Certification of an ambulatory unit by Centers for Medicare and Medicaid Services (CMS) is essential for any facility that wants to be reimbursed by Medicare and Medicaid for patient services.
Accreditation of the facility is recommended to verify that the center meets the specific criteria that are indicative of high quality care.
The number and size of the ORs in the unit must be determined first.
Each OR should have a substerile room adjacent for entry and scrub sinks in the immediate area. There should be one scrub sink per two ORs. In the OR, there should be sufficient space for sterile supplies and equipment as well as an anesthesia machine (if desired) and anesthesia supplies.
In general, approximately 3000 sq ft of surgery center space is needed for each OR, with each OR providing 1000-1500 cases per year. In addition, three preoperative and three postoperative bays per OR should be included in the design for maximum efficiency. The OR size should range from 14 × 16 to 14 × 20 sq ft. Remaining open floor space is the most important factor after considering all equipment, plumbing, air conditioning, cabinets, etc.
Selection of floor and wall coverings may impact costs of maintenance and cleaning. Iodine-based prepping solutions and various dyes may stain certain floors. Tile walls will facilitate terminal cleaning of ORs.
Preoperative Holding Areas
Two or three preoperative holding areas per OR are generally needed to keep adequate processing and flow of patients into the OR. There should be a planned restroom for the patients in this area for voiding prior to OR. There should be lockers available for the patients to secure their clothes and personal possessions.
Recovery Rooms two or three recovery room beds per OR are needed to achieve optimum efficiency of the facility. This area must be staffed by nursing for postoperative monitoring. It is acceptable to use the preoperative admitting rooms for second-phase recovery.
Handwashing stations in the recovery room are essential. Support areas in the postanesthesia care unit for medication preparation, supply storage, soiled linen, and equipment storage must also be considered. Storage space, along with suction and oxygen, should also be available at each bay. Typically, all medications for the facility (particularly controlled substances) are kept in one area located within the recovery room as this area is readily available to staff and under continual observation.
Individual lighting for each bay allows for optimal patient comfort. Some access to natural light while providing privacy (such as clerestory windows) also promotes a sense of wellbeing for patients and staff. In addition, recovery areas must have a designated “kitchen” area to provide oral intake for patients after surgery. Specific requirements for food preparation vary from state to state, so these laws should also be considered when designing the recovery area.
2012 Operating Room Design Manual
Operating Room Equipment Storage
An OR equipment storage area must be planned to store supplies and OR equipment (e.g., mayo stands, kick buckets, etc.).
Obtaining the footprint for large storage items (e.g., cribs, mobile x-ray equipment, video towers, wheelchairs, lasers, microscopes, etc.) prior to design will help ensure that storage areas are sufficiently large for anticipated current use and potential expansion. Moving electronic equipment may cause expensive damage, so locating storage areas in close proximity to ORs both for efficiency and to minimize breakage is advised.
Control center. It is advised to designate a central location in the OR suite where all activities in the ORs are monitored. The area must be situated to allow visualization of all pedestrian traffic entering the restricted area.
Soiled utility room. An area is required for dirty supplies and linens as well as providing a space for waste receptacles.
There should be a separate area for cleaning and decontaminating instruments for sterilization. Space should be allotted for sterilizing equipment needed for the procedures.
Laboratory. It is desirable to have a small area located near the preoperative area for laboratory testing (e.g., blood glucose or pregnancy testing) that might need to be performed on the morning of surgery. In general, tests that do not require separate inspection and accreditation by the state should be selected.
This list varies from state to state.
Anesthesia workroom. The workroom provides an area where all excess anesthesia supplies are stored. Extra monitoring equipment should be stored in case of breakage so that a patient’s heart rate, blood pressure, cardiogram, and oxygen saturation can always be monitored in the perioperative period.
Locker rooms. Areas for staff to change into scrubs must be available, with a bathroom and break or lunch room attached. This area should have direct contact to the surgical suite.
Bathrooms. The bathrooms should be located near the OR and recovery room. Handicap access to the restrooms is essential. An emergency call bell should be placed in each patient toilet.
Waiting rooms. There should be sufficient space planned for family waiting. This area should have an information counter and a restroom in the vicinity. A public telephone and accessibility to drinking water should be considered.
There should be adequate space for the business office, medical director’s office, and consultation room. There should also be an area for medical record storage.
2012 Operating Room Design Manual
Communications. Communication systems must be included in the design process. These include telephone and fax systems, emergency lights, call lights, paging systems, networking (both internal and Internet), and systems for electronic information management and billing.
Sterilization and Space Heating
Sterilization requires 60 psi of steam. Sterilizers may be purchased with self-contained electric heat or separate electric steam generators if an onsite boiler is not available. Most offsite ambulatory centers do not have an onsite steam boiler system since it requires maintenance staff, space, and steam-to-hot water converters. There are small, 60-psi natural gas boilers that are available for sterilization. The essential electrical system must serve the flash sterilizers. Space heating in most small offsite ambulatory centers is provided by hot water heating systems or electric duct reheating systems since little space and maintenance personnel are required for these systems. The essential electrical system must supply the HVAC space heating in the ORs.
HVAC and Humidification
The HVAC heating and supply, return, and exhaust ventilation in the OR is supplied by the essential electrical system. The HVAC system chosen for a facility requires special attention to space requirements, maintenance, installation costs, and temperature control. The HVAC controller involves locating a thermostat, a humidistat, and a recorder in the OR. Alternatively, the recorder may be located in a remote location outside of the OR. There should be, at a minimum, two exhaust air grills. If there are more than two exhaust grills, they should be centered on the walls of the OR. If there are only two exhaust grills, they should be located opposite each other. Humidifiers are required in the ORs and can be powered by any fuel source.
Medical Gas and Vacuum Systems
The National Fire Protection Association (NFPA) has set guidelines for electrical systems as well as medical gas and vacuum systems in the health care center. Their recommendations are the basis for a number of joint commission and CMS standards and regulations.
Ambulatory ORs require level one or level two piped gas and vacuum systems. A level one system is one in which interruption of the piped gases and vacuum system would result in imminent danger of morbidity and mortality to the patient. A level two system is one in which interruption of the piped gases and vacuum systems would place patients at a manageable risk of morbidity and mortality. A level three system is one in which the interruption of the gas and vacuum supply would have no detrimental effects on the patient. Most free-standing centers would be either level one or two since the administration of general anesthesia frequently occurs. In addition, the use of supplemental oxygen usually accompanies regional anesthesia and monitored anesthesia care.
2012 Operating Room Design Manual
Level one systems have multiple pumps to ensure continued flow of the medical gases and vacuum systems. Another difference between the three systems is the alarm features, which are more sensitive in the level one system.
There is no code or requirement for the number of medical gas and vacuum outlets per OR.
Guidelines have been set by the American Institute of Architects for the total number of outlets for medical gases and vacuum systems. The Joint Commission has made recommendations as well. General recommendations include one oxygen and one vacuum station for minor surgery ORs, two oxygen and two vacuum stations for intermediate surgery ORs, and two oxygen and three vacuum stations for major surgery OR stations. Each station must have an adequate flow rate for proper delivery to the patient and adequate functioning of connected equipment. The free-air allowance CFM (l ft3/min) at 1 atmosphere for “major A” OR (e.g., transplant and open heart) is 3.5 (100) per room, “major B” OR (all other major cases) is 2.0 (60) per room, and minor cases is 1.0 (30) per room. All medical piped gases must be identified by a color coding system. Color coding for piped medical gases in the United States is as follows: oxygen (green), nitrous oxide (blue), nitrogen (black), air (yellow), and vacuum (white).
Medical gas and vacuum piping can be delivered through surgical ceiling columns. They can be either rigid in design or retractable.
When designing the facility, the ceiling columns should be placed at opposite ends of the OR table to provide easy access for the anesthesiologist. Extra electric outlets as well as grounding receptacles can be placed on these columns for convenience. Medical booms that descend from the ceiling typically include hoses for medical gases and suction as well as electrical outlets. The placement of these booms may critically impact patient throughput as well as safety for staff and patients. The anesthesia machine is routinely placed behind and slightly to the right of the OR bed, so the gas outlet and circuit is to the right of the anesthesiologist. Therefore, the boom should be located to the right and behind the anesthesia machine and the door to the OR to the left. With this configuration, neither the patient nor the staff need to walk through or around the boom to access the OR table or equipment.
The total oxygen needs and consumption for the facility must be calculated. One must consider the procedures done at the facility, number of oxygen stations, and the number of procedures to be performed monthly. In the acute care setting, consider oxygen utilization to be 1000 ft3 (28 m3)/bed/month. Any facility requiring more than 35,000ft3/month must have a bulk storage system of oxygen. Those requiring less than 35,000 ft3/month can use a cylinder manifold system for oxygen supply. The common source for nitrous oxide is the cylinder manifold system. Nitrous oxide should not be stored in a cold environment, as the lack of heat for vaporization will occur, and it will be unable to maintain the line pressure. Medical compressed air can be delivered to the facility via a cylinder manifold or a medical air compressor system.
2012 Operating Room Design Manual
Essential Electrical Systems
The NFPA defines the need for a Type 1 essential electrical system as a facility with critical care areas or electrical life support systems. Any Type 1 essential electrical system must have emergency electrical power. The NFPA requires a minimum of three automatic transfer switches for any facility with an essential electrical load of more than 150 kVA. If the load on the essential electrical system is less than 150 kVA, the NFPA only requires one automatic transfer switch. Thus, a facility must project their kVA usage to determine the number of automatic transfer switches needed. The most common system of emergency power has been the engine-generator configuration. Whatever method of emergency power is used, the need for a supply of 60-HZ (AC) power to the essential electrical system must be established within 10 seconds of power failure. Battery-operated OR lights are required to prevent danger to a patient during the potential 10 seconds of darkness. For ambulatory units that do not have electric life support systems or critical care areas, the NFPA defines the need for a Type 3 essential electrical system. A Type 3 system would require power for life safety and the termination of the current procedures. Life safety is battery power for lights, fire alarm systems, and emergency exits.
The NFPA requires that the life safety power remain for 1.5 hours after interruption of normal power.
Ground Fault Interrupters
Isolated power systems are essential in ORs that are considered wet areas, where the interruption of power is not acceptable to patient safety. Even routine procedures in the ambulatory setting have saline, urine, and a number of other fluids in the OR suite. These wet- procedure locations have the potential to have electrical equipment come in contact with the fluids and result in electrical shock.
Ground fault interrupters are used to prevent people from an electric shock in wet-procedure locations. The problem with ground fault interrupters is that once a fault current is detected, power to all downstream equipment is disrupted. This is of particular concern when that equipment is a ventilator or other type of patient life support. Isolated power systems contain the ground fault interrupter while maintaining the downstream power needed in critical care areas. A line isolation monitor will alarm at the first signs of a potential fault current and allow the problem to be addressed.
Instruments and pieces of equipment for ambulatory ORs may number in the thousands and may require purchases from hundreds of manufacturers.
Many capital purchases, including defining specifications, manufacturer, shipping, installation, biomedical certification, and training of personnel in use, require lead times of several months. Furthermore, equipment specifications should be given to architects, engineers, and contractors prior to beginning the design process so that appropriate electrical, plumbing, space needs, and building code requirements are addressed.
2012 Operating Room Design Manual
Whether freestanding or attached, the initial phase of equipment procurement should be determination of types of procedures, surgical specialties, and anticipated volume. Staff (i.e., surgeons, anesthesiologists, and nurses) should be queried as to preferences and minimum quality required to meet standards. Cost and availability should also be considered. For ASUs attached to larger facilities, a survey of existing equipment will help determine how much additional equipment must be purchased.1
All facilities must meet the standards set by the NFPA in regards to fire safety. Fire extinguishers and fire alarms should be placed in all facilities, and documented fire drills should be performed.
All ambulatory surgery facilities should be prepared for the management of life- saving emergencies. All monitoring equipment, such as blood pressure, cardiac monitor, thermometer, and pulse oximeter, should be present. A stethoscope, Ambu bag, oxygen, oral airways, laryngoscope, and various sizes of endotracheal tubes should always be present. Intravenous (IV) fluid and IV catheters should also be on hand. A defibrillator and crash cart with all emergency drugs, including dantrolene, should be prepared and routinely checked for expiration dates. All staff should be trained in advanced cardiac life support and pediatric advanced life support if the facility treats children. The proximity of the facility should be within minutes of a hospital that can accept any transfers.
The single biggest draw for ASC/ASU facilities is the convenience and ease for patients and the convenience and efficiency for surgeons. To this end, adding certain amenities to the facility as part of the design process will contribute to the overall satisfaction of both patients and staff and ultimately optimize center efficiency. Some of these issues are:
• A private, pleasant registration area that accommodates the patient and family with appropriate soundproofing to meet Health Insurance Portability and Accountability Act compliance
• Generalized soundproofing in patient and staff areas to decrease noise pollution
• Natural daylight in patient and staff areas to promote wellbeing, mood, and faster
• Parking areas that are flat (i.e., no curbs), well lighted, and at least partially covered for
• Hand washing stations that are readily visible to patients and conveniently located for
• A separate anesthesia office space that allows for storage of references and resources
as well as some privacy for conferring with staff or colleague
2012 Operating Room Design Manual
1. Hampton L. Equipping your new surgery center. Outpatient Surgery Magazine. 2003(Jan):98-101.
1. Iveerson R. Patient safety in office-based surgery. The ASF Source. Ambulatory Surgery Facilities. 2003; 10(2).
2. Kerckhove K. Re-evaluating the isolated power equation. Electrical Products and Solutions. 2008.
3. Mercier D, Philip B. Is your ambulatory surgery center licensed, accredited or certified?
ASA Newsletter. 2008(Oct).
4. Nash H, Birch N. Outpatient facilities-the clinical conundrum called ambulatory care. NLB Engineering. ASHE Update. 2004(July/Aug).
5. Philip B, Twersky R. Ambulatory surgical and office based care: demonstrating quality. ASA Newsletter. 2002(Nov).
6. Serbin S. Before you break ground. Outpatient Surgery Magazine. 2003(Jan); 114-5.
7. Springman SR, ed. Twersky R. Ambulatory Anesthesia: The Requisites in Anesthesiology. Philadelphia, PA: Mosby-Elsevier; 2006.
8. Watkins P. New surgical construction from A to Z. Supplement to Outpatient Surgery Magazine. 2008(Jan); 16-23.
9. Phillips P. eMedicine. Outpatient Surgical Suite. 2006(Dec).
10. Wentink K, Jackson R. Medical gas vacuum systems. Plumbing Systems and Design Magazine. 2006(Jan/Feb).
11. Yerden T. Planning and construction: design and development for dummies. Supplement to Outpatient Surgery Magazine. 2008(Jan); 10-12.
12. National Fire Protection Association Code 101.
13. National Fire Protection Association Code 99 (Standard for Healthcare Facilities).
14. American Institute of Architects’ guidelines for design and construction of hospital and health care facilities.
2012 Operating Room Design Manual
15. AORN standards. Available at: http://www.aorn.org/PracticeResources/AORNStandardsAndRecommendedPractices/.
16. Centers for Medicare and Medicaid. Available at: www.cms.org.
17. AORN. Available at: www.aorn.org.
18. American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF). Available at: www.aaaasf.org.
19. Accreditation Association for Ambulatory Health Care (AAAHC). Available at: www.aaahc.org.
20. Joint Commission (formerly JCAHO). Available at: www.jointcommission.org/accreditationprograms/ambulatorycare.
21. US Green Building Council (LEED certification). Available at: www.usgbc.org/leed/.
22. Green Guide for Healthcare. Available at: www.gghc.org.
Wednesday, November 18, 2015
Know about the CDC regulations with doing laundry in your facility
Procedures permitted in an ASC (42 CFR 416.65) are those that generally do not require extended length...
CODE SECTIONS Article 21, Chapter 7 California Administrative Code (CAC) Article 21 - Plan Review, Building Inspection and Certification of ...
Surgeons can lease ORs, staff and equipment from an existing facility. Can ASCs operate as timeshare properties? Yes, thanks to a little-...
TEN STEPS TO PASSING PI PERFORMANCE DURING DME ACCREDITATION SURVEY Here is a checklist to help DME companies, Home HEALTH AGENCIES,...
ASC Hospital Transfer Requirements Summary, by State References Courtesy, Outpatient Surgery Magazine January, 2011 30 States require that t...
On October 9, Governor Jerry Brown signed S.B. 100, enacting a new law that tightens scrutiny of California ambulatory surgery centers throu...
'via Blog this' Click on this link to the CLIA certificate application that must be submitted to the state medicare laboratory of...
DME Accreditation | Durable Medical Equipment License