7. Condition for Coverage: Environment (Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
The ASC must have a safe and sanitary environment, properly constructed, equipped, and maintained to protect the health and safety of patients.
The ASC must comply with requirements governing the construction and maintenance of a safe and sanitary physical plant, safety from fire, emergency equipment and emergency personnel.
A surveyor trained in surveying for the applicable Life Safety Code standards must survey for compliance with the Safety from Fire Standard; the rest of the standards under this Condition are surveyed by Health surveyors.
Standard: Physical Environment
(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
(1) Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.
State Agencies may wish to assign surveyors who are trained in evaluating healthcare facility design and construction assist in evaluating compliance with this standard.
"Operating room" in an ASC also includes procedure rooms.
Operating rooms must be designed in accordance with industry standards for the types of surgical procedures performed in the room. National organizations, such as the American Institute of Architects may be used as a source of guidance to evaluate OR design and construction in an ASC. If a State's licensure requirements include specifications for OR design and construction, the ASC must, in accordance with §416.40, comply with those State requirements.
The location of the OR within the ASC and the access to it must conform to accepted standards of practice, particularly for infection control, with respect to the movement of people, equipment and supplies in and out of the OR. The movement of staff and patients on stretchers must proceed safely, uninhibited by obstructions.
The OR temperature and humidity must be monitored and maintained in accordance with accepted standards of practice.
The ORs must also be appropriately equipped for the types of surgery performed in the ASC. Equipment includes both facility equipment (e.g., lighting, generators or other back-up power, air handlers, medical gas systems, air compressors, vacuum systems, etc.) and medical equipment (e.g., biomedical equipment, radiological equipment if applicable, OR tables, stretchers, IV infusion equipment, ventilators, etc.). Medical equipment for the OR includes, in addition to the emergency equipment listed in §416.44(c), the appropriate type and volume of surgical and anesthesia equipment, including surgical instruments. Surgical instruments must be available in a quantity that is commensurate with the ASC's expected daily procedure volume, taking into consideration the time required for appropriate cleaning and sterilization. Equipment for rapid emergency sterilization of OR equipment/materials whose sterility has been compromised must be available on-site. However, an ASC that routinely uses sterilization procedures intended for emergency use only as its standard method of sterilization between cases, in order to reuse surgical instruments, must be cited for violating §§416.44(a)(1) & (3) and the Infection Control Condition at §416.51. It is not necessary for the ASC to have equipment for routine sterilization of equipment and supplies on-site, so long as this service is provided to the ASC under arrangement.
The OR equipment must be inspected, tested and maintained by the ASC in accordance with Federal and State law (including regulations) and manufacturers' recommendations.
Standard: Physical Environment(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
The ASC is required to have both a waiting area and a recovery room, which must be separate from each other as well as other parts of the ASC. They may not be shared with another healthcare facility or physician office. (See the interpretive guidelines for §416.2 concerning sharing of physical space by an ASC and another entity.)
There must be a room within the ASC where patients recover immediately after surgery. A "room" consists of an area with at least semi-permanent walls from floor to ceiling separating it from other areas of the ASC. The recovery room must be equipped to allow appropriate monitoring of the patient's recovery. The type of equipment required depends on the type(s) of surgery performed in the ASC. The size of the recovery room must be commensurate with the number of ORs in the ASC and the expected volume of patients who will be in recovery simultaneously.
The recovery room may also be used for preoperative preparation of patients as well as for post-operative recovery, consistent with accepted standards of practice. Under no circumstances, however, may the recovery room also be used as a general waiting area for patients awaiting preoperative preparation or for people who accompany patients. Likewise, patients recovering from surgery may not be placed in a waiting room or area, unless they have already been discharged from the ASC and are, for example, waiting briefly while the adult who accompanied them brings a car to the ASC's entrance.
Consistent with accepted standards of practice, including infection control standards, and protection of patients' rights to privacy and confidentiality of their clinical information the ASC may permit individuals who accompany patients to be present in the recovery room during the patient's recovery from surgery.
Standard: Physical Environment(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
(3) The ASC must establish a program for identifying and preventing infections, maintaining a sanitary environment, and reporting the results to appropriate authorities.
ASCs are required to have a program to follow up on each patient after discharge, in order to identify and track infections associated with the patient's stay in the ASC. ASCs are not expected to establish routine post-surgical laboratory testing for infectious diseases, but if it learns of an infection in the post-discharge period from the patient or patient's physician, the ASC might consider inquiring whether there is a lab confirmation of an infectious disease, and, if there are indications that the infection was associated with the patient's stay in the ASC, report the case to the appropriate State authorities if the disease is a reportable disease under State law (including regulations). ASCs may delegate portions of this follow-up responsibility to the physicians on the ASC's staff who will see the patients in their office post-discharge only if the ASC's program includes a mechanism for ensuring that the results of the follow-up are reported back to the ASC and documented in the patient's medical record.
Noncompliance with all other requirements under this standard are to be cited under §416.51, Condition for Coverage - Infection Control.
Standard: Safety From Fire(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
(1) Except as otherwise provided in this section, the ASC must meet the provisions applicable to Ambulatory Healthcare Centers of the 2000 edition of the Life Safety Code of the National Fire Protection Association, regardless of the number of patients served. The Director of the Office of the Federal Register has approved the NFPA 101® 2000 edition of the Life Safety Code, issued January 14, 2000, for incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. A copy of the Code is available for inspection at the CMS Information Resource Center, 7500 Security Boulevard, Baltimore, MD and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030. Copies may be obtained from the National Fire Protection Association, 1 Batterymarch Park, Quincy, MA 02269. If any changes in this edition of the Code are incorporated by reference, CMS will publish notice in the Federal Register to announce the changes.
(2) In consideration of a recommendation by the State survey agency, CMS may waive, for periods deemed appropriate, specific provisions of the Life Safety Code which, if rigidly applied, would result in unreasonable hardship upon an ASC, but only if the waiver will not adversely affect the health and safety of the patients.
(3) The provisions of the Life Safety Code do not apply in a State if CMS finds that a fire and safety code imposed by State law adequately protects patients in an ASC.
(4) An ASC must be in compliance with Chapter 21.2.9.1, Emergency Lighting, beginning on March 13, 2006.
(5) Notwithstanding any provisions of the 2000 edition of the Life Safety Code to the contrary, an ASC may place alcohol-based hand rub dispensers in its facility if-
Because ASCs are not permitted to provide care to patients exceeding 24 hours, they are, for purposes of compliance with National Fire Protection Association (NFPA) Life Safety Code (LSC) requirements, subject to a combination of healthcare and business occupancy requirements. They are, therefore, unlike hospitals and other facilities that keep patients more than 24 hours, which are considered healthcare occupancies.
Compliance with LSC requirements for an ASC is assessed by a surveyor trained in the application of NFPA LSC standards.
The provisions of the NFPA LSC (2000 edition), Chapter 20, New Ambulatory Health Care Occupancies, apply as of January 10, 2003, the date when CMS adopted the NFPA 2000 edition for ASCs, to any new buildings used for an ASC, alterations to existing ASCs, and alterations to existing buildings for new occupation by an ASC. The chapter includes: general requirements regarding structure and applicability; means of egress requirements; requirements related to protection from hazards, alarms and other emergency requirements, and subdivision of space; building services; and operating features. For older ASCs that have not undergone renovations, the provisions of chapter 21, Existing Ambulatory Health Care Occupancies apply.
Emergency Power
The NFPA 2000 LSC requires that when general anesthesia or life support equipment is used, the ambulatory health care facility (ambulatory surgical center) shall be provided with an essential electrical system in accordance with NFPA 99, Health Care Facilities, 1999 edition. For ASCs newly constructed or renovated after January 10, 2003, a Type 1 essential electrical system shall be installed which may include a generator as the source of back-up electrical power. Existing ASCs may continue to use a Type 3 electrical system and may continue to use batteries as the source of back-up electrical power. Existing ASCs that change procedures that include the use of general anesthesia or life support equipment not previously required will be required to upgrade there existing electrical system to a Type 1 system including a generator back-up electrical source of power. In all cases, ASCs are expected to have a reliable source of back-up power that enables them to protect patients and staff when power is lost, including proceeding with the surgical procedure until such point as it is safe to either terminate or complete it.
Use of Alcohol-based Skin Preparations
See the interpretive guidelines for §416.42 related to use of alcohol-based skin preparations in anesthetizing locations. In light of alcohol's effectiveness as a skin antiseptic, there is a need to balance the risks of fire related to use of alcohol-based skin preparations with the risk of surgical site infection by:
- Using skin prep solutions that are: 1) packaged to ensure controlled delivery to the patient in unit dose applicators, swabs, or other similar applicators; and 2) provide clear and explicit manufacturer/supplier instructions and warnings;
- Ensuring that the alcohol-based skin prep solutions do not soak into the patient's hair or linens. Sterile towels should be placed to absorb drips and runs during application and should then be removed from the anesthetizing location;
- Ensuring that the alcohol-based skin prep solution is completely dry prior to draping. This may take a few minutes or more, depending on the amount and location of the solution. The prepped area should be inspected to confirm it is dry prior to draping;
- Verifying that all of the above has occurred prior to initiating the surgical procedure. This can be done, for example, as part of a standardized preoperative "time out" to minimize the risk of medical errors during the procedure such as verifying that the patient is receiving the correct surgery.
Failure to take these measures to reduce the risk of surgical fire when an alcohol-based skin preparation is used must be cited as a condition-level violation of §416.44.
State Code in Lieu of LSC
The process by which CMS reviews a State's request to use of its State Code in lieu of the NFPA LSC is addressed in Survey and Certification policy memorandum S&C-08-34, September 5, 2008. CMS will advise any SA when and if it approves a State application to use the State Code in lieu of the LSC.
Standard: Emergency Equipment
The ASC must make all of the above-listed equipment readily available to each OR. ASC's with multiple ORs must ensure that there is sufficient equipment to handle multiple simultaneous emergencies. In the case of a tracheostomy set, we are interpreting the regulation to permit ASCs to have a cricoidotomy set instead, since it is a type of tracheostomy equipment suited for emergency use.
The ASC's medical staff must adopt a policy, in writing, that addresses what additional emergency equipment and supplies, such as medications routinely used in emergencies, if any, are needed and whether they must be present in each OR, or, in what quantity and locations to be readily available to all ORs as needed.
The ASC's medical staff may only add equipment or medications; it may not eliminate any of the equipment listed in the regulatory standard.
In the case of an ASC with more than 1 OR the medical staff should adopt a policy, in writing, that addresses:
- Which of the items on the above-listed equipment must be present in each OR; and
- For equipment not present in each OR, how many items must be available, in which locations, in order to make the equipment readily available when needed in each OR.
Although the regulation addresses availability of emergency equipment to the OR specifically, a prudent ASC should also make this equipment readily available to the recovery room. An automated electronic defibrillator (AED) may satisfy the regulatory requirement at §416.44(c)(4), so long as the ASC's medical staff emergency equipment policy specifically indicates that an AED is sufficient, given the ASC's patient population and types of procedures.
Mechanical and electrical equipment must be regularly inspected, tested and maintained. Emergency supplies must be regularly monitored and replaced as they expire.
Standard: Emergency Personnel
(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
Whenever there is a patient who has been registered in the reception area and not yet discharged from the ASC, including patients in the waiting area, in pre-operative preparation, in surgery, or in the recovery room, the ASC must also have clinical personnel present who have appropriate training and competence in the use of the requirement emergency equipment and supplies. It is not necessary for the ASC to have one person who knows how to use all the equipment/supplies, so long as for each type of equipment/supply there is always some staff member present who is competent to use it. For example, performing a tracheostomy is outside the scope of practice of a registered nurse and must be performed by a physician. On the other hand, use of an ambu-bag is within the RN's scope of practice.
There must also be staff present in the ASC who are trained in cardiopulmonary resuscitation (CPR) techniques. Although the regulation does not require that staff must be trained in advanced cardiac life support (ACLS) techniques, an ASC would be well-advised to consider having staff trained in ACLS, depending on the types of surgery performed and the characteristics of the ASC's patient population.
For ASCs that perform multiple procedures simultaneously, or have multiple persons in the recovery room simultaneously, there must be sufficient trained personnel to deal with multiple simultaneous emergencies.