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Using a Plan-Do-Study-Act Cycle to Introduce a New OR Service Line
Using a Plan-Do-Study-Act Cycle to Introduce a New OR Service Line DON K. NAKAYAMA, MD, MBA; TIMOTHY N. BUSHEY, RN, BSN, MSN; IRENE HUBBARD, RN, BSN, MHA; DAWN COLE, RN; AMANDA BROWN, MD; TIMOTHY M. GRANT, MD; ISSAM J. SHAKER, MD
ABSTRACT In 2008, a multidisciplinary team at the Medical Center of Georgia, Macon, began a one-year Plan-Do-Study-Act (PDSA) cycle to implement a high-quality pediatric surgery service line. The PDSA team defined goals, objectives, and measurable performance metrics and then reviewed cases and aggregated data monthly to identify and improve clinical, process, instrument, and supply problems as well as patient transfer issues. The PDSA cycle led to improvements in team performance, communication, and patient transfer and decreased the number of problems associated with instruments, supplies, equipment, and surgeon tardiness. AORN J 92 (September 2010) 335-343. © AORN, Inc, 2010. doi: 10.1016/j.aorn.2010.01.018 Key words: plan-do-study-act, surgical team performance, system-based practice, quality improvement, pediatric surgery.
K
ey components of effectively introducing a new service line in the OR include organizing and educating personnel and managing the complex interaction of a number of hospital systems. A new service line introduces new procedures and patients, which add to the demands on the OR, its personnel, and OR support services. In addition, hand offs and coordination of care may become complicated with the increased volume of patients coming through nursing departments, the postanesthesia care unit, and critical care areas. The safe and effective delivery of quality care depends on proper system design that includes procedures, job design, equipment, communication, and information technology.1 Errors, when
they occur, reflect weaknesses in the overall system and as such represent opportunities to improve the system. Studies have identified that the myriad hospital systems that interact with the OR affect OR team performance.1-3 Estimates of the extent to which individual surgical complications result from system-based errors are 2% to 21%.4,5 Familiar to busy OR staff members, but not studied in the literature, are the often tangled processes required to bring and return patients, records, medications, needed personnel, instruments, supplies, and equipment to and from the OR. The Plan-Do-Study-Act (PDSA) cycle is a process for enacting and evaluating change. According to the Institute for Healthcare Improvement,
doi: 10.1016/j.aorn.2010.01.018
© AORN, Inc, 2010
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“The PDSA cycle is shorthand for testing a change by developing a plan to test the change (Plan), carrying out the test (Do), observing and learning from consequences (Study), and determining what modifications should be made to the test (Act).”6 The PDSA cycle is a stepwise approach to instituting process changes and is particularly valuable for instituting changes that involve a number of difference systems. As such, the PDSA cycle has great potential for helping to implement changes in the OR. A PDSA cycle was implemented at the Medical Center of Central Georgia (MCCG), a 518bed tertiary referral community hospital in Macon, in response to events after a decision by leaders in the department of surgery to hire a pediatric surgeon to serve the increasing number of pediatric patients, especially those requiring neonatal intensive care unit (NICU) and pediatric intensive care unit (PICU) levels of care. The addition of a board-certified pediatric surgeon to the staff quickly led to an increase in caseload and case complexity. Pediatric surgery is a challenging field that requires new knowledge and involves novel procedures and techniques. The caseload of pediatric surgery ranges from routine to complex and life threatening in newborn to adolescent age groups. A modern practice includes thoracic and general abdominal procedures, the correction of congenital malformations in the neonatal period, surgical oncology, and pediatric trauma. PROBLEMS FACED WITH THE NEW SERVICE LINE Before the introduction of the pediatric surgical service line, the arrival of a pediatric surgeon led to a threefold increase in the annual pediatric procedure volume, to more than 750 procedures from a baseline of 200 during a 12-month period, and an increase in critically ill infants and children undergoing surgery. Inexperience among nursing staff members presented a major problem. Although some anesthesiologists and nurse anesthetists had 336
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NAKAYAMA ET AL extensive experience and training in pediatric anesthesia and others had enough experience to be comfortable handling more difficult pediatric cases, several had little experience or interest in covering pediatric procedures except the most basic procedures, such as appendectomies in older children. Nursing staff members and surgical technologists had less experience with pediatric procedures simply because they had not been done at MCCG previously; many were willing to staff these procedures, but some were reluctant. Some staff members expressed a general reluctance to perform pediatric procedures because of the patients’ small size, the small margins for error involved, and a sense of emotional attachment that a sick baby or child evokes. Increased pediatric volumes affected other hospital processes and services that, in turn, affected OR performance. For example, nurse-to-nurse transfers of care and communication problems arose with the increased volume of critically ill infants and children who arrived from the NICU and PICU areas because previously there were few surgical patients and, as a result, these nurses had limited interaction with OR nursing staff members. Problems with instruments and supplies occurred as central and sterile supply departments began to mobilize resources and organize supply chains to support higher volumes and new procedures. Additional changes involved pharmacy staff members who had to ensure correct pediatric dosages for antibiotics and anesthetic medications, as well as blood bank staff members who had to supply neonatal patients with cytomegalovirusnegative blood products at reduced volumes. Overall system problems culminated in two major medication errors. The PDSA cycle offered a systematic approach to the pediatric service line and was therefore implemented. THE PDSA CYCLE The PDSA cycle has been recommended by the Joint Commission7 and Institute of Medicine8 and is an effective approach to quality improvement
USING A PLAN-DO-STUDY-ACT CYCLE projects that involve a complex interplay of multiple systems (eg, a project to improve care in a critical care unit). A PDSA cycle team includes representatives from all areas involved in direct patient care and patient care support such as nurses, respiratory therapists, pharmacists, and clerical staff members. Nursing leaders and hospital administrators also should be involved to facilitate the implementation of recommended changes and to overcome bureaucratic challenges. Team leadership requires someone with sufficient stature (eg, the medical director of the unit) to make sure that the task takes priority and the team efforts continue to completion. The PDSA cycle addresses three fundamental questions. What are we trying to accomplish? What changes can we make that will result in an improvement? How will we know that a change is an improvement?
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or early extubation) to determine whether this leads to improvement in VAP rates. IMPLEMENTATION OF PDSA AT MCCG In April 2008, a multidisciplinary team met to discuss and organize a pediatric surgical program at MCCG. The team consisted of representatives from hospital administration (eg, OR nurse managers, hospital directors from departments such as central supply, pharmacy, material management) to provide system leadership; pediatric specialty surgeons and anesthesiologists to give clinical technical expertise; and nurse leaders from the OR, postanesthesia care unit, and inpatient and critical care areas to drive the project and oversee data collection.
The team used a PDSA cycle as described by W. Edwards Deming9 and described in a health care context by Berwick.10 The overall goal or our PDSA project was to A key feature of the PDSA cycle is to have implement a high-quality pediatric surgical serquantitative measures that, in turn, define goals vice line. The objectives included developing a within those meapediatric OR team sures. The team then consisting of key uses the measures at members (ie, surA plan-do-study-act cycle team involves regular intervals to geon, anesthesiolorepresentatives from all areas involved in see whether changes direct patient care and patient care support as gist, nurse anesthewell as administrators. The team leader should tist, circulating nurse, in work, procedures, make sure the task takes priority and team and organization resurgical technologist) efforts continue to completion. sult in real improvewho would provide ments in care. For direct care in the OR example, a PDSA and staff 90% of the cycle team might use rates of ventilator-associated pediatric procedures; having standard equipment, pneumonia (VAP) as its measure with a goal of instruments, and supplies available for all procedecreasing VAP rates by 50%. The team then dures and completing procedures with two or institutes a program of strict hand washing, use of fewer instrument trays to promote standardization; sterile suction equipment, and upright positioning. and organizing smooth transfers of care from paAfter an appropriate interval of time, the team tient care areas to the OR and back again. The evaluates whether rates have changed, which tells team then defined performance metrics to monitor the team whether the changes in nursing care proprogress toward achieving these goals. The focus tocols were effective. Then, the team can plan was on inpatient OR services; outpatient proceanother intervention (eg, routine antiacid regimen dures were excluded.
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Forming the Pediatric OR Team Effective teams are characterized by openness, collaboration, and the ability to learn from mistakes.7 They are essential components in the delivery of the highest level of care and are necessary for maximizing OR capacity and efficiency.1-3,11 In addition, the outcome of life-threatening crises that occur in the OR and the prevention of OR mishaps such as retained sponges and inaccurate needle counts clearly depend on effective team function.12-14 The PDSA team identified anesthesiologists, nurse anesthetists, nurses, and surgical technologists who had the necessary certifications, skills, experience, and interest in pediatric surgical procedures to unite as the pediatric OR team. To foster teamwork and develop individual and group experience and expertise, whenever possible, the pediatric surgical team members performed the pediatric surgical procedures in the inpatient OR, regardless of complexity or level of urgency (eg, elective, emergency), for one year. At the end of the elective day, once per week, the staff pediatric surgeon or the pediatric anesthesiologist led a walk-through session with the OR team to review and practice complex, unique, or unusual procedures or scenarios, with attention on identifying the locations of instruments, supplies, equipment, and medications. The walkthrough scenarios provided an opportunity for team members to practice procedures such as an emergency tracheotomy and malignant hyperthermia. These interactions allowed team members to clarify expectations for their actions during urgent circumstances.
Comparisons were made using R ⫻ C contingency table analyses and chi-square tests; differences were considered significant at P ⬍ .05. Accumulation of data for publication was approved by the MCCG Institutional Review Board. The PDSA team also discussed and addressed problems in procedures in which specific clinical and process issues were identified. For example, there were cases of newborn infants who were hypothermic on arrival to the NICU. The PDSA team began to collect temperatures on all patients in the NICU to determine the scope of the problem while instituting measures to keep infants warm during transport.
Data Collection and PDSA Team Meetings The PDSA team developed a paper checklist to gather data on all inpatient OR procedures performed by the pediatric general surgeons during the one-year implementation period (Figure 1). For the PDSA project, the attending surgeon led a review of all problems encountered during the procedure. All comments and observations were recorded on the checklist, and results were collected and reviewed monthly by the PDSA team.
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RESULTS Performance data were discussed at the monthly PDSA cycle meetings. The number of routine emergency and urgent cases (eg, appendectomies) during evening, night, and weekend shifts were handled adequately by the staff members on those shifts. In the first quarter, the PDSA team instituted a pediatric call team for more complicated cases involving critically ill patients in the NICU and PICU. Although the overall participation of the pediatric OR team fell below the desired level of 90%, team members were available for 98% of the complicated procedures. The other 2% of procedures involved extreme emergencies in which immediate surgical intervention was required with the available staff members present. Team Performance For the purposes of review, the following areas of team performance were defined: availability of needed instruments, supplies, and equipment; whether more than two instrument trays were opened, which helped identify whether instrument tray pick lists supported the procedures; clinical or process problems that were the responsibility of the surgeon, the anesthesia team (anesthesiologist and nurse anesthetist),
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Figure 1. Worksheet used for each patient. The attending surgeon is responsible for completing the form. All team members have an opportunity to add items and comments.
circulating nurse, or the scrub person; and any problems involving transfers of care to and from the OR.
A grading system was used to summarize the number of problems encountered during a procedure. A grade of “A” was given to a procedure with no problem areas identified, “B” to procedures involving one or two areas of concern, “C” for procedure with three or four problem areas, “D” for five or six problem areas, and “F” for
procedures involving all seven areas. The grades were used as a summary of overall team performance for each procedure, and the distribution of grades during the month reflected the overall quality of the care provided by the pediatric service line. Staffing Between July 1, 2008, and June 30, 2009, 359 inpatient procedures were performed by the MCCG pediatric surgical service. The goal of AORN Journal
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staffing 90% of procedures with pediatric OR staff members was nearly met during the year. Results showed that pediatric OR team anesthesiologists, circulating nurses, and surgical technologists staffed 75% of procedures and team nurse anesthetists staffed 55%. During the four three-month quarters, overall team performance improved for all procedures, as reflected by the distribution of letter grades. There were more “Bs” than “As” (58% versus 29%, respectively) during the first quarter, but improvements occurred each quarter, and there were more “As” than “Bs” (61% versus 30%, respectively) by the fourth quarter (Figure 2). There were a few “Cs” and “Ds” (9% of all procedures) and no “Fs.” The improvement in grade distribution over four quarters was significant (P ⫽ .001). Instrument Needs for Common Procedures To address the team’s goal to standardize and simplify instrument needs for common procedures, any instruments, supplies, or equipment that were needed for the procedure but not immediately available were recorded. Instruments, supplies, and equipment problems affected 30% of all procedures during all four quarters of the year.
Figure 2. Distribution of grades by quarter: A ⴝ no problems or events, B ⴝ one or two problems or events, C ⴝ three or four problems or events, and D ⴝ five or six problems or events).
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NAKAYAMA ET AL Instrument Trays The PDSA team’s goal of using two or fewer instrument trays per procedure to promote standardization revealed two types of circumstances in which third or fourth trays were opened during a procedure. First, in several procedures the wrong tray was pulled and opened because the wrong procedure was scheduled (eg, open cholecystectomy instead of a laparoscopic cholecystectomy), an additional procedure was added (eg, placement of a central line), or a procedure that was planned was not performed (eg, a gastrostomy was planned but not performed in a patient receiving a fundoplication). In other cases, the central supply department sent the wrong instrument tray. Second, some trays were lacking a single instrument, so another tray was pulled to obtain that item. These circumstances reflected problems with planning and instrument processing. Surgeon-Related Problems The PDSA team reviewed problem cases (ie, a case in which there was an surgical, clinical, or process-related error or problem that required an intervention by a member of the surgical team) and determined whether an individual team member was responsible for its occurrence. The PDSA review identified 50 procedures with 62 surgeon problems (14%). The majority (55%) were process related; scheduling problems (eg, the wrong procedure, last-minute changes to planned procedures) were most frequent, followed by being late to the OR. Clinical problems accounted for 45% of surgeon-related problems and included technical problems (eg, unintentional enterotomies) and preoperative and postoperative order problems (eg, no order for preoperative antibiotics) (Table 1). The PDSA team found that posting routines and communication between staff members at the surgeon’s office and the OR scheduling desk were primary problem areas. Discussion of the incidence of surgeon-related problems led to changes in surgeon behavior, including a significant decrease
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nated team members perform pediatric procedures so they would accumulate the needed experience.
TABLE 1. Surgeon Issues (N ⴝ 62)
Type of problem Clinical Technical Perioperative antibiotics not given or ordered (6 patients) Process Scheduling Preoperative paperwork Surgeon tardiness Communication problems
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Number of occurrences 28 13 15 34 12 8 9 5
in tardiness and fewer changes in planned surgeries on the printed schedule. Simple clerical procedures were implemented that decreased surgeonattributed process errors by 65% (P ⬍ .05). Anesthesia-Related Problems The anesthesia team had 46 procedures with 53 problems (13% of 359 procedures) (Table 2). In contrast to surgeon-related problems, most problems encountered by the anesthesia team were clinical (46 of 53 problems, 87%), with difficult intubation occurring most commonly (5%) followed by difficulties in IV access (2%). An anesthesiologist was not available because of his or her presence in another room (a traditional complaint of surgeons) in only two procedures (less than 1%). Whether the anesthesiologist or nurse anesthetist was a team member did not affect on the incidence of anesthesia-related problems. The PDSA team therefore concluded that anesthesia problems were largely related to the patient population. The workforce shortage and relatively small volume of pediatric procedures at MCCG prevents full staffing of fellowship-trained pediatric anesthesiologists; however, the anesthesiologists and nurse anesthetists on the pediatric OR team were able to handle clinical problems without compromising patient outcomes. To the PDSA team, the relatively high incidence of clinically problematic procedures emphasized the need to have desig-
Circulating Nurse and Scrub Person Problems The PDSA team examined the circulating nurses’ and scrub persons’ tasks related to making sure that all supplies and instruments are available in the room and ready. Instrument problems occurred in 41 procedures in which the scrub person was not part of the team, an incidence that decreased to 24% with a pediatric OR team scrub person (P ⫽ .001). The incidence of instrument, supply, and equipment problems did not decrease, however, with the presence of a team circulating nurse, who was responsible for ensuring the availability of correct supplies and functioning equipment. Patient Transfer Issues Problems that involved the movement of patients to and from the OR were varied and involved all areas that interact with the OR (eg, preoperative processing and holding areas, postanesthesia care units, inpatient nursing units, intensive care areas). Additionally, problems during the transfer of patients from the NICU and PICU were identified as specific problems in 40% of procedures, with prolonged waits in preoperative holding areas and delayed transfer to the OR.
TABLE 2. Anesthesia Issues (N ⴝ 53)
Type of problem Clinical Technical (eg, difficult intubation, 7 patients) Patient management issues (eg, oxygen desaturation ⬍ 90%, 6 patients) Postoperative Process Staff Equipment
Number of occurrences 46 30 14
2 7 2 5
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The PDSA review of patient and patient data transfers revealed many issues. The multidisciplinary makeup of the PDSA team allowed for resolution of interdepartmental issues during PDSA meetings. For example, the weight of two patients was recorded in pounds rather than kilograms in the preoperative processing area, which caused a problem in calculating relevant arrest medications that were kilogram based. The outdated scales were removed and replaced with digital scales reading kilograms. In addition, discussions with the NICU and PICU staff members revealed that sending a patient down from the critical care area left the unit short-staffed, especially when patients were ventilated and on multiple IV drip medications. Close communication on the progress of the OR schedule and direct transfer of patients from the unit to the OR led to a decrease to 27% from 40% (P ⬍ .05) in NICU and PICU transfer problems.
CONCLUSION The experience of implementing the PDSA cycle at MCCG illustrates the challenges brought about by a new service line in any field, of which pediatric surgery is one example. The power of PDSA is that it provides a management tool to achieve goals using measurable objectives that involve a multiplicity of interacting departments, which made it an appropriate choice for introducing a new pediatric surgical service line. The PDSA review defined goals, objectives, and ongoing metrics of OR performance to determine quality improvement and whether interventions were effective. The PDSA team provided a multidisciplinary forum to address problems as they arose. The approach used at MCCG included team members at both the clinical and administrative levels. The pediatric OR team consisted of designated anesthesiologists, nurse anesthetists, nurses, and surgical technologists. Input and involvement in team improvement issues fostered ownership and teamwork. 342
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The PDSA team provided administrative support to improve systems that enhanced patient movement through the system and allowed OR team members to do their jobs well. Administrative support is crucial to the success of a PDSA cycle. Curtis and colleagues emphasize that organizational support is an essential step in the development of an interdisciplinary intensive care unit quality improvement team.15 Entin et al noted that simply installing a team structure without addressing the organizational structure of care does not ensure that the team will operate efficiently.16 A PDSA process requires commitment at all levels over the long-term. Individual team members must support the team, for example, by arriving on time to the OR, making sure case posting and orders are accurate, communicating effectively, and honestly evaluating their responsibility and contribution to teamwork and team function. Although the PDSA cycle at MCCG focused on pediatrics, it has obvious utility in any service line providing care to patients of any age. The OR at MCCG is now planning to use the PDSA cycle for quality improvement in established services such as orthopedic surgery and general surgery. Acknowledgements: The authors thank Darla Rich, RN, NP; Sally Lester, RN; Cyndee Adams, RN; Rebecca Cogburn, RN; Suzanne Garvin, RN; Aimee Lowery, RN; Roberta Permenter, RN; and the members of the pediatric surgical service line team who participated as members of the PDSA cycle team at Medical Center of Central Georgia, Macon. References 1.
2.
Jain AK, Thompson JM, Chaudry J, McKenzie S, Schwartz RW. High-performance teams for current and future physician leaders: an introduction. J Surg Educ. 2008;65(2):145-150. Leach LS, Myrtle RC, Weaver FA, Dasu S. Assessing the performance of surgical teams. Health Care Manage Rev. 2009;34(1):29-41.
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Harders M, Malangoni MA, Weight S, Sidhu T. Improving operating room efficiency through process redesign. Surgery. 2006;140(4):509-514. Fabri PJ, Zayas-Castro JL. Human error, not communication and systems, underlies surgical complications. Surgery. 2008;144(4):557-563. Regenbogen SE, Greenberg CC, Studdert DM, Lipsitz SR, Zinner MJ, Gawande AA. Patterns of technical error among surgical malpractice claims: an analysis of strategies to prevent injury to surgical patients. Ann Surg. 2007;246(5):705-711. Plan-Do-Study-Act (PDSA) Worksheet (IHI tool). Institute for Healthcare Improvement. http://www.ihi.org/ IHI/Topics/Improvement/ImprovementMethods/Tools/ Plan-Do-Study-Act%20%28PDSA%29%20Worksheet. Accessed June 2, 2010. Data utilization. The Joint Commission. http://www. jointcommission.org/NR/rdonlyres/A619A3C2-641640BC-8CFB-A9EFE21AD4CB/0/hcss_ig_sec8_2.pdf. Accessed June 2, 2010. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001. Best M, Neuhauser D. W. Edwards Deming: father of quality management, patient, and composer. Qual Saf Health Care. 2005;14(4):310-312. Berwick DM. Developing and testing changes in delivery of care. Ann Intern Med. 1998;128(8):651-656. Cendán JC, Good M. Interdisciplinary work flow assessment and redesign decreases operating room turnover time and allows for additional caseload. Arch Surg. 2006;141(1):65-69. Vincent C, Moorthy K, Sarker SK, Chang A, Darzi AW. Systems approaches to surgical quality and safety: from concept to measurement. Ann Surg. 2004;239(4): 475-482. Powers KA, Rehrig ST, Irias N, et al. Simulated laparoscopic operating room crisis: an approach to enhance the surgical team performance. Surg Endosc. 2008;22(4): 885-900. Greenberg CC, Regenbogen SE, Lipsitz SR, DiazFlores R, Gawande AA. The frequency and significance of discrepancies in the surgical count. Ann Surg. 2008; 248(2):337-341. Curtis JR, Cook DJ, Wall RJ, et al. Intensive care unit quality improvement: a “how-to” guide for the interdisciplinary team. Crit Care Med. 2006;34(1): 211-218. Entin EB, Lai F, Barach P. Training teams for the perioperative environment: a research agenda. Surg Innov. 2006;13(3):170-180.
Don K. Nakayama, MD, MBA, is the Milford B. Hatcher professor and chair, Department of Surgery at Mercer University School of Medicine, Macon, GA, and the program director of
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the residency in surgery at the Medical Center of Central Georgia, Macon. Dr Nakayama has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Timothy N. Bushey, RN, BSN, MSN, was the data manager in the surgery center at the Medical Center of Central Georgia, Macon. Mr Bushey has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Irene Hubbard, RN, BSN, MHA, is the director of the surgery center at the Medical Center of Central Georgia, Macon. Ms Hubbard has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Dawn Cole, RN, is the vice president of surgical services at the Medical Center of Central Georgia, Macon. Ms Cole has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Amanda Brown, MD, is a staff anesthesiologist at the Nexus Medical Group, Macon, GA. Dr Brown has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Timothy M. Grant, MD, is a staff anesthesiologist at the Nexus Medical Group, Macon, GA. Dr Grant has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Issam J. Shaker, MD, is a clinical professor of surgery at Mercer University School of Medicine, Macon, GA, and attending surgeon at the Medical Center of Central Georgia, Macon. Dr Shaker has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
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ABSTRACT In 2008, a multidisciplinary team at the Medical Center of Georgia, Macon, began a one-year Plan-Do-Study-Act (PDSA) cycle to implement a high-quality pediatric surgery service line. The PDSA team defined goals, objectives, and measurable performance metrics and then reviewed cases and aggregated data monthly to identify and improve clinical, process, instrument, and supply problems as well as patient transfer issues. The PDSA cycle led to improvements in team performance, communication, and patient transfer and decreased the number of problems associated with instruments, supplies, equipment, and surgeon tardiness. AORN J 92 (September 2010) 335-343. © AORN, Inc, 2010. doi: 10.1016/j.aorn.2010.01.018 Key words: plan-do-study-act, surgical team performance, system-based practice, quality improvement, pediatric surgery.
K
ey components of effectively introducing a new service line in the OR include organizing and educating personnel and managing the complex interaction of a number of hospital systems. A new service line introduces new procedures and patients, which add to the demands on the OR, its personnel, and OR support services. In addition, hand offs and coordination of care may become complicated with the increased volume of patients coming through nursing departments, the postanesthesia care unit, and critical care areas. The safe and effective delivery of quality care depends on proper system design that includes procedures, job design, equipment, communication, and information technology.1 Errors, when
they occur, reflect weaknesses in the overall system and as such represent opportunities to improve the system. Studies have identified that the myriad hospital systems that interact with the OR affect OR team performance.1-3 Estimates of the extent to which individual surgical complications result from system-based errors are 2% to 21%.4,5 Familiar to busy OR staff members, but not studied in the literature, are the often tangled processes required to bring and return patients, records, medications, needed personnel, instruments, supplies, and equipment to and from the OR. The Plan-Do-Study-Act (PDSA) cycle is a process for enacting and evaluating change. According to the Institute for Healthcare Improvement,
doi: 10.1016/j.aorn.2010.01.018
© AORN, Inc, 2010
September 2010
Vol 92
No 3 ● AORN Journal
335
September 2010
Vol 92
No 3
“The PDSA cycle is shorthand for testing a change by developing a plan to test the change (Plan), carrying out the test (Do), observing and learning from consequences (Study), and determining what modifications should be made to the test (Act).”6 The PDSA cycle is a stepwise approach to instituting process changes and is particularly valuable for instituting changes that involve a number of difference systems. As such, the PDSA cycle has great potential for helping to implement changes in the OR. A PDSA cycle was implemented at the Medical Center of Central Georgia (MCCG), a 518bed tertiary referral community hospital in Macon, in response to events after a decision by leaders in the department of surgery to hire a pediatric surgeon to serve the increasing number of pediatric patients, especially those requiring neonatal intensive care unit (NICU) and pediatric intensive care unit (PICU) levels of care. The addition of a board-certified pediatric surgeon to the staff quickly led to an increase in caseload and case complexity. Pediatric surgery is a challenging field that requires new knowledge and involves novel procedures and techniques. The caseload of pediatric surgery ranges from routine to complex and life threatening in newborn to adolescent age groups. A modern practice includes thoracic and general abdominal procedures, the correction of congenital malformations in the neonatal period, surgical oncology, and pediatric trauma. PROBLEMS FACED WITH THE NEW SERVICE LINE Before the introduction of the pediatric surgical service line, the arrival of a pediatric surgeon led to a threefold increase in the annual pediatric procedure volume, to more than 750 procedures from a baseline of 200 during a 12-month period, and an increase in critically ill infants and children undergoing surgery. Inexperience among nursing staff members presented a major problem. Although some anesthesiologists and nurse anesthetists had 336
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NAKAYAMA ET AL extensive experience and training in pediatric anesthesia and others had enough experience to be comfortable handling more difficult pediatric cases, several had little experience or interest in covering pediatric procedures except the most basic procedures, such as appendectomies in older children. Nursing staff members and surgical technologists had less experience with pediatric procedures simply because they had not been done at MCCG previously; many were willing to staff these procedures, but some were reluctant. Some staff members expressed a general reluctance to perform pediatric procedures because of the patients’ small size, the small margins for error involved, and a sense of emotional attachment that a sick baby or child evokes. Increased pediatric volumes affected other hospital processes and services that, in turn, affected OR performance. For example, nurse-to-nurse transfers of care and communication problems arose with the increased volume of critically ill infants and children who arrived from the NICU and PICU areas because previously there were few surgical patients and, as a result, these nurses had limited interaction with OR nursing staff members. Problems with instruments and supplies occurred as central and sterile supply departments began to mobilize resources and organize supply chains to support higher volumes and new procedures. Additional changes involved pharmacy staff members who had to ensure correct pediatric dosages for antibiotics and anesthetic medications, as well as blood bank staff members who had to supply neonatal patients with cytomegalovirusnegative blood products at reduced volumes. Overall system problems culminated in two major medication errors. The PDSA cycle offered a systematic approach to the pediatric service line and was therefore implemented. THE PDSA CYCLE The PDSA cycle has been recommended by the Joint Commission7 and Institute of Medicine8 and is an effective approach to quality improvement
USING A PLAN-DO-STUDY-ACT CYCLE projects that involve a complex interplay of multiple systems (eg, a project to improve care in a critical care unit). A PDSA cycle team includes representatives from all areas involved in direct patient care and patient care support such as nurses, respiratory therapists, pharmacists, and clerical staff members. Nursing leaders and hospital administrators also should be involved to facilitate the implementation of recommended changes and to overcome bureaucratic challenges. Team leadership requires someone with sufficient stature (eg, the medical director of the unit) to make sure that the task takes priority and the team efforts continue to completion. The PDSA cycle addresses three fundamental questions. What are we trying to accomplish? What changes can we make that will result in an improvement? How will we know that a change is an improvement?
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or early extubation) to determine whether this leads to improvement in VAP rates. IMPLEMENTATION OF PDSA AT MCCG In April 2008, a multidisciplinary team met to discuss and organize a pediatric surgical program at MCCG. The team consisted of representatives from hospital administration (eg, OR nurse managers, hospital directors from departments such as central supply, pharmacy, material management) to provide system leadership; pediatric specialty surgeons and anesthesiologists to give clinical technical expertise; and nurse leaders from the OR, postanesthesia care unit, and inpatient and critical care areas to drive the project and oversee data collection.
The team used a PDSA cycle as described by W. Edwards Deming9 and described in a health care context by Berwick.10 The overall goal or our PDSA project was to A key feature of the PDSA cycle is to have implement a high-quality pediatric surgical serquantitative measures that, in turn, define goals vice line. The objectives included developing a within those meapediatric OR team sures. The team then consisting of key uses the measures at members (ie, surA plan-do-study-act cycle team involves regular intervals to geon, anesthesiolorepresentatives from all areas involved in see whether changes direct patient care and patient care support as gist, nurse anesthewell as administrators. The team leader should tist, circulating nurse, in work, procedures, make sure the task takes priority and team and organization resurgical technologist) efforts continue to completion. sult in real improvewho would provide ments in care. For direct care in the OR example, a PDSA and staff 90% of the cycle team might use rates of ventilator-associated pediatric procedures; having standard equipment, pneumonia (VAP) as its measure with a goal of instruments, and supplies available for all procedecreasing VAP rates by 50%. The team then dures and completing procedures with two or institutes a program of strict hand washing, use of fewer instrument trays to promote standardization; sterile suction equipment, and upright positioning. and organizing smooth transfers of care from paAfter an appropriate interval of time, the team tient care areas to the OR and back again. The evaluates whether rates have changed, which tells team then defined performance metrics to monitor the team whether the changes in nursing care proprogress toward achieving these goals. The focus tocols were effective. Then, the team can plan was on inpatient OR services; outpatient proceanother intervention (eg, routine antiacid regimen dures were excluded.
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Forming the Pediatric OR Team Effective teams are characterized by openness, collaboration, and the ability to learn from mistakes.7 They are essential components in the delivery of the highest level of care and are necessary for maximizing OR capacity and efficiency.1-3,11 In addition, the outcome of life-threatening crises that occur in the OR and the prevention of OR mishaps such as retained sponges and inaccurate needle counts clearly depend on effective team function.12-14 The PDSA team identified anesthesiologists, nurse anesthetists, nurses, and surgical technologists who had the necessary certifications, skills, experience, and interest in pediatric surgical procedures to unite as the pediatric OR team. To foster teamwork and develop individual and group experience and expertise, whenever possible, the pediatric surgical team members performed the pediatric surgical procedures in the inpatient OR, regardless of complexity or level of urgency (eg, elective, emergency), for one year. At the end of the elective day, once per week, the staff pediatric surgeon or the pediatric anesthesiologist led a walk-through session with the OR team to review and practice complex, unique, or unusual procedures or scenarios, with attention on identifying the locations of instruments, supplies, equipment, and medications. The walkthrough scenarios provided an opportunity for team members to practice procedures such as an emergency tracheotomy and malignant hyperthermia. These interactions allowed team members to clarify expectations for their actions during urgent circumstances.
Comparisons were made using R ⫻ C contingency table analyses and chi-square tests; differences were considered significant at P ⬍ .05. Accumulation of data for publication was approved by the MCCG Institutional Review Board. The PDSA team also discussed and addressed problems in procedures in which specific clinical and process issues were identified. For example, there were cases of newborn infants who were hypothermic on arrival to the NICU. The PDSA team began to collect temperatures on all patients in the NICU to determine the scope of the problem while instituting measures to keep infants warm during transport.
Data Collection and PDSA Team Meetings The PDSA team developed a paper checklist to gather data on all inpatient OR procedures performed by the pediatric general surgeons during the one-year implementation period (Figure 1). For the PDSA project, the attending surgeon led a review of all problems encountered during the procedure. All comments and observations were recorded on the checklist, and results were collected and reviewed monthly by the PDSA team.
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RESULTS Performance data were discussed at the monthly PDSA cycle meetings. The number of routine emergency and urgent cases (eg, appendectomies) during evening, night, and weekend shifts were handled adequately by the staff members on those shifts. In the first quarter, the PDSA team instituted a pediatric call team for more complicated cases involving critically ill patients in the NICU and PICU. Although the overall participation of the pediatric OR team fell below the desired level of 90%, team members were available for 98% of the complicated procedures. The other 2% of procedures involved extreme emergencies in which immediate surgical intervention was required with the available staff members present. Team Performance For the purposes of review, the following areas of team performance were defined: availability of needed instruments, supplies, and equipment; whether more than two instrument trays were opened, which helped identify whether instrument tray pick lists supported the procedures; clinical or process problems that were the responsibility of the surgeon, the anesthesia team (anesthesiologist and nurse anesthetist),
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Figure 1. Worksheet used for each patient. The attending surgeon is responsible for completing the form. All team members have an opportunity to add items and comments.
circulating nurse, or the scrub person; and any problems involving transfers of care to and from the OR.
A grading system was used to summarize the number of problems encountered during a procedure. A grade of “A” was given to a procedure with no problem areas identified, “B” to procedures involving one or two areas of concern, “C” for procedure with three or four problem areas, “D” for five or six problem areas, and “F” for
procedures involving all seven areas. The grades were used as a summary of overall team performance for each procedure, and the distribution of grades during the month reflected the overall quality of the care provided by the pediatric service line. Staffing Between July 1, 2008, and June 30, 2009, 359 inpatient procedures were performed by the MCCG pediatric surgical service. The goal of AORN Journal
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staffing 90% of procedures with pediatric OR staff members was nearly met during the year. Results showed that pediatric OR team anesthesiologists, circulating nurses, and surgical technologists staffed 75% of procedures and team nurse anesthetists staffed 55%. During the four three-month quarters, overall team performance improved for all procedures, as reflected by the distribution of letter grades. There were more “Bs” than “As” (58% versus 29%, respectively) during the first quarter, but improvements occurred each quarter, and there were more “As” than “Bs” (61% versus 30%, respectively) by the fourth quarter (Figure 2). There were a few “Cs” and “Ds” (9% of all procedures) and no “Fs.” The improvement in grade distribution over four quarters was significant (P ⫽ .001). Instrument Needs for Common Procedures To address the team’s goal to standardize and simplify instrument needs for common procedures, any instruments, supplies, or equipment that were needed for the procedure but not immediately available were recorded. Instruments, supplies, and equipment problems affected 30% of all procedures during all four quarters of the year.
Figure 2. Distribution of grades by quarter: A ⴝ no problems or events, B ⴝ one or two problems or events, C ⴝ three or four problems or events, and D ⴝ five or six problems or events).
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NAKAYAMA ET AL Instrument Trays The PDSA team’s goal of using two or fewer instrument trays per procedure to promote standardization revealed two types of circumstances in which third or fourth trays were opened during a procedure. First, in several procedures the wrong tray was pulled and opened because the wrong procedure was scheduled (eg, open cholecystectomy instead of a laparoscopic cholecystectomy), an additional procedure was added (eg, placement of a central line), or a procedure that was planned was not performed (eg, a gastrostomy was planned but not performed in a patient receiving a fundoplication). In other cases, the central supply department sent the wrong instrument tray. Second, some trays were lacking a single instrument, so another tray was pulled to obtain that item. These circumstances reflected problems with planning and instrument processing. Surgeon-Related Problems The PDSA team reviewed problem cases (ie, a case in which there was an surgical, clinical, or process-related error or problem that required an intervention by a member of the surgical team) and determined whether an individual team member was responsible for its occurrence. The PDSA review identified 50 procedures with 62 surgeon problems (14%). The majority (55%) were process related; scheduling problems (eg, the wrong procedure, last-minute changes to planned procedures) were most frequent, followed by being late to the OR. Clinical problems accounted for 45% of surgeon-related problems and included technical problems (eg, unintentional enterotomies) and preoperative and postoperative order problems (eg, no order for preoperative antibiotics) (Table 1). The PDSA team found that posting routines and communication between staff members at the surgeon’s office and the OR scheduling desk were primary problem areas. Discussion of the incidence of surgeon-related problems led to changes in surgeon behavior, including a significant decrease
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nated team members perform pediatric procedures so they would accumulate the needed experience.
TABLE 1. Surgeon Issues (N ⴝ 62)
Type of problem Clinical Technical Perioperative antibiotics not given or ordered (6 patients) Process Scheduling Preoperative paperwork Surgeon tardiness Communication problems
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Number of occurrences 28 13 15 34 12 8 9 5
in tardiness and fewer changes in planned surgeries on the printed schedule. Simple clerical procedures were implemented that decreased surgeonattributed process errors by 65% (P ⬍ .05). Anesthesia-Related Problems The anesthesia team had 46 procedures with 53 problems (13% of 359 procedures) (Table 2). In contrast to surgeon-related problems, most problems encountered by the anesthesia team were clinical (46 of 53 problems, 87%), with difficult intubation occurring most commonly (5%) followed by difficulties in IV access (2%). An anesthesiologist was not available because of his or her presence in another room (a traditional complaint of surgeons) in only two procedures (less than 1%). Whether the anesthesiologist or nurse anesthetist was a team member did not affect on the incidence of anesthesia-related problems. The PDSA team therefore concluded that anesthesia problems were largely related to the patient population. The workforce shortage and relatively small volume of pediatric procedures at MCCG prevents full staffing of fellowship-trained pediatric anesthesiologists; however, the anesthesiologists and nurse anesthetists on the pediatric OR team were able to handle clinical problems without compromising patient outcomes. To the PDSA team, the relatively high incidence of clinically problematic procedures emphasized the need to have desig-
Circulating Nurse and Scrub Person Problems The PDSA team examined the circulating nurses’ and scrub persons’ tasks related to making sure that all supplies and instruments are available in the room and ready. Instrument problems occurred in 41 procedures in which the scrub person was not part of the team, an incidence that decreased to 24% with a pediatric OR team scrub person (P ⫽ .001). The incidence of instrument, supply, and equipment problems did not decrease, however, with the presence of a team circulating nurse, who was responsible for ensuring the availability of correct supplies and functioning equipment. Patient Transfer Issues Problems that involved the movement of patients to and from the OR were varied and involved all areas that interact with the OR (eg, preoperative processing and holding areas, postanesthesia care units, inpatient nursing units, intensive care areas). Additionally, problems during the transfer of patients from the NICU and PICU were identified as specific problems in 40% of procedures, with prolonged waits in preoperative holding areas and delayed transfer to the OR.
TABLE 2. Anesthesia Issues (N ⴝ 53)
Type of problem Clinical Technical (eg, difficult intubation, 7 patients) Patient management issues (eg, oxygen desaturation ⬍ 90%, 6 patients) Postoperative Process Staff Equipment
Number of occurrences 46 30 14
2 7 2 5
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The PDSA review of patient and patient data transfers revealed many issues. The multidisciplinary makeup of the PDSA team allowed for resolution of interdepartmental issues during PDSA meetings. For example, the weight of two patients was recorded in pounds rather than kilograms in the preoperative processing area, which caused a problem in calculating relevant arrest medications that were kilogram based. The outdated scales were removed and replaced with digital scales reading kilograms. In addition, discussions with the NICU and PICU staff members revealed that sending a patient down from the critical care area left the unit short-staffed, especially when patients were ventilated and on multiple IV drip medications. Close communication on the progress of the OR schedule and direct transfer of patients from the unit to the OR led to a decrease to 27% from 40% (P ⬍ .05) in NICU and PICU transfer problems.
CONCLUSION The experience of implementing the PDSA cycle at MCCG illustrates the challenges brought about by a new service line in any field, of which pediatric surgery is one example. The power of PDSA is that it provides a management tool to achieve goals using measurable objectives that involve a multiplicity of interacting departments, which made it an appropriate choice for introducing a new pediatric surgical service line. The PDSA review defined goals, objectives, and ongoing metrics of OR performance to determine quality improvement and whether interventions were effective. The PDSA team provided a multidisciplinary forum to address problems as they arose. The approach used at MCCG included team members at both the clinical and administrative levels. The pediatric OR team consisted of designated anesthesiologists, nurse anesthetists, nurses, and surgical technologists. Input and involvement in team improvement issues fostered ownership and teamwork. 342
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The PDSA team provided administrative support to improve systems that enhanced patient movement through the system and allowed OR team members to do their jobs well. Administrative support is crucial to the success of a PDSA cycle. Curtis and colleagues emphasize that organizational support is an essential step in the development of an interdisciplinary intensive care unit quality improvement team.15 Entin et al noted that simply installing a team structure without addressing the organizational structure of care does not ensure that the team will operate efficiently.16 A PDSA process requires commitment at all levels over the long-term. Individual team members must support the team, for example, by arriving on time to the OR, making sure case posting and orders are accurate, communicating effectively, and honestly evaluating their responsibility and contribution to teamwork and team function. Although the PDSA cycle at MCCG focused on pediatrics, it has obvious utility in any service line providing care to patients of any age. The OR at MCCG is now planning to use the PDSA cycle for quality improvement in established services such as orthopedic surgery and general surgery. Acknowledgements: The authors thank Darla Rich, RN, NP; Sally Lester, RN; Cyndee Adams, RN; Rebecca Cogburn, RN; Suzanne Garvin, RN; Aimee Lowery, RN; Roberta Permenter, RN; and the members of the pediatric surgical service line team who participated as members of the PDSA cycle team at Medical Center of Central Georgia, Macon. References 1.
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Jain AK, Thompson JM, Chaudry J, McKenzie S, Schwartz RW. High-performance teams for current and future physician leaders: an introduction. J Surg Educ. 2008;65(2):145-150. Leach LS, Myrtle RC, Weaver FA, Dasu S. Assessing the performance of surgical teams. Health Care Manage Rev. 2009;34(1):29-41.
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Harders M, Malangoni MA, Weight S, Sidhu T. Improving operating room efficiency through process redesign. Surgery. 2006;140(4):509-514. Fabri PJ, Zayas-Castro JL. Human error, not communication and systems, underlies surgical complications. Surgery. 2008;144(4):557-563. Regenbogen SE, Greenberg CC, Studdert DM, Lipsitz SR, Zinner MJ, Gawande AA. Patterns of technical error among surgical malpractice claims: an analysis of strategies to prevent injury to surgical patients. Ann Surg. 2007;246(5):705-711. Plan-Do-Study-Act (PDSA) Worksheet (IHI tool). Institute for Healthcare Improvement. http://www.ihi.org/ IHI/Topics/Improvement/ImprovementMethods/Tools/ Plan-Do-Study-Act%20%28PDSA%29%20Worksheet. Accessed June 2, 2010. Data utilization. The Joint Commission. http://www. jointcommission.org/NR/rdonlyres/A619A3C2-641640BC-8CFB-A9EFE21AD4CB/0/hcss_ig_sec8_2.pdf. Accessed June 2, 2010. Institute of Medicine. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington, DC: National Academy Press; 2001. Best M, Neuhauser D. W. Edwards Deming: father of quality management, patient, and composer. Qual Saf Health Care. 2005;14(4):310-312. Berwick DM. Developing and testing changes in delivery of care. Ann Intern Med. 1998;128(8):651-656. Cendán JC, Good M. Interdisciplinary work flow assessment and redesign decreases operating room turnover time and allows for additional caseload. Arch Surg. 2006;141(1):65-69. Vincent C, Moorthy K, Sarker SK, Chang A, Darzi AW. Systems approaches to surgical quality and safety: from concept to measurement. Ann Surg. 2004;239(4): 475-482. Powers KA, Rehrig ST, Irias N, et al. Simulated laparoscopic operating room crisis: an approach to enhance the surgical team performance. Surg Endosc. 2008;22(4): 885-900. Greenberg CC, Regenbogen SE, Lipsitz SR, DiazFlores R, Gawande AA. The frequency and significance of discrepancies in the surgical count. Ann Surg. 2008; 248(2):337-341. Curtis JR, Cook DJ, Wall RJ, et al. Intensive care unit quality improvement: a “how-to” guide for the interdisciplinary team. Crit Care Med. 2006;34(1): 211-218. Entin EB, Lai F, Barach P. Training teams for the perioperative environment: a research agenda. Surg Innov. 2006;13(3):170-180.
Don K. Nakayama, MD, MBA, is the Milford B. Hatcher professor and chair, Department of Surgery at Mercer University School of Medicine, Macon, GA, and the program director of
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the residency in surgery at the Medical Center of Central Georgia, Macon. Dr Nakayama has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Timothy N. Bushey, RN, BSN, MSN, was the data manager in the surgery center at the Medical Center of Central Georgia, Macon. Mr Bushey has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Irene Hubbard, RN, BSN, MHA, is the director of the surgery center at the Medical Center of Central Georgia, Macon. Ms Hubbard has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Dawn Cole, RN, is the vice president of surgical services at the Medical Center of Central Georgia, Macon. Ms Cole has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Amanda Brown, MD, is a staff anesthesiologist at the Nexus Medical Group, Macon, GA. Dr Brown has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Timothy M. Grant, MD, is a staff anesthesiologist at the Nexus Medical Group, Macon, GA. Dr Grant has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article. Issam J. Shaker, MD, is a clinical professor of surgery at Mercer University School of Medicine, Macon, GA, and attending surgeon at the Medical Center of Central Georgia, Macon. Dr Shaker has no declared affiliation that could be perceived as posing a potential conflict of interest in the publication of this article.
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