RE: MBSAQIP Draft Standards for Public Comment

December 19, 2012 RE: MBSAQIP Draft Standards for Public Comment Dear Colleagues: For decades, surgeons have recognized the importance of accreditation as a way for programs to demonstrate their commitment to quality, patient safety and accountability for both patients and payers. In an era of increasing accountability, program accreditation is a critical opportunity for surgeons to lead this process by combining expert knowledge with the best data available in developing the standards. Accreditation allows providers to identify what resources are truly fundamental to providing high quality care for bariatric and metabolic surgery patients and provides a defined framework for programs to use as leverage when lobbying their hospital administration, while at the same time discouraging inappropriate use of resources. Additionally, accreditation provides a unique opportunity for programs to engage in the process of self-analysis, peer-review, consultation, and collaboration with national experts in order to drive improvement. The American College of Surgeons (ACS) was founded in 1913 with the goal of improving surgical care and setting standards, and the current Joint Commission (JCAHO) grew out of the ACS Hospital Standards Committee in 1951. The ACS has been accrediting trauma programs through the Trauma Verification Program since 1987 and cancer programs through the Commission on Cancer since 1930. In 2005, in response to a growing need in the bariatric surgery community, the ACS released the first Bariatric Surgery Center Network (ACS BSCN) accreditation standards manual. The American Society for Metabolic and Bariatric Surgery (ASMBS), founded in 1983, was formed to advance the art and science of metabolic and bariatric surgery by continually improving the quality and safety of care and treatment of people with obesity and related diseases through educational and support programs for surgeons and integrated health professionals. The leadership of the ASMBS found it within their mission to release their own set of accreditation standards for Bariatric Surgery

Centers of Excellence (BSCOE) in 2004, creating two separate but similar accrediting bodies for bariatric surgery. Both programs focused on three key principles: the leadership of surgeons, the necessity for a multidisciplinary team, and the reporting of outcomes to a national registry. Accreditation was based on procedure volume of 125 cases per facility per year, as well as other structural and process measures that provided a framework for facilities performing these types of procedures. Even discounting the impact of the introduction of laparoscopy (a change from 2.1 percent in 1998 to more than 90 percent in 2008) and inclusion in the data of the adjustable gastric band (less 30 day mortality and morbidity), the adoption of accreditation standards led to a remarkable decrease in mortality from one in 200 patients to one in 1,750 patients. The incremental improvement in safety was facilitated by the adoption of laparoscopy and inclusion of the adjustable gastric band, which has a strong safety profile at 30 days, but recent study also shows a direct result of the implementation of the programs themselves, especially in higher risk patients. The majority of centers offering bariatric surgery programs in the United States participated in one of the two accreditation programs. Major payers, including the Centers for Medicare and Medicaid through the 2006 National Coverage Decision, endorsed the performance of metabolic and bariatric surgery within one of these centers. The data registries for both programs were under development in 2006 and in 2011 had more than 100,000 patients per year being entered into one of the two registries. Evolution of the Metabolic and Bariatric Surgery Safety Paradigm The first step in the evolution of the MBS safety paradigm was to unify the two existing programs. In April of 2012, the two programs united to form the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) reporting to a shared second-generation data registry as of March 1, 2012. The program has enjoyed widespread support, with more than 725 centers participating in the joint program just following the transition. The second step in the evolution of the safety paradigm was to establish committees with equal representation by the ACS and ASMBS and begin the work of transforming the first-generation quality programs into the new accreditation standards and process. This detailed process has involved a critical evaluation of the current

literature, an extensive review of new collaborative models, both in bariatric and general surgery, and extensive discussion of the advantages and areas for improvement within the current system with surgical leadership, integrated health team members, and payers. This draft of the standards combines key elements of the previous standards of both organizations as well as a careful examination of the capability of the current data registry and recognition of the complexities of the accurate reporting of clinical data and use of that data for quality improvement. The new standards are based on the following pillars: 1. Accurate reporting of 100 percent of bariatric cases by certified, specifically designated Metabolic and Bariatric Surgery Clinical Reviewers 2. Use of the data for quality improvement at each facility 3. Establishing a metabolic and bariatric surgery committee within each facility that includes all surgeons operating in the institution 4. Providing an infrastructure of multidisciplinary care in each program 5. Ongoing accreditation through reports and safety monitoring of any mortality and patients whose length of stay exceeds 14 days 6. Re-evaluation of the former 125 case volume criteria to create more meaningful volume thresholds relative to outcomes and safety The intensity of this process, the commitment of the surgeon and integrated health members of the committees, and the absolute passion for safety and quality that is the hallmark of our specialty has infused this draft of the standards with a clear vision of evolving the safety paradigm to the next level. We are now ready for step three of this process: public comment. This draft of the new, unified MBSAQIP program standards is now ready for your review and comment. Please comment on or before Tuesday, January 15, 2013. Please click here to begin the survey (you may also copy and paste the link into your web browser): https://www.surveymonkey.com/s/yrtzfp3

With special thanks to the members of the MBSAQIP Standards Subcommittee of the Committee on Metabolic and Bariatric Surgery (CMBS) and the members of the CMBS. Standards Subcommittee Co-Chairs: Wayne English, MD, and Ronnie Clements, MD Standards Subcommittee Members: Karen Schulz, RN, CNS, CBN; Tim Jackson, MD; Ramsey Dallal, MD; Ed Felix, MD; and Barry Inabnet, MD CMBS Committee Members: Robin Blackstone, MD; Ninh Nguyen, MD; David Provost, MD; Dan Jones, MD; Matt Hutter, MD; Bruce Wolfe, MD; Wayne English, MD; and Ronnie Clements, MD ACS Staff: Clifford Ko, MD, MS, MSHS, FACS Director, Division of Research and Optimal Patient Care (DROPC); Karen Richards Administrative Director, DROPC; Sameera Ali Assistant Administrative Director, DROPC; Amy Robinson-Gerace - Program Manager, MBSAQIP; Mehwesh Khalid Project Assistant, DROPC Kindest regards, Robin Blackstone, MD, FACS Co-chair, Committee on Metabolic and Bariatric Surgery Ninh T. Nguyen, MD, FACS Co-chair, Committee on Metabolic and Bariatric Surgery

STANDARDS MANUAL DRAFT COPY for Public Comment December 19, 2012 January 15, 2013

TABLE OF CONTENTS MBSAQIP Designations and Accreditation Pathways for Initial Application Designations Pathways PAGE i i iv CORE STANDARDS Standard 1 Case Volume, Patient Selection, and Approved Procedures by Designation Level 1 1.1 Volume Criteria by Designation Level 1 1.2 Patient Selection Low Acuity 5 1.3 Approved Procedures Outpatient Centers 7 Standard 2 Institution Commitment to Quality Care 8 2.1 Metabolic and Bariatric Surgery Committee (MBSC) 8 2.2 Metabolic and Bariatric Surgery Director (MBSD) 10 2.3 Metabolic and Bariatric Coordinator (MBC) 13 2.4 Metabolic and Bariatric Surgery Clinical Reviewer (MBSCR) 15 2.5 Health Care Facility Accreditation 18 2.6 Institutional Requirements for Metabolic and Bariatric Surgeon Credentialing 19 2.7 Qualified Metabolic and Bariatric Surgery Call Coverage 22 2.8 Designated Area of Hospital, with Knowledgeable and Consistent Nursing Staff, for Postoperative Metabolic and Bariatric Surgery Patients 24 2.9 Designated Personnel 27 Standard 3 Appropriate Equipment and Instruments 28 3.1 Facilities, Equipment, and Instruments 28 3.2 Appropriate Use of Equipment According to Weight 31 Standard 4 Critical Care Support 32 4.1 Advanced Cardiovascular Life Support (ACLS)-Qualified Provider 32

4.2 Ability to Stabilize Patients and Transfer 34 4.3 Written Transfer Agreement 35 4.4 Required Available Services 37 4.4-1 Anesthesia Services 37 4.4-2 Critical Care Unit (CCU) / Intensive Care Unit (ICU) Services 38 4.4-3 Comprehensive Endoscopy Services 39 4.4-4 Comprehensive Diagnostic and Interventional Radiology Services 40 4.4-5 Access to Additional Required Services 41 Standard 5 Continuum of Care 42 5.1 Patient Education Protocols 42 5.2 Perioperative Care Protocols 44 5.3 Long-Term Follow-Up 46 5.4 Support Groups 48 Standard 6 Data Collection 49 6.1 Data Entry of All Metabolic and Bariatric Procedures/Interventions 49 6.2 Metabolic and Bariatric Surgery Clinical Reviewer (MBSCR) 53 6.3 Data Variables 54 6.4 Data Reports, Quality Metrics, and Quality Monitoring 55 6.5 Data Validation 56 Standard 7 Continuous Quality Improvement Process 57 7.1 Institutional Collaborative 57 7.2 Process Improvement Projects 59 7.3 Ongoing Monitoring of Safety Culture 60 DESIGNTATION-SPECIFIC STANDARDS Standard 8 Inpatient Center Band-Only 62 8.1 Meets All MBSAQIP Standards with Limitations of Procedures Performed 62 Standard 9 Outpatient Center 64 9.1 Meets all MBSAQIP Standards with Limitations of Procedures Performed 64 9.2 Inpatient Admitting Privileges 66

MBSAQIP Designations and Accreditation Pathways for Initial Application This section provides a listing of all designations offered by the MBSAQIP as well as a pathway to achieve full MBSAQIP accreditation. Designations 1. Data Collection Center (not accredited) 2. Accredited Inpatient Center (by facility type) Comprehensive Low Acuity Band-Only 3. Accredited Outpatient Center Designation Requirements Overview Data Collection Center 1. A Metabolic and Bariatric Surgical Clinical Reviewer (MBSCR) has been identified by the center and the MBSCR has successfully completed training and begun data entry to the MBSAQIP Data Registry Platform. 2. Center is not required to demonstrate compliance with standards. 3. No annual case volume is required. 4. Centers in the U.S. and Canada can apply for full accreditation status once they have met all standards and the center case volume threshold, if any, for the designation level they are seeking. International Centers are invited to participate as a Data Collection Center. However, accreditation is not currently offered to centers outside of the U.S. and Canada. i MBSAQIP Designations and Accreditation Pathways for Initial Application

Accredited Inpatient Center Comprehensive 1. Center has demonstrated compliance with all MBSAQIP core standards (Standards 1 7) and successfully completed a site visit. 2. Center performs a minimum of 50 approved bariatric stapling operations annually (see list of qualifying stapling procedures in Standard 1.1). 3. Approved to perform all approved procedure types (band and stapling). 4. Only approved to provide care to patients 18 years of age and older. 5. Trained MBSCR has entered a minimum of 50 approved bariatric stapling cases on low acuity patients into the MBSAQIP Data Registry Platform within the previous 12 months (may apply for site visit prior to completing 12 months of data entry if volume requirement has been met). Low Acuity 1. Center has demonstrated compliance with all MBSAQIP core standards (Standards 1 7) and successfully completed a site visit. 2. Center performs a minimum of 25 approved bariatric stapling operations for lowacuity centers annually (see list of qualifying stapling procedures and definition of low acuity restrictions in Standard 1.1). 3. Approved to perform all approved procedure types (band and stapling) on lowacuity patients. 4. Only approved to provide care to patients 18 years of age and older. 5. Trained MBSCR has entered a minimum of 25 approved bariatric stapling cases on low-acuity patients into the MBSAQIP Data Registry Platform within the previous 12 months (may apply for site visit prior to completing 12 months of data entry if volume requirement has been met). ii MBSAQIP Designations and Accreditation Pathways for Initial Application

Band-Only 1. Center has demonstrated compliance with all MBSAQIP core standards (Standards 1 7), in addition to Band-Only standards (see Standard 8), and successfully completed a site visit. 2. No minimum center volume is required. 3. Approved to perform all approved procedure types (band and stapling). However, center is only recognized for accreditation purposes as a band-only center and is only approved to perform stapling procedures on low-acuity patients. 4. Only approved to provide care to patients 18 years of age and older. 5. A MBSCR has been identified by the center and the BSCR has successfully completed training and begun data entry to the MBSAQIP Data Registry Platform. Accredited Outpatient Center 1. Center has demonstrated compliance with all MBSAQIP core standards (Standards 1 7), in addition to Outpatient standards (see Standard 10), and successfully completed a site visit. 2. No minimum center volume is required. 3. Approved to perform gastric banding procedures only (see Standard 1.4 for complete list of approved procedures). 4. Only approved to provide care to patients 18 years of age and older. 5. A MBSCR has been identified by the center and the BSCR has successfully completed training and begun data entry to the MBSAQIP Data Registry Platform. iii MBSAQIP Designations and Accreditation Pathways for Initial Application

Pathways Please note that the following pathways are for unaccredited, initial applicant centers. Centers currently fully accredited by the ASMBS BSCOE or ACS BSCN programs will maintain their accreditation status under the MBSAQIP at the designation level appropriate to their annual case volume and facility type. iv MBSAQIP Designations and Accreditation Pathways for Initial Application

v MBSAQIP Designations and Accreditation Pathways for Initial Application

Standard 1 Case Volume, Patient Selection, and Approved Procedures by Designation Level All elective primary and revisional procedures, as well as complications and reoperations (elective and nonelective) related to metabolic and/or bariatric surgery require submission to the MBSAQIP Data Registry Platform. 1.1 Volume Criteria by Designation Level Definitions and Requirement Center Volume Criteria Data Collection Center Inpatient Center Low Acuity Inpatient Center Comprehensive Inpatient Center Band Only Outpatient Center No volume requirement not accredited 25 49 stapling* procedures annually approved to perform all approved procedure types on low-acuity patients A minimum of 50 stapling* procedures annually approved to perform all approved procedure types No volume requirement approved to perform all approved procedure types stapling on low acuity only No volume requirement permitted to perform gastric banding procedures only (see Standard 1.4) *See list of stapling procedures approved to meet volume requirements below Stapling Procedures The following is a list of procedures that may be counted toward a center s stapling case volume to meet volume criteria for designation: Laparoscopic Procedures 43644 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and Roux-en-Y gastroenterostomy (roux limb 150 cm or less) 1 Standard 1: Institution Commitment to Quality Care

43645 Laparoscopy, surgical, gastric restrictive procedure; with gastric bypass and small intestine reconstruction to limit absorption 43775 Laparoscopy, surgical, longitudinal gastrectomy (i.e., sleeve gastrectomy) Additional laparoscopic procedures for which there are corresponding open procedure CPT codes on the approved list of stapling procedures below (i.e., 43845 - Biliopancreatic diversion with duodenal switch), but do not currently have a laparoscopic CPT code assigned, will count toward the center s stapling volume. These procedures can be coded using 43659 - Unlisted laparoscopy procedure, stomach. A description of the procedure, meeting the description of a corresponding approved open procedure code, must be included in the case form and will be reviewed at the time of the site visit. Open Procedures 43501 Gastrotomy; with suture repair of bleeding ulcer 43620 Gastrectomy, total; with esophagoenterostomy 43621 Gastrectomy, total; with Roux-en-Y reconstruction 43622 Gastrectomy, total; with formation of intestinal pouch, any type 43631 Gastrectomy, partial, distal; with gastroduodenostomy 43632 Gastrectomy, partial, distal; with gastrojejunostomy 43633 Gastrectomy, partial, distal; with Roux-en-Y reconstruction 43634 Gastrectomy, partial, distal; with formation of intestinal pouch 43810 Gastroduodenostomy 43820 Gastrojejunostomy; without vagotomy 43825 Gastrojejunostomy; with vagotomy, any type 43840 Gastrorrhaphy, suture of perforated duodenal or gastric ulcer, wound, or injury 43842 Gastric restrictive procedure, without gastric bypass, for morbid obesity; vertical-banded gastroplasty 43843 Gastric restrictive procedure, without gastric bypass, for morbid obesity; other than vertical-banded gastroplasty 2 Standard 1: Institution Commitment to Quality Care

43845 Gastric restrictive procedure with partial gastrectomy, pylorus-preserving duodenoileostomy and ileoileostomy (50 to 100 cm common channel) to limit absorption (biliopancreatic diversion with duodenal switch) 43846 Gastric restrictive procedure, with gastric bypass for morbid obesity; with short limb (150 cm or less) Roux-en-Y gastroenterostomy 43847 Gastric restrictive procedure, with gastric bypass for morbid obesity; with small intestine reconstruction to limit absorption 43848 Revision, open, of gastric restrictive procedure for morbid obesity, other than adjustable gastric restrictive device (separate procedure) 43850 Revision of gastroduodenal anastomosis (gastroduodenostomy) with reconstruction; without vagotomy 43855 Revision of gastroduodenal anastomosis (gastroduodenostomy) with reconstruction; with vagotomy 43860 Revision of gastrojejunal anastomosis (gastrojejunostomy) with reconstruction, with or without partial gastrectomy or intestine resection; without vagotomy 43865 Revision of gastrojejunal anastomosis (gastrojejunostomy) with reconstruction, with or without partial gastrectomy or intestine resection; with vagotomy All other metabolic and bariatric procedures performed at the center must be entered in the MBSAQIP Data Registry Platform (see Standard 6.1 for a complete list of procedures) but do not count towards a center s stapling case volume. 3 Standard 1: Institution Commitment to Quality Care

Documentation Data will be audited by MBSAQIP and/or chart audit at site visit. Measure of Compliance Compliance: The program fulfills the following criterion: Center meets volume requirements for designation level sought. 4 Standard 1: Institution Commitment to Quality Care

1.2 Patient Selection Low Acuity Definitions and Requirement Institutions designated as an Inpatient Low Acuity, or Inpatient Band-Only center are only approved to perform procedures on low-acuity patients as defined below: 1) Age < 60 years 2) Males with a BMI < 55 and females with a BMI < 60 3) Patients without: a. organ failure b. an organ transplant c. candidate for transplant 4) Patients must be ambulatory 5) Only approved to perform revisional intra-abdominal procedures when classified as an emergent case. Not approved to perform elective revisional intra-abdominal procedures. a. Emergent Case Definition: An emergent case is usually performed within a short interval of time between patient diagnosis or the onset of related preoperative symptomatology. It is implied that the patient s well-being and outcome is potentially threatened by unnecessary delay and the patient s status could deteriorate unpredictably or rapidly. The Principal Operative Procedure must be performed during the hospital admission for the diagnosis. Patients who are discharged after diagnosis and return for an elective, semi-elective, or urgent procedure related to the diagnosis would not be considered to have had an emergent case. 5 Standard 1: Institution Commitment to Quality Care

Documentation Data will be audited by MBSAQIP and/or chart audit at site visit. Measure of Compliance Compliance: The program fulfills the following criterion: All patients fall within low-acuity requirements when appropriate to the designation level they are seeking. 6 Standard 1: Institution Commitment to Quality Care

1.3 Approved Procedures Outpatient Centers Definitions and Requirement A freestanding Outpatient Center may only perform the following procedures: Gastric banding and explantation Gastric band and/or port removal Endoscopic device procedures and emerging technology currently approved by the FDA All patients must be 18 years of age or older Documentation Data will be audited by MBSAQIP and/or chart audit at site visit. Measure of Compliance Compliance: The program fulfills the following criterion: All procedures performed at the facility are approved procedures for Outpatient centers. 7 Standard 1: Institution Commitment to Quality Care

Standard 2 Institution Commitment to Quality Care The institution and its medical staff provide the structure, process, and personnel to obtain and maintain the quality standards of the MBSAQIP in caring for metabolic and bariatric surgical patients. The institution agrees to achieve cross-organizational commitment to the metabolic and bariatric program incorporating collaboration with credentialed metabolic and bariatric surgeons at all levels of the medical staff and administration. 2.1 Metabolic and Bariatric Surgery Committee (MBSC) Definitions and Requirement The institution must establish a Metabolic and Bariatric Surgery Committee (MBSC) consisting of, at a minimum, the Metabolic and Bariatric Surgery Director (MBSD), all surgeons performing metabolic and bariatric surgery at the institution, the Metabolic and Bariatric Coordinator (MBC), the Metabolic and Bariatric Surgical Clinical Reviewer (MBSCR), and institutional administration representatives involved in the care of metabolic and bariatric surgical patients. The MBSC is the primary forum for Continuous Quality Improvement, as outlined in Standard 6. It provides a setting for sharing best practices, for responding to adverse events, and for fostering a culture to improve patient care. All surgical practices performing bariatric surgery at the institution must participate in these projects in a collaborative manner focusing on improved quality of care for the metabolic and bariatric patient. There must be a minimum of four quarterly meetings each year, at least one of which is a comprehensive review of the program. The members required to attend depend on the subject matter of the meeting. All active metabolic and bariatric surgeons are required to attend at least three of the four meetings in a given calendar year. 8 Standard 2: Institution Commitment to Quality Care

Documentation The institution provides a roster of the members of the MBSC and each person s role. *The institution provides copies of the minutes from at least four quarterly MBSC meetings. *The institution provides copies of the attendance records from the MBSC meetings to demonstrate that all metabolic and bariatric surgeons attended at least three meetings in a given calendar year. Measure of Compliance Compliance: The program fulfills all the following criteria: Copy of the roster with roles. *Copies of the minutes from a minimum of four quarterly MBSC meetings. *Copies of the attendance records from the MBSC meetings documenting that all bariatric surgeons attended at least three meetings in a given calendar year. * Centers reaccrediting in 2012/2013 will be given an extension until January 1, 2014, to comply with this requirement. 9 Standard 2: Institution Commitment to Quality Care

2.2 Metabolic and Bariatric Surgery Director (MBSD) Definitions and Requirements The Director, as a physician-surgeon, must be actively practicing metabolic and bariatric surgery in the institution and have full privileges and credentials to perform metabolic and bariatric surgery. The position of Director of an institution s metabolic and bariatric surgery program must be filled by a single individual. In conjunction with the administration of the institution, the Director organizes, integrates, and leads all metabolic and bariatric surgery-related services throughout the designated institution. Specific responsibilities of the Director include: 1) The Director chairs the MBSC and attends the three out of the four quarterly meetings and the majority of other meetings. 2) The Director is responsible for overseeing the accreditation process and ensuring continuous compliance with MBSAQIP requirements. If the institution falls out of compliance with any MBSAQIP requirements or there is any substantive change in the program that could affect accreditation, the Director or designee must contact the MBSAQIP within 30 days. The Director is responsible for providing a response to MBSAQIP inquiries within 30 days. 3) The Director must ensure compliance with outcomes data collection as well as participate in quality improvement efforts for all metabolic and bariatric surgery performed in the institution. The Director is responsible for the development of quality standards, the evaluation of surgical outcomes, and the development of institution-wide specific quality improvement initiatives in response to adverse events and to improve the structure, process, and outcomes of the program. 4) The Director is also responsible for the education of relevant institution staff in the various aspects of the metabolic and bariatric surgery patient with a focus on patient safety and complication recognition. The director leads the standardization and integration of metabolic and bariatric patient care throughout the institution. Formal education and written protocols to both nurses and all surgeon-providers detailing the 10 Standard 2: Institution Commitment to Quality Care

rapid communication and basic response to critical vital signs is specifically required to minimize delays in the diagnosis and treatment of serious adverse events. 5) The Director, in consultation with the Metabolic and Bariatric Surgery Committee, is also responsible for determining the inclusion and exclusion criteria for patient selection in the institution. This includes the types of procedures performed and the acuity/risk of the patient relative to the services the institution can safely offer. These recommendations should be made to the appropriate institutional body (e.g., credentialing, department of surgery, medical staff, etc.). Furthermore, the Director submits recommendations to the appropriate institutional administrative body relative to the scope of metabolic and bariatric practice of each individual surgeon based on that surgeon s experience, training, and outcomes. 6) The Director is responsible for overseeing the process in which emerging technologies and procedures may be safely introduced by surgeons into the institution with adequate patient protection, oversight (including IRB approval), and outcomes reporting. 7) The Director is responsible for institution-wide communication of policy. Communication with all appropriate personnel through formal metabolic and bariatric program team meetings is a basic quality and safety improvement effort. 8) The Director is responsible for reporting to the appropriate institutional entities (e.g., Chief of Surgery, Credentialing Committee, Medical Staff, Risk Management, etc.) significant ethical and/or quality deviations by surgeons performing metabolic and bariatric surgery and, when appropriate, plans for remediation or formal recommendations to limit or redact privileges. 9) The institution s organizational framework must incorporate the Director position, and the Director must have the authority and resources to fulfill the above listed duties. 11 Standard 2: Institution Commitment to Quality Care

Documentation The institution provides a copy of the metabolic and bariatric surgery privileges and credentials of the MBSD. The institution provides meeting minutes that document the MBSD is leading the design and implementation of quality and safety improvement initiatives throughout the institution. The institution provides a job description for the MBSD position that illustrates that the MBSD is fully integrated into the institution s organizational framework and has the authority and resources to fulfill all duties as outlined in items 1 9 above. Measure of Compliance Compliance: The program fulfills all the following criteria: Copy of MBSD privileges and credentials. Copy of meeting minutes that document the MBSD is leading the design and implementation of quality and safety improvement initiatives throughout the institution. Copy of job description, policy, procedure, or by-laws that indicate the MBSD position is fully integrated into the institution s organizational framework and has the authority and resources to fulfill all duties as outlined in items 1 9 above. 12 Standard 2: Institution Commitment to Quality Care

2.3 Metabolic and Bariatric Coordinator (MBC) Definitions and Requirements Metabolic and bariatric surgery programs must have a designated Metabolic and Bariatric Coordinator who reports to and assists the Metabolic and Bariatric Surgery Director. The MBC position of an institution s metabolic and bariatric surgery program must be given to a single individual. The MBC must be a full-time position if the metabolic and bariatric program performs 150 metabolic and bariatric procedures or more annually. The MBC assists in program development, managing the accreditation process and ensuring continuous compliance with MBSAQIP requirements, maintaining relevant policies and procedures, patient education, outcomes data collection, quality improvement efforts, and education of relevant institution staff in the various aspects of the metabolic and bariatric surgery patient with a focus on patient safety. The MBC supports the development of written protocols and education of nurses detailing the rapid communication and basic response to critical vital signs that is specifically required to minimize delays in the diagnosis and treatment of serious adverse events. The MBC serves as the liaison between the institution and all surgeons performing metabolic and bariatric surgery at the institution and, if applicable, all general surgeons providing call coverage. The MBC assists in maintaining the call schedule between all covering surgeons. The Coordinator works closely with the Metabolic and Bariatric Surgery Clinical Reviewer (MBSCR) to assure timely submission of outcomes data. It is required that a licensed health care professional or registered dietitian fills this position. The institution s organizational framework must incorporate the Coordinator position, and the Coordinator must have the authority and resources to fulfill the above listed duties. 13 Standard 2: Institution Commitment to Quality Care

Documentation The institution provides documentation that the MBC position is fully integrated into the organizational framework and has the authority and resources to fulfill all duties. The institution provides a copy of policy, procedure, or by-laws that indicate the MBC position is the responsibility of a single individual and, if applicable, a full-time position if procedure volume exceeds 150 cases each year. The institution provides a copy of the health care license or registration of the MBC. Measure of Compliance Compliance: The program fulfills all the following criteria: Copy of policy, procedure, or by-laws that indicate that the MBC position is fully integrated into the organizational framework and has the authority and resources to fulfill all duties. Copy of policy or procedure indicating the MBC position is the responsibility of a single individual and, if applicable, a full-time position if procedure volume exceeds 150 cases each year. Copy of health care license or registration of the MBC. 14 Standard 2: Institution Commitment to Quality Care

2.4 Metabolic and Bariatric Surgery Clinical Reviewer (MBSCR) Definitions and Requirements Timely and accurate data entry is essential to ensure quality improvement can occur that will ultimately enhance patient safety. Each institution is required to provide a Metabolic and Bariatric Surgical Clinical Reviewer to enter data into the MBSAQIP Data Registry Platform. Designated MBSCR(s) are not approved to be supervising patient care (for example, a surgeon, physician assistant, or advanced practice nurse). The MBSCR must be a full-time position if the metabolic and bariatric program performs 150 metabolic and bariatric procedures or more annually. This is necessary to ensure that the MBSCR is not only able to fulfill case abstraction duties, but also fulfill ongoing training and recertification requirements, retrieve and enter longterm follow-up data on a compounding number of patients over time, and fulfill requests for patient data and reports to the MBSC and hospital quality improvement staff for analysis. During the initial phase of program participation, the MBSCR may take on limited additional administrative duties (not involved in supervising patient care) as long as all of his or her responsibilities as MBSCR are fulfilled and given highest priority. The MBSCR must be provided with the appropriate resources and access to data and information systems at both the institution and the physicians offices. The MBSCR should work closely with the institution and clinicians to ensure that appropriate short-term and long-term data points are available in the medical records. Training and Maintenance of MBSCR Certification The MBSCR should be an individual with appropriate clinical knowledge and expertise to collect the required data. A current job description is available on the MBSAQIP website. Satisfactory completion of online initial training is required, as well as ongoing education and training. Maintenance of certification as an MBSCR is required and is based upon satisfactory completion of initial online training, participation in ongoing educational webinars, satisfactory completion of a yearly certifying exam, as well as compliance with data audits. 15 Standard 2: Institution Commitment to Quality Care

MBSCR Access to Systems/Records Requirements In addition to the MBSAQIP Data Registry Platform access, it is required that the MBSCR have access to all patient-related data from the institution and physician s office(s) that is required to be submitted to MBSAQIP. The institution is required to immediately notify MBSAQIP if any personnel should no longer have access to the MBSAQIP Data Registry Platform. MBSCR Workspace/Equipment Requirements Ensuring confidentiality of patient information during data collection is imperative while the MBSCR engages in the data entry process. It is essential to provide appropriate workspace to protect this confidentiality. Requirements for Timely Data Entry Data entry to the MBSAQIP Data Registry Platform is time sensitive and it is the responsibility of the MBSCR to ensure that case and follow-up data are entered into the platform within prescribed data entry timeframes (as illustrated in the MBSCR training and data registry technical user manuals) to ensure 100 percent data capture. MBSCR Meeting Attendance and Participation The MBSCR works closely with both clinical and administrative staff and participate in at least two Metabolic and Bariatric Surgery Committee meetings annually. 16 Standard 2: Institution Commitment to Quality Care

Documentation Maintenance of certification for the MBSCR is tracked by the MBSAQIP. The institution provides a copy of policy, procedure, or by-laws to demonstrate that the MBSCR position is fully integrated into the institution s organizational framework and has the authority and resources to fulfill all duties, including timely data entry to the MBSAQIP Data Registry Platform. *The institution provides a copy of the Metabolic and Bariatric Surgery Committee meeting minutes indicating that the MBSCR has participated in at least two meetings annually. Measure of Compliance Compliance: The program fulfills all the following criteria: Maintenance of MBSCR certification as verified by MBSAQIP. Copy of policy, procedure, or by-laws that indicate the MBSCR position is fully integrated into the organizational framework and has the authority and resources to fulfill all duties, including timely data entry to the MBSAQIP Data Registry Platform. *Copy of the Metabolic and Bariatric Surgery Committee meeting minutes indicating that the MBSCR has participated in at least two meetings annually. * Centers reaccrediting in 2012/2013 will be given an extension until January 1, 2014, to comply with this requirement. 17 Standard 2: Institution Commitment to Quality Care

2.5 Health Care Facility Accreditation Definitions and Requirements Health care facility accreditation ensures that the care for the metabolic and bariatric surgery patient is provided in a safe environment. The facility must be fully accredited by a recognized federal, provincial, or state authority such as The Joint Commission, state health department, Det Norske Veritas, or American Osteopathic Association. Documentation The institution provides a copy of the health care facility accreditation document from the accrediting agency. Measure of Compliance Compliance: The program fulfills the following criterion: Copy of the health care facility accrediting certificate or letter by accrediting agency demonstrating current accreditation status. 18 Standard 2: Institution Commitment to Quality Care

2.6 Institutional Requirements for Metabolic and Bariatric Surgeon Credentialing Definitions and Requirements The institution must have at least one actively practicing, credentialed metabolic and bariatric surgeon. The institution s credentialing body must adhere to a current nationally recognized credentialing guideline such as that produced by ASMBS, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), or ACS, which are separate from general surgery guidelines. The following requirements apply to all surgeons performing metabolic and bariatric surgery with privileges at the institution: 1. Must be fully credentialed to perform metabolic and bariatric surgery and be board certified or in the examination process by the American Board of Surgery (ABS), American Osteopathic Board of Surgery (AOBS), or Royal College of Physicians and Surgeons of Canada (RCPSC). See below regarding exceptions for non-board certified surgeons. 2. Must have a state medical license in good standing. 3. Must have received specialty training in metabolic and bariatric surgery, which includes completion of a formal metabolic and bariatric surgery fellowship and/or documentation of previous or proctored metabolic and bariatric surgery experience. Supporting documentation, including a case log list or metabolic and bariatric surgery training certificate, must be provided to the Metabolic and Bariatric Surgery Director to assess the applicant surgeon s metabolic and bariatric surgery experience. 4. Must be a member and participate in at least one nationally recognized professional surgical society with ethical guidelines and oversight. Exceptions for Non-Board-Certified Surgeons Performing Metabolic and Bariatric Surgery The Metabolic and Bariatric Surgery Director and the Chief of Surgery must have a policy or procedure for how to consider non-boardcertified surgeons to obtain privileges to perform 19 Standard 2: Institution Commitment to Quality Care

metabolic and bariatric surgery at the institution on a case-by-case basis. The following are required: Valid state medical license Completion of an accredited general surgery residency The following factors should be considered (not all need to be satisfied): Experience: training, leadership, achievements, and outcomes. Completion of an approved fellowship post-residency in metabolic and bariatric surgery or a fellowship that included exposure to the performance and management of metabolic and bariatric surgery (i.e., laparoscopic fellowship) with a letter of recommendation from the program director that the surgeon is qualified in metabolic and bariatric surgery, and provides a case log of cases. Publication of peer-reviewed articles on metabolic and bariatric surgery. Satisfactory completion of Fundamentals of Laparoscopic Surgery (FLS). Membership and participation in nationally recognized professional societies such as the ACS, the ASMBS, SAGES, or The Society for the Surgery of the Alimentary Tract (SSAT). Documentation The institution provides a copy of unrestricted general surgery privileges and separately defined metabolic and bariatric surgery privileges for all actively practicing metabolic and bariatric surgeons at the institution. The institution provides documentation to demonstrate compliance with requirements 1 4 above for all board certified metabolic and bariatric surgeons with privileges at the institution. The institution provides documentation to demonstrate compliance with requirements above for all non-board certified metabolic and bariatric surgeons with privileges at the institution. The institution provides a copy of policy or procedure demonstrating how a non-board certified surgeon(s) is granted metabolic and bariatric surgery privileges if applicable. 20 Standard 2: Institution Commitment to Quality Care

Measure of Compliance Compliance: The program fulfills the following criteria: Copy of unrestricted general surgery privileges and separately defined metabolic and bariatric surgery privileges for all actively practicing metabolic and bariatric surgeons at the institution. All actively practicing, board certified metabolic and bariatric surgeons with privileges at the institution have provided documentation demonstrating compliance with items 1 4 above. All actively practicing, non-board certified metabolic and bariatric surgeons with privileges at the institution have provided documentation demonstrating compliance with requirements above. 21 Standard 2: Institution Commitment to Quality Care

2.7 Qualified Metabolic and Bariatric Surgery Call Coverage Definitions and Requirements All surgeons performing metabolic and bariatric surgery at the institution must have qualified coverage by a colleague who is responsible for the emergency care of a metabolic and bariatric surgery patient including the full range of complications associated with metabolic and bariatric surgery in the absence of the primary surgeon. All covering surgeons must be available within the timeframe determined by institutional policy. It is the responsibility of the MBSC to ensure that continuous call coverage is provided either by qualified local coverage or through transfer agreements to an institution with qualified coverage. If the program has one or more general surgeons, not privileged to perform metabolic and bariatric surgery, the covering general surgeon must be credentialed with full, unrestricted general surgery privileges and must have undergone adequate education and training as determined by the MBSC. Documentation The institution provides a copy of the call schedule. The institution provides a copy of the roster of surgeons who provide metabolic and bariatric surgery call coverage with documentation of unrestricted general surgery privileges for each surgeon. The institution provides proof of education of general surgeons covering bariatric emergency care. 22 Standard 2: Institution Commitment to Quality Care

Measure of Compliance Compliance: The program fulfills the following criteria: Copy of the metabolic and bariatric surgery call schedule. Copy of the roster of surgeons who provide metabolic and bariatric surgery call coverage with documentation of unrestricted general surgery privileges for each surgeon. Provides proof of education of general surgeons covering bariatric emergency care. 23 Standard 2: Institution Commitment to Quality Care

2.8 Designated Area of Hospital, with Knowledgeable and Consistent Nursing Staff, for Postoperative Metabolic and Bariatric Surgery Patients Definitions and Requirements There must be a designated area in the institution where care for the metabolic and bariatric surgery patient is provided in a safe environment. The institution must have a dedicated metabolic and bariatric surgery floor or designated cluster/group of beds maintained in a consistent area of the hospital. There must be well-established, properly managed, and ongoing in-service education programs for the metabolic and bariatric team. The educational programs must ensure a basic understanding of metabolic and bariatric surgery, including the risks and benefits for all procedures performed at the center and the appropriate management and care of the metabolic and bariatric patient. Institutions must also have a system in place to ensure the ongoing competencies of staff in recognizing these signs and symptoms. All personnel on the units caring for metabolic and bariatric surgery patients, and overflow units, are required to complete three training sessions: Training Session 1 Course Name: Signs and Symptoms of Postoperative Complications Course Description: In-service education must help ensure that those caring for metabolic and bariatric patients are able to recognize the potential signs and symptoms of common metabolic and bariatric surgery complications (e.g., pulmonary embolus, anastomotic leak, infection, and bowel obstruction) so the patient can be managed promptly. Required Staff: All staff that has, or potentially has, direct contact with metabolic and bariatric patients Minimum Frequency: Required annually 24 Standard 2: Institution Commitment to Quality Care

Training Session 2 Course Name: Sensitivity Training Course Description: In-service education must support a culture where all staff members are prepared to manage severely obese patients, whether or not metabolic and bariatric surgery is the reason for admission, with understanding and compassion to appreciate the burdens of the comorbidities of severe obesity. Required Staff: All hospital staff interacting with metabolic and bariatric surgery patients Minimum Frequency: At initial hire and repeated within each accreditation renewal cycle Training Session 3 Course Name: Patient Transfer and Mobilization Course Description: In-service education must address the safe transfer and mobilization of severely obese patients, which is for the benefit of the patient as well as the staff. This is important not only for the metabolic and bariatric surgery patients the staff encounters, but also for the benefit of the increasing number of severely obese individuals in the institution for other reasons. Required Staff: All hospital staff interacting with metabolic and bariatric surgery patients Minimum Frequency: At initial hire and repeated within each accreditation renewal cycle 25 Standard 2: Institution Commitment to Quality Care

Documentation The institution provides a copy of document that designates metabolic and bariatric surgery care to a specific area(s) within the institution. *The institution must have a policy or procedure demonstrating that in-service training is provided as outlined above. Measure of Compliance Compliance: The program fulfills the following criteria: Copy of letter indicating designated specific area(s) for care of the metabolic and bariatric surgery patient. *Copy of a policy or procedure demonstrating that in-service training modules are provided as outlined above. * Centers reaccrediting in 2012/2013 will be given an extension until January 1, 2014, to demonstrate compliance for this requirement. 26 Standard 2: Institution Commitment to Quality Care

2.9 Designated Personnel Definition and Requirements The institution must have a policy or procedure in place that involves an integrated health approach to the metabolic and bariatric surgery patient. The program must provide access or referral to the following disciplines, as needed. a. Registered nurses, advanced practice nurses, or other physician extenders b. Nutritionists/dietitians c. Psychologist, psychiatrist, social worker, or other behavioral health care provider d. Physical/exercise therapists Documentation The institution provides a copy of the policy or procedure showing the integrated health team caring for the metabolic and bariatric surgery patient is fully integrated into the institution s organizational framework. Measure of Compliance Compliance: The program fulfills the following criterion: Copy of the policy or procedure showing the integrated health team caring for the metabolic and bariatric surgery patient is fully integrated into the institution s organizational framework. 27 Standard 2: Institution Commitment to Quality Care

Standard 3 Appropriate Equipment and Instruments The institution must maintain appropriate equipment and instruments for the care of metabolic and bariatric surgical patients. This includes furniture, wheelchairs, operating room tables, floor-mounted or floor-supported toilets, beds, radiologic capabilities, surgical instruments, and other facilities required for the safe delivery of care to patients with morbid obesity. 3.1 Facilities, Equipment, and Instruments Definitions and Requirements Furniture and equipment must be able to accommodate patients who are within the patient weight limits established by the metabolic and bariatric program. Weight capacities must be documented by the manufacturer s specifications, and this information must be readily available to relevant staff. A labeling system, readily identifying weight limits, for all equipment is required. Appropriate patient movement/transfer systems must also be located wherever metabolic and bariatric surgery patients receive care. Personnel must be trained to use the equipment and be capable of moving patients without injury to the patient or themselves (see Standard 2.8 regarding in-service education on patient transfers and mobilization). MBSAQIP requires institutions to have a full line of equipment and instruments for the care of patients who undergo metabolic and bariatric surgery. This includes the following equipment that can accommodate morbidly obese patients appropriate for the institution s patient population: examination tables operating room tables radiological tables and facilities fluoroscopic technologies 28 Standard 3: Appropriate Equipment and Instruments