October 2, 2000 - pSMILE



Timer Calibration Verification - Guidelines

|Timer Calibration Verification |Guideline Number |Equ15-01-G |

| | |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 |10-Feb-20 |

|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. |

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).

|Timer Calibration Verification Policy |Policy Number |Equ15-01-P V.3.0 |

| |Effective Date |25 Sept. 08 |

|Approval Signature: Laboratory Director |Last Review |10-Feb-20 |

| |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 Information as required |N/A |

|Supporting Documents |N/A |

Timer Calibration Verification - Process

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

| |Effective Date |25 Sept. 08 |

|Approval Signature: Laboratory Director |Last Review |10-Feb-20 |

| |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|To be determined by Laboratory |Technical SOPs that require the use of |

|is determined | |a timer |

|Timer Maintenance and Calibration is |QA Technologist |Timer Maintenance and Calibration SOP |

|performed |Technicians/Technologists | |

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

|Author(s), Name & Title |Josephine Shim MBA, MT (ASCP) | | |

| |QA/QC International Manager |Equ15-01- SOP |25 Sept. 08 |

| | |V.4.0 | |

| |Name, Title |Signature |Date |

|Approved By | | | |

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| |Name, Title |Signature |Date |

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|SOP Annual Review | | | |

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| |Version # [1.0] |Revision Date [dd/mm/yy] |Description (notes) |

|Revision History | | | |

| |2.0 |09 Sept. 08 |Sections A and B added to the procedure. These sections describe how|

| | | |to verify a timer using the atomic clock or a website with a NIST |

| | | |traceable source. |

| |3.0 |26 Nov. 08 |Added a reference for the java script website an additional |

| | | |telephone number for the atomic clock. |

| |4.0 |20 Oct 11 |Removed section on the atomic clock as this is no longer available. |

| | | |Added a NIST website to be used for calibration. |

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

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|Distributed Copies to | | | | |

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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 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

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 . The bottom NIST clock on the right hand side.

[pic]

2. Please note that it is the time interval, not the actual time that is important for the timer verification process.

3. Take the timer to be checked to the same location as the computer used to access the NIST website.

4. 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).

5. 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).

6. Compare the times as indicted on the record sheet and indicate if the timing device being verified is within the defined acceptability limits.

7. 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.

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)

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.

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)

APPENDIX C

NIST Calibration Tool Source

NIST instruments can be purchased from Fisher Scientific at .

 

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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