requirements;

(ii) a provision which recognizes clearly that the responsibilities of the agency's governing authority are in no way lessened by entering into the management contract, that the governing authority retains full legal authority over the operation of the agency, and that any powers not delegated specifically to the managing authority through the provisions of the contract remain with the governing authority;

(iii) a provision which states that notwithstanding any other provision of the contract, the governing authority retains:

(a) direct, independent authority to hire or fire the agency's administrator or manager;

(b) independent control of the agency's books and records;

(c) authority over the disposition of assets and the authority to incur on behalf of the agency liabilities not associated normally with the day-to-day operation of the agency; and

(d) authority for the independent adoption and enforcement of policies affecting the delivery of health care services;

(iv) an express representation that any management contract approved by the commissioner is the sole agreement between the managing authority and the governing authority for the purpose of managing the day-to-day activities of the agency, or any portion thereof, relating to the geographic service area that is covered by the management contract, and that any amendments or revisions to the management contract which increase the amount or extent of authority delegated to the managing authority shall be effective only with the prior written consent of the commissioner;

(3) a management contract shall not be approved if the governing authority does not retain sufficient authority and control to discharge its responsibilities as the agency operator. The elements of control set forth in subparagraph (2)(iii) of this subdivision shall not be delegated to a managing authority. The governing authority must retain authority to independently adopt, amend and implement policies and procedures regarding the operation of the agency in order to ensure the provision of quality home care services and that the agency is operated in compliance with all applicable statutes and regulations;

(4) a governing authority wishing to enter into a management contract shall submit a proposed written contract to the department at least 60 days prior to the intended effective date, unless a shorter period is approved in writing by the commissioner due to extraordinary circumstances. The department shall review proposals expeditiously and shall notify the governing authority of any changes that must be made. The governing authority shall also submit, within the same time frame, the following:

(i) documentation demonstrating that the proposed managing authority holds all necessary approvals to do business in New York State;

(ii) information necessary to determine that the character and competence of the proposed managing authority, and its principals, officers and directors, is satisfactory, including evidence that all agencies or health care facilities it has managed or operated, in or outside of New York State, have provided a high level of care;

(5) during the period between an agency's submission of a request for approval of a management contract and disposition of that request, an agency may not enter into any arrangement for management contract services other than a written interim consultative agreement with the proposed managing authority. Any interim agreement shall be consistent with the provisions of this section, and shall be submitted to the department no later than five days after its effective date;

(6) an agency's governing authority shall retain the authority to terminate the contract and discharge the managing authority and its employees from their positions at the agency for cause on not more than 60 days' notice. In such event, the agency shall notify the department in writing at the time the managing authority is notified. The agency's governing authority shall provide a plan for the operation of the agency subsequent to the termination and discharge, to be submitted with the notification to the department;

(n) ensure that any franchise agreement complies with the following:

(1) for purposes of this section, a franchise agreement means a contract or agreement between a licensed home care services agency's governing authority (franchisee) and a franchisor by which:

(i) the governing authority is granted the right to engage in the business of offering home care services under a marketing plan or system developed in substantial part by a franchisor, and the governing authority is required to pay, directly or indirectly, a franchise fee; or

(ii) the governing authority is granted the right to engage in the business of offering home care services associated substantially with the franchisor's trademark, service mark, trade name, logotype, advertising, or other commercial symbol designating the franchisor or its affiliate, and the governing authority is required to pay, directly or indirectly, a franchise fee;

(2) a governing authority may enter into a franchise agreement if the requirements of this subdivision are met. A franchise agreement which has been approved by the department prior to the effective date of this subdivision need not be amended further in order to meet the specific requirements of this subdivision. A franchise agreement entered into on or after the effective date of this subdivision shall be effective only with the prior written consent of the commissioner. A governing authority seeking to enter into a franchise agreement shall submit to the department a copy of the proposed agreement complying with the provisions of this section at least 60 days prior to the intended effective date, unless a shorter period is approved by the commissioner due to extraordinary circumstances. The department shall review proposals expeditiously and shall notify the governing authority of any changes that must be made. Such agreements shall include the following:

(i) a description of the proposed roles of the governing authority and franchisor during the period of the proposed agreement. The description shall reflect clearly the governing authority's ongoing responsibility for the operation and management of the agency and for compliance with all statutory and regulatory requirements;

(ii) a provision which recognizes clearly that the responsibilities of the agency's governing authority are in no way lessened by entering into the agreement and that the governing authority has full legal authority over the operation and management of the agency, and that the governing authority retains the right and authority to independently adopt, amend and implement policies and procedures regarding the operation of the agency in order to ensure the provision of quality home care services and that the agency is operated in compliance with all applicable statutes and regulations;

(iii) a provision which recognizes that the policies, standards, procedures, manuals and other documents developed by the franchisor which relate to the operating standards, policies and procedures for the agency shall be available for inspection and copying by the department in accordance with the department's statutory and regulatory authority. Such documents, when received by the department, shall be subject to the relevant provisions of the Freedom of Information Law including, if applicable, provisions relating to excepting from disclosure documents which are trade secrets or are maintained for the regulation of commercial enterprise which if disclosed would cause substantial injury to the competitive position of the subject enterprise;

(iv) an express representation that any franchise agreement approved by the commissioner is the sole franchise agreement between the franchisor and the governing authority for the agency, or any portion thereof, relating to the geographic service area that is covered by the franchise agreement;

(3) a franchise agreement shall not be approved if the governing authority does not retain sufficient authority and control to discharge its responsibilities as the agency operator. The following elements of control shall not be delegated to a franchisor:

(i) authority to hire or fire agency staff;

(ii) control of the agency's books and records;

(iii) authority over the disposition of assets or the authority to incur liabilities on behalf of the agency; and

(iv) sole authority for the independent adoption of policies and procedures affecting the delivery of health care services. Although the governing authority may agree to adopt and utilize policies and procedures developed by the franchisor, the governing authority must retain authority to independently adopt, amend and implement policies and procedures regarding the operation of the agency in order to ensure the provision of quality home care services and that the agency is operated in compliance with all applicable statutes and regulations;

(4) an agreement which contains elements of both a franchise agreement and a management contract shall be subject to the applicable provisions of this subdivision and subdivision (m) of this section.

(o) Health provider network access and reporting requirements. The governing authority or operator of an agency shall obtain from the department's health provider network (HPN), HPN accounts for each agency that it operates and ensure that sufficient, knowledgeable staff will be available to and shall maintain and keep current such accounts. At a minimum, 24-hour, seven- day-a-week contacts for emergency communication and alerts, must be designated by each agency in the HPN communications directory. A policy defining the agency's HPN coverage consistent with the agency's hours of operation shall be created and reviewed by the agency no less than annually. Maintenance of each agency's HPN accounts shall consist of, at a minimum, the following:

(1) sufficient designation of the agency's HPN coordinator(s) to allow for HPN individual user application;

(2) designation by the governing authority or operator of an agency of sufficient staff users of the HPN accounts to ensure rapid response to requests for information by the State and/or local Department of Health;

(3) adherence to the requirements of the HPN user contract; and

(4) current and complete updates of the communications directory reflecting changes that include, but are not limited to, general information and personnel role changes as soon as they occur, and at a minimum, on a monthly basis.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 766.9