ROTEM

PURPOSE OF TEST

The ROTEM® delta is intended for qualitative and quantitative in vitro assessment of the functional coagulation status in adult patients. The ROTEM® delta records the clot firmness changes in a sample of citrated whole blood as the sample clots, retracts and lyses in real time. Coagulation evaluations with the ROTEM® delta are commonly used to assess clinical conditions in organ transplantation, cardiovascular surgery, cardiology procedures and trauma to assess peri-operative hemorrhage and / or thrombosis.

POLICY

ROTEM DELTA THROMBOELASTOMETRY

SUPPLIES

ROTEM Testing Supplies

MANUFACTURER'S INFORMATION

Operating Manual – Rotem delta software Version 2.1-US  Part 1 / Part 2   

Control Solution Package Insert

IDA Pages (Clinical Indications, Documentation Plan, Clinical Actions) [What is this?]

OR

INITIAL ORIENTATION, TRAINING & COMPETENCY

Initial Orientation & Training Super User – This must be completed (once) with all new staff trained to use this test.

Initial Orientation & Training Basic User – This must be completed (once) with all new staff trained to use this test.

ROTEM Training Tutorial

6 Methods of Competency – This must be completed by all testing personnel 1) twice in the first year; and 2) annually thereafter.

Written Competency Exam – This must be completed by all testing personnel 1) twice in the first year; and 2) annually thereafter.

QUALITY CONTROL & MAINTENANCE DOCUMENTATION

Quality Control Information

IQCP QCP ROTEM

Log Template

TECHNICAL SUPPORT

For technical issues, contact Tech Support @ 919.941.7777

MATERIAL SAFETY DATA SHEETS (MSDS)

MSDS 503-24 ROTROL N VER 002

MSDS 503-25 ROTROL P VER 002

MSDS 503-01 star-TEM VER 003

MSDS 503-02 in-TEM VER 003

MSDS 503-04 ap-TEM VER 003

MSDS 503-05 ex-TEM VER 003

MSDS 503-06 fib-TEM VER 003

MSDS 503-09 hep-TEM VER 003