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 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.
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| 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.
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| 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.
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| 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.
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| 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.
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| 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).
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| 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.
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| 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.
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| 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.
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| 10. |
The Applicant maintains documentation of a program dedicated to a goal of
long-term patient follow-up of at least 75 percent at five years with a monitoring and
tracking system for outcomes. The Applicant also maintains an agreement to
provide a yearly outcome summary to the SRC in a manner consistent with HIPAA
regulations.
This requirement is based on the observation that a significant number of
patients develop nutritional deficiencies, return of previous emotional
disorders as well as other late complications related to their procedure. 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 as provided by a
licensed or certified health care provider. The follow-up data can be gathered
by the operating surgeon, the surgeon's office, or through visits to a
health care provider. The applicant agrees to enter all patients who undergo
surgery in the group's or individual's practice; no patients will be excluded.
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| 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.
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| 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.
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| 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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