5. Condition for Coverage: Surgical Services (Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
Interpretive Guidelines: §416.42
Qualified Physician: Surgery in an ASC may only be performed by a qualified physician. With respect to ASCs, a physician is defined in accordance with §1861(r) of the Social Security Act to include a doctor of medicine or osteopathy, a doctor of dental surgery or dental medicine, and a doctor of podiatric medicine. In all cases, the physician must be licensed in the State in which the ASC is located and practicing within the scope of his/her license.
In addition, the regulation requires that each physician who performs surgery in the ASC has been determined qualified and granted privileges for the specific surgical procedures he/she performs in the ASC. The ASC's governing body is responsible for reviewing the qualifications of all physicians who have been recommended by qualified medical personnel and granting surgical privileges as the governing body determines appropriate.
The ASC must have written policies and procedures that address the criteria for clinical staff privileges in the ASC and the process that the governing body uses when reviewing physician credentials and determining whether to grant privileges and the scope of the privileges for each physician. See the interpretive guidelines for §416.45(a), Medical Staff Membership and Clinical Privileges for further guidance.
Safe Manner: The surgical procedures that take place in the ASC must be performed in a "safe manner." "In a safe manner" means primarily that physicians and other clinical staff follow acceptable surgical standards of practice in all phases of a surgical procedure, beginning with the pre-operative preparation of the patient, through to the post-operative recovery and discharge. Acceptable standards of practice include maintaining compliance with applicable Federal and State laws, regulations and guidelines governing surgical services, as well as, any standards and recommendations promoted by or established by nationally recognized professional organizations (e.g., the American Medical Association, American College of Surgeons, Association of Operating Room Nurses, Association for Professionals in Infection Control and Epidemiology, etc.).
Requirements addressed in other ASC Conditions for Coverage are important components of the provision of surgical services in a "safe manner," and condition-level deficiencies in these other areas may also constitute condition-level noncompliance with the Surgical Services Condition. These other pertinent ASC regulatory requirements include:
and
In addition, acceptable standards of practice include the use of standard procedures to ensure proper identification of the patient and surgical site, in order to avoid wrong site/wrong person/wrong procedure errors. Generally accepted procedures to avoid such surgical errors require:
Conducting surgery in a safe manner also requires appropriate use of liquid germicides in the operating or procedure room. It is estimated that approximately 100 surgical fires occur each year in the United States, resulting in roughly 20 serious patient injuries, including one to two deaths annually. Fires occur when an ignition source, a fuel source, and an oxidizer come together. Heat-producing devices are potential ignition sources, while alcohol-based skin preparations provide fuel. Procedures involving electro-surgery or the use of cautery or lasers involve heat-producing devices. There is concern that an alcohol-based skin preparation, combined with the oxygen-rich environment of an anesthetizing location, could ignite when exposed to a heat-producing device in an operating room. Specifically, if the alcohol-based skin preparation is improperly applied, the solution may wick into the patient's hair and linens or pool on the patient's skin, resulting in prolonged drying time. Then, if the patient is draped before the solution is completely dry, the alcohol vapors can become trapped under the surgical drapes and channeled to the surgical site.
On the other hand, surgical site infections (SSI) also pose significant risk to patients; according to the Centers for Disease Control and Prevention (CDC), such infections are the third most commonly reported healthcare associated infections. Although the CDC has stated that there are no definitive studies comparing the effectiveness of the different types of skin antiseptics in preventing SSI, it also states that "Alcohol is readily available, inexpensive, and remains the most effective and rapid-acting skin antiseptic." Hence, 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.
The use of an alcohol-based skin preparation in ASCs is not considered safe, unless appropriate fire risk reduction measures are taken, preferably as part of a systematic approach by the ASC to preventing surgery-related fires. A review of recommendations produced by various expert organizations concerning use of alcohol-based skin preparations in anesthetizing locations indicates there is general consensus that the following fire risk reduction measures are appropriate:
ASCs that employ alcohol-based skin preparations in ORs or procedure rooms should establish appropriate policies and procedures to reduce the associated risk of fire. They should also document the implementation of these policies and procedures in the patient's medical record.
Failure by an ASC to develop and implement appropriate measures to reduce the risk of fires associated with the use of alcohol-based skin preparations in ORs or procedure rooms is cited as condition-level noncompliance with §416.44.
Finally, in order for surgery to be performed in a safe manner in the ASC, there must be evidence that the ASC is complying with the requirements at §416.43, concerning quality assessment and performance improvement, in order to assure ongoing, rapid identification of factors that might pose a threat to patient safety and effective responses to identified problems. Therefore, condition-level noncompliance with §416.43 may also warrant a citation of Condition-level noncompliance with §416.42.
1 CDC Hospital Infection Control Practices Advisory Committee, "Guideline for Prevention of
Surgical Site Infection, 1999," Infection Control and Hospital Epidemiology April 1999 (Vol. 20 No. 4) 251.
2 Ibid., 257.
3 Tentative Interim Amendment (TIA 05-02) to (National Fire Protection Association) NFPA 99,
2005 edition, 13.4.1.2.2. Germicides and Antiseptics, issued July 29, 2005 and effective August 18, 2005. See also AORN Guidance Statement: Fire Prevention in the Operating Room; and Patient Safety Advisory June 2005 (Vol. 2 No. 2) 14, Prepared by ECRI for the Pennsylvania Patient Safety Reporting System.
Standard: Anesthetic Risk and Evaluation (Rev.71, Issued: 05-13-11, Effective: 5-13-11-Implementation: 05-13-11)
(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
Interpretive Guidelines: §416.42(a)(1)
The purpose of the exam immediately before surgery is to evaluate, based on the patient's current condition, whether the risks associated with the anesthesia that will be administered and with the surgical procedure that will be performed fall within an acceptable range for a patient having that procedure in an ASC, given that the ASC does not provide services to patients requiring hospitalization. The assessment must be specific to each patient; it is not acceptable for an ASC to assume, for example, that coverage of a specific procedure by Medicare or an insurance company in an ASC setting is a sufficient basis to conclude that the risks of the anesthesia and surgery are acceptable generically for every ASC patient. The requirement for a physician to examine the patient immediately before surgery is not to be confused with the separate requirement at 42 CFR 416.52(a)(1) for a pre-admission history and physical assessment performed by a physician, although it is expected that the physician will review the materials from such pre-admission examination as part of the evaluation. Nevertheless, this requirement does constitute one component of the requirement at 42 CFR 416.52(a)(2) for a pre-surgical assessment upon admission.In those cases, however, where the comprehensive history and physical assessment is performed in the ASC on the same day as the surgical procedure, the assessment of the patient’s procedure/anesthesia risk must be conducted separately from the history and physical, including any update assessment incorporated into that history and physical. See the interpretive guidelines for §§416.52(a)(1) & (2).
The ASC must have approved policies and procedures to assure that the assessment of anesthesia-related and procedural risks is completed just prior to every surgical procedure. (Ideally, the ASC would conduct such an assessment prior to the patient's admission as well as immediately prior to surgery, but this is not specifically required by the regulations.)
The ASC's policies must address the basis or criteria used within the ASC in conducting these risk assessments, and must assure consistency among assessments.
The regulations do not specify the content or methodology to be employed in such assessments. As an illustrative example, an ASC might choose to incorporate consideration of a patient's ASA Physical Classification into its criteria. Although the American Society of Anesthesiologists did not create its ASA Physical Status Classification System for the purpose of predicting operative risk, this system has nevertheless been found to be useful in predicting morbidity and mortality in surgical patients1 and has been used by surgical facilities as a standard tool. This system classifies patients' physical status in 6 levels:
As the ASA PS level of a patient increases, the range of acceptable risk associated with a specific procedure or type of anesthesia in an ambulatory setting may narrow. An ASC that employed this classification system in its assessment of its patients might then consider, taking into account the nature of the procedures it performs and the anesthesia used, whether it will accept for admission patients who would have a classification of ASA PS IV or higher. For many patients classified as ASA PS level III, an ASC may also not be an appropriate setting, depending upon the procedure and anesthesia.
If a State establishes licensure limitations on the types of procedures an ASC may perform that are based on patient classifications and would permit ASCs to perform fewer procedures than they would under the CfCs, then the ASC must conform to those State requirements. However, State requirements that would expand the types of procedures an ASC may offer beyond what is permitted under the CfCs are superseded by the Federal CfC requirements.
1P. 636, Davenport et al., "National Surgical Quality Improvement Program Risk Factors Can Be Used to Validate American Society of Anesthesiologists Physical Status Classification Levels," Annals of Surgery, Vol. 243, No. 5, May 2006
Standard: Anesthetic Risk and Evaluation (Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
Interpretive Guidelines: §416.42(a)(2)
An evaluation of the patient's recovery from anesthesia, to determine whether the patient is recovering appropriately, must be completed and documented before the patient is discharged from the ASC. The American Society of Anesthesiology (ASA) guidelines do not define moderate or conscious sedation as anesthesia. While current practice dictates that the patient receiving conscious sedation be monitored and evaluated before, during, and after the procedure by trained practitioners, a postanesthesia evaluation is not required.
The evaluation must be completed and documented by a physician or anesthetist, as defined at 42 CFR 410.69(b), i.e., a certified registered nurse anesthetist (CRNA) or an anesthesiologist's assistant. See the discussion at §416.42(b) for more discussion of CRNA and anesthesiologist's assistant requirements.
ASCs would be well advised in developing their policies and procedures for postanesthesia care to consult recognized guidelines. For example, Practice Guidelines for Postanesthetic Care, Anesthesiology, Vol 96, No 3, March, 2002, provides the recommendations of the American Society of Anesthesiologists for routine postanesthesia assessment and monitoring, including monitoring/assessment of:
Depending on the specific surgery or procedure performed, additional types of monitoring and assessment may be necessary.
Standard: Administration of Anesthesia
(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
(1) A qualified anesthesiologist, or
(2) A physician qualified to administer anesthesia, a certified registered nurse anesthetist (CRNA) or an anesthesiologist's assistant as defined in §410.69(b) of this chapter, or a supervised trainee in an approved educational program. In those cases in which a non-physician administers the anesthesia, unless exempted in accordance with paragraph (c) of this section, the anesthetist must be under the supervision of the operating physician, and in the case of an anesthesiologist's assistant, under the supervision of an anesthesiologist.
Standard: State Exemption
(1) An ASC may be exempted from the requirement for physician supervision of CRNAs as described in paragraph (b)(2) of this section, if the State in which the ASC is located submits a letter to CMS signed by the Governor, following consultation with the State's Boards of Medicine and Nursing, requesting exemption from physician supervision of CRNAs. The letter from the Governor must attest that he or she has consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State's citizens to opt-out of the current physician supervision requirement, and that the opt-out is consistent with State law.
(2) The request for exemption and recognition of State laws, and the withdrawal of the request may be submitted at any time, and is effective upon submission.
Interpretive Guidelines: §416.42(b) & (c)
The ASC's policies and procedures must include criteria, consistent with State law governing scope of professional practice and other applicable State law, for determining the anesthesia privileges to be granted by the governing body to an eligible individual practitioner and a procedure for applying the criteria to individuals requesting privileges. The ASC must specify the anesthesia privileges for each practitioner who administers anesthesia, or who supervises the administration of anesthesia by another practitioner. The privileges granted must be in accordance with State law and the ASC's policy. The type and complexity of procedures for which the practitioner may administer anesthesia, or supervise another practitioner supervising anesthesia, must be specified in the privileges granted to the individual practitioner.
When granting anesthesia privileges to a physician who is not an anesthesiologist, the ASC's governing body must consider the practitioner's scope of practice, State law, the individual competencies, education, and training of the practitioner and the practitioner's compliance with the ASC's other criteria for granting physician privileges.
When an ASC permits operating physicians to supervise CRNAs administering anesthesia, the governing body must adopt written policies that explicitly provide for this.
A CRNA is defined at §410.69(b) as a "...registered nurse who:
(i) has passed a certification examination of the Council on Certification of Nurse Anesthetists, or any other certification organization that may be designated by the Secretary; or
(ii) is a graduate of a program described in paragraph (3) of this definition and within 24 months after that graduation meets the requirements of paragraph (4)(i) of this definition." A CRNA may administer anesthesia in an ASC when under the supervision of the operating physician.
If the ASC is located in a State where the Governor has submitted a letter to CMS attesting that he or she has consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State, and has concluded that it is in the best interests of the State's citizens to opt-out of the current physician supervision requirement, and that the opt-out is consistent with State law, then a CRNA may administer anesthesia without physician supervision.
An anesthesiologist's assistant is defined at §410.69(b) as a "...person who - (1) works under the direction of an anesthesiologist; (2) is in compliance with all applicable requirements of State law, including any licensure requirements the State imposes on nonphysician anesthetists; and (3) is a graduate of a medical school-based anesthesiologist's assistant education program that - (A) is accredited by the Committee on Allied Health Education and Accreditation; and (B) includes approximately two years of specialized basic science and clinical education in anesthesia at a level that builds on a premedical undergraduate science background." An anesthesiologist's assistant may administer anesthesia when under the direct supervision of an anesthesiologist. The anesthesiologist must be immediately available if needed, meaning the anesthesiologist is:
A trainee who is a physician in training to be an anesthesiologist in a recognized graduate medical education program, or a student in a recognized nurse anesthesia or anesthesiologist's assistance educational program may administer anesthesia in an ASC when supervised by the operating physician, in the case of a nurse anesthetist trainee, or by an anesthesiologist, in the case of a physician trainee or an anesthesiologist's assistant trainee.