01 Purpose.

The purpose of this chapter is to set minimum, reasonable standards for licensure of assisted living programs in Maryland. This chapter is intended to maximize independence and promote the principles of individuality, personal dignity, freedom of choice, and fairness for all individuals residing in assisted living programs while establishing reasonable standards to promote individuals’ health and safety.

02 Definitions.

  1. In this chapter, the following terms have the meanings indicated.
  2. Terms Defined.

(1) Abuse of a Resident.

(a) “Abuse of a resident” means physical, sexual, mental, or verbal abuse or the improper use of physical or chemical restraints or involuntary seclusion as those terms are defined in this regulation.

(b) “Abuse of a resident” does not include:

(i) The performance of an accepted medical procedure ordered by a physician or administered by another health care practitioner practicing within the scope of the physician or health care practitioner’s license; or

(ii) Compliance with a valid advance directive.

(2) Activities of Daily Living.

(a) “Activities of daily living” means normal daily activities.

(b) “Activities of daily living” includes:

(i) Eating or being fed;

(ii) Grooming, bathing, oral hygiene including brushing teeth, shaving, and combing hair;

(iii) Mobility, transfer, ambulation, and access to the outdoors, when appropriate;

(iv) Toileting; and

(v) Dressing in clean, weather-appropriate clothing.

(3) Administration of Medication.

(a) “Administration of medication” means the act of preparing and giving medication to a resident.

(b) “Administration of medication” includes:

(i) Identifying the time to administer the medication;

(ii) Opening the medication container;

(iii) Removing the medication from the container; or

(iv) Giving the medication to the resident.

(c) “Administration of medication” does not include residents who have the cognitive ability to recognize their medications but only require assistance such as:

(i) A reminder to take the medication;

(ii) Physical assistance with opening a medication container; or

(iii) Assistance with removing medication from the container.

(4) “Adult medical daycare” has the meaning stated in Health-General Article, §§14-201 and 14-301, Annotated Code of Maryland.

(5) “Advance directive” means:

(a) A witnessed written document, voluntarily executed by the declarant consistent with the requirements of Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland; or

(b) A witnessed oral statement, made by the declarant consistent with the provisions of the Health-General Article, Title 5, Subtitle 6, Annotated Code of Maryland.

[(6) “Agent” means a person who manages, uses or controls the funds or assets that legally may be used to pay an applicant’s or resident’s share of the costs or other charges for assisted living services.]

(6) “Alzheimer’s dementia special care” means the care required by any individual with dementia including a probable or confirmed diagnosis of Alzheimer’s disease or a related disorder, regardless of their placement in the facility.

(7) “Alzheimer’s special care unit” means a secured or segregated special unit or program specifically designed for individuals with dementia, including a probable or confirmed diagnosis of Alzheimer’s disease or a related disorder.

[(8) “Assessment” means a process of evaluating an individual’s health, functional and psychosocial history, and condition using the Resident Assessment Tool.]

[(9)] (8)   “Assist rail” means a handrail or other similar, substantially constructed device that is installed to enable residents to move safely from one point or position to another.

[(10) “Assisted living manager” means the individual who is:

(a) Designated by the licensee to oversee the day-to-day operation of the assisted living program; and

(b) Responsible for the duties set forth in Regulation .15 of this chapter.]

[(11)] (9)Assisted Living Program.

(a) “Assisted living program” means a residential or facility-based program that provides housing and supportive services, supervision, personalized assistance, health-related services, or a combination of these services to meet the needs of individuals who are unable to perform, or who need assistance in performing, the activities of daily living or instrumental activities of daily living, in a way that promotes optimum dignity and independence for the individuals.

(b) “Assisted living program” does not include:

(i) A nursing home, as defined under Health-General Article, §19-301, Annotated Code of Maryland;

(ii) A State facility, as defined under Health-General Article, §10-101, Annotated Code of Maryland;

(iii) A program licensed or approved by the Department under Health-General Article, Title 7 or Title 10, Annotated Code of Maryland;

(iv) A hospice care program licensed by the Department under Health-General Article, Title 19, Annotated Code of Maryland;

(v) Services provided by family members;

(vi) Services provided by a licensed residential service agency or licensed home health agency in an individual’s own home; or

(vii) A Certified Adult Residential Environment Program that is certified by the Department of Human Resources under Article 88A, §140, Annotated Code of Maryland.

[(12)] (10)“Authorized prescriber” means an individual who is authorized to prescribe medications under Health Occupations Article, Annotated Code of Maryland.

[(13)] (11)“Background check” means a check of court and other records by a private agency.

[(14)] (12) “Bank” means a bank, trust company, savings bank, savings and loan association, or financial institution that is:

(a) Authorized to do business in this State; and

(b) Insured by the Federal Deposit Insurance Corporation.

(13) “Case management” means the delegating nurse or case manager’s collaborative process of assessment, planning, implementation, evaluation, coordination, and monitoring of services to meet the physical, functional, and psychosocial needs or an individual.

[(15)] (14) “Certified medication technician” means an individual who is certified as a medication technician by the Maryland Board of Nursing under COMAR

[(16)] (15) “Chemical restraint” means the administration of drugs with the intent of significantly curtailing the normal mobility or normal physical activity of a resident in order to protect the resident from injuring the resident or others.

[(17)] (16) Cognitive Impairment.

(a) “Cognitive impairment” means the loss of those thought processes that orchestrate relatively simple ideas, movements, or actions into goal-directed behavior.

(b) “Cognitive impairment” includes lack of judgment, planning, organization, self-control, and the persistence needed to manage normal demands of the individual’s environment.

[(18)] (17) “Common-use telephone” means a telephone:

(a) That is within the facility;

(b) That is accessible to residents;

(c) That is located so that residents can have private conversations; and

(d) With which residents can make local calls free of charge.

[(19)] (18) “Contact isolation” means the creation of barriers and other protection such as gloves, masks, or gowns to prevent the spread of infection by close or direct contact between an infected individual and others.

(19) “Controlled Dangerous Substance (CDS)” means a drug or substance listed in Schedule I through Schedule V as defined in Criminal Law Article, §5-101, Annotated Code of Maryland.

(20) “Criminal history records check” means a check of criminal history information, as defined in Criminal Procedure Article, §10-201, Annotated Code of Maryland, by the Department of Public Safety and Correctional Services.

(21) “Delegating nurse” means a registered nurse who:

(a) Is licensed to practice registered nursing in this State as defined in Health Occupations Article, Title 10, Annotated Code of Maryland; [and]

(b) Has successfully completed the Board of Nursing’s approved training program for registered nurses, delegating nurses, and case managers in assisted living[.] ;

(c) Provides nursing oversight and case management to assure resident clinical needs are met;

(d) Provides delegation, supervision, and on-site instruction and guidance to certified nursing assistants, certified medication technicians, and unlicensed direct care staff; and

(e) Appropriately assigns nursing tasks to other licensed nursing staff.

(22) “Delegation of nursing tasks” means the formal process approved by the Maryland Board of Nursing which permits professional nurses to assign nursing tasks to other individuals if the registered nurse:

(a) Provides proper training, supervision, and monitoring; and

(b) Retains responsibility for the nursing tasks.

(23) “Department” means the Department of Health and Mental Hygiene.

(24) “Discharge” means releasing a resident from an assisted living program, after which the releasing program no longer is responsible for the resident’s care.

(25) “Emergency admission” means the temporary admittance of an individual in an assisted living program when the individual’s health and safety would be jeopardized by not permitting immediate admittance.

(26) “Facility” means the physical plant in which an assisted living program is operated.

(27) Facilitating Access.

(a)  “Facilitating access” means:

(b) “Facilitating access” does not mean guaranteeing payment for services that:

(i) Are not covered by the resident agreement; or

(ii) Cannot be paid for by the resident or the resident’s [agent] representative.

(28) “Family council” means a group of individuals who work together to protect the rights of and improve the quality of life of residents of an assisted living program.

(29) “Financial exploitation” means the misappropriation of a resident’s assets or income, including spending the resident’s assets or income:

(a) Against the will of or without the consent of the resident or the resident’s [agent] representative; or

(b) For the use and benefit of a person other than the resident, if the resident or [agent] representative has not consented to the expenditure.

(30) “Frequent” means occurring or appearing quite often or at close intervals, but not continuously.

(31) “Health care practitioner” means an individual who provides health care services and is licensed under Health Occupations Article, Annotated Code of Maryland.

(32) “Health condition” means the status of a resident’s physical, mental, and psychosocial well-being.

(33) “Home health services” means those services provided under the provisions of Health-General Article, [§19-404, Annotated Code of Maryland, and COMAR 10.07.10] §19-401 and §19-4A-01.

(34) “Household member” means an individual living in an assisted living facility who is not a resident or staff member.

(35) “Incident” means:

(a) The death of a resident from other than natural causes;

(b) The disappearance or elopement of a resident;

(c) An assault on a resident resulting in injury;

(d) An injury to a resident which may require treatment by a health care practitioner, or an event such as a fall which could subsequently require treatment;

(e) Abuse of a resident;

(f) An error or omission in medication or treatment which may result in harm to the resident; or

(g) An emergency situation or natural disaster.

(36) “Informal dispute resolution (IDR)” means an informal process that provides a licensee the opportunity to question the Department about deficiencies cited on a recent inspection.

(37) “Instrumental activities of daily living” means home management skills, such as shopping for food and personal items, preparing meals, or handling money.

(38) “Intensive” means highly concentrated.

[(39) “Intermittent nursing care” means nursing care which is provided episodically, irregularly, or for a limited time period.]

(39) “Interim medication” means medication stored at the assisted living facility with the intention of expediting immediate initiation of emergency or nonemergency dosing until the pharmacy is able to provide a regular supply.

(40)  Involuntary Seclusion.

(a) “Involuntary seclusion” means the separation of a resident from others or from the resident’s room against the resident’s will or the will of the resident’s representative.

(b) “Involuntary seclusion” does not mean separating a resident from other residents on a temporary and monitored basis.

[(41) “Lavatory” means a basin used to maintain personal cleanliness that has hot and cold running water and sanitary drainage.]

[(42)] (41) “Law enforcement agency” means the Maryland State Police or a police agency of a county or municipal corporation.

[(43)] (42) “License” means a document issued by the Secretary to operate an assisted living program in Maryland.

[(44)] (43) “Licensed pharmacist” means an individual who is authorized to practice pharmacy under Health Occupations Article, Title 12, Annotated Code of Maryland.

[(45)] (44)“Licensee” means the person, association, partnership, or corporation to whom a license is issued.

[(46)] (45) “Management firm” means an organization, under contract with an applicant for a license or a current licensee, that is intended to have or has full responsibility and control over the day-to-day operations of the assisted living program.

(46) “Manager” means the individual who is:

  1. Designated by the licensee to oversee the day-to-day operation of the assisted living program; and

(b) Responsible for the duties set forth in Regulation .15 of this chapter.

(47) “Medical Orders for Life-Sustaining Treatment (MOLST) form” means the form required to be developed pursuant to Health General Article, §5-608.1, Annotated Code of Maryland.

[(47)] (48)—[(50)] (51)

(52) “Nursing assessment” means an assessment completed by a registered nurse that:

(a) Is comprehensive, systematic, and ongoing;

(b) Is the foundation for the analysis of data to determine:

(i) Nursing diagnoses;

(ii) Expected resident outcomes; and

(iii) The resident plan of care;

(c) Includes but is not limited to:

(i) Extensive initial and ongoing collection of resident data;

(ii) Past history, current health status, and potential changes to the resident’s condition;

(iii) Identification of alterations to the resident’s previous condition; and

(iv) Synthesis of biological, psychological, spiritual, and social aspects of the resident’s condition.

[(51)] (53)  Nursing [Overview] Oversight.

(a) “Nursing [overview] oversight” means a process by which a registered nurse assures that the health and psychosocial needs of the resident are met.

(b) “Nursing [overview] oversight” includes:

(i) Observation;

(ii) Assessment;

(iii) Staff education; and

(iv) The development, implementation, and evaluation of a resident’s service plan.

[(52)] (54)  “Occasional” means occurring from time to time, on an infrequent or irregular basis, with no particular pattern.

[(53)] (55)“Office of Health Care Quality (OHCQ)” means the Office of Health Care Quality of the Department of Health and Mental Hygiene.

[(54)] (56) “Ongoing” means continuing over an extended period of time.

(57) “Permanent intravenous access device” means an access device that is not temporary in nature and is secured in place by means such as suturing or implantation under the skin.

[(55)] (58) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.

(59) “Personal care services” means the range of assistance needed by a resident to complete activities of daily living.

[(56)] (60)  “Personal representative” means an individual appointed by the court with the duties and authority to settle and distribute the estate of the decedent.

[(57)] (61) “Physical abuse” means the sustaining of any physical injury or pain to a resident as a result of cruel or inhumane treatment, or as a result of a malicious act by any individual.

[(58)] (62) Physical Restraint.

(a) “Physical restraint” means the use of a device or physical action to prevent, suppress, or control head, body, or limb movement, that cannot be readily and easily removed by the resident.

(b) “Physical restraint” does not mean a protective device as defined in this regulation.

[(59)] (63)  “Plan of correction” means a written response from the assisted living program that addresses each deficiency cited as a result of an inspection by the Department.

(64) “Program” means an assisted living program.

[(60)] (65) “Protective device” means any device or equipment, except bedside rails:

(a) That:

(i) Shields a resident from self-injury;

(ii) Prevents a resident from aggravating an existing physical problem; or

(iii) Prevents a resident from precipitating a potential physical problem;

(b) That may limit but does not eliminate, the movement of the resident’s head, body, or limbs; and

(c) That is prescribed by a physician.

[(61)] (66)  “Quality assurance” means a system for maintaining professionally acceptable standards of care by:

(a) Identifying opportunities to improve;

(b) Studying problems if any, and their root causes; and

(c) Implementing and monitoring interventions to ensure the intended improvement is achieved and sustained.

[(62)] (67) “Relief personnel” means qualified individuals who have been hired to substitute for staff members:

(a) In emergency situations; or

(b) When the [assisted living] manager or other staff is absent from the program for extended hours.

[(63)] (68) “Representative” means a person referenced in Regulation [.34] .30 of this chapter.

[(64)] (69)  “Resident” means an individual 18 years old or older who requires assisted living services.

[(65)] (70)  “Resident agreement” means a document signed by both the resident or the resident’s agent and the assisted living manager, or designee, stating the terms that the parties agree to, including, at a minimum, the provisions set forth in Regulations [.24] .20 and [.25] .21 of this chapter.

[(66)] (71)  “Resident Assessment Tool” means:

(a)  Maryland’s Assisted Living Resident Assessment [and Level of Care Scoring] Tool [(DHMH Form 4506)] that is:

[(a)] (i)  Incorporated by reference in Regulation .03 of this chapter; and

[(b)] (ii)  Used by assisted living facilities to assess the current health, physical, and psychosocial status of prospective and current residents.

(b) Does not include or replace a nursing assessment.

[(67)] (72)  Restraint.

(a) “Restraint” means any chemical restraint or physical restraint as defined in §B(16) and (58) of this regulation.

(b) “Restraint” does not include a protective device.

[(68)] (73)  “Sanction” means a disciplinary penalty imposed for a violation of statutes or regulations relating to the operation of an assisted living program, including but not limited to, those penalties referenced in Regulations [.56, .57, .60, .62, and .63] .51, .52, .55, .57 and .58 of this chapter.

[(69)] (74) “Secretary” means the Secretary of Health and Mental Hygiene, or the Secretary’s designee.

[(70)] (75) “Self-administration of medication” means a resident having the cognitive and physical ability to take medication as prescribed by an authorized prescriber:

(a) At the correct time;

(b) By the correct route; and

(c) In the correct dosage.

 [(71) “Service plan” means a written plan developed by the licensee, in conjunction with the resident and the resident’s representative, if appropriate, which identifies, among other things, services that the licensee will provide to the resident based upon the resident’s needs as determined by the Resident Assessment Tool.]

(76) “Service plan” means a written plan incorporated by reference in Regulation .03 of this chapter that is developed by the licensee, in conjunction with the resident or resident’s representative based upon the resident’s needs as determined by the:

(a) Resident Assessment Tool: and

(b) Nursing Assessment.

[(72)] (77) Sexual abuse” means a crime listed in Criminal Law Article, Title 3, Subtitle 3, Annotated Code of Maryland.

[(73)] (78) “Short-term residential care” means a stay[, either continuous or intermittent,] in an assisted living program of not more than 30 consecutive days from the date of initial admission[, which cannot exceed 30 days per year].

[(74)] (79) Significant Change of Condition.

(a) “Significant change of condition” means a shift in a resident’s health, functional, or psychosocial conditions that either causes an improvement or deterioration in a resident’s condition as described in Appendix A of the Resident Assessment Tool.

(b) “Significant change of condition” does not include any ordinary, day-to-day fluctuations in health status, function, or behavior, or an acute short-term illness, such as a cold, unless these fluctuations continue to recur.

[(75)] (80) “Staff” means supervisors, assistants, aides, or other employees, including independent contractors retained by an assisted living program, to provide the care and services required by this chapter.

(81) “Stage four pressure ulcer” means a localized injury to the skin and underlying tissue, as a result of pressure, which involves full-thickness tissue loss with exposed bone, tendon or muscle, which often includes undermining and tunneling, and may include slough or eschar on some parts of the wound bed.

(82) “Stage three pressure ulcer” means a localized injury to the skin and underlying tissue, as a result of pressure, which involves full-thickness tissue loss that does not expose bone, tendon or muscle and may include undermining, tunneling, and slough which does not obscure the depth of tissue loss.

[(76)] (83) “Substantial” means considerable in importance, degree, amount, frequency, or extent.

[(77)]  (84)  “Treatment” means medical or psychological management to cure or improve a disease or condition.

[(78) “Unclaimed deceased resident” means a resident of an assisted living program:

(a) Who has not prearranged and prepaid for the disposal of the resident’s body; or

(b) For whom no individual has claimed the body and assumed funeral or burial responsibility.]

[(79)] (85) “Verbal abuse” means the use of any oral or gestured language that includes disparaging or derogatory terms, which is directed to a resident, or within a resident’s hearing distance, regardless of the resident’s age, ability to comprehend, or disability