PURPOSE OF TEST
The GEM Hemochron 100 (GH100) analyzer for the Low Range Activated Clotting Time (ACT-LR) assay is a quantitative assay for monitoring anticoagulation with low to moderate unfractionated heparin (UFH) doses in fresh whole blood samples. The GEM Hemochron 100 ACT-LR test demonstrates linear correlation to the anticoagulation effects of UFH concentrations up to 2.5 units/mL. It is intended for monitoring UFH administered during extracorporeal life support and cardiology procedures. The test is for in vitro diagnostic use in point-of-care testing (POCT) settings for patients aged 18 years and above and is not intended for use with aprotinin therapy; see Limitations of Method section in Policy for more information.
POLICY
Activated Clotting Time by GEM Hemochron 100
SUPPLIES
GEM Hemochron 100 ACT-LR Testing Supplies – PENDING
MANUFACTURER’S INFORMATION
Test Cartridge (aka Cuvette) Package Insert
IDA Pages (Clinical Indications, Documentation Plan, Clinical Actions)
Cardiac Cath Lab HG7 / Interventional Radiology Bldg 5, HB4, HG5 / OR HG7
INITIAL ORIENTATION, TRAINING & COMPETENCY
Initial Orientation & Training – this form must be completed once with all new staff trained to use this test for any department.
- Initial Orientation & Training
- GH100 ACT Quick Reference Guide – refer to during training; also next to each GH100 in Cath Lab and IR3.(PENDING UPLOAD)
6 Methods of Competency and Written Competency Quiz – these 2 forms must be completed by all testing personnel 1) along with initial training form (above) and before technical duties are performed; 2) 6 months after initial training (California Law): and 3) annually thereafter.
Example timeline for a new hire:
* Initial training, competency/quiz due (3 forms): January 1st 2023
* Semiannual competency/quiz, due 6 months later (2 forms): July 1st 2023 (+/- 30 days)
* Annual competency/quiz due (2 forms): January 1st 2024 (+/- 30 days), and then annually thereafter
QUALITY CONTROL
TECHNICAL SUPPORT
For technical issues, contact Tech Support @ 1-800-678-0710
SAFETY DATA SHEETS (SDS)