Bariatric Surgery Review Committee
Program Requirements Update
September 28, 2007
The
Bariatric Surgery Review Committee (the "Committee") meets approximately once
per month to discuss issues arising in the site inspection and application
review process for the various Bariatric Surgery Center of Excellence
programs. The Committee issues clarifications of and interpretive guidelines
for the basic program requirements as needed. The Committee may also recommend
additional program requirements, or changes to existing requirements, to SRC's
Board of Directors for consideration. Only the Board of Directors can revise
the basic program requirements. The Committee also seeks input from the
leadership of the American Society for Metabolic and Bariatric Surgery (ASMBS).
All the members of the Committee are bariatric surgeons and members of ASMBS.
The
following are the clarifications and interpretive guidelines adopted by the
Committee from November 2006 through June 2007. Guidelines are effective
immediately unless otherwise noted.
The
Committee intends to issue future updates approximately twice per year.
Hospital
Based Program
Requirement
One: Sensitivity Training
The
Committee determined that sensitivity training is included as an aspect of
in-service training. Applicants are required to provide written acknowledgment
during the site inspection that sensitivity training is provided to relevant
staff at least once every three years.
(Adopted 11/06,
01/07)
Requirement
Two: Recognized Procedures Qualifying for Volume Requirements
The
Committee clarified that only bariatric surgical procedures formally recognized
by the American Society for Metabolic and Bariatric Surgery (ASMBS) are counted
in determining whether an applicant meets the applicable volume requirements. This standard applies to both surgeon and hospital applicants.
Reminder
Note: The
following procedures, whether performed open or laparoscopic, are formally
recognized by ASMBS as of June 2003:
Gastric
Bypass (short or long limbed, transected or not transected, banded or not
banded)
Vertical
Banded Gastroplasty
Gastric
Banding
Duodenal
Switch
Biliopancreatic
Diversion
Within
the context of the surgical procedures recognized by ASMBS, the Committee
clarified that repair of a slipped gastric band is a primary bariatric
procedure which is counted towards the volume requirements. Port revisions,
tubing repairs, gastric band removals and internal hernia repairs are not
primary bariatric procedures and are not counted towards the volume requirements.
(04/07,
05/07)
Requirement
Two: Requirements for BSCOEs Doing New Procedures
The
Committee continues to assess the issue of BSCOE-designated surgeons beginning
to perform new or additional procedures which were not being performed at the
time of the site inspection. Under current contractual requirements, BSCOEs are required to inform
SRC of substantive changes to their program. This includes performing
additional procedures which were not being performed at the time of approval. Staff is developing a list of required information and documentation which Centers
will need to submit when they begin performing new procedures, including proof
of credentialing by the hospital. The Committee also recommends and encourages
participating hospitals to follow the ASMBS credentialing guidelines. In
addition, the Committee urges participating surgeons to verbally advise their
patients of their actual data on surgical outcomes and their experience in
performing the recommended surgical procedure as a part of their preoperative
patient consultations.
(03/07,
04/07, 06/07)
Requirement
Three: Required Attendance at Bariatric Program Meetings
Attendance
of members of an applicant hospital's central supply and business departments
at bariatric program staff meetings is optional.
(05/07)
Requirement
Four: Electronic ICU Monitoring
Exclusive
use of an offsite 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 Four.
(05/07)
Requirement
Six: Applicant and Covering Surgeon CME Requirement
Effective December 1, 2007, applicant surgeons are
required to have no less than 16 hours of Level I CME instruction in bariatric
surgery every two years, and covering surgeons are required to have no less
than 8 hours of Level I CME instruction in bariatric surgery every two years.
(03/07, 06/07)
Reminder Note: As announced last year, as of January 1, 2007, new applicants for Full Approval
and current BSCOE centers applying for renewal must demonstrate that non-bariatric
covering surgeons are board certified, have at least eight hours of Category 1 CME in bariatric surgery, and have assisted on at
least five non-stapling gastric procedures and/or 10 gastric stapling and/or
anastomotic procedures, depending on the covering arrangement within the
previous three years.
Requirement
Seven: Minimum Clinical Pathways Specified Reminder
As
announced last year, as of June 1, 2007 the following specific clinical
pathways are required (i.e., they must be approved and implemented prior to the
site inspection):
1)
Anesthesia including monitoring and airway management.
2) Perioperative
care including monitoring and airway management.
3) DVT
management.
4) Instructions for the management of
warning signs such as tachycardia, fever, and hemorrhage.
In
addition, at least 10 of the following additional clinical pathways must be
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, applicant surgeons and other applicable staff must be aware
of these protocols and follow them.
Requirement
Eight: Job Description for Bariatric Surgical Coordinators Established
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.
(01/07)
Reminder
Note: As
announced last year, effective June 1, 2007 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.
Requirement
Nine: Support Group Leadership Qualifications
The Committee
has previously noted that 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.
In
addition, the Committee clarified that the requirement that a licensed health
care professional either lead or attend support group meetings applies to a
program's primary support group meetings, but not to auxiliary or outlying
meetings held in remote locations.
(11/06,
12/06, 04/07, 06/07)
Freestanding
Outpatient Program
Requirement
One: Sensitivity Training
The
Committee determined that sensitivity training is included as an aspect of
in-service training. Applicants are required to provide written acknowledgment
during the site inspection that sensitivity training is provided to relevant
staff at least once every three years.
(02/07)
Requirement
Two: Recognized Procedures Qualifying for Volume Requirements
The
Committee clarified that the 50 minimum surgeries required to be performed by
the applicant surgeon do not all have to be performed at the applicant
freestanding center. This is consistent with the requirements for the Hospital
Based program. In addition, although procedures counted towards the
applicant's volume requirements may include non-banding procedures, only
bariatric surgical procedures formally recognized by ASMBS are counted towards
the volume requirements.
(05/07)
Requirement
Three: Required Attendance at Bariatric Program Meetings
Attendance
of members of an applicant hospital's central supply and business departments
at bariatric program staff meetings is optional.
(05/07)
Requirement
Seven: Minimum Clinical Pathways Specified
The
Committee clarified that its prior pronouncement regarding clinical pathways
for the Hospital Based program also applies to the Freestanding Outpatient
program. Accordingly, the following specific clinical pathways are required
(i.e., they must be approved and implemented prior to the site inspection):
1)
Anesthesia including monitoring and airway management.
2)
Perioperative care including monitoring and airway management.
3) DVT
management.
4) Instructions for the management of
warning signs such as tachycardia, fever, and hemorrhage.
In
addition, at least 10 of the following additional clinical pathways must be
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, applicant surgeons and other applicable staff must be aware
of these protocols and follow them.
(05/07)
Requirement
Nine: Support Group Leadership Qualifications
The
Committee applied its prior decision in the Hospital Based program regarding
support group leadership to the Freestanding Outpatient program. 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.
The
requirement that a licensed health care professional either lead or attend support
group meetings applies to a program's primary support group meetings, but not
to auxiliary or outlying meetings held in remote locations.
(05/07,
06/07)
Requirement
Twelve: Covering Surgeon Privileges at Transfer Facility
A
covering surgeon must have surgical privileges at the transfer facility
referred to in Requirement Twelve.
(02/07)
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