Part 766 - Licensed Home Care Services Agencies--Minimum Standards

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete
Statutory Authority: 
Public Health Law, Sections 576, 2164, 2500-a, 2522(6), 2528, 2904, 2904-b, 3612, 3612(6), 4175; SSL Sections 364(2), 365-a)

Section 766.1 - Patient rights

Section 766.1 Patient rights. (a) The governing authority shall establish written policies regarding the rights of the patient and shall ensure the development of procedures implementing such policies. These rights, policies and procedures shall afford each patient the right to:

(1) be informed of these rights, and the right to exercise such rights, in writing prior to the initiation of care, as evidenced by written documentation in the clinical record;

(2) be given a statement of the services available by the agency and related charges;

(3) be advised before care is initiated of the extent to which payment for agency services may be expected from any third party payors and the extent to which payment may be required from the patient.

(i) The agency shall advise the patient of any changes in information provided under this paragraph or paragraph (2) of this subdivision as soon as possible, but no later than 30 calendar days from the date the agency becomes aware of the change.

(ii) All information required by this paragraph shall be provided to the patient both orally and in writing;

(4) be informed of all services the agency is to provide, when and how services will be provided, and the name and functions of any person and affiliated agency providing care and services;

(5) participate in the planning of his or her care and be advised in advance of any changes to the plan of care;

(6) refuse care and treatment after being fully informed of and understanding the consequences of such actions;

(7) be informed of the procedures for submitting patient complaints;

(8) voice complaints and recommend changes in policies and services to agency staff, the New York State Department of Health or any outside representative of the patient's choice. The expression of such complaints by the patient or his/her designee shall be free from interference, coercion, discrimination or reprisal;

(9) submit patient complaints about the care and services provided or not provided and complaints concerning lack of respect for property by anyone furnishing service on behalf of the agency, to be informed of the procedure for filing such complaints, and to have the agency investigate such complaints in accordance with the provisions of subdivision (j) of section 766.9 of this Part. The agency is also responsible for notifying the patient or his/her designee that if the patient is not satisfied by the response the patient may complain to the Department of Health's Office of Health Systems Management;

(10) be treated with consideration, respect and full recognition of his/her dignity and individuality;

(11) privacy, including confidential treatment of patient records, and to refuse release of records to any individual outside the agency except in the case of the patient's transfer to a health care facility, or as required by law or third-party payment contract; and

(12) refuse consent to advanced tasks performed by an advanced home health aide, in which case the agency shall provide for the performance of such tasks by a registered professional nurse.

(b) The governing authority shall make all personnel providing patient care services on behalf of the agency aware of the rights of patients and the responsibility of personnel to protect and promote the exercise of such rights.

(c) If a patient lacks capacity to exercise these rights, the rights shall be exercised by an individual, guardian or entity legally authorized to represent the patient.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 766.2 - Patient service policies and procedures

766.2 Patient service policies and procedures. (a) The governing authority shall ensure for each health care service provided that:

(1) written policies and procedures consistent with current professional standards of practice are developed and implemented for each service and are reviewed and revised as necessary;

(2) that the delivery of each service is documented in the clinical record;

(3) to the extent possible, services are provided by the same personnel to the same patient;

(4) persons providing care in the home display proper and current identification, including name, title and current photograph of care provider and name of agency providing the service, to be returned to the agency upon termination of employment;

(5) written policies and procedures for the storage, cleaning and disinfection of medical supplies, equipment and appliances are established;

(6) professional staff evaluate the appropriateness, cleanliness and safety of equipment prescribed;

(7) any nursing or therapeutic service, procedure or treatment not previously provided in homes by the agency is first reviewed by the quality improvement committee as described in section 766.9 of this Part before being provided routinely. If the needs of a patient require such a service, procedure or treatment, it may be implemented prior to review by the quality improvement committee if:

(i) medical consultation has been obtained regarding safety and appropriateness; and

(ii) staff have been trained to provide that specific service, procedure or treatment;

(8) a discharge plan is initiated prior to agency discharge of the patient in order to assure a timely, safe and appropriate transition for the patient; and

(9) a patient is discharged by the agency after notification of the authorized practitioner, as defined in subdivision (b) of section 766.4 of this Part, and consultation with the patient and any other professional staff involved in coordinating the plan of care, no less than 48 hours prior to patient discharge.

(b) For purposes of this Part, health care services shall include nursing, advanced home health aide services, home health aide services, personal care, physical therapy, occupational therapy, speech/language pathology, nutrition services, social work, respiratory therapy, physician services and medical supplies, equipment and appliances.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 766.3 - Plan of care

766.3 Plan of care. The governing authority or operator shall ensure that:

(a) all patients are accepted for health care services only after a determination has been made by a registered professional nurse or by an individual directly supervised by a registered professional nurse that the patient's needs can be safely and adequately met by the agency;

(b) a plan of care is established for each patient based on a professional assessment of the patient's needs and includes pertinent diagnosis, prognosis, need for palliative care, mental status, frequency of each service to be provided, medications, treatments, diet regimens, functional limitations and rehabilitation potential;

(c) orders for therapy services shall include the specific procedures and modalities to be used and the amount, frequency and duration of such services; and

(d) the plan of care is reviewed and revised as frequently as necessary to reflect the changing care needs of the patient, but no less frequently than every six months;

(1) each review shall be documented in the clinical record; and

(2) agency professional personnel shall promptly alert the patient's authorized practitioner and other affected care providers to any significant changes in the patient's condition that indicate a need to alter the plan of care.
 

Effective Date: 
Wednesday, May 15, 2013
Doc Status: 
Complete

Section 766.4 - Medical orders

766.4 Medical orders.(a) The governing authority or operator shall ensure that an order from the patient's authorized practitioner is established and documented for the health care services the agency provides to those patients who:

(1) are being actively treated by an authorized practitioner for a diagnosed health care problem;

(2) have a health care need or change in physical status requiring medical intervention; or

(3) are advanced home health aide, home health aide, or personal care services patients of a certified home health agency.

(b) For purposes of this Part, authorized practitioner shall refer to a doctor of medicine, a doctor of osteopathy, a doctor of podiatry, a licensed midwife or a nurse practitioner authorized under federal and state law and applicable rules and regulations to provide medical care and services to the patient except as may be limited by third party contract.

(c) Such orders shall be reviewed and revised as the needs of the patient dictate but no less frequently than every six months, except where an authorized practitioner, as part of an authorization, orders personal care services for up to one year for a Medicaid patient.

(d) Medical orders shall reference all diagnoses, medications, treatments, prognoses, need for palliative care, and other pertinent patient information relevant to the agency plan of care; and

(1) shall be authenticated by an authorized practitioner within 12 months after admission to the agency; and

(2) when changes in the patient's medical orders are indicated, orders, including telephone orders, shall be authenticated by the authorized practitioner within 12 months.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 766.5 - Clinical supervision

766.5 Clinical supervision. The governing authority shall ensure for all health care services that:

(a) sufficient numbers of appropriately trained and oriented supervisory staff are available to ensure the quality of patient care services provided by the agency. Such supervision shall include:

(1) ongoing review of cases and delegation of assignments by appropriate health care professionals;

(2) in-home visits to direct, demonstrate and evaluate the delivery of patient care;

(3) provision of clinical consultation; and

(4) professional consultation on agency policies and procedures;

(b) all staff delivering care in patient homes are adequately supervised. The department shall consider the following factors as evidence of adequate supervision:

(1) staff regularly provide services at the times and frequencies specified in the patient's plan of care and in accordance with the policies and procedures of their respective services;

(2) staff are assigned to the care of patients in accordance with their licensure, and their training, orientation, and demonstrated skills;

(3) clinical records are kept complete and changes in patient condition, adverse reactions, and problems with informal supports or home environment are charted promptly and reported to supervisory staff; and

(4) plans of care are revised as needed and changes are reported to the patient's authorized practitioner, other staff providing care to the patient, and other agencies which authorize payment for services, as appropriate and necessary;

(c) home health aides or personal care aides are supervised, as appropriate, by a registered professional nurse, or a therapist if the aide carries out simple procedures as an extension of physical therapy, occupational therapy or speech/language pathology;

(d) in-home supervision by professional staff of home health aides and personal care aides occurs:

(1) to demonstrate to and instruct the aide in the treatments or services to be provided with successful re-demonstration by the aide during the initial service visit or where there is a change in personnel providing care, if the aide does not have documented training and experience in performing the tasks prescribed in the plan of care;

(2) where any of the conditions set forth in paragraph (3) of subdivision (b) of this section occur, to evaluate the condition and initiate any revision in the plan of care which may be needed; and

(3) to instruct the aide as to the observations and written reports to be made to the supervising nurse or therapist; and

(e) direct supervision of an advanced home health aide is conducted by a registered professional nurse who:

(i) provides training, guidance, direction and oversight, and evaluation related to the performance of advanced tasks by the advanced home health aide;

(ii) assigns advanced tasks to be performed by the advanced home health aide after completing a nursing assessment to determine the patient’s current health status and care needs;

(iii) provides case specific training to the advanced home health aide to verify and ensure the advanced home health aide can safely and competently perform the advanced tasks for the patient;

(iv) provides written, patient specific instructions for performing advanced tasks, including the criteria for identifying, reporting, and responding to problems, errors or complications;

(v) conducts a comprehensive medication review including evaluation of the patient’s current medication use, and prescribed drug regimen and identifies and resolves any discrepancies prior to assigning the advanced home health aide to administer medications;

(vi) determines direct supervision of the advanced home health aide based on the complexity of advanced tasks, the skill and experience of the advanced home health aide assigned to perform the advanced tasks, and the health status of the patient for whom the advanced tasks are being performed;

(vii) while on duty is continuously available to communicate with the advanced home health aide by phone or other means;

(viii) conducts home visits or arranges for another qualified registered professional nurse whenever necessary to protect the health and safety of the patient;

(ix) performs an initial and ongoing assessments of the patient’s needs; and

(x) conducts a home visit at least every two weeks and more frequently as determined by the registered professional nurse, to observe, evaluate, and oversee services provided by the advanced home health aide;

(f) a process is in place to document the limitation or revocation of the assignment of advanced tasks by an advanced home health aide when deemed appropriate by a supervising registered professional nurse and to ensure that such information is available to other registered professional nurses that may supervise such aide; and

(g) any failure by a supervising registered professional nurse to comply with the requirements of paragraph (e) of this subdivision shall be reported to the department.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 766.6 - Patient care record

766.6 Patient care record. (a) The agency shall maintain a confidential record for each patient admitted to care to include:

(1) identifying patient data;

(2) medical orders, if applicable;

(3) nursing assessments conducted to provide services;

(4) an individualized plan of care;

(5) signed and dated progress notes following each patient visit or phone contact by all professional personnel providing care which include a summary of patient status and response to the plan of care and any contacts with family, informal supports and other community resources that are relevant to the patient's condition and treatment;

(6) supervisory reports of the registered professional nurse, licensed practical nurse or the therapist, if applicable, of the advanced home health aide, home health aide, or personal care aide;

(7) observations and reports made to the registered professional nurse, licensed practical nurse or therapist by the advanced home health aide, home health aide, or personal care aide, including activity sheets;

(8) documentation of accidents and incidents;

(9) documentation of the patient's receipt of information regarding his/her rights; and

(10) a discharge summary when the patient is discharged from the agency including:

(i) documentation of discharge planning preparation;

(ii) notification to the patient's authorized practitioner;

(iii) reasons for discharge and date of discharge;

(iv) summary of care given and patient's progress;

(v) patient status upon discharge including a description of any remaining needs for patient care and supportive services;

(vi) patient or family ability to self-manage in relation to any remaining problems; and

(vii) recommendations and referral for any follow-up care, if needed.

(b) Each patient's record shall be kept securely for not less than six years after discharge from the licensed home care services agency and available to the department upon request.

(c) In the case of minors, records are to be kept for not less than six years after discharge, or three years after they reach majority (18 years), whichever is the longer period.

(d) In the event that an agency discontinues operation for any reason, the governing authority, immediately preceding the discontinuance of the operation, shall make effective arrangements to maintain, store, assure access to and make available to the patient and the department upon request, all clinical records for a period consistent with the requirements of subdivisions (b) and (c) of this section. The governing authority shall notify the department in writing as to where the clinical records will be stored and how they will be made available to former patients.

(e) Each agency shall maintain written policies and procedures which:

(1) safeguard clinical records against loss or unauthorized access; and

(2) govern use, removal and release of information.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 766.7 RESERVED

Section 766.8 RESERVED

Section 766.9 - Governing authority

Section 766.9 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 (iii) of paragraph (2) 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, twenty-four 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, but not be limited to, 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.

Effective Date: 
Wednesday, May 15, 2013
Doc Status: 
Complete

Section 766.10 - Contracts

766.10 Contracts. (a) The governing authority or operator may enter into contracts with individuals, organizations, agencies and facilities when necessary, to obtain or provide patient care services.

(b) No licensed home care service may be provided by arrangement without a written contract which specifies:

(i) services to be provided,

(ii) manner in which services will be supervised and evaluated,

(iii) charges and other financial arrangements; and

(iv) any provisions made for indemnification between the agency and the contract providers.

(c) Contract personnel shall meet the personnel requirements as set forth in section 766.11 of this Part, which can be verified by written documented evidence and examined by the agency and the department.

(d) Contractual arrangements pursuant to subdivision (a) of this section, shall not diminish the licensed home care services agency's responsibility for maintaining adequacy of services provided by the agency and shall specify the following terms and conditions:

Notwithstanding any other provisions in this contract, the licensed home care services agency remains responsible for:

(1) ensuring that any service provided pursuant to this contract complies with all pertinent provisions of Federal, State and local statutes, rules and regulations;

(2) ensuring the quality of all services provided by the agency; and

(3) ensuring adherence by agency staff to the agency plan of care established for patients.

(e) Nurses or therapists providing care and service under individual contract with the agency or as personnel of another contracted agency shall maintain liaison to assure that care planning and service delivery provided by such individuals are coordinated, supervised and integrated effectively into the patient services responsibilities required by this Part;

(f) If the licensed home care services agency contracts to provide personal care services with a local social services district, the physician's orders and nursing and social assessment may, pursuant to the contract and consistent with the provisions set forth in this Part, be maintained by the local social services district purchasing the services, provided that the local social services district furnishes such written documentation and information, including copies of the physician's orders and nursing assessment, and access to its staff, as may be required by the department or by the licensed agency to assure compliance with applicable statutes, rules and regulations. Nothing herein shall be construed to diminish the responsibilities of the local social services district under applicable State or Federal statutes, rules and regulations.

(g) If a licensed home care services agency contracts with a certified home health agency, long term home health care program, AIDS home care program or hospice, to provide personal care or home health aide services, the patient assessment, plan of care, clinical record entries, supervision of such services and the obtaining of medical orders may, pursuant to the contract and consistent with the provisions set forth in this Part, be conducted and documentation maintained by the agency purchasing the service, provided that the certified home health agency, long term home health care program, AIDS home care program or hospice, furnishes such written documentation and information and access to its staff, as required by the licensed agency, to permit the licensed home care services agency to assure compliance by its employees with applicable statutes, rules and regulations.
(h) If a licensed home care services agency contracts with a certified home health agency, the administrative and general costs of such licensed home care services agency shall not exceed the annual statewide average administrative and general limitation applied to certified home health agencies in accordance with subdivision (7) of section 3614 of the public health law.

Effective Date: 
Wednesday, June 4, 2008
Doc Status: 
Complete

Section 766.11 - Personnel

766.11 Personnel. The governing authority or operator shall ensure for all health care personnel:

(a) the development and implementation of written personnel policies and procedures, which are reviewed at least annually and revised as necessary;

(b) (1) that qualifications for advanced home health aides, home health aides, and personal care aides as specified in section 700.2 of this Title are met; and

(2) that the information required by Public Health Law section 3613(3)(a)-(f) has been entered into the home care services worker registry in accordance with Part 403 of this Title.

(c) that the health status of all new personnel is assessed and documented prior to assuming patient care duties. The assessment shall be of sufficient scope that no person shall assume his/her duties unless he/she is free from a health impairment which is of potential risk to the patient or which might interfere with the performance of his/her duties, including the habituation or addiction to depressants, stimulants, narcotics, alcohol or other drugs or substances which may alter the individual's behavior;

(d) that a record of the following tests, examinations or other required documentation is maintained for all personnel who have direct patient contact:

(1) a certificate of immunization against rubella which means:

(i) a document prepared by a physician, physician assistant, specialist assistant, nurse practitioner, licensed midwife or a laboratory possessing a laboratory permit issued pursuant to Part 58 of this Title, demonstrating serologic evidence of rubella antibodies; or

(ii) a document indicating one dose of live virus rubella vaccine was administered on or after the age of twelve months, showing the product administered and the date of administration, and prepared by the health practitioner who administered the immunization; or

(iii) a copy of the document described in subparagraph (i) or (ii) of this paragraph which comes from a previous employer or the school which the individual attended as a student;

(2) a certificate of immunization against measles for all personnel born on or after January 1, 1957, which means:

(i) a document prepared by a physician, physician assistant, specialist assistant, nurse practitioner, licensed midwife or a laboratory possessing a laboratory permit issued pursuant to Part 58 of this Title, demonstrating serologic evidence of measles antibodies; or

(ii) a document indicating two doses of live virus measles vaccine were administered with the first dose administered on or after the age of 12 months and the second dose administered more than 30 days after the first dose but after 15 months of age showing the product administered and the date of administration, and prepared by the health practitioner who administered the immunization; or

(iii) a document indicating a diagnosis of the person as having had measles disease prepared by the physician, physician assistant, specialist assistant, licensed midwife or nurse practitioner who diagnosed the person's measles; or

(iv) a copy of the document described in subparagraph (i), (ii), or (iii) of this paragraph which comes from a previous employer or the school which the person attended as a student;

(3) a written statement, if applicable, from any licensed physician, physician assistant, specialist assistant, licensed midwife or nurse practitioner, which certifies that immunization with measles and/or rubella vaccine may be detrimental to the person's health. The requirements of paragraphs (1) and (2) of this subdivision relating to measles and/or rubella immunization shall be inapplicable until such immunization is found no longer to be detrimental to such person's health. The nature and duration of the medical exemption must be stated in the individual's personnel record and must be in accordance with generally accepted medical standards (for example, the recommendations of the American Academy of Pediatrics and the Immunization Practices Advisory Committee of the U.S. Department of Health and Human Services);

(4) either tuberculin skin test or Food and Drug Administration (FDA) approved blood assay for the detection of latent tuberculosis infection, prior to assuming patient care duties and no less than every year thereafter for negative findings. Positive findings shall require appropriate clinical follow up but no repeat tuberculin skin test or blood assay. The agency shall develop and implement policies regarding follow-up of positive test results; and

(5) an annual, or more frequent if necessary, health status assessment to assure that all personnel are free from any health impairment that is of potential risk to the patient, family or to employees or that may interfere with the performance of duties; (6) documentation of vaccination against influenza, or wearing of a surgical or procedure mask during the influenza season, for personnel who have not received the influenza vaccine for the current influenza season, pursuant to section 2.59 of this Title. (e) that personal identification is produced by each applicant and verified by the agency prior to retention of an applicant by the agency;

(f) (i) that prior to patient contact, employment history from previous employers, if applicable, and recommendations from other persons unrelated to the applicant if not previously employed, are verified; and (ii) a criminal history record check to the extent required by Part 402 of this Title.

(g) that personnel records include verifications of employment history and qualifications for the duties assigned and, as appropriate, signed and dated applications for employment; records of professional licenses and registrations; records of physical examinations and health status assessments; performance evaluations; dates of employment, resignations, dismissals, and other pertinent data provided that all documentation and information pertaining to an employee's medical condition or health status, including such records of physical examinations and health status assessment shall be maintained separate and apart from the non-medical personnel record information and shall be afforded the same confidential treatment given patient medical records under section 766.6 of this Part;

(h) that time and payment records are kept for all personnel;

(i) that all personnel receive orientation to the policies and procedures of the home care services agency operation and in-service education necessary to perform his/her responsibilities. At a minimum:

(1) home health aides must participate in 12 hours of in-service education per year;

(2) personal care aides must participate in six hours of in-service education per year; and

(3) advanced home health aide must participate in 18 hours of in-service education per year which must include medication management, infection control, and injection safety, and must be directly supervised by a registered professional nurse;

(j) that there is a current written job description for each position which delineates responsibilities and specific education and experience requirements; and

(k) that an annual assessment of the performance and effectiveness of all personnel is conducted including at least one in-home visit to observe performance, if applicable.

(l)(1) that a program is implemented and enforced for the prevention of circumstances which could result in an employee or patient/client becoming exposed to significant risk body substances which could put them at significant risk of HIV or other blood-borne pathogen infection during the provision of services, as defined in sections 63.1 and 63.9 of this Title. Such a program shall include:

(i) use of scientifically accepted protective barriers during job-related activities which involve, or may involve, exposure to significant risk body substances. Such preventive action shall be taken by the employee with each patient/client and shall constitute an essential element for the prevention of bi-directional spread of HIV or other blood-borne pathogen;

(ii) use of scientifically accepted preventive practices during job-related activities which involve the use of contaminated instruments or equipment which may cause puncture injuries;

(iii) training at the time of employment and yearly staff development programs on the use of protective equipment, preventive practices, and circumstances which represent a significant risk for all employees whose job-related tasks involve, or may involve, exposure to significant risk body substances;

(iv) provision of personal protective equipment for employees which is appropriate to the tasks being performed;

(v) a system for monitoring preventive programs to assure compliance and safety.

(2) that a policy/procedure is implemented and enforced for the management of individuals who are exposed to significant risk body substances under circumstances which constitute significant risk of transmitting or contracting HIV or other blood-borne pathogen infection. The policy/procedure shall include:

(i) a system for reporting to a designated individual in the agency exposure thought to represent a circumstance which constitutes significant risk of transmitting or contracting HIV or other blood-borne pathogen infection;

(ii) evaluation of the circumstances of a reported exposure and services for providing follow-up of the exposed individual which includes:

(a) medical and epidemiological assessment of the individual who is the source of the exposure, where that individual is known and available;

(b) if indicated epidemiologically, HIV or other blood-borne pathogen counseling and voluntary testing of the source individual. Disclosure of the HIV status of the source individual can be made with the express written consent of the protected individual, or a person authorized pursuant to law to consent to health care for the protected individual if such person lacks capacity to consent, or pursuant to court order, if the HIV status is not known to the exposed individual;

(c) appropriate medical follow-up of the exposed individual; and

(iii) assurances for protection of confidentiality for those involved in reported exposures.

Effective Date: 
Wednesday, December 12, 2018
Doc Status: 
Complete

Section 766.12 - Records and reports

766.12 Records and reports. (a) The governing authority or operator shall ensure the prompt submission of all records and reports required by the department and that:

(1) copies of the following records are retained on file at the principal administrative office in New York State of the home care services agency and available to the department upon request:

(i) the license issued by the department to operate as a home care service agency;

(ii) the certificate of incorporation and any amendments thereto, if applicable;

(iii) partnership agreement, if applicable;

(iv) certificate of doing business under an assumed name, if applicable;

(v) contracts and other agreements related to delivery of patient care entered into by the operator;

(vi) rules and bylaws of the governing authority and quality assurance committees, if applicable;

(vii) current written operating policies and procedures;

(viii) a current patient roster; and

(ix) listing of all personnel;

(2) copies of the following records are retained on file at each branch office of the home care services agency:

(i) the agency's policies and procedures;

(ii) a listing of all of the branch office's personnel; and

(iii) a current patient roster of all patients receiving care from the branch office and a copy of the patient care record of each such patient;

(3) at a minimum, the following reports and records are retained by the home care services agency and available to the department upon request:

(i) minutes of the meetings of the governing authority and the committees thereof which shall be retained for three years from the date of the meeting;

(ii) records of all financial transactions directly related to delivery of patient care which shall be retained three years from the date of the transaction;

(iii) personnel records, which shall be retained three years from the date of employee termination or resignation;

(iv) records of grievances and complaints which shall be retained for three years from the date of resolution;

(v) all records related to patient care and services; and

(vi) any other records required to be kept by this Part or Part 765.

(b) All records required by subdivision (a) of the section to be retained shall be maintained in hard copy or electronic form. If electronic storage is maintained, such records shall;

(1) be secure from unwarranted access;

(2) have confidentially protected, when appropriate; and

(3) be immediately available to the agency and the department in hard copy format upon request.

(c) The home care services agency shall furnish annually to the department a copy of:

(1) statistical summaries of all health care services, including the type, frequency and reimbursement for services provided, including reimbursement from federal and state governmental agencies, on forms provided by the department;

(2) if a for-profit corporation, a list of the principal stockholders and the number and percent of the total issued and outstanding shares of the corporation held by each, duly certified by the secretary of the corporation as to completeness and accuracy;

(3) if a not-for-profit corporation, a list of directors, officers and corporate members, if such members number 10 or fewer; and

(4) other such records and reports as may be legally required by the department.

(d) The agency shall furnish simultaneously to the department copies of all notices and documents required to be filed with the Securities and Exchange Commission.
 

Effective Date: 
Wednesday, June 4, 2008
Doc Status: 
Complete