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Patient Safety
Quality Improvement Processes and High-Reliability Organizations
High-reliability organizations (HROs) create “consistent care practices that reduce irrational variation, decrease complexity, and lower risk.”[1] Lean and Six Sigma process improvement methodologies emphasize optimization to reduce variability and eliminate waste; both are derived from large-scale industrial engineering processes.[2] Operating room quality and efficiency initiatives require engagement of frontline staff and “consistent attention to sustain gains over time.”
Sutcliffe observed that HRO “attributes and operating dynamics…provide a template on which to better understand how safe and reliable performance can be achieved under trying conditions.”[3] Vitale and Divya wrote that with “countermeasures…built into the organization,” high-reliability organizations are often “able to prevent catastrophic events in environments where errors are expected because of high-complexity and various risk factors involved.”[4] Key strategies proposed include “incorporating work-aids into clinical workflows, promoting interdisciplinary collaboration and teamwork, and investing in a culture of psychological safety.”
Ruchlin and colleagues wrote that “normal accident theory asserts that errors result from system failures” and that an effective system “collects, analyzes, and disseminates information from incidents and near misses as well as regular proactive checks on the system's vital signs.”[5] Because adverse events can be complex and difficult to anticipate, high-reliability organizations work to build a culture of justice, flexibility, reporting, and learning. Ruchlin noted that that a safety culture is supported by “migrated distributed decision making” – which includes empowering staff to address observed deficiencies, management by exception (a process of “identifying and handling cases that deviate from the norm”), and “fostering a sense of the ‘big picture.’” Staff at all levels must be empowered to speak up.[6]
Professional society safety advocacy campaigns “did not universally coincide with dropping fracture rates” but “often were associated with substantial decreases in following years…likely because injury prevention messages are dispersed from providers to the public over time.[7]
Perioperative Care and Screening
Shore and colleagues noted that “preoperative use of combustive cigarettes (nicotine/cannabis) represents perioperative risks for induction/anesthesia, postoperative pain, and analgesia requirements and issues with delayed wound and fracture healing.”[8] They further wrote that “higher levels of preoperative anxiety and the presence of mental health pathology are associated with slower recovery, higher levels of postoperative pain, and the increased likelihood for chronic pain.” The authors recommended standardized preoperative screening for adolescents to identify potential risk factors.
Perioperative care pathways and bundles have been “associated with a decreased risk of surgical site infection and decreased length of stay in pediatric spinal deformity surgery.”[9] Using the Delphi process, the Children’s Spine Study Group offered 22 best practice recommendations for prevention of surgical site infection in children undergoing growth-preserving surgery for early onset scoliosis.[10]
A checklist for operative treatment of pediatric supracondylar humerus fracture at the University of Washington was not shown to result in clinically significant patient care benefit, suggesting the need for validation and refinement.[11]
Clinic Pathways
The need for frequent follow-up radiographs for pediatric fractures and spinal deformity care has been challenged, with several studies finding a lack of benefit for routine images for specific conditions.[12]
A review at Children’s Hospital Los Angeles reported a higher rate of cast injury in neuromuscular patients (38.8 per 1000), even with foam padding, compared to otherwise healthy children (7.6 per 1000).[13] Researchers in Chicago reported a reproducible simulation using cylindrical wax models that was effective in measuring cast saw performance of both trainees and experienced users.[14] A multimodal quality improvement program at Nationwide Children’s Hospital in Ohio achieved >90% reduction in cast complications to 1.61 per 1,000 casts.[15] During cast use, running the cast saw vacuum resulted in significantly faster cooling compared to running the cast saw alone.[16]
Other Issues
A study of 51 patients with orthopedic implants found that children with growing spine implants (12 patients) had elevated serum levels of metals including titanium (mean 3.3 ng/mL), chromium (mean 1.18 ng/mL), and cobalt (mean 0.63 ng/mL) levels compared to children with extremity implants (titanium 0.98 ng/mL, chromium 0.26 ng/ml, cobalt 0.26 ng/mL).[17] The clinical significance is presently unknown.
While the incidence is very low, adolescents experience an increased risk of venous thromboembolism (VTE) compared to younger children. Authors of one study suggested that “adolescent females with a family history of blood clotting disorders and those with a change in mobility after surgery should be considered for prophylaxis,”[18] although evidence quality is low and there is no national consensus.
References
[1] Shea KG. Strategies and Tools to Enhance Patient Safety: HROs, HEROs, and Safety Culture. J Pediatr Orthop. 2020;40 Suppl 1:S30-S32. doi:10.1097/BPO.0000000000001500
[2] Raman DL, Bixby EC, Wang K, et al. A Comprehensive Unit-based Safety Program to Improve Perioperative Efficiency in Adolescent Idiopathic Scoliosis. J Pediatr Orthop. 2022;42(3):123-130. doi:10.1097/BPO.0000000000001992. Level III retrospective comparative study.
[3] Sutcliffe KM. High reliability organizations (HROs). Best Pract Res Clin Anaesthesiol. 2011;25(2):133-144. doi:10.1016/j.bpa.2011.03.001
[4] Vitale MG, Raman DL. Safety Does Not Happen by Accident: Preventing Human Error Through High-Reliability Practices. J Pediatr Orthop. 2022;42(Suppl 1):S35-S38. doi:10.1097/BPO.0000000000002067.
[5] Ruchlin HS, Dubbs NL, Callahan MA. The role of leadership in instilling a culture of safety: lessons from the literature. J Healthc Manag. 2004;49(1):47-59.
[6] Godlock GC, Miltner RS, Sullivan DT. Deference to Expertise: Making Care Safer. Creative Nursing. 2017 Feb;23(1):7-12. DOI: 10.1891/1078-4535.23.1.7. PMID: 28196562.
[7] Karkenny AJ, Burton DA, Maguire KJ, Hanstein R, Otsuka NY. Do Professional Society Advocacy Campaigns Have an Impact on Pediatric Orthopaedic Injuries?. J Pediatr Orthop. 2018;38(3):e122-e127. doi:10.1097/BPO.0000000000001133. Level V-systematic review of descriptive data.
[8] Shore BJ, Flaugh R, Shannon BA, Curran P, Hogue G. Preoperative Considerations for Teenagers Undergoing Orthopaedic Surgery: VTE Prevention, Mental Health Assessment, Vaping, and Drug Addiction. J Pediatr Orthop. 2021;41(Suppl 1):S64-S69. doi:10.1097/BPO.0000000000001764.
[9] Miller DJ, Cahill PJ, Janicki JA, Stephenson LP, Choi PD. What's New in Pediatric Orthopaedic Quality, Safety, and Value? A Systematic Review With Results of the 2016 POSNA Quality, Safety, and Value Initiative (QSVI) Challenge. J Pediatr Orthop. 2018;38(10):e646-e651. doi:10.1097/BPO.0000000000001241. Level 4-literature review.
[10] Glotzbecker MP, St Hilaire TA, Pawelek JB, et al. Best Practice Guidelines for Surgical Site Infection Prevention With Surgical Treatment of Early Onset Scoliosis. J Pediatr Orthop. 2019;39(8):e602-e607. doi:10.1097/BPO.0000000000001079. Level V.
[11] Williams AK, Cotter RA, Bompadre V, Goldberg MJ, Steinman SS. Patient Safety Checklists: Do They Improve Patient Safety for Supracondylar Humerus Fractures? J Pediatr Orthop. 2019;39(5):232-236. doi:10.1097/BPO.0000000000000928. Level III
[12] Miller DJ, Cahill PJ, Janicki JA, Stephenson LP, Choi PD. What's New in Pediatric Orthopaedic Quality, Safety, and Value? A Systematic Review With Results of the 2016 POSNA Quality, Safety, and Value Initiative (QSVI) Challenge. J Pediatr Orthop. 2018;38(10):e646-e651. doi:10.1097/BPO.0000000000001241. Level 4-literature review.
[13] Lin AJ, Cao LA, Lightdale-Miric N, Bent MA. Neuromuscular Patients Are 40% More Likely to Get a Cast Injury. J Pediatr Orthop. 2022;42(3):144-148. doi:10.1097/BPO.0000000000002001. Note that there is a discrepancy between the text (38.8 injuries per 1,000 casts in patients with neuromuscular diagnosis) and the abstract (37.4 injuries per 1,000 other patients).
[14] Liles J, Wieschhaus K, Wieschhaus K, Adams W, Cappello T, Evans D. Validation of a Cost-effective Cast Saw Simulation-based Educational Module to Improve Cast Removal Safety. J Pediatr Orthop. 2022;42(2):70-76. doi:10.1097/BPO.0000000000001987. Level III—diagnostic test
[15] Balch Samora J, Samora WP, Dolan K, Klingele KE. A Quality Improvement Initiative Reduces Cast Complications in a Pediatric Hospital. J Pediatr Orthop. 2018;38(2):e43-e49. doi:10.1097/BPO.0000000000001117.
[16] Puddy AC, Sunkin JA, Aden JK, Walick KS, Hsu JR. Cast saw burns: evaluation of simple techniques for reducing the risk of thermal injury. J Pediatr Orthop. 2014;34(8):e63-e66. doi:10.1097/BPO.0000000000000274.
[17] Mathew SE, Xie Y, Bagheri L, et al. Are Serum Ion Levels Elevated in Pediatric Patients With Metal Implants? J Pediatr Orthop. 2022;42(3):162-168. doi:10.1097/BPO.0000000000001957. Level II prospective comparative study.
[18] Shore BJ, Flaugh R, Shannon BA, Curran P, Hogue G. Preoperative Considerations for Teenagers Undergoing Orthopaedic Surgery: VTE Prevention, Mental Health Assessment, Vaping, and Drug Addiction. J Pediatr Orthop. 2021;41(Suppl 1):S64-S69. doi:10.1097/BPO.0000000000001764.