equ15-01 timer cal verfn sop-app

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SMILEJohns Hopkins University

Baltimore, MD USA

Timer Calibration Verification - Guidelines

Timer Calibration VerificationGuidelineNumber

Equ15-01-G

V.3.0

Effective Date 25 Sept 08

Subject

Timer Calibration Verification

of 1

Supersedes Equ15-01-GV.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 toaccurately 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.

Audi t: Equipment Section

CAP Accreditation Checklis t:

1. Limited service laboratory checklist manual, Instrument andEquipment

2. Hematology –Coagulation checklist Manual, Instrument andEquipment

3. Chemistry and Toxicology checklist manual, Methods andInstrument systems

Background Information:

1 Timer calibration is to be verified twice per year after maintenance




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Timer Calibration Verification - Policy

Timer Calibration Verification PolicyPolicy Number Equ15-01-P V.3.0

Effective Date 25 Sept. 08

Approval Signature: Laboratory Director Last Review 27 July 2010

Supersedes Equ15-01-P V.2.0

Policy The laboratory has processes and procedures to effectively ensurethat timers are maintained and calibrated to ensure that theiraccuracy and precision is preserved.

Purpose This policy provides direction for the processes and procedures toeffectively ensure that the maintenance and calibration of timers iscarried out as required to ensure the accuracy and precision of theinstruments.

Responsibility The Laboratory Medical Director is responsible for ( to be determinedby Laboratory )

The Laboratory Manager is responsible for ( to be determined by theLaboratory )

The Lead Technologists are responsible for ( to be determined by

the Laboratory ) AdditionalInformation as

N/A




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Timer Calibration Verifi cation - Process

Timer Calibration VerificationProcess

Policy Number Equ15-01-Pro V3.0

Effective Date 25 Sept. 08

Approval Signature: LaboratoryDirector

Last Review 26-Oct-2011

Supersedes N/A Equ15-01-Pro V2.0

Process for Timer Calibration Verification

What Happens Who’s Responsible Instruct ions

Maintenance andCalibration policy forTimers is determined

• To be determined byLaboratory

Technical SOPs thatrequire the use of a

timer

Timer Maintenance andCalibration is performed

• QA Technologist• Technicians/Technologists

Timer Maintenanceand Calibration SOP




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Author(s), Name &Title

Kurt Michael M.ED., MT (ASCP)

Josephine Shim MBA, MT(ASCP)

DocumentNumber

EffectiveDate

QA/QC International ManagerEqu15-01- SOP

V.4.0

25 Sept. 08

ApprovedBy

Name, Title Signature Date

SOP AnnualReview

Name, Title Signature Date

RevisionHistory

Version #[1.0]

Revision Date[dd/mm/yy] Description (notes)

Sections A and B added to the




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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 comparedto a current certified traceable timer/stopwatch such as a NationalInstitute of Standards and Technology (NIST) traceable stopwatch.

Definition

1. NIST Certified timer: a timer that has been verified as accurate froman outside, NIST source.

2. NIST verified timer: a timer that has been verified as accurateagainst a NIST in house source (such as a website). This can beaccomplished by following either procedure A below.

Pre-analytic Procedure1. 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 berepaired 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 afterthe timer has been removed permanently from service.

5. At time of calibration verification, timers should be inspected for




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Timer Calibration Procedure

If using an Uncertified Timer, the timer will need to be verified first beforetesting other timers in the laboratory. Verify the timer by following theinstructions outlined in either Section A and then use the verified timer toperform timer checks as outlined in Section B.

Note : Timers used at the bench are to be considered contaminated andshould only be handled with gloves and other personal protectiveequipment and/or thoroughly disinfected before calibration verification.

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

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

hand side.

http://www.nist.gov/index.html







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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 isimportant for the timer verification process.

4. Once you have located the NIST timer you can change the timezone using the arrows to the left and right.

5. Take the timer to be checked to the same location as the computerused to access the NIST website.

6. At the beginning of the hour start the laboratory timer that is beingverified Document the time for both the computer website and the




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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 secondat the end of the test time of one hour.

Once the timer has gone through the verification procedure and haspassed, this timer can then be used to check other timers in thelaboratory .

Note: The tolerance limits for the NIST verified timer are different fromthe limits listed under section B. The limits for the NIST verified timerare 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 andshould only be handled with gloves and other personal protectiveequipment and/or thoroughly disinfected before calibrationverification.

2. Set the laboratory timer at a setting used in a procedure, and startthe Test timer and the NIST certified or verified timersimultaneously.

3. Stop the NIST verified timer precisely as the timer being checkedindicates that the set time has elapsed.

4. Record times from both the verified timer and the “Test Timer” onthe Timer Calibration Verification Record Sheet (Appendix B).

5. Calculate the difference between the two times and record. If there




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10. Repeat the process for all times called for in the testing proceduresfor 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 orVerified timer must be ± 2% of the total “Test Timer” setting or as themanufacturer 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




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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, JHUSchool of Medicine, November 2000 Baltimore, MD, USA.

Appendices

1. Appendix A -Timer Verification for Non-Certified Timer against NISTTraceable Source - Record Sheet

2. Appendix B – Example of Timer Calibration Verification RecordSheet

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 athttps://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 tachometerbattery, but it may be negotiable.

https://www1.fishersci.com/





Equ1.5-01 Appendix A

Timer Acceptability Criteria: The NIST verified timer should read one hour +/- 1 second at the end of the test time of one hour.

Reviewed by: ____________________ Date: ___________________________________

Reviewer's Comments: ____________________________________________________________

Date

App endix A: Timer Ver if icati on fo r Non-Cer ti fi ed Timer agains t NIST Traceabl e Sou rce - Record Sheet

St ar t t ime Stop t ime To tal t ime St ar t t ime

(Laboratory Name)

Difference -Total Time Aminus Total

Time B

Acceptable/Unacceptable

TechInitials

Stop time Total t ime

NIST Source (A) Non Certified Timer (B)

LaboratoryNon-Certified

Timer ID#

TimeInterval forVerification



Appendex I - Timer Cal ibrat ion Verif ication Record Sheet

Equ15-01_App_B_Timer_Cal_Verfn_Sht.xls Version cal/ver101-AP1

Timer # :___________ Locati on of timer:_______________________ *one timer per sheet

Timer Criteria: Acceptable difference must be equal to or less than 2% of the timer setting.

Reviewed by:__________________________________ Date:_____________________

Appendix B - Timer Calibration Veri fi cat ion Record Sheet

DateTech

(Initials)

Time Intervalfor

Verification

NIST Calibr atedTimer - Actual

Time

TimeDifference

Timer - ActualTime

List testing procedures for which the timer is used:____________________

Accep tabl eRange

SupervisorReview (Intials

and Date)

Acceptab le/Unacceptable

equ15-01 timer cal verfn sop-app

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