I. Facility Section (to be completed by the facility s risk and/or quality department) Facility Name: Address: Date: Contact Person: Directions Please check the appropriate yes or no answer boxes where indicated and complete blank lines on this form. If a question asks for a description or if you would like to include additional information, provide this information on a separate document, record the corresponding section and question number, and send the document with this form. Please return both the Facility Section and the Physician Section together to your assigned risk management consultant. A. Quality Review Process and Evidence-Based Practice A multidisciplinary practice committee oversees the bariatric/weight-loss surgery services program and clinical service areas. Ensure that committee meeting minutes reflect the review of records, actions taken, and evaluations of the effectiveness of actions taken. t Sure 1. Does a written description of the program address responsibility for the overall direction of bariatric and weight-loss surgery services? 2. Is a dedicated medical director involved in developing the bariatric surgical services program, along with the members of the bariatric team (e.g., surgeon, cardiologist, pulmonologist, anesthesiologist, psychiatrists/psychologists, social workers, nursing, AHP, respiratory care, dietary, PT/OT)? 3. Does a multidisciplinary practice committee review specific clinical indicators, take action(s) in response to the clinical indicator data, and then evaluate the effectiveness of the action(s) specific to the bariatric/weight-loss services program? 4. How are new bariatric/surgical weight-loss services evaluated to determine their impact on patient care in other departments, such as the emergency department and diagnostic imaging? 5. Is a specific bariatric/surgical weight-loss quality plan in place? If not, is a facility-wide quality plan in place that addresses the bariatric/surgical weight-loss program? COPYRIGHTED 1
A. Quality Review Process and Evidence-Based Practice Always Sometimes Never 6. Please indicate how often representatives from the following departments attend bariatric quality and program management meetings: a. Surgery b. Anesthesia c. Cardiology d. Pulmonology e. Nutrition Services f. Radiology g. Psychology/Psychiatry h. Education i. PT/OT 7. Please identify the clinical indicators and generic quality screens reviewed by the multidisciplinary oversight committee: Blood loss requiring transfusion Laparoscopic procedure converted to an open procedure Intra-operative complications and/or unexpected outcomes Wound infections or wound related complications Unplanned return to surgery Skin injuries (e.g., burns, positioning) Retained objects Venous thrombosis Pulmonary embolism Readmission to the hospital within 30 days Mortality Anesthesia-related problems Extended length of stay Difficult airway management Peripheral nerve deficits Medication errors Other (Please list) Anesthesia clinical indicators Deaths or cardiopulmonary arrests within 48 hours of general/regional anesthesia Difficult airway management/intubation/extubation Failed tracheal intubation or intubation injury Respiratory failure/collapse immediately post-extubation n-cardiogenic pulmonary edema within 48 hours of anesthetic are Peripheral nerve deficit within 48 hours of anesthetic care Acute myocardial infraction within 48 hours of anesthetic care Medication error 2
A. Quality Review Process and Evidence-Based Practice 8. How are clinical indicators selected and how frequently are they re-evaluated? B. Bariatric Clinical Staff Competency and Orientation Formal training and educational programs regarding bariatrics, weight-loss procedures and the care of clinically morbidly obese patients are in place for all clinical staff members involved in the care of morbidly obese surgical services patients. Core elements of an orientation, training and educational program include: sensitivity training regarding attitudes and interactions with morbidly obese patients, high-risk clinical presentations and potential comorbid condition complications (e.g., diabetes, cardiac, respiratory and vascular), safe patient handling, skin safety assessments, patient positioning, mobility safety, equipment safety, and emergency response. 1. The bariatric and weight-loss surgery orientation includes: (Please check all boxes that apply) Sensitivity training Respiratory care and airway management Physical and rehabilitation therapies Recognition of common co-morbid conditions (e.g., diabetes, cardiac, respiratory, sleep apnea) Surgical staff member training specific to bariatric surgery (e.g., medical/anesthesia, patient positions, transfers) Patient positioning surgical skin safety Equipment and mobility safety (e.g., weight limitations of equipment, lifting, surgical tables) Venous thromboembolism care Cardiopulmonary assessment Infection prevention and control Clinically pertinent pre-operative, intra-operative and post-operative nursing assessments Evacuation plan which includes safe patient handling and transport for environmental emergencies (e.g., fire, weather) Other (Please list) t Sure 2. Is annual education provided on the above items? 3. Are mock codes conducted for potential adverse events that present a challenge with the morbidly obese patient, such as cardiac arrests, falls, and airway obstructions? 4. Have an evacuation route and a mode of transport for morbidly obese patients been designated? 3
C. Credentialing, Privileging, Peer Review and Proctoring Formal processes are in place for credentialing, privileging, peer reviewing and proctoring all practitioners performing bariatrics and weight-loss surgical procedures. The processes are consistent with the credentialing and privileging guidelines of professional and regulatory organizations (e.g., ASMBS). 1. Has the facility established specific criteria for granting privileges to surgeons who perform weight-loss procedures? 2. Do the credentialing requirements of the medical staff reflect recommendations from professional medical societies and the recommended criteria for laparoscopic approaches (e.g., ASBMS global credentialing requirements)? 3. Is a process in place for conducting peer review and proctoring new weight-loss surgeons/providers, anesthesiologists, CRNAs, and advanced practice providers and for reviewing new procedures? 4. Are the physicians required to obtain a minimum number of continuing medical education credits to remain proficient in weight-loss surgery? (The ASMBS recommends 25 CMEs every two years) 5. Do the surgeons/physicians have documentation of bariatric/weight-loss training and/or CME credits? 6. For OPEN bariatric surgical procedure privileges: a. How many proctored cases (with a fully trained bariatric/weight-loss surgeon) are required? b. How many cases with successful outcomes (acceptable perioperative complication rates) are required prior to granting privileges? 7. For LAPAROSCOPIC bariatric surgical procedure privileges: a. How many proctored cases (with a fully trained bariatric/weight-loss surgeon) are required? b. How many cases with successful outcomes (acceptable perioperative complication rates) are required prior to granting privileges? c. Is the surgeon/provider required to have both OPEN privileges and advanced laparoscopic privileges? 8. Are clinical indicators for peer review of bariatric cases established that include: a. Complications (leakage, return to surgery, post-operative infection) b. Mortality D. Informed Consent (Surgery and Anesthesia) Informed consent for bariatric surgical procedures occurs between the bariatric surgeon and the patient and covers the material risks, benefits, and alternatives to the procedure. 1. In addition to the key elements of informed consent, does the bariatric/weight-loss surgical consent include the following items? a. Health risks associated with morbid obesity b. Alternative treatment options to weight-loss surgery c. Potential complications in the post-operative period d. Pre-surgical strategies to reduce surgical risks e. Potential impact of weight-loss surgery on family and significant others f. Common psychological adjustments following surgery g. Post-surgical requirements (e.g., diet, medications, long- term follow-up) h. Irreversability of gastric bypass COPYRIGHTED 4
D. Informed Consent (Surgery and Anesthesia) 2. Possibility of converting to an open procedure from laparoscopy 3. Are medical record audits currently conducted for informed consent documentation? E. Pre-Operative Patient Preparation and Care Surgical treatment is offered to patients who are well-informed, motivated and present as an acceptable operative risk. Prospective patients are screened by the bariatric/weight-loss physician/surgeon and the multidisciplinary healthcare team to ensure appropriate selection. Pre-operative, intra-operative and post-operative documentation includes an assessment of patient risk factors and a patient plan of care. Patients undergoing weight-loss procedures are at higher risk for perioperative complications, such as respiratory arrest, pulmonary emboli, skin breakdown, and musculoskeletal and/or neurological impairment. 1. Are patient selection criteria in place? 2. Do patient selection questions and documentation templates include an evaluation of the following? a. Past history of weight loss b. Rationale for surgical management and medical necessity b. Objective documentation of morbid obesity (BMI > 40) c. Psychological evaluation d. Medical evaluation and clearance for surgery e. Evaluation of patient/family dynamics f. Patient s ability to understand the long-term commitment g. Comprehensive diet history and nutritional assessment by registered dietician 3. Are medical record audits performed regarding the documentation of patient selection criteria? 4. Are weight-loss procedures performed on adolescents or children? 5. If you have answered yes to question 4, do you have formal guidelines on weight-loss procedures for children and adolescents? 6. Is the pre-operative preparation documented in the medical record and does it reflect all evaluations and clearances by the appropriate bariatric/weight-loss healthcare team members? 7. Does the intra-operative documentation reflect the following information? t sure if medical records are reviewed relative to documentation a. Clinically pertinent care and monitoring by OR staff b. Proper positioning and securing of the patient c. Ongoing monitoring of skin integrity 8. Are medical record audits conducted for documentation? 9. Are written policies and protocols that are specific to bariatric/weight-loss patients in place for post-operative monitoring? 10. Do discharge instruction tools and/or templates include immediate post-operative follow-up and long-term follow-up regarding the following? a. Patient/family education b. Social service support c. Nutritional services 5
E. Pre-Operative Patient Preparation and Care d. Group therapies e. Ongoing follow-up f. Exercise/activity program F. Environment of Care The facility has equipment and oversized furniture which is able to accommodate the morbidly obese patient and is readily available in all applicable patient care areas (e.g., ED, lab, diagnostic imaging, ambulatory surgery, restrooms, and inpatient and outpatient areas). 1. Does the facility s general environment of care include consideration of at least the following? a. Structures in all areas in which the morbidly obese patient may present are able to accommodate patients who weigh at least 500 pounds. b. Weight-bearing capacity of floors have been evaluated to ensure they will accommodate morbidly obese patients and furniture. c. Elevators to transport morbidly obese patients are sufficient in size and weight capacity to accommodate patients, equipment, and staff members. d. Weight-rated, floor-mounted toilets are available in the patient care areas. e. Reinforced grab bars are available in all toilet and shower areas. f. All public areas are equipped with oversized, weight-rated furniture. 2. Are general bariatric equipment and supplies available in all areas in which the morbidly obese patient may present (e.g., ED, outpatient/inpatient units, ambulatory care, imaging, laboratory, and surgical services), including the following? a. Morbidly obese-sized patient gowns, ID bracelets, blood pressure cuffs b. Bariatric beds with built-in scales, wheelchairs, stretchers, lateral transfer devices, and lift devices c. Bariatric walkers and recliners d. Large lead aprons/tables/scanners in radiology 3. Are all staff members trained in the use of bariatric/morbidly obese medical equipment? 4. Are all staff members who care for morbidly obese patients required to attend injury prevention programs? 5. Do the facility s surgical suites have the following available? a. Wider, weight-specific (e.g., 500 pounds) surgical carts and/or procedural tables that are bolted to the floor and have the appropriate weight capacity noted on them (Please note the weight capacity at the facility: ) b. Retractors suitable for morbidly obese patients undergoing surgical procedures c. Specifically designed stapling instruments d. Appropriately long surgical instruments e. Customized equipment, such as difficult intubation kits, tracheotomy tubes, restraints, and positioning devices 6
II. Physician Section (May need to collaborate with the weight-loss surgeon/provider) Physician Name: Address (if applicable): Date: Contact Person: Directions Please check the appropriate yes or no answer boxes where indicated and complete blank lines on this form. If a question asks for a description or if you would like to include additional information, provide this information on a separate sheet of paper, record the corresponding section and question number, and attach the document to this form. (If the provider and/or facility has been requested to complete this self-assessment at the request of a Coverys underwriting representative, upon completion, please return this Physician Section to the appropriate person at your facility so that it may be submitted together with the completed Facility Section.) 1. What weight-loss procedures do you perform? Gastric Restrictive Procedures Vertical banded gastroplasty (VBG) with vertical stapling Laparoscopic adjustable gastric banding Other 2. By what method do you perform weight-loss procedures? Open Laparoscopic/minimally invasive surgery/robotic Both 3. List all hospitals at which you have privileges to perform bariatric/weight-loss procedures: 4. In what surgical specialties are you trained? 5. How many years have you been in practice? 6. Are you? Board certified If yes, what is your board certification: Board eligible Neither 7. Indicate your training and education in bariatric/weight-loss procedures: 8. How many bariatric/weight-loss procedures have you performed? 9. How long have you been performing bariatric/weight-loss procedures? 10. When did the current bariatric/weight-loss program begin at this facility? 11. How many surgeries (all types) do you perform annually? 12. How many bariatric/weight-loss procedures do you perform annually? 7
13. What is the maximum patient weight you will accept for a weight-loss procedure? 14. Have your privileges to perform weight-loss procedures or any other surgical procedures ever been denied, restricted or suspended from any facility at which you have practiced? If yes, please explain on a separate sheet of paper 15. Have you received patient complaints or been named in a claim because of your weight-loss or general surgery practice or a patient outcome? If yes, please explain circumstances and resolutions on a separate sheet of paper 16. Have you applied to or are you a member of any medical societies for bariatric/weight-loss procedures, such as: a. American Society for Metabolic and Bariatric Surgery (ASMBS)? b. Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)? c. American College of Surgeons (ACS)? d. Other: 17. Do you perform weight-loss procedures on adolescents or pediatrics? 8