5. Surgical Services

(Rev. 56, Issued: 12-30-09, Effective/Implementation: 12-30-09)
§416.42 Condition for Coverage: Surgical Services
Surgical procedures must be performed in a safe manner by qualified physicians who have been granted clinical privileges by the governing body of the ASC in accordance with approved policies and procedures of the ASC.
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:
§416.44(a)(1), concerning operating room design and equipment – for example:
• The surgical equipment and supplies are sufficient so that the type of surgery conducted can be performed in a manner that will not endanger the health and safety of the patient;
• Surgical devices and equipment are monitored, inspected, tested, and maintained by the ASC in accordance with Federal and State law, regulations and guideline, and manufacturer’s recommendations; and that
• Access to the operative and recovery area is limited to authorized personnel and that the traffic flow pattern adheres to accepted standards of practice;
§416.44(a)(2), concerning a separate recovery room;
§416.44(a)(3) and §416.51, concerning infection control, for example:
• The conformance to aseptic and sterile technique by all individuals in the surgical area;
• That there is appropriate cleaning between surgical cases and appropriate terminal cleaning applied;
• That operating room attire is suitable for the kind of surgical case performed, that persons working in the operating suite must wear only clean surgical costumes, that surgical costumes are designed for maximum skin and hair coverage;
• That equipment is available for rapid “emergency” high-level disinfection/ sterilization of operating room materials;
• That sterilized materials are packaged, handled, labeled, and stored in a manner that ensures sterility e.g., in a moisture- and dust-controlled environment, and policies and procedures for expiration dates have been developed and are followed in accordance with accepted standards of practice.
• That temperature and humidity are monitored and maintained within accepted standards of practice; and
§416.44(c) & (d), concerning emergency equipment and personnel – for example:
• That surgical staff are trained in the use of emergency equipment and in cardiopulmonary resuscitation.
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:
• A pre-procedure verification process to make sure all relevant documents (including the patient’s signed informed consent) and related information are available, correctly identified, match the patient, and are consistent with the procedure the patient and the ASC’s clinical staff expect to be performed;
• Marking of the intended procedure site by the physician who will perform the procedure or another member of the surgical team so that it is unambiguously clear; and
• A “time out” before starting the procedure to confirm that the correct patient, site and procedure have been identified, and that all required documents and equipment are available and ready for use.
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:
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. These instructions for use should be carefully followed;
Ensuring that the alcohol-based skin prep solution does 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 prior to draping the patient;
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; and
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 pre-operative “time out” used to verify other essential information to minimize the risk of medical errors during the procedure.
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.
Survey Procedures: §416.42
• Determine whether the ASC has policies and procedures that establish the criteria and process the governing body uses when granting surgical privileges to a physician. Ask for documentation that the governing body approved these policies and procedures.
• Ask the ASC to identify each physician who currently has surgical privileges or has had surgical privileges within the previous 6 months. Ask the ASC for documentation of the governing body’s action to grant privileges to each of these physicians. Conduct this review in conjunction with the review of compliance with §§416.45(a)&(b).
• For each surgical case record that is reviewed as part of the survey team’s medical record review, verify that the individual performing the surgery was a physician who had been granted privileges by the ASC’s governing body.
• Observe at least one surgical case from the pre-operative phase through to the recovery room and discharge phase in order to determine whether standard procedures are followed to avoid wrong site/procedure/patient surgical errors, and that the requirements described above are met.
• Determine whether the ASC employs appropriate measures to reduce the risk of surgical fires.
• Ask the ASC whether it has ever had a surgical fire, and if so, what follow-up actions did it take to prevent the recurrence of surgical fires.
Endnotes for Condition for Coverage: Surgical Services
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, 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.
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