16 Del. Admin. Code § 3301-8.0

Current through Register Vol. 28, No. 5, November 1, 2024
Section 3301-8.0 - Services to Residents
8.1 Group Home Services:
8.1.1 The group home, shall provide to all residents the care deemed necessary for their comfort, safety nutritional requirements and general well being
8.1.2 The group home shall have in effect a written transfer agreement with one (1) or more hospitals, which provides the basis for an effective working arrangement under which inpatient hospital care, or other hospital services, are available promptly to the facilities residents, when needed.
8.1.3 The group home shall have a written contract agreement for promptly obtaining required laboratory, x-ray and other diagnostic services. These services may be obtained from other facilities that meet applicable local, state and Federal laws and regulations.
8.1.4 The group home shall have arrangements for the provision of all other services and supplies to meet the health and psychosocial needs of each resident. Such arrangements may be other met by appropriately licensed facility staff or by contractual agreements with organizations or individuals licensed as applicable by the State of Delaware.
8.1.5 The group home shall immediately inform the attending or emergency physician, registered nurse and if known, notify the resident's legal representative, interested family member, or other parties as designated by the resident when there is:
8.1.5.1 an accident involving the resident.
8.1.5.2 a significant change in the resident's physical, mental, or psychosocial status (i.e., a deterioration in health, mental or psychosocial status in either life threatening conditions or clinical complications);
8.1.5.3 a need to alter treatment significantly (i.e., a need to discontinue an existing form of treatment due to adverse consequences, or to commence a new form of treatment).
8.2 Medical and Nursing Services:
8.2.1 The group home shall provide for medical and nursing services either directly or through contract arrangements with organizations or individuals licensed as applicable by the State of Delaware.
8.2.2 All persons admitted to a group home shall be under the care of a licensed physician and shall be seen by their attending physician at least every 30 days, unless Justified otherwise and documented by the attending physician.
8.2.3 All group homes shall arrange for one (1) or more licensed physicians to be called in an emergency. Names and phone numbers of these physicians shall be posted in a conspicuous location.
8.2.4 All orders for medications, treatments, diets, and diagnostic services shall be in writing and signed by the attending physician. Telephone orders shall be countersigned by the physician within fourteen (14) working days.
8.2.5 All statements of medical treatment goals and treatment plans shall be reviewed and updated as needed by the attending physician, to insure continuing appropriateness of the goals, consistency of management methods with the goals and the achievement of progress towards the goals.
8.2.6 A progress note shall be written and signed by the physician if he/she makes an on-site visit.
8.2.7 The nursing services provided either directly or through contractual arrangements include:
8.2.7.1 An assessment of the resident upon admission, by a registered nurse and development of written resident care plans in conjunction with the physician and other professionals as needed.
8.2.7.1.1 Individual written resident care plans to meet the resident's needs shall be developed within seven (7) days of admission and reviewed at least every 62 days by registered nurses and other professional disciplines, as required.
8.2.7.1.2 In the event that there is a significant change in the resident's medical or psychosocial condition the care plan shall be modified to meet the needs of the resident.
8.2.7.2 The coordination and monitoring of resident care and services with the physician and other health professionals by a registered nurse who visits the group home at least weekly.
8.2.7.3 A supervisory visit to the group home at least every two weeks by a registered nurse who conducts an assessment of the care provided by the certified nurse assistants.
8.2.7.4 The administration of treatments and medications by licensed nurses in accordance with the Nurse Practice Act.
8.2.8 There must be a sufficient number of trained personnel to provide for direct care of residents with a minimum of two (2) nursing service personnel on duty at all times. However, should all residents be ambulatory and capable of self-evacuation, only one nursing service personnel shall be required on duty at all times. Each nurse assistant employed by the group home shall have met the training and testing requirements for certification and be registered in good standing on the Delaware Nurse Aide Registry.
8.3 Infection Control:
8.3.1 Prevention and Control Services

The facility shall establish and implement an infection prevention and control program. The Administrator shall ensure the development and implementation of the program.

The facility shall establish and implement written policies and procedures regarding infection prevention and control including, but not limited to:

8.3.1.1 Universal Precautions as established by the Centers for Disease Control and Prevention (CDC).
8.3.1.2 A system for investigating, reporting, and evaluating the occurrence of all infections, diseases, or conditions which are reportable to the Division of Public Health that may be related to staff activities and procedures of the facility;
8.3.1.3 Notifiable diseases shall be reported to the County Public Health Administrator;
8.3.1.4 Care of residents with communicable diseases;
8.3.1.5 Policies and procedures for exclusion from work and authorization to return to work for personnel with communicable diseases;
8.3.1.6 Surveillance techniques to minimize sources and transmission of infection;
8.3.1.7 Disinfection, cleaning and care practices and techniques used in the facility including, but not limited to the following:
8.3.1.7.1 Care of utensils, instruments, solutions, dressings, articles and surfaces;
8.3.1.7.2 Selection, storage, use and disposition of disposable and non-disposable resident care item;
8.3.1.7.3 Methods to ensure that sterilized materials are packaged and labeled to maintain sterility and to permit identification of expiration dates;
8.3.1.7.4 Procedures for care of equipment and other devices that provide a portal of entry for pathogenic micro-organisms;
8.3.1.7.5 Techniques to be used during each resident contact including hand washing before and after caring for a resident;
8.3.1.7.6 Criteria and procedures for isolation of residents.
8.3.1.7.7 All personnel shall receive orientation at the time of employment and annual in-service education regarding the infection prevention and control program
8.3.2 Infectious Disease and Waste Removal

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, and for the collection, storage, handling and disposition of all pathological and infectious wastes to be removed from the facility, including, but not limited to the following:

8.3.2.1 Needles and syringes and other solid, sharp, or rigid items shall be placed in a puncture resistant container and incinerated or compacted prior to disposal.
8.3.2.2 Needles and syringes shall be destroyed or disposed of in a safe and proper manner by an infectious waste hauler approved by the Department of Natural Resources and Environmental Control.
8.3.2.3 Non-rigid items, such as blood tubing and disposable equipment and supplies, shall be incinerated or placed in double, heavy duty, impervious plastic bags and disposed of by an infectious waste hauler approved by the Department of Natural Resources and Environmental Control.
8.3.2.4 Fecal matter and liquid waste, such as blood and blood products, shall be flushed into, the sewage system or otherwise disposed of in accordance with federal, state and local standards or regulations.
8.3.2.5 All pathology specimens, tissue and waste, including gross and microscopic tissue removed surgically or by any other procedure and products of conception must be disposed of in compliance with OSHA (Occupational Safety and Health Administration), EPA (Environmental Protection Agency), DNREC (Department of Natural Resources and Environmental Control) and other state and local standards covering the treatment of medical waste.
8.3.2.6 Collection, storage, handling and disposition procedures of all pathological and infectious wastes within the facility shall meet the of all state and federal codes.
8.3.3 Specific Requirements for COVID-19
8.3.3.1 Before their start date, all new staff, vendors and volunteers must be tested for COVID-19 in accordance with Division of Public Health guidance.
8.3.3.2 All staff, vendors and volunteers must be tested for COVID-19 in a manner consistent with Division of Public Health guidance.
8.3.3.3 The facility must follow recommendations of the Centers for Disease Control and Prevention and the Division of Public Health regarding the provision of care or services to residents by staff, vendor or volunteer found to be positive for COVID-19 in an infectious stage.
8.3.4 The facility shall amend their policies and procedures to include:
8.3.4.1 Work exclusion and return to work protocols for staff tested positive for COVID-19;
8.3.4.2 Staff refusals to participate in COVID-19 testing;
8.3.4.3 Staff refusals to authorize release of testing results or vaccination status to the facility;
8.3.4.4 Procedures to obtain staff authorizations for release of laboratory test results to the facility to inform infection control and prevention strategies; and
8.3.4.5 Plans to address staffing shortages and facility demands should a COVID-19 outbreak occur.
8.4 Medications:
8.4.1 All medication administered to residents shall be ordered in writing, dated and signed by the attending physician. All prescription medications shall be properly labeled in accordance with 24 Del.C. Ch. 25 and the regulations of the Delaware Board of Pharmacy. The label shall contain the following information:
8.4.1.1 The prescription number;
8.4.1.2 The date such drugs were originally dispensed to the resident;
8.4.1.3 The resident's full name;
8.4.1.4 The brand or established name and strength of the drug to the extent that it can be measured;
8.4.1.5 The physician's directions as found on the prescription;
8.4.1.6 The physician's name;
8.4.1.7 The name and address of the dispensing pharmacy or physician.
8.4.2 Medications may be self-administered or administered in accordance with the Nurse Practice Act. Those residents who, upon admission, are incapable of self-administration or who become incapable of self-administration will have the medications administered according to the Nurse Practice Act.
8.4.3 The group home provider licensee shall maintain a record of all medication provided to a resident indicating time of day, type of medication, dose, route of self-administration/administration, by whom given and any reactions noted.
8.4.4 Medication Storage
8.4.4.1 Provisions for the locked storage of medications shall be provided. Medication storage area shall contain a work counter, refrigerator and hand sink. The key to the medication storage must be in the possession of or accessible only to personnel responsible for the distribution for self-administration/administration of medications. If secure storage of medications is provided in resident rooms for those residents capable of self-administration the key to the medication storage must be in the possession of the resident.
8.4.4.1.1 No stock supplies of drugs except those approved for the emergency drug kit and those commonly available without prescription (non-legend drugs), e.g., antacids, aspirin, laxatives, shall be kept in the facility.
8.4.4.1.2 Prescription medication not requiring refrigeration shall be kept in the original container stored in a locked cabinet or drawer, and clearly labeled for the specific resident. These medications shall be stored within the U.S.P. recommended temperature range of 59 - 86°F unless the manufacturer's labeling suggests otherwise.
8.4.4.1.3 Prescription medication requiring refrigeration shall be stored in a separate and secure locked container within the refrigerator. The temperature range must be maintained within U.S.P. requirements.
8.4.4.1.4 Schedule II substances/prescriptions shall be kept in separately locked, securely fixed boxes or drawers in the locked medication cabinet; hence, under two (2) locks.

Schedule II substances shall be handled in the manner outlined by the State and Federal laws and regulations. AD unused Schedule 11 substances shall be returned to the pharmacist for disposition.

8.4.4.1.5 Internal medications shall be stored separately from external medications.
8.4.4.2 The group home provider shall insure that prescription medication is not used by other than the resident for whom the medication was prescribed.
8.4.4.3 The group home provider is responsible for maintaining an adequate supply of medication at all times.
8.4.4.4 Prescription medication which is no longer needed by a resident shall be disposed of by a physician, pharmacist or other designee who must be a licensed medical professional in accordance with Delaware Board of Pharmacy Regulations. All unused portions of any resident's discontinued or expired prescriptions shall be immediately isolated and destroyed or returned to the pharmacist or provider pharmacy supplying pharmaceutical services within 72 hours. The appropriate notation of such return or destruction, providing a quantity, description and date on the resident's medical administration record shall be prowled. The person performing the return or destruction shall initial this document.
8.4.4.5 The facility may keep on the premises an emergency drug kit with quantities of medications approved by the Board of Pharmacy. These medications shall only be used by licensed physicians or licensed nurses in an emergency situation. Stocking of this kit shall be arranged with a pharmacist who checks the contents after use and/or periodically.
8.5 Food Service:
8.5.1 A minimum of three (3) meals or equivalent shall be served in each twenty-four (24) hour period. Meals shall be served at regular times comparable to normal mealtimes in the community. There must not be more than a fourteen (14) hour span between the evening meal and breakfast.
8.5.2 Meals shall provide nutrients and calories for each resident based upon compliance with current recommended dietary allowances of the Food and Nutrition Board of the National Academy of Sciences, National Research Council, except as ordered by a physician.
8.5.3 Food preparation methods that conserve nutrients shall be utilized. Excessive exposure to light, prolonged storage, and prolonged cooking in a large quantity of water shall be avoided.
8.5.4 Food shall be prepared so that it will have an appetizing aroma and appearance. Food shall be held and served at proper temperatures in accordance with the current Delaware Food Code.
8.5.5 Food shall be prepared in a form designated to meet individual needs.
8.5.6 When residents refuse food served, substitutes of similar nutritive value shall be offered.
8.5.7 Bedtime snacks shall be offered routinely to all residents to the extent medical orders permit.
8.5.8 Diets and nutritional supplements shall be saved as prescribed by the physician. Meal and supplement intake shall be monitored by nursing service personnel and recorded in each resident's clinical record.
8.5.9 A copy of a recent diet manual shall be available for planning therapeutic menus and as a resource.
8.5.10 Menus shall be planned in advance and a copy of the current week's menus shall be posted in the kitchen and in a public area.
8.5.10.1 Portion sizes shall be listed on a menu in the food service area.
8.5.10.2 The names of fruit, vegetables or starch shall be specified on the menu (for example: orange juice, green beans, rice).
8.5.10.3 All menus, both regular and therapeutic, shall be approved by the dietitian.
8.5.11 Menus showing food actually served each day shall be kept on file for at least one (1) month. When changes in the menu are necessary, substitutions of similar nutritive value shall be provided.
8.5.12 A three (3) day supply of food shall be kept on the premises at all times.
8.5.13 A suspected occurrence of food poisoning shall be reported immediately, by telephone, to the County Public Health Administrator.
8.6 Nutrition Services
8.6.1 The facility must employ a dietitian directly or through contractual arrangements, either full time, part time or on a consultant basis, and provide on-site services to residents as needed.
8.6.2 The immediate nutritional needs of residents shall be addressed upon admission with consultation by the dietitian as needed. A comprehensive nutritional assessment which includes height and weight and an evaluation of calories, protein and fluid requirements shall be completed by the dietitian and updated and reviewed as indicated by the resident's condition.
8.6.3 The facility shall obtain residents' weights monthly or more often as needed.
8.6.4 Weight changes of 5 pounds or 5% of body weight in one month shall be reported to the physician and dietitian.
8.7 Records and Reports:
8.7.1 There shall be a separate clinical record maintained at the group home on each resident which shall be a chronological history of the resident's stay in the group home. Each resident's records shall contain:
8.7.1.1 Admission record: Including resident's name, birth date, home address prior to entering the facility, identification numbers, such as social security, Medicaid, Medicare, date of admission, physician's name, address and phone number, admitting diagnosis, next of kin (relationship, name, address and phone number).
8.7.1.2 History and physical examination: Prepared by physician within seven (7) days of the resident's admission. A summary and history which was prepared at the hospital and the resident's physician examination which was performed at the hospital, if performed within seven (7) days prior to admission to the home, may be substituted. Additionally, a record of an annual medical evaluation performed by a physician must be contained in each resident's file.
8.7.1.3 Statement of complete diagnosis and prognosis.
8.7.1.4 Physician's orders shall include:
8.7.1.4.1 Complete list of medications, medication name, dosage, frequency and route of administration, indication for usage;
8.7.1.4.2 If "as needed" medications are ordered, the reason why the resident takes the medication and the maximum dose in a 24 hour period;
8.7.1.4.3 Treatments, diets and level of permitted activity.
8.7.1.5 Physician's progress notes with each on-site visit. If medical services are obtained in the physician's office a summary including diagnosis and prognosis, changes in medication mid therapy and necessary follow-up will be provided.
8.7.1.6 Nursing notes, shall be recorded by each person providing professional nursing services to the resident, indicating date, time, scope of service provided and signed by the provider of the service.
8.7.1.7 Medication sheets: Including medication, name, dosage, frequency and route of administration, space for the resident to record his/her initials if medication is self-administered or for recording the initials of the medical professional authorized and responsible for administration of the medication.
8.7.1.8 Inventory of personal effects both upon admission and at time of transfer and/or discharge.
8.7.1.9 For discharged or transferred residents, the records shall contain the following:
8.7.1.9.1 A discharge summary containing the:
8.7.1.9.1.1 Date and time of discharge,
8.7.1.9.1.2 Place to which the resident was discharged;
8.7.1.9.1.3 Condition of resident at time of discharge.
8.7.1.9.2 The resident's written consent for discharge or discharge order from the resident's physician.
8.7.1.9.3 Copies of the name of the resident's guardian, powers of attorney and advance directives, if applicable.
8.7.1.10 Special service notes: e.g., social services and activities, results of special consultations, requested by the physician such as physical therapy, dental and podiatry if services me provided in the group home.
8.7.1.11 Nutrition progress notes.
8.7.1.12 Copy of an interagency transfer form if the resident was admitted from an acute care facility or any other long term care facility or transferred to an acute care or other type of health care facility.
8.7.1.13 Documentation of the percentage of intake for each meal.
8.7.1.14 Recording of weights obtained including the date the weight was obtained.
8.7.1.15 Laboratory work, special tests, and x-rays ordered by the physician.
8.7.2 Records shall be available at all times to legally authorized persons; otherwise, such records shall be held confidential.
8.7.3 Clinical records shall be retained for five (5) years from the date of discharge.
8.7.4 Should the facility cease operation, all resident records shall be transferred with the resident to another home or facility, with written receipt acknowledging the transfer which shall be signed by the resident and the new administrator.
8.7.5 If a facility ceases operation, arrangements, shall be made to retain discharge records for five (5) years following closure.
8.7.6 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.

Incident reports shall be kept on file in the facility. Reportable incidents shall be communicated immediately to the Division of Long Term Care Residents Protection, 3 Mill Road, Suite 308, Wilmington, DE 19806; phone number: 1-877-453-0012; fax number: 1-877-264-8516.

16 Del. Admin. Code § 3301-8.0

5 DE Reg. 1079 (11/1/01)
25 DE Reg. 762( 2/1/2022) (Final)