The mandate of the sterile processing service (SPS) is to supply consistently clean, sterile, or high-level disinfected instruments to ensure surgical and procedural safety.Reference Rutala and Weber 1 Sterile processing is a multistep process that involves transport from the point of care to the sterile processing unit, removal of bioburden, washing and disinfection, appropriate packaging of instruments, and sterilization of instruments.Reference Burlingame 2
Interruptions in care attributable to SPS quality assurance failures are rare. However, we received reports of staining on instruments at our facility on at least 4 different occasions, which resulted in multiple operating-room shutdowns lasting from 1 week to several months. Considering the operating-room closures, a multidisciplinary team of clinicians, engineers, and administrators collaborated to identify substitute options for processing sterile instruments. Here, costs and benefits of alternative strategies for standing up SPS are evaluated.
METHODS
Estimation of Costs
Potential solutions were identified, and mean monthly and annual economic costs were compared. Costs were calculated by summing all direct expenditures and included all 1-time, fixed costs (eg, installation of equipment, construction, purchase of reusable supplies) and recurring costs (eg, utilities, transportation, personnel, routine payments for services rendered).
Manufacturer’s estimates were used to calculate the cost of purchasing or renting mobile sterilization units. Energy expenditures were based upon projected use and local utility costs. Cost of installing permanent utilities and estimated utility costs for mobile trailers were based on estimates from subject-matter experts. The cost of outsourcing services to another facility was estimated based on per-load charges multiplied by the mean daily number of sterilization loads, plus transportation and personnel costs.
Intangible Effects
Intangible costs (both benefits and harms) were explored qualitatively without conversion to a specific dollar amount. Downstream consequences of operating room closures, such as injury to facility reputation, training program disruption, and staff turnover were evaluated.
Data Analysis
All costs are presented in 2016 US dollars and are presented from the hospital perspective over a 5-year horizon. A sensitivity analysis was performed to identify critical decision points. All analyses were completed using Microsoft Excel 2010 (Microsoft, Redmond, WA).
RESULTS
Study Setting
Estimates are based on a high-complexity Veterans Affairs (VA) facility with ~110 inpatient beds, 5,000 admissions per year, and >4,000 surgical procedures per year. The facility includes 8 operating rooms and 12 surgical specialties, including cardiac, orthopedic, and neurosurgery.
We identified 3 approaches to reopening sterile processing after steam failures. The first option was repairing facility infrastructure. However, because of the diversity of the facility-specific problems that can be encountered and the wide range in cost to fix these problems, cost estimation for this strategy is not presented. The second option was utilization of mobile sterilization trailers either for purchase or lease, with or without with independent equipment, water, and steam sources. The third option was outsourcing sterilization to another facility.
Over the 5-year study period, outsourcing sterilization was the least expensive strategy. Renting a sterilization trailer was the most expensive option after ~2 years (Figure 1; Table 1).
FIGURE 1 Cumulative projected cost comparison of sterilization solutions over time. Legend: 
Option A, lease trailers (temporary utilities) 
Option B, purchase trailers (temporary utilities) 
Option C, purchase trailers (permanent utilities, already in existence) 
Option D, purchase trailers (permanent utilities, construction needed) 
Option E, outsourcing
TABLE 1 Cumulative Projected Cost Comparison of Alternative Sterilization Solutions, Using Macro-Cost Estimation.
a Cost estimated assuming use of temporarily utility solutions.
b Cost estimated assuming use of permanent utility solutions.
Intangible Costs
Strategies that involve significant delays may lead to additional costs of sending patients to other facilities for surgical procedures and costs attributable to staff turnover; staff turnover during our operating room shutdowns was high. Low surgical volume and complexity led to additional concerns about the loss of our surgical residency program. Loss of clinical and support staff and surgical residents presents a significant challenge when the operating room reopens, as post-closure staffing may not be sufficient to support usual surgical volume.
Unforeseen consequences of major reductions in surgical admissions were also identified. Reduced postoperative admissions resulted in workload shifted from the surgical service to the medical service. The effect of this shifting workload was a high burden on the medical house staff. The higher workload briefly lead to residency program work-hour violations, which required implementation of an admission limit for the Medicine service. Combined, lack of surgical cases (affecting the surgery training program) and excess admissions (affecting the internal medicine training program) may lead to potential sanctions—or complete loss of—training programs in facilities without functional sterile processing services.
DISCUSSION
Sterile processing is an essential aspect of all healthcare systems; inpatient and surgical programs depend upon sterile instruments to safely provide advanced medical care.Reference Burlingame 2 – Reference Chobin and Swanson 4 Over the course of several years, our facility experienced several episodes of SPS quality-assurance challenges resulting from steam quality and infrastructure concerns. These quality gaps led to several interruptions in clinical operations across many disciplines, including surgery, medical subspecialties, and dermatology, among others.Reference Hernandez 5
Sterile processing challenges are not unique to our facility.Reference Hernandez 5 , Reference Blackmore, Bishop, Luker and Williams 6 The New York University Hospital System was forced to identify SPS alternatives following catastrophic damage to facility infrastructure after Hurricane Sandy.Reference Adalja, Watson, Bouri, Minton, Morhard and Toner 7 , Reference Evans 8 In July, 2015, the largest hospital in Texas was forced to shut down surgical operations after SPS quality-assurance concerns similar to those experienced at our facility were identified. Most recently, Detroit Medical Center was found to have SPS quality assurance challenges and may face loss of Medicare and Medicaid funding after an unannounced inspection by the Centers for Medicare and Medicaid Services (CMS) in August 2016.Reference Punke 9 A repeat inspection will determine the termination or continuation of the contract between CMS and the medical center, with potentially dire economic consequences for the facility.Reference Punke 9
We found several key factors that affect the optimal economic strategy for supporting SPS. The following variables should be considered: (1) expected duration of the potential solution, (2) facility capacity for accommodating the solution in terms of logistics, (3) infrastructure (eg, the amount of reuseable medical equipment needed, based on changes in sterilization turnaround time and utilities and physical space to accommodate mobile sterilization units), and (4) any regulatory issues that may create barriers to different strategies.
Feasibility is an additional consideration. Repairing or replacing internal water and steam systems was not an option for our facility, but it may be an economically sound strategy for facilities with fewer infrastructure challenges. Our facility is in an urban setting; thus, outsourcing was an available option. However, rural healthcare systems lacking nearby facilities with necessary infrastructure to support increased SPS demand may not be able to implement this strategy.
Our analysis has several limitations. First, our data are based on a VA facility that has a different economic structure than private healthcare systems. Costs of implementation delays were not quantified or included in cost estimates; however, costs for strategies that can be implemented quickly would be minimally affected by loss of patients and clinical care staff and would also be less likely to be negatively impacted by other intangible costs, such as potential loss of training programs, loss of staff, or loss of Medicare and Medicaid reimbursements. Thus, strategies most significantly impacted by implementation delays (ie, lease or purchase of a sterilization trailer) are less attractive economically than outsourcing. Finally, our cost estimate of outsourcing sterile processing to another facility is based on the volume of our operating room and hospital; the relative costs may be different at different levels of surgical and sterile processing volume.
In conclusion, the most economically sound option for reopening sterilization operations varies depending on the root cause of the problem and its projected time horizon. Sterile process service shutdowns are associated with substantial downstream negative effects that should be considered when evaluating potential solutions.
ACKNOWLEDGMENTS
We would like to thank the entire staff of the Eastern Colorado VA Health Care System for their efforts to restore surgical operations.
Financial support: W.B.E. was supported by a Veterans Integrated Service Network (VISN)-1 Career Development Award. No other financial support was provided relevant to this article.
Potential conflicts of interest: All authors report no conflicts of interest relevant to this article.
