SMILE
Johns Hopkins University
Baltimore, MD USA
Thermometer Calibration Verification -Guidelines
Thermometer Calibration Verification / Guideline Number / Equ1.4-01-GEffective Date
Subject
Thermometer Calibration / Page / 1 of 1
Supercedes / New
Review by / Heidi Hanes / Review date / 9-Feb-12
Audit:
Equipment: Section .
CAP Accreditation Checklist:
1. Limited service laboratory checklist manual, Instrument and Equipment
2. Chemistry and Toxicology checklist manual, Methods and Instrument s systems
Background Information:
1. Thermometer calibration is to be verified once per year, after maintenance, malfunction or in accordance with manufacture’s recommendations, whichever is most frequent
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; Chemistry and Toxicology checklist manual (Revised 10/31/2006)
Thermometer Calibration Verification- Policy
Effective Date
Approval Signature: Laboratory Director / Review Cycle / 1 year
Supercedes / New
Policy / The laboratory has processes and procedures to effectively ensure that thermometers are maintained and calibrated to ensure, accuracy and precision, are preserved.
Purpose / This policy provides direction for the processes and procedures to effectively ensure that the maintenance and calibration of thermometers is carried out as required to ensure the accuracy and precision of the instrument.
Responsibility / The Laboratory Medical Director is responsible for (to be determined by the 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
Thermometer Calibration Verification- Process
Effective Date
Approval Signature: Laboratory Director / Review Cycle / 1 year
Supersedes N/A / New
Process for Thermometer Calibration Verification
What Happens / Who’s Responsible / InstructionsMaintenance and Calibration policy for thermometer is determined / · To be determined by the Laboratory / Technical SOPs that require the use of a thermometer
Thermometer maintenance and calibration is performed / · QA Technologist
· Technicians/Technologists / Thermometer Maintenance and Calibration SOP
Author(s), Name & Title / Kurt Michael M.ED., MT (ASCP) / Document Number / Effective Date
QA/QC International Manager / Equ1.4-01-SOP / 26 Feb 2007
Approved By / Name, Title / Signature / Date
SOP Annual Review / Name, Title / Signature / Date
Revision History / Version # [1.0] / Revision Date [dd/mm/yy] / Description (notes)
Distributed Copies to / Name (or location) / # of copies / Name (or location) / # of copies
I acknowledge that I have read, understand and agree to follow this SOP.
Name (print) / Signature / Date
Purpose
1. To ensure the thermometers used in procedures, water baths, incubators, refrigerators, and freezers are accurate when compared to a certified thermometer such as a National Institute of Standards and Technology (NIST) traceable thermometer.
Pre-analytic Procedure
1. Unacceptable thermometers may be cleaned or serviced and retested. If unable to repair, discard.
2. Calibration records should indicate dates of removal or return to service or if
thermometer is discarded.
3. All Thermometer Calibration Verification Record sheets should remain on file as a
record, even after the thermometer has been removed permanently from service.
4. Thermometers at time of calibration verification should be inspected for readability and cleaned.
Analytic Procedure
Specimen Information: N/A
Reagents/Media: N/A
Supplies:
1. A certified thermometer or a new NIST thermometer comes with period of time for which it is certified. Following this time or an accident that causes the thermometer to malfunction, it must be sent to a service center qualified to recertify its accuracy. This is to be done yearly after the initial purchase certification has expired.
Equipment Calibration/Maintenance:
1. Thermometers 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. Place the probe of the NIST traceable thermometer under the same conditions and near the thermometer being verified. If the test thermometer is in glycerin or other liquid, then the traceable thermometer must also be is this liquid.
3. Allow both thermometers to equilibrate.
4. Record both temperatures of the test thermometer being verified and the certified thermometer, as accurately as possible, on the Thermometer Calibration Verification Record Sheet.
5. Calculate the difference between the two thermometers and record. If there is a difference between the Test thermometer and the Certified thermometer, indicate whether the Test thermometer difference is low with a minus sign or high with a plus sign.
6. Assess the acceptability of the difference using the criteria specified under Interpretation of Results section. If acceptable, label the thermometer with the date, the tech and the signed difference and proceed to step (8).
7. If the difference is NOT acceptable, repeat the process. If still NOT acceptable, remove the thermometer from use, record the failure on the Thermometer Calibration Verification Record Sheet, notify the supervisor and obtain an alternate, acceptable and uniquely numbered thermometer.
8. Ensure all fields of the Thermometer Calibration Verification Record Sheet are complete and filed in the Log Notebook. Note all actions taken on Record sheet. (See appendix I for an example sheet).
9. Repeat the process for all temperatures for which the thermometer is used.
Quality Control:
1. NIST Certificate for thermometer or equivalent
Test Method Instructions: N/A
Calculations: N/A
Expected Values:
Established by lab
Interpretation of Results:
Temperature Tolerances: Established by lab, examples below
Instrument Tolerance (˚C)
Incubator + 2˚
Water bath + 2˚
Heating block + 2˚
Refrigerator + 2˚
Freezer (-20˚C) + 2˚
Freezer (-70˚ C) + 5˚, must be cooler than –65˚ C
Method Limitations: N/A
Post-analytic Procedure
Result Entry into Lab Record System:
1. Thermometer Calibration Log Notebook for holding Record sheets
2. Thermometer Calibration Verification Record Sheets
a) Sheet identified with the same unique number as the Test thermometer at
b) Initial calibration.
c) Filed in the Thermometer Calibration Log Notebook
d) Sheet contains the following information (See appendix I)
· Procedures for using centrifuge
· Centrifuge location
· Calibration date
· Technologist signature/initials
· Test thermometer reading
· Certified thermometer reading
· Difference between Test and Certified
· Acceptance or rejection
· Any actions taken (clean, adjust, etc.)
Notification of Result to Appropriate Personnel: N/A
Archiving Results and Report Documents:
1. Temperature Calibration records should indicate dates of removal, return to service or if Thermometer is discarded.
2. All Thermometer Calibration Verification Record sheets should remain on file as a
record, even after the thermometer 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.
ASM Clinical Microbiology Procedures Handbook, editor in chief, Isenberg, Henry D, 2004, Washington, DC.
Appendices
1. Appendix I – Example of Thermometer Calibration Verification Record Sheet
2. Appendix II - NIST Calibration Tool Source
Thermometer Calibration Verification Version#: 1.1 Page 10 of 10
SMILE
Johns Hopkins University
Baltimore, MD USA
APPENDIX I
Procedures using thermometer:Location:
Test
Thermometer. / Certified Thermometer. / Degree C or F / Accept / Actions
Date / Tech / Reading / Reading / Difference / or Reject / Taken
Thermometer Calibration Verification Version#: 1.1 Page 10 of 10
SMILE
Johns Hopkins University
Baltimore, MD USA
APPENDIX II
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.
Thermometer Calibration Verification Version#: 1.1 Page 10 of 10