An office surgery suite is that portion of a physician's office where surgery is performed according to Rule 64B-8-9009 Standard of Care for Office Surgery. These minimum standards of design and construction apply to a physician's office required to register under Rule 64B8- 9.009.(1)(a).
The minimum standards of design, construction and specified minimum essential utilities and facilities of this section shall be applicable to the all office surgery suites that are required to be registered but have not yet been registered with the Florida Department of Health in accordance with Florida Administrative Code 64B8- 9.0091 Requirement for Physician Office Registration; Inspection or Accreditation, and to all newly constructed office surgery suites, and all additions, alterations or renovations to all existing office surgery suites on the effective date of this code.
In addition to the minimum requirements of this section, an office surgery suite shall also be in compliance with the following:
The fire codes as described in Chapter 69A-3.012, "Standards of the National Fire Protection Association Adopted," Florida Administrative Code.
Office surgery suites that provide services or treatment, on an outpatient basis, to four or more patients at the same time that either renders the patients incapable of taking action for self-preservation under emergency conditions without the assistance from others or that provide surgical treatment requiring general anesthesia to four or more patients at the same time, shall meet the requirements of Ambulatory Health Care Occupancies as described in NFPA 101, Life Safety Code and this code.
All other office surgery suites shall comply with the requirements of Business occupancy as described in NFPA 101, Life Safety Code, and this code.
There shall be a waiting room or lobby area of sufficient size to accommodate patients and visitors.
There shall be a public toilet(s) with handwashing station(s), public access to a telephone for local calls, and an electric water fountain or a water and cup-dispensing unit. When the office surgery suite is located within an office building, these functions may be provided as part of the office building's public areas.
As determined by the functional program of the office surgery suite, there shall be an admitting office, secure medical record storage, director of nursing office, in-service training or conference area.
There shall be a toilet room(s) with handwashing station located within the office surgery suite for patients.
As determined by the functional program of the office surgery suite, the following elements shall be provided for clinical services.
Patient change areas. An area(s) shall be provided for patients to change from street clothing into surgical gowns and to prepare for surgery. Provisions shall be made for patient privacy and for securing patients' personal effects.
A separate and distinct primary recovery area(s) shall be provided that is located adjacent to the operating room(s). It shall contain a minimum of one (1) Pre-operative station per each operating room and shall not be part of the restricted area of the office surgery suite. There shall be 3 feet (0.914 meter) of clear floor area around three sides of each recovery station for work and circulation.
The Pre-operative area(s) shall be located in direct view of a nurse station.
Cubicle curtains or other provisions for privacy during Pre-operative care shall be provided.
There shall be a dedicated handwashing station located in or immediately adjacent to the Pre-operative area(s).
If determined by the functional program taking into consideration the types of surgery and procedures performed, the types of anesthesia used, average recovery periods, and staffing levels, this area may be shared with the Post-operative Area.
There shall be at a minimum one operating room in each office surgery suite. The size and location of the operating room(s) shall be dependent on the level of care provided and equipment utilized based on the functional program.
The size of the operating room(s) shall be as defined by the American College of Surgeons Classes as adapted from the American College of Surgeons publication 04GR-0001: Guidelines for Optimal Ambulatory Surgical Care and Office-Based Surgery, which was developed by the Board of Governors Committee on Ambulatory Surgical Care and published in May 2000.
To be used for Level I Office Surgery as defined by Rule 64B8-9.009, Florida Administrative Code.
Class A operating rooms shall have a minimum clear floor area of 150 square feet (14 m2) with a minimum clear dimension of 12 feet (3.65 meters).
There shall be a minimum clear distance of 3 feet 6 inches (1.07 m) at each side, the head, and the foot of the operating table.
To be used for Levels I, II and IIA, Office Surgery, as defined in Rule 64B8-9.009, Florida Administrative Code.
Class B operating rooms shall have a minimum clear dimension of 15 feet (4.57 m).
Room arrangement shall permit a minimum clear dimension floor area of 250 square feet (23.23 m2) with a minimum of 3 feet 6 inches (1.07 m) at each side, the head, and the foot of the operating table.
To be used for Levels I, II, IIA and III, Office Surgery, as defined in Rule 64B8-9.009, Florida Administrative Code.
Class C operating rooms shall have a minimum clear floor area of 400 square feet (37.16 m2) and a minimum clear dimension of 18 feet (5.49 m).
Room arrangement shall permit a minimum clear dimension of 4 feet (1.22 m) at each side, the head, and the foot of the operating table.
The Class B and C operating room(s) shall be located within the semi-restricted area within the office surgery suite.
The operating room(s) shall be equipped with an emergency communication system connected to at least one continuously occupied location within the office surgery suite, such as a control or nurse station.
Area(s) for recovery in office surgery suites shall be provided in accordance with the functional program with the following minimum requirements.
A separate and distinct primary recovery area(s) shall be provided that is located within or adjacent to the operating room(s). It shall contain a minimum of one (1) recovery station per each operating room and shall not be part of the restricted area of the office surgery suite. There shall be 3 feet (0.9 m) of clear floor area around three sides of each recovery station for work and circulation.
The recovery area shall be located in direct view of the nurse station.
Cubicle curtains or other provisions for privacy during post-operative care shall be provided.
There shall be a dedicated handwashing station located in or immediately adjacent to the recovery area(s).
As required by the functional program, a designated supervised step-down recovery area may be provided for patients who do not require postanesthesia recovery but need additional time for their vital signs to stabilize before safely leaving the office surgery suite. This area shall contain a clinical workspace, space for family members, and provisions for privacy. It shall have convenient patient access to toilets large enough to accommodate a patient and an assistant. Handwashing stations and nourishment facilities shall be included within or immediately adjacent to this area(s).
The following areas and spaces shall be provided.
Provisions shall be made for storage and preparation of medications administered to patients. A refrigerator for pharmaceuticals and a double-locked storage for controlled substances shall be provided.
Scrub station(s) shall be provided outside of and near the entrance to each operating room and may service two operating rooms if needed. Scrub station(s) shall be arranged to minimize incidental splatter on nearby personnel or supply carts. The scrub stations shall be trimmed with foot, knee, or ultrasonic controls (no single lever wrist blades).
The soiled workroom shall contain a handwashing station, a sink large enough to accommodate the cleaning of the largest piece of surgical instrument utilized in the operating room, a work counter, and waste receptacle(s). This may be the same workroom as described in Section 469.4.7, "Sterilizing facilities."
This station(s) shall be convenient to the general operating room(s) and postanesthesia recovery area(s). A clinical sink or toilet equipped with a rinsing device may meet this requirement.
As required by the functional program, provisions shall be made for cleaning, testing, and storing anesthesia equipment and supplies.
Medical gas storage with space for reserve nitrous oxide and oxygen cylinders, if such gas is used in the office surgery suite, shall be provided and located outside of the restricted surgical area(s). Service and delivery access shall be possible without entering the restricted surgical area(s). All cylinders shall be securely chained or fastened to prevent accidental damage.
General, surgical and equipment storage room(s) or closet enclosures shall be provided for equipment and supplies used or required in the surgical suite.
A minimum of one (1) change area shall be provided for staff working within the office surgery suite. This area(s) shall contain locker(s), toilet(s), handwashing station(s), and space for donning scrub attire.
An area shall be provided for patients to change from street clothing into surgical gowns and to prepare for surgery. Provisions shall be made for patient privacy and for securing patients' personal effects.
This area shall be convenient for use and out of the required exit access.
Lounge and toilet facilities with a handwashing station for staff shall be provided as required by the functional program.
For office surgery suites that provide accommodations for overnight stays, a nourishment room or area shall be provided. It shall contain a refrigerator, double compartment sink, counter, and storage for food items and utensils.
A room containing a floor receptor or service sink shall be provided exclusively for the office surgery suite. Storage space for housekeeping supplies and equipment shall be provided in this room or in the general storage room(s). Hazardous supplies such as cleaning chemicals shall be protected in accordance with the requirements of the referenced fire safety codes.
Space shall be provided for emergency resuscitation equipment and supplies such as crash/anesthesia cart(s) with convenient access to and use from both the surgery and recovery areas.
A system for providing sterilized equipment and supplies shall be provided. When sterilization is provided offsite, adequate handling (receiving and distribution) and on-site storage of sterile supplies shall be accommodated, and shall meet the minimum requirements for sterilization performed onsite.
Adequate space shall be available for the cleaning and sanitizing of clean and soiled carts and vehicles transporting supplies.
This room shall be physically separated from all other areas of the office surgery suite. Workspace shall be provided to handle the cleaning and the gross cleaning, debridement, and disinfections of all medical/surgical instruments and equipment. The soiled workroom shall contain work surfaces(s), sink(s), flush-type devices(s), and washer/sterilizer decontaminators or other decontamination equipment as appropriate to the functional program.
This workroom shall have access to an immediately adjacent handwashing station and shall contain appropriate and sufficient workspace and equipment for terminal sterilizing of medical and surgical equipment and supplies. Clean and soiled work areas shall be physically separated. Access to the sterilization room shall be restricted. The clean assembly room shall have adequate space for the designated number of work areas as defined in the functional program as well as space for storage of clean supplies, sterilizer carriages and instrumentation.
Storage for packs, etc., shall include provisions for ventilation, humidity, and temperature control.
Toilet room doors for patient use shall open outward or be equipped with hardware that permits access from the outside in emergencies.
Handwashing stations shall be located and arranged to permit proper use and operation. Each handwashing station shall be equipped with single service paper towel dispensers and a soap dispenser.
Provisions for hand drying shall be included at all handwashing stations except scrub stations. Hand drying shall be accomplished by single towel dispensers or electrical hand driers.
Wall bases in operating rooms and areas that are frequently subject to wet cleaning shall be monolithic and coved directly up from the floor, tightly sealed to the wall, and constructed without voids. Seam welds in sheet flooring shall utilize manufacturer's weld product recommendations. Vinyl composition tile (VCT) shall not be used in these areas.
Heavy ceiling mounted equipment such as operating room lights, tracks or other equipment shall have suspension systems specially designed for that application.
Cubicle curtains and draperies designed for appropriate patient privacy shall be noncombustible or flame retardant.
Floors subject to continuous use while wet, such as shower areas, shall have a nonslip surface.