Surgical Review Corporation

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 the 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 as an American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Surgery Center of Excellence.

The requirements for Provisional Status are as follows:

1) Institutional Commitment to Excellence
An institutional commitment at the highest levels of the applicant medical staff and the institution's administration to excellence in the care of bariatric surgical patients as documented with an ongoing, regularly scheduled, in-service education program in bariatric surgery.

An institutional commitment that is also demonstrated by employing credentialing guidelines for bariatric surgery.

Interpretative Notes
Hospitals must have a cross-organizational commitment to bariatric surgical care, from the highest levels of the medical staff to the administration and all staff who come into direct contact with bariatric patients.

Importantly, hospitals must have defined bariatric surgery credentialing and privileging guidelines that are separate from general surgery guidelines.

Hospitals must also have ongoing, in-service education programs for the bariatric team that are well-established and properly managed. These education programs must ensure a basic understanding of bariatric surgery concepts as well as the appropriate management and care of the bariatric patient. The following in-services must be well-attended and documented:

Sensitivity training: in-service education must support a culture where staff members are prepared to manage morbidly obese patients with understanding and compassion and appreciate the burdens of the comorbidities of the disease.
Signs and symptoms of postoperative complications: in-service education must help ensure that those directly caring for patients are able to recognize the potential signs and symptoms of common bariatric surgery complications (e.g., pulmonary embolus, anastomotic leak, infection and bowel obstruction) so the patient can be managed promptly. Hospitals must also have a system in place to ensure the ongoing competencies of staff in recognizing these signs and symptoms.
Patient transfers and mobilization: in-service education must address the safe transfer and mobilization of morbidly obese patients, which is for the benefit of the patient as well as the staff.

The minimum frequency required for the above training is once every three years for all relevant staff. However, most BSCOE hospitals provide this training every year and other programs are encouraged to do so as well. Training in these three areas is also required upon hiring for all new employees who will have direct contact with bariatric patients.

2) Surgical Experience and Volumes
The applicant institution has performed at least 125 bariatric surgical cases in the preceding 12-month period.

Each applicant surgeon has performed at least 125 total bariatric cases lifetime with at least 50 cases performed in the preceding 12-month period.

Interpretative Notes
Hospitals must have performed a minimum of 125 bariatric surgical cases in the preceding 12 months. Surgeons must have served as primary surgeon for at least 50 bariatric surgeries in the preceding 12 months and 125 during their lifetime. If the surgeon's role as primary surgeon has been properly documented, 75 of the lifetime surgeries may have been performed during fellowship or residency. Cases in which the surgeon serves as co-surgeon or assisting surgeon do not count.

Only primary bariatric surgical procedures formally recognized by the ASMBS count toward the hospital and surgeon volume requirements. As of March 2009, the following procedures, whether open or laparoscopic, are the only primary procedures that qualify: - Gastric bypass: short- or long-limbed, transected or not transected, banded or not banded
- Vertical banded gastroplasty
- Gastric banding
- Duodenal switch
- Biliopancreatic diversion
- Sleeve gastrectomy
The following additional procedures also count toward the volume requirements:
- Select repairs on postoperative bariatric surgery patients: slipped gastric band, jejuno-jejunostomy, colonic mesentery, Peterson hernias and hernias forming around an adhesion
- Laparoscopic removal of an eroded gastric band
Procedures that do not count toward hospital and surgeon volume requirements include:
- Port revisions, tubing repairs, gastric band removals (unless eroded as outlined above), and repairs of inguinal, incisional, umbilical and port site hernias
- Abdominal wall hernias and exploratory procedures used to make a diagnosis that do not result in the repair of an internal hernia

Each hospital and surgeon procedure must be thoroughly documented to enable a medical chart review.

3) Designated Medical Director
The applicant maintains a designated physician Medical Director for bariatric surgery who participates in the relevant decision-making administrative meetings of the institution.

Interpretative Notes
Hospitals must have a designated physician medical director for bariatric surgery who participates in the interdisciplinary team meetings that are required to ensure that bariatric-related decisions are addressed in a comprehensive manner. Discussions held during these regularly scheduled meetings must be documented through minutes that demonstrate the medical director’s involvement in key program decisions. The medical director must be a bariatric surgeon who actively addresses medical staff, nursing, administration, central supply, operating room personnel and business issues related to the delivery of bariatric surgical care. They must also run an organized and structured department of bariatric surgery.

The medical director must be an actively practicing bariatric surgeon – and meet all of the surgeon qualifications in Requirement 6 – if they are personally applying to the BSCOE program as one of the hospital’s co-applicant surgeons.
However, the medical director does not need to be an actively practicing bariatric surgeon if they are not personally applying for or maintaining their BSCOE surgeon designation.

The medical director must have been officially appointed through the facility’s standard administrative/medical staff process, and they cannot be self-appointed. Of note, this position can be filled with two co-medical directors.

4) Responsive Critical Care Support
The applicant hospital maintains, within 30 minutes of request, a full complement on staff of the various consultative services required for the care of bariatric surgical patients including the immediate availability of an ACLS-qualified physician on-site who can perform patient resuscitations.

Interpretative Notes
If a bariatric surgery patient requires critical care, hospitals and their associated surgeons must ensure that they receive appropriate care.

Consultants: hospitals must maintain – and identify by name – on staff a full complement of consultative services and equipment required for the care of patients who undergo bariatric surgery. At a minimum, this includes the following:

On-site 24/7: an advanced cardiac life support (ACLS)-qualified physician must be on-site at all times. This ensures that a qualified provider is able to perform patient resuscitations at any time in cases where anesthesia is not being given.

Of note, this coverage may be provided by a senior resident who holds ACLS certification. Hospitals with an emergency department can fulfill this requirement with a board-certified emergency room physician, as long as the hospital's policies dictate that this physician will be available at all times. This requirement may not be fulfilled with a nurse.
Four consultants who must be on-site within 30 minutes:

- Anesthesiologist or certified registered nurse anesthetist (CRNA) who supervises anesthesia delivery on all bariatric surgery patients and is physically present while any of these patients is anesthetized
- Physician capable of performing endoscopies to diagnose complications
- Interventional radiologist to diagnose complications
- One physician with critical care credentials to manage complications: a critical care physician/intensivist, hospitalist, cardiologist or pulmonologist

Having an off-site intensive care unit (ICU) monitoring system (live video feed and remote vital sign monitoring) does not fulfill the need of having consultants physically on-site within 30 minutes.

Hospitals must also be able to identify by name other leading consultant support team members, including the cardiologist, nutritionist/dietitian, psychiatrist/mental health provider and pulmonologist. When applicable, this would also include an infectious disease specialist or nursing program manager.

Critical Care Equipment: hospitals that have an ICU must have appropriate equipment, which is covered under Requirement 5. Hospitals that do not have an ICU on-site must be able to support critical care delivery. They must therefore have ventilators and hemodynamic monitoring equipment on-site so that qualified staff members are able to perform any necessary patient resuscitation.

Written Transfer Agreements: if applicable, hospitals must have a written transfer agreement that details the transfer plan of bariatric surgery patients to other emergency or critical care facilities.

5) Appropriate Equipment and Instruments
The applicant maintains a full line of equipment and instruments for the care of bariatric surgical patients including furniture, wheel chairs, operating room tables, floor mounted or floor supported toilets, beds, radiologic capabilities, surgical instruments and other facilities suitable for morbidly obese patients.

Interpretative Notes
Hospitals need to have a full line of equipment and instruments for the care of patients who undergo bariatric surgery. This includes surgical/operating facilities and surgical instruments for the morbidly obese as well as appropriate radiological tables and facilities for evaluation, fluoroscopic technologies for band adjustments, medical imaging equipment for diagnostic purposes, and ICU equipment.

Additional required elements include chairs, beds, scales, floor-mounted or supported toilets, wheelchairs, examination and operating room tables, crash carts and stretchers/litters that are strong enough and wide enough to accommodate the morbidly/severely obese. Furniture and equipment must be able to accommodate patients that are within the patient weight limits established by the bariatric program. Weight capacities must be documented by the manufacturer's specifications, and this information must be readily available to relevant staff.

Appropriate patient movement/transfer systems must also be located wherever bariatric surgery patients receive care. Personnel must be trained to use the equipment and, most importantly, capable of moving these individuals without injury to the patient or themselves (see Requirement 1 regarding in-service education on patient transfers and mobilization).

Hospitals and surgical offices do not need to change all of the equipment, furniture and instruments throughout the entire facility. This requirement only applies to those areas where patients undergoing bariatric surgery receive care. For some hospitals, this is a dedicated bariatric patient care area. For others, it occurs in several areas throughout the hospital.

Radiology equipment with a weight capacity of more than 450 pounds (200 kilograms) has only recently become available. If the hospital's radiology equipment has a weight capacity less than 450 pounds, written policies and/or protocols referenced in clinical pathways must detail how patients who exceed the weight capacity are accommodated (see Requirement 7 for clinical pathways).

While not a requirement, ambulances serving the institution should also be equipped to manage bariatric surgery patients with appropriate stretchers, straps and transfer devices.

6) Surgeon Dedication and Qualified Call Coverage
The applicant has a bariatric surgeon who spends a significant portion of his or her efforts in the field of bariatric surgery and who has qualified coverage and support for patient care.

Interpretative Notes
Surgeons must be truly dedicated to bariatric surgery, spending a significant portion of their efforts in the field and keeping current on techniques and literature. Surgeons must therefore be certified as a general surgeon by the American Board of Surgery (ABS), American Osteopathic Board of Surgery (AOBS), or Royal College of Physicians and Surgeons of Canada (RCPSC). Surgeons must also have a minimum of 24 hours of Category 1 continuing medical education (CME) in bariatric surgery every three years and show evidence of bariatric surgical expertise in accordance with ASMBS guidelines.

Surgeons must have qualified coverage by a colleague who can be responsible for the complete care of a bariatric patient – including the full range of complications associated with surgery of the morbidly obese – in the absence of the primary surgeon.

Covering bariatric and general surgeons must be board certified or eligible by the ABS, AOBS or RCPSC. They must also have at least 12 hours of Category 1 CME in bariatric surgery every three years (half of the amount required for BSCOE designation).

Within 10 years of the application date, covering bariatric and general surgeons must have performed or assisted on a minimum number of surgeries for each type of bariatric procedure performed by the applicant surgeon:
- Nonstapling gastric coverage: 5 nonstapling gastric procedures
- Gastric stapling or anastomatic coverage: 10 gastric stapling or anastomatic procedures
- Gastric sleeve coverage: 5 gastric sleeves, 10 gastric bypass or 10 duodenal switch procedures
All covering surgeons must be available on-site within 30 minutes.

Surgeons and their covering surgeons who are not board certified will be considered on a case-by-case basis based on experience, demonstration of good standing, licensing and fellowship. This includes surgeons who have been board certified through credentialing bodies in other countries.

7) Clinical Pathways and Standard Operating Procedures
The applicant utilizes clinical pathways and orders that facilitate the standardization of perioperative care for the relevant procedure. In addition, all bariatric surgical procedures are standardized for each surgeon.

Interpretative Notes
Hospitals and surgeons must document and use clinical pathways and standardized orders to facilitate improved outcomes for the "uncomplicated patient" who undergoes bariatric surgery. The surgeon decides which bariatric operation(s) they will perform and what perioperative care will be. In turn, SRC requires that operations are performed in a standardized manner and perioperative care details are well-documented and followed by the surgeon’s team. Importantly, these standardized processes will also enable aggregate research on outcomes.

Clinical pathways, a sequence of orders and therapies describing the routine care of the uncomplicated patient from initial patient evaluation through long-term follow-up, must be established and documented. Said another way, they must cover the preoperative, intraoperative/surgical and postoperative phases of bariatric surgery patient care.

Clinical pathways must be developed for each procedure performed by the surgeon and hospital (see Requirement 2 for the list of primary procedures formally recognized by the ASMBS as of March 2009). Within this, surgical pathways must detail the surgical technique for each surgeon and procedure. The standardized orders referenced in the clinical pathways must be similarly detailed and adhered to.

Clinical pathways can be documented in a variety of formats, including tables, algorithms/process maps and paragraph form. While consistency for each bariatric program is encouraged, it is not mandatory.

Clinical pathways must be formally adopted and implemented prior to the SRC site inspection. Nurses, physician assistants, residents, applicant surgeons and other applicable staff must be aware of and following them.

Four clinical pathways are mandatory:

Anesthesia, including monitoring and airway management
Perioperative care, including monitoring and airway management
Deep vein thrombosis (DVT) management
Management of warning signs of complications such as tachycardia, fever and hemorrhage

Ten of the following 11 clinical pathways are also required:

Indications
Contraindications
Initial patient instruction
Patient evaluation
Laboratory studies
Imaging studies
Patient education/consent
Admission workup and evaluation
Preoperative and postoperative nutrition regimen
Wound care management
Pain management

8) Bariatric Nurses, Physician Extenders and Program Coordinator
The applicant utilizes designated nurse or physician extenders who are dedicated to serving bariatric surgical patients and who are involved in continuing education in the care of bariatric patients.

Interpretative Notes
Hospitals and surgeons must create a bariatric program in which the non-physician staff members can manage day-to-day aspects in compliance with the BSCOE requirements, including the provision of patient education.

Nurses and physician extenders: hospitals must have designated surgical and nonsurgical nurses as well as physician extenders who serve bariatric surgical patients. These individuals must receive the ongoing in-service education outlined in Requirement 1. Physician extenders are defined as any healthcare provider who assists a bariatric surgeon or practice.
Patient education and BOLD consent: hospitals and surgeons should have nurses and physician extenders who provide education and care to bariatric surgery patients.

Patient education includes offering patients a patient informed consent form that allows their information in BOLD to be used for aggregate data analysis and research purposes. As outlined in Requirement 10 and the BOLD Participation Agreement, this process must be followed for every patient that undergoes bariatric surgery.
Designated bariatric surgery area: hospitals must have a dedicated bariatric floor or designated cluster/group of beds that are maintained in a consistent area of the hospital. The area must be staffed with a team of dedicated bariatric nurses and physician extenders.
Bariatric program coordinator: bariatric surgery programs must have a designated bariatric coordinator who supervises program development, patient and staff education, ongoing BSCOE compliance and multidisciplinary team meetings. This person serves as the liaison between the affiliated hospital and surgical practice(s). The coordinator also typically serves as the primary SRC contact person (along with the designated BOLD Administrator for training and data entry).

A licensed health care professional must occupy the bariatric coordinator position full-time if the bariatric program handles more than 150 bariatric surgeries annually or part-time if 150 or less. These duties can be split between two individuals, as long as one is a licensed health care professional.

9) Patient Support Groups
The applicant makes available organized and supervised support groups for all patients who have undergone bariatric surgery at the institution.

Interpretative Notes
Organized and supervised support groups must be available for all bariatric surgery patients. Support groups can be organized by the practice and/or hospital, but the entity responsible for administering each support group must be clearly identified. Patients must have knowledge of their support group options.

At a minimum, one primary in-person support group must be offered at least once a quarter and be facilitated or attended by a licensed health care provider. All patients must be notified about primary group(s). Although encouraged, licensed health care providers are not required for other support groups, including auxiliary or outlying meetings held in remote locations.

All in-person support group activities should be documented, including group location, meeting time, supervisor, curriculum and attendance (in compliance with HIPAA). Other activities, including web-based support groups, online forums, exercise, instruction and clothing sales should be noted but do not require full documentation.

10) Long-Term Patient Follow-Up, Including BOLD^sm
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^sm (BOLD^sm) in a manner consistent with Health Insurance Portability and Accountability Act (HIPAA) regulations.

Interpretative Notes
Hospitals and surgeons must have a comprehensive long-term patient follow-up program that consistently monitors and tracks outcomes, complications and comorbidities for all bariatric surgery patients. Providers must provide bariatric surgical outcomes data on all patients through BOLD in a manner consistent with HIPAA regulations. The program must be designed with the goal of following up with 75% of all patients for five years or more after bariatric surgery.

The long-term patient follow-up process must be thoroughly documented and identify which patients are included in follow-up (e.g., all patients, all operated patients or incomplete patient entry). This includes identification of the persons or entities responsible for follow-up, frequency and timing of post-discharge follow-up visits as well as formats and tools (including data entry into BOLD) for tracking and documenting follow-up visits.

The bariatric surgeon does not need to personally provide the follow-up. However, bariatric programs need to have mechanisms in place to follow the care if it is delivered by another/third party licensed or certified health care provider (such as the patient’s primary care physician) and ensure that the data is accurately entered into BOLD in a timely fashion.

All bariatric surgical patients must be provided the opportunity to consent to use of their data in BOLD for aggregate data analysis and research purposes. Data on all patients that undergo bariatric surgery – both consented and non-consented – must be entered into BOLD. Non-consented data is not used for research but is used to monitor compliance. This applies to all patients who undergo bariatric surgery as of the date access to BOLD is granted (commonly referred to as "BOLD activation").

Complete listing of program requirement updates:


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