Standard Operating Procedure

Subject Quality Control of Refrigeration Units

Index Number Lab-8750
Section Laboratory
Subsection Regional/Affiliates
Category Departmental
Contact Rachel Blum
Last Revised 3/30/2018

References
Required document for Laboratory Accreditation by the College of American Pathologists (CAP), Centers
for Medicare and Medicaid Services (CMS) and/or COLA.

Applicable To
Employees of the Gundersen St. Joseph’s Hospital laboratories and Gundersen Tri-County Hospital
laboratories.

Detail
PRINCIPLE:
Storage of blood components, blood samples from patients and donors, and reagents for blood bank
use, require careful storage requirements. Separate well-demarcated compartments must be available
for anything other than blood or components when the refrigerator is used. All refrigerators for Blood
Bank use should be clearly labeled with biohazard labels. All areas should be clean, well-lighted, and well
organized. Food or beverage may never be stored in refrigerators designated for Blood Bank use. All
patient and donor samples must be in tightly sealed containers.

Blood Components, blood samples from patients and donors, and reagents for blood bank use must be
maintained within strict range of temperature, in order to ensure efficacy and avoid some potentially
severe complications. For refrigerated storage, refrigerators must have a fan or be of the capacity and
design to ensure stable, designated, temperature is maintained throughout. The temperature of all
areas of the Blood Bank refrigerator(s) must be between 1 and 6°C.

Blood components requiring refrigerated storage, and stored in areas outside the Blood Bank, must be
stored in refrigerators that meet the same standards. Blood components must never be stored in
unmonitored refrigerators. In large refrigerators, it is advisable to have two independent thermometers
immersed in liquid comparable to the smallest component stored. One of these thermometers should
be placed on a top shelf within the refrigeration unit, the other on a lower shelf. The temperature of
both of these thermometers must be between 1 and 6°C at all times. These thermometers should be
checked daily. Each must agree with the temperature displayed on the recorder.

Temperature records are required for all blood storage refrigerators. The sensor for the temperature
monitor system should be immersed in water. The volume of water in the container should be no
greater than the volume of the smallest component stored.

There must be a system to continuously monitor the temperature of Blood Bank refrigerators. There
must be continuous surveillance of temperature. Standard recorders provide a continuous written

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record (temperature chart). For circumstances when these recording devices fail to function,
temperatures must be recorded at least every 4 hours. Temperature fluctuations that exceed the
regulatory requirements must be explained in writing on the written record (i.e., door ajar, or alarm
check). At the end of each 7 day cycle, the recording chart from mechanical recording device should be
changed, dated and initialed by the individual changing the chart.
Blood Bank refrigerators must be equipped with an alarm system. The alarm must alert personnel to
take appropriate action before stored blood components reach undesirable temperatures. The alarm
has battery back-up in the event of a power outage.

Alarms must signal in an area that has adequate personnel coverage 24 hours per day (ie—the hospital
nurses station).

Alarms must be checked for proper performance. Monthly checks are appropriate until consistent
behavior of a particular storage unit has been demonstrated. Thereafter, alarms should be tested
regularly and frequently enough to detect malfunctions as well as to achieve and maintain personnel
competency. For equipment in good condition, quarterly checks are usually sufficient.

SPECIMEN COLLECTION AND HANDLING: N/A

REAGENTS/MATERIALS:
1. Calibrated thermometer
2. Container for water
3. Water
4. Ice
5. Table Salt
6. Alarm test log for recording results

EQUIPMENT / INSTRUMENTATION:
Hillsboro: Helmer Blood Bank Refrigerator with alarm system
Whitehall: CT-1 Blood Bank Refrigerator with Jewett Temperature Monitor and Model DTPM1 power
monitor and audible alarm

Implementation
PROCEDURE:
A. PROCEDURE FOR DAILY TEMPERATURE MONITORING OF REFRIGERATED BLOOD BANKS:
1. Observe the temperature of thermometer on upper and/or lower shelf of refrigerated blood
bank, the digital temperature readout, and the chart recorder.
2. Record the observed temperatures on the appropriate log.

INTERPRETATION:
Each thermometer must read between 1- 6°C.
The temperature display on the internal thermometer must agree with the mechanically
recorded temperature on the written record within one degree C.

QUALITY CONTROL:

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If any of the recorded temperatures are not within the expected range, it may be necessary to
rearrange the contents of the refrigerator to facilitate more even cooling.
If any of the recorded temperatures are outside the acceptable temperature range of 1-6°C, all
blood components, patient and donor samples and reagents must be moved. Follow procedures
for “Power Outage” in Storage of Blood and Blood Products Policy. Contact Maintenance for
repair and adjustment of blood bank refrigerators when performance does not meet acceptable
limits.

B. PROCEDURE FOR PLACEMENT OF WRITTEN RECORD (RECORD GRAPH) ON CONTINUOUS

TEMPERATURE MONITORING DEVICE ON BLOOD BANK REFRIGERATORS:
1. Open the housing door to access the Recording Graph.
2. Remove the center thumb screw.
3. Gently lift the stylus pen. Remove the completed recording graph.
4. Label the completed chart with date and time, plus initials of the individual changing the graph.
5. Place a new chart on the recording device. Align the new chart so that the recording pen is in
alignment with the current day and time on the recording chart. Label the new chart with the
date and time, plus initials of the individual placing the graph on the recording device.
6. Replace the center thumb screw and tighten gently. Close the housing door.
7. File the completed record in the Blood Bank.

INTERPRETATION:
At the end of each time period, record charts from mechanical recording devices should contain
a complete tracing for the entire period of time monitored.

QUALITY CONTROL:
A chart that habitually records a perfect circle suggests that the recorder is not functioning
properly. Slight variations are expected in every refrigerator.
A perfect tracing may indicate a stylus or pen frozen in a single position.
A chart with missing segments may indicate a stylus without ink.
A chart with no recording may indicate a malfunction in the stylus or in the mechanics of the
recorder. This may also result if multiple graphs are placed inadvertently on the recorder at the
same time. A similar problem may occur if the center thumb screw is too tight.
If the record chart fails to perform correctly contact the Maintenance Dept.
All corrective actions must be recorded on the record chart.

C. PROCEDURE FOR WEEKLY CHART RECORDER BATTERY CHECK (HILLSBORO)

1. Battery indicator light should be green.
2. Remove one of the connector caps on battery for chart recorder.
3. Red light should come on.
4. Replace connector.
5. Indicator light should turn green.
6. Record results on BLOOD BANK ALARM TESTS sheet in Blood Bank QC book.

D. PROCEDURE FOR MONTHLY ALARM CHECKS FOR BLOOD BANK REFRIGERATOR (HILLSBORO)
1. Automatic low temperature alarm check
a. Identify the low temperature setting for the alarm.

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b. From the MAIN screen, select the System Alarm Test & Status option
c. Press the UP or DOWN button to highlight the “Start Low Alarm Test” option.
d. Press the ENTER button. The HOME screen will reappear. You should see the words
LOW ALARM TEST IN PROGRESS. When the test is complete, the message clears.
e. View the event log to see the temperature at the time the low temperature test started.
Compare this value with the alarm setpoint value. They should match. If not, refer to
Section 8, “Understanding and addressing operational issues” in the refrigerator
manual.
f. Record results on the BLOOD BANK ALARM TEST sheet in the Blood Bank QC book.
2. Automatic high temperature alarm check
a. Identify the high temperature setting for the alarm.
b. From the MAIN screen, select the System Alarm Test & Status option.
c. Press the UP or DOWN button to highlight the “Start High Alarm Test” option.
d. Press the ENTER button. The HOME screen will reappear. You should see the words
HIGH ALARM TEST IN PROGRESS. When test is complete, the message clears.
e. View the event log to see the temperature at the time the high temperature test
started. Compare this value with the alarm setpoint value. They should match. If not,
refer to Section 8, “Understanding and addressing operational issues” in the refrigerator
manual.
f. Consult the event log on the refrigerator for event.
g. Record results on the BLOOD BANK ALARM TESTS sheet in the Blood Bank QC book.
3. Power failure alarm test
(Please be sure to take precautions to protect items in the fridge from extended exposure to
adverse temperatures before doing this test as the power will be disconnected)
a. Find the current setting for the power failure timer.
b. Change this setting to zero minutes by doing the following:
i. Select the SET ALARM SETPOINTS option from the CONFIGURATION screen. The
High Alarm Setpoint will be highlighted.
ii. Press the DOWN button to select the setting you want to change.
iii. Then press the INC or DEC button until the new value you want appears.
iv. Press the back button until you reach the HOME screen.
4. Open door alarm test
a. Find the current setting for the door open timer.
b. Change the setting to zero minutes
c. Open the refrigerator door. The door open alarm should sound immediately and a
message should appear on the HOME screen. An event should be added to the event
log.
d. Close the door. The alarm and message should clear and an event should be added to
the event log.
e. Change setting back to original setting.
f. Record results on the BLOOD BANK ALARM TESTS sheet in the Blood Bank QC book.
5. No Battery alarm test
a. Disconnect the refrigerator from power.
b. The display should continue to display information and the battery picture should still
be filled in.
c. If the display is blank, replace the batteries.

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d. Connect the refrigerator to AC power.

e. Record results on the BLOOD BANK ALARM TESTS SHEET IN THE Blood Bank QC book.
f. Procedure Note: Replace batteries if they have been in use for one year. When
changing batteries, all batteries must be replaced with fresh batteries.
E. PROCEDURE FOR QUARTERLY ALARM CHECKS OF BLOOD BANK REFRIGERATOR:
1. To test the low temperature of alarm activation, place the alarm thermocouple and a
thermometer in a container of water in the temperature range of 1-6°C.
2. Slowly add crushed ice to the mixture, stirring well.
3. You may add several grams of sodium chloride (table salt) to the slurry. This step in the
procedure is optional.
4. If possible, close the refrigerator door so that the interior is not significantly affected.
5. Allow the thermocouple and thermometer to remain in the slurry. Continue to stir occasionally
until the alarm sounds.
6. Note the temperature at the time of alarm. Record the temperature as Low Temperature of
Alarm Activation on the "Refrigerated Equipment, Blood Bank Quality Control" Form.
7. Replace the container of ice and water with a fresh container filled with cold water in the
temperature range of 1-6°C.
8. Gradually add warm water, agitating occasionally.
9. Record the temperature at which the alarm sounds as High Temperature of Alarm Activation on
the "Refrigerated Equipment Quality Control" Form.
10. Record the date, and initials of individual performing the test.
11. If low or high temperatures of activation do not meet acceptable limits, notify Maintenance.
Document all corrective actions on the “Refrigerated Equipment Quality Control” form.

PROCEDURE NOTES:
a. The thermocouple for the alarm should have a long cord and be easily accessible. It
need not be in the same container as the recording thermocouple.
b. To check temperatures of alarm activation, changes in temperature should be allowed
to occur at a rate that allows slowly responding thermocouple to accurately measure
changes.
c. Alarms should sound simultaneously at the site of the refrigerator and at the location of
the remote alarms.

INTERPRETATION & RECORDING RESULTS:

The low temperature of activation should be no lower than 1°C. The high temperature of alarm
activation must be lower than 6°C. Low activation above 1°C and high activation below 6°C do
not conflict with the AABB Standards.
The amount of water in which the thermocouple is immersed must be no larger than the
volume of the smallest component stored. It is acceptable if due to evaporation or spills, the
thermocouple is immersed in a smaller volume, but the alarm may be more sensitive to changes
in temperature fluctuations.

PROCEDURE NOTES:
See above in each procedure.

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In all quarterly and monthly procedures, the alarm in the nurses’ station should sound, and they should
respond within 1 minute. This response should be documented with the nurse’s name and time that
they called on the BLOOD BANK ALARM TESTS sheet in the Blood Bank QC book (Hillsboro).

CALCULATIONS: N/A

INTERPRETATION AND RECORDING RESULTS:

If the technologist questions any of the test results, he or she can repeat the test and/or have another
tech repeat the test. The technologist can also consult the technical leader and/or Medical Director as to
how the results should be reported. There is also someone available 24 hours per day at the Blood
Center of Wisconsin at Milwaukee who can offer advice.

LIMITATIONS: N/A

REVIEW AND CHANGES:

This document and all attached forms should be reviewed optimally on an annual basis, with 2 years as
the maximum review date. Review will be done by the Technical Leader, Supervisor, Manager, Medical
Director or designated person. Changes require retyping document or form and review by the Medical
Director.

REFERENCES:
1. Clinical Laboratory Technical Procedure Manuals, Approved Guidelines, 3rd Ed., Dec. 1996, (CP-
A3) Vol. 16, No. 15.
2. American Association of Blood Banks Technical Manual, 17th Ed.
3. Wenz B., Owens RT, A Simplified Method for Monitoring and Calibrating Refrigerator Alarm
Systems. Transfusion 1980:20:75-8.
4. Code of Federal Regulations, 21CFR 606.60, April 1994.
5. Helmer Refrigerator Operation Manual, c.2009

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