1. (1) General Provisions. Each ambulatory surgical center shall have an ongoing quality assessment and improvement system designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, and opportunities to improve its performance to enhance and improve the quality of care provided to the public.

   1. (a) Such a system shall be based on the mission and plans of the organization, the needs and expectations of the patients and staff, up-to-date sources of information, and the performance of the processes and their outcomes.

   2. (b) Each system for quality assessment and improvement, which shall include utilization review, must be defined in writing, approved by the governing board, and enforced, and shall include:

      1. A written delineation of responsibilities for key staff;

      2. A policy for all members of the organized medical staff, whereby staff members do not initially review their own cases for quality assessment and improvement program purposes;

      3. A confidentiality policy;

      4. Written, measurable criteria and norms;

      5. A description of the methods used for identifying problems;

      6. A description of the methods used for assessing problems, determining priorities for investigation, and resolving problems;

      7. A description of the methods for monitoring activities to assure that the desired results are achieved and sustained; and,

      8. Documentation of the activities and results of the program.

2. (2) Each center shall have in place a systematic process to collect data on process outcomes, priority issues chosen for improvement, and the satisfaction of the patient. Processes measured shall include:

   1. (a) Appropriate surgical procedures;
   2. (b) Preparation of patient for the procedure;
   3. (c) Performance of the procedure and monitoring of the patient;
   4. (d) Provision of post-operative care;
   5. (e) Use of medications including administration and monitoring of effects;
   6. (f) Risk management activities;
   7. (g) Quality assessment and improvement activities including clinical laboratory services and radiology services;
   8. (h) Results of autopsies if needed.

3. (3) Each center shall have a process to assess data collected to determine:

   1. (a) The level and performance of existing activities and procedures,
   2. (b) Priorities for improvement, and,
   3. (c) Actions to improve performance.
4. (4) Each center shall have a process to incorporate quality assessment and improvement activities in existing ambulatory surgical center processes and procedures.

Rulemaking Authority 395.1055 FS. Law Implemented 395.1055 FS. History–New 11-13-95, Amended 2-23-16.