The client is a not-for-profit 300-bed teaching hospital serving one of the most ethnically diverse populations in New York City. It is part of a larger, not-for-profit health system comprising one other major hospital and numerous clinics, including a traumatic brain injury institute with a Level I trauma center designation.
The client facility is a designated stroke center and operates a full-service Emergency Department (with separate adult and pediatric units) that serves nearly 45,000 patients. Mental health services are also available, in addition to an on-site ambulatory care center as well as over 40 general and specialty clinics. The health system collectively receives over 340,000 outpatient care visits, treats nearly 175,000 Emergency Room patients, and performs over 5,000 births each year.
Nexera performed an operations assessment of the client’s Sterile Processing Department. The department was in disarray—cluttered and dirty. It was evident that it had not been properly maintained for a long time, as key functional elements showed signs of neglect or were in need of repair. Materials and equipment essential for sterile processing tasks were unavailable, causing instrumentation defects, an inability to supply the operating room (OR) with a proper end product, and the need to continuously rework trays.
A process evaluation identified the inefficiencies and lack of compliance about which the OR staff and hospital administration had already expressed concern. At the request of the executive vice president, the Nexera team was asked to provide transitional workforce support, particularly to address the absence of a sterile processing manager.
The department had never been renovated. Equipment was in critical need of replacement; one washer decontaminator and one sterilizer had been inoperable for over six months, requiring alternate methods for tray processing.
The department, which was under the direct management of the executive vice president, received neither direction nor support from the clinical departments. As a result, processes suggested clinical deficiencies. Further, the lead technician wasn’t certified and lacked the technical knowledge required for instrument tray assembly. The department functioned without assistance—staff members were left to assess priorities and prepare essential next-day OR and patient care-area materials. There was no accountability for delivered products nor a sense of urgency about processing trays that arrived in the department.
Consequently, next-day case trays were delivered incomplete causing OR caseload delays as well as a reliance on immediate-use sterilization to support daily operations. Immediate-use sterilization is acceptable when items are contaminated or dropped during surgery, but dependence on immediate-use sterilization to fulfill typical OR needs is dangerous, as the essential cleaning and decontamination processes are curtailed, leaving the potential for contaminated instrumentation. Most instrument tray turnover took more than 24 hours and were not prepared when needed.
The OR expressed a need for on-time tray delivery, a consistent quality product, a speedier process, and a higher degree of interdepartmental teamwork—issues of particular importance, due to a projected increase in volume as a result of physician recruitment initiatives and the addition of a new specialty service line.
The assessment focused on five major areas: sterile processing procedures (covered assembly, preparation, packaging, sterilization, storage, and delivery), quality systems, OR–Sterile Processing communications, management systems, and staff education. The findings for each of these functional areas are summarized below:
Sterile Processing Procedure Assessment
- Lack of instrument processing knowledge
- Equipment broken and poorly maintained
- Minimal or no adherence to regulatory standards
- Lack of monitoring systems
- Over 40% of next-day surgical instrument trays not sterilized for the day of surgery
- Department rendered ineffective, due to lack of critical supplies and primary materials needed to complete surgical trays
- Long instrument turnover delaying OR caseload
- No quality audits performed on assembled instrument sets
- Surgical instruments show signs of deficient preventive maintenance
- Rust on many instrumentation sets
- No prime materials to replace broken or malfunctioning instruments
OR–Sterile Processing Communications
- Sterile Processing has little insight into OR schedule, resulting in delayed tray preparation and surgical cases
- Sterile Processing lacks leadership required to direct functions and communicate needs as daily caseload progresses
- Departments operate independent of one another
- Limited communication between departments
- Established policies and procedures not followed
- Staff competencies do not meet recommended standards
- Environmental conditions do not meet recommended standards
- No indication that policies and procedure manuals, instructions for use, or materials safety sheets are updated
- Staff receives no direction for day-to-day tasks and responsibilities
- Staff feels on their own to manage issues
- Lack of leadership; no department manager
- Difficulty finding ways to resolve issues in a timely manner
- Staff lacks understanding of procedures and how they should be followed
- Staff not empowered to take action when issues arise
- Technicians do not understand protocols
- Technicians not properly trained
- Inconsistencies completing necessary functions; potential for mishap
A Nexera sterile processing transition manager took responsibility for implementing each of the key activities described below and spent two weeks working with the sterile processing nurse administrator to foster a greater understanding of all sterile processing operations and eventually to transition management.
The department was reorganized, workflow patterns were established to maximize space, improve operations, efficiently store and distribute surgical instrument trays, adhere to best practice and infection control guidelines, and amend the physical environment (which enhanced the staff’s ability to focus, process information, and improve productivity).
Procedures for instrument assembly, preparation, sterilization, storage, and transport were developed and implemented. In addition, several risk assessments were conducted:
- An instrument tray count sheet risk assessment – to estimate the number of trays that required a list update
- Skill and competency risk assessments – for critical procedures for decontamination, preparation, packaging, sterilization, storage, and transporting surgical instruments
- A decontamination risk assessment – general, process, and documentation
- A preparation and packaging risk assessment – instrument identification, instrument inspection, sterilization process identification, instrument replacement, and documentation
- A sterilization risk assessment – equipment efficacy training, load preparation, discrepancy analysis, and documentation
- A storage and transport risk assessment – transporting contaminated and clean instruments, storage requirements, inventory requirements, and documentation
A quality control process was implemented aimed at minimizing cost, maximizing productivity, and ensuring the consistency and effectiveness of the overall process, with an emphasis on the importance of providing technicians with the tools necessary to perform tasks required for decontamination, assembly, and sterilization (instrument replacement, tables, brushes, thermometers, heat sealers, tests, etc.). Lastly, an instrument tray inventory assessment was conducted to understand specific use and to identify additional tray needs. All surgical instrument trays were put through a preventive maintenance rotation to ensure that the sharpness and functionality of the instruments were consistent with manufacturers’ specifications, while replacement inventory was purchased and stored near the assembly workstations.
The reorganized department offered better process workflow, the elimination of excess inventory, and maximized space. The new space and revamped workstation provided the staff with a clutter-free environment that fostered safety. Environmental conditions related to temperature and humidity were corrected, as was the physical state of the department. Interdisciplinary projects improved procedures for reprocessing equipment repairs, new equipment installation, and ancillary areas.
The staff’s instrument recognition, medical terminology comprehension, process improvement principles, and all phases of instrument reprocessing skills were improved. In addition, the team-building exercises cultivated a culture of learning and cooperation.
An OR instrument tray priority list was implemented to ensure that all surgical instrument trays required for the next day were 100% complete and ready for OR use. The staff now understands the OR schedule and can identify which instruments are needed.
The team applies a quality assurance process for instrument decontamination that includes verification of the cleaning process itself, endoscope cleaning, and streamlined transportation of contaminated instruments from point-of-use to the decontamination area.
The Nexera team joined forces with the OR and Purchasing Departments to implement a repair and maintenance program for surgical instruments in addition to a repair program for the reprocessing equipment, the washer, the sterilizer, and the water treatment system that supplies the Sterile Processing Department. The water treatment system is now compliant with guidelines for washing surgical instruments. The hospital’s rigid container system was refurbished, allowing the staff to use the many rigid containers that were previously damaged and kept in storage. This particular initiative reduced the need to purchase disposable wrappers.
Nexera helped select, coach, and train the sterile processing manager hired by the hospital. Tools for process sustainability were incorporated into the department’s daily routine. The manager was presented with a new policies and procedures manual, a report of completed staff competencies, and a quality process matrix for ongoing performance reporting to the Infection Control Committee.
The initiatives and projects completed at the client facility prepared staff for what turned out to be a successful Joint Commission survey, one for which there were no negative sterile processing findings. The Joint Commission surveyor was exceedingly pleased with both the global improvements and the quality processes implemented. Upon survey completion, the executive vice president sent Nexera a note that said, “We had our four-day unannounced JCAHO survey last week and we all did very well. I appreciate and thank you for all of your wonderful support, assistance, and leadership.”
If protocols are not followed when processing instrument trays in sterile processing and ancillary services, it presents a major risk to the patients being served. Furthermore, documentation ensures that all processes are monitored and established parameters and key performance indicators are met. In order to run a successful operation, the Sterile Processing Department and the OR must function as a cohesive unit.