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programs and obtain payment for the treat- ment. To qualify, healthcare facilities must pass an initial assessment and then maintain passing results from subsequent inspections and surveys. Sterile processing and endo- scope reprocessing activities continue to be a focus of surveyors, with findings that may include expiration dating issues.
“Expired product” his finding usually involves remote areas that maintain expiration-dated supplies. A few examples: The decontamination area where cleaning solutions are stored beneath sinks, sterile storage areas where bins are used to store peel packs, and product-in-hand sanitization dispensers that are not frequently used.
“Expired indicator strips within sterilized pouches”
In these findings, the expiration date printed on the chemical indicator strip within a sterilized pouch is beyond the indicator’s expiration date. The surveyor states that the sterilization pouch should be reprocessed. In this case, it’s possible the surveyor may not be knowledgeable about what the chemical indicator’s expi- ration date signifies (the date by which the indicator must be put through a steriliza- tion process). An indicator strip sterilized on the last day of its expiration date will show an expired expiration date within the sterilized pouch the next day but will still be within its endpoint stability shelf life as specified by the chemical indica- tor’s instructions for use. In essence, the chemical reaction or physical change that occurs creates the opportunity for a new expiration date. hen presented with this finding, it is important to share the facility’s policies and procedures that address the recon- ciliation of expiration dates and endpoint stability. Be prepared for the follow-up question, “How do you ensure that the indicator strip is read within the endpoint stability time frame?”
“No open-bottle expiration dating” his finding is usually noted when survey- ors are evaluating high level disinfection practices, but it can be found wherever chemistries (including cleaning chemis- tries) are used. It often occurs in depart- ments where the entire contents of a bottle will be used within a single shift, so team members do not see the need to document an open bottle expiration date on this con- tainer. o avoid this finding, its important to train staff to label all open bottles every time and to audit staff practices to ensure that instructions for use are followed.
Solutions decanted into basins or sinks also fall within this finding category. Basins should be labeled with the appro- priate epiration date as defined in the solution’s instructions for use. Be aware that some solutions may have different expiration dating rules between decanted solution and solution that is stored in the opened original bottle.
Preparing for the surveyor While the SPD and team should always be in a state of survey readiness, day-to-day issues can grab people’s attention and allow important processes to be missed. Managing expiration-dated items is one of those tasks that can be overlooked. Here are a few tips to help manage expi- ration dating so that the department will be survey-ready: • Establish a regularly scheduled department walk-through. Inspect all areas that have expiration-dated items to ensure that all are within their pre-expiration periods and that proper inventory rotation is occurring. Remember that time-limited items are not all labeled with a typical expiration date. Examine work areas to look for product labeling, work bin locations, open bottles, basins and any other items that expire. Check inven- tory rotation in department storage, sterile storage and remote storage areas. onfirm that is followed.
• Audit policies, procedures, and work instructions to assure the inclusion of expiration dating in all its forms. onfirm that staff demonstrates understanding of and competence with expiration dating policies, procedures and work instructions, which are often included in the training and competency test- ing for product use and department processes. Remember to include any operating room staff with responsibil- ity for evaluating items supplied by sterile processing in your training and competency evaluation.
• ae ustications written and approed per facility policies for all expiration dates set within the department. This can include event-related packaging, hang time, and reconciliation of multi-expi- ration dated items within a single pack. Risk assessments may be necessary to establish facility policy regarding expi- ration dating. They should be available or included with each justification.
Understanding and competency will optimize expiration dating
Sterile processing technicians must manage and adhere to expiration dates
40 September 2022 • HEALTHCARE PURCHASING NEWS •
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on time-limited items used for medical device reprocessing and preparation. These dates are in place to assure fully effective decontamination and steriliza- tion products and processes. Some are set by the manufacturer, and some are determined within the department. By developing complete and effective written policies, procedures and work instruc- tions for expiration dating, a department can simplify the nuances and complex- ity of this function. And by providing regular training and competency test- ing, managers can maintain proper protocols and avoid expiration dating findings during surveys. n the end, it all comes back to supporting optimal patient outcomes, which is the goal of everyone in healthcare.
Michele McKinley, LVN, CRCST, CIS, CHL, AGTS, ASQ CMQ/OE, ASQ CQA is a senior clinical educa- tion specialist for STERIS Corporation. She has been in the healthcare eld for years, as an operating room
technician, materials management coordinator for the operating room, materials manager, and site manager for outsourced sterile process- ing. Michele has also worked as a consultant in the areas of sterile processing, operating room and endoscopy cleaning, and sterilization processes. he holds licenses and certications as an LVN, CRCST, CIS, CHL, AGTS, ASQ CMQ/OE, ASQ CQA, and is a member of HSPA, AORN, SGNA, APIC and ASQ.
Tammy Gentry, CCSVP, is the global prod- uct manager of sterility assurance products at STERIS Corporation. She has been in medical device product management for many years, beginning with a career in field sales for Baxter Healthcare, and then managing medical devices for companies like B. Braun,
McGaw, Allergan and Invacare before joining STERIS. She currently manages sterilization consumables such as chemical indicators, cleaning indicators and sterilization packag- ing. Tammy holds a BA from Miami University in Speech Communications and Public Relations and a CCSVP from HSPA.
References:
1. ASGE Quality Assurance in Endoscopy Committee. (2022, June 01) GI endoscope reprocessing: a comparative review of organizational guidelines and guide for endoscopy units and regulatory agencies. GIE Gastrointestinal Endoscopy. 95(6), 1048-1059 DOI:
https://doi.org/10.1016/j.gie.2021.09.024
2. Bunn, D. and Smith, C. (2017, December 1) Expiration Dating. Communique. Lesson No. CRCST 157, pgs. 41-43
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