Appendix B Standards for Licensure of Assisted Living Residences Comprehensive Personal Care Homes and Assisted Living Programs.docx

N.J.A.C. 8:36-17.5

N.J.A.C. 8:36

Standards for Licensure of Assisted Living Residences, Comprehensive Personal Care Homes, and Assisted Living Programs § 8:36-1.1 Scope

§ 8:36-1.2 Purpose

§ 8:36-1.3 Definitions

§ 8:36-2.1 Certificate of need

§ 8:36-2.2 Application for licensure

§ 8:36-2.3 Newly constructed or expanded facilities

§ 8:36-2.4 Surveys

§ 8:36-2.5 License

§ 8:36-2.6 Surrender of license

§ 8:36-2.7 Waiver

§ 8:36-2.8 Action against a license

§ 8:36-2.9 Hearings

§ 8:36-2.10 Advertisement of assisted living

§ 8:36-3.1 Appointment of administrator

§ 8:36-3.2 Qualifications of the administrator of an assisted living residence or comprehensive personal care home § 8:36-3.3 Qualifications of trainers for assisted living administrators

§ 8:36-3.4 Administrator's responsibilities

§ 8:36-3.5 Actions against an assisted living administrator

§ 8:36-3.6 Assisted Living Administrators Panel

§ 8:36-4.1 Posting and distribution of statement of resident rights

§ 8:36-5.1 Types of services provided to residents

§ 8:36-5.2 Ownership

§ 8:36-5.3 Transfer of ownership

§ 8:36-5.4 Submission and availability of documents

§ 8:36-5.5 Personnel

§ 8:36-5.6 Staffing requirements

§ 8:36-5.7 Policy and procedure manual

§ 8:36-5.8 Resident transportation § 8:36-5.9 Written agreements § 8:36-5.10 Reportable events § 8:36-5.11 Notices § 8:36-5.12 Maintenance of records

§ 8:36-5.13 Admission and retention of residents

§ 8:36-5.14 Involuntary discharge

§ 8:36-5.15 Notification requirements

§ 8:36-5.16 Interpretation services

§ 8:36-5.17 Referral and transfer agreements

§ 8:36-5.18 Managed risk agreements

§ 8:36-6.1 Resident care policies and procedures

§ 8:36-6.2 Financial arrangements and full disclosure

§ 8:36-6.3 Personal needs allowance

§ 8:36-7.1 Initial assessments and resident service plans

§ 8:36-7.2 Health care assessment and health service plan

§ 8:36-7.3 General and health service plans

§ 8:36-7.4 Health care services

§ 8:36-7.5 Provision of health care services

§ 8:36-8.1 Qualifications of professional nurses

§ 8:36-8.2 Nurse staffing requirements

§ 8:36-9.1 Qualifications of personal care assistants § 8:36-9.2 Certified medication aides

§ 8:36-9.3 Minimum personal care assistant staffing

§ 8:36-10.1 Qualifications of dietitians

§ 8:36-10.2 Provision of meals

§ 8:36-10.3 Designation of a food service coordinator

§ 8:36-10.4 Responsibilities of dietitians

§ 8:36-10.5 Requirements for dining services

§ 8:36-11.1 Qualifications of pharmacists § 8:36-11.2 Provision of pharmaceutical services § 8:36-11.3 Supervision of medication administration § 8:36-11.4 Administration of medications § 8:36-11.5 Certified Medication Aide Program

§ 8:36-11.6 Designation of a pharmacist

§ 8:36-11.7 Storage and control of medications

§ 8:36-12.1 Provision of resident activities

§ 8:36-13.1 Qualifications of social workers

§ 8:36-13.2 Provision of social work services § 8:36-14.1 Emergency medical services § 8:36-14.2 Emergency plans and procedures § 8:36-14.3 Drills and tests § 8:36-15.1 Health record § 8:36-15.2 Record availability § 8:36-15.3 Confidentiality § 8:36-15.4 Record retention § 8:36-15.5 Register § 8:36-15.6 Residents' individual records § 8:36-15.7 Record of death § 8:36-16.1 Scope § 8:36-16.2 Restrictions § 8:36-16.3 Ventilation § 8:36-16.4 Exit access passageways and corridors § 8:36-16.5 Automatic fire detection system § 8:36-16.6 Fire suppression systems § 8:36-16.7 Interior finish requirement § 8:36-16.8 General residential unit requirements § 8:36-16.9 Toilets, baths and handwashing sinks § 8:36-16.10 Kitchenettes

§ 8:36-16.11 Community space § 8:36-16.12 Laundry equipment § 8:36-16.13 Dietary department § 8:36-16.14 Administration and public areas § 8:36-16.15 Fire extinguisher specifications § 8:36-16.16 Sounding devices § 8:36-16.17 Telecommunications § 8:36-17.1 Provision of services § 8:36-17.2 Housekeeping

§ 8:36-17.3 Resident environment

§ 8:36-17.4 Waste removal

§ 8:36-17.5 Heating and air conditioning

§ 8:36-17.1 Provision of services

§ 8:36-17.2 Housekeeping

§ 8:36-17.3 Resident environment

§ 8:36-17.4 Waste removal

§ 8:36-17.5 Heating and air conditioning

§ 8:36-17.6 Water supply

§ 8:36-17.7 Building and grounds maintenance

§ 8:36-17.8 Laundry services § 8:36-18.1 Infection control program

§ 8:36-18.2 Development of infection control policies and procedures

§ 8:36-18.3 General infection control policies and procedures

§ 8:36-18.4 Employee health and resident policies and procedures for infection prevention and control § 8:36-18.5 Staff education and training for infection prevention and control

§ 8:36-18.6 Regulated medical waste

§ 8:36-19.1 Scope and purpose

§ 8:36-19.2 Alzheimer's/dementia program policies and procedures

§ 8:36-19.3 Staff training program for Alzheimer's disease and dementia

§ 8:36-19.4 Services for residents with Alzheimer's/dementia

§ 8:36-20.1 Scope and purpose

§ 8:36-20.2 Mandatory policies and procedures

§ 8:36-20.3 Staffing

§ 8:36-21.1 Quality improvement program

§ 8:36-21.2 Use of restraints

§ 8:36-21.3 Personal care services

§ 8:36-22.1 Eligibility

§ 8:36-22.2 Services provided to residents

§ 8:36-22.3 Physical plant

§ 8:36-22.4 Other requirements

§ 8:36-22.5 Prohibition of resident discharge on conversion of facility

§ 8:36-22.6 Combination of license categories

§ 8:36-22.7 Supplemental Security Income recipients

§ 8:36-23.1 Tenant/resident eligibility

§ 8:36-23.2 Service provider requirements

§ 8:36-23.3 Services provided to residents

§ 8:36-23.4 Policy and procedure manual

§ 8:36-23.5 Resident transportation § 8:36-23.6 Notices § 8:36-23.7 Maintenance of records § 8:36-23.8 Notification requirements

§ 8:36-23.9 Administration and staffing § 8:36-23.10 Financial arrangements § 8:36-23.11 Resident assessments, service plans, health care plans and health care services

§ 8:36-23.12 Dining services and meal preparation assistance § 8:36-23.13 Pharmaceutical services § 8:36-23.14 Resident activities § 8:36-23.15 Resident records § 8:36-23.16 Resident rights and responsibilities

§ 8:36-23.17 Reportable events § 8:36-23.18 Other requirements

§ 8:36-1.1 Scope

(a) The rules in this chapter pertain to all facilities which provide assisted living services. These rules constitute the basis for the licensure of assisted living residences, comprehensive personal care homes, and assisted living programs by the New Jersey State Department of Health and Senior Services.

(b) Assisted living residences shall comply with N.J.A.C. 8:36-1 through 21; comprehensive personal care homes shall comply with N.J.A.C. 8:36-1 through 21, where applicable, and 22; and assisted living programs shall comply with N.J.A.C. 8:36-1 through 22, where applicable, and 23.

§ 8:36-1.2 Purpose

(a) The purpose of this chapter is to establish minimum standards with which an assisted living residence, comprehensive personal care home or assisted living program must comply in order to be licensed to operate in New Jersey.

(b) The purpose of these rules is to establish standards for assisted living residences, comprehensive personal care homes (which may be collectively referred to as assisted living facilities) and assisted living programs, all of which are intended to promote "aging in place" in a homelike setting for frail elderly and disabled persons, including persons who require nursing home level of care. Assisted living residences, comprehensive personal care homes and assisted living programs assure that residents receive supportive health and social services as they are needed to enable them to maintain their independence, individuality, privacy, and dignity in an apartment-style living unit or, in the case of assisted living programs, a living unit in publicly subsidized housing. The assisted living environment actively encourages and supports these values through effective methods of service delivery and facility or program operation and promotes resident self direction and personal decision-making while protecting residents' health and safety.

(c) An assisted living residence or comprehensive personal care home offers a suitable living arrangement for persons with a range of capabilities, disabilities, frailties, and strengths. In general, however, assisted living is not appropriate for individuals who are incapable of responding to their environment, expressing volition, interacting, or demonstrating any independent activity. For example, individuals in a persistent vegetative state should not be placed or cared for in an assisted living residence, comprehensive personal care home or assisted living program.

(d) In the case of hospice, the purpose of these rules is to promote the establishment of assisted living residences or comprehensive personal care homes to serve terminally ill persons who lack adequate caregiving support to meet their needs while residing at home.

§ 8:36-1.3 Definitions

The following words and terms, when used in this chapter, shall have the following meanings, unless the context clearly indicates otherwise:

"Activities of daily living (ADL)" means the functions or tasks for self-care, which are performed either independently or with supervision or assistance. Activities of daily living include dressing, bathing, toilet use, transfer, locomotion, bed mobility, and eating.

"Advanced practice nurse" means an individual who is certified by the New Jersey State Board of Nursing in accordance with N.J.S.A. 45:11-23 et seq.

"Aging in place" means a process whereby individuals remain in their living environment despite the physical and/or mental decline and growing needs for supportive services that may occur in the course of aging. For aging in place to occur, services are added, increased, or adjusted to compensate for the individual's physical and/or mental decline.

"Assistance with transfer" means providing the physical assistance of no more than two facility staff while the resident moves between bed and a standing position or between bed, chair or wheelchair.

"Assisted living" means a coordinated array of supportive personal and health services, available 24 hours per day, to residents who have been assessed to need these services including persons who require nursing home level of care. Assisted living promotes resident self direction and participation in decisions that emphasize independence, individuality, privacy, dignity, and homelike surroundings.

"Assisted living program" means the provision of or arrangement for meals and assisted living services, when needed, to the tenants (also known as residents) of publicly subsidized housing which because of any Federal, State, or local housing laws, rules, regulations or requirements cannot become licensed as an assisted living residence. An assisted living program may also provide staff resources and other services to a licensed assisted living residence and a licensed comprehensive personal care home.

"Assisted living program provider" means an organization licensed by the New Jersey Department of Health to provide all services required of an assisted living program.

"Assisted living residence" means a facility that is licensed by the Department of Health to provide apartment-style housing and congregate dining and to assure that assisted living services are available when needed, for four or more adult persons unrelated to the proprietor. Apartment units offer, at a minimum, one unfurnished room, a private bathroom, a kitchenette, and a lockable door on the unit entrance.

"Assisted living values" means the organization, development and implementation of services and other facility or program features so as to promote and encourage each resident's choice, dignity, independence, individuality and privacy in a homelike environment. Assisted living values promote the concepts of aging in place and shared responsibility.

"Available" means ready for immediate use (pertaining to equipment) or capable of being reached (pertaining to personnel), unless otherwise defined.

"Bedridden" means physically unable to rise from bed, even with assistance with transfer from the bed.

"Bounded choice" means limits placed on a resident's choice as a result of an assessment, in accordance with N.J.A.C. 8:36-5.18, which indicates that such resident's choices or preferences place the resident or others at a risk of harm or lead to consequences which violate the norms of the facility or program or the rights of others.

"Center" or "Centers" means ecologically designed compact forms of development and redevelopment that are necessary to assure efficient infrastructure and protection of natural resources in the various regions of the State of New Jersey pursuant to the State Plan for Development and Redevelopment created pursuant to the requirements of the State Planning Act, N.J.S.A. 52:18A-196 through 207.

"Certificate of Need and Licensing Program" or "Program" means a unit of the Department for which the contact information is Certificate of Need and Licensing Program, New Jersey Department of Health, PO Box 358, Trenton, NJ 08625-0358, (609) 292-6552.

"Choice" means the number of opportunities and viable options available to residents to act on their preferences and to exercise control over their lives.

"Commissioner" means the Commissioner of the New Jersey Department of Health.

"Communicable disease" means an illness due to a specific infectious agent or its toxic products which occurs through transmission of that agent or its products from a reservoir to a susceptible host.

"Comprehensive personal care home" means a facility which is licensed by the Department of Health to provide room and board and to assure that assisted living services are available when needed, to four or more adults unrelated to the proprietor. Residential units in comprehensive personal care homes house no more than two residents and have a lockable door on the unit entrance.

"Continuing care retirement community" means a facility that has received a certificate of authority pursuant to the Continuing Care Retirement Community Regulation and Financial Disclosure Act, N.J.S.A. 52:27D-330 et seq.

"Customized resident medication package" means a unit-of-use package prepared by a pharmacist for a specific resident comprising a series of containers and containing two or more prescribed solid oral dosage forms, and so designed or labeled as to indicate the day and time, or period of time, that the contents within each container are to be taken.

"Defibrillator" means a medical device heart monitor and defibrillator that has received approval of its pre-market notification filed pursuant to 21 U.S.C. § 360.(k) from the United States Food and Drug Administration, is capable of recognizing the presence or absence of ventricular fibrillation or rapid ventricular tachycardia, is capable of determining, without intervention by an operator, whether defibrillation should be performed, and upon determining that defibrillation should be performed, automatically charges and requests delivery of an electrical impulse to an individual's heart.

"Department" means the New Jersey Department of Health.

"Dignity" means the self-worth of a resident. Dignity is enhanced and supported when the facility or program, and its staff and policies and procedures, demonstrate courtesy, respect the resident's right to make decisions, and allow personal assistance and care to be provided in privacy, with acceptance of disabilities and emphasis on abilities. (See N.J.A.C. 8:36-1.2(b)).

"Direct supervision" means supervision on the premises.

"Division of Health Facility Survey and Field Operations" or "Division" means a unit of the Department for which the contact information is Division of Health Facility Survey and Field Operations, New Jersey Department of Health, PO Box 367, Trenton, NJ 08625-0358, (800) 792-9770 "Documented" means written, signed, and dated.

"Drug regimen review" means an individual resident record review conducted by the consultant or provider pharmacist, including, but not limited to, laboratory tests, dietary requirements, medication administration records, physician's, advanced practice nurse's, or physician assistant's and nurse's clinical notes, physician's, advanced practice nurse's, or physician assistant's orders and progress notes, in order to monitor for potentially significant adverse drug reactions, drug-to-drug and drug-food interactions, allergies, contraindications, rationality of therapy, drug use evaluation and laboratory test results.

"Employee" means a person who is gainfully employed in the assisted living facility on a full- or part-time basis and for whom a record of hours worked and wages paid are maintained and who meets the health, age and other requirements of this chapter. Reimbursement for such employment may include salaries, wages, room and board, or any combination thereof. A person placed in the assisted living facility under a purchase of care or service agreement by the facility, or the resident, is not considered an employee.

"Full-time" means a time period established by the facility as a full working week as defined in the facility's policies and procedures.

"Governing authority" means the organization, person, or persons designated to assume legal responsibility for the management, operation, and financial viability of the facility.

"Guardian" means a person appointed by a court of competent jurisdiction to handle the affairs and protect the rights of any resident of the facility who has been declared a mental incompetent. Guardian does not include a person affiliated with the facility, its operations or personnel, unless so ordered by the court.

"Half-time" means a time period established by the facility as a half working week as defined in the facility's policies and procedures.

"Health care facility" means a facility defined in N.J.S.A. 26:2H-1 et seq., and amendments thereto.

"Health Care Plan Review Unit" means a unit within the Division of Codes and Standards in the New Jersey Department of Community Affairs for which the contact information is PO Box 817, Trenton, NJ 08625-0817, (609) 633-8151.

"Health care service" means any service provided to a resident of an assisted living residence or comprehensive personal care home that is ordered by a physician and required to be provided or delegated by a licensed, registered or certified health care professional. Any other service, whether or not ordered by a physician, that is not required to be provided by a licensed, registered or certified health care professional is not to be considered a health care service. For purposes of this definition, a certified health care professional excludes certified homemaker/home health aides, certified nurse aides, certified personal care assistants, and certified medication aides.

"Homelike environment" means a residential setting where a sense of family and community pervades to foster emotional attachment to people and place and in which a resident's preferred lifestyle, habits and use of personal belongings are encouraged and supported.

"Hospice" means a program of palliative and supportive services provided to terminally ill persons and their families in the form of physical, psychological, social, and spiritual care.

"Independence" means the support and enhancement of resident capabilities and facilitation of resident abilities so that the resident's preferences and choices may be implemented within a barrier-free environment.

"Individuality" means each resident's unique needs, capabilities, personalities, backgrounds and preferences.

"Job description" means written specifications developed for each position in the facility, containing the qualifications, duties and responsibilities, and accountability required of employees in that position.

"Licensed nursing personnel" (licensed nurse) means registered professional nurses or practical nurses licensed by the New Jersey Board of Nursing in accordance with N.J.A.C. 13:37.

"Managed risk" means the process of balancing resident choice and independence with the health and safety of the resident and other persons in the facility or program. If a resident's preference or decision places the resident or others at risk or is likely to lead to adverse consequences, such risks or consequences are discussed with the resident, and, if the resident agrees, a resident representative, and a formal plan to avoid or reduce negative or adverse outcomes is negotiated, in accordance with the provisions of N.J.A.C. 8:36-5.18.

"Managed risk agreement" means the written formal plan developed in consideration of shared responsibility, bounded choice and assisted living values and negotiated between the resident and the facility or program to avoid or reduce the risk of adverse outcomes which may occur in an assisted living environment.

"Medication administration" means a procedure in which a prescribed medication or biological is given to a resident by an authorized individual in accordance with all laws and regulations governing such procedures. The complete process of administration includes:

1. Removing an individual dose from a previously dispensed, properly labeled container (including a unit dose or unit-of-use container);

2. Verifying it with the prescriber's orders;

3. Giving the individual dose to the resident;

4. Seeing that the resident takes it (if oral); and

5. Recording the required information, including but not limited to the method of administration, time administered, initials of individuals who administered the medication, and effect of the medication when "prn" or as-needed medications are administered.

"Medication administration record" or "MAR" means an individual resident record that contains, but is not limited to: resident name, date of birth, diagnosis(es), age, physician, name and medication strength, dosage form, route of administration, frequency, date and time of administration, initials of individual administering the medication, a section containing the full signature and title of each individual who initials the MAR, date medication ordered, stop date if applicable, allergies, and all other professionally acceptable information appropriate to MARs.

"Medication aide" means a person who is qualified in accordance with N.J.A.C. 8:36-9.2.

"Medication Aide Training Competency and Evaluation Program" or "MATCEP" means a Department approved minimal 30-hour training course conducted by a Department approved registered professional nurse and registered pharmacist, to instruct certified nurse aides, certified homemaker/home health aides or certified personal care assistants, in the administration of medications to residents, within assisted living residences, comprehensive personal care homes and assisted living programs.

"Medication dispensing" means a procedure entailing the interpretation of the original or direct copy of the prescriber's orders for a medication or a biological and, pursuant to that order, the proper selection, measuring, labeling, packaging, and issuance of the medication or biological to a resident or a service unit of the facility, in conformance with all applicable Federal, State, and local rules and regulations.

"Medication error" means any preventable event that may cause or lead to inappropriate medication use or resident harm, while the medication is in the control of the health care professional. Such events may be related to professional practice, health care products, procedures, and systems including: prescribing; order communication; product labeling, packaging and nomenclature; compounding; dispensing; distribution; administration; education; monitoring; and use. The error may or may not be seen by the surveyor during an observation of a resident receiving medication.

"Nursing home-level care" means that an individual requires "nursing facility services" as defined at N.J.A.C. 8:85-2.1. Nursing home-level care is provided to individuals who have chronic medical condition(s) resulting in moderate to severe impairments in physical, behavioral, cognitive, and/or psychosocial functioning. The need for nursing home-level care and services is determined by a registered professional nurse and identified in a plan of care.

"Nursing supervision" means services which are provided to a resident whose condition requires continued monitoring of vital signs and physical and cognitive status. Such services shall be medically complex enough to require ongoing assessment, planning, or intervention by a nurse; required to be performed by or under the supervision of licensed nursing personnel or other professional personnel for safe and effective performance; required on a daily basis; and consistent with the nature and severity of the resident's condition or the disease state or stage.

"Pain management," in accordance with N.J.A.C. 8:43E-6, means the assessment of pain and, if appropriate, treatment in order to assure the needs of patients or residents of health care facilities who experience problems with pain are met. Treatment of pain may include the use of medications or application of other modalities and medical devices such as, but not limited to, heat or cold, massage, transcutaneous electrical nerve stimulation (TENS), acupuncture, and neurolytic techniques such as radiofrequency coagulation and cryotherapy.

"Personal care" means services supportive to residents' care and comfort, including, but not limited to, assistance with activities of daily living. Except as required by these rules, personal care need not be provided by a personal care assistant.

"Personal care assistant" means an individual who is qualified in accordance with N.J.A.C. 8:36-9.1.

"Pharmacist" means an individual who is licensed by the New Jersey State Board of Pharmacy, in accordance with N.J.A.C. 13:39-3.

"Physician" means an individual who is licensed or authorized by the New Jersey State Board of Medical Examiners to practice medicine in the State of New Jersey, in accordance with N.J.A.C. 13:35.

"Physician assistant" means an individual who is licensed by the New Jersey State Board of Medical Examiners, pursuant to N.J.S.A. 45:9-27.10 et seq.

"Privacy" means a resident's degree of control over a specific physical area and/or time; levels of intimacy with family and others; and communication and contact with others outside the facility or program environment.

"Program site" means a licensed assisted living residence, a licensed comprehensive personal care home or a publicly subsidized housing unit whose tenants may voluntarily be receiving the services of a licensed assisted living program provider.

"Publicly subsidized housing" means any housing for which the construction costs and/or the permanent financing have been underwritten with funds from any local, State or Federal entity (including low-income housing tax credits) for the purpose of making the housing affordable to persons with incomes below the area median. For the purpose of this definition, "publicly subsidized housing" can also mean rental housing developments in which all individual units available for rent are receiving rental assistance from a local, State, or Federal entity in order to make the units affordable to individuals with incomes below the area median.

"Resident" means an individual who lives in an assisted living residence or comprehensive personal care home or is a tenant in publicly subsidized housing who voluntarily participates in an assisted living program.

"Residential unit" means a separate apartment or unit where one or more individuals reside within the assisted living residence or a room or rooms where residents reside within a comprehensive personal care home.

"Responsible person" means a person who has been designated by the resident and who has agreed to assist the resident, as needed, in arranging for health, social and financial services or making decisions regarding such services.

"Self administration" means a procedure in which any medication is taken orally, injected, inserted, or topically or otherwise administered by a resident to himself or herself.

"Shared responsibility" means that residents (and if the resident wishes, the resident's family) and providers of assisted living services share responsibility for planning and decision making affecting residents. To participate fully in shared responsibility, residents shall be provided with clear and understandable information about the possible consequences of their decision-making, in accordance with the provisions of N.J.A.C. 8:36-5.18(a)2.

"Shift" means a time period defined as a full working day by the facility in its policy manual.

"Signature" means, at a minimum, the first initial and full surname and title (for example, R.N., L.P.N., D.D.S., M.D., D.O., R.Ph.) of an individual, legibly written with his or her own hand. A controlled electronic signature system may be used.

"Specialized long-term care" or "specialized care" means the care of individuals who must use a respirator or mechanical ventilator, and the care of individuals with severe behavior management problems, such as combative, disruptive, and aggressive behaviors.

"Staff education plan" means a written plan which describes a coordinated program for employee education for each service, including inservice programs and on-the-job training.

"Staff orientation plan" means a written plan for the orientation of each new employee to the duties and responsibilities of the service to which he or she has been assigned, as well as to the personnel policies of the facility.

"Supervision" means authoritative procedural guidance by a qualified individual for the accomplishment of a function or activity within his or her sphere of competence, with initial direction and periodic on-site inspection of the actual act of accomplishing the function or activity.

"Total bed complement" means the resident census.

"Unit dose drug distribution system" means a system in which medications are delivered to the resident areas in single unit packaging, and which meets the following criteria:

1. Each medication shall be individually wrapped and labeled with the generic or trade (brand) name and strength of the medication, lot number or reference code, expiration date, and manufacturer's name, and shall be ready for administration to the resident;

2. Cautionary instructions shall appear on the resident's record of medication administration, and the system shall include provisions for noting additional information, including, but not limited to, special times or routes of administration and storage conditions; and,

3. Commercial repackagers shall comply with 21 CFR 201.1, incorporated herein by reference, as amended and supplemented, and N.J.A.C. 8:39.

"Unit-of-use" means a system in which medications are delivered to the resident areas either in single unit packaging, bingo or punch cards, blister or strip packs, or other system where each medication is physically separate. Individually labeled unit dose medications may be combined in a "bingo or punch card" to create a unit-of-use drug distribution system.

1. Labeling shall conform to paragraph 1 in the definition of "unit dose drug distribution system" above.

2. Cautionary instructions shall appear on the resident's record of administration and/or unit-of-use package, and the system shall include provisions for noting additional information, including, but not limited to, special times or routes of administration and storage conditions.

§ 8:36-2.1 Certificate of need

(a) According to N.J.S.A. 26:2H-1 et seq., and amendments thereto, a health care facility shall not be instituted, constructed, expanded, licensed to operate, or closed except upon application for, and receipt of, a certificate of need issued by the Commissioner in accordance with N.J.A.C. 8:33.

(b) Certificate of need application forms, CN-19, and instructions for completion thereof, may be obtained from the Certificate of Need and Licensing Program or from the Department's forms page at https://www.nj.gov/health/forms.

(c) The facility or program shall implement all conditions imposed by the Commissioner as specified in the certificate of need approval letter. Failure to implement the conditions may result in the imposition of sanctions in accordance with N.J.S.A. 26:2H-1 et seq., and amendments thereto.

§ 8:36-2.2 Application for licensure

(a) Following receipt of a certificate of need, any person, organization, or corporation desiring to operate an assisted living residence, comprehensive personal care home or assisted living program shall make application to the Commissioner for a license on forms prescribed by the Department. Such forms may be obtained from the Certificate of Need and Licensing Program.

(b) Any long-term care facility, residential health care facility, or Class "C" boarding home planning to provide assisted living services shall obtain licensing approval from the Department prior to initiating services.

(c) A copy of the assisted living residence or comprehensive personal care home admission agreement or other document stating the scope of a facility's services shall be forwarded to the Director of the Certificate of Need and Licensing Program for review when application for licensure is made. Review shall ensure that the admission agreement does not violate any requirements contained herein, any conditions placed on certificate of need approval, or any applicable State or Federal statutes. This subsection shall not apply when a continuing care retirement community (CCRC) contracts with its residents to provide assisted living pursuant to a continuing care agreement. This subsection does apply, however, when a CCRC provides assisted living to a person who is not a party to a continuing care agreement. The admission agreement shall include, but not be limited to, the following:

1. Proposed charges for room, board and all levels of service and care and for all additional services and care not included in the standard package of rates in accordance with N.J.A.C. 8:36-6.2;

2. Specification of how and when the resident will be notified of any change in charges, and a statement that each resident has the right to request written justification of any increase in charges in accordance with N.J.A.C. 8:36-6.2;

3. A statement that each resident has the right to appeal an involuntary discharge as specified at N.J.A.C. 8:36-5.14(b); and

4. Specification of the criteria identified at N.J.A.C. 8:36-5.1(d) which will be used to discharge residents and an explanation of how the discharge process will be implemented, including which facility staff will participate and the extent of resident participation.

(d) The Department shall charge a nonrefundable fee of $ 1,500 plus $ 15.00 per bed (for the number of licensed beds) for the filing of an application for licensure and each annual renewal of an assisted living residence or comprehensive personal care home license thereafter. The facility shall apply for a license for the maximum number of beds available in its residential units. These fees shall not exceed the maximum caps set forth at N.J.S.A. 26:2H-12, as may be amended from time to time.

(e) The application shall include, but not be limited to, the following:

1. An evaluation of the previous licensing track record of the proposed licensed operator in New Jersey and other states, where applicable. This evaluation shall include assisted living and other licensed health care facilities owned, operated or managed by the prospective licensed operator and any such facilities owned, operated, or managed by any entity affiliated with the proposed operator;

2. The proposed licensed operator's capacity to comply with licensing requirements;

3. A description of the physical plant, including the number and type of beds requested;

4. An evaluation of any requested waivers to licensing requirements that are sought in accordance with N.J.A.C. 8:36-2.7;

5. A description of how the architectural design will promote the essential values of assisted living, including privacy, choice, independence, dignity and a home-like environment;

6. A description of how the physical plant will facilitate the care of residents with common long-term care problems, such as reduced mobility, incontinence and dementia; and

7. A statement of the proposed licensed operator's commitment to assuring access to assisted living for individuals with nursing home level of care needs, as defined in N.J.A.C. 8:36-1.3. This statement shall indicate that within 36 months after licensure, at least 20 percent of the facility's residents shall be individuals with nursing home-level of care needs. This percentage shall be computed based on the number of resident days per calendar year and may include direct admissions as well as maintained residents with nursing home-level of care needs.

(f) In addition to the application requirements of (e) above, if an applicant is required to submit plans under N.J.A.C. 8:36-2.3, the applicant shall submit a description of how the location of the proposed facility will promote the physical integration or social connection of the residents into a neighborhood, center or other area with existing services or amenities.

(g) The Department shall charge a nonrefundable fee of $ 750.00 for the filing of an application to add bed or non-bed related services to an existing assisted living residence or comprehensive personal care home.

(h) The Department shall charge a nonrefundable fee of $ 375.00 for the filing of an application to reduce bed or non-bed related services at an existing assisted living residence or comprehensive personal care home.

(i) The Department shall charge a nonrefundable fee of $ 375.00 for the filing of an application for the relocation of an assisted living residence or comprehensive personal care home.

(j) The Department shall charge a nonrefundable fee of $ 1,500 for the filing of an application for the transfer of ownership of an assisted living residence or comprehensive personal care home.

(k) All applicants shall demonstrate that they have the capacity to operate an assisted living residence or program or a comprehensive personal care home in accordance with the rules in this chapter. An application for a license or change in service shall be denied if the applicant cannot demonstrate that the premises, equipment, personnel, including principals and management, finances, rules and bylaws, and standards of health care are fit and adequate and that there is reasonable assurance that the health care facility will be operated in accordance with the standards required by these rules. The Department shall consider an applicant's prior history in operating a health care facility either in New Jersey or in other states in making this determination. Any evidence of licensure violations representing serious risk of harm to residents may be considered by the Department, as well as any record of criminal convictions representing a risk of harm to the safety or welfare of residents.

(l) The Department shall charge a nonrefundable fee of $ 1,125.00 for the filing of an application for licensure and each annual renewal of an assisted living program. The application shall include, but not be limited, to the following:

1. A copy of the written contract between the program provider and the publicly subsidized housing unit in accordance with N.J.A.C. 8:36-23.2(c);

2. A copy of the written agreement or contract between the program provider and residents that will be used at each program site, including clearly addressing N.J.A.C. 8:36-23.3(d); and

3. An evaluation of the requirements specified in (e)1 and 2 above.

(m) Each licensed assisted living program office site may provide services in an area that covers no more than two contiguous counties, although the facility may apply to establish and license sufficient sites to provide services for multiple counties, up to and including a Statewide service area.

(n) Each applicant for a license to operate a facility or program may make an appointment for a preliminary conference at the Department with the Certificate of Need and Licensing Program.

(o) Each assisted living residence and comprehensive personal care home shall be assessed a biennial inspection fee of $ 1,500. This fee shall be assessed in the year the facility will be inspected, along with the annual licensure fee for that year. The fee shall be added to the initial licensure fee for new facilities. Failure to pay the inspection fee shall result in non-renewal of the license for existing facilities and the refusal to issue an initial license for new facilities. This fee shall be imposed only every other year even if inspections occur more frequently and only for the inspection required to either issue an initial license or to renew an existing license. It shall not be imposed for any other type of inspection.

(p) Each assisted living program shall be assessed a biennial inspection fee of $ 750.00. This fee shall be assessed in the year the facility will be inspected, along with the annual licensure fee for that year. The fee shall be added to the initial licensure fee for new facilities. Failure to pay the inspection fee shall result in non-renewal of the license for existing facilities and the refusal to issue an initial license for new facilities. This fee shall be imposed only every other year even if the inspections occur more frequently and only for the inspection required to either issue an initial license or to renew an existing license. It shall not be imposed for any other type of inspection.

§ 8:36-2.3 Newly constructed or expanded facilities

(a) Any assisted living residence or comprehensive personal care home with a construction program, whether a certificate of need is required or not, shall submit plans to the Health Care Plan Review Unit, for review and approval prior to the initiation of construction.

(b) The licensure application for a newly constructed, renovated, or expanded facility shall include the written final release of the physical plant construction plans by the Health Care Plan Review Unit.

(c) Prior to occupying a new or renovated building, the facility shall submit a certificate of occupancy, issued by the local municipality, to the Health Care Plan Review Unit, and shall submit the following items to the Certificate of Need and Licensing Program of the Department:

1. A copy of the certificate of occupancy; and

2. A copy of the letter from DCA recommending approval to the Department of the construction or renovation that was completed.

§ 8:36-2.4 Surveys

(a) When the written application for licensure is approved and the building is ready for occupancy, representatives of the Division of Health Facility Survey and Field Operations of the Department shall conduct a survey of the facility to determine if the facility adheres to the provisions of this chapter.

1. The facility shall be notified in writing of the findings of the survey, including any deficiencies found.

2. When the deficiencies, if any, have been corrected, the facility shall notify the Division, which shall schedule one or more resurveys of the facility prior to occupancy.

(b) A license shall be issued to a facility when the following conditions are met:

1. A preliminary conference to review the conditions for licensure (see N.J.A.C. 8:36-2.2(d)1 through 8) and operation has taken place between the Certificate of Need and Licensing Program and representatives of the facility, who will be advised that the purpose of the conference is to allow the Department to determine the facility's compliance with N.J.S.A. 26:2H-1 et seq., and amendments thereto, and the rules pursuant thereto;

2. The initial survey required by N.J.A.C. 8:36-2.4(a) results in a finding of substantial compliance with the requirements of this chapter;

3. The completed licensure application is on file with the Department;

4. The fee for filing of the application has been received by the Department;

5. A copy of the admission agreement is on file with the Department;

6. The applicant has submitted approvals from the local zoning, fire, health, and building authorities, and a copy of the certificate of occupancy or a certificate of continued occupancy that has been issued by the appropriate local authority, to the Certificate of Need and Licensing Program;

7. Written approvals of the water supply and sewage disposal system from local officials are on file with the Department for any water supply or sewage disposal system not connected to an approved municipal system; and

8. Personnel are employed in accordance with the staffing requirements in this chapter.

(c) No facility shall admit residents to the facility until the facility has the written approval and/or license issued by the Certificate of Need and Licensing Program. Violators of this requirement shall be subject to penalties for operating a facility without a license, pursuant to N.J.S.A. 26:2H-14 and N.J.A.C. 8:43E-1.

(d) Survey visits may be made to a facility at any time by authorized staff of the Department. Such visits may include, but not be limited to, the review of all facility documents and resident records and conferences with residents.

§ 8:36-2.5 License

(a) A license shall be issued if surveys by the Department have determined that the facility is in substantial compliance with the requirements of this chapter, and is operated as required by N.J.S.A. 26:2H-1 et seq.

(b) A license shall be granted for a period of one year or less, as determined by the Department.

(c) The license shall be conspicuously posted in the facility.

(d) The license shall not be assignable or transferable. The license shall be immediately void if the facility permanently ceases to operate or if its ownership changes.

(e) The license, unless suspended or revoked, shall be renewed annually on the original licensure date, or within 30 days thereafter but dated as of the original licensure date. The facility will receive a request for renewal fee 30 days prior to the expiration of the license. A renewal license shall not be issued unless the licensure fee is received by the Department.

(f) The license shall not be renewed if local rules, regulations and/or requirements are not met, on a case-by-case basis.

§ 8:36-2.6 Surrender of license

The facility shall notify each resident, the resident's physician, and any guarantors of payment at least 30 days prior to the voluntary surrender of a license, or as directed under an order of revocation, refusal to renew, or suspension of license. In such cases, the license shall be returned to the Certificate of Need and Licensing Program within seven working days after the voluntary surrender, revocation, non-renewal, or suspension of license.

§ 8:36-2.7 Waiver

(a) The Commissioner or his or her designee may, in accordance with the general purposes and intent of N.J.S.A. 26:2H-1 et seq., and amendments thereto, and this chapter, waive sections or part of sections of these rules if, in his or her opinion, such waiver would not endanger the life, safety, or health of residents or the public.

(b) A facility seeking a waiver of these rules shall apply in writing to the Director of the Certificate of Need and Licensing Program.

(c) A written request for waiver shall include the following:

1. The specific rule(s) or part(s) of the rule(s) for which waiver is requested;

2. The reasons for requesting a waiver, including a statement of the type and degree of hardship that would result to the facility upon adherence;

3. An alternative proposal which would ensure resident safety; and

4. Documentation to support the request for waiver.

(d) The Department reserves the right to request additional information before processing a request for waiver, depending upon the waiver requested.

(e) All requests for waivers to the physical plant requirements in N.J.A.C. 8:36-16 and 22 shall be fully explained, justified, and made a part of the certificate of need application submitted in accordance with N.J.S.A. 26:2H-1 et seq. and N.J.A.C. 8:36-2.1(a).

§ 8:36-2.8 Action against a license

(a) If the Department determines that operational or safety deficiencies exist, it may require that all admissions to the facility cease. This may be done simultaneously with, or in lieu of, action to revoke licensure and/or impose a fine and in accordance with N.J.A.C. 8:43E-1.1 et seq. The Commissioner or his or her designee shall notify the facility in writing of such determination.

(b) The Commissioner may order the immediate removal of residents from a facility whenever he or she determines that there is imminent danger to any resident.

§ 8:36-2.9 Hearings

(a) If the Department proposes to suspend, revoke, deny, assess a monetary penalty, or refuse to renew a license, the licensee or applicant may request a hearing which shall be conducted pursuant to the Administrative Procedure Act, N.J.S.A. 52:14B-1 et seq. and 52:14F-1 et seq., and the Uniform Administrative Procedure Rules, N.J.A.C. 1:1.

(b) Prior to transmittal of any hearing request to the Office of Administrative Law, the Department may schedule a conference to attempt to settle the matter.

§ 8:36-2.10 Advertisement of assisted living

Only facilities licensed as assisted living residences or comprehensive personal care homes may describe and offer themselves to the public as providing assisted living services and care or other similar services. Violation of this requirement shall constitute operation of a health care facility without a license, and shall be subject to penalty in accordance with N.J.S.A. 26:2H-14 and N.J.A.C. 8:43E-1.

§ 8:36-3.1 Appointment of administrator

(a) An administrator shall be appointed and an alternate shall be designated in writing to act in the absence of the administrator. The administrator or a designated alternate shall be available at all times and shall be on-site at the facility on a full-time basis in facilities that have 60 or more licensed beds, and on a half-time basis in facilities that have fewer than 60 licensed beds, in accordance with the definition of "full-time" and "half-time" at N.J.A.C. 8:36-1.3.

§ 8:36-3.2 Qualifications of the administrator of an assisted living residence or comprehensive personal care home

(a) The…