Monthly Qa Checklist - Roche CoaguChek XS Procedures Manual

Mark Yes, No, or N/A (Not Applicable). If you answer "No" to any item, explain on the reverse.
Check CoaguChek XS Operator Certification Checklists:
Is a Checklist present for each CoaguChek XS system operator?
Check the Policies and Procedures Approval Form:
Have all CoaguChek XS operators read and signed this form on page ii?
Has the current anticoagulation management program director approved the
CoaguChek XS procedure?
Have any changes made to the Policies & Procedures Manual been are
approved, signed, and dated by the current anticoagulation management program
director?
If any revisions have been made, have all affected personnel been made aware
of them?
Observe one or two CoaguChek XS operators:
Do operators follow the manufacturer's instructions for test performance and
troubleshooting?
Were patients properly identified using two distinct identifiers?
Were test strips stored properly and within the "Use by" date?
If personnel competency problems were identified or observed, was corrective
action instituted to assist employees to improve performance?
Check CoaguChek XS Testing Log:
Were all patient tests logged completely and correctly (including second identifier,
QC acceptability, reagent lot numbers, etc.)?
Did any complaints or communication problems concerning testing or
reporting patient specimens occur this month?
If so, were they resolved by the program director and documented on this Monthly
QA Checklist?
Did any mix-ups occur this month with patient identification?
If an incorrect patient test result was reported, did the operator notify the person
who ordered the test of the correction and submit a corrected report? Are both
original and corrected reports being kept for 2 years?
Pull five patient charts and check the following:
Written test requests are available for PT/INR tests ordered.
Manually entered results were transferred accurately, located in the correct patient
chart, and in the proper area of the patient chart.
Caregiver saw test report and acted on it when necessary.
Attach any pertinent reports to this checklist (complaints, incidents, etc.). Also, explain any changes made
to laboratory policies and procedures as a result of this Quality Assessment program. Describe corrective
actions taken and how changes have improved quality of the testing process. Also, note how pertinent
staff members were involved in this quality assessment process (discussions or active participation).
Comments: __________________________________________________________________
____________________________________________________________________________
___________________________________________________________________________.
Program Director Approval: __________________________

MONTHLY QA CHECKLIST

9-8
Date: __________________