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GS1 Standards and the FDA Ruling: Are You Asking the
Right Questions?
By Jean Sargent, CMRP, FAHRMM
Ever since the 1970s, we have been using the GS1 standards each time we go to the grocery store. The clerk (or you) scans the barcode on the packages, you pay and you’re on your way. Healthcare has been talking about getting to this point for many years. That time has now come.
The FDA will be releasing a guidance document this summer that will require that packages, including pharmaceuticals and supplies, equipment and instruments, be scanned and assigned to the patient. This guidance will provide a timeframe—six to eight months is assumed—for the industry to add final comments. The FDA will then turn this guidance into a requirement.
So how and where do you begin to understand how this will affect you and your facility? First, you must begin by asking questions of various departments, beginning with your own.
Here are some key questions to ask:
- What systems do you utilize in your department?
- Do you have an instrument tracking system?
- Do you use the OR system for case cart activities?
- Do you use the materials system to order supplies?
- What items do you/your team handle on a daily basis that will require scanning when the ruling is finalized?
- How will your department’s daily functions change?
- If you are a staff member, is your supervisor/manager aware of the impending ruling? If not, share this information.
Go beyond the CSSD
After you have gained a better understanding of how GS1 will impact your own department, don’t stop there. Ask the director of materials/supply chain management what they know/understand about the GS1 standards and the impending FDA ruling, and what is being done in your facility to prepare. This program will likely be driven by this department.
Next, speak with the director of pharmacy and ask the same questions. You may find that pharmacy is aware of the changes and is working on becoming prepared. Pharmacy is different than other supplies because many pharmaceuticals will be purchased in bulk and will need to be packaged individually by a third party. The FDA has released the final guidance document in regard to the Secure Drug Supply Chain. (The website is listed below)
What is happening in the operating room? Many of the OR systems have been updated to capture the scanning of the information. Your facility may have recently completed an upgrade or may be looking to do so in the future, so your facility may be compliant with the FDA ruling.
Information technology is essential to the implementation of the FDA ruling/GS1 standards. There will be a need to update systems and develop or update interfaces between systems, and this will have an impact on medical records. Many facilities are in the process of designing or implementing an electronic medical record. It’s important to remember that the FDA and Medicare will require that all products be scanned to the patient’s medical record and this information must be included on the bill. Medicare has stated that without this detail they will not reimburse.
The facility’s chief executive officer, chief financial officer, chief nursing officer, chief operating officer, and chief information officer will all need to be made aware of this change and provide support in order to be compliant.
This is an important next step for healthcare efficiency and, more importantly, patient safety. I encourage you to ask these questions and ensure your facility is aware and working toward compliance. As you speak with other departments and knowledge is missing, assist by passing along this information and directing them to the following websites for more information.
FDA: www.fda.gov/cdrh/ocd/udi/
Guidance for Industry, Standards for Securing the Drug Supply Chain - Standardized Numerical Identification for Prescription Drug Packages FINAL GUIDANCE www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/default.htm
GS1 US Healthcare: www.GS1US.org/healthcare
This is a very exciting time and I am thrilled to be an early adopter. I hope you will be, too!
Jean Sargent, CMRP, FAHRMM, serves as supply chain director for USC Health Sciences. She is also a member of the GS1 Healthcare US Leadership Team and past president of AHRMM.
