Cindy A. King RN, CPHQ, is director of clinical, quality and compliance for Health Inventures.
Q: I am the clinical coordinator at an ASC in Massachusetts. We are a state-licensed, Medicare-certified and AAAHC-accredited facility. Is it required for us to have a consulting radiologist for a mini C-Arm as well in Massachusetts? Also, if we do need a radiologist on staff, do they need to be in the OR for a mini-C-Arm case — can an MD, with training in x-ray, take the images instead?
Cindy King: As a general rule of thumb, whenever a question arises that pertains to an ASC's daily operations, I recommend re-checking the following three areas: your state-specific ASC licensure regulations, CMS rules/regulations for ASCs and the corresponding accreditation association standards. Since approximately 90-95 percent of day-to-day facility operations typically correspond to some type of regulation, these are the best places to start. Additionally, one can research applicable literature that may also provide guidelines for the topic in question and, lastly, it is always important to know what other ASCs are doing in your community from the perspective of a "community standard" as well.
With any topic that involves rules and regulations, your facility will be held to those that are the most stringent. In this situation, CMS regulation 416.49(b) Standard: Radiologic Services must be followed, which states:
(1) The ASC must have procedures for obtaining radiological services from a Medicare-approved facility to meet the needs of patients.
(2) Radiologic services must meet the hospital conditions of participation for radiologic services specified in 482.26 (which corresponds to CMS regulations for hospitals; refer to Appendix A, Survey Protocol, Regulations and Interpretive Guidelines for Hospitals of the State Operations Manual).
According to the Interpretive Guidelines (Rev.56, Issued, Effective/Implementation: 12/30/09) as it pertains to the above information, if the ASC uses radiological services as an integral part of the surgical procedures it performs then to meet the need of the ASC's patients, those radiological services must be provided in a manner that complies with the statements above. If the ASC does not provide these radiological services directly (i.e., utilizing its own staff), then it must obtain them via a contract or other formal arrangement from a Medicare-approved — i.e., a Medicare-participating — facility. Radiological services integral to the procedure itself are those imaging services performed immediately before, during or after the procedure that are medically necessary to the completion of the procedure. The scope and complexity of radiological services provided within the ASC should be specified in writing and approved by the governing body. (Note: If an ASC does not perform any procedures where radiological services are integral to the procedure, then the ASC is not required by this regulation to have arrangements for obtaining radiological services).
Among several other applicable rules/regulations that involve 482.26(a), 482.26(c) states that a qualified full-time, part-time or consulting radiologist must supervise the ionizing radiology services and must interpret only those radiologic tests that are determined by the medical staff to require a radiologist's specialized knowledge. For purposes of this section, a radiologist is a doctor of medicine or osteopathy who is qualified by education and experience in radiology. The Interpretive Guidelines go on to say that "supervision of the radiology services may only be performed by a radiologist who is a member of the medical staff".
Also, according to AAAHC 2010 Accreditation Handbook, Chapter 13 (Diagnostic & Other Imaging Services) C., healthcare professionals providing imaging services and/or interpreting results have: appropriate training & credentials, been granted privileges to provide these services and have appropriate safety training and provide their services in a safe manner.
So in order to demonstrate current compliance with the above, the following should be in place at your facility:
- A written contract/agreement pertaining to Radiology Services (i.e., use of x-ray technologists) from a Medicare-participating facility:
If you have any radiology technicians that are providing these services, those individuals should be credentialed as allied health professionals or if they are facility employees, they need to have a signed job description outlining their specific-tasks related to this service along with verification of their state licensure.
- A radiologist who has been credentialed and privileged by your ASC to perform the above services (i.e., consulting privileges at a minimum).
- From a state law perspective (105 CMR: Department of Public Health for Massachusetts), 120.405 K., it states that a facility shall ensure that only a licensed physician or a radiologic technologist who is trained in the safe use of fluoroscopic x-ray systems licensed in accordance with 105 CMR 125.000 shall be allowed to operate these systems. All persons using fluoroscopic x-ray systems shall have at a minimum documented training in the topics specified in 105 CMR 120.405(K)(2).
So as long as the involved surgeon who is operating the mini C-arm has been credentialed and privileged to do so at your facility, the consulting radiologist is not required to be physically present during the case but is required by CMS regulations to have "supervision" over ionizing services.
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