Header:
NORTH DAKOTA ADMINISTRATIVE CODE
TITLE 33. STATE DEPARTMENT OF HEALTH
ARTICLE 7. LICENSING MEDICAL HOSPITALS
CHAPTER 1.1. HOSPITALS
Date:
08/31/2009
Document:
33-07-01.1-09. Governing body.
The governing body is legally responsible for the quality of patient care services, for patient safety and security, for the conduct, operation, and obligations of the hospital as an institution, and for ensuring compliance with all federal, state, and local laws.
1. General acute hospital. The hospital must have a governing body legally responsible for directing the operation of the hospital in accordance with its mission. Hospitals operated by governmental organizations, with the exception of those sponsored by the federal government, shall provide written notification to the department of their designated governing bodies and the legal authority establishing these designations. No contracts, arrangements, or other agreements may limit or diminish the responsibility of the governing body in any way.
a. The governing body, in order to achieve and maintain generally accepted standards of professional practice and patient care services in the hospital, shall establish, cause to implement, maintain, and, as necessary, revise its practices, policies, and procedures for the ongoing evaluation of the services operated or delivered by the hospital and for the identification, assessment, and resolution of problems that may develop in the conduct of the hospital.
b. The governing body shall receive orientation and continuing education addressing the mission of the hospital, their roles and responsibilities, patients' rights, and the organization, goals, and operation of the hospital.
c. The governing body shall adopt written bylaws reflecting its legal responsibility and accountability to the patients and its obligation to the community. The bylaws must specify at least the following:
(1) The role and purpose of the hospital.
(2) The duties and responsibilities of the governing body.
(3) The responsibilities of any governing body committees, including the requirement that minutes reflect all business conducted, including findings, conclusions, and recommendations.
(4) The relationships and responsibilities of the governing body, hospital administration, and medical staff, and the mechanism established by the governing body for holding such parties accountable.
(5) The mechanisms for adopting, reviewing, and revising governing body bylaws.
(6) The mechanisms for formal adoption of the organization, bylaws, rules, and regulations of the medical staff.
d. Meetings of the governing body must be held in order for the governing body to evaluate the conduct of the hospital, including the care and treatment of patients as well as its own performance. Based on these evaluations, the governing body shall take necessary actions sufficient to correct noted problems. A record of all governing body proceedings which reflects all business conducted, including findings, conclusions, and recommendations, must be maintained for review.
e. The governing body shall ensure the establishment and maintenance of a coordinated quality improvement program that integrates the review activities of all hospital services for the purpose of enhancing the quality of patient care.
f. The governing body shall ensure that policies and procedures are reviewed at a minimum of every three years and when changes in standards of practice occur and shall at a minimum include:
(1) Personnel records including application forms and verification of credentials where applicable.
(2) Periodic performance appraisals.
(3) Patient care needs and services as determined by the hospital.
(4) Patient rights to include at least the following and require that each patient admitted be notified of these rights.
(a) The right to considerate and respectful care.
(b) The right to treatment and services consistent with acceptable professional standards of practice.
(c) The right to make informed decisions involving care in collaboration with the licensed health care practitioner.
(d) The right to personal privacy and confidentiality of information.
(e) The right to review the patient's own medical record and to have information explained.
(f) The right to formulate advanced directives consistent with the federal Self Determination Act.
(g) The right to consent or decline to participate in proposed research studies.
(h) The right to expect reasonable continuity of care at the time when hospital care is no longer needed.
(i) The right to be informed of hospital policies and practices that relate to patient care, treatment, and responsibilities.
(j) The right to be free from abuse, neglect, and misappropriation of patient property.
(5) The orientation program for all new employees.
(6) The governing body shall ensure the establishment and maintenance of a risk management plan that includes a mechanism for reporting, investigating, acting on, and documenting incidents and identified risks.
(7) The transfer and discharge of patients, including discharge planning to meet the patients' needs.
(8) An effective procedure for reporting transfusion reactions and adverse drug reactions to the licensed health care practitioner. The governing body shall ensure that blood transfusions and intravenous medications are administered in accordance with state law.
(9) An effective disaster plan.
g. The governing body shall develop a procedure to ensure that all personnel for whom licensure or certification is required have a valid and current license or certificate.
h. The governing body shall take all appropriate and necessary actions to monitor and restore compliance when deficiencies with statutory or regulatory requirements are identified.
i. The governing body shall appoint a chief executive officer who is responsible to the governing body for the management of the hospital. The governing body shall assure the chief executive officer's effective performance through ongoing documented monitoring and evaluation of that performance against written criteria developed for the position. Criteria must include, at a minimum, the hospital's compliance with statutory and regulatory requirements, the corrective actions required and taken to achieve such compliance, and the maintenance of corrective actions to achieve continued compliance in previously deficient areas.
j. The governing body shall ensure that the medical staff comply with the following:
(1) Determine in accordance with state law which categories of licensed health care practitioners are eligible candidates for appointment to the medical staff.
(2) Appoint a physician as chief of staff who has been approved by the medical staff and is qualified for membership on the medical staff. The chief of staff is responsible for directing the medical staff organization and shall report to the governing body.
(3) Ensure the implementation of written criteria for selection, appointment, and reappointment of medical staff members and for the delineation of their medical privileges.
(4) Ensure that staff membership or professional privileges in the hospital are not dependent solely upon certification, fellowship, or membership in a specialty body or society.
(5) Appoint members of the medical staff after considering the recommendations of the existing members of the medical staff in accordance with written procedures.
(6) Ensure that actions taken on applications for medical staff appointments and reappointments including the delineation of privileges are put in writing.
(7) Approve and ensure that the medical staff has written bylaws, rules, and regulations.
(8) Require that members of the medical staff abide by the medical staff bylaws, rules, and regulations.
(9) Ensure that the medical staff is accountable to the governing body for the quality of care provided to patients.
(10) Require that members of the medical staff practice only within the scope of privileges granted by the governing body.
k. The governing body shall ensure that the following patient care practices are implemented and monitored and take corrective action as necessary to attain compliance:
(1) Every patient of the hospital, whether an inpatient, emergency service patient, or outpatient, must be provided care that meets generally acceptable standards of professional practice.
(2) Every patient must be under the care of a licensed health care practitioner who is credentialed by the medical staff.
(3) Patients must be admitted to the hospital only by a licensed health care practitioner with admitting privileges.
(4) Staff must be available at all times, sufficient to meet the patient care needs.
(5) A patient's licensed health care practitioner shall arrange for the care of the patient by an alternate licensed health care practitioner during his or her unavailability.
(6) One or more licensed health care practitioners must be on duty or call at all times and available to the hospital within thirty minutes to give necessary orders or medical care to patients in case of emergency.
(7) Every patient must receive effective discharge planning consistent with identified patient and family needs from the hospital. Discharge planning must be initiated in a timely manner. Patients, along with necessary medical information, must be transferred or referred to appropriate facilities, agencies, or outpatient services, as needed, for followup or ancillary care.
(8) That all medical orders must be in writing and signed and dated by a licensed health care practitioner.
l. The governing body is responsible for providing a physical plant equipped with the needed facilities and services for the care of patients in compliance with construction standards contained in chapter 33-07-02.1.
m. The governing body is responsible for services furnished in the hospital whether or not they are furnished by outside entities under contracts. The governing body shall ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable laws, codes, rules, and regulations.
(1) The governing body shall ensure that the services performed under a contract are provided in a safe and effective manner.
(2) The hospital shall maintain a list of all contracted services, including the scope and nature of the services provided.
2. A primary care hospital shall have a governing body that is legally responsible for the conduct of the hospital and shall at least:
a. Adopt written bylaws reflecting its legal responsibility and accountability to the patients and its obligation to the community. The bylaws must specify at least the following:
(1) The role and purpose of the hospital.
(2) The duties and responsibilities of the governing body.
(3) The responsibilities of any governing body committees, including the requirement that minutes reflect all business conducted, including findings, conclusions, and recommendations.
(4) The relationships and responsibilities of the governing body, hospital administration, and medical staff, and the mechanism established by the governing body for holding such parties accountable.
(5) The mechanisms for adopting, reviewing, and revising governing body bylaws.
(6) The mechanisms for formal adoption of the organization, bylaws, rules, and regulations of the medical staff.
b. Ensure that the medical staff:
(1) Are approved by the governing body after considering the recommendations of the existing members of the medical staff.
(2) Have current bylaws and written policies that are approved by the governing body.
(3) Are accountable to the governing body for the quality of care provided to patients.
(4) Are selected on the basis of individual character, competence, training, experience, and judgment.
c. Approve a chief executive officer who is responsible for managing the hospital.
d. In accordance with a written policy, ensure that:
(1) Every patient is under the care of a licensed health care practitioner who is a member of the medical staff.
(2) Whenever a patient is admitted to the hospital by a physician assistant, the physician assistant's supervising physician must be notified of that fact, by phone or otherwise, within four hours after the admission and a written notation of that consultation and of the physician's approval or disapproval must be placed in the patient's medical record.
(3) A licensed health care practitioner must be on duty or on call at all times and available to the hospital to give necessary orders and medical care in the case of emergency.
(4) Sufficient staff must be available at all times to meet patient care needs.
(5) That all medical orders must be in writing and signed and dated by a licensed health care practitioner.
e. Maintain a list of all contracted services, including the scope and nature of the services provided, and ensure that a contractor providing services to the hospital:
(1) Furnishes services that permit the hospital, including the contracted services, to comply with all applicable laws, codes, rules, and regulations.
(2) Provides the services in a safe and effective manner.
f. Ensure that the medical and nursing staff of the hospital are licensed, certified, or registered in accordance with state statutes and rules and that each such staff member provides health services within the scope of his or her license, certification, or registration.
g. Ensure that all drugs and biologicals are administered by, or under the supervision of, personnel in accordance with federal and state laws and rules and in accordance with medical staff policies and procedures which have been approved by the facility's governing body.
h. Ensure that each order for drugs and biologicals is consistent with federal and state law and is in writing and signed by the licensed health care practitioner who is both responsible for the care of the patient and legally authorized to prescribe.
i. Ensure that blood transfusions and intravenous medications are administered in accordance with state law.
j. Establish a quality improvement committee, at least one member to be an appropriately licensed health care practitioner.
k. Provide a physical plant equipped with the needed facilities and services for patients in compliance with construction standards contained in chapter 33-07-02.1.
l. Have written contracts for referral purposes. The hospital shall have agreements with at least the following:
(1) A general acute hospital.
(2) A provider of specialized diagnostic imaging or laboratory services that are not available at the facility.
3. Specialized hospitals are subject to the governing body requirements for general acute hospitals in this section.
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