Point of Care Testing - Clinitek Status Data Definition Tool

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Point of Care Testing - Clinitek Status
Data Definition Tool
This audit is to be completed by the manager or designee on a monthly basis. POCT audits are due by the last day of the month. following the review.
Instructions: Indicate Yes, No, NA (Not Applicable) for each question below.
Updated 11-10-14
Submit 1 POCT audit per month using the Point of Care Testing - Clinitek Status audit tool.
QUESTION
STANDARD
Has all testing performed in this patient care area been approved by the
Diagnostic Laboratories?
NOTE: All POCT Testing must be approved prior to implementation. If
WT.01.01.01, EP 4
WT.02.01.01, EP 1 & 2
1 unsure of area approval, contact Point of Care personnel.
Is there a designated trained trainer with documented current
2 competency?
Has the patient care area notified the Laboratory (POC) of changes in
3 the list of testing personnel?
WT.03.01.01, EP 2, 3, 4, & 6
YES
Yes means you are NOT doing any
lab tests that you have not been
approved for. Approval comes
from the POCT committee.
Manager/Educators Person trained by POCT in the
office training records last year to train other staff.
Emails
WT.02.01.01, EP 1
Are current documentation records for training and competency
4 records readily accessible?
Can staff produce a copy of the current procedure (hard copy or
5 online)?
Has the manager performed a documented review of patient chart
documentation to verify that patient results are properly documented
6 per procedure? (Review of Manager log)
WT.02.01.01, EP's 1 & 2
WT.03.01.01, EP 3
7 Are all reagents, controls, and kits stored at proper temperature?
WT.01.01.01, EP 2 & 6
Are all reagents, controls, and kit boxes labeled with an appropriate
8 expiration date and initials?
WT.01.01.01, EP 2
Have QC documentation logs been completed as required by
9 procedure?
10 Have corrective actions been documented?
11 Are all QC records kept for a minimum of 2 years?
LOCATION
POCT testing book
WT.01.01.01, EP 5
Have sent POCT updates when
someone leaves work area or
new staff comes to work area.
Manager/Educators Orientation records must be kept
office training records permanently, annual
recertifications must be kept for
2 years.
Computer/POCT
Can find procedure
manual
POCT testing book
Manager has done quarterly
chart audits.
WT.05.01.01, EP 4
Where supplies are
kept
Where supplies are
kept
Controls are refrigerated until
needed. Strips at RT
Strips are labeled with open date,
controls with 31 day altered
expiration date and initials
QC Log Book
Package insert matches control
lot in use, and QC is done daily
when patients are tested.
Problem log
QC Log Book
If had problem it is noted
Yes, if you have your records
WT.04.01.01, EP 1 & 2
WT.05.01.01, EP 1
WT.01.01.01, EP 2
WT.05.01.01, EP 5
Has the manager or designee performed a weekly review and sign off of
12 quality control and other test specific required documentation?
Is all original documentation of patient results retained for a minimum
13 of 2 years?
14 Are maintenance records available and complete?
WT.01.01.01, EP 2
WT.04.01.01, EP 1 & 2
WT.05.01.01, EP 1
WT.05.01.01, EP 5
WT.05.01.01 EP 4 & 5
QC Log Book
There is a signature to indicate
reviewed weekely.
Instrument
printouts/Log book
On QC Log
Are they accessible for last 2
years
Records are complete
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