The Agency proposes to revise rules related to ambulatory surgical center licensure.

 

AGENCY FOR HEALTH CARE ADMINISTRATION

Health Facility and Agency Licensing

RULE NOS.:RULE TITLES:

59A-5.0065Patient Rights

59A-5.007Organized Medical Staff

59A-5.011Surveillance, Prevention, and Control of Infection

59A-5.019Quality Assessment and Improvement

PURPOSE AND EFFECT: The Agency proposes to revise rules related to ambulatory surgical center licensure.

SUMMARY: These revisions will: update terms defined and used within the rule chapter; remove non-specific language; update rule references; and update references in rulemaking authority and law implemented.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: A SERC has not been prepared by the agency. For rules listed where no SERC was prepared, the Agency prepared a checklist for each rule to determine the necessity for a SERC.

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.

RULEMAKING AUTHORITY: 395.1055 FS.

LAW IMPLEMENTED: 381.026, 395.001, 395.0191, 395.0193, 395.1055, 395.301, 395.3025 FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE HELD AT THE DATE, TIME AND PLACE SHOWN BELOW (IF NOT REQUESTED, THIS HEARING WILL NOT BE HELD):

DATE AND TIME: Monday, November 30, 2015, 2:00 p.m. – 3:00 p.m.

PLACE: Agency for Health Care Administration, Conference Room C, 2727 Mahan Drive, Building #3, Tallahassee, FL 32308

Pursuant to the provisions of the Americans with Disabilities Act, any person requiring special accommodations to participate in this workshop/meeting is asked to advise the agency at least 3 days before the workshop/meeting by contacting: Jessica Munn, Hospital & Outpatient Services Unit, 2727 Mahan Drive, Tallahassee, Florida, [phone]. If you are hearing or speech impaired, please contact the agency using the Florida Relay Service, 1(800)955-8771 (TDD) or 1(800)955-8770 (Voice).

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Jessica Munn, Hospital & Outpatient Services Unit, Bureau of Health Facility Regulation at [phone] or email: [e-mail]

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

59A-5.0065 Patient Rights.

Each ambulatory surgical center shall develop and adopt policies and procedures to ensure the protection of patient rights; which at a minimum shall include those patient rights specified in Sections 381.026, 395.301, and 395.3025, F.S.

Rulemaking Authority 395.1055 FS. Law Implemented 381.026, 395.001, 395.301, 395.1055, 395.3025 FS. History–New 11-13-9, Amended ____________.

 

59A-5.007 Organized Medical Staff.

(1) Each ambulatory surgical center shall have an organized medical staff organized under written by-laws approved by the governing board body and responsible to the governing board body of the ambulatory surgical center for the quality of all medical care provided to patients in the center and for the ethical and professional practices of its members.

(2) through (2)(f) No change.

(g) Review of ambulatory surgical center admissions with respect to need for admission, discharge practices and evaluation of the services ordered and provided.

(h) Surveillance of the ambulatory surgical center’s infection potentials and cases and the promotion of a preventive and corrective program, designed to minimize these hazards.

(i) Surveillance of pharmacy policies and procedures, and including review of at least monthly on-site consultant pharmacist visits, shall ensure standards of practice are maintained,  including review of at least monthly on-site consultant pharmacist visits, and proper disposal of outdated prescription and controlled drugs in accordance with Rules 64B16-28.702, 64B16-28.110, 64B16-28.303 59X-28.702, F.A.C. and Chapters 465 and 893, F.S.

Rulemaking Authority 395.1055, FS. Law Implemented 395.001, 395.0191, 395.0193, 395.1055 FS. History–New 6-14-78, Formerly 10D-30.07, Amended 2-3-88, Formerly 10D-30.007, Amended 11-13-95, _______.

 

59A-5.011 Surveillance, Prevention, and Control of Infection.

(1) Each ambulatory surgical center shall establish an Infection Control Program involving members of the medical staff, nursing staff, other professional and administrative staff as appropriate. The program shall provide for:

(1)(a) through (2) No change.

(3) The policies and procedures devised by the infection control program shall be approved by the governing board body, and shall contain at least the following:

(3)(a) through (3)(b) No change.

(c) Specific policies related to the handling and disposal of biomedical waste in accordance with Chapter 64E-16, 10D-104, F.A.C. and, June 1995, OSHA 29 CFR Part 1910.1030, Bloodborne Pathogens. Occupational Exposure to Blood Borne Pathogens Final Rule, and the Department of Environmental Protection Code Chapter 62-712, F.A.C., on Biomedical Waste, June 1995.

(3)(d) through (3)(g) No change.

(h) A requirement that all cases of communicable diseases as set forth in Chapter 64D-3 10D-3, F.A.C., June 1995, be promptly and properly reported in accordance with the provisions of that rule;

(4) The individuals involved in the infection control program shall meet at least quarterly, shall maintain written minutes of all meetings, and shall make a report at least annually to the quality assurance committee and the governing board body.

(5) Each ambulatory surgical center shall establish an employee health policy to minimize the likelihood of transmission of communicable disease by both employees and patients. Such policies shall include, but not be limited to, work restrictions for an employee whenever it is likely that communicable disease may be transmitted, until such time as a medical practitioner certifies that the employee may return to work.

(6) Each center shall ensure that biomedical waste is disposed of according to the Department of Environmental Protection rule Chapter 62-712, F.A.C., 1995.

Rulemaking Authority 395.1055, FS. Law Implemented 381.0035, 395.001, 395.1055 FS. History–New 6-14-78, Formerly 10D-30.11, Amended 2-3-88, Formerly 10D-30.011, Amended 11-13-95,_______.

 

59A-5.019 Quality Assessment and Improvement.

(1) through (1)(a) No change.

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

(1)(b) 1. Through (2)(f) No change.

 

(g) Quality assessment and improvement activities including at least clinical laboratory services and radiology services;

(2)(h) through (4) No change.

Rulemaking Authority 395.1055 FS. Law Implemented 395.001, 395.1055 FS. History–New 11-13-95, Amended___________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Jessica Munn

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Elizabeth Dudek

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: 10/26/2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: 03/02/2015