The proposed rule amendments are intended to set forth revised criteria for approval of physician office accrediting organizations.

 

DEPARTMENT OF HEALTH
Board of Medicine

RULE NO: RULE TITLE
64B8-9.0092: Approval of Physician Office Accrediting Organizations
PURPOSE AND EFFECT: The proposed rule amendments are intended to set forth revised criteria for approval of physician office accrediting organizations.
SUMMARY: The proposed rule amendments set forth accreditation surveyor qualifications and set forth quality assurance criteria for accrediting agencies.
SUMMARY OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 458.309(3) FS.
LAW IMPLEMENTED: 458.309(3) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Larry McPherson, Jr., Executive Director, Board of Medicine/MQA, 4052 Bald Cypress Way, Bin # C03, Tallahassee, Florida 32399-3253.

THE FULL TEXT OF THE PROPOSED RULE IS:

64B8-9.0092 Approval of Physician Office Accrediting Organizations

(1) Definitions.

(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 six (6) months of the date on which the office was granted provisional accreditation.

(b) through (c)  No change.

(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) through (c) No change.

(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 Florida Health Care Risk Manager licensed through AHCA 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 disciplined 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)  No change.

(f) Copies of all adverse incident reports filed with the state by any of the applicants accredited offices pursuant to Section 458.331, F.S.

(g) No change.

(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 456 455 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 comply with the following requirements:

(a) The accrediting agency must implement, administer and monitor have 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 systems 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 Section 458.351, F.S. and as set forth in subsection (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 Section 458.351, F.S., are reviewed.  In addition to those incidents set forth in Section 458.351, F.S., 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 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 have 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;

d.  Unplanned transfusion;

e.  Aspiration pneumonitis;

f.  Pulmonary embolus;

g.  Local anesthetic toxicity;

h.  Anaphylaxis;

i.  Possible Malignant Hyperthermia;

j.  Infection;

k.  Return to operating room;

l.  Unplanned Post-procedural Treatment in physician's office or emergency department within 30 days  after discharge;

m.  Unplanned Admission to hospital or acute care facility within 30 days;

n.  Cardiopulmonary Arrest or Death within 30 days;

o. Continuous Quality Indicators;

p.  Cardiovascular complications in recovery requiring treatment (including: arrhythmias; hypotension, hypertension);

q.  Respiratory complications in recovery requiring treatment (including asthma);

r.  Nausea not controlled within 2 hrs in recovery;

s.  Pain not controlled within 2 hrs in recovery;

t.  Postoperative vomiting rate;

u.  Prolonged PACU stay in excess of 2 hours;

v.  Medication error;

w.  Injuries, e.g. eye, teeth;

x.  Time to return to light activities of daily living (ADL);

y.  Common postoperative sequelae, eg sore throat, muscle pain, headache;

z.  Post-dural puncture headache or transient radicular irritation;

aa.  Discharge without escort or against medical advice (AMA);

bb.  Patient satisfaction;

cc.  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 agency must have at least one anesthesiologist that implements, administers, and monitors the quality assurance processes set forth above.

(c) The accrediting agency must have ongoing anesthesia-related accreditation and quality assurance processes involving the active participation of anesthesiologists.

(c)  (d)  No change.

(d) (e)  No change.

(e) (f)  If the accrediting agency or organization finds indications at any time during accreditation activities that conditions in the physician office pose a potential threat immediate jeopardy to patients, the accrediting agency or organization will immediately report the situation to the Department.

(f) (g)  No change.

(g) (h)  No change.

(5)  Accrediting Organizations shall be approved for a period 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) (5) Renewal of Approval of Accrediting Organizations. Every accrediting organization approved by the Board pursuant to this rule is required to renew such approval every 3 years. Each to submit to the Board a new complete written application submission shall be filed with the Board at least three months prior to the end of its term of approval third anniversary of the accrediting organization’s initial approval and each subsequent renewal of approval by the Board. 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) (6)  No change.

Specific Authority  458.309(3) FS.  Law Implemented  458.309(3) FS.  History – New 3-9-00, Amended 3-25-02, 12-28-04,                          .

NAME OF PERSON ORIGINATING PROPOSED RULE: Surgical Care Committee, Board of Medicine
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Board of Medicine
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 12, 2006
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: May 5, 2006