July 19, 2016

Process improvements raise SPD standards and quality

By: OR Manager

When audits revealed areas of deficit in the sterile processing departments (SPDs) of the Memorial Hermann Health System in Houston, leaders pulled together a team to help implement a quality improvement plan. By analyzing and standardizing their processes, creating auditing tools, and educating staff, they significantly increased quality scores throughout the system.

Memorial Hermann, which has 13 acute care hospitals with more than 160 ORs and 13 SPDs, had received negative findings related to instrument handling on visits from the Joint Commission, so Karen deKay, MSN, RN, CNOR, CIC, infection prevention manager for surgical services, was assigned to investigate. When deKay used an internally developed audit tool to assess compliance with national instrument-related guidelines and surveyed SPD managers to identify issues related to instrumentation, the results came as a surprise.

“I found that not only were we deviating from the standards, but also there was great variation from facility to facility,” she says. For example, seven different preenzymatic products were being used throughout the system. deKay also found variations in staffing, education, square footage of departments, and how instruments were processed.

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Karen deKay, MSN, RN, CNOR, CIC

Karen deKay, MSN, RN, CNOR, CIC

deKay turned to the system’s quality department and a process manager trained in Lean and Six Sigma to develop an improvement plan, which focused on six key areas (sidebar, p 11).

Here’s a closer look at each of those areas. During this process, which started in 2012, deKay partnered with Stacy Kelley, BSN, RN, systems clinical director for sterile processing at Memorial Hermann. (Management of the SPD recently moved from the OR to materials management.)


Shared vision

A shared vision was essential to create buy-in, and that buy-in started at the top, deKay says. “Because the results of the assessment I did were not favorable, administration asked that the executive leadership at each facility assign a process owner and an executive sponsor to the project,” she explains. Process owners were OR directors or SPD managers with OR directors as their co-leaders. Executive sponsors were at the chief operating officer (COO) level; process owners had to report progress to the COOs.

The process owners and executive sponsors then formed an instrument task force (ITF) for each facility. The ITFs, which met every 2 weeks, included staff and managers from the OR, SPD, labor and delivery, and the catheterization lab.

deKay took an innovative approach to engaging the teams—she videotaped the instrumentation handling process in each of the task force areas, set it to music, and showed it to ITF members. The members compared what they saw to the standards they had on a worksheet.

“It was instant buy-in because they saw what was happening,” deKay recalls. “They clapped when the standard was met and booed when it wasn’t; they wanted to fix things right away.”

At another meeting, the teams visited the decontamination area to watch the cleaning. “Many task force members had never been in the area before,” deKay says.

Standardization also helped create a shared vision. “My goal was to standardize processes and work smarter, not harder,” deKay says. “We tried to streamline processes and make them simpler.” She compared processes with standards from the Association for the Advancement of Medical Instrumentation (AAMI) and AORN, but notes, “Standards are statements; I put what the staff were doing into steps, so they would be consistent.”

deKay brought together the ITFs for two half-day work sessions at a central location. She assigned the ITF stakeholders to three teams, each of which had a scribe and a particular focus area. Ultimately, the teams reached consensus on 86% of the steps, for a final list of 103 that covered instrument handling from the point of care through precleaning and decontamination. This list helped in developing audit and quality tools.


Quality oversight

Stacy Kelley, BSN, RN

Stacy Kelley, BSN, RN

Four audit tools are used: quality process audit, decontamination critical to quality audit, finished goods audit, and audit of compliance with the loaner policy.

The quality process audit, conducted twice a year, has 85 elements (sidebar, p 13). deKay completed the first audits and then taught the facilities’ infection preventionists how to conduct them.

“We did inter-relator reliability to ensure they were being conducted consistently,” she says. Results are shared with senior leadership and have become part of the SPD leadership’s incentive metrics.

SPD managers conduct monthly decontamination critical to quality audits, using the 27 steps from the 103-step list that are critical for decontamination (sidebar, p 13). “It helps SPD managers assess employees and prepare for the biannual audit,” deKay says.

A quality nurse who works in the SPD department conducts each finished goods audit, based on a checklist that reflects International Organization Standardization concepts (sidebar, p 14).

“We want each and every time to produce quality products, just like you want every car or any other manufactured product to be of high quality each time it’s produced,” Kelley says. The quality nurse evaluates about 500 instruments sets each month, with the number at each facility determined by its volume.

The nurse asks the SPD manager to pull the requested number of instrument sets at random and makes a detailed evaluation of each. “They are evaluating what a perfect instrument tray looks like,” Kelley says.

The review includes checking that chemical indicators are placed properly, tip protectors are used correctly, and instruments are clean, undamaged, and placed correctly in the tray for optimal sterilization. The nurse repackages the set afterwards to avoid extra work for the SPD staff. The audit score is shared with the SPD manager, who takes steps to correct any deficits.

The loaner policy has the following key points:

• All loaner trays must be delivered within 24 hours of surgery start time.

• Any late tray must have approval by OR/SPD leadership, or the vendor faces a monetary fine.

• Each loaner must be delivered with instructions for use and a count sheet.

• There is a mandatory in-service for any new tray.

Leaders in the SPD, OR, and supply chain are notified by email if a loaner set is being checked in past the 24-hour rule. The vendor receives a monetary fine unless the violation was because of a late add-on or urgent procedure, or the vendor has previously cleared the check-in with the SPD or supply chain leadership.

Communicating information is key for success, according to both Kelley and deKay. “We’re a very competitive group, especially with the quality audits,” Kelley says. “When the scores go out, there’s a competition to beat the best score.”

Managers use positive results to show staff how well they are doing, while discussing any areas that need to be addressed. “It gives you an objective view of how your department is running,” deKay says.

Results also are shared at OR council meetings (the system’s OR leadership team) and C-suite meetings.

No staff were added to conduct the audits, although deKay says later the team identified staff shortages in the SPD; contract employees were used until staff were hired.


Leaders at Memorial Hermann Health System used the quality improvement pathway as a guide for improving SPD performance. All images courtesy of Memorial Hermann Health System. Used with permission.

Leaders at Memorial Hermann Health
System used the quality improvement pathway as a guide for improving SPD performance.
All images courtesy of Memorial Hermann Health System.
Used with permission.

Safe and clean environment

deKay’s initial assessment revealed cleaning and maintenance deficiencies for the SPD. “We found that no one was taking responsibility for what needed to be done from an environmental or engineering perspective,” she says.

In response, she created process checklists, one each for SPD, environmental services, and engineering, and met with the departments to review them. “The checklists define everyone’s tasks, the frequency, and who is responsible,” she says. Each task includes the frequency and the relevant AAMI and AORN standards.

deKay and Kelley also partnered with an external third party to conduct validation testing on all immediate use and large steam sterilizers twice a year. “This gives us an extra level of assurance that our autoclaves work as we expect them to,” Kelley says. A summary of the report is sent to SPD managers, and problems are identified by area of responsibility, for instance, engineering or the SPD.

Of course, daily testing is performed in addition to the biannual testing, but Kelley says that methodology and documentation weren’t consistent. Her data management team standardized the process. For example, visual inspection, a chemical test, a flow check, and a temperature check are all used for automated washers. Staff conduct the tests every morning before they start the decontamination process and use a scan sheet to capture results.


A sample from the competency checklist for an SPD employee.

A sample from the competency checklist for an SPD employee.

Employee development

“If you don’t invest in developing your people, everything you’ve done is for naught,” Kelley says. SPD and supply chain leadership focused on three areas: education, certification, and career development.

“We had spent less than $10 per employee on formal education for those in sterile processing,” Kelley says. That amount was significantly less than what was spent on education in other clinical departments, even though education is critical for understanding the “why” of sterile processing.

To correct this discrepancy, the team launched quarterly education seminars for SPD staff. Clinicians, hospital leaders, and vendors speak, and breakout sessions offer opportunities for hands-on learning and team building. Attendees earn continuing education credits toward certification.

In addition, SPD now has a dedicated educator. “Having someone who has the knowledge and expertise of what is necessary for a high reliability sterile processing department committed just to the department is critical,” Kelley says. If a separate educator isn’t possible because of budget constraints, she suggests partnering with the OR educator to design education programs.

SPD staff must have a high school diploma or have passed the general education development test to be hired; Memorial Hermann also requires certification through the International Association of Healthcare Central Service Materiel Management organization.

“Certified staff are more dedicated and committed to what they do,” Kelley says. Existing staff had 1 year to become certified, and new staff have 1 year after the date they are hired. The department pays for staff to attend the 6-week certification class offered by the SPD educator, and staff are reimbursed for the cost of the certification exam once they have taken it.

Those who do not pass receive additional education before taking the test again. Any employee who is unable to pass within the 1-year window receives help from management to be placed in another department, Kelley says.

Career development began with revamping job descriptions and developing competencies (sidebar, p 12). The SPD educators developed core competencies to eliminate the inconsistencies deKay had found with onboarding and annual competency testing. Now all new SPD staff complete the same orientation.

“We identified the core competencies that need to be checked every year,” Kelley says. Some are evaluated in quiz form; others require return demonstrations. She notes that AORN now has a sample competency list for SPD staff.

Competency development paid off during a recent Joint Commission survey. “The surveyors asked for sterile processing employees’ files at every one of our facilities to check annual competencies,” Kelley says, adding that files also need to be kept for contract employees.

Another component of employee development was reorganizing the leadership team to better use their skills. For example, a manager became a system educator, and responsibilities of the five regional directors were refined as needed.


A sample of the 85-element quality process audit tool.

A sample of the 85-element quality process audit tool.

Data management

Data is not useful unless it’s organized and reported in a standardized fashion.

“We needed to have reportable data that could be disseminated to SPD leadership teams and the C-suite,” Kelley says. “We partnered with our quality, risk, and data management teams to put together a dashboard of metrics.”

The first step in building the dashboard was to create operational definitions for the metrics to be collected, which include those related to quality and productivity.

The next step was to create a standard format for collecting that information. Kelley and deKay cite immediate use steam sterilization (IUSS) as an example of the process.

“We had 11 different ways of collecting IUSS rates and 11 different ways of reporting them,” Kelley says. “The math didn’t add up.” After deKay and Kelley consulted with the OR council, which is composed of OR directors from Memorial Hermann facilities and representatives from other departments such as supply chain, quality, and education, they decided to use the definition from AORN. “We were able to create an automated way to capture the information we wanted,” Kelley adds.

The dashboard can be accessed by OR, SPD, and executive leaders. “Data management and information sharing helps leaders and staff know they’re on the right path,” deKay says.

This audit tool focuses on the 27 steps related to decontamination. Note that items are divided according to location—in this example, “point of care” and “upon arrival.”

This audit tool focuses on the 27 steps related to decontamination. Note that items are divided according to location—in this example, “point of care” and “upon arrival.”

SPD quality team

Although Kelley and deKay drive the quality initiatives, they are developing an SPD quality team, which will collaborate, as its purpose states, “in tackling unique, facility-specific issues through standardization, solid infrastructures, metrics, robust improvement tools, and education.” The team is a work in progress, but the plan is to include OR and SPD leaders, infection preventionists, the SPD educator, and data managers, among others.

“We also want to include someone who is working directly on processing instruments,” deKay says, adding, “Having a team dedicated to continuing the quality process is crucial to continued success.”

This excerpt shows the level of detail the quality nurse focuses on during the inspection.

This excerpt shows the level of detail the quality nurse focuses on during the inspection.

Getting results

As a result of the efforts at Memorial Hermann, the last Joint Commission survey found no deficiencies in the SPD area, and system quality audit scores have improved significantly over the past 4 years.

Kelley and deKay offer suggestions for achieving high quality in the SPD area. “It’s important to build the SPD team to be an equal department to the OR,” Kelley says. “They need to be recognized as a critical component of the OR process and not be cast aside as the ugly duckling. SPD staff are not always recognized or appreciated for the work that they do.”

Ultimately, the patient is the beneficiary of these efforts. “Standardization makes processes highly reliable, so there’s less chance of error and better patient care,” deKay says. ✥


Cynthia Saver, MS, RN, is president of CLS Development, Inc, Columbia, Maryland, which provides editorial services to healthcare publications.


deKay K, Kelley S. SPD: Instrument quality in action. Presented at AORN Surgical Congress & Expo, 2016.

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