(1) An outpatient center is organized under a governing body that sets policy and is responsible for the organization. This governing body must meet regularly, but at least quarterly.
(2) The outpatient center administration must:
(a) operate under clearly defined mission, goals, and objectives for the organization;
(b) employ qualified personnel, both medical and managerial;
(c) adopt policies and procedures necessary for the orderly conduct of the organization, including the scope of clinical and surgical activities;
(d) ensure that the quality of care is evaluated and that identified problems are appropriately addressed;
(e) maintain effective communication throughout the organization, including ensuring a correlation between quality management and improvement activities and other management functions of the organization; and
(f) follow generally accepted accounting principles.
(3) Facility requirements for an outpatient center include:
(a) compliance with regulations established in the local jurisdiction, including applicable local and state codes for construction, fire prevention, public safety and access, and annual inspections by the fire department; and
(b) an emergency plan for use in the event of fire or natural disaster and documents exercise of the plan on an annual basis. The "exercise" may involve a functional review of the process. That review must be documented accordingly.
(4) Each outpatient center for surgical services will have a quality management and improvement plan which must include:
(a) a peer review process that includes:
(i) at least two licensed health care professionals one of whom is a physician, and operating within their scope of practice; and
(ii) that the results of the peer review are reported to the governing body.
(b) a credentialing process that provides a monitoring function to ensure the continued maintenance of licensure and certification, or both, of professional personnel who provide health care services at the outpatient center;
(c) a quality improvement program that:
(i) is ongoing;
(ii) is data-driven;
(iii) is broad in scope;
(iv) addresses clinical and administrative issues as well as actual patient outcomes;
(v) has a defined set of quality improvement goals and objectives;
(vi) actively seeks patient feedback, evaluates complaints and suggestions, and works to improve patient satisfaction;
(vii) includes the active participation of the medical staff;
(viii) respects the health care rights of all patients, including the right to privacy;
(ix) at least annually conducts evaluation of outpatient center effectiveness;
(x) describes to the outpatient center's governing board the reports, findings, and activities relating to quality improvement; and
(xi) analyzes ongoing comprehensive self-assessment of the quality of care, including medical necessity of care or procedures performed and appropriateness of care. The findings from this process should be used to update facility policies and procedures.
(d) a risk management plan that:
(i) has a designated individual or committee that is responsible for the risk management program; and
(ii) addresses safety of patients and other important issues including:
(A) consistent application of the risk management program throughout the organization;
(B) review of all deaths, trauma, or other adverse incidents including reactions to drugs and materials;
(C) review and analysis of all actual and potential infection control occurrences and breaches, surgical site infections, and other health care acquired infections;
(D) review of patient complaints;
(E) impaired health care professionals;
(F) establishment and documentation of coverage after normal working hours;
(G) methods for prevention of unauthorized prescribing; and
(H) periodic review of clinical records and clinical record policies.