Department of Health and Social Services

Division of Long Term Care Residents Protection

PROPOSED

PUBLIC NOTICE

3320 Intensive Behavioral Support and Educational Residences (IBSER)

In compliance with the State's Administrative Procedures Act (APA - Title 29, Chapter 101 of the Delaware Code) and under the authority of Title 29 of the Delaware Code, Section 7971(d)(1), Delaware Health and Social Services (DHSS) / Division of Long Term Care Residents Protection is proposing the creation of Regulation 3320, Intensive Behavioral Support and Educational Residences (IBSER) to regulate facilities within this new licensure category.

Any person who wishes to make written suggestions, compilations of data, testimony, briefs or other written materials concerning the proposed new regulations must submit same to Susan Del Pesco, Director, DHSS, Division of Long Term Care Residents Protection, 3 Mill Rd, Suite 308, Wilmington, DE 19806 by December 1, 2011.

The action concerning the determination of whether to adopt the proposed regulation will be based upon the results of Department and Division staff analysis and the consideration of the comments and written materials filed by other interested persons.

SUMMARY OF PROPOSED CHANGES

This regulatory proposal creates regulations for various aspects and business practices of these facilities as listed below:

Statutory Authority

29 Del.C. §7971(d)(1), Duties and functions of the Division

3320 Intensive Behavioral Support and Educational Residence

Intensive Behavioral Support and Educational Residence (IBSER) regulations apply to individuals who are 18 years of age and older, with autism, developmental disabilities, dual diagnoses of severe mental or emotional disturbances and who have specialized behavioral needs. These regulations establish the minimal acceptable level of living and programmatic conditions for such individuals.

“AWSAM” means assistance with medications as defined in 25 Del.C. §1902(c).

“Behavior Management Committee” (BMC) is the committee that establishes and reviews each resident’s Specialized Behavior Support Plan (SBS Plan) as described in §16.2 of these regulations.

“Comprehensive behavior support plan” means a written document, designed by the individual, his or her family, and his or her education, habilitation or treatment team, and includes the elements described in §19.1.2 of these regulations.

“Chemical restraint" means the use of any medication that is used for discipline or convenience to effect control over an individual's behavior, is not part of the individual's usual medication regimen, and is not required to treat a medical symptom, i.e. a physical or psychological condition.

“Director” means the Chief Operating Officer of the IBSER.

“Division” means the Division of Long Term Care Residents Protection, Department of Health and Social Services.

“Funding Agency” – means is a governmental or private agency that provides funding for the support and treatment of residents in the IBSER’s care.

“Human Rights Committee” (HRC) means an advisory committee established as a mechanism for the protection of rights and welfare of persons receiving services from the facility.

“Incident” means an occurrence or event, a record of which must be maintained in facility files, which includes all reportable incidents and the additional occurrences or events listed in section 23.0 of these regulations.

“Legal Representative” includes payor source, guardian or surrogate.

“Medical Protective Equipment” means health-related protective devices prescribed by a physician or dentist for use only during and after specific medical or surgical procedures, or for use as protection in response to an existing medical condition.

Medical Protective Equipment includes:

Physical equipment or orthopedic appliances or other restraints necessary for medical treatment, routine physical examinations, or medical tests,

Devices used to support functional body position or proper balance, or to prevent a person from falling out of bed, falling from a wheelchair; or

Equipment used for safety such as seatbelts, helmets, mittens, wheelchair tie-downs or other types of devices.

”Reportable Incident” means an occurrence or event which must be reported immediately to the Division and for which there is reasonable cause to believe that a resident has been abused, neglected, mistreated or subjected to financial exploitation or misappropriation of their property as those terms are defined in 16 Del.C. §1131. Reportable incident also includes an occurrence or event listed in §23.4 of these regulations.

“Resident” is the individual residing in the IBSER and subject to IBSER regulation.

“Restraint” is any manual method, physical, or mechanical device, material, or equipment attached or adjacent to the resident's body that the resident cannot remove easily which restricts freedom of movement or normal access to one's body. Restraints include, but are not limited to, wrap mats, standing basket holds, leg restraints, arm restraints, hand mitts, soft ties or vests, side rails, lap cushions, and lap trays that the resident cannot easily remove. Also included is the use of Velcro to hold a sheet, fabric or clothing so tightly that the resident’s movement is restricted and any use of equipment or furniture positioning that likewise prevents the resident from rising voluntarily. The following are prohibited: a prone (face down) restraint of any kind and a seated basket hold.

“Seclusion” means the separation of an individual from others in a locked room. The use of seclusion is expressly prohibited.

“Specialized Behavior Support Plan” (SBS Plan) is a written document, the consent to which must be provided in writing by the resident, his or her guardian or surrogate. The SBS Plan must confirm that restraint protocols have been reviewed. The SBS Plan may be supplemented by a Comprehensive Behavior Support Plan when appropriate.

3.1 When a facility is licensed under this law or regulation and plans to construct, extensively remodel or convert any buildings, one (1) copy of property prepared plans and specifications for the entire facility are to be submitted to the Division. An approval in writing is to be obtained before such work is begun. After the work is completed, in accordance with the plans and specifications, a new license to operate will be issued.

3.2 Separate licenses are required for facilities at separate locations, even though operated under the same management. A separate license is not required for separate buildings maintained at the same location by the same management. A change in ownership necessitates a new application and a new license.

3.3 Inspections

3.3.1 Every residence for which a license has been issued under this chapter shall be periodically inspected by a representative of the Division. Inspections shall include the review of current facility policies and procedures. Inspections must be unannounced.

3.3.2 Each Licensed facility must submit to the Division quarterly reports on each of its residents. The quarterly reports prepared for the funding agency supporting each resident must meet this reporting requirement unless otherwise informed by the Division that additional information is required.

3.4 Licenses shall be issued in the following categories:

3.4.1 Annual License. An annual license (12 months) may be renewed yearly if the holder is in full compliance with the provisions of 16 Del.C., Ch. 11 and the rules and regulations of the Department of Health and Social Services.

3.4.2 Provisional License. A provisional license shall be granted for a term of ninety (90) days only, and shall be granted to a facility during its first 90 days of operation. A provisional license may also be granted to a facility, which although not in full compliance, is nevertheless demonstrating evidence of improvement.

4.1 All required records maintained by the residence must be open to inspection by the authorized representatives of the Division.

4.2 The term "Intensive Behavioral Support Educational Residence" must not be used as part of the name of any facility in this State, unless it has been so classified and licensed by the Department of Health and Social Services.

4.3 No rules may be adopted by the licensee or administrators which are in conflict with these regulations.

4.4 The Division must be notified, in writing, within 10 days of any change in the Director.

4.5 The residence must establish and follow written policies and procedures regarding the rights and responsibilities of the residents, and these policies and procedures are to be made available to sponsoring agencies, and authorized representatives of the Division.

4.6 The facility must provide safe storage for residents' valuables.

4.7 The provider must assure emergency transportation and care through use of appropriate transfer agreements with local medical facilities.

4.8 All residents must be afforded all protections and privileges contained in the Delaware Patient’s Bill of Rights.

4.9 The facility must cooperate fully with the state protection and advocacy agency, as defined in 16 Del.C. §1107.

5.1 Premises and Equipment

5.1.1 A licensee must ensure that the facility’s or program’s premises and equipment accessible to or used by residents are free from any danger to their health, safety and well-being.

5.1.2 A licensee must maintain on file written documentation that the buildings and premises of the facility or program conform to all applicable federal, State and local zoning fire, health, education, and construction laws, ordinances and regulations.

5.1.3 A licensee must ensure that porches, elevated walkways and elevated areas of more than two feet in height have barriers that meet all regulatory standards to prevent falls.

5.1.4 A licensee must ensure that all indoor and outdoor areas, toilets, wash basins, tubs, sinks, and showers are maintained in an operable, safe and sanitary manner. Showers and tubs must have a handrail or a handgrip.

5.1.5 A licensee must utilize approved products and procedures in accordance with labeled instructions to ensure that the premises are protected from insect infestation.

5.1.6 A licensee must ensure that all premises used by residents are rodent-free.

5.1.7 Living Unit Space

5.1.7.1 No residence may house more than 16 residents—regardless of whether the residents are subject to IBSER or to DelaCare regulations. A facility must ensure that the living unit(s) have designated space for daily living activities, including dining, recreation, indoor activities and areas where residents may visit privately with their parent(s), legal guardian, relatives and friends.

5.1.7.2 A facility must ensure that a dining area is provided which must be maintained in a clean manner, be well-lighted and ventilated. The licensee must ensure that dining room tables and chairs or benches are sturdy and appropriate for the sizes and ages and capabilities of the residents.

5.1.8 Furnishings and Maintenance

5.1.8.1 A licensee must ensure that buildings are furnished with comfortable, clean furniture in good repair and appropriate to the age, size and capabilities of the residents.

5.1.8.2 A licensee must ensure that the premises are maintained and cleaned in a scheduled or routine manner.

5.1.8.3 A licensee must ensure that all cleaning equipment, including mops and buckets, are cleaned and stored in an area separate and distinct from the kitchen and food preparation, serving and storage areas. Kitchen and bathroom sinks must not be utilized for cleaning mops, emptying mop buckets. Kitchen sinks must not be used for any purpose not connected with food preparation or the cleaning of dishes, pots, pans and utensils.

5.1.8.4 A facility licensed to care for 13 or more residents must have a service sink.

5.1.9 Storage

5.1.9.1 A licensee must provide areas with sufficient space for storing all supplies and equipment in a safe and sanitary manner.

5.1.9.2 A licensee must ensure that all poisonous and toxic materials are stored in accordance with the following:

5.1.9.2.1 All poisonous and toxic materials must be prominently and distinctly labeled for easy identification as to contents;

5.1.9.2.2 All poisonous and toxic materials must be stored so as to not contaminate food or constitute a hazard to residents, employees and volunteers;

5.1.9.2.3 All poisonous and toxic materials must be stored in a secure and locked room with access only by authorized employees.

5.1.9.2.4 Flammable liquids, gasoline, or kerosene may not be stored on the premises except in a manner and place that has been authorized in writing by the Office of the Fire Marshal.

5.2 Toilet and Bathing

5.2.1 A facility must ensure that there are toilet and bathing accommodations that meet the following specifications:

5.2.1.1 For every eight residents, there must be at least one flush toilet, wash basin, and bathtub or shower;

5.2.1.2 These toileting and bathing facilities must not be located more than one floor from any bedroom; and

5.2.1.3 Bathrooms must have at least one unbreakable mirror fastened to the wall at an age appropriate height.

5.2.2 A licensee must ensure that toilets, showers, sinks, and bathing facilities and other are provided for residents and:

5.2.2.1 Allow for privacy unless this privacy is in conflict with toilet training or needed supervision; and

5.2.2.2 Are maintained in a safe and sanitary manner.

5.2.3 A licensee must ensure that bathroom surfaces subject to splash are cleanable and impervious to water.

5.2.4 A licensee must ensure that bathroom floors, showers, and bathtubs have slip-proof surfaces. Glass shower doors must be marked for safety.

5.2.5 A licensee must ensure that bathrooms are equipped with operable windows or mechanical ventilation systems to the outside.

5.3 Bedroom Accommodations

5.3.1 A facility must ensure that any bedroom used by residents includes:

5.3.1.1 A designated area for sleeping;

5.3.1.2 A floor area of at least 70 square feet in a single-occupancy bedroom and at least 50 square feet per person in a multiple-occupancy bedroom, excluding closet space;

5.3.1.3 Sufficient space for beds to be at least three feet apart at the head, foot, and sides. Bunk beds must be at least five feet apart at the head, foot and sides;

5.3.1.3.1 No more than four residents for sleeping per room;

5.3.1.3.2 A door that may be closed;

5.3.1.3.3 A direct source of natural light;

5.3.1.3.4 A window covering to ensure privacy; and

5.3.1.3.5 Lights with safety covers or shields.

5.3.2 A facility must ensure that each resident is provided with:

5.3.2.1 A bed;

5.3.2.2 A cleanable, fire retarding mattress with mattress cover;

5.3.2.3 Clean bed linens at least every seven calendar days or more often if needed;

5.3.2.4 A pillow; and

5.3.2.5 Blanket(s) appropriate for season and weather.

5.3.3 A facility may use cots or portable beds in an emergency only and for no longer than a period of 72 hours.

5.3.4 A facility must ensure that there are no more than two tiers when bunk beds are used. In addition, the facility must ensure that the distance between the top bunk mattress and ceiling is of sufficient height to enable the resident to sit upright in bed without his or her head touching the ceiling.

5.3.5 Unless clinically contraindicated, a facility must provide and locate in the bedroom for each resident a chest of drawers, a bureau, or other bedroom furniture for the storage of clothing and other personal belongings.

5.3.6 A facility may not permit a resident to share the same bed with any other resident.

5.3.7 A facility must ensure that residents occupy a bedroom only with members of the same sex.

5.4 Water Supply and Sewage Disposal

5.4.1 A licensee must maintain on file written documentation that the building’s water supply and sewage disposal system are in compliance with applicable State laws and regulations of the Delaware Division of Public Health and the Delaware Department of Natural Resources and Environmental Control, respectively.

5.4.2 A licensee must ensure that hot tap water does not exceed 115 degrees Fahrenheit at all outlets accessible to residents, and that cold or tempered water are also provided.

5.5 Garbage and Refuse

5.5.1 A licensee must ensure that:

5.5.1.1 Garbage is stored outside in watertight containers with tight-fitting covers that are insect and rodent proof;

5.5.1.2 Garbage and refuse are removed from the premises at intervals of at least once a week; and

5.5.1.3 Garbage and refuse are contained in an area that is separate from any outdoor recreation areas.

5.6 Lighting

5.6.1 A licensee must ensure that kitchens and all rooms used by residents, including bedrooms, dining rooms, recreation rooms and classrooms, are suitably lighted for safety and comfort, with a minimum of 30 foot candles of light. All other areas must have a minimum of 10 foot candles of light.

5.6.2 A licensee must ensure that all lights located over, by or within food preparation, serving and storage areas have safety shields or light covers.

5.6.3 A licensee must ensure that all corridors are illuminated during night-time hours.

5.6.4 During night-time hours, a licensee must provide for exterior lighting of the building(s), parking areas, pedestrian walkways or other premises subject to use by residents, visitors, employees and volunteers.

5.7 Heating

5.7.1 A licensee must ensure that a minimum temperature of 68 degrees Fahrenheit is maintained at floor level in all rooms occupied by residents.

5.7.2 A licensee must ensure that all working fireplaces, pipes, and electric space heaters accessible to residents are protected by screens, guards, insulation or any other suitable, non-combustible protective device. All radiators accessible to residents must be protected by screens, guards, insulation or any other suitable, non-combustible protective device.

5.7.3 Portable fuel burning or wood burning heating appliances are prohibited.

5.8 Ventilation

5.8.1 A licensee must ensure that each habitable room has direct outside ventilation by means of windows, louvers, air conditioning or mechanical ventilation.

5.8.2 A licensee must ensure that:

5.8.2.1 Each door, operable window and other opening to the outside is equipped with insect screening in good repair and not less than 16 mesh to the inch, unless the facility is air conditioned and provided that it does not conflict with applicable fire safety requirements; and

5.8.2.2 This screening can be readily removed in emergencies.

5.8.3 A licensee must ensure that ventilation outlets are maintained in a clean and sanitary manner, and kept free from obstructions.

5.8.4 A licensee must ensure that all floor or window fans accessible to residents have a protective grill, screen or other protective covering.

5.9 Access to Telephone

5.9.1 A licensee must ensure that each building used by residents has at least one working telephone that is directly available for immediate access or that is connected to an operating central telephone system.

5.9.2 A licensee must ensure that the licensee’s telephone number is clearly posted and available to residents, their parent(s) or legal guardian, and the general public.

5.9.3 A licensee must provide residents in care reasonable access to a free telephone that has statewide access and has processes in place for free calls to other states.

5.9.4 A licensee must provide residents reasonable privacy for telephone use.

6.1 A licensee must ensure that kitchens are provided with the necessary operable equipment for the preparation, storage, serving and clean-up of all meals for all of the residents and employees regularly served by such kitchens. A licensee that does not prepare food on the premises and that utilizes single-service (disposable) dishes, pots, pans and utensils is not governed by this Requirement.

6.2 A licensee must ensure that a kitchen or food preparation area has a hand washing sink within the food preparation area and separate from the sink used for food preparation and dish washing.

6.3 A licensee must ensure that:

6.3.1 A mechanical dishwasher is used for the cleaning and sanitizing of all dishes, pots, pans and utensils after each meal; and

6.3.2 The dishwasher is capable of sanitizing at the proper time, temperature and pressure ratio, and those dishes, pots, pans and utensils are washed in accordance with the manufacturer’s instructions. Dishwasher temperatures must be checked periodically and documented.

6.4 A licensee must ensure that all food service equipment and utensils are constructed of material that is nontoxic, easily cleanable and maintained in good repair.

6.5 A licensee must ensure that all food services equipment, eating and drinking utensils, counter-tops and other food contact areas are thoroughly cleaned and sanitized after each use.

6.6 A licensee must ensure that the floor, walls and counter-top surfaces of the kitchen are made of cleanable materials and impervious to water to the level of splash.

6.7 A licensee must ensure that the kitchen has a cook stove and oven with an appropriately vented hood that is maintained in a safe and operable condition in accordance with fire and safety regulations.

6.8 A licensee must ensure that the kitchen is so constructed or supervised as to limit access by residents when necessary.

6.9 A licensee must ensure that food preparation areas and appliances, dishes, pots, pans, and utensils in which food was prepared or served are cleaned following each meal.

6.10 A licensee must ensure that all foods subject to spoilage are stored at temperatures that will protect against spoilage. This means that:

6.10.1 All refrigerated foods are to be kept cold at 41 degrees Fahrenheit or below.

6.10.2 All frozen foods are to be kept at 0 degrees Fahrenheit or below.

6.10.3 All hot foods are to be kept at 140 degrees Fahrenheit or above, except during periods that are necessary for preparation and serving. Refrigerators and freezers must be equipped with accurate, easily readable thermometers located in the warmest part of the refrigerator or freezer.

6.10.4 There must be three days’ supply of food in each facility at all times as posted on the menus.

6.10.5 Opened foods that are to be stored must immediately be dated with the date that the foods were opened.

6.11 A licensee must ensure that:

6.11.1 All food storage areas are clean, dry and free of food particles, dust and dirt;

6.11.2 All packaged food items and can goods are stored at least six inches above the floor in sealed or closed containers that are labeled;

6.11.3 All dishes, pots, pans and utensils are stored in a clean and dry place; and

6.11.4 All paper goods are stored at least six inches above the floor.

7.1 Fire safety in Facilities must comply with the rules and regulations of the State Fire Prevention Commission or the appropriate local jurisdiction. All applications for a license or renewal of a license must include a letter certifying compliance by the Fire Marshal with jurisdiction. Notification of non-compliance with the applicable rules and regulations must be grounds for revocation of a license.

7.2 The facility must have a minimum of two means of egress.

7.3 The facility must have an adequate number of UL approved smoke detectors in working order.

7.3.1 In a single level facility, a minimum of one smoke detector must be placed between the bedroom area and the remainder of the facility.

7.3.2 In a multi-story facility, a minimum of one smoke detector must be on each level. On levels which have bedrooms, the detector must be placed between the bedroom area and the remainder of the facility.

7.4 There must be at least one functional two and one-half to five pound ABC fire extinguisher on each floor of living space in the facility that is readily accessible to staff. Inspections shall be completed by the service company or as regulated by the Fire Marshal. Each extinguisher must be checked annually.

7.5 Evacuation Drills

7.5.1 A licensee must conduct at least four emergency evacuation drills annually and maintain on file a record of each drill. Two of these drills must include evacuations, unless the Division, in writing, has determined that an evacuation is clinically contraindicated. Where a licensee utilizes two or more employee shifts, there must be at least four emergency evacuation drills conducted annually for each shift.

7.5.2 Emergency evacuation drills must include all persons on the premises, including employees, volunteers, residents and visitors.

7.5.3 The location of egress during these evacuation drills must be varied, with window evacuation procedures discussed as an alternative, if not practiced.

7.5.4 During drills, persons must be evacuated with staff assistance to the designated safe area outside of the facility.

7.5.5 As evidenced by evacuation drill reports that are maintained by the Facility, drills must assure that all persons and staff are familiar with the evacuation requirements and procedures. Any problems persons have evacuating a building during a drill must result in a written plan of specific corrective action(s) to be taken.

7.5.6 Persons who are unable to achieve the exit schedule prescribed by the Life/Safety Code with available assistance must be either relocated or provided with additional assistance.

7.6 Emergency Procedures

7.6.1 A licensee must develop, adopt, follow and maintain on file written policies and procedures governing the handling of emergencies, including:

7.6.1.1 Accident;

7.6.1.2 Bomb threat;

7.6.1.3 Fire;

7.6.1.4 Flooding;

7.6.1.5 Medical;

7.6.1.6 Missing resident, including referral to Gold Alert Program;

7.6.1.7 Power outage;

7.6.1.8 Severe weather conditions;

7.6.1.9 Radiation, if within a 10-mile radius of a nuclear reactor.

7.6.2 The policies and procedures must include:

7.6.2.1 An emergency evacuation plan;

7.6.2.2 Instructions and telephone numbers for contacting ambulance, emergency medical response team, fire, hospital, poison control center, police, and other emergency services;

7.6.2.3 Location and use of first aid kits; and

7.6.2.4 Roster and telephone numbers of employees to be contacted during an emergency.

7.6.3 A licensee must ensure that each newly admitted resident is provided an orientation regarding emergency procedures and the location of all exits within 48 hours of admission.

7.6.4 The procedures must contain instructions related to the use of alarm and signal systems. Provisions must be made to alert persons living in the facility according to their abilities, and these provisions must be included in the procedures.

7.6.5 Evacuation routes and the location of fire-fighting equipment must be posted in areas used by the public as required by the applicable fire safety regulations. The number and placement of postings are otherwise dictated by building use and configuration and by the needs of persons and staff.

7.6.6 The provider must maintain an adequate communication system to ensure that on and off-duty personnel and local fire and safety authorities are notified promptly in the event of an emergency or disaster.

7.6.7 The telephone numbers of the nearest poison control center and the nearest source of emergency medical services must be posted.

7.6.8 Provisions must be made for emergency auxiliary heat and lighting by means of alternate sources of electric power, alternate fuels, and stand-by equipment, or arrangements with neighbors, other agencies or community resources.

7.6.9 A licensee must prohibit the storage or use of any firearms or other weapons on the grounds of the facility or program or in any building used by residents.

8.1 Division Notification

8.1.1 A licensee must notify the Division in writing at least 90 consecutive calendar days before any of the following changes occur:

8.1.1.1 A change of ownership or sponsorship;

8.1.1.2 A change of location;

8.1.1.3 A change in the name of the facility or program;

8.1.1.4 A change in the applicable type of regulated service being provided;

8.1.1.5 A change in population capacity; or

8.1.1.6 The anticipated closing of the facility or program.

8.2 Governing Body

8.2.1 A licensee must have an identifiable functioning governing body. The governing body must designate a Director.

8.3 Director Responsibilities

8.3.1 A licensee must delineate in writing the job responsibilities and functions of the Director. The Director must adopt and implement a chain of command that ensures the proper and effective supervision and monitoring of employees and volunteers.

9.1 A licensee must develop, adopt, follow and maintain on file a current written description of the facility’s or programs:

9.1.1 Admission policies governing the specific characteristics, and treatment or service needs of residents accepted for care; and

9.1.2 Services provided to residents, including those provided directly by the licensee or arranged through another source.

9.2 A licensee must make available to the public a brochure or other generic written description of its mission, policies and the types of services offered by the facility or program.

10.1 A licensee must develop, adopt, follow and maintain on file on the premises written procedures governing the maintenance and security of resident records in care. These procedures must:

10.1.1 Assure that records are stored in a secure manner; and

10.1.2 Assure confidentiality of and prevent unauthorized access to such records.

10.2 Administrative Records

10.2.1 A licensee must develop, adopt, follow and maintain on file on the premises up-to-date administrative records containing the following:

10.2.1.1 Organizational chart;

10.2.1.2 Name and position of persons authorized to sign agreements and to submit official documentation to the appropriate government agency; and

10.2.1.3 Written standard operating procedures.

10.3 All records maintained by the facility must at all times be open to inspection and copying by authorized representatives of the Division as well as all other agencies as required by state and federal laws and regulations. Such records must be made available in accordance with 16 Del.C., Ch. 11, Subchapter I, Licensing by the State.

A licensee must secure and maintain on file written documentation of appropriate motor vehicle, fire and comprehensive general liability insurance, as required by State law(s) and regulations.

12.1 A licensee must develop, adopt, follow and maintain on file written personnel policies and procedures governing the recruitment, screening, hiring, supervision, training, evaluation, promotion, and disciplining of employees and volunteers.

12.2 Personnel; Qualifications

12.2.1 Director Qualifications

12.2.1.1 A Director, at the time of appointment, must be at least 21 years of age and must possess one of the following:

12.2.1.1.1 A master’s degree in social work, sociology, psychology, guidance and counseling, education, business administration, a human behavioral science, public administration or a related field from an accredited college, and three years of full-time work experience in human services or a related field, at least two years of which must have been in an administrative or supervisory capacity; or

12.2.1.1.2 A bachelor’s degree in social work, sociology, psychology, guidance and counseling, education, business administration, a human behavioral science, public administration or a related field from an accredited college, and four years of post-bachelor’s degree full-time work experience in human services or a related field, at least two years of which must have been in an administrative or supervisory capacity.

12.2.2 Direct Care Supervisor Qualifications

12.2.2.1 A direct care supervisor, at the time of appointment, must be at least 21 years of age and must possess at least one of the following:

12.2.2.1.1 A bachelor’s degree from an accredited college and one year of full-time work experience in a residential care facility or program;

12.2.2.1.2 An associate degree or a minimum of 48 credit hours from an accredited college and two years of full-time work experience in a residential care facility or program; or

12.2.2.1.3 A high school diploma or equivalent and three years of full-time work experience in a residential care facility or program.

12.2.3 Direct Care Worker Qualifications

12.2.3.1 A direct care worker, at the time of appointment, must be at least 21 years of age and must possess a high school diploma or an equivalent.

12.2.4 Service Supervisor Qualifications

12.2.4.1 A service supervisor, at the time of appointment, must be at least 21 years of age and must possess at least one of the following:

12.2.4.1.1 A master’s degree in social work, sociology, psychology, criminal justice, education, guidance and counseling, human behavioral science or a related field from an accredited college and at least two years of full-time work experience in social work, human services, teaching, counseling or a related field, at least one year of which must have been in a supervisory capacity; or

12.2.4.1.2 A bachelor’s degree in social work, sociology, psychology, criminal justice, education, guidance and counseling, human behavioral science or a related field from an accredited college and at least four years of full-time work experience in social work, human services, teaching, counseling or a related field, at least two years of which must have been in a supervisory capacity.

12.2.5 Service Worker Qualifications

12.2.5.1 A service worker, at the time of appointment, must be at least 21 years of age and must possess a bachelor’s degree from an accredited college in social work, sociology, psychology, criminal justice, education, guidance and counseling, a human behavioral science or a related field and at least two years of full-time work experience in human services, teaching, counseling or a related field.

12.3 Administrative Oversight and Supervisor-to-Staff Ratios

12.3.1 The Director must ensure that there is a sufficient number of administrative, supervisory, social service, educational, recreational, direct care, and support employees or volunteers to perform the functions prescribed by these requirements and to provide for the care, needs, protection and supervision of residents. The ratio of direct care workers to residents during off-grounds activities or excursions must be the same as the ratios of direct care workers to residents that are required during on-grounds activities.

12.4 A licensee must have either:

12.4.1 A full-time Director; or

12.4.2 If its licensed capacity is less than 13 residents, a part-time Director and a full-time service supervisor.

12.4.3 A licensee must ensure that a designated employee is in charge on the premises at all times when residents are present.

12.4.4 A licensee must have a ratio of one service supervisor for every ten service workers or fraction thereof. A full-time Director may also serve as the service supervisor when there are three or fewer service workers.

12.5 Minimum Staffing at all times

12.5.1 A minimum of one (1) direct care worker who meets the training requirements of Section 13.0 below must be on duty and on site whenever (1) to five (5) residents are present in the home.

12.5.2 A minimum of two (2) staff members who meet the training requirements of Section 13.0 below must be on duty and on site whenever six (6) or more residents are present in the home.

12.5.3 At all times, at least one (1) service worker must be available on call.

13.1 A licensee must ensure that all new employees and volunteers participate in an orientation that includes the purpose, policies and procedures of the facility or program, the employee’s role and responsibilities and the State’s requirements to report allegations of abuse, neglect, mistreatment and financial exploitation.

13.2 A licensee must ensure that each new employee, volunteer, or any current employee or volunteer whose job function changes, and whose primary role or function requires interaction with residents, receives at least 15 hours of planned training preceding the assumption of his or her work assignment on an independent basis. The training must include instruction in:

13.2.1 Carrying out job responsibilities;

13.2.2 The licensee’s purpose, policies and procedures, including those governing behavior management, crisis management and safety;

13.2.3 Emergency procedures and the location of emergency exits and emergency equipment, including first aid kits;

13.2.4 The role of employees and volunteers in client service delivery and the protection of residents;

13.2.5 The Delaware abuse, neglect, mistreatment and financial exploitation law(s) and regulations; and

13.2.6 The provisions of these licensing requirements.

This requirement must not apply to licensed professionals under contract with the licensee.

13.3 A licensee must ensure that each employee and volunteer whose primary role or function requires interaction with residents and who works 24 or more hours a week receives at least 40 hours of training annually, including the 15 hours of training provided pursuant to subsection 13.2. This training must cover subject matters designed to maintain, improve or enhance the employee’s knowledge of or skills in carrying out his or her job responsibilities, including:

13.3.1 Instruction in administering cardiopulmonary resuscitation (CPR) and first aid, including the location of first aid kits;

13.3.2 Cultural sensitivity; and

13.3.3 Behavior management policies and procedures.

13.4 A licensee must ensure that any employee or volunteer whose primary role or function requires interaction with residents and who works fewer than 24 hours a week receives at least 20 hours of training annually.

13.5 A licensee must maintain on file written materials documenting the delivery of orientation and training for all employees and volunteers.

14.1 A licensee must develop, adopt and maintain on file a personnel record for every employee and volunteer.

14.2 The personnel record must contain the following:

14.2.1 Employment application;

14.2.2 Name, current address and phone number of the employee;

14.2.3 Verification of education where specified by these requirements;

14.2.4 Documentation of training received prior to and during employment at the facility or program;

14.2.5 Work history;

14.2.6 Three references from persons who are unrelated to the employee or volunteer, one of which must be from any previous employer;

14.2.7 Any health verification including meeting the minimum requirements for pre-employment tuberculosis (TB) testing which requires all employees to have a base line two-step tuberculin skin test (TST) or single Interferon Gamma Release Assay (IGRA or TB blood test) such as QuantiFeron. Any required subsequent testing according to risk category shall be in accordance with the recommendations of the Centers for Disease Control and Prevention (CDC) of the U. S. Department of Health and Human Services. Should the category of risk change, which is determined by the Division of Public Health, the facility must comply with the recommendations of the CDC for the appropriate risk category.

14.2.8 Verification of completed criminal history record information check and abuse registry information check;

14.2.9 Verification of receipt by the employee or volunteer of his or her current job description;

14.2.10 A valid Driver’s License if required to transport residents;

14.2.11 An annual employee performance evaluation;

14.2.12 Employee disciplinary actions and history; and

14.2.13 All other reports required by statute or regulation.

14.3 Job Descriptions for Employees

14.3.1 A licensee must maintain on file a current written job description for every employee and for every volunteer who works more than 24 hours a week.

14.3.2 A licensee must ensure that an employee’s and volunteer’s permanent or temporary assignment and functions must be consistent with his or her respective current written job description.

15.1 A licensee must develop, adopt, follow and maintain on file policies and procedures governing the qualifications and use of volunteers. The qualifications must be appropriate to the duties they perform.

15.2 A licensee must assign designated employees to supervise volunteers.

15.3 Any volunteer who provides services or assistance on a routine basis is subject to the same background check as employees, unless the volunteer is limited to less than 3 visits in a calendar year.

16.1 Human Rights Committee

16.1.1 Membership:

16.1.1.1 At least five adult individuals of high professional standing, two of whom must be professionally knowledgeable or experienced in the theory and ethical application of various treatment techniques used to address behavioral problems.

16.1.1.2 A majority of Committee members must be external to the licensee or its parent organization. One member must be a member of the community or parent of a resident. One member must be a licensed mental health professional, a licensed physician, a licensed clinical psychologist, or a clinical social worker.

16.1.1.3 The Committee must meet at least on a quarterly basis

16.1.2 The Human Rights Committee is responsible for:

16.1.2.1 Determining that residents in care are receiving humane and proper treatment;

16.1.2.2 Reviewing and making recommendations regarding the licensee’s policies and procedures governing the use of restraint;

16.1.2.3 Reviewing the restraint records and advising the Director accordingly;

16.1.2.4 Recording and maintaining on file written minutes of all of its meetings, and providing the Director with a copy of these minutes;

16.1.2.5 Making inquiries into any allegations of abusive techniques or the misuse of restraint procedures. A report of the inquiry must be provided by the Committee to the Director and sent to the Division;

16.1.2.6 Monitoring the qualifications and training of employees who have been given responsibility for administering restraint procedures and to make recommendations to the Director accordingly; and

16.1.2.7 Reviewing and making recommendations on comprehensive behavioral support plans that include the application of some form of restraint procedures.

16.2 Behavior Management Committee (BMC). The BMC must be comprised of the licensee’s clinical director and all on-staff clinicians. It must establish a SBS Plan upon admission of a resident and must conduct SBS Plan reviews on each resident on at least a monthly basis.

16.2.1 With regard to each SBS Plan, the BMC review must provide input as to the presumed clinical efficacy and ethical acceptability of the plan.

16.2.2 Each SBS Plan author must present to the BMC for review:

16.2.2.1 A description of the results of the most recent functional assessment to identify environmental factors that correlate with the occurrence of dangerous target behaviors;

16.2.2.2 A description of the individual and his or her clinical/educational/vocational progress;

16.2.2.3 Documentation of each time a form of restraint was utilized with the resident in the form of clinical data for review by BMC members;

16.2.2.4 A description of positive reinforcement components of the SBS Plan that are designed to teach and strengthen appropriate replacement behaviors;

16.2.2.5 A description of the most recent mental health review and recent changes in medication or other psychiatric interventions;

16.2.2.6 A description of any medical conditions that might be expected to impact on the occurrence of dangerous behaviors;

16.2.2.7 A description of any familial or other emotional variables that might be expected to impact on the occurrence of dangerous behaviors;

16.2.2.8 A summary of the risk benefit analysis for each proposed intervention;

16.2.2.9 A summary statement as to the general effectiveness of the SBS Plan and a recommendation for future use.

16.3 Following approval by the BMC, review by the HRC must occur prior to implementation of the SBS Plan, or the Comprehensive Behavior Support Plan.

16.4 Prior to implementation of the SBS Plan or the Comprehensive Behavior Support Plan, informed consent must be obtained from:

16.4.1 The individual, and/or parent /guardian.

16.4.2 A physician attesting that there are no known medical conditions that would contraindicate use of the restraint.

16.5 Episodes of restraint utilization must be documented as follows:

16.5.1 Date and time, staff involved, location, activity, antecedent conditions, specific behaviors observed, interventions implemented, duration of interventions, well being checks, clinical review and approval for interventions longer than 15 minutes, physical examination for possible injury after the termination of the restraint utilization, supervisor signature; and

16.5.2 A report of each episodes of restraint utilization as documented in 16.5.1 must be provided to the Division on the fifth day of each month for the previous month in a manner prescribed by the Division.

16.6 When a restraint utilization event is less than 15 minutes, it must be reviewed by a clinician within one business day of said intervention.

16.7 Each SBS that has been approved and implemented must be reviewed at least monthly by the BMC for the first 90 days following implementation and quarterly thereafter.

16.8 Individual and aggregate clinical data on the frequency of restraint interventions for each individual must be reviewed monthly by the HRC.

17.1 A licensee must provide each employee or volunteer who has contact with residents written information governing the reporting provisions of the Delaware abuse, neglect, mistreatment and financial exploitation law(s) and regulations, and must maintain on file written documentation of their receipt of this information.

17.2 A licensee must not discourage, inhibit, penalize or otherwise impede any employee, volunteer or resident reporting any suspected or alleged incident of abuse, neglect, mistreatment or financial exploitation.

17.3 A licensee must develop, adopt, follow and maintain on file written policies and procedures for handling any incident of suspected abuse, neglect, mistreatment or financial exploitation. The policies and procedures must contain provisions specifying that:

17.3.1 The licensee immediately must take appropriate remedial action to protect residents from harm;

17.3.2 The licensee must take appropriate long-term corrective action to eliminate the factors or circumstances that may have caused or may have otherwise resulted in a continuing risk of abuse or neglect to residents;

17.3.3 Any employee or volunteer involved in an incident of alleged abuse or neglect must be removed or suspended from having direct contact with any residents, or must be reassigned to other duties that do not involve having contact with residents until the investigation of the incident has been completed;

17.3.4 The licensee must take appropriate disciplinary action against any employee or volunteer who committed an act of abuse or neglect, mistreatment or financial exploitation.

17.3.5 All incidents must be reported to the Division pursuant to Section 23.0 below, and to the police if criminal conduct is suspected.

18.1 A licensee must develop, adopt, follow and maintain on written file policies and procedures governing the accurate and timely recording of each incident in which a time-out technique or a non-violent physical intervention strategy is used. Such policies and procedures must ensure that the identity of the resident, the date, time, place, and circumstances of, and the name of the employee or volunteer who administered the time-out technique or the non-violent physical intervention strategy is recorded. The nature of the technique or strategy and the elapsed time used must also be recorded.

18.2 A licensee must ensure that the Director or his or her designee reviews the documentation on a weekly basis.

19.1 These regulations describe the procedures to be followed whenever the use of restraints is required. All residents have the right to be free from physical or mental abuse, discipline and corporal punishment. All residents have the right to be free from restraints of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Facility staff must review restraint protocols with residents and their legal representative upon admission and document the review.

19.2 Restraint procedures may be employed only when:

19.2.1 The individual is exhibiting a problem behavior that is so severe that it poses a risk to the safety and wellbeing of the individual or others;

19.2.2 It is part of a written comprehensive behavior support plan that incorporates all of the elements cited below;

19.2.3 An initial medical evaluation has been conducted to assess and address medical conditions that may be contributing to the problem behavior;

19.2.4 A physician, nurse practitioner or other qualified and licensed medical professional has determined that there are no contraindications to the use of the intervention;

19.2.5 It has been determined that less-restrictive alternative interventions are not safe, feasible or effective;

19.2.6 A functional behavioral assessment has been conducted to identify the situations and conditions that trigger and/or maintain the severe problem behavior, and means taken to address and correct those conditions.

19.3 The written comprehensive behavior support plan which includes the use of restraint must be developed by the individual, his or her family, and his or her education, habilitation or treatment team. The team must include a Board Certified Behavior Analyst, Licensed Psychologist, or other properly credentialed professional with documented training and experience in behavioral treatment of severe behavior disorders; a physician and/or psychiatrist; nurse practitioner; or medical professional and other relevant professionals;

19.3.1 The behavioral clinical professional must ensure that the comprehensive behavior support plan conforms to current best practices and ethical standards pertaining to the behavioral treatment of severe problem behavior, and is responsible for overseeing its implementation.

19.3.2 The physician, nurse practitioner or other medical professional determines that there are no medical contraindications to the planned intervention.

19.4 The comprehensive behavior support plan that includes a restraint component must include:

19.4.1 Individualized arrangements addressing the strengths, preferences, needs, and circumstances of the individual and his or her family;

19.4.2 Informed consent rendered voluntarily and in writing by the individual, his or her parents or legally authorized guardians or surrogates after they have been provided with complete, accurate, and understandable information about all aspects of the intervention techniques that will be used with the individual;

19.4.3 Review by the BMC and the HRC to ensure professional and ethical standards are met;

19.4.4 Procedures to diffuse prevent or reduce a problem before it evolves into a significant event that places the individual or others at risk;

19.4.5 Methods to teach and support alternative skills, to both replace the problem behavior and improve the individual’s capabilities and quality of life;

19.4.6 Implementation by personnel with documented training to implement the entire comprehensive behavior support plan competently, safely and ethically.

19.5 Comprehensive behavior support plans including the use of restraint must feature the following safeguards and methods of oversight:

19.5.1 Staff must receive frequent monitoring and direct supervision from the behavioral clinical professionals and administration. Data on all usages of restraint are provided and reviewed at frequent intervals by all levels of the administration.

19.5.2 The plan includes safeguards to minimize all risks of harm and insure the individual’s safety at all times, including during restraint.

19.5.3 The plan is adjusted as needed based on frequent review by the behavioral clinical professionals of data representing objectively measured occurrences of the problem behavior, and implementation of the intervention procedures.

19.5.4 Safeguards are provided during the restraint procedures to insure the individual’s safety at all times.

19.5.5 Upon initiation of the restraint procedure staff must notify the on-site supervisor, and behavioral clinical professional for approval of the implementation of the procedure.

19.5.6 Trained staff must continuously monitor the individual during the restraint procedure, as follows:

19.5.6.1 If the individual is observed to be in medical distress, e.g., exhibiting labored breathing, or there is evidence of physical injury, the individual must immediately be released from restraint, and medical attention applied.

19.5.6.2 The restraint procedure is terminated when there is no imminent risk to either the individual or others.

19.5.6.3 At the termination of the intervention the individual is observed by both the staff terminating the procedure and a second staff person to evaluate the individual’s medical and emotional condition.

19.5.6.4 If any signs of medical or emotional distress are observed, a medical and/or behavioral clinical professional must be contacted and decisions made about the next steps to resolve the situation.

19.6 Documentation of each use of a restraint or seclusion procedure must include:

19.6.1 The behavior that necessitated the restraint procedure;

19.6.2 The specific restraint procedure employed;

19.6.3 The date and time of the restraint procedure, and time the restraint procedure was terminated;

19.6.4 The person who authorized, initiated, applied and terminated the restraint procedure; and

19.6.5 Any injuries sustained and treatment received.

19.7 If emergency use of restraint occurs six or more times in a 1-month period, the comprehensive behavior support plan must be reviewed and modified, if indicated.

19.8 The following are prohibited:

19.8.1 A prone (face down) restraint of any kind;

19.8.2 A seated basket hold;

19.8.3 Restraint procedures that employ painful stimuli;

19.8.4 Restraint of an individual’s hands, with or without a mechanical device, behind his or her back;

19.8.5 Physical holds relying on the inducement of pain for behavioral control;

19.8.6 Movement that results in hyperextension or twisting of body parts;

19.8.7 Any restraint procedure in which a pillow, blanket, or other item is used to cover the individual’s face as part of the restraint process;

19.8.8 Any restraint procedure that may exacerbate a known medical or physical condition;

19.8.9 Use of any restraint technique medically contraindicated for an individual;

19.8.10 Restraint without continuous monitoring;

19.8.11 All forms of chemical restraint; and

19.8.12 Seclusion.

19.8.13 Electroconvulsive Therapy

20.1 Employee and Volunteer Health

20.1.1 Prior to employing any person or accepting any volunteer, a licensee must secure and maintain on file written documentation certifying and verifying that the prospective employee and volunteer has had a general physical examination within 12 months prior to the date of employment. The examination must include a medically accepted procedure for screening for tuberculosis.

20.1.2 Minimum requirements for pre-employment and tuberculosis (TB) testing are those currently recommended by the Centers for Disease Control and Prevention of the U.S. Department of Health and Human Services.

20.1.3 To be eligible to work in the facility or program, an employee or volunteer must be free from active tuberculosis; and

20.1.4 If a licensee determines that the prospective employee or volunteer has not had a general physical examination within 12 consecutive calendar months prior to the anticipated date of employment or volunteer work, or if a licensee is unable to document that such an examination was completed, a licensee must require the prospective employee or volunteer, as a condition of employment, to have such a general physical examination within three consecutive calendar months of the date of employment or volunteer work.

21.1 A licensee must develop, adopt, follow and maintain on file written policies and procedures governing the use, administration or assistance with administration of medications, prescription and non-prescription medications to residents.

21.2 The facility must establish and adhere to written medication policies and procedures which must address:

21.2.1 Obtaining and refilling medications

21.2.2 Storing and controlling medications

21.2.3 Disposing of medications; and

21.2.4 Administration of medication and self-administration of medication.

21.3 Each facility must have a drug reference guide, with a copyright date no older than 2 years, available and accessible for use by employees.

21.4 Medication must be stored and controlled as follows:

21.4.1 Medication must be stored in a locked container, cabinet, refrigerator or area that is only accessible to authorized personnel.

21.4.2 Medication that is not in locked storage may not be left unattended and may not be accessible to unauthorized personnel.

21.4.3 Medication must be stored in the original labeled container.

21.4.4 A bathroom or laundry room may not be used for medication storage.

21.4.5 All expired or discontinued medication must be disposed of according to the facility’s medication policies and procedures.

21.5 A separate medication log must be maintained for each resident documenting the administration of the medication by licensed staff member or staff assistance with self-administration by the resident (AWSAM). The log is either preprinted by the pharmacy or created by the facility. Instructions must appear as on the prescription container label. When a resident refuses a medication or is unavailable, the incident must be documented on the medication log or according to facility policy.

21.6 Psychotropic medications are prohibited for disciplinary purposes for the convenience of staff or as a substitute for appropriate treatment service. An informed, written consent of the parents or legal guardian is secured and maintained in the resident’s file prior to the administration of any psychotropic medication.

21.7 A minimum of a three (3) day supply of each resident’s medication must be available at all times.

21.8 The facility admitting residents on prescribed psychotropic medication and/or residents on prescribed medication for chronic illness, such as diabetes or asthma, must ensure that each of these residents receives a minimum of one hour per month of Medical Consultant services. The Medical Consultant services must include:

21.8.1 Review of administration of the resident’s medication, including determination of problems in adherence or administration and development of corrective action plans.

21.8.2 Assessment and monitoring of the resident with regard to the impact of their medication, including whether the medication is having its desired effects and whether the resident is suffering from undesired side-effects.

21.8.3 Service as liaison between the licensee and the resident’s physician(s).

21.8.4 Provision of instruction of employees regarding the expected outcomes from each resident’s medication regime and the possible side-effects of that medication regime.

21.9 Residents receiving medication must be trained to take their own medication, where possible. Staff who have successfully completed a Board of Nursing approved AWSAM training program may assist residents in the taking of medication provided that the medication is in the original container and properly labeled. The medication must be taken exactly as indicated on the label.

21.10 No person other than a physician or licensed nurse may administer medication by injection.

21.11 Records must be kept on file at the facility identifying AWSAM trained staff.

21.12 Each facility must complete an annual AWSAM report on the form provided by the Board of Nursing. The report must be submitted pursuant to the Delaware Nurse Practice Act, 24 Del.C. Ch. 19.

A licensee must employ universal precautions for protection from disease and infection in accordance with the most current guidelines of the Centers for Disease Control and Prevention.

23.1 Incident reports, with adequate documentation, must be completed for each incident. Adequate documentation includes the name of the resident(s) involved; the date, time and place of the incident; a description of the incident; a list of other parties involved, including witnesses; the nature of any injuries; resident outcome; and follow-up action, including notification of the resident's guardian or surrogate, attending physician and licensing or law enforcement authorities, when appropriate.

23.2 All incident reports whether or not required to be reported must be retained in facility files for three years. Reportable incidents must be communicated immediately, which means within eight hours of the occurrence of the incident, to the Division. The method of reporting shall be as directed by the Division.

23.3 Incident reports which must be retained in facility files are as follows:

23.3.1 All reportable incidents as detailed below.

23.3.2 Falls without injury and falls with minor injuries that do not require transfer to an acute care facility or neurological reassessment of the resident.

23.3.3 Errors or omissions in treatment or medication.

23.3.4 Injuries of unknown source.

23.3.5 Lost items which are not subject to financial exploitation.

23.3.6 Skin tears.

23.3.7 Bruises of unknown origin.

23.4 Reportable incidents are as follows:

23.4.1 Abuse as defined in 16 Del.C., §1131.

23.4.2 Physical abuse with injury if resident to resident and physical abuse with or without injury if staff to resident or any other person to resident.

23.4.3 Any sexual act between staff and a resident and any non-consensual sexual act between residents or between a resident and any other person such as a visitor.

23.4.4 Emotional abuse whether staff to resident, resident to resident or any other person to resident.

23.4.5 Neglect, mistreatment or financial exploitation as defined in 16 Del.C., §1131.

23.4.6 Resident elopement under the following circumstances:

23.4.6.1 A resident's whereabouts on or off the premises are unknown to staff and the resident suffers harm.

23.4.6.2 A cognitively impaired resident's whereabouts are unknown to staff and the resident leaves the facility premises.

23.4.6.3 A resident cannot be found inside or outside a facility and the police are summoned.

23.4.7 Significant injuries.

23.4.8 Injury from an incident of unknown source in which the initial investigation or evaluation supports the conclusion that the injury is suspicious. Circumstances which may cause an injury to be suspicious are: the extent of the injury, the location of the injury (e.g., the injury is located in an area not generally vulnerable to trauma), the number of injuries observed at one particular point in time, or the incidence of injuries over time.

23.4.9 Injury which results in transfer to an acute care facility for treatment or evaluation or which requires periodic neurological reassessment of the resident's clinical status by professional staff for up to 24 hours.

23.4.10 Areas of contusions or bruises caused by staff to a dependent resident during ambulation, transport, transfer or bathing.

23.4.11 An error or omission in medication/treatment, including drug diversion, which causes the resident discomfort, jeopardizes the resident's health and safety or requires periodic monitoring for up to 48 hours.

23.4.12 A burn greater than first degree.

23.4.13 Any serious unusual and/or life-threatening injury.

23.4.14 Entrapment which causes the resident injury or immobility of body or limb or which requires assistance from another person for the resident to secure release.

23.4.15 Suicide or attempted suicide.

23.4.16 Poisoning.

23.4.17 Fire within a facility.

23.4.18 Utility interruption lasting more than eight hours in one or more major service including electricity, water supply, plumbing, heating or air conditioning, fire alarm, sprinkler system or telephones.

23.4.19 Structural damage or unsafe structural conditions.

23.4.20 Water damage which impacts resident health, safety or comfort.

23.5 The facility must maintain and follow written policies and procedures, in accordance with 16 Del.C., Ch. 25, regarding health care decisions including advance directives. The facility must provide written information to all residents explaining such policies and procedures.

24.1 In the event of the closing of a facility, the facility shall:

24.1.1 Notify the Division, and the Ombudsman, at least 90 days before the planned closure.

24.1.2 Notify each resident directly and his/her attending physician and, if applicable, his/her responsible party by telephone and in writing at least 90 days before the planned closure.

24.1.3 Give the resident or the resident's responsible person an opportunity to designate a preference for relocation to a specific facility or for other arrangements.

24.1.4 Arrange for relocation to other facilities in accordance with the resident's preference, if possible.

24.1.5 Ensure that all resident records, medications, and personal belongings are transferred with the resident and, if to another facility, accompanied by an interagency transfer form.

24.1.6 Provide an accounting of resident trust fund accounts which must be transferred to each resident's possession or to the facility to which the resident relocates. A record of the accounting of the funds must be maintained by the closing facility for audit purposes.

24.1.7 Advise any applicant for admission to a facility which has a planned closure date in writing of the planned closure date prior to admission.

25.1 Waivers may be granted by the Division for good cause.

25.2 Should any section, sentence, clause or phrase of these regulations be legally declared unconstitutional or invalid for any reason, the remainder of said regulations shall not be affected thereby.

15 DE Reg. 600 (11/01/11) (Proposed)