c . Processes to be auditing . Which processes / issues / opportunities do you want to address ? There are many opportunities in SPD however , I would advise to tackle one opportunity at a time especially if this is the first time implementing quality improvement programs . Choose the issue that your SPD is most frequently encountering . For example : i . Reduction of assembly errors by ____ % and increase accuracy by ____ %. ii . Reduce by ____ % non-conformities in the cleaning process .
2 . Make certain to have adequate resources . To ensure products and services produced by SPD conform to established standards , and quality , the department must have adequate resources . The quality of work an employee performs is directly impacted by the process , systems and equipment available to perform those tasks . For example , if the technician does not have the tools to inspect lumens , how can the technician ensure there is no bioburden left behind ? If there is insufficient inventory of trays and they are constantly recycling trays and the phone is constantly ringing , how can an error free tray be assembled ? Materials , equipment , information systems and workforce are necessary to have a smooth operation . a . Materials : Materials like scissors testing materials , replacement instruments , replacement rigid containers , labels , testing materials , nylon bristles pipe cleaners , and the manufacturer ’ s instructions for use ( IFU ) should always be available . Cleaning , assembling and sterilizing instruments without knowing the specific manufacturer recommendations is performing guess work presenting a major risk to the patient . b . Equipment : Advancements in surgery have brought to the OR specialized instrumentation . Many of these devices require specific equipment to clean it and without it there is no assurance that the instrument can be cleaned . Ensure to read all IFU ’ s and list the equipment and supplies needed to process the medical devices own by the hospital . Compare the list to the current equipment and assess if the specification required by the medical device manufacturers are being met . i . e ., temperature and time in the washer decontaminators , ultrasonic cleaner frequencies , the use of critical water , etc . c . Information systems : We need to adhere to proper documentation , and we are required to have more knowledge . One aspect of our job that does not seem to evolve is that in most hospitals , sterile processing departments still document manually . Consequently , there is no traceability , and many records are illegible . The need for instrument tracking systems is no longer a “ wish ” but a necessity . The SPD records are legal documents and as such must be maintained accurately according to the hospital record retention policy . Instrument traceability is not only a recommended practice but part of the accrediting standards of organizations such as DNV and the Joint Commission . d . Workforce : A successful CQI process requires resources and inspection time should incorporated when calculating staffing needs . CQI tasks can eliminate many issues SPD encounters , therefore , everyone must perform quality audits . Sufficient time must be allowed for the staff to complete all the required device manufacturer reprocessing steps .
3 . Determine the skills you need to implement a CQI process . A successful program needs the technicians to have the necessary competency to perform the audits . a . Technicians charged with performing the internal audits need to receive comprehensive training to ensure they measure and collect the necessary data . Develop a training curriculum for quality audits and include the specifics staff needs to learn for the inspection process . b . At minimum staff need to understand : i . Who will perform audits : everyone , a QA tech , the supervisor ? Clear responsibilities hold people accountable . ii . What will be audited : every tray , every instrument , every package or random checks . What are they looking for when inspecting ? iii . Where will the audits be performed : handwash , washer , assembly , sterilization or sterile stores iv . When will the audits be performed : every shift , every day , or random days ? v . Why – sometimes all it takes for people to adhere to new processes is to know why we are making the changes . vi . How the data will be collected : manually , or via scanning the outcomes . Define the inspection tools to be used during the audits and how to use them .
4 . Implement and measure the success of your CQI system . Perform consistent internal audits . The only way to reduce errors and produce a top-quality product is to consistently audit the processes and provide correction to non-conformities before they reach the customer . a . Decontamination : Audit bioburden residue on instruments and flexible scopes , detergent efficacy , the automatic detergent injectors , condition of instruments coming from the customer , etc . b . Assembled packages : Before they are wrapped : accuracy , cleanliness , sharps protection , functionality . Also audit peel pouches and rigid container bottoms and lids . c . Sterilizer loads - before and after they come out of the sterilizer . Check for control labels , tamper proof locks , tape , tears and labels . d . Documentation : Audit if all the packages and peel pouches on the sterilization load were recorded ? These should have the department and content on the label . Other audits can be : if the correct cycles were chosen for the items sterilized , lot control labels and verification of the sterilizer print out . These are legal documents therefore everything must be legible if the department does not have an instrument tracking system . Ensure that loaner instrument trays description is recorded according to the name of the tray . Documenting i . e ., “ Stryker loaner ’ will present major setbacks if you must recall records and proof that the trays were processed correctly . e . Sterile storage : Are the shelves cleaned ? Are all labels in place ? Was the integrity of the packages compromised ? Has the package been on the shelf for an extended period ?
5 . Strive for perfection and continual improvement . This process will require a change in culture and constant emphasis on the new concepts .
www . healthcarehygienemagazine . com • may 2021
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