The initial application is for Provisional
Status designation. The application for Provisional Status focuses on:
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Resources of the applicant institution.
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Training and experience of the surgeons and surgical group.
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Whether the criteria for Provisional Status are met.
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. |
a. 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.
b. An institutional commitment that is also demonstrated by employing
credentialing guidelines for bariatric surgery.
Interpretative Notes for Requirement 1: This requirement refers to a culture in which the staff is prepared to manage morbidly obese patients and manage these individuals with understanding and compassion and appreciate the burdens of the comorbidities 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 the common complications including pulmonary embolus, anastomotic leak, infection and bowel obstruction so that these can be managed promptly. Sensitivity training is included as an aspect of in-service training. Applicants are required to provide written acknowledgement during the site inspection for Full Approval that sensitivity training is provided to relevant staff at least once every three years. |
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| 2. |
a. The reasonable expectation that the applicant institution will perform at
least 125 bariatric surgical cases per year.
b. The reasonable expectation that each applicant surgeon will have performed
at least 125 total bariatric cases lifetime, with at least 50 cases performed in
the preceding 12-month period.
Interpretative Notes for Requirement 2: “Bariatric surgical cases” are defined as primary operations and/or revisions.
“Performed” is defined as conducting a significant part of the operation as primary surgeon. Applicants may not include cases in which they served as the assisting surgeon.
Applicants may include up to 75 operations performed during their fellowship in the total lifetime count.
NOTE: Provisional Status applicants that have performed at least 50 percent of the required minimum number of surgeries at the time of Provisional Status application will be approved, since there is a reasonable expectation that they will be able to achieve the minimum number during the two-year Provisional Status term prior to applying for Full Approval. Applicants for Full Approval must be able to demonstrate that they have actually performed the minimum number of required surgeries.
Qualifying procedures: Only bariatric surgical procedures formally recognized by the ASMBS are counted in determining whether an applicant meets the applicable volume requirements. This standard applies to both surgeon and hospital applicants. The following procedures, whether performed open or laparoscopic, are recognized as of March 2009:
- 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
Within the context of the surgical procedures recognized by ASMBS, the repair of a slipped gastric band is a bariatric procedure which is counted toward the volume requirements.
In addition, repairs of jejuno-jejunostomy, colonic mesentery, Peterson hernias and hernias forming around an adhesion are bariatric procedures that are counted toward the volume requirements when performed on a post-bariatric surgery patient.
Port revisions, tubing repairs, gastric band removals and repairs of inguinal, incisional, umbilical and port site hernias are not primary bariatric procedures and are not counted toward the volume requirements.
Abdominal wall hernias and exploratory procedures used to make a diagnosis that do not result in the repair of an internal hernia do not count toward the volume requirements.
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| 3. |
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 for Requirement 3: The position of Bariatric Surgery Medical Director shall be filled by a qualified bariatric surgeon who is appointed through the administrative/medical staff process with hospital minutes documenting his or her participation in the bariatric program decisions. Regularly scheduled meetings to address the bariatric program in the institution which involve medical staff, nursing, administration, and operating room personnel are required. Attendance of an applicant hospital’s central supply and business departments at bariatric program staff meetings is optional. |
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| 4. |
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 for Requirement 4: The facility must have a full-time staff with experience managing critically ill, morbidly obese patients with ventilators and invasive hemodynamic monitoring technologies that can support the management of a critically ill patient until he or she is sufficiently stable to leave the facility.
For Provisional Status, the failure to have an ACLS-qualified physician on site who can perform patient resuscitations does not automatically disqualify the applicant, because the requirement can be met during the period of Provisional Status. However, this requirement is considered critical, so the failure to have an ACLS-qualified physician on site may warrant Monitoring Status until such time as the requirement is met. The failure to have an ACLS-qualified physician on-site is grounds for denial of the application for Full Approval. ACLS coverage may be provided by a Senior Resident who is immediately available on site 24-hours per day.
The failure to have available within 30 minutes of request all of the following consultative staff (i.e., all of these consultants must be available on-site within 30 minutes) is grounds for denial of the application for Full Approval:
- anesthesiologist/CRNA,
- internist with critical care expertise,
- endoscopist, and
- radiologist with interventional capability.
Failure to have all of these staff does not automatically disqualify the applicant for Provisional Status, but may warrant Monitoring Status until such time as the requirements are met.
Use of an off-site electronic ICU monitoring system (i.e., live video feed and vital sign monitoring at a remote location) without having an intensivist or other recognized consultative staff member either on-site or immediately available does not satisfy Requirement 4. |
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| 5. |
The applicant maintains a full line of equipment and instruments for the
care of bariatric surgical patients including furniture, wheelchairs,
operating room tables, floor-mounted or floor-supported toilets, beds, radiologic capabilities, surgical instruments and
other facilities suitable for morbidly obese patients.
Interpretative Notes for Requirement 5: Furniture, floor mounted or floor supported toilets, beds, scales, wheel chairs, operating room tables and litters, strong enough and extra wide to accommodate the severely obese according to the weight limits established by the institution, must be available for those patients who need this specialized equipment. Toilets not directly mounted to the floor must be floor supported. Patient movement/transfer systems for morbidly obese patients must be in place throughout the institution wherever the morbidly obese receive care. Ambulances serving the institution should also be equipped to manage these large patients with appropriate stretchers, straps, and transfer devices. Finally, and perhaps most important, the staff must be trained to use the equipment and be capable of moving these large individuals without injury either to the patients or the staff. |
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| 6. |
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 for Requirement 6: The applicant surgeon must be certified 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). In order for the applicant surgeon to demonstrate significant experience in managing bariatric patients and their complications, he or she must have no less than twenty-four (24) hours of Category 1 Continuing Medical Education (CME) in bariatric surgery every three years. 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). 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 certified (or eligible for certification) 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. In addition, the covering call surgeon must be available on-site within thirty (30) minutes of request. In order for the covering surgeon to demonstrate significant experience in managing bariatric patients and their complications, he or she must have at least twelve (12) hours of Category 1 Continuing Medical Education (CME) in bariatric surgery every three years, and have assisted on at least five (5) non-stapling gastric procedures and/or ten (10) gastric stapling and/or anastomotic procedures, depending on the covering arrangement, within the previous three years. These requirements apply only to general surgeons who cover bariatric cases and do not apply to coverage by a bariatric surgeon.
Note: The applicant and covering surgeon must meet all of the requirements noted above, as well as board certification, in order to obtain Full Approval, but do not need to have met all requirements at the time of the application for Provisional Status. An applicant or covering surgeon may be board eligible and receive Provisional Status designation, but must be board certified in order to obtain Full Approval. |
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| 7. |
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 for Requirement 7: 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, will be done in a standardized manner. Similarly, the surgeon should determine the details of the planned perioperative care. These details will 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 following specific clinical pathways are required for Full Approval (i.e., the pathways must have been formally adopted and implemented at the time of the site inspection):
- Anesthesia including monitoring and airway management.
- Perioperative care including monitoring and airway management.
- DVT management.
- Instructions for the management of warning signs of complications such as tachycardia, fever, and hemorrhage.
In addition, at least 10 of the following additional clinical pathways must have been formally adopted and implemented at the time of the site inspection:
- Indications
- Contraindications
- Initial patient instruction
- Patient evaluation
- Laboratory studies
- Imaging studies
- Patient education/consent
- Admission workup and evaluation
- Preoperative and postoperative dietary regimen
- Wound care management
- Pain management
Nurses, physician assistants, residents, applicant surgeons and other applicable staff must be aware of these protocols and follow them.
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 for Full Approval. |
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| 8. |
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 for Requirement 8: The hospital should have a subset of nurses who routinely care for the bariatric patients and receive regular in-service education on their care, preferably assigned to a designated bariatric floor or wing. There should be a Bariatric Coordinator designated to supervise the bariatric program.
Effective December 1, 2007, an applicant’s bariatric surgical coordinator must meet the following criteria: The coordinator must be a licensed health care professional, whose duties include care coordination of the bariatric surgery program, bariatric surgery program development, patient and staff education, oversight of ongoing BSCOE compliance, oversight of ongoing multidisciplinary team meetings for the bariatric surgery program, and acting as a liaison between the hospital and surgical practice(s). The coordinator may be employed by either the hospital or surgeon, and the duties do not necessarily have to be performed by one person.
Applicant centers performing more than 150 bariatric surgeries annually are required to have a full-time bariatric coordinator. Centers performing 150 surgeries or less per year may employ a part-time bariatric coordinator. This provision is effective June 1, 2007, for renewing BSCOE centers and for new applicants whose site inspections occur on or after that date.
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.
Limited Waiver for Coordinator. Centers that were designated as BSCOEs prior to December 1, 2007, whose bariatric coordinators are not licensed health care professionals, may be considered for approval on renewal of their initial BSCOE term provided the coordinator meets one of the following:
- The bariatric coordinator has been continuously employed by the applicant as a bariatric coordinator performing the required duties for at least three (3) years prior to the application; or
- The bariatric coordinator has been continuously employed as a bariatric coordinator in a bariatric surgery practice or institution performing the required duties for at least five (5) years prior to the application; or
- The bariatric coordinator has a bachelor’s degree from an accredited institution and at least three (3) years of clinical work experience in the field of bariatric surgery.
Centers designated as BSCOEs prior to December 1, 2007, may only rely on the preceding exception for renewal of their initial term. |
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| 9. |
The applicant makes available organized and supervised support groups for
all patients who have undergone bariatric surgery at the institution.
Interpretative Notes for Requirement Number 9: 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. A licensed health care professional must either lead or be present at support group meetings. A qualifying licensed health care professional includes a surgeon, physician, physician’s assistant, nurse, dietician, nutritionist, psychologist, psychiatrist, licensed practical nurse, physical therapist or licensed clinical social worker. This requirement applies to the program’s primary support group meetings, but not to auxiliary or outlying meetings held in remote locations.
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| 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 agreement to
provide annual outcome summaries to SRC 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 bariatric surgery in the group or individual practice into the Bariatric Outcomes Longitudinal Database™ (BOLD™); no patients will be excluded.
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. |
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Complete listing of program requirement updates:
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