216-RICR-40-10-17. Licensing Home Nursing Care Providers and Home Care Providers (version Amendment, 04/02/2003 to 04/07/2005)

RULES AND REGULATIONS FOR LICENSING HOME NURSING CARE PROVIDERS AND HOME CARE PROVIDERS (R23-17-HNC/HC/PRO) STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS Department of Health August 1997 As amended: February 1998 May 1999 (E) September 1999 (E) November 1999 December 1999 (E) January 2000 January 2002 (re-filing in accordance with the provisions of section 42-35-4.1 of the Rhode Island General Laws, as amended) July 2002 March 2003 i INTRODUCTION These Rules and Regulations For Licensing of Home Nursing Care and Home Care Providers (R23-17-HNC/HC/PRO) are promulgated pursuant to the authority conferred under Chapters 23-17 and 42-35 of the General Laws of Rhode Island, as amended. They are established for the purpose of adopting minimum standards for licensed home nursing care and home care providers in this state. Pursuant to the provisions of section 42-35-3(c) of the General Laws of Rhode Island, as amended, the following were given consideration in arriving at the regulations: (1) alternative approaches to the regulations; (2) duplication or overlap with other state regulations; and (3) significant economic impact placed on facilities through these amended regulations. No alternative approach, duplication or overlap, nor significant economic impact was identified. Consequently, the regulations are adopted in the best interest of the public health, safety and welfare. These Rules and Regulations for Licensing Home Nursing Care and Home Care Providers shall supersede all previous Rules and Regulations for Licensing of Home Health Agencies (R23-17-HHA) and any previous versions of the Rules and Regulations for Licensing Home Nursing Care and Home Care Providers promulgated by the Department of Health and filed with the Secretary of State. ii TABLE OF CONTENTS Page PART I LICENSING PROCEDURES AND DEFINITIONS 1 1.0 Definitions 1 2.0 General Requirements for Licensure 6 3.0 Application for License 7 4.0 Issuance and Renewal of License 8 5.0 Statewide Standard--Uncompensated Care 12 6.0 Change of Ownership, Operation, and/or Location 12 7.0 Inspections 13 8.0 Deficiencies/Plans of Correction 13 9.0 Denial, Suspension, Revocation of License 14 PART II ORGANIZATION AND MANAGEMENT 15 10.0 Governing Body 15 10.5 Quality Improvement 17 11.0 Service Accessibility 19 12.0 Personnel 20 12.23 Administrator 24 PART III PATIENT CARE MANAGEMENT 26 13.0 Rights of Patients 26 14.0 Confidentiality 28 15.0 Admission/Discharge Policies 28 16.0 Clinical Records 28 17.0 Nursing Assistant Services 30 18.0 Supervision of Therapeutic Services 31 19.0 Reporting of Communicable Diseases 31 PART IV PHYSICAL PLANT 32 20.0 General Provisions 32 20.5 Medical Waste Disposal 32 PART V ADDITIONAL REQUIREMENTS--HOME NURSING CARE PROVIDERS 33 PART VI VARIANCE PROCEDURES, PRACTICES/PROCEDURES & SEVERABILITY 36 PART VII REFERENCES 37 APPENDIX I 39 1 PART I LICENSURE PROCEDURES AND DEFINITIONS Section 1.0 Definitions Wherever used in these rules and regulations the following terms shall be construed as follows: 1.1 "Abuse" means: (i) Any assault as defined in chapter 5 of title 11, including, but not limited to, hitting, kicking, pinching, slapping, or the pulling of hair; provided, however, unless it is required as an element of the offense charged, it shall not be necessary to prove that the patient or resident was injured by the assault; (ii) Any assault as defined in chapter 37 of title 11; (iii) Any offense under chapter 10 of title 11; (iv) Any conduct which harms or is likely to physically harm the patient or resident except where the conduct is a part of the care and treatment, and in furtherance of the health and safety of the patient or resident; or (v) Intentionally engaging in a pattern of harassing conduct which causes or is likely to cause emotional or psychological harm to the patient or resident, including but not limited to, ridiculing or demeaning a patient or resident, making derogatory remarks to a patient or resident or cursing directed towards a patient or resident, or threatening to inflict physical or emotional harm on a patient or resident. 1.2 "Administrator" shall mean an individual who: (1) is a licensed physician; or (2) has training and experience in health service administration and at least one year of supervisory or administrative experience in home nursing care or home care or related health programs; or (3) is a registered nurse who meets qualifications of as set forth in reference 2. 1.3 "Attending physician" means a physician identified by the patient/client/family as having a significant role in the determination and delivery of the individual's medical care. 1.4 "Branch office" means a location from which a licensed home nursing care provider or licensed home care provider provides services within a portion of the total geographic area served by the licensed central office. 1.5 "Change in operator" means a transfer by the governing body or operator of a home nursing care or home care provider agency to any other person (excluding delegations of authority to the medical or administrative staff of the facility) of the governing body's authority to: a) hire or fire the chief executive officer of the home nursing care provider or home care provider; b) maintain and control the books and records of the home nursing care provider or home care provider; 2 c) dispose of assets and incur liabilities on behalf of the home nursing care provider or home care provider; or d) adopt and enforce policies regarding operation of the home nursing care provider or home care provider. This definition is not applicable to circumstances wherein the governing body of a home nursing care provider or home care provider retains the immediate authority and jurisdiction over the activities enumerated in subsection (a) through (d) herein. 1.6 "Change in owner" means: (1) in the case of a home nursing care provider or home care provider agency which is a partnership, the removal, addition or substitution of a partner which results in a new partner acquiring a controlling interest in such partnership. (2) in the case of a home nursing care provider or home care provider agency which is an unincorporated solo proprietorship, the transfer of the title and property to another person; (3) in the case of a home nursing care provider or home care provider agency which is a corporation: a) a sale, lease, exchange or other disposition of all, or substantially all of the property and assets of the corporation; or b) a merger of the corporation into another corporation; or c) the consolidation of two (2) or more corporations, resulting in the creation of a new corporation; or d) in the case of a home nursing care provider or home care provider agency which is a business corporation, any transfer of corporate stock which results in a new person acquiring a controlling interest in such corporation; or e) in the case of a home nursing care provider or home care provider agency which is a non-business corporation, any change in membership which results in a new person acquiring a controlling vote in such corporation. 1.7 "Director" shall mean the Director of the Rhode Island Department of Health. 1.8 “Equity” means non-debt funds contributed towards the capital costs related to an initial licensure or change in owner or change in operator of a home nursing care provider or home care provider agency which funds are free and clear of any repayment or liens against the assets of the proposed owner and/or licensee and that result in a like reduction in the portion of the capital cost that is required to be financed or mortgaged. 3 1.9 "Fluency" means the ability to converse freely in a language. 1.10 "Health care facility" means any institutional health service provider, facility or institution, place, building, agency, or portion thereof, whether a partnership or corporation, whether public or private, whether organized for profit or not, used, operated, or engaged in providing health care services, including, but not limited to, hospitals; nursing facilities; home nursing care providers (which shall include skilled nursing services and may also include activities allowed as a home care provider or as a nursing service agency); home care provider (which may include services such as personal care or homemaker services); rehabilitation centers; kidney disease treatment centers; health maintenance organizations; free-standing emergency care facilities and facilities providing surgical treatment to patients not requiring hospitalization (surgi-centers); hospice care and physician office settings providing surgical treatment. The term "health care facility" also includes organized ambulatory care facilities which are not part of a hospital but which are organized and operated to provide health care services to outpatients such as central services facilities serving more than one (1) health care facility or health care provider, treatment centers, diagnostic centers, rehabilitation centers, outpatient clinics, infirmaries and health centers, school-based health centers, and neighborhood health centers; providing, however, that the term "health care facility" shall not apply to organized ambulatory care facilities owned and operated by professional service corporations as defined in Chapter 5.1 of Title 7, as amended (the "Professional Service Corporation Law"), or to a private practitioner's (physician, dentist, or other health care provider) office or group of the practitioners' offices (whether owned and/or operated by an individual practitioner, alone or as a member of a partnership, professional service corporation organization, or association). Facilities licensed by the Department of Mental Health, Retardation and Hospitals and the Department of Human Services and clinical laboratories licensed in accordance with Chapter 16.2 of the Rhode Island General Laws, as amended, as well as Christian Science institutions, also known as Christian Science Nursing Facilities, listed and certified by the Commission for Accreditation of Christian Science Nursing Organizations/Facilities, Inc. shall not be considered health care facilities for purposes of these rules and regulations. 1.11 “Health care provider” means any person licensed by this state to provide or otherwise lawfully providing health care services, including, but not limited to, a physician, hospital, intermediate care facility or other health care facility, dentist, nurse, optometrist, podiatrist, physical therapist, psychiatric social worker, pharmacist, or psychologist, and any officer, employee or agent of that provider acting in the course and scope of his/her employment or agency related to or supportive of health services. 1.12 "Home care provider" means any person that provides, arranges to provide, offers to provide, or in any other way provides for the delivery of any direct health care services in the home requiring supervision by a registered nurse (RN), but excludes the delivery of direct nursing care by a registered (RN) or licensed practical (LPN) nurse on an on-going basis; and includes services rendered by a licensed health care professional, including but not limited to, a speech pathologist/audiologist, physical, occupational, or respiratory therapist. Also as used herein, "home care provider" includes homemaker services as defined in section 1.15. Nursing service agency services may also be provided under this license provided such services are rendered in accordance with the Rules and Regulations for the Licensing of Nursing Service Agencies of reference 6 herein. 4 1.13 "Home nursing care provider" means any person that provides, arranges to provide, offers to provide, or in any other way provides for the delivery of direct nursing services in the home by a registered (RN) or practical (LPN) nurse. As used herein, "home nursing care provider" may include home care provider services. Nursing service agency services may also be provided under this license provided such services are rendered in accordance with the Rules and Regulations for the Licensing of Nursing Service Agencies of reference 6 herein. 1.14 "Home health aide" means "nursing assistant" (see section 1.21 herein). 1.15 "Homemaker", or however else called, means a trained non-professional worker who performs related housekeeping services in the home for the sick, disabled, dependent or infirm. 1.16 "Homemaker services" means housekeeping services performed in the home for the sick, disabled, dependent, or infirm by a trained non-professional worker who is supervised in accordance with the requirements of section 12.9 herein. 1.17 "Licensing agency" means the Rhode Island Department of Health. 1.18 "Medical services" means such professional services and supplies rendered by or under the direction of persons duly licensed under the laws of this state to practice medicine, surgery or podiatry as may be specified by any medical service plan. Medical services shall not be construed to include hospital services. 1.19 "Mistreatment" means the inappropriate use of medications, isolation, or use of physical or chemical restraints: (1) As punishment; (2) For staff convenience; (3) As a substitute for treatment or care; (4) In conflict with a physician's order; or (5) In quantities which inhibit effective care or treatment, or which harms or is likely to harm the patient or resident. 1.20 "Neglect" means the intentional failure to provide treatment, care, goods, and services necessary to maintain the health and safety of the patient or resident, or the intentional failure to carry out a plan of treatment or care prescribed by the physician of the patient or resident, or the intentional failure to report patient or resident health problems or changes in health problems or changes in health conditions to an immediate supervisor or nurse, or the intentional lack of attention to the physical needs of a patient or resident including, but not limited to toileting, bathing, meals, and safety. No person shall be considered to be neglected for the sole reason that he or she relies on or is being furnished treatment in accordance with the tenets and teachings of a well-recognized church or denomination by a duly-accredited practitioner of a well-recognized church or denomination. 5 1.21 "Nursing assistant" means a nurse's aide, or home health aide, who is a paraprofessional, registered, pursuant to the provisions of Chapter 23-17.9 of the Rhode Island General laws, as amended, and who is trained to give personal care and related health care and assistance based on his/her level of preparation to individuals who are sick, disabled, dependent or infirm, and who are residents of or receive services from health care facilities licensed pursuant to Chapter 23-17 of the Rhode Island General Laws, as amended, or who are receiving services from agencies licensed pursuant to Chapter 23-17.7 of the Rhode Island General Laws, as amended. 1.22 "Patient" means a person who receives home nursing care or home care provider services or who is judged to need home nursing care or home care provider services based upon the results of an initial screening. The terms "patient" and "client" are synonymous in the context of the rules and regulations herein. 1.23 "Person" shall mean any individual, trust or estate, partnership, corporation (including associations, joint stock companies, and insurance companies) state or political subdivision or instrumentality of a state. 1.24 "Personal care services" means those services provided to a patient that do not require the skills of a licensed nurse. These services may include, but are not limited to: bathing, dressing, grooming, caring for hair/nails, and assistance with ambulation. 1.25 "Physician" shall mean any individual licensed to practice medicine or osteopathy in this state or any other state in the United States. 1.26 “Plan of care” or “care plan”, as used herein, means the comprehensive written plan for the patient’s care. The plan shall include physician orders for medications, treatments, procedures, or therapeutic services, where indicated; and shall also encompass patient assessments and treatment goals/objectives, including provisions for personal care and social needs. (For further requirements related to the patient’s plan of care, see sections 16.1(d) and 21.8 herein). 1.27 "Service provided directly" shall mean services rendered by employees of a licensed home nursing care provider or home care provider agency. 1.28 "Supervision" shall mean clinical guidance provided by a qualified person for the assessment and monitoring of patient care management. 1.28.1 Registered nurses and other appropriate professionals of the health care team, licensed, registered and/or certified as may be required by the laws of Rhode Island, shall supervise (directly or indirectly) nursing assistants. A registered nurse shall supervise any acts, functions or tasks performed by a nursing assistant that are nursing-related. 1.29 “Therapeutic services”, as used herein, means those treatments provided by a licensed health care professional that have medicinal or healing properties, such as infusion, respiratory, occupational, speech, or physical therapy and that are included in the patient’s care plan. 1.30 "Uncompensated care" means health care services provided by a home nursing care or home care provider for which the home nursing care or home care provider does not and has not 6 expected payment and which health care services are not recognized as either a receivable or as revenue in the home nursing care or home care provider's financial statements. Section 2.0 General Requirements for Licensure 2.1 No person acting alone or jointly with any other person, shall establish, conduct or maintain a home nursing care provider or home care provider agency in this state without a license in accordance with the requirements of section 23-17-4 of reference 1 and in conformity with the rules and regulations herein. Provided, however, that any person, firm, corporation or other entity which provides volunteer registered and licensed practical nurses to the public shall not be required to have a license as a health care facility. 2.2 A certificate of need is not required as a precondition to the establishment and initial licensure of any home nursing care provider or home care provider and such other activities in accordance with reference 4. 2.3 No facility shall hold itself or represent itself as a home nursing care provider or home care provider or use the term "home nursing care provider or home care provider", "home health care provider" or other similar term in its advertising, publicity or any other form of communication, unless licensed as a home nursing care provider or home care provider in accordance with the provisions herein. 2.4 Each home nursing care provider or home care provider that maintains a branch office shall disclose to the licensing agency the location of agency records (i.e., central office or branch office. At a minimum, all clinical records shall be maintained at the branch office for those patients served by the branch office. Financial Interest Disclosure 2.5 Any health care facility licensed pursuant to Chapter 23-17 of the Rhode Island General Laws, as amended, which refers clients/patients to another such licensed health care facility or to a residential care/assisted living facility licensed pursuant to Chapter 23-17.4 of the Rhode Island General Laws, as amended, or to a certified adult day care program in which the referring entity has a financial interest shall, at the time a referral is made, disclose in writing the following information to the client/patient: (1) that the referring entity has a financial interest in the facility or provider to which the referral is being made; (2) that the patient/client has the option of seeking care from a different facility or provider which is also licensed and/or certified by the state to provide similar services to the patient/client. 2.6 The referring entity shall also offer the patient/client a written list prepared by the Department of Health of all such alternative licensed and/or certified facilities or providers. Said written list may be obtained by contacting: Rhode Island Department of Health Division of Facilities Regulation 3 Capitol Hill, Room 306 Providence, RI 02908 7 2.7 Non-compliance with sections 2.5 and 2.6 (above) shall constitute grounds to revoke, suspend or otherwise discipline the licensee or to deny an application for licensure by the Director, or may result in imposition of an administrative penalty in accordance with Chapter 23-17.10 of the Rhode Island General Laws, as amended. Section 3.0 Application for License, Initial License, or Changes in the Owner, Operator, or Lessee 3.1 Application for a license to conduct, maintain or operate a home nursing care provider or home care provider shall be made to the licensing agency upon forms provided by it, and shall contain such information as the licensing agency reasonably requires, including but not limited to, evidence of ability to comply with the provisions of reference 1 and the rules and regulations herein. 3.1.1 Each application shall be accompanied by a non-returnable, non-refundable application fee of five hundred dollars ($500) made payable to the General Treasurer, State of Rhode Island. No additional licensure fee shall be charged when a home nursing care provider or home care provider changes location during any calendar year for which an annual license fee has already been paid for that home nursing care provider or home care provider. 3.1.2 Each home nursing care or home care provider that maintains a branch office shall indicate on the application the location of the central office as well as the location(s) of the branch office(s). 3.2 A notarized listing of names and addresses of direct and indirect owners whether individual, partnership, or corporation with percentages of ownership designated shall be provided with the application for licensure and shall be updated annually. The list shall include each owner (in whole or in part) of any mortgage, deed or trust, note or other obligation secured (in whole or in part) by the home nursing care provider or home care provider or any of the property or assets of the home nursing care provider or home care provider. 3.3 This list also include all officers, directors and other persons of any subsidiary corporation owning stock, if the home nursing care provider or home care provider is organized as a corporation and all partners if the home nursing care provider or home care provider is organized as a partnership. 3.4 Application for initial licensure or for changes in the owner, operator, or lessee of a home nursing care provider or home care provider shall be made on forms provided by the licensing agency and shall contain but not be limited to information pertinent to the statutory purpose expressed in section 23-17-3 of Chapter 23-17 or to the considerations enumerated in section 4.5 herein. Twenty-five (25) copies of such applications are required to be provided. 3.4.1 Each application filed pursuant the provisions of this section shall be accompanied by a non-returnable, non-refundable application fee, made payable to the Rhode Island General Treasurer, as follows: applicants shall submit a fee equal to one tenth of one percent (0.1%) of the projected annual facility net operating revenue contained in the application; provided, however, that the minimum fee shall be five hundred dollars ($500) and the maximum fee shall not exceed ten thousand dollars ($10,000). 8 Section 4.0 Issuance and Renewal of License 4.1 Upon receipt of an application for a home nursing care provider license, the licensing agency shall issue a home nursing care provider license or renewal thereof for a period of no more than one (1) year, if the applicant meets the requirements of reference 1 and all of the rules and regulations herein. Upon receipt of an application for a home care provider license, the licensing agency shall issue a home care provider license or renewal thereof for a period of no more than one (1) year, if the applicant meets the requirements of reference 1 and all of the rules and regulations herein, with the exception of Part V. The license issued, unless sooner suspended or revoked, shall expire by limitation on the 31st day of December following its issuance and may be renewed from year to year subject to inspection and approval by the licensing agency. 4.2 Each license shall be issued only for the premises and persons named in the application and shall not be transferable or assignable except with the written approval of the licensing agency. Home nursing care providers and home care providers operating under a single license may establish branch offices under that same single license and such license shall be maintained and posted in the central office. Any initial license or any change in owner, operator, or lessee of a licensed home nursing care provider or home care provider shall require prior review by the Health Services Council and approval of the licensing agency as provided in section 4.5 and 4.6 herein, or for expedited reviews conducted pursuant to sections 4.8 and 4.9 herein, as a condition precedent to the transfer, assignment or issuance of a new license. 4.3 A license issued hereunder shall be the property of the state and loaned to such licensee and it shall be kept posted in a conspicuous place on the licensed premises. 4.4 Except for expedited reviews conducted pursuant to sections 4.8 and 4.9 herein, review of applications for initial licensure or for changes in the owner, operator, or lessee of licensed home nursing care provider or home care provider agencies shall be conducted according to the following procedures: a) Within ten (10) working days of receipt, in acceptable form of an application for initial licensure or for a license in connection with a change in the owner, operator or lessee of an existing home nursing care provider or home care provider, the licensing agency will notify and afford the public thirty (30) days to comment on such application. b) The decision of the licensing agency will be rendered within ninety (90) days from acceptance of the application. c) The decision of the licensing agency shall be based upon the findings and recommendations of the Health Services Council unless the licensing agency shall afford written justification for variance therefrom. 9 d) All applications reviewed by the licensing agency and all written materials pertinent to licensing agency review, including minutes of all Health Services Council meetings, shall be accessible to the public upon request. 4.5 Except as otherwise provided in Chapter 23-17 of the General Laws of Rhode Island, as amended, a review by the Health Services Council on an application for initial license or for a license in the case of a proposed change in the owner, operator, or lessee of a licensed home nursing care provider or home care provider may not be made subject to any criterion unless the criterion directly relates to the statutory purpose expressed in section 23-17-3 of the General Laws. In conducting reviews of such applications the Health Services Council shall specifically consider and it shall be the applicant’s burden of proof to demonstrate: 4.5.1 the character, commitment, competence, and standing in the community of the proposed owners, operators or directors of the home nursing care provider or home care provider as evidenced by: (A) In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, whether within or outside Rhode Island, the demonstrated commitment and record of that (those) person(s): (i) in providing safe and adequate treatment to the individuals receiving the health care facility's services; (ii) in encouraging, promoting and effecting quality improvement in all aspects of health care facility services; and (iii) in providing appropriate access to health care facility services; (B) A complete disclosure of all individuals and entities comprising the applicant and (C) The applicant’s proposed and demonstrated financial commitment to the health care facility. 4.5.2 the extent to which the facility will provide or will continue, without material effect on its viability at the time of change of owner, operator, or lessee, to provide safe and adequate treatment for individuals receiving the home nursing care provider or home care provider's services as evidenced by: (A) The immediate and long term financial feasibility of the proposed financing plan; (i) The proposed amount and sources of owner's equity to be provided by the applicant; (ii) The proposed financial plan for operating and capital expenses and income for the period immediately prior to, during and after the 10 implementation of the change in owner, operator or lessee of the health care facility; (iii) The relative availability of funds for capital and operating needs; (iv) The applicant's demonstrated financial capability; (v) Such other financial indicators as may be requested by the state agency; 4.5.3 the extent to which the facility will provide or will continue to provide safe and adequate treatment for individuals receiving the home nursing care provider or home care provider's services and the extent to which the facility will encourage quality improvement in all aspects of the operation of the health care facility as evidenced by: (A) the credibility and demonstrated or potential effectiveness of the applicant's proposed quality assurance programs; 4.5.4 the extent to which the facility will provide or will continue to provide appropriate access with respect to traditionally underserved populations as evidenced by: (A) In cases where the proposed owners, operators, or directors of the health care facility currently own, operate, or direct a health care facility, or in the past five years owned, operated or directed a health care facility, both within and outside of Rhode Island, the demonstrated record of that person(s) with respect to access of traditionally under served populations to its health care facilities; and (B) The proposed immediate and long term plans of the applicant to ensure adequate and appropriate access to the programs and health care services to be provided by the health care facility. 4.5.5 in consideration of the proposed continuation or termination of emergency, primary care and/or other core health care services by the facility: (A) The effect(s) of such continuation or termination on the provision of access to safe and adequate treatment of individuals, including but not limited traditionally underserved populations. 4.5.6 And in cases where the application involves a merger, consolidation or otherwise legal affiliation of two or more health care facilities, the proposed immediate and long term plans of such health care facilities with respect to the health care programs to be offered and health care services to be provided by such health care facilities as a result of the merger, consolidation or otherwise legal affiliation. 4.6 Subsequent to reviews conducted under sections 4.4, 4.5, 4.8 and 4.9 of these regulations, the issuance of a license by the licensing agency may be made subject to any condition, provided that no condition may be made unless it directly relates to the statutory purpose expressed in section 23-17-3 of the General Laws of Rhode Island, as amended, or to the review criteria set forth in section 4.4 herein. This shall not limit the authority of the licensing agency to require 11 correction of condition or defects which existed prior to the proposed change of owner, operator, or lessee and of which notice had been given to the facility by the licensing agency. 4.7 Each home nursing care provider or home care provider shall meet the statewide community standard for the provision of uncompensated care as a condition of initial and continued licensure. 4.8 Applicants for initial licensure may, at the sole discretion of the licensing agency, be reviewed under expedited review procedures established in section 4.9 if the licensing agency determines (a) that the legal entity seeking licensure is the licensee for one or more health care facilities licensed in Rhode Island pursuant to the provisions of Chapter 23-17 whose records of compliance with licensure standards and requirements are deemed by the licensing agency to demonstrate the legal entity’s ability and commitment to provide quality health services; and (b) that the licensure application demonstrates complete and satisfactory compliance with the review criteria set forth in set forth in section 4.5 herein. 4.9 Expedited reviews of applications for initial licensure of home nursing care provider or home care provider agencies shall be conducted according to the following procedures: a) Within ten (10) working days of receipt, in acceptable form, of an application for initial licensure the licensing agency will determine if such application will be granted expedited review and the licensing agency will notify the public of the licensing agency’s initial assessment of the application materials with respect to the review criteria in section 4.5 as well as the licensing agency’s intent to afford the application expedited review. At the same time the licensing agency will afford the public a twenty (20) day period during which the public may review and comment on the application and the licensing agency’s initial assessment of the application materials and the proposal to afford the application expedited review. b) Written objections from affected parties directed to the processing under the expedited procedures and/or the satisfaction of the review criteria shall be accepted during the twenty (20) day comment period. Objections must provide clear, substantial and unequivocal rationale as to why the application does not satisfy the review criteria and/or why the application ought not to be processed under the expedited review mechanism. The licensing agency may propose a preliminary report on such application provided such proposed report incorporates findings relative to the review criteria set forth in section 4.5. The Health Services Council may consider such proposed report and may provide its advisory to the Director of Health by adopting such report in amended or unamended form. The Health Services Council, however, is not bound to recommend to the Director that the application be process under the provisions for expedited review as delineated in sections 4.8 and 4.9. The Health Services Council shall take under advisement all objections both to the merits of the application and to the proposed expedited processing of the proposed application and shall make a recommendation to the Director regarding each. Should the Health Services Council not recommend to the Director that the application be processed under expedited review procedures as initially proposed, such application may continue to be processed consistent with the time frames and procedures for applications not recommended for expedited review. If expedited review is not granted, then the comment period may be 12 forthwith extended consistent with the time frames in section 4.4 for applications not proposed for expedited review. The Director, with the advice of the Health Services Council, shall make the final decision either to grant or to deny expedited review and shall make the final decision to grant or to deny the application on the merits within the expedited review mechanism and time frames. Section 5.0 Statewide Standard for the Provision of Uncompensated Care 5.1 The statewide community standard for uncompensated care shall be one percent (1%) of net patient revenue earned on an annual basis. Uncompensated care shall be cost adjusted by applying a ratio of costs to charges from the licensee's Medicare Cost Report. Licensees not filing Medicare Cost Reports shall submit an audited financial report or such other report as deemed acceptable to the Director. Section 6.0 Change of Ownership, Operation and/or Location 6.1 When a change of ownership or operation or location of a home nursing care provider or home care provider or when discontinuation or addition of a service(s) is contemplated, the licensing agency shall be notified in writing. 6.2 Thirty (30) days prior to voluntary cessation of any facility license, the Department of Health shall be notified and provided with a plan for orderly closure; notification and transfer of patients; transfer, storage, or proper disposal of medical records; and notification of the public. 6.3 A license shall immediately become void and shall be returned to the licensing agency when a home nursing care provider or home care provider discontinues services or when any changes in ownership occur in accordance with the rules and regulations herein and section 23-17-6 of reference 1. a) When there is a change in ownership or in the operation or control of the home nursing care provider or home care provider, the licensing agency reserves the right to extend the expiration date of such license, allowing the agency to operate under the same license which applied to the prior license for such time as shall be required for the processing of a new application or reassignment of patients, not to exceed six (6) weeks. Section 7.0 Inspections 7.1 The licensing agency shall make, or cause to be made, such inspections and investigations, including medical records, as deemed necessary in accordance with section 23-17-10 of reference 1 and the rules and regulations herein. 7.1.1 The Director shall make, or cause to be made, quality improvement and licensure inspections of each licensed home nursing care provider or home care provider at a minimum of once (1) in a twelve (12) month period. Said inspections shall include, but not be limited to: home visits, patient surveys; and employee interviews. 7.2 Refusal to permit inspections shall constitute a valid ground for license denial, suspension or revocation. 13 7.3 Every home nursing care provider or home care provider shall be given notice by the licensing agency of all deficiencies reported as a result of an inspection or investigation. Section 8.0 Deficiencies and Plans of Correction 8.1 The licensing agency shall notify the governing body or other legal authority of a facility of violations of individual standards through a notice of deficiencies which shall be forwarded to the facility within fifteen (15) days of inspection of the facility unless the Director determines that immediate action is necessary to protect the health, welfare, or safety of the public or any member thereof through the issuance of an immediate compliance order in accordance with section 23-1-21 of the General Laws of Rhode Island, as amended. 8.2 A facility which received a notice of deficiencies must submit a plan of correction to the licensing agency within fifteen (15) days of the date of the notice of deficiencies. The plan of correction shall detail any requests for variances as well as document the reasons therefore. 8.3 The licensing agency will be required to approve or reject the plan of correction submitted by a facility in accordance with section 8.2 above within fifteen (15) days of receipt of the plan of correction. 8.4 If the licensing agency rejects the plan of correction, or if the facility does not provide a plan of correction within the fifteen (15) day period stipulated in section 8.3 above, or if a facility whose plan of correction has been approved by the licensing agency fails to execute its plan within a reasonable time, the licensing agency may invoke the sanctions enumerated in section 9.0 herein. If the facility is aggrieved by the sanctions of the licensing agency, the facility may appeal the decision and request a hearing in accordance with reference 3. Section 9.0 Denial, Suspension, Revocation of License or Curtailment of Activities 9.1 The licensing agency is authorized to deny, suspend or revoke the license or curtail activities of any home nursing care provider or home care provider which: (1) has failed to comply with the rules and regulations pertaining to the licensing of home nursing care provider or home care provider agencies; or (2) has failed to comply with the provisions of reference 1. 9.1.1 Reports of deficiencies shall be maintained on file in the licensing agency and shall be considered by the licensing agency in rendering determinations to deny, suspend or revoke the license or to curtail activities of a home nursing care provider or home care provider. 9.2 Whenever an action shall be proposed to deny, suspend or revoke a home nursing care provider or home care provider license, or curtail its activities, the licensing agency shall notify the home nursing care provider or home care provider by certified mail, setting forth reasons for the proposed action, and the applicant or licensee shall be given an opportunity for a prompt and fair hearing in accordance with section 23-17-8 of reference 1 and section 42-35-9 of reference 3, General Laws of Rhode Island, as amended, and in accordance with the provisions of section 23.1 herein. 14 9.2.1 However, if the licensing agency finds that public health, safety or welfare of patients requires emergency action and incorporates a finding to that effect in its order, the licensing agency may order summary suspension of license or curtailment of activities pending proceedings for revocation or other action in accordance with sections 42-35-14 (c) and 23-1-21 of the General Laws of Rhode Island, as amended. 9.3 The appropriate state and federal agencies shall be notified of any action taken by the licensing agency pertaining to either denial, suspension, or revocation of license, or curtailment of activities. 15 PART II ORGANIZATION AND MANAGEMENT Section 10.0 Governing Body 10.1 Each home nursing care provider or home care provider shall have an organized governing body or equivalent legal authority ultimately responsible for: (1) the management, fiscal affairs and operation of the agency; (2) the assurance of quality care and services; and (3) compliance with all federal, state and local laws and regulations pertaining to home nursing care provider or home care provider agencies and the rules and regulations herein. 10.2 The governing body, or equivalent legal authority, shall provide appropriate personnel, physical resources and equipment to facilitate the delivery of prescribed services and shall furthermore: a) appoint an administrator and/or director of nursing services in accordance with the provisions of section 12.23 herein; b) identify the range of services to be provided which must include no less than those services required in sections 21.5—21.7 and 11.4 as applicable; c) define the geographic areas to be served; and d) carry out such other functions as may be relevant to the organization and operation of the agency. 10.3 The governing body, or equivalent legal authority, shall adopt and maintain by-laws or acceptable equivalent which defines responsibilities for the operation and performance of the organization, and shall identify purposes and means of fulfilling same. In addition, the governing body or equivalent legal authority, shall establish administrative policies pertaining to no less than the following: a) responsibilities of the administrator and/or director of nursing services; b) acquiring and maintaining employee bonding insurance (theft and damage) (a minimum amount of $10,000.00 per loss) and liability insurance (a minimum amount of $500,000.00 per occurrence); c) the modalities of services to be provided; d) circumstances under which definitive care cannot be provided and procedures for referral; e) linkages and referrals with other health care facilities, which shall include a mechanism for recording, transmitting and receiving information essential to the continuity of patient care. Such information shall contain no less than the following: i) patient identification data such as: name, address, age, gender, name of next-of- kin, health insurance coverage, etc. 16 ii) diagnosis and prognosis, medical status of patient, brief description of current illness, plan of care, including such information as medications, treatments, dietary needs, baseline laboratory data; iii) functional status; iv) therapeutic services such as: physical therapy, infusion therapy, occupational therapy, or speech therapy; v) psychosocial needs; and vi) such other information pertinent to ensure continuity of patient care. f) reports of patient's condition and transmission thereof to the patient's attending physician; g) policies and procedures regarding persons employed by the facility; Said policies shall include, but not be limited to, the following: i) compliance with health screening and inservice education requirements of section 12.0 herein; ii) timely completion of the bureau of criminal identification (BCI) check; iii) timely judgment regarding continued employment of an employee upon whom disqualifying information has been found (see sections 12.15—12.21 herein). h) such other matters as may be relevant to the organization and operation of the agency. 10.4 The governing body or other legal authority shall organize agency services to ensure an integrated continuum of patient care. An organizational chart with written description of the organization, authorities, responsibilities, accountability, and relationships shall be maintained which shall include but not be limited to: a) a description of each service offered; b) policies and procedures pertaining to each service; c) a description of the system for the maintenance of the patient's clinical record; and d) standards of clinical practice. Quality Improvement 10.5 The governing body shall ensure that there is an effective, ongoing, agency-wide quality improvement program to evaluate the provision of patient care. Further, the agency shall have written policies and procedures establishing a mechanism for the annual evaluation of 17 professional standards of practice and administrative practices, conducted by professional personnel, including agency staff. 10.5.1 Such evaluation shall assess the extent to which the agency's programs and services are appropriate, adequate, effective and efficient based on data such as: number of patients on services, patient visits, reasons for discharge, diagnoses, sources of referral, patients denied services, community needs, staff days for each service offered and such other criteria as may be deemed appropriate. 10.6 The organized agency-wide quality improvement program shall be ongoing and shall have a written plan of implementation. The written quality improvement plan shall include at least the following: a) program objectives; b) organization(s) involved; c) oversight responsibility (e.g., reports to the governing body); d) agency-wide scope; e) program administration and coordination; f) involvement of all patient care disciplines/services; g) methodology for monitoring and evaluating quality of care; h) priority setting and problem resolution; i) determination of the effectiveness of action(s) taken; j) documentation of the quality improvement plan review. 10.7 All patient care services, including services rendered by a contractor, shall be evaluated. 10.8 The agency shall take and document appropriate remedial action to address problems identified through the quality improvement program. The outcome(s) of the remedial action shall be documented and submitted to the governing body for their consideration. 10.9 The provisions of section 10.6 herein shall be deemed to have been met if the agency has met similar requirements of a national accrediting body, as approved by the Director. Uniform Reporting System 10.10 Each home nursing care provider or home care provider shall establish and maintain records and data in such a manner as to make uniform a system of periodic reporting. The manner in which the requirements of this regulation may be met shall be prescribed from time to time in directives promulgated by the Director. 18 10.11 Each home nursing care provider or home care provider shall report to the licensing agency detailed statistical data pertaining to its operation and services. Such reports and data shall be made at such intervals and by such dates as determined by the Director. 10.12 The licensing agency is authorized to make the reported data available to any state or federal agency concerned with or exercising jurisdiction over the home nursing care provider or home care provider. 10.13 The directives promulgated by the Director pursuant to these regulations shall be sent to each home nursing care provider or home care provider to which they apply. Such directives shall prescribe the form and manner in which the statistical data required shall be furnished to the licensing agency. Disaster Planning 10.14 The plan and procedures shall be developed with the assistance of qualified safety, emergency management, and/or other appropriate experts. 10.15 Each home nursing care provider or home care provider shall develop back-up or contingency plans to address possible internal systems and/or equipment failures. Pending and Actual Labor Disputes/Actions 10.16 Health care facilities shall provide the licensing agency with prompt notice of pending and actual labor disputes/actions which would impact delivery of patient care services including, but not limited to, strikes, walk-outs, and strike notices. Health care facilities shall provide a plan, acceptable to the Director, for continued operation of the facility, suspension of operations, or closure in the event of such actual or potential labor dispute/action. Latex 10.17 Any home nursing care provider or home care provider that utilizes latex gloves shall do so in accordance with the provisions of the Rules and Regulations Pertaining to the Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department promulgated by the Department of Health. Section 11.0 Service Accessibility 11.1 Accessibility to agency: Each agency shall establish a mechanism to enable patients to make telephone contact with responsible staff of the agency on a twenty-four (24) hour basis, seven (7) days a week. 19 11.2 Medical supplies and equipment: Each home nursing care provider or home care provider shall assist patients in arranging for the procurement of medical supplies and equipment as may be prescribed in the plan of care. Written Agreements 11.3 There shall be written agreements for the provision of service(s) not provided directly by the home nursing care provider or home care provider which clearly delineate the responsibilities of the parties involved and shall include no less than the following provisions: a) designation of service(s) to be provided which must be within the scope and limitations set forth in the plan of care and which must not be altered in type, amount, frequency, or duration (except in case of adverse reaction) by the individual or agency; b) the responsibility of the licensed home nursing care provider or home care provider for the provision of services to the patient; c) assurance of compliance with the patient care policies of the licensed home nursing care provider or home care provider; d) establishment of procedures for and frequency of patient care assessment and attendance at case conferences; e) mechanism for submission of clinical progress notes on patient care; f) documented evidence that personnel and services under contract meet the requirements specified herein for home nursing care provider or home care provider personnel and services, including licensure, health screenings, and criminal background checks. In instances where the contracted services are provided by another Department of Health Division of Facilities Regulation licensee, said license shall suffice to meet the requirements of this section. g) reimbursement mechanism, charges and terms for renewal or termination of the agreement; and h) such other provisions as may be mutually agreed upon. 11.4 Scope of Services a) Each home nursing care/home care provider shall provide either directly, or by written contractual agreement with another Department-licensed agency, homemaker, nursing assistant services or other therapeutic service(s) (e.g., physical/occupational therapy). b) Additional health services or related services may be provided by agencies as may be deemed appropriate to meet community needs in a manner consistent with 20 professionally-recognized standards of practice and all applicable current laws and regulations. Section 12.0 Personnel 12.1 Each home nursing care provider or home care provider shall employ a sufficient number of qualified personnel to provide effective patient care and other related services. 12.2 A job description for each classification of position shall be established, clearly delineating qualifications, duties, authority and responsibilities inherent in each position. 12.3 Written personnel policies supporting sound patient care and personnel practices shall be made available to all full-time or part-time personnel and shall include provisions for: a) annual evaluation of employee performance that is reviewed with and signed by the employee within forty-five (45) days of the evaluation; and b) such other matters as deemed appropriate. 12.4 An inservice educational program shall be conducted on an ongoing basis, which shall include an orientation program for staff personnel employed by the agency providing direct care and a continuing program for the development and improvement of skills of staff to ensure the delivery of quality home care services. The inservice program shall include recognition and reporting of abuse, neglect, mistreatment, and exploitation. 12.5 A mechanism to establish an audit trail of employees shall be implemented and shall include, at a minimum, for each employee: c date of employment by the home nursing care provider or home care provider agency; and d date(s) , name(s), and address(es) of each assignment. 12.6 For every person employed by the home nursing care provider or home care provider who is licensed, certified, or registered by the Department, a mechanism shall be in place to electronically verify such licensure via the Department's licensure database. 12.7 Personnel files shall be maintained for each employee and shall be available at all times for inspection by the licensing agency. Such files shall include no less than the following documentation: a) a certified copy of birth certificate or copy of the U.S. Immigration and Naturalization Service Employment Eligibility Verification form (“I-9”); or immigration papers or resident alien card; b) information pertaining to qualifications for employment; c) records of completion of required training and educational programs; d) evidence of current licensure or certification as may be required by law; e) resume of previous employment; 21 f) records of required health examination which shall be kept confidential and in accordance with provisions of section 12.15 herein; g) documentation of complaints and follow-up; h) findings of a criminal records check, if employed after July 26, 1993; i) employee orientation, evaluation (annual) and documentation of in-service education; and j) such other matters as may be relevant to the organization and operation of the agency. Supervision of Homemakers 12.8 All homemaker services performed by a homemaker shall be in accordance with the provisions of Chapter 23-17 of the General Laws of Rhode Island, as amended, and the rules and regulations herein. 12.9 Homemaker services shall be rendered in accordance with a plan of care and shall be supervised by a professional (registered) nurse, licensed in this state, or by an individual with a bachelor's degree in social work, home economics, gerontology or other related field of study, and who shall be responsible for no less than the following: a) conducting the initial in-home assessment and assessments no less than every three (3) months thereafter or more frequently as the condition of the patient/client may require; b) monitoring the performance of the homemakers and maintaining appropriate clinical records; c) coordinating management of services (inter and intra-agency); d) assigning only delegable duties in accordance with section 12.11 herein; e) maintaining a record for each patient/client with appropriate documentation of services rendered which is signed by the homemaker rendering services; f) such other functions and activities as may be deemed necessary and appropriate. Training Program for Homemakers 12.10 Homemakers shall be required to have successfully completed a basic training program of twenty (20) hours of classroom instruction, as indicated in Appendix I, and with no less than five (5) hours of practical experience. The course of instruction shall be designed to provide skill in all the duties listed in 12.11 herein and to provide homemaker skills information and an orientation to basic human needs. 22 a) Upon completion of the homemaker training program, each homemaker must satisfactorily pass the final examination of the training program in order to be eligible to function as a homemaker. Duties of Homemakers 12.11 A homemaker who has satisfactorily completed a training program approved by the Director, as described in section 12.10 (above) of these regulations, may perform the following duties under an established plan of care and under the supervision of a qualified person in accordance with section 12.9 herein: „ change bed linens (unoccupied); „ grocery shopping; „ general housekeeping (washing dishes, cleaning kitchen, bathroom, patient’s/client's room); „ laundry and ironing; „ meal preparation; „ shopping, errand-running; „ recording services rendered. 12.12 Notwithstanding the provisions of section 12.11 (above), additional duties may be assigned to homemakers provided such duties do not include the duties of a nursing assistant, as listed in reference 13. a) Such additional duties must be clearly delineated in agency policies and procedures, but may not be in conflict with other state regulations. 12.13 A health care facility shall require all persons, including students, who examine, observe, or treat a patient or resident of the facility to wear a photo identification badge which states, in a reasonably legible manner: 1. The first name; 2. Licensure registration status, if any; 3. Fluency in languages other than English, if any, and; 4. Staff position of that person. 12.14 A home nursing care provider or home care provider agency shall be considered for all purposes an employer and those persons that it supplies on a temporary basis shall be considered employees and not independent contractors and home nursing care providers or home care providers shall be subject to all state and federal laws which govern employer/employee relationships. Health Screening 12.15 Upon hire and prior to delivering services, a pre-employment health screening shall be required for each individual who has or may have direct contact with a patient of the home care provider/home care nursing provider. Such health screening shall be conducted in accordance with the Rules and Regulations Pertaining to Immunization, Testing, and Health Screening for Health Care Workers (R23-17-HCW) promulgated by the Department of Health. Criminal Records Check 23 12.16 Any person seeking employment in a nursing facility, a home nursing care provider, or a home care provider which is or is required to be licensed, registered or certified with the Department of Health if that employment involves routine contact with a patient or resident, without the presence of other employees, shall undergo a criminal background check to be initiated prior to or within one (1) week of employment. All employees hired prior to the enactment of section 23-17-34 of the Rhode Island General Laws, as amended, shall be exempted from the requirements of this section. 12.17 Said employee, through the employer, shall apply to the bureau of criminal identification of the state or local police department for a statewide criminal records check. Fingerprinting shall not be required. 12.18 In those situations in which no disqualifying information has been found, the bureau of criminal identification (BCI) of the state police or local police shall inform the applicant and the employer in writing of this fact. 12.19 Upon the discovery of any disqualifying information, as defined herein, the bureau of criminal identification of the state police or the local police department will inform the applicant in writing of the nature of the disqualifying information; and, without disclosing the nature of the disqualifying information, will notify the employer in writing that disqualifying information has been discovered. a) Disqualifying information is described in section 23-17-37 of the Rhode Island General Laws, as amended, as information produced by a criminal records review pertaining to conviction, for the following crimes will result in a letter to the employee and employer disqualifying the applicant from said employment: murder, voluntary manslaughter, involuntary manslaughter, first degree sexual assault, second degree sexual assault, third degree sexual assault, assault on persons sixty (60) years of age or older, assault with intent to commit specified felonies (murder, robbery, rape, burglary, or the abominable and detestable crime against nature), felony assault, patient abuse, neglect or mistreatment of patients, burglary, first degree arson, robbery, felony drug offenses, larceny or felony banking law violations. b) For purposes of this section, the term "conviction" shall mean, in addition to judgments of conviction entered by a court subsequent to a finding of guilty or a plea of guilty, those instances where the defendant has entered a plea of nolo contendere and has received a sentence of probation and those instances where a defendant has entered into a deferred sentence agreement with the Attorney General. 12.20 The employer shall maintain on file, subject to inspection by the Department, evidence that criminal records checks have been initiated on all employees seeking employment after July 26, 1993 and the results of the checks. Failure to maintain that evidence would be grounds to revoke the license or registration of the employer. 12.21 An employee against whom disqualifying information has been found may request that a copy of the criminal background report be sent to the employer who shall make a judgement regarding the continued employment of the employee. 24 12.22 It shall be the responsibility of the bureau of criminal identification of the state police or the local police department to conduct the criminal records check to the applicant for employment without charge to either the employee or the employer. Administrator and/or Director of Nursing Services 12.23 A full-time administrator as defined in section 1.2 herein shall be appointed by and be responsible to the governing body or other legal authority for no less than the following: a) the management and operation of the agency; b) the implementation of policies, statutory and regulatory provisions; c) acting as liaison between the governing body and the professional and paraprofessional staff and the community; d) the preparation and implementation of an effective budgeting, accounting and reporting system; e) the establishment of standards of professional practice developed in cooperation with the governing board and staff; f) the establishment of policies and procedures governing the range of health care services provided by the agency; g) the establishment of a quality improvement program which includes a review mechanism for patient care management; h) the preparation of an annual report; i) the employment of qualified professional and paraprofessional staff; and j) for such other related functions as may be delegated by the governing body or other legal authority. 12.24 In the event that a non-nurse is appointed administrator of the home nursing care provider or home care provider agency, the nursing service shall be under the direction of a registered nurse who is licensed in this state and who shall be responsible to the administrator for the management of professional services, the standards of practice, and other related professional aspects of patient care services. 25 PART III PATIENT CARE MANAGEMENT Section 13.0 Rights of Patients 13.1 Each patient/client of a home nursing care provider or home care provider agency has the right to be informed of his or her rights under Chapter 23-17.16-1 and the home nursing care provider or home care provider agency must protect and promote the exercise of these rights. 13.2 The home nursing care provider or home care provider agency must provide the patient/client with a written notice of the patient/client rights in section 13.5 (below) in advance of furnishing care to the patient/client or during the initial evaluation visit before the initiation of treatment. 13.3 A copy of the written notice of rights signed by the patient/client will be maintained in the patient/client record by the home nursing care provider or home care provider agency and in the patient/client's home. The home nursing care provider or home care provider agency must maintain documentation showing that it has complied with the requirements of this section. 13.4 The provisions of section 13.0 herein shall not apply to nursing services or home health services conducted by and for those who rely exclusively upon spiritual means through prayer alone in accordance with the creed or tenets of a recognized church or religious denomination. 13.5 Each home care patient/client has the following rights: (1) To receive services without regard to race, creed, color, gender, sexual orientation, age, disability, or source of payment. (2) To receive safe, appropriate and high quality care and services in a timely manner with consideration, dignity, respect and privacy. (3) To accept or refuse care and to be informed of the consequences of such action. (4) To be free from mental or physical abuse, physical punishment, neglect, damage to or theft of property, or exploitation of any kind. (5) To have his or her property treated with respect. (6) To exercise his or her rights as a patient/client of the home nursing care provider or home care provider agency. When the patient/client is unable to exercise his or her rights, an agent or legal guardian may exercise the patient's/client's rights. (7) To be informed, in advance, about the care to be furnished (and not to be furnished), the plan of care, and of any changes in the care to be furnished before the change is made. (8) To help plan the care and services received or to help change the care and services. (9) To be advised in advance of the disciplines that will furnish care, the frequency of visits proposed to be furnished, and the names and qualifications of all individuals providing care. 26 (10) To receive information necessary to make decisions about care (or to have a family member receive such information, as appropriate) and to have access to their records. (11) To receive information and counseling about advanced directives such as the living will and durable power of attorney for health care, to formulate advanced directives, and to receive written information about the policy of the home nursing care provider or home care provider agency on patient/client advanced directives and state COMFORT ONE protocol. (12) To have his or her personal and clinical records treated and maintained in a confidential manner and to be advised by the agency of its policies and procedures regarding disclosure of clinical records. (13) To be advised, before care is initiated, if the provider is a full participating provider in the patient's/client's health care plan, the cost of services, the extent to which payment for the home nursing care provider or home care provider agency services may be expected from insurance, government and other sources, and the extent to which payment may be required from the patient/client and the charges they will be required to pay. (14) To be informed of the home nursing care provider or home care provider agency's billing procedures and the patient/client payment responsibilities. (15) To be informed of the home nursing care provider or home care provider agency's ownership and control. (16) To be informed of any experimental research or investigational activities and the right to refuse such. (17) To voice grievances (or to have the patient's/client's family or guardian voice grievances on the patient's/client's behalf if the patient/client is unable to do so) regarding treatment or care that is (or fails to be) furnished, or regarding the lack of respect for property by anyone who is furnishing services on behalf of the home nursing care provider or home care provider agency; to be advised on how to voice grievances; and not to be subjected to discrimination or reprisal for doing so. (18) To have the patient's/client's complaints investigated, or complaints made by the patient's/client's family or guardian, regarding treatment or care that is (or fails to be) furnished, or regarding the lack of respect for the patient/client or the patient's/client's property by anyone furnishing services on behalf of the home nursing care provider or home care provider agency, and the home nursing care provider or home care provider agency must document both the existence of the complaint and the resolution of the complaint. (19) To be informed in writing of his or her rights to appeal a determination or decision made by the home nursing care provider or home care provider agency with regard to eligibility for service, the types or levels of service in the care plan, a termination or change in service, or if the patient/client feels that his or her rights under this section have been violated. (20) To be advised in writing of the names, addresses, and telephone numbers of the state ombudsperson, the Attorney General's Medicaid Fraud Control Unit, the state licensing agency 27 and the availability of the state toll-free home health hotline, the hours of its operation, and that the purpose of the hotline is to receive complaints or questions about local home nursing care providers or home care providers (Telephone number: 401-222-7770). (21) No charge shall be made for furnishing a health record or part thereof to a patient, his/her attorney or authorized representative if the record or part thereof is necessary for the purpose of supporting an appeal under any provision of the Social Security Act (42 U.S.C. section 301 et seq.) and the request is accompanied by documentation of the appeal. A provider shall furnish a health record requested pursuant to this section within thirty (30) days of the request. Section 14.0 Confidentiality 14.1 Disclosure of any health care information relating to individuals shall be subject to the provisions of the "Confidentiality of Health Care Information Act", Chapter 5-37.3 of the General Laws of Rhode Island, as amended, and other relevant statutory and federal requirements. Section 15.0 Admission and Discharge Policies 15.1 Providers shall establish policies pertaining to eligibility for admission to and discharge from agency services. Such policies shall be based on the following criteria: a) pre-admission assessment of patient care needs; b) reasonable expectations of the agency's capability to respond to the medical and nursing needs of the patient; c) plan of care; d) constraints imposed by limitation of services, family conditions; e) community or other resources to ensure continuity of patient care; and f) such other criteria as may be deemed appropriate. Section 16.0 Clinical Records 16.1 Accurate and complete clinical records maintained in accordance with accepted professional standards shall be kept on each patient and filed in an accessible location within the agency. Such records shall contain no less than the following information: a) identifying data (name, address, date of birth, gender, date of admission or readmission); b) sources of patient referral; c) name of physician (including address and telephone number); 28 d) original plan of care for services provided; i) personal care objectives; ii) homemaker objectives, as appropriate; e) medical diagnosis and nursing assessment, therapeutic goals, prognosis and all conditions relevant to the plan of care, including any known allergies and reactions, surgical procedures, surgical complications, infections, prior diagnoses, presence of pressure ulcers, incontinence, disabilities; f) documentation of each patient contact; g) changes in and reviews of the patient's plan of care, signed by responsible professional; h) documentation of an advance directive (if any) and a copy of the advance directive, if provided to the facility by the patient; and i) discharge summaries. 16.1.1 Agency personnel involved in the care of patients shall participate, to the extent possible, in developing care plans. When practical, designated agency personnel shall complete a “Continuity of Care” form as approved by the Director for each patient who is discharged to another health care facility, such as a hospital or nursing facility, or other facility licensed under the provisions of Chapter 23-17 of the Rhode Island General Laws, as amended. Said form shall be provided to the receiving facility, agency, or provider prior to, upon transfer, or discharge of the patient. (See the Department’s website for the approved form: www.healthri.org). 16.2 Records shall be maintained by the agency for a period of at least five (5) years following the date of discharge and shall be safeguarded against loss or unauthorized use. This requirement shall also apply to computerized or electronic records. 16.2.1 Records shall be maintained by the agency for a minimum of five (5) years after a minor patient turns eighteen (18) years of age. 16.3 Each agency shall have written policies and procedures to govern the use and removal of records and determine the conditions for release of information in accordance with statutory provisions pertaining to confidentiality. Section 17.0 Nursing Assistant Services 17.1 Each home nursing care provider or home care provider which chooses to provide home nursing care and home care as provided herein shall be subject to the same training requirements for nursing assistants and the duties of the individuals shall be the same as those prescribed in the Rules and Regulations for the Registration of Nursing Assistants and the State Review and 29 Approval of Nursing Assistant Training and Competency Evaluation Programs (R23-17.9-NA) of reference 13. Supervision of Nursing Assistants 17.2 Supervision of nursing assistants shall be directed to the management of patients’/clients' care and services, the performance of duties, and shall be available at all times during the established hours of operation of the agency and at such other times as they are providing services to patients/clients. 17.3 Supervision of nursing assistants as employees of home nursing care provider or home care provider agencies: Nursing assistant services shall be: 1. provided in accordance with a plan of care; and 2. monitored/supervised no less than once every three (3) months by a professional (registered) nurse or other appropriate health care professional who is licensed in this state; and 3. provided in accordance with the rules and regulations of reference 13 herein. Such supervision shall include the following duties: a) conducting the initial in-home assessment prior to commencement of service, unless documented extraordinary circumstances prevent such timing. In these cases the initial in-home assessment must be conducted within forty-eight (48) hours. Subsequent assessments and direct supervision of the nursing assistant (at least one supervisory session) must be conducted no less than every three (3) months thereafter or more frequently as the condition of the patient/client may require; b) involving other professional disciplines where personal care is provided, as may be deemed necessary to ensure the provision of quality care; c) developing, reviewing and revising the plan of care, as the condition of the patient/client may require but no less than once every three (3) months; d) assigning only delegable duties as set forth in reference 13 for nursing assistants; e) on-site monitoring the performance of nursing assistants no less than once every three (3) months and maintaining appropriate records of such monitoring; f) coordinating the management of services (inter- and intra-agency); g) monitoring the clinical record for each patient/client which includes appropriate recording of the plan of care, services rendered, and which is signed by the person rendering services; and h) such other functions and activities as may be deemed necessary and appropriate. Section 18.0 Supervision of Therapeutic Services 30 18.1 Therapeutic services may include, but are not limited to, speech pathology/audiology, physical therapy, occupational therapy and respiratory care. Supervision of therapeutic services shall be in accordance with applicable rules and regulations for licensing of said therapists of references 19, 20, 21, and 22. Section 19.0 Reporting of Communicable Diseases 19.1 Each facility shall report promptly to the Rhode Island Department of Health, Division of Disease Control, cases of communicable diseases designated as "reportable diseases" by the Director of Health, when such cases are diagnosed in accordance with the most current rules and regulations pertaining to the reporting of communicable diseases of reference 18. 31 PART IV PHYSICAL PLANT Section 20.0 General Provisions 20.1 Each licensed home nursing care provider or home care provider shall maintain an office(s) located in this state with adequate space and equipment to accommodate staff personnel to carry out their professional and administrative responsibilities in an efficient manner within a safe environment. 20.2 Adequate space shall be provided for the storage and maintenance of equipment, supplies and records necessary for patient care services and for the operation of the agency. 20.3 All equipment and furnishings shall be maintained in good condition, properly functioning and replaced as necessary. 20.4 Each agency shall maintain an effective telephone communication system accessible to patients and personnel on a twenty-four (24) hour basis, seven (7) days a week, in accordance with section 11.1 herein. 20.5 Medical Waste Disposal In accordance with section 2.04 of the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste (DEM-DAH-MW-01-92), medical waste generated by individuals on the premises of a single- family home or single-family dwelling unit or by members of households residing in single and multiple residences, hotels, and motels which serve as a residence for individuals, provided the dwelling is not serving as a commercial or professional office where individuals who are not members of the family residing at such dwelling are receiving medical care by a health care professional is specifically excluded from the definition of regulated medical waste and the requirements of the aforementioned regulations. Medical waste generated by health care providers in private homes where they provide medical services to individuals residing in said homes is also exempt from the requirements of the Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste (DEM-DAH-MW-01-92), promulgated by the Rhode Island Department of Environmental Management. 32 PART V ADDITIONAL REQUIREMENTS--HOME NURSING CARE PROVIDERS In addition to meeting the General Requirements as set forth in sections 1.0--20.0 herein, home nursing care providers shall meet the additional requirements of section 21.1 -- 21.9. (below). Section 21.0 Governing Body & Management Professional Advisory Committee 21.1 An advisory group of professional personnel ("Professional Advisory Committee") shall be established by the governing body or other legal authority which shall include at least: a) one (1) physician and a registered nurse; and b) a representative of each therapeutic service offered by the agency, which may also include appropriate representation from other professional disciplines. 21.2 The administrator of the agency shall be ex-officio member of the committee. 21.3 At least one (1) member shall neither be an owner nor an employee of the agency. 21.4 The Professional Advisory Committee shall meet at least twice (2) per year to advise the agency on professional issues and to establish and annually review the agency's policies pertaining to: a) the scope of services offered; b) admission and discharge policies; c) plans of care; d) clinical records; e) personnel qualifications; f) program evaluation; and g) such other matter as may be deemed appropriate by the governing body or other legal authority. The physician member of the Professional Advisory Committee shall attend at least one (1) meeting per year and show evidence of participation (e.g., review of agenda/minutes) in any other Professional Advisory Committee meetings. Scope of Services 33 21.5 Each home nursing care provider shall provide direct nursing services in the home, or by contractual agreement with another Department-licensed agency, delivered by a registered (RN) or licensed practical (LPN) nurse. 21.6 Each home nursing care provider may provide homemaker and nursing assistant services, either directly or by contractual agreement with another Department-licensed agency; and may provide other therapeutic service(s), to be provided either directly or by contractual agreement. 21.7 Additional health services or related services may be provided by agencies as may be deemed appropriate to meet community needs in a manner consistent with acceptable standards of practice. Medical Services 21.8 Patients admitted for medical services shall be under the care of a licensed physician responsible for the development of the plan of care. a) A care plan prescribed by the attending physician, if appropriate, shall contain no less than the following: 1) pertinent diagnosis, including mental status, level of consciousness, ability to communicate including language, speech and hearing; 2) types of services and equipment required, frequency of visits, prognosis, rehabilitative potential, functional limitations, activities permitted, nutritional requirements, medications and treatments, safety measures (if any), instructions for continuing care, referral or discharge; dates/times of any follow-up appointment(s), when known; and 3) the physician's orders for any services which shall specify the procedures and modalities to be used including the amount, frequency and duration of therapy and/or care, including therapeutic services, such as physical therapy, occupational therapy, speech therapy, clinical social work, nutritional assessment, audiology, IV therapy, PEG feeding, wound/dressing, surgical drains, central line, oxygen, diet, all medications prescribed. b) The plan of care shall not be modified without consent of the attending physician and shall furthermore be reviewed by the attending physician and agency staff as often as the severity of the patient's condition requires but no less than once every sixty (60) days beginning with the start of care date. 21.9 Direct Nursing Services Direct nursing services shall be provided by registered and/or practical nurses duly licensed in this state and in accordance with the written plan of care, acceptable standards of nursing practice and the Rules and Regulations for the Licensing of Professional (Registered), Certified Registered Nurse Practitioners, Certified Registered Nurse Anesthetists and Practical Nurses and Standards for the Approval of Basic Nursing Education Programs (R5-34-NUR/ED). 34 PART VI VARIANCE PROCEDURE, PRACTICES AND PROCEDURES, AND SEVERABILITY Section 22.0 Variance Procedure 22.1 The licensing agency may grant a variance either upon its own motion or upon request of the applicant from the provisions of any rule or regulation in a specific case if it finds that a literal enforcement of such provision will result in unnecessary hardship to the applicant and that such variance will not be contrary to the public interest, public health and/or health and safety of patients. 22.2 A request for a variance shall be filed by an applicant in writing setting forth in detail the basis upon which the request is made. 22.2.1 Upon the filing of each request for variance with the licensing agency and within a reasonable time thereafter, the licensing agency shall notify the applicant by certified mail of its approval, or in the case of a denial, a hearing date, time and place may be scheduled if the home nursing care provider or home care provider appeals the denial. Section 23.0 Rules Governing Practices and Procedures 23.1 All hearings and reviews required under the provisions of Chapter 23-17 of the General Laws of Rhode Island, as amended, shall be held in accordance with the provisions of the Rules and Regulations of the Rhode Island Department of Health Regarding Practices and Procedures Before the Department of Health and Access to Public Records of the Department of Health (R42-35-PP). Section 24.0 Severability 24.1 If any provision of these regulations or the application thereof to any facility or circumstances shall be held invalid, such invalidity shall not affect the provisions or application of the regulations which can be given effect, and to this end the provisions of the regulations are declared to be severable. Monday, February 24, 2003 home providers-final regs-march03.doc 35 PART VII REFERENCES 1. "Licensing of Health Care Facilities," Chapter 23-17 of the General Laws of Rhode Island, as amended. 2. "Conditions of Participation for Home Health Agencies," United States Department of Health and Human Services, 42 CFR, Part 484. 3. "Administrative Procedures Act," Chapter 42-35 of the General Laws of Rhode Island, as amended. 4. "Health Care Certificate of Need Act of Rhode Island," Chapter 23-15 of the General Laws of Rhode Island, as amended. 5. "Licensing of Nursing Service Agencies," Chapter 23-17.7 of the General Laws of Rhode Island, as amended. 6. Rules and Regulations for the Registration of Nursing Service Agencies (R23-17.7 NSA), Rhode Island Department of Health, July 2002 and subsequent amendments thereto. 7. Rules and Regulations Governing the Generation, Transportation, Storage, Treatment, Management and Disposal of Regulated Medical Waste in Rhode Island (DEM-DAH-MW-01- 92), Rhode Island Department of Environmental Management, April 1994 and subsequent amendments thereto. 8. "An Act Relating To Nursing Assistant Services," Chapter 23-17.9 of the General Laws of Rhode Island, as amended. 9. "Health Department," Chapter 23-1 of the General Laws of Rhode Island, as amended. 10. Rules and Regulations of the Rhode Island Department of Health Regarding Practices and Procedures Before the Department of Health and Access to Public Records of the Department of Health (R42-35-PP), Rhode Island Department of Health, October 2000 and subsequent amendments thereto. 11. "Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in Health Care Facilities, 1994" U.S. Department of Health & Human Services, Public Health Service, Centers for Disease Control & Prevention, October 28, 1994, vol. 43, no. RR-13. 12. "Confidentiality of Health Care Information," Chapter 5-37.3 of the General Laws of Rhode Island, as amended. 13. Rules and Regulations for the Registration of Nursing Assistants and the Approval of Nursing Assistant Training Programs (R23-17.9-NA), Rhode Island Department of Health, November 2001 and subsequent amendments thereto. 14. Blood borne Pathogens, Occupational Safety and Health Administration (OSHA), 29 CFR Part 1910--1000 to end, section 1910.1030, pp. 316--326, July 1, 1994. 15. CDC. General Recommendations on Immunizations: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians 36 (AAFP). MMWR, February 8, 2002; 51 (RR02); 1--36. Available online at: www.cdc.gov/mmwr/preview/mmwrhtml/rr5102a1.htm 16. The Red Book: Report on the Committee for Infectious Diseases, American Academy of Pediatrics, 1994. 17. Rules and Regulations for the Licensing of Professional (Registered), Certified Registered Nurse Practitioners, Certified Registered Nurse Anesthetists and Practical Nurses and Standards for the Approval of Basic Nursing Education Programs (R5-34-NUR/ED), Rhode Island Department of Health, September 2001 and subsequent amendments thereto. 18. Rules and Regulations Pertaining to the Reporting of Communicable, Environmental and Occupational Diseases (R23-10-DIS), Rhode Island Department of Health, September 2002 and subsequent amendments thereto. 19. Rules and Regulations for Licensing Physical Therapists and Physical Therapist Assistants (R5- 40-PT/PTA), Rhode Island Department of Health, November 2001 and subsequent amendments thereto. 20. Rules and Regulations for Licensing Occupational Therapists and Occupational Therapy Assistants (R5-40.1-OCC), Rhode Island Department of Health, November 2001 and subsequent amendments thereto. 21. Rules and Regulations for Licensing Respiratory Care Practitioners (R23-39-RCP), Rhode Island Department of Health, November 2001 and subsequent amendments thereto. 22. Rules and Regulations for Licensing Speech Pathologists and Audiologists (R5-48-SPA), Rhode Island Department of Health, November 2001 and subsequent amendments thereto. 23. “Statutory Form Durable Power of Attorney for Health Care”, Chapter 23-4.10 of the Rhode Island General Laws, as amended. 24. “Rights of the Terminally Ill Act”, Chapter 23-4.11 of the Rhode Island General Laws, as amended. 25. Rules and Regulations Pertaining to Immunization, Testing, and Health Screening for Health Care Workers (R23-17-HCW), Rhode Island Department of Health, July 2002 and subsequent amendments thereto. 26. Rules and Regulations Pertaining to the Use of Latex Gloves by Health Care Workers, in Licensed Health Care Facilities, and by Other Persons, Firms, or Corporations Licensed or Registered by the Department (R23-73-LAT), Rhode Island Department of Health, May 2002 and subsequent amendments thereto. 37 APPENDIX I HOMEMAKER TRAINING PROGRAM (20 Classroom Hours) (5 Hours Practical Experience) # Hours Orientation to Homemaker Agency: 2 Policies/Procedures Ethical Responsibilities/Accountability Confidentiality Function of Homemaker as a team member Understanding Basic Human Needs: 6 Children/aged Physically disabled People with terminal illness People with mental illness/dementia Infection Control: 1 Hand Washing & Cross Contamination Universal Precautions (appropriate to the homemaker) Emergency Procedures 1 Care of the Home: 5 Planning and serving meals 5 Shopping, food preparation, basic nutrition Cleanliness, general housekeeping Accident prevention Care of food preparation areas/dishes Laundry and ironing Making unoccupied beds Disposal of trash/medical waste