SMILE

Johns Hopkins University

Baltimore, MD USA

RxL Dimension Calibration/Verification Policy

Policy The laboratory has processes and procedures to effectively ensure

that…
Purpose This policy provides direction for the processes and procedures to
effectively ensure that…

Responsibility The department supervisor/Manager is responsible for

implementation and training of Technical staff using this procedure.
It is the responsibility of each trained staff member to carry out the
process as described in this SOP.
Additional Include as many other policy topics related to the subject. Refer to
Information as CLSI for guidance.
required
Supporting The following processes support this policy:
Documents  List all processes included for this subject.
RxL Dimension Calibration/Verification Policy Number Equ211-02-P
Effective Date 12-Jul-11
Policy

Approval Signature: Laboratory Director Review Cycle 1 year

Supersedes New
Review by Heidi Hanes Review date 12-Feb-20

RxL Dimension Calibration/Verification SOP

RxL Dimension Calibration/Verification SOP

 SMILE
Johns Hopkins University
Baltimore, MD USA

Omar Dualeh Document Effective

Author(s), Name & Number Date
Title Equ211-02-SOP 12-Jul-11
SMILE Comments: This document is provided as an example only. It must be revised to accurately reflect your
lab’s specific processes and/or specific protocol requirements. Users are encouraged to ensure compliance with local
laws and study protocol policies when considering the application of this document. If you have any questions
contact SMILE.

Name, Title Signature Date

Approved
By

Name, Title Signature Date

SOP
Annual
Review

Version # [0.0] Revision Date Description (notes)

[dd/mm/yy]
Revision
History

Name (or location) # of copies Name (or location) # of copies

Distributed
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Associated Forms:

RxL Dimension Calibration/Verification SOP

 SMILE
Johns Hopkins University
Baltimore, MD USA

I acknowledge that I have read, understand and agree to follow this SOP.
Name (print) Signature Date

RxL Dimension Calibration/Verification SOP

 SMILE
Johns Hopkins University
Baltimore, MD USA

PURPOSE

This standard operating procedure (SOP) covers the Calibration/Verification for the RxL
Max Dimension system.

SCOPE

This procedure applies to the Calibration/Verification on the RxL Dimension. It is vital to perform
proper calibration on the analyzer as per manufacturer instructions so as to ensure accurate results
are been obtained. You should calibrate also if any of the following occur.

 Manufacturer-recommended calibration interval is due.

 Before a major critical measuring project.
 After a major critical measuring project.
 After an event.
 Per requirements.
 Monthly, quarterly, or semiannually.

Calibration frequency:
Most methods required to be calibrated within 90 day for a complete calibration frequency for all
methods please refer to Appendix A

1.0 CALIBRATION PROCEDURE

1.1 Calibration/Verification set up
Step Action
1. From Operating Menu
 press F5:Process Control
 press F1: Calibration
 Enter Password
 press F2: SETUP and RUN
2. Select the test method to be calibrated - if lot number is incorrect
 Press F1: Other LOT
 Press F1: Other Lot
3. Enter all appropriate calibration information from package insert on screen
a. Calibrator lot #
b. Reagent lot #
c. Bottle values/ Assign values

RxL Dimension Calibration/Verification SOP

 SMILE
Johns Hopkins University
Baltimore, MD USA

4. Press F8: QC yes/no to change to yes

5. Press F4: Assign cups
 If additional methods need to be calibrated, select the method.
6. Press F7: Load/run
7. Load cups into assigned position
8. Press F4: RUN

1.2 Calibration of the Urine Drugs of Abuse Methods in the Qualitative Mode
Step Action
1. From Operating Menu
2. Press F1: Enter data and enter
 patient name: calibrator name
 mode: sample cup
 priority: QC
 sample no: lot #
 fluid: 3rd QC (serum QC3)
 tests: request DAU method in triplicate
3. Place sample cup with the calibrator in the indicated sample wheel position
4. Press F2: Process single
5. Process negative and positive controls

IF……… THEN……
Tolerance Limits If result fall within assay – Proceed with
specific specification. analysis
And QC values are within
acceptable limits
If result falls out-side assay Troubleshoot the
specific specification, and assay and/or
QC values are out of instrument and
Acceptable limits. repeat calibration

1.3 Documentation
After calibration all calibration and QC run should be attached to calibration log
Sheet and must be documented on calibration log book.

RxL Dimension Calibration/Verification SOP

 SMILE
Johns Hopkins University
Baltimore, MD USA

2.0 CALIBRATION TROUBLESHOOTING

This section contains information on troubleshooting a calibration that has unacceptable:
If Then
Precision is  Review calibrator preparation, storage conditions,
unacceptable and expiration date on the package insert sheet of the
calibrator product. For lyophilized products, the
preparation steps must be followed precisely.
 Review the instrument maintenance logs and the
System counters screen for any maintenance that
may be overdue. Check the system count for the
sample probe tip, especially if the problem is on a
method with a low sample volume.
 Check that all temperatures are within range on the
Daily Maintenance screen. Check the temperatures
with a calibrated thermometer according to the
"Calibrating Cuvette System Temperature,"
"Calibrating Reagent System Temperature," and
"Calibrating HM Module Temperature" procedures
in your operator's guide.
 If any data point are missing due to a process error:
o For logit methods, you must reject the
calibration
o For linear methods, up to three data points
can be missing as long as there is at least
one data point for each level. If the
calibration meets the criteria, it can be
accepted.
Calibration Statistics  Ensure that you are using the insert sheet for the
unacceptable correct calibrator lot that you are calibrating.
 Review calibrator preparation, storage conditions,
and expiration date on the package insert sheet of
the calibrator product. For lyophilized products, the
preparation steps must be followed precisely.
 Check that the sample cups were loaded into the
segment in the proper order. If they were not, you
must press F8: Reject Data and rerun the
calibration.
 Review the instrument maintenance logs and the
system Counters screen for any maintenance that
may be overdue. Check the cycle count for the
sample probe tip, especially if the problems on a

RxL Dimension Calibration/Verification SOP

 SMILE
Johns Hopkins University
Baltimore, MD USA

method with a low sample volume.

 Check that all temperatures are within range of the
Daily Maintenance screen. Check the temperatures
with a calibrated thermometer according to the
"Calibrating Cuvette System Temperature,"
"Calibrating Reagent System Temperature," and
"Calibrating HM Module Temperature" procedure
in your operator's guide.
 Compare the C4 term on the Calibration Review
Data screen to the C4 value on the method insert
sheet. If it is not the same, call the Technical
Assistance Center. Only logit methods have a C4
term.
Quality Control ● Refer to your local quality control procedure
unacceptable manual.

3.0 REFERENCE

RxL Max Dimension operating manual

4.0 Appendix

Appendix A – Fast Facts Sheet

RxL Dimension Calibration/Verification SOP