SMILE

Johns Hopkins University

Baltimore, MD USA

Timer Calibration Verification - Guidelines

Guideline Equ15-01-G

Timer Calibration Verification Number V.3.0

Effective Date 25 Sept 08

Subject Page 1 of 1
Timer Calibration Verification Supersedes
Equ15-01-G
V.2.0

Review by Heidi Hanes Review date 9-Feb-12

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 directed to countercheck facts when considering their use in other applications.
If you have any questions contact SMILE.
Audit: Equipment Section

CAP Accreditation Checklist:

1. Limited service laboratory checklist manual, Instrument and
Equipment
2. Hematology –Coagulation checklist Manual, Instrument and
Equipment
3. Chemistry and Toxicology checklist manual, Methods and
Instrument systems

Background Information:
1. Timer calibration is to be verified twice per year, after maintenance,
malfunction or in accordance with manufacturer’s recommendations,
whichever is most frequent. New timers must be verified before
being used with a certified traceable stopwatch such as a National
Institute of Standards and Technology (NIST) traceable stopwatch.
Uncertified timing devices must be verified at the time of testing
against a NIST traceable source.
Resources:
1. College of American Pathologists (CAP) 2006. Commission on
Laboratory Accreditation, Laboratory Accreditation Program; Limited
Service Laboratory Checklist manual (Revised 10/31/2006).
2. College of American Pathologists (CAP) 2006. Commission on
Laboratory Accreditation, Laboratory Accreditation Program;
Hematology-Coagulation Checklist Manual (Revised10/31/2006).
3. College of American Pathologists (CAP) 2006. Commission on
Laboratory Accreditation, Laboratory Accreditation Program;
Chemistry and Toxicology checklist manual (Revised 10/31/2006).

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Policy Number Equ15-01-P V.3.0

Timer Calibration Verification Policy
Effective Date 25 Sept. 08
Approval Signature: Laboratory Director Last Review 27 July 2010
Supersedes Equ15-01-P V.2.0

Timer Calibration Verification - Policy

Policy The laboratory has processes and procedures to effectively ensure

that timers are maintained and calibrated to ensure that their
accuracy and precision is preserved.

Purpose This policy provides direction for the processes and procedures to
effectively ensure that the maintenance and calibration of timers is
carried out as required to ensure the accuracy and precision of the
instruments.

Responsibility The Laboratory Medical Director is responsible for (to be determined

by Laboratory)
The Laboratory Manager is responsible for (to be determined by the
Laboratory)
The Lead Technologists are responsible for (to be determined by the
Laboratory)

Additional N/A
Information as
required

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Supporting N/A
Documents

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Timer Calibration Verification - Process

Timer Calibration Verification Policy Number Equ15-01-Pro V3.0

Process
Effective Date 25 Sept. 08
Approval Signature: Laboratory Last Review 26-Oct-2011
Director
Supersedes N/A Equ15-01-Pro V2.0

Process for Timer Calibration Verification

What Happens Who’s Responsible Instructions

Maintenance and
Calibration policy for
Timers is determined
Timer Maintenance and
Calibration is performed
 To be determined by Technical SOPs that
Laboratory require the use of a
timer
 QA Technologist Timer Maintenance
and Calibration SOP
 Technicians/Technologists

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Kurt Michael M.ED., MT (ASCP) Document Effective

Number Date
Author(s), Name & Josephine Shim MBA, MT
Title (ASCP)
Equ15-01- SOP 25 Sept. 08
QA/QC International Manager
V.4.0

Name, Title Signature Date

Approved
By

Name, Title Signature Date

SOP
Annual
Review

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Version # Revision Date

Description (notes)
[1.0] [dd/mm/yy]
Revision
History Sections A and B added to the procedure.
These sections describe how to verify a
2.0 09 Sept. 08
timer using the atomic clock or a website
with a NIST traceable source.
Added a reference for the java script
3.0 26 Nov. 08 website an additional telephone number
for the atomic clock.
Removed section on the atomic clock as
4.0 20 Oct 11 this is no longer available. Added a NIST
website to be used for calibration.

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

Distributed
Copies to

I acknowledge that I have read, understand and agree to follow this SOP.

Name (print) Signature Date

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Timer Calibration Verification - SOP

Purpose
1. To ensure timers used in procedures are accurate when compared
to a current certified traceable timer/stopwatch such as a National
Institute of Standards and Technology (NIST) traceable stopwatch.

Definition
1. NIST Certified timer: a timer that has been verified as accurate from
an outside, NIST source.
2. NIST verified timer: a timer that has been verified as accurate
against a NIST in house source (such as a website). This can be
accomplished by following either procedure A below.

Pre-analytic Procedure
1. This procedure applies to all laboratory timers including those timers
that are included as parts of other instruments such as centrifuges.
2. Timers that are not verified using the procedure outlined in this SOP
may be cleaned or serviced and retested. If a timer cannot be
repaired it should be discarded.
3. Calibration records should indicate dates of removal, return to
service or if timer is discarded.
4. All calibration sheets should remain on file as a record, even after
the timer has been removed permanently from service.
5. At time of calibration verification, timers should be inspected for
readability, alarm quality, and cleaned.

Analytic Procedure
Specimen Information: N/A

Reagents/Media: N/A

Supplies:
1. NIST certified stopwatch/timer or uncertified timer to be validated
against NIST traceable source.
2. Laboratory timer (referred to as Test), identified by a unique
assigned number

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Timer Calibration Procedure

If using an Uncertified Timer, the timer will need to be verified first before
testing other timers in the laboratory. Verify the timer by following the
instructions outlined in either Section A and then use the verified timer to
perform timer checks as outlined in Section B.
Note: Timers used at the bench are to be considered contaminated and
should only be handled with gloves and other personal protective
equipment and/or thoroughly disinfected before calibration verification.

A. Procedure for Verification of a laboratory Timer against NIST Traceable

Website
1. Locate the official National Institute of Standards and Technology at
NIST traceable website at http://www.nist.gov/index.html. Scroll
down to the bottom of the page to see the NIST clock on the right
hand side.

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2. If desired, you can follow the instructions on the site to post the
“Official U.S Time” widget to your computer..

3. Please note that it is the time interval, not the actual time that is
important for the timer verification process.
4. Once you have located the NIST timer you can change the time
zone using the arrows to the left and right.
5. Take the timer to be checked to the same location as the computer
used to access the NIST website.
6. At the beginning of the hour start the laboratory timer that is being
verified. Document the time for both the computer website and the
timer that is being verified. (Appendix A).
7. At the end of the hour, go back to the computer and the timer that is
being verified. As the computer clock reaches the end of the hour
stop the timer. Record the ending time from the computer website
and the time from the timing device on the Timer Verification for
Non-certified Timer against NIST Traceable Source – record sheet
(Appendix A).
8. Compare the times as indicted on the record sheet and indicate if
the timing device being verified is within the defined acceptability
limits.
9. If the verified timer is acceptable label it with the date of verification
and the initials of the laboratory staff member who performed the
test.

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Tolerance Limits for Verification of a Timer against NIST Traceable Source

The NIST verified timer should read one hour (60 Minutes) +/- 1 second
at the end of the test time of one hour.
Once the timer has gone through the verification procedure and has
passed, this timer can then be used to check other timers in the
laboratory.
Note: The tolerance limits for the NIST verified timer are different from
the limits listed under section B. The limits for the NIST verified timer
are more stringent since it will be used as the reference method.

B. Equipment Calibration/Maintenance:
1. Timers used at the bench are to be considered as contaminated and
should only be handled with gloves and other personal protective
equipment and/or thoroughly disinfected before calibration
verification.
2. Set the laboratory timer at a setting used in a procedure, and start
the Test timer and the NIST certified or verified timer simultaneously.
3. Stop the NIST verified timer precisely as the timer being checked
indicates that the set time has elapsed.
4. Record times from both the verified timer and the “Test Timer” on the
Timer Calibration Verification Record Sheet (Appendix B).
5. Calculate the difference between the two times and record. If there
is a difference between the verified timer/stopwatch and the timer
that is being checked, indicate whether the “Test Timer” difference is
short or long with a minus or plus sign.
6. Assess the acceptability of the difference using the criteria specified
under Tolerance Limits for Timer Verification section of the SOP or
by the manufacturer. If acceptable, label the timer with the date, the
initials of the laboratory personnel performing the test and the
signed difference and proceed to step (9).
7. If the difference is NOT acceptable, repeat the process. If the setting
on the timer can be adjusted to reliably achieve the correct timing,
then mark the corrected setting with the verified time. Note the
action on the Timer Record Log
8. If still NOT acceptable, remove the timer from use, record the failure
on the Timer Calibration Verification Record Sheet (Appendix B),
notify the supervisor and obtain an alternate, acceptable and
uniquely numbered timer.
9. Ensure all fields of the Timer Calibration Verification Record Sheet
are complete and filed in the Log Notebook. Note all actions taken
on Record sheet. (See Appendix B for an example sheet)

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10. Repeat the process for all times called for in the testing procedures
for which this timer is used.

Quality Control: N/A

Test Method Instructions: N/A

Calculations: N/A

Tolerance Limits for Timer Verification:

Acceptable difference between the “Test Timer” and the Certified or Verified
timer must be ± 2% of the total “Test Timer” setting or as the manufacturer
recommends and in accordance with testing procedure.

Method Limitations: N/A

Post-analytic Procedure
How are Results Prioritized: N/A

Notification of Result to Appropriate Personnel: N/A

Archiving Results and Report Documents:

1. Timer Calibration records should indicate dates of removal, return to
service or if centrifuge is discarded.
2. All Timer Calibration Verification Record sheets should remain on file
as a record, even after the timer has been removed permanently
from service.
Specimen Retention: N/A

References:

1. The Johns Hopkins Hospital CoreLab Procedure Notebook,

Department of Pathology, division of Clinical Chemistry, 2001, Johns
Hopkins Hospital
2. CLSI (NCCLS), Clinical Laboratory Technical Procedure Manuals;
Approved Guideline---Fourth Addition, GP2-A4, Vol. 22 No. 5.

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3. Joint Commission on Accreditation of Healthcare Organizations,

How to Meet the Most Frequently Cited Laboratory Standards, 1996,
Oakbrook Terrace, IL.
4. Timer Verification SOP V1.0, Muhimbili University of Health and
Allied Sciences, Dar Es Salaam, Tanzania.
5. JHU Immunogenetics Laboratory: Digital Timer SOP and Log, JHU
School of Medicine, November 2000 Baltimore, MD, USA.

Appendices

1. Appendix A -Timer Verification for Non-Certified Timer against NIST

Traceable Source - Record Sheet
2. Appendix B – Example of Timer Calibration Verification Record
Sheet
3. Appendix C - NIST Calibration Tool Source (attached)

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APPENDIX C
NIST Calibration Tool Source

NIST instruments can be purchased from Fisher Scientific at

https://www1.fishersci.com/.

NIST thermometer: Catalog# 15-077-55

NIST timer: Catalog# 14-649-11
NIST tachometer: Catalog# 05-028-23

Shipping will be extra. They will charge a hazardous fee for the tachometer
battery, but it may be negotiable.

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