3
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.
Summary of Contents for i-STAT 1
Page 1: ...i STAT 1 System Manual Rev Date 20 Jan 12 Art 714336 00L ...
Page 18: ...1 8 Art 714363 00U Rev Date 02 Aug 12 ...
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Page 176: ...10 10 Art 714372 00L Rev Date 30 Jul 12 ...
Page 182: ...11 6 Art 714373 00F Rev Date 17 Jan 11 ...
Page 184: ...12 2 Art 714374 00J Rev Date 25 Aug 11 ...
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Page 488: ...Kaolin ACT 4 Art 715878 00M Rev Date 31 Jan 12 ...
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Page 556: ...Art 714261 00E Rev Date 10 Jan 11 8 ...
Page 560: ...Art 716240 00D Rev Date 03 Mar 10 4 ...
Page 572: ...Art 715617 00D Rev Date 06 11 08 ...
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Page 590: ...Art 720735 00B Rev Date 06 11 08 ...
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Page 598: ...Art 722831 00A Rev Date 19 Feb 09 ...
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Page 614: ...Art 721317 00D Rev Date 13 Aug 12 4 ...
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Page 618: ...Art 721296 00A Rev Date 07 16 08 ...
Page 620: ...REV DATE 16 Oct 12 ART 714446 00L ...
Page 627: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 6 REV DATE 16 Oct 12 ART 714446 00L ...
Page 628: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 7 REV DATE 16 Oct 12 ART 714446 00L ...
Page 629: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 8 REV DATE 16 Oct 12 ART 714446 00L ...
Page 630: ...PROCEDURE MANUAL FOR THE i STAT SYSTEM 9 REV DATE 16 Oct 12 ART 714446 00L ...
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