55.0 Temperature Dependent Equipment


Title of Manual: Specimen Collection

Version No: 1.0

Title: Temperature Dependent Equipment

Effective Date: 12/20/10
Revised Date: 06/23/14

Document #: GPA.SPC.55.0


I. PURPOSE

All pieces of refrigerated equipment used for storage of reagents, controls, and specimens must have the temperature checked and recorded on a daily basis. These temperatures must fall within the specified range as determined by the specimen requirements, the equipment manufacture and / or the reagent supplier. If applicable, humidity checks should be conducted daily at the same time the temperature check is performed.

This is to be performed by all personnel who have the responsibility of monitoring refrigerated equipment and who have been trained on this protocol.

II. MATERIALS

Reagents

Supplies

Equipment

 

● Certified thermometers

 


III. PROCEDURE

1. Record the refrigerator/freezer temperatures on a daily basis except for those days that the facility is closed.
    On dates when the facility is closed, the blank spaces on the log should be marked with an X or the space     marked through with a thick black line.
2. Refrigerator/freezer temperatures should be checked and recorded each morning when the facility is first     opened. If there has been any interruption in electrical service or extreme variation in temperature that
    would have an adverse effect on specimen storage, notify your supervisor immediately.
3. Phlebotomist will record the temperature of the refrigerator on the temperature log and initial.
4. The temperature logs will be audited monthly by management to ensure temperatures are recorded.
    Any blank spaces where temperatures are not recorded must be addressed with corrective actions
    documented on the lines at the bottom of the chart.
5. When temperatures fall outside the specific range, the following steps should be taken:
        a. Ensure the door is closed completely and recheck again in 1-2 hours to determine if it is in range.
        b. If the temperature is still outside the specific range, adjust the setting slightly and recheck again in
            1-2 hours to determine if it is in range.
        c. If the above steps do not remedy the situation, contact management.
        d. Document any corrective actions taken in response to all temperature variances.
6. Use the following guidelines to determine is specimens should be relocated.
        a. If the temperature exceeds the stated range by 3 degrees or less on either side of the range, leave the
            specimens in place and follow remedial actions stated above.
        b. If the temperature exceeds either end of the stated range by 4 degrees or more, the specimens will have
            to be moved to another refrigeration unit. Notify management immediately and place a note on the
            door of the unit not to use and where items have been relocated.
        c. Document any actions taken in response to all temperature variances on the lines at the bottom of
            the chart.

IV. QUALITY CONTROL

N/A

V. CALCULATIONS/CALIBRATION

N/A

VI. INTERPRETATIONS

N/A

VII. METHOD PERFORMANCE SPECIFICATIONS

N/A

VIII. REFERENCES

N/A

IX. RELATED DOCUMENTS

N/A

X. DOCUMENT HISTORY

X - MINOR REVISION
(Laboratory Director’s Signature on Original Subsequent Document Attached)

MAJOR REVISION
(Requires Laboratory Director & Department Director Signature - where applicable)

Reason for Change

2/10/14 New Document Control Format

6/23/14 Moved procedures to
Specimen Collection Manual



Laboratory Director

(Signature)

Date

Natalie Depcik-Smith, MD
(Print)



Department Director

(Signature)

Date

Robert M. Gay, M.D.
(Print)



Designee

Date

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)

(Print)

(Signature)



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