175 Neb. Admin. Code, ch. 9, § 006

Current through September 17, 2024

Section 175-9-006 - STANDARDS OF OPERATION, CARE AND TREATMENT

Each hospital is to be organized, managed, and administered by the licensee to ensure each patient receiving services at the facility receives necessary care and treatment in a safe manner, and in accordance with current standards of practice, the Health Care Facility Licensure Act, 175 NAC 1, and this chapter. Each hospital offsite location and mobile unit must meet the standards except where specified otherwise.

006.01.LICENSEE RESPONSIBILITY. The responsibilities of the licensee include:

(A) Implementing policies and procedures to govern the total operation and maintenance of the facility;

(B) Maintaining hospital compliance with all applicable state and federal statutes, codes, Rules, and regulations;

(C) Ensuring the quality of all services, care and treatment provided a patient whether those services, care or treatment are furnished by hospital staff or through contract with an outside entity;

(D) Designating an administrator in writing who is responsible for the day to day management of the hospital;

(i) Defining the duties and responsibilities of the administrator in writing;

(ii) Notifying the Department in writing within 5 working days if:

(1) A vacancy in the administrator position occurs including the name of who is responsible for the position until another administrator is appointed; and

(2) A vacancy in the administrator position is filled including the effective date and name of person appointed to that position;

(E) Determining which categories of practitioners are eligible candidates for appointment to the medical staff;

(F) Ensuring that medical staff membership or clinical privileges in the hospital does not depend solely upon certification, fellowship or membership in a specialty body or society although board certification can be one permissible criterion;

(G) Appointing and reappointing medical staff members and delineating clinical privileges, according to credential review procedures established by the medical staff and approved by the governing authority;

(H) Establishing criteria for membership on the medical staff or clinical privileges, in collaboration with the medical staff;

(i) Making final decisions regarding medical staff recommendations for denial of appointments and reappointments, and for the denial limitation, suspension, or revocation of privileges, ensuring the practitioner has a right to be heard upon request;

(J) Ensuring the medical staff is accountable to the licensee for the quality of medical care and treatment provided;

(K) Ensuring a medical staff committee and a utilization review committee are formed and operated for the purpose of reviewing care and treatment provided to provide a high standard of medical care and promote the efficient use of the hospital;

(L) Ensuring that any person working at and having any information or knowledge relating to the medical and hospital care provided or the efficient use of the hospital facilities, provides all related facts and information to the hospital medical staff committee or utilization review committee upon request by the committee or committees;

(M) Reviewing reports and making recommendations regarding all Quality Assurance Performance Improvement, Medical Staff, and Utilization Review Committee activities. Ensuring these reports are utilized to implement programs and policies to maintain and improve the quality of patient care and treatment;

(N) Establishing and promoting effective communication and coordination between the governing authority, the medical staff, administration, and the hospital departments;

(O) Approving the organization, bylaws, rules, and regulations, and policies and procedures of the medical staff and departments in the hospital; and

(P) Establishing visitation policies which are in the best interest of patients to ensure their health and safety, and provide protection from communicable diseases, exposure to dangerous substances, and hazardous equipment.

006.02GOVERNING AUTHORITY RECORDKEEPING. If a licensee has a governing authority, it must hold regularly scheduled meetings and minutes of the meetings must be retained for a minimum of 7 years.

006.03.ADMINISTRATION. The administrator is to plan, organize, and direct the day to day operations of the hospital. The administrator is directly responsible to the licensee and the governing authority, if any, in all matters related to the maintenance, operation, and management of the facility. The administrator's responsibilities include:

(A) Being on the premises a sufficient number of hours to ensure adequate attention to the management of the hospital;

(B) Providing for the protection of patients' health, safety, and well-being;

(C) Ensuring staffing in numbers and qualifications to meet patient care and treatment, and operation needs;

(D) Designating a substitute in writing, to act in their absence as needed;

(E) Being available during all hours of facility operation; and

(F) Ensuring the completion, maintenance, and submission of reports and records as required by federal or state statute, regulation, and the Department.

006.04ADMINISTRATIVE RECORDS. Accurate and complete administrative records of each facility's operation, including an annual report that summarized the scope and volume of services provided by the facility must be maintained and kept for a minimum of 7 years.

006.05PERMANENT PATIENT INDEX. A permanent patient index must be maintained that includes:

(A) Name and identification numbers of each patient;

(B) Dates of admission and discharge;

(C) Name of admitting physician or health care practitioner; and

(D) Location to which patient was discharged.

006.06CONSUMER SATISFACTION. A written process to measure consumer satisfaction with the services being provided by the facility must be established, implemented, and revised as necessary.

006.07OFF-CAMPUS, SATELLITE LOCATIONS AND MOBILE UNITS. All off-campus, satellite locations or mobile units are to be approved by the Department and listed on the license prior to patient care and treatment being provided at a location.

006.08MOBILE UNITS. Each mobile unit must have a designated location schedule available to the public at all times, identifying where the unit will be located so that unannounced inspections can occur as required in 175 NAC 1.

006.09MEDICAL STAFF. Each hospital is to have a medical staff that is organized and functions in a manner consistent with the size, needs, and resources of the facility. The medical staff responsibilities are:

(A) Participating in the Quality Assurance Performance Improvement meetings;

(B) Abiding by hospital and medical staff policies;

(C) Establishing a disciplinary process for violation of a policy;

(D) Reviewing the background, experience, training, and credentials of applicants for initial medical staff membership; and

(E) Recommending criteria and procedures for appointment and reappointment, and to delineate clinical privileging to ensure the provision of quality patient care and treatment.

006.09(i)MEDICAL STAFF APPOINTMENT. Membership on the medical staff will be limited to those disciplines specified in the medical staff bylaws, rules and regulations or other similar governance document. Criteria for appointment and reappointment must include continuing licensure or authority to practice in Nebraska.

006.09(ii)CLINICAL PRIVILEGES. The medical staff is to establish a written process for the delineation of clinical privileges which includes:

(1) Each discipline and the procedures or tasks for which medical staff in that discipline must be privileged to perform;

(2) A process for the review of clinical privilege requests, including a competency component;

(3) A process for notification of clinical privilege decisions; and

(4) A process for appealing decisions to deny, limit, or otherwise modify privileges.

006.09(iii)MEDICAL STAFF BYLAWS. The medical staff must recommend and adhere to the medical staff bylaws. Medical staff bylaws must include:

(1) A description of how the medical staff is organized;

(2) The time frame for medical staff meetings and the rules for conducting business;

(3) Methods for evaluating clinical practice in the hospital;

(4) Criteria and procedures for membership and clinical privileges;

(5) The procedure for medical staff adoption and amendment of medical staff bylaws; and

(6) Provision for establishing a utilization review committee.

006.10STAFFING. A licensee must maintain a sufficient number of staff with the required experience, orientation, training, and competency necessary to meet the care and treatment needs of patients and the operational needs of the hospital. Each hospital must be staffed 24 hours per day. All staff are to wear visible identification to identify them to patients or their designee by name and title. A written job description is to be on file outlining the minimum qualifications and job duties for each position. Any unlicensed staff who assist in the provision of care and treatment provided to patients, must be supervised by a health care professional. Staff cannot provide care or treatment that is outside the scope of practice permitted by the credential held by the individual.

006.11STAFF CREDENTIALS. Staff credentials are to be verified prior to staff assuming assigned job duties, and the licensee must maintain evidence that such status is checked and maintained throughout the entire time of employment.

006.12STAFF HEALTH STATUS. A health history screening for all staff must be completed prior to staff assuming job duties. A licensee must make sure staff health status is maintained in a manner to prevent the potential transmission of disease to patients, visitors, and other staff.

006.13CRIMINAL BACKGROUND AND REGISTRY CHECKS. Criminal background and registry checks must be completed on any staff members who have direct and unsupervised access to or who provide care and treatment to patients at the facility. These checks must be completed prior to the staff having unsupervised contact with any patients at the facility. Documentation of such checks is to be maintained for as long as the staff member is employed at the facility.

006.13(A)CRIMINAL BACKGROUND CHECKS. A criminal background check must be completed through a governmental law enforcement agency or a private entity.

006.13(B)REGISTRY CHECKS. A check for adverse findings must include these Nebraska registries and similar registries in states where the individual has resided in the past 10 years:

(i) Nurse Aide Registry;

(ii) Adult Protective Services Central Registry;

(iii) Central Register of Child Protection Cases; and

(iv) Sex Offender Registry.

006.13(C)USE OF CRIMINAL BACKGROUND AND REGISTRY INFORMATION. Written policies and procedures are to be implemented and revised as necessary related to the use of information obtained through pre-employment criminal background and registry checks. These are to include the following:

(i) Staff with adverse findings on the registries regarding abuse, neglect or misappropriation must not be employed at the facility;

(ii) How information will be used in making hiring decisions;

(iii) Whether employment can begin prior to receiving the results of the checks, how the safety or property of patients will be safeguarded until the results are available; what happens if the results have adverse findings; and

(iv) How to maintain documentation of this information.

006.14STAFF TRAINING. Staff must receive initial and ongoing training and demonstrate competency before being assigned to independently perform job duties and assigned tasks. Training must be provided by a person qualified by education, experience, and knowledge in the subject area provided. The facility is to maintain the following documentation in each staff member's personnel file:

(A) Date and time training was provided;

(B) Summary of the information provided to staff;

(C) Instructor name;

(E) Staff sign in documentation; and

(F) Results of competency or other testing completed as a result of each training.

006.15STAFF ORIENTATION. An orientation program must be provided for all new staff and for existing staff who are given new assignments. Documentation of this training must be maintained in each staff member's personnel file. The initial orientation program is to include the following:

(A) Job duties and responsibilities;

(B) The facility sanitation and infection control program;

(C) Organizational structure;

(D) Patient rights;

(E) Patient care policies and procedures;

(F) Personnel policies and procedures;

(G) Emergency preparedness and disaster procedures;

(H) Disaster preparedness plan;

(I) Reporting requirements for abuse, neglect, and exploitation in accordance with the Adult Protective Services Act, Neb. Rev. Stat. § 28-372, or in the case of a child in accordance with Neb. Rev. Stat. § 28-711, and with facility policies and procedures; and

(J) The facility hand hygiene program.

006.16PATIENT RIGHTS. Each patient is to be afforded the opportunity to exercise his or her rights. Documentation that all patients or designee, when appropriate, have been informed of their rights in a manner and format they can understand must be kept in the medical record for each patient. Each patient has the right to:

(A) Respectful, safe care given by trained and competent staff;

(B) Be informed of their rights during admission in a manner and format they can understand;

(C) Participate in the development and implementation of a plan of care and any changes to that plan;

(D) Make informed decisions regarding care and treatment options and be provided with information necessary to assist in making those decisions;

(E) Be informed of the possible consequences of refusing care and treatment, to freely make a choice, and to be free from retaliation from the facility and staff for choosing to refuse care and treatment options;

(F) Formulate advance directives and to have the facility comply with the directives unless the facility notified the patient or designee in writing they are unable to comply and the reasons the facility is unable to comply;

(G) Personal privacy and confidentiality of their medical records;

(H) Freedom from abuse, neglect, and exploitation;

(I) View information contained in their own medical record within a reasonable time when requested, excluding limited circumstances where the attending physician determines and documents that disclosure to the patient would be harmful;

(J) Freedom from restraints or seclusion used for staff convenience and not utilized to treat medical conditions;

(K) Receive services without discrimination based upon race, color, religion, gender, national origin, or payer source; however, hospitals are not required to provide uncompensated or free care and treatment unless otherwise required by law;

(L) Voice complaints and file grievances without discrimination or reprisal and have those complaints and grievances addressed within a reasonable period of time; and

(M) Receive visitors. The hospital may refuse access to any person for any of the following reasons:

(i) The patient refuses to see the visitor;

(ii) The presence of the visitor may be injurious to the health and safety of the patient;

(iii) The visitor's behavior is unreasonably disruptive to the facility and the behavior is documented by the facility;

(iv) The presence of the visitor threatens the security of patients, staff, or facility property; or

(vi) The visitor is restricted by court order, the patient's guardian or legal representative or designee.

006.17ABUSE, NEGLECT AND EXPLOITATION. A licensee must address any situation where there is reason to believe that abuse, neglect, or exploitation of a patient has occurred by a staff member, volunteer, family member, visitor, or any other person as provided in the Adult Protective Services Act or Child Protective Services Act.

006.17(A)REPORTING. Any suspected abuse, neglect or exploitation of a patient must be reported to:

(i) The Adult and Child Abuse and Neglect Hotline via telephone immediately; and

(ii) Local law enforcement as required by state and federal laws.

006.17(B)INVESTIGATION. Any incident of suspected abuse, neglect, or exploitation of a patient must be thoroughly investigated and a written report of the investigation must be submitted to the Department within 5 working days of the occurrence.

006.17(C)PROTECTION. All patients must be protected throughout the investigation of any suspected abuse, neglect, or exploitation. Actions must be implemented as a result of the investigation to ensure patient safety and to prevent the potential for recurrence.

006.18ADVANCED DIRECTIVES. Each licensee must comply with the requirements of the Health Care Power of Attorney Act and the Rights of the Terminally Ill Act. Patients or designees must be informed in a manner and format they can understand upon admission of the facility policies and procedures, and at the time of any change to the policies and procedures.

006.19PATIENT EDUCATION RECORD KEEPING REQUIREMENTS. Documentation of all education provided to a patient or their designee is to be retained in each patient's medical record. This information needs to include:

(A) The name of the persons who were provided education and their relationship to the patient;

(B) Information provided; and

(C) The date the education was provided, along with the name and title of the person providing the education.

006.20DISCHARGE PLANNING. Discharge planning must be provided for all patients and his or her designee which is to include:

(A) Development of a discharge plan which includes input from the patient or designee;

(B) Identification of the staff responsible for the discharge planning program;

(C) Education regarding identified diagnoses, treatment provided, medications, and follow up needed in a manner and format the patient or designee can understand;

(D) A complete and accurate list of community-based services, resources, and facilities for the patient or designee to choose from to meet their post-hospital care needs; and

(E) Any transfer of necessary medical information to facilitate continuity of care upon discharge.

006.20(i)DISCHARGE PLANNING RECORD KEEPING REQUIREMENTS. Documentation of all discharge planning and education provided to a patient or his or her designee must be retained in each patient's medical record. This needs to include:

(1) The name of the persons who were involved in the discharge planning process and their relationship to the patient;

(2) Information provided;

(3) Date and time the discharge information was provided to the patient or designee along with the name and title of the person providing the education.

006.21PERSONAL POSSESSIONS. Patient personal possessions or belongings brought into the facility at the time of admission must be safeguarded. The facility must maintain documentation of patient personal items upon admission and must reconcile them with the patient and or designee upon discharge from the facility.

006.22PLAN OF CARE. A plan of care is to be established according to each patient's individual needs which must be kept current throughout the hospital stay. The plan of care must include a communication component which encompasses methods and interventions outlining how facility staff need to communicate with the patient and their designee in a manner and method the patient and designee can comprehend. The plan of care may be interdisciplinary when appropriate to meet a patient's needs.

006.23LABORATORY SERVICES. A licensee must provide clinical laboratory services either directly or through agreement, or contract, which comply with the federal Clinical Laboratory Improvement Amendments of 1988 as amended. Laboratory services are to include:

(A) Identification of a physician who meets the qualifications for laboratory director, preferably a pathologist;

(B) Necessary laboratory services and testing as determined by the medical staff;

(C) Emergency laboratory services, including urinalysis, complete blood counts, blood typing and cross matching, and other necessary emergency laboratory services and tests as determined by the medical staff;

(D) Receipt and reporting of tissue specimens; and

(E) Which tissue specimens require macroscopic examination and which tissue specimens require both macroscopic and microscopic examination as determined by the medical staff.

006.23(i)LABORATORY SERVICES RECORD KEEPING. All laboratory testing reports and results must be maintained in the individual patient records to whom they apply.

006.23(ii)LABORATORY SERVICES PHYSICAL PLANT REQUIREMENTS. A licensee is to have dedicated laboratory areas for sample collection, protection, analyzing, testing and storage.

006.24NUTRITIONAL SERVICES. Nutritional services must include:

(A) Assessment of a patient's nutritional status by a licensed medical nutrition therapist;

(B) A therapeutic diet order for a patient may be written by the following professions, if approved by the medical staff and credentialed by the licensed hospital, in accordance with state and federal law:

(i) Medical Practitioner; or

(ii) Licensed Medical Nutritional Therapist in accordance with Neb. Rev. Stat. § 38-1813;

(C) Education on diet and nutrition in a language and format the patient or designee can understand;

(D) A sufficient number of qualified and competent dietary and nutritional staff as determined by each individual hospital needs on duty;

(E) Menus to be planned, written, and followed;

(F) Meals are to be served to patients at appropriate times and intervals; and

(G) The Nebraska Food Code must be met at all times.

006.24(i)NUTRITIONAL SERVICES PHYSICAL PLANT REQUIREMENTS. If food preparation is provided onsite, a licensee is to have dedicated space and equipment for the preparation, storage, and processing of meals. Food service physical environment must comply with the Nebraska Food Code, except when used exclusively for activities or training purposes.

006.24(ii)DINING AREAS. If provided, dining areas for patients must have an outside wall with windows for natural light and ventilation and must not be in spaces used for sleeping, offices, or corridors. Each dining area needs to:

(1) Be furnished with tables and chairs that accommodate or conform to patient needs;

(2) Have a floor area of 15 square feet per patient in existing facilities; and

(3) Allow for group dining at the same time in either separate dining areas, or a single dining area, dining in 2 shifts or dining during open dining hours.

006.25PHARMACY SERVICES. Medications, devices, and any biologicals must be under the supervision of a licensed Nebraska pharmacist or licensed Nebraska physician. The storage, control, handling, compounding, and dispensing of drugs, devices, and biologicals must be in accordance with state and federal law. Any licensee that has a pharmacy or engages in the practice of pharmacy must do so in accordance with the Pharmacy Practice Act. Each licensee must identify a qualified, competent Nebraska licensed pharmacist designated as the pharmacist-in-charge.

006.25(A)HOSPITAL PHARMACY QUALITY ASSURANCE REPORT. All hospital pharmacies must complete and submit a Hospital Pharmacy Quality Assurance Report form and annual inventory of controlled substances to the Division of Public Health for review.

006.25(A)(i)DUE DATE. The Hospital Pharmacy Quality Assurance Report and inventory must be submitted no later than May 1 annually.

006.25(A)(ii)PLAN OF CORRECTION. If deficiencies are found in either the Hospital Pharmacy Quality Assurance Report or the inventory the licensee must submit a plan of correction.

006.26MEDICATIONS, BIOLOGICALS AND DEVICES. Medications, biologicals, and devices may only be provided to patients as legally prescribed by a medical practitioner and administered by a health care professional who has medication administration included in their scope of practice and may only be dispensed by a Nebraska licensed pharmacist or a Nebraska licensed physician with a dispensing permit. Pharmacy services are to include:

(A) A current policy and procedure manual regarding the administration and handling of all medications and biologicals in the facility available to all staff at all times;

(B) A documented count of all controlled substances completed every shift;

(C) Authorized personnel permitted access to medications and biologicals;

(D) Written procedures for the self-administration of medication, if applicable;

(E) Medication error and adverse reaction reporting and documentation;

(F) Information related to interactions, contraindications, side effects, toxicology, dosage, indications for use, and routes of administration available to staff at all times;

(G) Emergency medications and biologicals;

(H) Checking for expired, mislabeled or otherwise unusable medications, devices or biologicals on a regular basis, and method of keeping them from being used for patients;

(I) Dispensing of medications and biologicals;

(J) If performed, compounding of medication must be done by personnel trained to compound, in compliance with written procedures for the process of compounding and in accordance with state and federal law;

(K) The use, storage of, and provision of sample medications and biologicals;

(L) Recording, reporting, and investigating the abuse or loss of any drugs and biologicals;

(M) Storage of all drugs, devices, and biologicals in secured areas, and in accordance with the manufacturer's, distributor's, packager's, or dispensing pharmacist's instructions regarding temperature, light, humidity, and other storage instructions;

(N) Information regarding all drugs, devices, and biologicals administered, provided, or dispensed to a patient must be recorded and maintained in the patient's medical record. The record must contain the date of administration or provision; the identification of the person who administered or provided the medication, device or biological to the patient; the patient's medication allergies and sensitivities; any refusal of medication by the patient or the patient's designee; and any time a drug, device, or biological ordered by a medical practitioner has not been provided to the patient in accordance with the medical practitioner's order;

(O) A complete and accurate record of all medications, devices, and biologicals received, stored, administered, provided, dispensed, or disposed of by the hospital must be kept and maintained for a minimum of 7 years; and

(P) Drugs, devices, and biologicals used as part of a clinical investigation must be maintained in a locked and separate area from all other drugs, devices, and biologicals, and must only be administered in accordance with the clinical study protocol.

175 Neb. Admin. Code, ch. 9, § 006

Amended effective 11/11/2023

Amended effective 11/12/2023