As the former executive director of the Certification Board for Sterile Processing and Distribution, Inc. (1988-2014), I had the opportunity to learn a great deal about certification and its impact on the safety of patients.
Few can argue that there is a critical need for competent sterile processing personnel; they perform essential duties that can affect patient outcomes. It is also acknowledged that procedures performed correctly can help to prevent healthcare-associated infections and employee injuries. There has been and continues to be an explosion of technology dictated by the more sophisticated procedures being performed. The profession is seeing new equipment, surgical instruments, chemicals, and sterilants. There is also a focus from the media and surveying organizations on medical errors and noncompliance with recognized standards and guidelines. The Institute of Medicine has stated that the majority of medical errors occur due to a lack of proper training and education.
Therefore, we must address the issues of competency and proper training for processing personnel. This is a patient safety issue which no longer can be ignored. It all starts with education. Educational programs can provide basic knowledge—which is key to competent performance—to sterile processing personnel. However, successful completion of an educational program does not ensure competency. How does this tie into certification?
Certification programs analyze the knowledge and skills required for the profession. They provide consensus data on what sterile processors need to know and be able to do. Certification is defined as a process indicating that an individual (or institution) has met predetermined standards. Many professions provide certification to individual practitioners; this is referred to as professional certification. This certification is often, but not always, provided by some form of external review, education, or assessment. For sterile processing personnel, there are two organizations offering professional certification on several levels.
Certification begins with compliance with standards. There are standards published by the National Commission for Certifying Agencies (NCCA) which must be met by any organization wishing to obtain accreditation from the NCCA for its certification program. Development of certification exams carries with it the potential for liability for the credential body, which has the responsibility of validating the competence of the individual being tested. Compliance with the standards of the NCCA ensures a program that does it best to protect the public (usually the patient) and the certificant.
One of the requirements of the NCCA is the verification of the knowledge and skills required for competent performance. This is determined by a Job Analysis Survey (JAS). The validity of certification requirements and examination procedures are dependent upon the results of the JAS. The contents of the JAS are determined initially by a core group of subject matter experts (SMEs), which is then sent to a peer-review group for consideration. After all the comments have been received, the JAS is posted on a website and the professionals notified of the need for their input. The ratings of the participants determine the exam content by domain (topic, e.g., decontamination practices) and importance (ultimately guiding the number of questions that should be developed for that domain). The survey should reflect input from a variety of healthcare settings, geographic diversity, and job titles.
It is important to understand that the JAS is the foundation for a legally defensible certification program because the knowledge and skills identified are based upon the profession’s ratings, not a specific group of sterile processing professionals.
The NCCA recommends that the JAS be updated at least every five years (or sooner if needed) to reflect changes in technology. For this reason, many certification organizations offer a five-year certification credential.
Competency is an individual’s actual performance in a particular situation. The best way to determine competency is through a certification examination process because it is legally defensible (if the process is accredited). Certification programs usually determine minimum competency levels. However, in order for individuals to perform competently, they need experience, which are the skills gained through practice. Therefore, continuing education is a critical component of competency to ensure the certificant remains current in knowledge and practice skills.
If we rely solely on annual competency assessments, we are not assured of the competency of the individual. The areas of performance are individually determined by the department and may not reflect critical areas of performance. These assessments should concentrate on key areas of performance including high risk/high volume or high risk/low volume procedures.
Education and training of sterile processing staff is the first step. Certification is the second step. Continuing education and annual competency assessments is the third step.
Nancy Chobin, RN, CSPM, CFER, is CEO of Sterile Processing University, LLC. She is an active member of several AAMI standards committees that deal with sterilization. She is a co-chair of ST/WG 84, which has started a revision to AAMI ST91, Flexible and semi-rigid endoscope processing in health care facilities, and ST/WG 12, which deals with instructions for reusable device reprocessing and provides the U.S. perspective on technical matters under development in the corresponding ISO Technical Committee 198 working group.