1.1 A Nursing facility (NF) is a residential institution, as defined in 16 Delaware Code, §1102(4), which provides services to residents which include resident beds, continuous nursing services, and health and treatment services for individuals who do not currently require continuous hospital care. Care is given in accordance with a physician's orders and requires the competence of a registered nurse (RN).
1.2 Nursing facilities shall be subject to all applicable local, state and federal code requirements. The provisions of 42 CFR Ch. IV Part 483, Subpart B, requirements for Long Term Care Facilities, and any amendments or modifications thereto, are hereby adopted as the regulatory requirements for skilled and intermediate care nursing facilities in Delaware. Subpart B of Part 483 is hereby referred to, and made part of this Regulation, as if fully set out herein. All applicable code requirements of the State Fire Prevention Commission are hereby adopted and incorporated by reference.
2.2 Advance Directive - Written instructions such as a living will or durable power of attorney for health care, in accordance with 16 Delaware Code, Chapter 25, relating to the provision of health care should the individual become incapacitated.
2.7.1 For facilities subject to 16 Delaware Code, §1164, an individual who meets the statutory requirements for a food service manager. A facility may seek a waiver of the statutory requirements if an insufficient pool of applicants exists. The facility must demonstrate the inability to hire a person who meets the requirements after a recruitment process of at least 90 days duration that included advertising in at least two newspapers of general circulation and one trade journal, offering a competitive salary. If those conditions are met, the Division may waive the education requirement for an applicant who meets the requirements of a "person in charge" as defined in the current Delaware Food Code.
2.7.2 For facilities not subject to 16 Delaware Code, §1164, an individual who, at a minimum, meets the requirements of a "person in charge" as defined in the current Delaware Food Code.
2.9 Incident - 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 9.7 of these regulations.
2.10 Nursing Home Administrator - A licensee of the Delaware Board of Examiners of Nursing Home Administrators who manages the facility on a full-time basis, and is responsible for the delivery quality care to its residents and for the implementation of the policies and procedures of the facility.
2.11 Nursing Services - Those curative, restorative, preventive or palliative health care services provided by certified nursing assistants, licensed practical nurses and registered nurses to assist a resident to attain or maintain his or her highest practicable physical, mental, and psychosocial well-being as determined by the resident's assessment and individual care plan.
2.12 Pediatric resident - A person residing in a nursing facility who is under 18 years of age and for who there is a care plan including medical care, treatment and other related services in accordance with the Regulations for Nursing Homes Admitting Pediatric Residents.
2.14 Rehabilitation - The actions and services such as physical therapy, occupational therapy, speech therapy and psychosocial services provided or required to restore an ill or injured person to self- sufficiency at his or her highest attainable level.
2.15 Reportable Incident - 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/misappropriation of their property as those terms are defined in 16 Delaware Code, §1131 and/or 42 CFR 483.13(c). Reportable incident also includes an occurrence or event listed in Section 9.8 of these regulations.
2.16 Resident - A person admitted to a nursing facility because of illness or impairment, under a physician's care, for whom there is planned continuing health care directed toward improvement in health or for whom palliative medical and nursing measures are required.
2.17 Restraint - A physical or chemical means of restricting or controlling a resident. Specifically, a mechanical device, material or equipment attached or adjacent to a resident's body that the resident cannot remove easily, and which restricts freedom of movement or normal access to the resident's body.
2.18 Satisfactory Compliance History - A sworn affidavit, as required by 16 Delaware Code, §1104(d), attesting to a licensure applicant's provision of quality care in a nursing facility, during the five years preceding the initial application, as determined by the absence of the following:
2.19 Social worker - For facilities subject to 16 Delaware Code, §1165, with at least 100 beds, an individual with a bachelor's degree in social work, or a bachelor's degree in a human services field including, but not limited to, sociology, special education, rehabilitation counseling, and psychology; and one year of supervised social work experience in a health care setting working directly with individuals. For facilities with fewer than 100 beds, the facility may designate the director of admissions or a nurse to assume the duties of the social worker.
3.4 Inspections and monitoring by the Division shall be carried out in accordance with 16 Delaware Code, §1107.
3.5 Upon receipt of a report of any violation(s) of these regulations, the facility shall submit a written plan of action to correct cited deficiencies within 10 working days or such other time period as may be specified. The plan of action shall address corrective actions and include all measures and completion dates to prevent their recurrence as follows:
3.7 The nursing facility shall comply with 42 CFR 483.10, 483.12, 483.13, 483.15 and/or 16 Delaware Code, §1121 regarding the rights of residents. Those rights shall be made available in writing to residents, guardians, representatives or next of kin.
3.8 Each facility shall provide, in writing, the refund and prepayment policy at the time of admission, and in the case of residents admitted while awaiting approval of third-party payment, an exact statement of responsibility in the event of retroactive denial. The facility shall notify residents, in writing, at least 30 days prior to a rate increase.
3.9 A facility may require an individual who has legal access to a resident's income or resources available to pay for facility care to sign a contract to provide for facility payment from the resident's income or resources. However, in doing so, the facility shall not require a third party to incur personal financial liability for the nursing facility expenses.
3.10 The nursing facility shall cooperate fully with the state protection and advocacy agency, as defined in 16 Del.C. §1102(7), in fulfilling functions authorized by Title 16, Chapter 11.
4.1 Licenses and renewals shall be issued to a nursing facility which meets the requirements of 16 Delaware Code, §1104. For initial licensure, the nursing facility shall also demonstrate during a physical inspection of the premises that the facility complies with all applicable regulations.
4.3.1 The imposition of temporary management by the Centers for Medicare and Medicaid Services (CMS) or any state jurisdiction against the applicant or associated entity during the preceding five years
4.3.7 Information as required by 16 Delaware Code, §1104(e)
4.4 Financial information disclosed to the Division as required by 16 Delaware Code, §1104(e) shall not be subject to Freedom of Information Act requests except as follows:
4.5 Each license shall be renewed on the anniversary date of initial licensure. Each license holder shall file an application for renewal at least 30 days prior to the expiration of the current license and pay the applicable fee as established in 16 Delaware Code, §1106(a).
4.7 Each license shall specify the number of licensed beds. A facility seeking to change the number of licensed beds shall apply to the Division for a modified license authorizing the revised number of beds.
4.8 Separate licenses are required for facilities maintained in separate locations, even though operated under the same management. A separate license is not required for separate buildings maintained by the same management on the same grounds.
4.9 When a facility plans to construct or extensively remodel a licensed facility or convert a building to a licensed facility, it shall submit one copy of properly prepared plans and specifications for the entire facility to the Division. An approval, in writing, shall be obtained before such work is begun. After the work is completed, in accordance with the plans and specifications, a modified license to operate shall be issued. All completed construction, extensive remodeling or conversions shall remain in accordance with the plans and specifications, as approved by the Division.
5.2 Each nursing facility shall have a full-time administrator. When an administrator will be temporarily absent for a period of two weeks or more, a management employee shall be designated to be in charge. The Division shall be notified in writing upon such designation.
5.3 The nursing facility shall designate a physician to serve as the medical director who shall be responsible for implementation of resident care policies and the coordination of medical care in the facility.
5.4.1 Nursing facilities subject to 16 Delaware Code, §1161 to §1165 shall provide professional nursing, nursing services direct care and other services in accordance with statutory requirements.
5.4.2 Nursing facilities not subject to 16 Delaware Code, §1161 to §1165 shall provide professional nursing, nursing services direct care and other services as follows:
126.96.36.199 In addition to the requirement above, the nursing facility shall have a full-time director of nursing who is a registered nurse. The director of nursing shall have overall responsibility for the coordination, supervision and provision of nursing services.
188.8.131.52 Facilities not subject to 16 Delaware Code, §1164 may increase the level of care and services for a current resident whose condition requires such an increase in the level of care and services as an alternative to discharge to another facility. Such increased care and services shall be provided by a qualified caregiver(s) whose scope of practice includes the provision of such care and services, and shall be available during any shift when the resident's needs require such care and services.
5.6.1 Nursing facilities that provide direct healthcare services to persons diagnosed as having Alzheimer’s disease or other forms of dementia shall provide dementia specific training each year to those healthcare providers who must participate in continuing education programs. This section shall not apply to persons certified to practice medicine under the Medical Practice Act, Chapter 17 of Title 24 of the Delaware Code.
5.6.2 The mandatory training must include: communicating with persons diagnosed as having Alzheimer’s disease or other forms of dementia; the psychological, social, and physical needs of those persons; and safety measures which need to be taken with those persons.
6.1 General Services. Any nursing facility not providing skilled services shall implement each resident's physician's orders obtained on the day of admission and renewed or revised every 60 days thereafter.
6.2.2 All nursing facilities shall arrange for one or more licensed physicians to be called in an emergency. Names, telephone and fax numbers of these physicians shall be posted at all nurses' stations.
6.2.3 For a resident admitted or readmitted from the hospital with orders for nine or more medications (excluding over-the-counter medications), the attending physician or designee or medical director shall conduct a comprehensive medication review and reconciliation of past and present medications within 5 days.
184.108.40.206 Coordinate orientation programs for new nursing services direct caregivers (including temporary staff) and in-service education, as appropriate, for such staff. Written records of the content of each in-service program and the attendance records shall be maintained for two years
220.127.116.11 Participate in the selection of prospective residents by evaluating the nursing services required and the facility's ability to competently provide those required services or ensure that such an evaluation is conducted by a designated registered nurse
6.3.4 The resident assessment shall include a screening instrument for mental illness, mental retardation, and developmental disabilities to assess if an individual has an active treatment need for one of these conditions.
6.3.5 Based on the physician's admission orders and the admission information for each resident, an interim individual nursing care plan shall be developed within 24 hours of admission pending the completion of a comprehensive resident assessment.
6.3.6 A comprehensive care plan shall be developed to address medical, nursing, nutritional and psychosocial needs within 7 days of completion of the comprehensive assessment. Care plan development shall include the interdisciplinary team that includes the attending physician, an RN/LPN and other appropriate staff as determined by the resident's needs. With the resident's consent, the resident, the resident's family or the resident's legal representative may attend care plan meetings.
6.3.7 The assessment and care plan for each resident shall be reviewed/revised as needed when a significant change in physical or mental condition occurs, and at least quarterly. A complete comprehensive assessment shall be conducted and a comprehensive care plan shall be developed at least yearly from the date of the last full assessment.
18.104.22.168 The resident's care plan shall document the facility's use of interventions, such as modifying the resident's environment to increase safety, and use of assistive devices to enhance monitoring in order to avoid the use of restraints.
22.214.171.124 Should such interventions and assistive devices fail to provide for the resident's safety, a physician's written order permitting the use of restraints shall be required and shall specify the type of restraint ordered.
126.96.36.199 When the use of restraints has been implemented, the facility shall initiate a systematic process, on an ongoing basis, documented in the care plan, in an effort to employ the least restrictive restraint.
188.8.131.52 In an emergency, when the resident's unanticipated violent or aggressive behavior places him/her or others in imminent danger, restraints may be used as a last resort to protect the safety of the resident or others, and such use shall not extend beyond the immediate episode.
6.3.9 The facility shall ensure that each nursing and ancillary staff member providing care to a resident under 18 years of age meets the standards as defined in regulations for nursing facilities admitting pediatric residents.
6.3.10 The facility shall ensure that all licensed or certified direct care staff receive CPR certification and shall ensure that at least one staff person with current CPR certification is present in the facility during all shifts.
6.4.1 The facility shall identify each resident's need for social services to attain or maintain the highest practicable physical, mental and psychosocial well-being of each resident; and shall assist each resident to obtain all required services to meet the individual resident's needs. These social services shall include, but not be limited to:
6.5.1 Meals. Therapeutic diets, mechanical alterations and changes in either must be prescribed by an attending physician within 72 hours of implementation. All meals and snacks shall be served in accordance with the therapeutic diet, if prescribed.
184.108.40.206 A comprehensive nutritional assessment which includes an evaluation of each resident's caloric, protein, and fluid requirements shall be completed within 14 days of admission in consultation with a dietitian.
6.7.2 For a resident admitted or readmitted from the hospital with orders for nine or more medications (excluding over-the-counter medications), the facility shall complete an on-site or off-site pharmacy review within 10 days of admission or readmission.
220.127.116.11 All medications (prescription and over-the-counter) shall be administered to residents in accordance with orders which are signed and dated by the ordering physician or prescriber. Each medication shall have a documented supporting diagnosis. Verbal or telephone orders shall be written by the nurse receiving the order and then signed by the ordering physician or prescriber within 10 days.
18.104.22.168 An individual resident may self-administer medications upon the written order of the physician, following determination by the interdisciplinary team that this practice is safe. The facility shall establish policies and procedures pertaining to the security of self-administered medication.
22.214.171.124 The facility's policies and procedures shall not prohibit or restrict a resident from receiving medications from the pharmacy of the resident's choice. However, the resident and/or his representative shall be informed of any ramifications of ordering medications from other than the facility's pharmacy, such as cost differences, responsibility for delivery of medication to the facility and length of ordering time.
126.96.36.199 Only licensed nurses shall administer medications and then record the administration on the resident's Medication Administration Record (MAR) immediately after administration to that resident.
188.8.131.52 The facility shall ensure that licensed nurses administering medications count controlled substances at the beginning and end of each shift. The on-coming medication nurse shall conduct, verify, and document the controlled substance count in the presence of the off-going medication nurse.
184.108.40.206 Any medications removed but not administered to the resident shall not be returned to the original container. In circumstances such as refusal of drugs by the resident, the drugs shall be discarded and the refusal recorded on the resident's Medication Administration Record (MAR). If the medication is a controlled substance, the signature of the administering nurse is required on the record of the controlled substance count.
220.127.116.11 Medication shall be released to residents on discharge or transfer only by the written authorization of the resident's physician. A resident who leaves the nursing facility on a short leave may be issued a quantity of medication to meet his/her needs, with the approval of the resident's physician.
18.104.22.168 The administrator or designee shall notify the Office of Controlled Substances in the Division of Professional Regulation and the Division of Long Term Care Residents Protection of any unexplained loss of controlled substances, syringes, needles, or prescription pads within 8 hours of discovery of such loss or theft.
22.214.171.124 Stock supplies of drugs available without a prescription (over-the-counter drugs such as antacids, aspirin, laxatives) may be kept in the facility. These over-the-counter drugs shall be labeled "house stock”.
126.96.36.199 Prescription medications for emergency or interim use may be stocked by the facility subject to Board of Pharmacy regulations.
188.8.131.52 Medications shall be labeled in accordance with 24 Delaware Code, §2522 and the regulations of the Board of Pharmacy.
184.108.40.206 Medications dispensed using a unit dose system shall be pharmacy-prepared or manufacturer-prepared in individually packaged and sealed doses that are identifiable and properly labeled. The label shall include, at a minimum, the brand and/or generic name of the medication, strength, and lot number and expiration date.
220.127.116.11 The facility shall follow Division of Public Health regulations for the Control of Communicable and Other Disease Conditions and Centers for Disease Control guidelines for communicable diseases.
18.104.22.168 A resident, when suspected or diagnosed as having a communicable disease, shall be placed on the appropriate precautions as recommended for that disease by the Centers for Disease Control. Residents infected or colonized with the same organism may share a room based on current standard of practice.
22.214.171.124 The admission of a resident with or the occurrence of a disease or condition on the Division of Public Health List of Notifiable Diseases/Conditions within a nursing facility shall be reported to the resident's physician and the facility's medical director. The facility shall also report such an admission or occurrence to the Division of Public Health's Health Information and Epidemiology office.
126.96.36.199 A resident diagnosed with active tuberculosis in an infectious stage shall not continue to reside in a nursing facility unless that facility has a room with negative pressure ventilation and staff trained to care for residents requiring respiratory isolation.
188.8.131.52 A resident of any facility unable to provide care as described above who is diagnosed with active tuberculosis in an infectious stage shall be transferred to an acute care hospital, and the facility shall notify the Division of Public Health's Health Information and Epidemiology office immediately.
184.108.40.206 Minimum requirements for pre-employment tuberculosis (TB) testing require 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 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 shall comply with the recommendations of the Center for Disease Control for the appropriate risk category.
220.127.116.11.2 Any person having a positive skin test but a negative X-ray shall receive an annual evaluation for signs and symptoms of active TB if they can not provide documentation of completion of treatment for LTBI (latent TB infection).
18.104.22.168 All facilities shall have on file evidence of annual vaccination against influenza for all residents, as recommended by the Immunization Practice Advisory Committee of the Centers for Disease Control, unless medically contraindicated.
22.214.171.124 All facilities shall have on file evidence of vaccination against pneumococcal pneumonia for all residents older than 65 and as recommended by the Immunization Practice Advisory Committee of the Centers for Disease Control unless medically contraindicated.
126.96.36.199 A resident who refuses to be vaccinated against influenza or pneumococcal pneumonia shall be informed by the facility of the health risks involved. The reason for the refusal(s) shall be documented in the resident's medical record annually.
188.8.131.52 All employees shall receive education and training on standard precautions, use of personal protective equipment, the importance of hand hygiene, the facility's infection control policies and reporting of exposures to blood or other potentially infectious materials.
184.108.40.206 If an accidental exposure to blood or other potentially infectious materials occurs (specifically to eye, mouth, other mucous membrane or non-intact skin), appropriate first aid treatment shall be given immediately and follow-up testing and counsel inginitiated. A copy of the exposure incident and follow-up treatment shall be maintained in the employee's personnel file.
220.127.116.11 Facilities shall establish procedures in accordance with Division of Public Health requirements and Centers for Disease Control guidelines for exclusion from work and authorization to return to work for staff with communicable diseases.
18.104.22.168 The nursing facility shall establish an infection control committee (or a subcommittee of an overall quality control program) of professional staff whose responsibility shall be to manage the infection control program in the facility. One member of the committee shall be designated the infection control coordinator.
22.214.171.124 The infection control coordinator shall maintain records of all nosocomial infections and corrective actions related to those infections to enable the committee to analyze clusters or significant increases in the rate of infection and to make recommendations for the prevention and control of additional cases.
126.96.36.199 The facility shall establish and implement policies and procedures for the collection, storage, handling and disposition of all pathological and infectious wastes within the facility as well as for those to be removed from the facility including the following:
188.8.131.52.1 Needles, syringes and other solid, sharp, or rigid items shall be placed in a puncture resistant container prior to disposal by an infectious waste hauler approved by the Department of Natural Resources and Environmental Control (DNREC).
184.108.40.206.2 Non-rigid items, such as blood tubing and disposable equipment and supplies, shall be placed in double, heavy duty, impervious plastic bags prior to disposal by an infectious waste hauler approved by DNREC.
7.1 All new construction, extensive remodeling or conversions to a nursing facility shall comply with the standards and guidelines set forth under the "Nursing Facilities" section of the current edition of Guidelines for Design and Construction of Health Care Facilities, a publication of the American Institute of Architects Committee on Architecture for Health with assistance of the U.S. Department of Health and Human Services.
7.3.4 The facility shall be equipped with a resident call system which meets the current standards of the Guidelines for Design and Construction of Health Care Facilities. An intermediate care facility serving only developmentally disabled residents shall be exempt from this regulation.
220.127.116.11 A minimum of one bathtub or shower shall be provided for every 20 residents not otherwise served by bathing facilities within residents' rooms. Each nursing unit shall have at least one bathtub.
18.104.22.168 Each tub or shower in a central bathing facility shall be in an individual room or enclosure with space for the private use of the tub or shower, for drying and dressing, and for a wheelchair and attendant. Showers shall be at least four feet square without curbs. Toilets in central bathing facilities shall have provisions for privacy.
7.6.5 The facility shall have a soiled utility room under negative pressure for storage of infectious waste and for disposal of body fluids. The room shall have a work counter, hand washing sink, and clinical sink or other bed pan cleaning device.
7.7.1 The facility shall supply sufficient equipment and supplies for nursing care to meet the needs of each resident. The facility shall obtain specific items when indicated for individual residents and approved by the attending physician or director of nursing.
8.3 Each facility shall develop and maintain all-hazard emergency plans for evacuation and sheltering in place. The plan must be submitted to the Division and DEMA in a digital format and it must conform to the template prescribed by the Division.
8.7 The Division may grant an extension of time for either requirement in 8.6 upon request and for good cause shown.
9.1 There shall be a separate clinical record maintained on each resident as a chronological history of the resident's stay in the nursing facility. Each resident's record shall contain current and accurate information including the following:
9.1.1 Admission record which shall include the resident's name, birth date, home address prior to entering the facility, identification numbers (including Social Security), date of admission, physician's name, address and telephone number, admitting diagnoses, name, address and telephone number of resident's representative, the facility's medical record number, and advance directive(s) if applicable.
9.1.2 History and physical examination prepared by a physician within 14 days of the resident's admission to the nursing facility. If the resident has been admitted to the facility from a hospital, the resident's summary and history prepared at the hospital and the resident's physical examination performed at the hospital, if performed within 14 days prior to admission to the facility, may be substituted. A record of subsequent annual medical evaluations performed by a physician must be contained in each resident's file.
9.1.4 Physician's orders which include a complete list of medications, dosages, frequency and route of administration, indication for usage, treatments, diets, restrictions on level of permitted activity if any, and use of restraints if applicable.
9.1.6 Nursing notes, which shall be recorded by each person providing professional nursing services to the resident, indicating date, time, scope of service provided and signature of the provider of the service. Nursing notes shall include care issues, nursing observations, resident change of status and other significant events.
9.1.7 Medication administration record (MAR) including medications, dosages, frequency, route of administration, and initials of the nurse administering each dose. The record shall include the signature of each nurse whose initials appear on the MAR.
9.5 Incident reports, with adequate documentation, shall be completed for each incident. Adequate documentation shall consist of 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 representative or family, attending physician and licensing or law enforcement authorities, when appropriate.
9.6 All incident reports whether or not required to be reported shall be retained in facility files for three years. Reportable incidents shall be communicated immediately, which shall be within eight hours of the occurrence of the incident, to the Division of Long Term Care Residents Protection. The method of reporting shall be as directed by the Division.
9.8.1 Abuse as defined in 16 Delaware Code, §1131.
9.8.2 Neglect, mistreatment or financial exploitation as defined in 16 Delaware Code, §1131.
22.214.171.124 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.
126.96.36.199 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.
188.8.131.52 Significant 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.
9.8.9 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.
9.9 The facility shall maintain written policies and procedures, in accordance with 16 Delaware Code Chapter 25, regarding health care decisions including advance directives. The facility shall provide written information to all residents explaining such policies and procedures.
10.1.1 Notify the Division of Long Term Care Residents Protection, the Ombudsman, the Division of Public Health and, if applicable, the Division of Medicaid and Medical Assistance and the Centers for Medicare and Medicaid Services at least 90 days before the planned closure.
10.1.6 Provide an accounting of resident trust fund accounts which shall be transferred to each resident's possession or to the facility to which the resident relocates. A record of the accounting of the funds shall be maintained by the closing facility for audit purposes.
11.2 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.