Author: C. Jason Rawlings(CRCST) | Director of Clinical Services
Certifications are nothing new in the world of healthcare, but up until last November, there was no such thing as an institutional certification for sterile processing in the United States. That month, DNV GL Healthcare launched its Sterile Processing Program Certification (SPPC), a first-of-its-kind certification that ensures healthcare facilities are prioritizing consistent quality sterile processing work.
DNV GL granted the first certification to College Medical Center (Long Beach, California), after identifying seven noncompliances in its initial site survey in December 2018. College Medical Center addressed the noncompliances in time for the follow-up survey and received certification this past February. Should your facility follow suit?
Here’s what you should know before you pursue certification.
DNV GL’s Sterile Processing Program Certification: What It Is and Why It Matters
SPPC is all about quality assurance. Does your department deliver the work that’s promised? Does it comply with federal and state regulations, while following the manufacturer’s instructions and overall best practices? Is the work consistent, or does it vary based on who’s working?
DNV GL’s certification assures executives and patients that your SPD is not only doing the work the way it should be done but is also actively seeking to improve the quality of the work. To be eligible for the certification, a facility must be accredited (by DNV GL or another accrediting organization), leadership within the SPD must have some sterile processing training, and the facility must conduct a gap analysis of where their SPD currently stands and what its deficiencies are in terms of the certification standards.
The certification requires facilities to create an interdisciplinary team to review SPD data every quarter and develop process improvements so that the department is always advancing its function within the larger organization. A successful certification demonstrates that your SPD—both in terms of facilities and actual services—meets or exceeds standards of care and that it’s on track to continue improving.
With sterile processing failures making headlines and emptying hospitals’ wallets through lawsuits, this certification provides an extra dose of confidence that your facility is ahead of the game when it comes to sterile processing.
Additionally, the interdisciplinary nature of both the certification survey and facility requirements for certification enables a broader understanding of the SPD: The way the SPD interacts with other departments will be evaluated from a process standpoint, so opportunities for improvement may be identified outside the narrow box of the actual SPD. Involving members of multiple departments on the interdisciplinary team breaks down organizational silos, while promoting the importance of sterile processing to those who may not see the SPD’s inner workings daily.
How the Sterile Processing Program Certification Works
Once your organization applies for certification, you’ll schedule a site survey with DNV GL. You’ll know beforehand when the site survey will happen, which means you’ll have time to evaluate your facility and make process adjustments prior to the visit. DNV GL intentionally makes its standards available for free online so that organizations can conduct self-evaluations—even before applying for certification.
Generally, the survey takes place over a single day, although larger facilities may require multiple days. The survey agenda is shared before the visit so that individuals who need to be present and available can plan. The survey ends with a verbal report to the facility. This verbal report points out any nonconformities that were identified during the survey.
DNV GL has three levels of nonconformity:
NC2: A low-level issue, generally when processes are in place but failing in different areas
NC1: A major nonconformity where there’s either a lack of processes or processes aren’t being consistently followed
NC1 Condition Level: A higher-level issue that may involve risk to patients or staff. These nonconformities require a resurvey within 60 calendar days of the initial survey. The issues must be resolved or reduced to lower level nonconformities in order for the organization to be certified. Otherwise, an additional survey will be scheduled another 60 days later.
Once a facility has been certified, site surveys are conducted on an annual basis to guard against drifting organizational standards. The second year focuses more on observing quality management processes in action, while the third year combines the first-year evaluation of quality management objectives and systems with second-year observation of internal quality management compliance.
In an interview on the Beyond Clean podcast, DNV GL Healthcare’s lead certification surveyor Jeremy Gibson-Roark advised SPD managers to run through the certification standards and make improvements before pursuing certification. He also encouraged them to see nonconformities as opportunities for improvements, rather than failures of compliance.
The point of having third parties come in for certification surveys is to point out the gaps that go unnoticed by the professionals who see them every day. Ultimately, certifying bodies like DNV GL, their surveyors, and the healthcare organizations are all on the same team and have the same goal: to keep patients as safe as possible while providing the best quality care.
ANSI/AAMI ST79:2017. Association for the Advancement of Medical Instrumentation (AAMI)
Performance Management & Quality Improvement. CDC. https://www.cdc.gov/publichealthgateway/performance/index.html
Performance Management: Turning Point. Public Health Foundation. http://www.phf.org/programs/turningpoint/Pages/Turning_Point_Performance_Management_Refresh.aspx
Process. A Publication of the International Association of Healthcare Central Service Material Management. May/June 2020. www.iahcsmm,org
Quality Audit – A Tool for Continuous Improvement and Compliance. https://www.mastercontrol.com/gxp-lifeline/quality_audit_tool_compliance_0810/
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