Fig. 11.1
Mitigating risk and event management (Adapted from Saxton JW, Finkelstein MM. Bariatric surgery: a comprehensive bariatric program can act to reduce liability risk and to promote patient safety. Bariatric Surgery White Paper. 2005)
In particular, preventable adverse events (PAE), which account for over half of the adverse events that occur in surgery, have been studied as a way to determine the quality of care [4]. The Agency for Healthcare Research and Quality (AHRQ) developed patient safety indicators (PSI) as a way to measure the rate of PAE that occur during hospitalizations (Table 11.1) [5]. Hospitals can track their PSIs as well as their PAEs to determine the cause of the adverse outcome [6].
1. Complications of anesthesia |
2. Death in low-mortality DRGs |
3. Pressure ulcer rate |
4. Failure to rescue |
5. Foreign body left in during procedure |
6. Iatrogenic pneumothorax |
7. Central venous catheter-related blood stream infection |
8. Postoperative hip fracture |
9. Postoperative hemorrhage or hematoma rate |
10. Postoperative physiologic and metabolic derangement rate |
11. Postoperative respiratory failure rate |
12. Postoperative pulmonary embolism or deep vein thrombosis rate |
13. Postoperative sepsis rate |
14. Postoperative wound dehiscence rate |
15. Accidental puncture or laceration rate |
16. Transfusion reaction |
17. Birth trauma – injury to neonate |
18. Obstetric trauma – vaginal delivery with instrument |
19. Obstetric trauma – vaginal delivery without instrument |
20. Obstetric trauma – cesarean delivery |
Near misses indicate when a hospital recognizes that an error has occurred without a subsequent adverse event. These near misses represent problems in the process of care; thus, hospitals actively evaluate the event in an effort to improve the process and thereby prevent further events.
The term “never event” is defined as an adverse event that is serious, largely preventable, and of concern to both the public and health-care providers for the purpose of public accountability and transparency around these specific events [7]. The original list of 27 never events was adopted by the National Quality Forum (NQF) in 2002 and the latest revision was published in 2012. Eleven states now require reporting of these events from hospitals, and another 16 states require reporting of serious adverse events that include the NQF never event list. Although never events are relatively rare, the Joint Commission states that 71 % are fatal [8]. In 2007, CMS announced that they would no longer pay for the additional cost associated with preventable errors, and since 2009, CMS has not paid for wrong site surgery [9]. CMS has added these events slowly and with public comment. A comparison of the NQF Never Events and CMS nonpaid events is listed in Table 11.2 [8, 9].
NSQ | CMS – no pay |
---|---|
Wrong site surgery | Wrong site surgery |
Wrong patient surgery | Wrong patient surgery |
Wrong surgical procedure | Wrong surgical procedure |
Retained foreign object | Retained foreign object |
Intraoperative or immediate postoperative death in an ASA Class I patient | Catheter-associated urinary tract infection |
Wrong sperm or donor egg in artificial insemination | Vascular catheter-associated infection |
Death/severe disability due to contamination of drugs, devices, or biologics | Mediastinitis following CABG |
Death/serious disability due to a device used for something other than that which it is intended | Surgical site infection following bariatric surgery |
Death/serious disability from air embolism | Death/serious disability from air embolism |
Infant discharged to wrong person | Surgical site infection following orthopedic procedures |
Death/serious disability from patient elopement | Deep vein thrombosis/pulmonary embolism in total knee and hip replacement |
Suicide/attempted suicide resulting in serious disability while being cared for in a health-care facility | |
Death/serious disability from medication error | |
Death/serious disability from incompatible blood products | Death/serious disability from incompatible blood products |
Maternal death/serious disability from labor and delivery in a low-risk patient | |
Death/serious disability from hypoglycemia when onset occurs while in a health-care facility | Death/serious disability from hypoglycemia when onset occurs while in a health-care facility |
Death/serious disability in neonates from hyperbilirubinemia | |
Stage 3 or 4 pressure ulcers | Stage 3 or 4 pressure ulcers |
Death/serious disability from spinal manipulative therapy | |
Death/serious disability from electric shock or electric cardioversion while an inpatient | Death/serious disability from electric shock or electric cardioversion while an inpatient |
Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains the wrong gas or a contaminated toxic substance | |
Death/serious injury from a burn while an inpatient | Death/serious injury from a burn while an inpatient |
Death/serious injury from a fall while an inpatient | Death/serious injury from a fall while an inpatient |
Death/serious injury from the use of restraints | |
Care delivered by someone impersonating a health-care provider | |
Patient abduction while an inpatient | |
Sexual assault while an inpatient | |
Death/serious injury from physical assault on the grounds of the health-care facility |
The Leapfrog Group was founded by a group of large employers that united in an effort to assess the quality of the health care they were purchasing for their companies. The Leapfrog Hospital Survey compares a hospital’s performance against the national standards of safety, quality, and efficiency [10]. In a survey of 1,285 hospitals that report voluntarily to the Leapfrog Group on never events, 50 % of the hospitals waived fees associated with the never event. Subsequently, these hospitals were more likely to achieve a perfect Leapfrog quality score [11].
In addition to its To Err Is Human report, the IOM also published a notable paper in 2001 entitled Crossing the Quality Chasm: A New Health Care System for the 21st Century. To Err concluded that most errors were not the result of a reckless individual; rather, they were most commonly due to a system error [2, 12]. Doing a root-cause analysis, recognizing the contributions of both the system and care providers to the event, and having administrative leadership and providers dedicated to implementing a solution are paramount to prevention. Crossing the Quality Chasm focused on defining the gap between how health care is typically delivered for an acute care event, and the care of chronic illnesses, which may be better treated with proper use of medical technology and the appropriate consultation with specialists, who are better qualified to treat the medical complexities [12, 13]. The conclusions of these reports are that (1) the system was not optimal for patient safety or care and (2) the improvement of health care was the responsibility of the hospital leadership along with every health-care provider. The report, in fact, states that “advances must be with all health care constituencies—health professionals, federal and state policymakers, public and private purchasers of care, regulators, organization managers and governing boards, and consumers—committing to a national statement of purpose for the health care system as a whole.” [12]
Another organization dedicated to improving health care is the Institute for Healthcare Improvement (IHI), which was founded in 1991. The group’s initial aim was to improve the lives of patients, the health of communities, and the joy of the health-care workforce [13]. More recently, it has implemented the Triple Aim, which is to provide better care, for better health, at a lower cost [14]. Another way to translate this aim is that it improves the value of health care. The three aims are to improve the experience of care, improve the health of the community, and reduce per capita costs of health care. IHI has also successfully implemented programs called the 100,000 Lives Campaign and the Five Million Lives Campaign. The programs are designed to save lives by implementing clinical focus in 12 different areas (Table 11.3) [15]. The former program was successfully introduced to more than 3,100 hospitals over 18 months, saving an estimated 122,000 lives [13, 16].
100,000 Lives Campaign |
1. Deploy rapid response teams |
2. Deliver reliable, evidenced-based care for acute myocardial infarction |
3. Prevent adverse drug reactions |
4. Prevent central line infections |
5. Prevent surgical site infections |
6. Prevent ventilator-associated pneumonia |
Five Million Lives Campaign |
1. Prevent harm from high-alert medications |
2. Reduce surgical complications |
3. Prevent pressure ulcers |
4. Reduce methicillin-resistant Staphylococcus aureus infection |
5. Deliver reliable, evidence-based care for congestive heart failure |
6. Get boards on board |
Evolution of Accreditation Standards
The year 2002 was a watershed year for the practice of bariatric surgery. At that time, perioperative mortality was reported to be up to 2 % [17], surgery was primarily through open incisions, and any general surgeon could perform a laparoscopic Roux-en-Y gastric bypass (RYGB) regardless of their training, experience, or whether the procedure was accompanied by thorough preoperative and postoperative programs. Highly publicized deaths on television and in print threatened the continued access to bariatric procedures, and malpractice premiums were spiraling higher. The American Society for Metabolic & Bariatric Surgery, the American College of Surgeons, and experienced surgeons from around the country believed that standardization of the education, training, surgery, and program structure was paramount to improve patient safety and effectiveness. In 2004, the Betsy Lehman Center for Patient Safety and Medical Error Reduction was founded in Massachusetts and its first taskforce focused on bariatric care. An expert panel of more than 100 specialists focused on 9 tasks to determine best practices. Their work included not surgical care, the need for a multidisciplinary approach, the need to educate bariatric-specific care at all health-care provider levels, and the importance of a database for long-term success and quality assurance. Their findings set the standard of care for Massachusetts. Because of the growth of bariatric surgery and the development of metabolic surgery, the panel reconvened in 2009 to update its recommendations based on the best evidence [18].
In 2004, the American Society for Metabolic & Bariatric Surgeons (ASMBS) established guidelines for accreditation as a Bariatric Surgery Center of Excellence (BSCOE). The Bariatric Surgeon Review Committee (BSRC) was composed of bariatric surgeons who were responsible for the evaluation of centers for provisional and final designation. They identified ten areas that a bariatric program or hospital must have in order to be considered a BSCOE, with an emphasis on surgical volume (125 cases) as the primary indicator of better quality. The hospitals who applied were site visited and in 2007, a national registry was established. The reporting of data was required to achieve accreditation. In 2012, 458 hospitals had met the criteria to become an ASMBS BSCOE and another 226 were in the process of achieving this distinction [19].
The American College of Surgeons (ACS) developed the Bariatric Surgery Center Network Accreditation Program (BSCN) in 2005. Many ACS recommendations were based on the findings of the Betsy Lehman report. The data on the 30-day outcomes from bariatric procedures was submitted to the National Surgical Quality Improvement Program (NSQIP) Bariatric Surgery Center Network database. That database was built on the platform of NSQIP but required 100 % reporting of cases. The NSQIP database also developed a set of bariatric-specific data to be collected on patients at 30 days, 6 months, and annually. This provides the long-term follow-up needed to further assess the quality and effectiveness of care. As of April 2012, there were 151 institutions that met the criteria for the ACS accreditation to practice bariatric surgery [20].
The ACS and the ASMBS programs evolved to contain a focus on similar elements of care, including process of care, site auditing, and required data reporting. The initial opportunity to begin discussion about merging the two programs came under the leadership of John Baker, ASMBS President, when he initiated a meeting with the newly appointed ACS Executive Director David Hoyt in January 2010. This was followed by Dr. Hoyt giving the Mason Lecture in 2010. In 2011, the ACS and the ASMBS, under the leadership of Robin Blackstone, President of ASMBS, and David Hoyt, Executive Director of ACS, with unanimous support from the ASMBS Executive Council and ACS Board of Regents, developed a unified accreditation program: the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Project (MBSAQIP). As of April 1, 2012, all previously accredited programs in either the ASMBS BSCOE or the ACS BSCN became part of the new program and as of March 1, 2012, began reporting 100 % of all cases to the data registry that had been used by the BSCN. The ASMBS and ACS each nominated equal numbers of surgeons to serve on the standards, data registry, and verification committees. The standards committee, charged with developing unified standards, also includes an integrated health team member. Six of the positions were filled with members of the ASMBS executive council, and in February 2013, all members of the ASMBS executive council joined one of the committees in liaison and oversight roles. The new unified standards are being developed. Unprecedented public input and transparency have resulted in significant improvement to the original design including the addition of surgeon-specific accreditation. Implementation of the new standards should occur by January 1, 2014. Having one set of criteria for accreditation endorsed by the surgical societies will set clear standards for patient experience, surgeons and integrated health teams, hospitals, and payers. The role of each society is complementary: the ACS is better able to give financial and logistical support to the project, while ASMBS offers specialty expertise, dedicated to establishing the content of the standards and developing the collaborative effort to improve safety through analysis of the data [21]. A true partnership has emerged between the two societies.
Fig. 11.2
ASMBS emergency care for the bariatric surgery patient
Measuring Outcomes and Databases
Reporting patient cases and their course of care to the data registry is the foundation of identifying a hospital as being accredited by the MBSAQIP. The main tenets of data integrity include having a Bariatric Surgery Clinical Reviewer who abstracts data directly from either the hospital or clinic record; having a high percentage of patients included at each data point of 30 days, 6 months, and annually; and reporting 100 % of cases [22]. The data is available in a non-risk-adjusted report for ongoing use for quality improvement at the program level and is produced in a semiannual risk-adjusted report. Although data has been entered by the majority of programs since March 1, 2012, a period of assimilation and familiarity with the database definitions will be required until the data is completely reliable.
The ultimate expression of the data registry is to use the data to improve safe care. The pioneer effort in this aspect of quality came through the Northern New England Collaborative, which was formed in the wake of the publication by the Health Care Financing Administration (HCFA) of the rates of mortality among patients having cardiac surgery. The initial reaction was disbelief, so surgeons formed the collaborative with a commitment to capture the clinical data in order to prove HCFA wrong. To their surprise, they found that HCFA was correct and that there was wide variability in outcomes across the participating centers. They were unfunded, yet had a major impact on the quality of care, driving mortality down in all participants. The modern iteration of this model is the Michigan Bariatric Surgery Collaborative (MBSC). Formed in 2006, the collaborative slowly gained acceptance by most of the surgeons/programs in Michigan. Uniquely, Blue Cross/Blue Shield of Michigan partnered with researchers and surgeons to fund the data collection and provide a forum for evaluation and use of the data. Today, the collaborative meets to discuss data and make decisions about how to direct care based on the risk-adjusted data collected [23]. The MBSAQIP program is designed to build on the examples of the Northern New England Collaborative and the MBSC to foster a national outcome registry that can be used by a collaborative made up of groups of surgeons in each hospital.
Checklists
In 1952, Dr. Virginia Apgar devised a scoring system to determine the health of a newborn child immediately on delivery. This score improved the immediate care delivered to a child in trouble while allowing for the accurate identification of the problem [24]. In a similar effort, Atul Gawande, MD, and the World Health Organization devised and published the surgical safety checklist in 2008 [25, 26] (Fig. 11.2). Surgical teams use the checklist at certain stages during the operation to help prevent errors and omissions. This can ensure that every person in the room is aware of the type of operation being done, can prepare for it, and anticipates possible events during the case. Studies have shown that implementation of the checklist reduced death and in-hospital complications significantly [26, 27].
Fig. 11.2
The World Health Organization’s surgical safety checklist (Reproduced from http://who.int/patientsafety/safesurgery/tools_resources/SSSL_Checklist_finalJun08.pdf by permission of the World Health Organization)
The checklist starts with a “sign in” or huddle, which occurs before the induction of anesthesia. At this time, the proper patient, procedure, site, and consent form are confirmed. An anesthesia safety check of their equipment is performed and the patient’s list of allergies and airway/aspiration risk is reviewed. The estimated length of time for the procedure and the likelihood of significant blood loss are determined. After the patient is prepped and draped and before the skin incision is made, a “time-out” is performed. All of the names of the members of the team and their roles are announced to assist with communication. A second confirmation of the correct patient and procedure is done. Critical patient data like allergies to medications and airway difficulty are reviewed. The nursing staff will determine if any special equipment that may be required for the case is in the room. Appropriate antibiotic usage, be it therapeutic or prophylactic, is reviewed. At the end of the case and before the patient leaves the operating room (OR), the nurse verbally confirms what procedure was done (as it may have changed from the one stated preoperatively), that the sponge and needle counts are correct, that the specimen (if any) is labeled properly, and if there were any equipment issues. Finally, the entire team reviews any concerns regarding recovery of the patient. While this appears to be an extensive checklist, some have even advocated for a more detailed preinduction checklist (Table 11.4) [25, 26].
Patient safety briefing checklist (before anesthesia induction) | ||
---|---|---|
Discussed | N/A | |
Team members identify themselves and assignment | ||
Surgeon | ||
Address patient and explain briefing | ||
Confirm patient’s identity and procedure (chart, consent, armband) | ||
Plan for surgery (type, duration, position, potential challenges) | ||
Special equipment and special needs (implants, grafts, Foley catheter) | ||
Radiology (images, fluoroscopy) | ||
Anticipated blood loss if >500 cc special IV access, blood products | ||
Anesthesia provider | ||
Allergies reviewed | ||
Type of anesthesia (potential challenges) difficult airway cart | ||
Prophylactic antibiotics administered | ||
Postoperative issues (pain, ventilation management, CPAP) | ||
If given break, relief has been updated | ||
Circulator | ||
Information on whiteboard | ||
Confirm correct patient, side, site | ||
Confirm position | ||
Confirm implants and special needs (which band) | ||
Confirm preoperative medications given | ||
Confirm intraoperative medications and fluids | ||
If given break, relief has been updated, counts carried out | ||
Scrub technician or nurse | ||
Equipment in the OR | ||
Special equipment and instruments available and functioning | ||
All solutions available and labeled | ||
All medications available and labeled | ||
If given break, relief has been updated, counts carried out | ||
Any other concerns: | ||
Post event debriefing: |
The Surgical Care Improvement Project (SCIP), started in 2006, is another program designed to improve patient care [28]. SCIP measures were initially designed to help prevent surgical infections and thus appropriate use of antibiotics and appropriate hair removal were detailed and reviewed. This product graduated to several preoperative measures designed to help reduce postoperative complications (Table 11.5) [28]. Expert panels then used these results and evidence-based research to detail what the proper care is for several clinical scenarios, for instance, requesting the use of beta-blockers the morning of surgery for those patients who use them and the removal of a Foley catheter on postoperative day one [28]. Several measures of the SCIP are included in Gawande’s surgical checklist. Although there has been some controversy about how patient safety has improved with these measures, the Joint Commission for accreditation of hospitals uses these criteria, in part to determine accreditation; and CMS uses these measures to determine reimbursement. Probably most important is the fact that how an individual hospital does on these national yardsticks of quality is published to the public.
Measure ID | |
---|---|
SCIP Inf-1 | Prophylactic antibiotic received within 1 h prior to surgical incision |
SCIP Inf-2 | Prophylactic antibiotic selection for surgical patients |
SCIP Inf-3 | Prophylactic antibiotics discontinued within 24 h after surgery end-time |
SCIP Inf-4 | Cardiac surgery patients with controlled 6 AM postoperative blood glucose |
SCIP Inf-6 | Surgery patients with appropriate hair removal |
SCIP Inf-9 | Urinary catheter removed on POD 1 or 2 with day of surgery being day 0 |
SCIP Inf-10 | Surgery patients with perioperative temperature management |
SCIP Card-2 | Surgery patients on beta-blocker therapy prior to arrival who received a beta-blocker during the perioperative period |
SCIP VTE-1 | Surgery patients with recommended venous thromboembolism prophylaxis ordered |
SCIP VTE-2 | Surgery patients who received appropriate venous thromboembolism prophylaxis within 24 h prior to surgery to 24 h after surgery |
Checklists can also be used as a quick way to identify medical problems. The American Society of Anesthesiologists (ASA) checklist to diagnose sleep apnea is one example [29]. Many obese patients have undiagnosed sleep apnea, which can lead to pulmonary complications in the interoperative and postoperative period. The ASA Obstructive Sleep Apnea (OSA) checklist is a valid test that can predict which patients have sleep apnea and if they are at risk for pulmonary complications (Table 11.6) [30].
Table 11.6
Obstructive sleep apnea (OSA)
Identification and assessment of OSA |
---|
Clinical signs and symptoms suggesting OSA |
1. Predisposing physical characteristics |
BMI 35 kg/m2 (95th percentile for age and gender) |
Neck circumference 17 in. (men) or 15 in. (women) |
Craniofacial abnormalities that affect the airway |
Anatomical nasal obstruction |
Tonsils nearly touching or touching in the midline |