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Art: 721317-00D Rev. Date: 13-Aug-12
OTHER QUALITY CENTERED ACTIVITIES FOR ALL i-STAT TESTS
While the following are not manufacturer’s quality system instructions and are not FDA required activities,
they are laboratory practices centered on quality and are suggested (not required) for all i‑STAT tests
whether they are categorized as moderate complexity or waived.
Number Activity Description
1 Review Interferences with Staff
Review “Factors that Affect Results” listed in the Cartridge and
Test Information sheets with clinical staff. Cartridge and Test
Information sheets are located on the Abbott Point of Care website
(www.abbottpointofcare.com/Customer‑Info‑Center/Cartridge‑and‑Test‑Info‑Sheets.aspx).
2 Train Staff on Backup System Measures
Ensure that users are trained on the backup provisions for testing should they be unable to
utilize the i‑STAT System in their area.
Backup provisions in many facilities include the use of a spare handheld reader, backup lot of
cartridges, sharing of the handheld reader, or use of a laboratory system.
There may be additional Clinical Laboratory Improvement Amendments (CLIA) or accrediting organization
requirements and individual state laws, codes, statutes or regulations which are not addressed in this
Technical Bulletin.
i-STAT is a registered trademark of the Abbott Group of Companies in various jurisdictions.
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