Every quarter, dedicated professionals in QUAD A accredited surgical facilities take the time to submit the required Patient Safety Data Reporting (PSDR) and information related to adverse events. Understandably, three months goes by fast and it is possible that the people who submit the reports may feel like this is a time consuming task added onto their already demanding workload. What people may not realize is how their efforts contribute to a dialogue between the QUAD A Education Foundation and researchers and educators who are dedicated to raising awareness related to trends that affect patient outcomes in outpatient surgery.
Why is PSDR Important?
Since 1999, QUAD A has required their accredited surgical facilities to report all adverse events and random care reviews by all surgeons operating in those facilities.1 QUAD A requires PSDR as a means to create a system-wide culture of clinical quality in Office-Based Surgical, Office-Based Procedural, Oral Maxillofacial Surgery, Pediatric Dentistry, International Surgery, and Medicare ASC accredited facilities. The data collected represents thousands of individual cases resulting in one of the nation's largest health care data repositories. Monitoring data from QUAD A facilities allows QUAD A to demonstrate the effectiveness of their accreditation standards and distinguishes QUAD A from other accrediting organizations. By using quality control processes, the data assures that QUAD A remains a respected authority on health care delivery to effectively provide a safeguard for patients. It also leads to data driven standards revisions that justify stricter requirements or just as importantly provide the rationales for modifying to more reasonable requirements when stricter mandates create counterintuitive risks to patients (eg, malignant hyperthermia standards for storing dantrolene for emergency airway).
How Is the Education Foundation Involved with PSDR?
The QUAD A Educational Foundation is a 501(c)(3) charitable organization that promotes and implements the educational, scientific and charitable activities of QUAD A. This means that all donations to the Foundation are tax deductible. The Foundation funds research that uses the exclusive patient safety data collected from accredited facilities. The findings from the research can be presented at professional conferences and published to contribute evidence in medical journals, including articles on patient mortality and adverse events in outpatient surgery.
Ongoing Dialogues Related to Patient Safety Data
QUAD A has used various methods to collect data since its inception in 1980. The following examples represent how the QUAD A data has contributed to a better understanding of complications and associated risk factors related to plastic surgery procedures in office-based settings.
Morello et al2 set out to address the question of patient safety in office surgical facilities by sending a survey to 418 accredited facilities. Their study was published in 1997 and documented the frequency of complications from the 400,675 operative procedures reported during a 5-year period.
In 2004, Keyes et al3 published an analysis of outpatient surgery center safety using data from an internet-based quality improvement and peer review program. They analyzed 411,670 procedures during a 2-year period from 2001 to 2002 and reported the most common sequela and found that significant complications were infrequent (ie, one unanticipated sequela in 299 procedures, an incidence of 0.33 percent). Seven deaths were reported (ie, one death in 58,810 procedures (0.0017 percent) which they identified as a comparable overall risk of death whether the procedure was performed in an AAAASF-accredited office surgery facility or a hospital surgery facility.
In 2008, Keyes et al1 used data from the predecessor to what we now call PSDR (at that time called Internet-Based Quality Assurance and Peer Review reporting system [IBQAP]) to report statistics on morbidity and mortality in QUAD A accredited surgery facilities. They analyzed data from January 2001 through June 2006 and reported 23 deaths in 1,141,418 outpatient procedures performed, with 13 of those deaths caused by pulmonary embolism. They concluded the procedure most commonly associated with death from pulmonary embolism in an office-based surgery facility is abdominoplasty and recommended further study “to determine predisposing factors, understanding its cause, and introduce guidelines to prevent its occurrence.”1 This study influenced changes to QUAD A standards related to the requirement of a risk assessment tool focusing on deep vein thrombosis:
8-B-23 The pre-operative clinical record includes a written screening protocol for venous thromboembolism (VTE) risk. This protocol and assessment tool is to be placed in the facility manual for reference.5
In 2018, Bucknor et al4 published a retrospective analysis using the QUAD A database for the years 2012 to 2017. They retrieved data associated with 42 deaths and reported that 54.8 percent of the deaths occurred after abdominoplasty and identified thromboembolism as the cause of death in 38.1 percent of the 42 deaths included in the study. They also reported that a VTE risk factor assessment was either incorrect or absent in 25 of the 42 cases (59.2 percent). This study highlighted the need for continued vigilance when surveying QUAD A facilities to ensure that risk assessment tools are being used as the findings validated that patients are better protected if a VTE risk assessment is documented.
In 2020, Crystal et al6 published a retrospective review that aimed to quantify opioid-related adverse events in outpatient plastic surgery settings. The researchers used the QUAD A quality improvement database to conduct the study analyzing 43,074 patient profiles with surgical procedures that occurred from 2001 to 2018. “Free-text search terms related to opioids and overdose were used to identify opioid-related adverse events….Descriptive statistics were used to quantify opioid-related adverse events.”6 They reported 28 plastic surgery patients who were identified as having an opioid-related adverse event, specifically:
- 3 fatal and 12 nonfatal opioid-related overdoses,
- 9 perioperative opioid-related adverse events, and
- 4 cases of opioid-related hypersensitivities or complications secondary to opioid tolerance.
This study increased awareness related to advocacy to support changes in practice to use multimodal anesthetic techniques and sparing opioid medications when possible, as well as educating patients on the risk and harms or opioid use.
Examples of Recent Education Foundation Projects
Since 2018, the Education Foundation has partnered with Dr. Sam Lin,7 who is an associate professor of surgery at Harvard Medical School and the Program Director for the Beth Israel Deaconess Medical Center/Harvard Plastic Surgery Residency Training Program and Co-Fellowship Director for the Aesthetic and Reconstructive Fellowship Program to conduct studies using the QUAD A data. Dr. Lin’s team provided valuable feedback about how our database could be improved to make the data easier to use for other researchers. With more than 20 years of data collection using evolving versions and formats, data and architecture inconsistencies made data analysis resource and time intensive and made it difficult for researchers to verify certain pieces of data. This resulted in a major priority for the Education Foundation to provide resources for a “data clean up” project to normalize and establish consistency in the data that was collected across different versions of PSDR. This project was completed in 2022. The project included implementing a new standardized format using controlled variables and CPT codes that involved approximately 14,400 lines of procedures and manually recoding more than 1 million records.
The Education Foundation is happy to report that Dr. Lin and his team are currently working on two research projects using the refined, updated database to study patient outcomes and correlations related to suction lipectomy/abdominoplasty and fat grafting (trunk/buttocks). We expect to have the results of the studies submitted for publication by the end of 2023 as well as proposals to present the results. One proposal has been accepted for a scientific conference in April 2023 and we expect other proposals to be submitted for professional association meetings in 2023 and 2024. We believe both studies will contribute to the body of knowledge available regarding these high-profile procedures and, ideally, will help lead us to a new understanding of ways to prevent adverse events.
Planning for Future Education Foundation Projects
Donations to the QUAD A Education Foundation support educational programs in the field of outpatient surgery, rural health, outpatient physical therapy and speech pathology as well as research dedicated to improving the safety of care in a variety of settings. Because of the early efforts of QUAD A leaders to establish an online system for surgical facilities to report all adverse events and random care reviews by all surgeons operating in those facilities, the current database is heavily populated with patient outcomes from plastic surgery procedures. As QUAD A has expanded into accrediting clinics specializing in rural health, outpatient physical therapy, and speech pathology, the Education Foundation goals will include projects that support research to improve care in facilities participating in those programs. We also plan to look to other universities, specialties, and research institutions to identify and expand channels to use our unique data to support their work and provide valuable insights that have the potential to improve care globally.
In addition to our focus on research, under the leadership of Dr. Robert Singer in 2007, the Education Foundation coordinated a national conference entitled “Patient Safety in the Office Based Surgery Setting.” The conference was held in Chicago and was chaired by Dr. Singer and Dr. Tom Russell, who was Executive Director of the American College of Surgeons at that time. The best way to describe the conference is to take an excerpt from an article published by Singer, Keyes, and Nahai in an open access 2019 publication8 that documented the history of QUAD A:
This landmark conference was developed by AAAASF-EF and included the other nationally recognized accrediting organizations: AAAHC, the Joint Commission, the Health Care Facilities Accreditation Program of American Osteopathic Association (AOA), American College of Surgeons (ACS), ASPS, ASAPS, American College of Foot and Ankle Surgeons (ACFAS), and the Federation of State Medical Boards (FSMB). At that meeting, the first ever patient safety summit was held with more than 90 participants from some 30 associations. The conference was an enormous success and elevated AAAASF nationally which led to its recognition by surgeons, legislators, state, and national health agencies as the “gold standard” for accreditation.
With technological advances and the 2020 pandemic, face-to-face meetings have evolved into webinars and online education formats. Due to the historic success of the 2007 patient safety summit, the Education Foundation will continue to assess opportunities to host or collaborate with organizations on these types of educational opportunities.
Who Donates to the Education Foundation?
Members of the QUAD A Board of Directors and Surveyors are the primary donors to the Foundation. As we disseminate more information from studies that use the QUAD A data, we expect more diversity in our donor base to include patients and their families, as well as surgical and other accredited facilities who are interested in supporting our work. If you have never donated to the Education Foundation, we encourage you to do so. Our efforts contribute to QUAD A standards, in conversations with regulators across the globe, and to the scholarship leading the way to developing best practices and educational content that make surgery safer.
References
1. Keyes GR, Singer R, Iverson RE, McGuire M, Yates J, Gold A, Reed L, Pollack H, Thompson D. Mortality in outpatient surgery. Plast Reconstr Surg. 2008 Jul;122(1):245-250. doi: 10.1097/PRS.0b013e31817747fd. PMID: 18594412.
2. Morello DC, Colon GA, Fredricks S, Iverson RE, Singer R. Patient safety in accredited office surgical facilities. Plast Reconstr Surg. 1997 May;99(6):1496-500. PMID: 9145115.
3. Keyes GR, Singer R, Iverson RE, McGuire M, Yates J, Gold A, Thompson D. Analysis of outpatient surgery center safety using an internet-based quality improvement and peer review program. Plast Reconstr Surg. 2004 May;113(6):1760-70. doi: 10.1097/01.prs.0000124743.75839.11. PMID: 15114143.
4. Bucknor A, Egeler SA, Chen AD, Chattha A, Kamali P, Brownstein G, Reed L, Watts D, Lin SJ. National Mortality Rates after Outpatient Cosmetic Surgery and Low Rates of Perioperative Deep Vein Thrombosis Screening and Prophylaxis. Plast Reconstr Surg. 2018 Jul;142(1):90-98. doi: 10.1097/PRS.0000000000004499. PMID: 29649062.
5. QUAD A. Office-based Surgery (OBS) Standards Manual. Version 15.2, effective February 1, 2023. OBS_Standards_Manual_v15.2.docx (live.com). Accessed February 6, 2023.
6. Crystal DT, Blankensteijn LL, Ibrahim AMS, Brownstein GM, Reed LS, Watts DC, Lin SJ. Quantifying the Crisis: Opioid-Related Adverse Events in Outpatient Ambulatory Plastic Surgery. Plast Reconstr Surg. 2020 Mar;145(3):687-695. doi: 10.1097/PRS.0000000000006570. PMID: 32097308.
7. Samuel J. Lin. Samuel J. Lin - Wikipedia. Last edited December 31, 2022. Accessed February 6, 2023.
8. American Association for Accreditation of Ambulatory Surgical Facilities (AAAASF) History: Its Role in Plastic Surgery Safety. Aesthetic Surg J Open Forum. 2019; 1-11. DOI: 10.1093/asjof/ojz008. www.asjopenforum.com. Accessed February 6, 2023.
Since 1980, QUAD A (a non-profit, physician founded and led global accreditation organization) has worked with thousands of healthcare facilities to standardize and improve the quality of health care they provide – believing that patient safety should always come first.
To learn more about QUAD A, their accreditation process, and why it’s so important to seek out accredited facilities when making healthcare related decisions, visit www.quada.org.
