- The ANSI National Accreditation Board has approved ISO accreditation for three testing methods by Axia Labs at Michigan State University for pharmaceutical RFID labelling and tracking.
- The lab is also launching Phase Two of a study of tracking RFID-tagged, palletized medications to a distributor and on to the dispenser.
Axia Lab, part of Michigan State University’s Axia Institute, has been granted ISO/IEC 17025:2017 accreditation by the ANSI National Accreditation Board (ANAB) for demonstrating technical competence in the field of testing.
The accreditation will help support the lab going forward as it tests RFID technology systems for healthcare and pharmaceutical management. The lab has been certified for three of its testing methods: threshold sweep, orientation sweep, and GS1’s Tagged-Item Performance Protocol (or TIPP) guidelines, said John Hatfield, executive director at the Axia Institute.
Axia Lab launched in 2021 to provide impartial testing and validation as well as research for passive UHF RFID technology. All tests are conducted at the Axia Lab itself—located at the MSU St. Andrews facility in Midland, MI.
Seal of Approval for Testing Methods
ANAB is a global multi-disciplinary accreditation body that provides certification for laboratories, inspection organizations and forensic service providers, among others. Its approval indicates the neutrality and technical competency of an agency or company’s system.
For Axia Lab, the approval for its recently established processes indicate they offer fair and neutral testing. “We were excited to get this accreditation—it basically puts a seal on the fact that we’re providing impartial testing,” Hatfield said.
“It means that we’re following certain processes and procedures, that our equipment has been accurately calibrated to support the testing, and [the resulting] competence, impartiality and validity of the results coming out of our lab.”
Orientation and Threshold Sweeps
Two of the testing methods that earned the certification were orientation and threshold testing.
An orientation sweep measures different performance parameters related to the optimal placement for an RFID tag on an item such as a medication. This is based on the reader antenna being rotated 360 degrees.
The threshold sweep measures different performance parameters on the reader side, tracking the sensitivity, backscatter and theoretical read range.
GS1 Requirements Certification
The third test method to earn accreditation is the GS1 tagged item performance protocol (TIPP) method to ensure tags perform according to the GS1 standard group’s requirements.
GS1’s TIPP is a communication tool for trading partners to establish trust and to build a coherent and stable RFID application across numerous RAIN UHF RFID products. The TIPP protocol ensures consistent and reliable performance in a variety of environments as well.
Additionally, Hatfield said, in June GS1 has accepted new pharmaceutical grades for the TIPP protocol, based on recommendations from RAIN Alliance and GS1 working groups. Axia Lab’s Bahar Aliakbarian and Ethan Claucherty served on both working groups focused on evaluation norms and kit protocol for TIPP-based systems.
Entering Phase Two of Pharma Supply Chain
In the meantime, the Axia Lab is proceeding into the next phase of an end-to-end RFID pilot for drug tracking.
Phase One in 2023 involved simulated tracking of tagged drugs in the lab setting, to determine how well RFID tag data could help meet the pending Drug Supply Chain Security Act (DSCSA) requirements for traceability of item level drugs.
Once the first phase was complete, “the feedback that we had immediately after that was, ‘now you need to go into the field and start doing your testing at greater velocity and at greater scale’,” said Hatfield.
Beginning this fall, the lab is doing just that. With Phase Two the lab has already begun tagging drugs that will be transported out of the site on four pallets, destined for intermediary distributor Cencora (formerly Amerisource Bergen).
Distributor to Receive Tagged Goods
Once received, Cencora will test how well the products can be identified as they arrive onsite. When they ship out of their site, the tags may be read again.
In a typical supply chain, the drugs then go to the dispenser that dispenses those medications to patients. In the case of this project, Axia Lab will serve as the dispenser, receiving the goods back from the distributor. That process ensures that drugs, which may be nearing expiration, never make their way to real patients.
Within the next four to six weeks, Axia Lab intends to have completed Phase Two testing and evaluated the results.
Solidifying its Position in Pharmaceutical RFID Testing
In the meantime, the ANAB accreditation for the Axia Lab provides a vote of confidence. “In terms of the companies we work with, I think it further solidifies our positioning in this industry,” Hatfield said.
Over the past years since the lab opened, he added, the lab researchers have gained deep knowledge in the healthcare and RFID industries “and we think that our services have the ability to support a number of different partners in the industry going forward.”
For instance, RFID tags or label manufacturers, as well as pharmacies using those manufacturers’ products, could come to the lab to not only testing the performance of an RFID product but receive a grade on its performance depending on the use case and environment throughout a supply chain.
They could then gain independent verification that tags work properly, with ANAB certification.
Working with Pharmaceutical Companies and Partners
Research continues for Axia with partners such as IoT and RFID solution provider CCL eAgile, medication management companies ARC Healthcare Technologies, Intelliguard, and HealthCare Logistics, inventory management system provider Terso Solutions, and Zebra.
They are working on research related to RFID-enabled pharmaceutical cabinets as well, in which RFID tagged products may be stored at a hospital pharmacy or other dispensary.
For an industry still seeking greater visibility in its supply chain, pharmaceutical adoption of RFID on drugs has been steady. “We’d like to see it happen quicker but it is certainly happening and there are a number of different entities in the healthcare industry trying to help the industry get there faster,” Hatfield said.
Role For RFID in DSCSA
Some of the Axia Lab’s testing may validate the fact that RFID tags applied to drugs provide an effective way to track the authenticity and safety of a product in accordance with the DSCSA. Although DSCSA requires individual identities for each product currently, it only requires 2D barcodes to accomplish that.
“Basically we can show that RFID is a viable technology that can help enhance the traceability you’re already doing” by adding the RFID tag to a 2D bar code, said Hatfield. And because RFID tags can be read in volume, without requiring a line of sight (as barcodes do) it can provide additional benefits such as reduction in labor.
Additionally, the lab is researching the concept of electronic pharmaceutical labeling as an alternative to prescription information leaflets which are currently required by the FDA. Axia’s team is collaborating with its partners including drug manufacturers including Lilly, Fresenius Kabi US, and Johnson & Johnson along with Avery Dennison Smartrac, Baptist Health, CCL eAgile, Cencora, em Microelectronic, GS1 US, Identiv, and NXP to explore the digital delivery of drug information to patients. A pilot of such a system is in development, Hatfield said.