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The Bariatric Surgery Review Committee (BSRC) reviews the information, determines whether the guidelines are met, and grants or denies the designation. Information in the application is accepted on an honor system; site inspections for Provisional Status applications will be required only on the rare occasion when information in the application is unclear or suggests that verification is warranted. If the application is denied, the applicant institution and the surgeon(s) are informed of the reason(s) for denial and invited to reapply when the deficiency(ies) is corrected.

The Provisional Status designation is for two years. Before that deadline, hospitals are encouraged to submit an application for Full Approval recognition as an American Society for Metabolic and Bariatric Surgery (ASMBS) Freestanding Outpatient Bariatric Surgery Center of Excellence®.

The requirements for Provisional Status are as follows:

1.	The Applicant has an institutional commitment by the facility's administration and medical staff to excellence in the care of outpatient bariatric surgical patients as documented with an ongoing regularly scheduled in-service education program in bariatric surgery and separate distinct credentialing guidelines for bariatric surgery. This requirement refers to a culture in which the staff is prepared to manage morbidly obese patients with understanding and compassion, and to appreciate the burdens of the co-morbidities of the disease. The staff should be aware of the basic concepts of bariatric surgery through in-service programs. Those directly caring for these patients should be able to recognize the early signs of common complications including pulmonary embolus, infection, and intra-abdominal complications as well as the complications of gastric banding procedures so that they can be managed promptly.

2.	a) The reasonable expectation that the applicant institution will perform a minimum of 100 bariatric surgical cases per year. b) The reasonable expectation that each applicant surgeon will perform a minimum of 50 cases per year with a total lifetime experience of at least 125 cases as primary surgeon. Bariatric surgical cases are defined as primary operations and/or revisions. Endoscopies, placement of feeding jejunostomies, hernia repairs, and plastic surgical reconstructions are not included in this classification. In addition, the definition of "Primary" operations excludes procedures involving stapling or division of the GI tract. Performed is defined as conducting a significant part of the operation as primary surgeon. Applicants may not include cases where they served only as the assisting surgeon. Applicants may include up to 75 operations performed as the primary surgeon during their fellowship in their total lifetime count.

3.	The Applicant has a dedicated Medical Director for bariatric surgery who participates in the relevant decision-making administrative meetings of the facility. The position of Bariatric Surgery Medical Director shall be filled by a qualified, board certified or previously board certified bariatric surgeon who is appointed through the administrative/medical staff process with facility minutes documenting his or her participation in the bariatric program decisions. Regularly scheduled meetings to address the bariatric program in the institution that involve medical staff, nursing, administration, central supply, operating room personnel, and the business office are required.

4.	The Applicant has a board certified anesthesiologist supervising anesthesia delivery on all bariatric patients and is physically present in house while any bariatric patient is anesthetized, or, when anesthesia is not being given, an Advanced Cardiac Life Support (ACLS) qualified physician is on site who can perform patient resuscitations. The facility must have a full-time staff with experience managing critically ill, morbidly obese patients with ventilators and invasive hemodynamic monitoring technologies who can support the management of a critically ill patient until he or she is sufficiently stable to be transferred to an inpatient facility.

5.	The Applicant has a full line of equipment and instruments for the care of bariatric patients including surgical and radiological facilities for evaluation of band placement, surgical instruments, etc. for the morbidly obese as well as the capability of performing band adjustments under fluoroscopic control. Furniture, beds, scales, floor-supported toilets, wheelchairs, operating room tables and litters strong enough and extra wide to accommodate the severely obese according to the weight limits established by the institution and documented by the manufacturer's specifications stating the weight capacity of the equipment, must be available for those patients who need this specialized equipment. Patient movement/transfer systems for morbidly obese patients must be in place throughout the institution wherever the morbidly obese receive care. Finally, and perhaps most importantly, facility personnel must be trained to use the equipment and be capable of moving these large individuals without injury either to the patients or themselves.

6.	The Applicant center must have a bariatric surgeon co-applicant who is or has been board certified or is currently board eligible by the American Board of Surgery (ABS), the American Osteopathic Board of Surgery (AOBS) and/or the Royal College of Physicians and Surgeons of Canada (RCPSC). The surgeon co-applicant must spend at least 50 percent of his or her efforts in the field of bariatric surgery. In addition, the surgeon must maintain surgical privileges at the inpatient transfer facility for managing the full range of complications from bariatric surgery and agree to manage and supervise complications which occur in their patients, including providing for band adjustments. The surgeon must be or have been certified, or be currently board eligible by the ABS, AOBS, and/or the RCPSC. In addition, the surgeon must show evidence of bariatric surgical expertise in accordance with the guidelines of the American Society for Metabolic and Bariatric Surgery (ASMBS).

7.	The Applicant utilizes standardized operations and clinical pathways to enable objective evaluation and inter-institutional comparisons of outcomes. It is the surgeon's responsibility and duty to select which primary operation(s) he or she will perform and it is the expectation of SRC that the procedure(s), no matter what the choice(s), will be done in a standardized manner. Similarly, the surgeon should determine the details of the planned perioperative care. These details must be documented so that each member of the surgeon's team is aware of the care plan and is prepared to follow the process as outlined by the surgeon. Unless such a process is followed, outcomes cannot be evaluated. The clinical pathway protocols, i.e. a sequence of orders and therapies describing the routine care of the uncomplicated patient, must be available for review during the site inspection.

8.	The Applicant has nurses or physician extenders dedicated to serving bariatric surgical patients who are involved in continuing education in the care of bariatric patients at the facility and in the surgeon's office. The facility should have a subset of nurses who routinely care for the bariatric patients and who receive regular in-service education on their care. There should be a bariatric coordinator designated to supervise the bariatric program. The physician's practice should also have nursing and physician extenders who provide continuing education and care to the bariatric patients in the practice. This should be outlined in the practice portfolio if it is a split practice that still performs significant general surgery.

9.	The Applicant maintains the availability of organized and supervised support groups for all patients who have undergone bariatric surgery at the facility. The activities of the support group should be documented including group locations, meeting times, supervisor, curriculum, and attendance. For example, such activities as on-line chat rooms, web-based support groups, exercise, instruction, and clothing sales should be noted.

10.	The applicant provides documentation of a program dedicated to a goal of long-term patient follow-up of at least 75 percent for bariatric procedures at five years with a monitoring and tracking system for outcomes, and agrees to provide surgical outcomes data on all patients to SRC through the Bariatric Outcomes Longitudinal Database (BOLD) in a manner consistent with Health Insurance Portability and Accountability Act (HIPAA) regulations. Interpretative Notes for Requirement 10: This requirement is based on the observation that a significant number of patients develop nutritional deficiencies, internal and external hernias, return of previous emotional disorders, as well as other late complications. There is no requirement that the surgeon provide the follow-up personally, only that he or she is aware of the long-term status of the patient. Accordingly, the follow-up data can be gathered during group sessions, reunions or through visits at other physicians' offices. The applicant agrees to enter all patients who undergo surgery in the group or individual practice into the Bariatric Outcomes Longitudinal Database™ (BOLD™). All surgical patients will be requested to consent to use of their data for aggregate data analysis and research purposes. Patient data will also be collected for program compliance purposes. Outsourcing patient follow-up to third parties is acceptable provided that the outsourcing agent can be site inspected and the surgeon and/or hospital maintains adequate communications with the outsourcing agent to track patient outcomes on an ongoing basis. Follow-up performed by the patient's primary care physician is also acceptable provided the surgeon or hospital maintains adequate communications with the primary care physician to track outcomes.

11.	The surgeon must have qualified coverage, i.e. by a colleague who is board certified or board eligible by the American Board of Surgery (ABS), the American Osteopathic Board of Surgery (AOBS) and/or Royal College of Physicians and Surgeons of Canada (RCPSC); has at least eight (8) hours of Continuing Medical Education (CME) in bariatric surgery; and has assisted on at least five (5) non-stapling gastric procedure and/or ten (10) gastric stapling involving anastomotic procedures, depending upon the coverage situation. Qualified coverage is defined as the coverage required for the full care of a bariatric patient in the absence of the primary surgeon. The covering surgeon must be or have been certified or be currently board eligible by the ABS, AOBS and/or RCPSC, have significant experience in the care of bariatric surgical patients and be capable of managing the full range of complications associated with surgery of the morbidly obese. If operations are limited to gastric banding procedures, the covering surgeon needs only to be familiar with these interventions as reflected by the involvement in five operations. Note: The covering surgeon must meet all of the board certification, CME, and assist requirements noted above in order to obtain Full Approval, but need not have met all requirements at the time of the application for Provisional Status.

12.	The Applicant maintains that their facility must have in place a written transfer agreement with an inpatient facility capable of managing the full range of complications of bariatric surgery 24/7/365 and with equipment capable of transferring morbidly obese patients to that inpatient facility. This requirement is intended to assure the prompt and safe transfer of a bariatric patient to a full service tertiary care facility. It should be possible to complete the transfer from the time of decision to care in the accepting facility in less than one hour. In addition, adequate staffing must be available to provide emergency support, including the time in transfer, until the patient's care is assumed by the other facility.

13.	The Applicant maintains that their facility will agree to limit bariatric surgery performed as an outpatient or 23 hours, 59 minutes stay to procedures in low risk patients (defined as patients age less than 60, a Body Mass Index (BMI) of less than 55, weight less than or equal to 425 pounds, an American Society of Anesthesiologists (ASA) classification of less than IV (four), and no previous history of deep venous thrombosis (DVT) or pulmonary embolism (PE)), that do not involve stapling or division of the gastrointestinal tract. This requirement is intended to limit the patient population to individuals who carry surgical risk levels appropriate to the outpatient setting. The definition noted above is a guideline; SRC recognizes that patient exigency may require exceptions with the understanding that patient safety must remain paramount.


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