(1) Definitions.

Terms Used In Florida Regulations 64B8-9.0092

  • Arrest: Taking physical custody of a person by lawful authority.
  • Complaint: A written statement by the plaintiff stating the wrongs allegedly committed by the defendant.
    (a) “Accredited” means full accreditation granted by a Board approved accrediting agency or organization. “Accredited” shall also mean provisional accreditation provided that the office is in substantial compliance with the accrediting agency or organization’s standards; any deficiencies cited by the accrediting agency or organization do not affect the quality of patient care, and the deficiencies will be corrected within thirty days of the date on which the office was granted provisional accreditation.
    (b) “Approved accrediting agency or organization” means nationally recognized accrediting agencies: American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF), Accreditation Association for Ambulatory Health Care (AAAHC) and Joint Commission on Accreditation of Healthcare Organizations (JCAHO). Approved organizations also include those approved by the Board after submission of an application for approval pursuant to this rule. American Accreditation Commission International (AACI) is an accrediting organization approved by the Board.
    (c) “Department” means the Department of Health.
    (2) Application. An application for approval as an accrediting organization shall be filed with the Board office at 4052 Bald Cypress Way, Bin #C03, Tallahassee, Florida 32399-3253, and shall include the following information and documents:
    (a) Name and address of applicant;
    (b) Date applicant began to operate as an accrediting organization;
    (c) Copy of applicant’s current accreditation standards;
    (d) Description of accreditation process, including composition and qualifications of accreditation surveyors; accreditation activities; criteria for determination of compliance; and deficiency follow-up activities. Accreditation surveyors shall meet the following qualifications:
    1. The surveyor must be an ABMS board certified physician with two (2) years experience performing office surgery, or
    2. A certified professional in Health Care Risk Management with two (2) years’ experience serving as a risk manager in a surgical facility, or
    3. An ABMS board certified anesthesiologist with two (2) years experience administering anesthesia in a surgical facility.
    4. In addition to the above-outlined qualification, accreditation surveyors may not have any discipline imposed on his or her license within the preceding seven (7) years, may not be in direct competition with the subject of the review or have any direct or indirect contractual relationship with the inspected facility or any of its physicians.
    (e) A list of all physician offices located in Florida that are accredited by the applicant, if any. If there are no accredited Florida physician offices, but there are accredited offices outside Florida, a list of the accredited offices outside of Florida is required.
    (f) Copies of all adverse incident reports filed with the state by any of the applicants accredited offices pursuant to Florida Statutes § 458.351
    (g) Statement of compliance with all requirements as specified in this rule.
    (3) Standards. The standards adopted by an accrediting organization for surgical and anesthetic procedures performed in a physician office shall meet or exceed provisions of Chapters 456 and 458, F.S., and rules promulgated thereunder. Standards shall require that all health care practitioners be licensed or certified to the extent required by law.
    (4) Requirements. In order to be approved by the Board, an accrediting organization must demonstrate compliance with the following requirements:
    (a) The accrediting agency must implement, administer and monitor a mandatory quality assurance program approved by the Board of Medicine that meets the following minimum standards:
    1. General Provisions. Each office surgery facility surgical center shall have an ongoing quality assurance program that objectively and systematically monitors and evaluates the quality and appropriateness of patient care, evaluates methods to improve patient care, identifies and corrects deficiencies within the facility, alerts the Medical Director to identify and resolve recurring problems, and provides for opportunities to improve the facility’s performance and to enhance and improve the quality of care provided to the public.
    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.
    b. Each system for quality assurance, which shall include utilization review, must be defined in writing, approved by the accrediting agencies governing body, enforced, and shall include:
    I. A written delineation of responsibilities for key staff,
    II. 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,
    III. A confidentiality policy that complies with all applicable federal and state confidentiality laws,
    IV. Written, measurable criteria and norms,
    V. A description of the methods used for identifying problems,
    VI. A description of the methods used for assessing problems, determining priorities for investigation, and resolving problems,
    VII. A description of the methods for monitoring activities to assure that the desired results are achieved and sustained; and,
    VIII. Documentation of the activities and results of the program.
    c. Each quality assurance program shall include a peer review system that entails the following:
    I. Peer review is performed at least every six months and includes reviews of both random cases and unanticipated adverse office incidents as defined in Florida Statutes § 458.351, and as set forth in sub-subparagraph (4)(a)1.d., of this rule;
    II. If the peer review sources external to the facility are employed to evaluate delivery of medical care, the patient consent form is so written as to waive confidentiality of the medical records or in the alternative medical records reviewed by such external peer review sources must use confidential patient identifiers rather than patient names; and,
    III. Peer review must be conducted by a recognized peer review organization or a licensed medical doctor or osteopathic physician other than the operating surgeon.
    d. Each quality assurance program shall include a system where all adverse incidents as defined in Florida Statutes § 458.351, are reviewed. In addition to those incidents set forth in Florida Statutes § 458.351, the following incidents shall also be reviewed:
    I. Unplanned hospital admissions that occurred within seven (7) days from the date the patient left the facility,
    II. Unscheduled return to the operating room for complication of a previous procedure,
    III. Untoward result of procedure such as infection, bleeding, wound dehiscence or inadvertent injury to other body structure,
    IV. Cardiac or respiratory problems during stay at facility or within 48 hours of discharge,
    V. Allergic reaction of medication,
    VI. Incorrect needle or sponge count,
    VII. Patient or family complaint,
    VIII. Equipment malfunction leading to injury or potential injury to patient.
    e. Each quality assurance program shall include an adverse incident chart review program which shall include the following information, in addition to the operative procedure performed:
    I. Identification of the problem,
    II. Immediate treatment or disposition of the case,
    III. Outcome,
    IV. Analysis of reason for problem; and,
    V. Assessment of efficacy of treatment.
    2. Each office surgery facility 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:
    a. Appropriate surgical procedures,
    b. Preparation of patient for the procedure,
    c. Performance of the procedure and monitoring of the patient,
    d. Provision of post-operative care,
    e. Use of medications including administration and monitoring of effects,
    f. Risk management activities,
    g. Quality assurance activities including at least clinical laboratory services and radiology services,
    h. Results of autopsies if needed.
    3. Each center shall have a process to assess data collected to determine:
    a. The level and performance of existing activities and procedures,
    b. Priorities for improvement; and,
    c. Actions to improve performance.
    4. Each center shall have a process to incorporate quality assurance and improvement activities in existing office surgery facility processes and procedures.
    (b) The accrediting agency must implement, administer and monitor anesthesia-related accreditation standards and quality assurance processes that meet the following minimum standards and are reviewed and approved by the Board of Medicine:
    1. Each accredited facility must have an anesthesia provider who participates in an ongoing continuous quality improvement and risk management activities related to the administration of anesthesia in that facility.
    2. Each facility must have a written quality improvement plan that specifies the individuals who are responsible for performing each element of the plan.
    3. The written plan should be in place to continually assess, document and improve the outcome of the anesthesia care provided.
    4. The plan must include a review of quality indicators, to include measures of patient satisfaction.
    5. The plan must include an annual review and check of anesthesia equipment to ensure compliance with current safety standards and the standards for the release of waste anesthetic gases.
    6. The quality assurance plan should include routine review of anesthesia and surgical morbidity and adverse, sentinel or outcome events which include but are not limited to the following:
    a. Follow-up on post-op day 1 and day 14,
    b. Cancellation rates and reasons,
    c. Central nervous system or peripheral nervous system new deficit,
    d. Need for reversal agents: narcotic, benzodiazepine,
    e. Reintubation,
    f. Unplanned transfusion,
    g. Aspiration pneumonitis,
    h. Pulmonary embolus,
    i. Local anesthetic toxicity,
    j. Anaphylaxis,
    k. Possible Malignant Hyperthermia,
    l. Infection,
    m. Return to operating room,
    n. Unplanned Post-procedural Treatment in physician’s office or emergency department within 30 days after discharge,
    o. Unplanned Admission to hospital or acute care facility within 30 days,
    p. Cardiopulmonary Arrest or Death within 30 days,
    q. Continuous Quality Indicators,
    r. Cardiovascular complications in recovery requiring treatment (including: arrhythmias; hypotension, hypertension),
    s. Respiratory complications in recovery requiring treatment (including asthma),
    t. Nausea not controlled within 2 hrs. in recovery,
    u. Pain not controlled within 2 hrs. in recovery,
    v. Postoperative vomiting rate,
    w. Prolonged PACU stay in excess of 2 hrs.,
    x. Medication error,
    y. Injuries, e.g. eye, teeth,
    z. Time to return to light activities of daily living (ADL),
    aa. Common postoperative sequelae, eg sore throat, muscle pain, headache,
    bb. Post-dural puncture headache or transient radicular irritation,
    cc. Discharge without escort or against medical advice (AMA),
    dd. Patient satisfaction,
    ee. Equipment maintenance.
    7. Each facility quality improvement plan must require annual reviews conducted by, at a minimum, the medical director, a representative of the anesthesia provider currently providing patient care and a representative of the operating room or recovery nursing staff.
    8. The accrediting organization must have at least one anesthesiologist in that organization that implements, administers, and monitors the quality assurance processes set forth above.
    (c) Accreditation periods shall not exceed three years.
    (d) The accrediting organization shall obtain authorization from the accredited entity to release accreditation reports and corrective action plans to the Board. The accrediting organization shall provide a copy of any accreditation report to the Board office within 30 days of completion of accrediting activities. The accrediting organization shall provide a copy of any corrective action plans to the Board office within 30 days of receipt from the physician office.
    (e) If the accrediting agency or organization finds indications at any time during accreditation activities that conditions in the physician office pose a potential threat to patients, the accrediting agency or organization will immediately report the situation to the Department.
    (f) An accrediting agency or organization shall send to the Board any change in its accreditation standards within 30 calendar days after making the change.
    (g) An accrediting agency or organization shall comply with confidentiality requirements regarding protection of patient records.
    (5) Accrediting Organizations shall be approved for a period of time not to exceed three (3) years.
    (6) If the Board discovers that an approved accrediting agency has violated or failed to comply with any provision of this rule, the Board shall issue an order to show cause outlining the alleged violation and requiring a representative from the accrediting agency to appear before the Board at its next regularly scheduled meeting to address the Board’s concerns. After such an appearance, if the Board determines that a violation occurred, the accrediting agency’s status as an office surgery accrediting agency shall be revoked. Failure to appear before the Board upon receipt of an order to show cause shall not preclude the Board from taking action against an accrediting agency.
    (7) Renewal of Approval of Accrediting Organizations. Every accrediting organization approved by the Board pursuant to this rule is required to submit to the Board a new complete written application at least three months prior to the end of its term of approval. Upon review of the submission by the Board, written notice shall be provided to the accrediting organization indicating the Board’s acceptance of the certification and the next date by which a renewal submission must be filed or of the Board’s decision that any identified changes are not acceptable and on that basis denial of renewal of approval as an accrediting organization.
    (8) Upon denial of its application, the accrediting organization must wait a minimum of six (6) months prior to reapplying.
    (9) Any person interested in obtaining a complete list of approved accrediting organizations may contact the Board of Medicine or Department of Health.
    (10) This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.
Rulemaking Authority Florida Statutes § 458.328(2). Law Implemented 458.328(1)(e) FS. History—New 3-9-00, Amended 3-25-02, 12-28-04, 1-30-07, 7-11-10, 5-28-12, 1-31-22, 8-28-22.