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.
This requirement refers to a culture in which the staff is prepared to manage
morbidly obese patients, to manage these individuals 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 bariatric patients should
receive sensitivity training and be able to recognize the early signs of common
complications including pulmonary embolus, anastomotic leak, infection and
bowel obstruction so that these complications can be managed promptly.
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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.
Bariatric surgical cases are defined as primary operations and/or
revisions. Endoscopies, placement of feeding jejunostomies, and
plastic surgical reconstructions are not included in this classification.
Performed is defined as conducting a significant part of the operation
as primary surgeon. Applicants may not include cases where they served as the
assisting surgeon.
Applicants may include up to 75 operations performed during their fellowship in
their total lifetime count.
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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.
The position of Bariatric Surgery Medical Director must be filled by a
qualified, board certified or previously board certified 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 that involve medical staff, nursing, administration, operating room personnel and nutrition are required. |
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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.
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.
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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, beds, radiologic capabilities, surgical instruments and
other facilities suitable for morbidly obese patients.
Furniture, beds, scales, wheelchairs, operating room tables, floor-supported
toilets and litters strong enough and wide enough 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, the staff must be trained to use
the equipment and be capable of moving these large individuals without injury
either to the patients or themselves.
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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.
The surgeon must be or have been certified, or be currently 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). 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
should 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 order for the on-call surgeon to demonstrate
significant experience in managing bariatric patients and their complications,
he or she must be Board certified or eligible, have at least eight (8) hours of
Category 1 Continuing Medical Education (CME) in bariatric surgery and have
assisted on at least five (5) non-stapling gastric procedures and/or 10 gastric
stapling and/or anastomotic procedures in the most recent three (3) years,
depending upon the covering arrangement. These requirements apply only to
general surgeons who cover bariatric cases and do not apply to coverage by a
bariatric surgeon. Effective January 1, 2007, these requirements must be met by
all new applicants; existing Bariatric Surgery Centers of Excellence® must meet
them by the time of reapplication.
Note: The covering non-bariatric 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.
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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.
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 clinical pathway protocols, i.e. a sequence of order and therapies
describing the routine care of the uncomplicated patient, must be formally
adopted, implemented, and available for review during the site inspection.
Effective June 1, 2007, the following specific clinical pathways will be
required: 1) Anesthesia including monitoring and airway management, 2)
Perioperative care including monitoring and airway management, 3) DVT
management, and 4) Instructions for the management of warning signs such as
tachycardia, fever, and hemorrhage. In addition to the four required pathways,
at least ten (10) of the following additional clinical pathways must have been
approved and implemented prior to 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, and Applicant Surgeons must be aware
of these protocols and follow them. |
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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.
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 who is a licensed health care professional.
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 policy if it is a combined
practice that also performs significant general surgery.
If an applicant center performs more than 150 bariatric surgeries annually, the
position of bariatric coordinator must be a full-time position. Centers
performing 150 surgeries or less per year may employ a part-time bariatric
coordinator. This ruling is effective June 1, 2007 for renewing BSCOEs and for
new applicants whose site inspections occur on or after that date.
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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.
The activities of the support group should be documented including group
locations, meeting times, supervisor and curriculum. For example, such
activities as on-line chat rooms, web-based support groups, exercise
instruction and clothing sales should be noted.
Effective June 1, 2007, a licensed healthcare professional must either lead or
be present for support group meetings. The healthcare professional present at
the meetings may be a surgeon, physician, physician's assistant, nurse,
psychiatrist, psychologist, dietitian or nutritionist.
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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.
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's
practice; no patients will be excluded.
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Complete listing of program requirement updates:
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