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Vascular surgeons, as well as related specialists, have increasingly become involved in the ownership of outpatient endovascular suites as proprietors (individual or partnered with other physicians or hospitals) or through lease arrangements. As such they would be responsible for the operation of the entity including any accreditation requirements, the financial aspects, quality, and patient safety.
There are some compelling reasons for physicians to become involved in these ventures. However, some have suggested that many of these suites will be established with minimal patient safeguards, outdated or inefficient technology, and ill-prepared or insufficient staff. Further, competition from these suites would reduce inpatient angiographic volume and experience as well as negatively impacting the finances of nearby hospitals. The main argument advanced by detractors of physician ownership has been that the profit motive may result in unnecessary testing or procedures and ?cherry picking? the less complicated and insured patient.
Accordingly, the Clinical Practice Council of the Society for Vascular Surgery (SVS) requested that a white paper be written to provide guidelines on the establishment and function of outpatient endovascular suites. However, there was a considerable debate as to what should be included in this white paper with some even suggesting that these outpatient suites should not be supported. Consequently, the Council requested the authors to initiate debate on the subject. Eventually the SVS may have sufficient information from its membership to produce a definitive statement as to the role and function of these outpatient facilities. Therefore, this editorial is based on the opinion of the authors. It is not a product of a systematic review nor is it a comprehensive analysis of the subject. Neither is it a product of the Society for Vascular Surgery. Readers are encouraged to consider the information presented, evaluate other material and reach their own conclusions. The authors would appreciate feedback in the form of letters to the editor of “Vascular Specialist” or directly to the authors. Their emails accompany this editorial.
What we think!
Diagnostic arteriography, venography, venous ablation, balloon angioplasty, atherectomy, vena caval filters, filter extraction, and stenting can all be performed in an outpatient setting and have been shown to be safe provided that standard quality controls are in place.
Compared to in-hospital centers, these free-standing outpatient suites may offer more efficient clinical operations, saving time and money for the patient, the surgeon and the insurance provider. Patients could benefit from the convenience and consistency of on-time appointments, convenient locations, shorter wait times, easier scheduling, onsite parking and less intimidating surroundings. The location and space allotted to the suite will vary. However, every effort should be made to assure that these positive attributes of outpatient endovascular suites are incorporated. The insurance carrier may benefit by reimbursing the center less than if the procedures were performed in a hospital. This would then result in lower co-pay for the patient and reduce overall premiums and the cost of healthcare. Vascular surgeons would have the convenience of working in a familiar facility usually in proximity to their clinic or private office. Importantly, they would work in an environment where they have direct control over safety, quality, personnel, equipment and cost.
Some endovascular suites are directly affiliated and attached to hospitals whereas others are independent and located at variable distances from hospitals or emergency facilities. Irrespective of ownership or location considerations, the prime concern for the vascular surgeon should be patient safety. Accordingly, special considerations may be required when these procedures are performed in locations at a distance from hospitals. Foremost, only procedures and technology proven to be safely performed as an outpatient should be considered for that setting. Newer technologies and procedures should probably not be utilized until their safety has been established. For example, although diagnostic carotid arteriography may be safely performed, stenting of carotid lesions probably should not be performed in these outpatient facilities at this time.
Procedures to prevent wrong side interventions, incorrect medication administration and other safety precautions, standard in hospital environments, must also be followed. Timely production of complete procedure reports and hard copy (digital or other media) of the images is strongly encouraged since these will most often be reviewed offsite.
Nowadays “cloud” storage of data may allow easy access to images although privacy concerns must be safeguarded. Tracking of complications such as hematoma formation, allergic reactions and other quality parameters such as contrast dosages, fluoroscopy time etc., should be performed on a regular basis.
In many states, complications must be reported to the relevant State Department of Health usually within 48 hours for their review. Most importantly, the endovascular suite should have in place a plan to deal with emergencies that may arise during or soon after a procedure such as cardio-pulmonary arrest, retroperitoneal bleeding, access site bleeding, false aneurysm, anaphylaxis etc. Standard care should incorporate having ACLS certified personnel present at all times with the ability to perform aggressive CPR including intubation, cardiac defibrillation etc.
Physicians administering or supervising moderate sedation/analgesia, deep sedation/analgesia, or general anesthesia should have appropriate education and training. Since hospitalization may sometimes be necessary, a protocol for transfer of the patient to the nearest hospital should also be in place.
Transfer mechanisms should include the ability to offer advanced life support. A written agreement with the receiving hospital should be mandatory. If anesthesia services are provided arrangements regarding the role of these ancillary personnel should be contracted.
High quality X-ray imaging is a prerequisite for evaluation of vascular anatomy and the safe placement of catheters, stents and other intravascular devices. The goal should be to provide the best quality device with the least radiation exposure to staff and patients. Fixed overhead units are considered to offer better images, expedited procedures and potentially less radiation but newer portable units do provide acceptable images for most applications.
However, the choice of image intensifier (fixed overhead or portable) will often be based on space as well as cost considerations. No matter which device is chosen, standard radiation safety precautions should be followed (radiation badges, monthly dosimetry reports, lead lined rooms, etc).Every attempt should be made to assure that the quality and safety of the suite is equal, or superior ,to the in-hospital facility where the surgeon would otherwise be performing these procedures.
Disposable equipment (catheters, contrast agents, angioplasty balloons etc.) should all be present in sufficient quantity and quality to allow the procedure to be performed completely and safely. Strict inventory review must be done on a scheduled basis. There should be sufficient room to perform procedures from the neck, brachial, femoral or distal leg positions. Monitoring equipment including blood pressure, oxygenation, EKG etc should be present.
A regular maintenance program for all equipment must be in place. Satisfactory post-procedural areas should be available and staffed with protocols in place to reach the treating surgeon should an emergency occur. The treating surgeon must be available for a rapid response to unexpected complications that may be life or limb-threatening.
Standard precautions to protect patient confidentiality must be followed and all city, state or federal regulations governing these suites should be observed. Compliance with federal statutes such as the Anti-Kickback law and Stark law as well as individual State requirements must be in place
Physicians who own or lease these endovascular suites must assume an active role in managing the facility. This can result in increased productivity, quality and efficiency but can also result in real or perceived conflict of interest due to increased utilization and compensation.
However, the simplistic implication that physician ownership leads to increased utilization ignores the complexities involved in decision making that include multiple regulatory policies and clinical, non-financial, incentives. Irrespective, the vascular surgeon who receives remuneration for managing or owning the suite should fully disclose this arrangement to the patient or involved parties. Such relationships should be fully transparent to all stakeholders and comply with Federal and State statutes. Ultimately, the patient should be given the opportunity to decide on the location where they are to have the planned procedure.
In summary, then, we believe that many endovascular procedures can be safely performed in outpatient endovascular suites and that this can result in benefits for patient and surgeon. The author’s support SVS members’ use of these suites, regardless of ownership, as long as potential conflicts of interest are fully disclosed to the patient and provided that high quality care is provided safely and cost effectively.
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