Temperature Documentation of Blood Product Storage Equipment 1.0

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					Temperature Documentation of Blood Product Storage
                  Equipment

    Guideline:                   Guideline Effective Date:               Revision Date:
 QCAI.002(Rev2.0)                       DDMMMYY                            01JAN05

1.0 Principle
      To read and document the temperature of blood product storage
      equipment used in the transfusion service.

2.0 Scope and Related Policies
      2.1.   The transfusion service shall have a written procedure outlining
             actions to be taken when the temperature of a refrigerator, freezer
             or platelet incubator is not within the allowable temperature
             range. 9.1 (D1.6), 9.3 (9.4.2)

      2.2.   Refrigerators, freezers and platelet incubators used for blood
             product storage shall be designed and validated to maintain a
             temperature throughout the cabinets within the range
             recommended by the supplier of the blood product. 9.1 (D5.1; D5.5.4), 9.3
             (9.4.4) See Canadian Blood Services Circular of Information. 9.2


             2.2.1.   The temperature for refrigerators for storage of blood and
                      blood components shall be 1 – 6o C. 9.1 (E4.1), 9.2, 9.3 (7.5.1.4)

             2.2.2.   The temperature for platelet incubators shall be
                      20 – 24 o C. 9.1 (E7.1), 9.2, 9.3 (7.7.4)

             2.2.3.   Granulocytes shall be stored at 20 – 24 o C without
                      agitation. 9.1 (E8.1), 9.3 (7.8.2)

             2.2.4.   Hospitals and transfusion facilities shall store all frozen
                      plasma components at ≤ –20 oC with an expiration date of
                      12 months from the date of collection. 9.1 (E5.1; E6.1) 9.3 (7.6.1;
                      7.6.3.1)


                      Cryosupernatant plasma shall be stored at ≤ –20 oC with
                      an expiration date of 12 months from the date of
                      collection, unless the manufacturer specifically provides
                      for longer storage times at significantly lower
                      temperatures. 9.1 (E5.1; E5.2), 9.3 (7.6.4.3)

      2.3.   Refrigerators for the storage of red cells shall have a calibrated
             temperature sensing device immersed in a fluid equal in volume
             and heat transfer characteristic to the smallest unit of donor red
             cells in storage. 9.1 (D5.5.2) The heat transfer characteristics of the
             fluid shall be similar to blood (e.g., 10% glycerol).



                                                                                QCAI.002(Rev2.0)
               Technical Resource Manual for Hospital Transfusion Services
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Temperature Documentation of Blood Product Storage
                  Equipment

    Guideline:                   Guideline Effective Date:                  Revision Date:
 QCAI.002(Rev2.0)                       DDMMMYY                               01JAN05

      2.4.   Refrigerators, freezers, and platelet incubators for blood product
             storage should have a system for continuous temperature
             monitoring and for recording the temperature at least every
             8 hours. 9.1 (D5.3), 9.3 (9.4.6) The recorded temperature shall be
             reviewed and documented daily. 9.1 (D5.3)

             2.4.1.        In storage equipment that is not continuously
                           monitored, the temperature shall be checked manually
                           with a calibrated thermometer and recorded at least
                           once every 4 hours.9.1 (D5.4), 9.3 (9.4.7)

             2.4.2.        If platelets are not stored in a controlled environment,
                           the ambient temperature in the area where the platelets
                           are stored shall be checked manually using a calibrated
                           thermometer and documented at least once every 4
                           hours. 9.1(D5.4; D5.6.2), 9.3 (9.4.7)

                           The temperature shall be within the range specified by
                           the supplier or appropriate corrective action shall be
                           taken. 9.1 (D5.6.2), 9.3 (9.4.2)

                           The temperature range of the area should be 20 –24 o C.
                           9.1 (E7.1), 9.2, 9.3 (7.7.4)


      2.5.   Temperature records of refrigerators, freezers, and platelet
             incubators shall be kept for a minimum of 5 years from the
             date of last temperature recording or as outlined in
             provincial act/rules and regulations. 9.1 (App. A), 9.3 (19.6.4.1; Table
             4)

      2.6.   Refrigerators for reagent storage shall be maintained as per
             manufacturer’s recommendations. 9.1 (D7.1.1)

             Refrigerators for specimen storage shall be maintained at a
             temperature between 1 and 6o C. 9.1 (D7.1.1), 9.3 (11.1.2.5)

             Temperature checks shall be performed and documented daily. 9.1
             (D7.1.1)



3.0 Specimens
      N/A




                                                                                   QCAI.002(Rev2.0)
                  Technical Resource Manual for Hospital Transfusion Services
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Temperature Documentation of Blood Product Storage
                  Equipment

    Guideline:                 Guideline Effective Date:                   Revision Date:
 QCAI.002(Rev2.0)                     DDMMMYY                                01JAN05

4.0 Materials
      Continuous temperature recording charts

      Internal calibrated thermometer(s) for each piece of equipment used for blood
      product storage.

      Daily Temperature Record form: QCAI.002F

      Forms QCAI.003F3, QCAI.004F# and QCAI.005F3 may be required if
      equipment malfunctions.

5.0 Quality Control/Management
      5.1.   Temperature of equipment for blood product storage shall be within the
             following range:

             •    Refrigerators for blood product storage: 1 to 6 o C
             •    Freezers for frozen plasma component storage: ≤ –20 o C
             •    Incubators for platelet storage: 20 to 24 o C
             •    Refrigerators for reagent and specimen storage: 1 to 6 o C

             Note: Refrigerator or freezer compartments used to store blood
             products should be kept separate from donor samples, recipient
             samples, tissues for transplantation, or blood centre reagents. 9.1 (E1.4), 9.3
             (9.4.3)


      5.2.   Independent calibrated thermometer(s) should be placed inside each
             piece of equipment. A large refrigerator or freezer requires enough
             thermometers for all areas of the storage unit.

      5.3.   Temperature records of refrigerators, freezers and platelet incubators
             shall be kept for a minimum of 5 years from the date of last temperature
             recording.

6.0 Procedure
      6.1.   For blood storage equipment that does not have a continuous
             temperature recording device, read and record the internal
             thermometer(s) temperature every 4 hours. If the temperature is outside
             the acceptable range, see procedural notes 8.1 and 8.2.

             6.1.1.      A technologist or designate shall daily review and initial the
                         documented temperatures on form QCAI.002F/equivalent.


                                                                                  QCAI.002(Rev2.0)
                 Technical Resource Manual for Hospital Transfusion Services
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Temperature Documentation of Blood Product Storage
                  Equipment

    Guideline:               Guideline Effective Date:                   Revision Date:
 QCAI.002(Rev2.0)                   DDMMMYY                                01JAN05

      6.2.   For equipment with continuous temperature recording devices, perform
             the following steps daily.

             6.2.1.    Read the chart on the continuous recording device and the
                       internal thermometer(s). Move the internal thermometer to the
                       next lower shelf (move to top shelf if on bottom).

             6.2.2.    Record and initial the temperatures of the continuous recording
                       device and the internal thermometer(s) on QCAI.002F or
                       equivalent. Ensure that the temperature has remained within an
                       acceptable range since the last documented record of
                       temperature. If the temperature is outside the acceptable range,
                       see procedural notes 8.1 and 8.2.

             6.2.3.    Compare the temperature of the internal thermometer(s) to the
                       temperature on the recording device. If the temperature
                       readings are not within 1 o C, see procedural note 8.3.

             6.2.4.    A technologist or designate shall review and initial the
                       documented temperatures daily on form QCAI.002F/equivalent.

      6.3.   Weekly, change the temperature charts on continuous temperature
             recording devices; preferably at the same day and time so that the record
             is complete.

             6.3.1.   Select the correct type and size of chart for each individual piece
                      of blood storage equipment. Charts usually have a stock number
                      that corresponds to the temperature range of the chart.

             6.3.2.   Remove the completed temperature recording chart from the
                      blood storage equipment. Date and sign chart on back with
                      “Removed by: data”

                      6.3.2.1. Read the chart to ensure that the temperatures
                               recorded have remained within an acceptable range for
                               the blood products stored.

                      6.3.2.2. File the completed chart for five years or as outlined in
                               provincial regulations. A second person should
                               document their review of the chart.

             6.3.3.   Record the current date and initials of person changing the chart
                      near the centre of the new temperature recording chart.

             6.3.4.   Wind the recording device(s), if applicable. Remove “key” and
                      wind temperature recording device.
                                                                                QCAI.002(Rev2.0)
               Technical Resource Manual for Hospital Transfusion Services
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Temperature Documentation of Blood Product Storage
                  Equipment

    Guideline:               Guideline Effective Date:                   Revision Date:
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             6.3.5.   Place the new temperature recording chart on the continuous
                      recording device.

                      • Place an ink line on day and time of start to align the pen
                        more easily.

                      • Move the chart so that the recording pen is set to the correct
                        day and time (e.g., Monday at 10:00 am).

                      • Check to see that the temperature recorded by the pen on the
                        chart corresponds closely to the internal temperature (± 1 o
                        C). If not within 1 o C see procedural note 8.3.

                      • Ensure chart is moving and the pen has adequate ink.

7.0 Reporting
      The records of temperature documentation shall be daily reviewed and initialed.

8.0 Procedural Notes
      8.1.   When the temperature is found to be outside the acceptable storage
             range (e.g., refrigerator temperature range should be 1 o C to 6 o C), do
             the following steps.

             8.1.1.   Follow directions for “Equipment Malfunction” procedure as
                      described on forms QCAI.003F3, QCAI.004F3 and QCAI.005F3.

             8.1.2. Complete an incident report form and submit as per hospital
                    policy.




                                                                                QCAI.002(Rev2.0)
               Technical Resource Manual for Hospital Transfusion Services
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Temperature Documentation of Blood Product Storage
                  Equipment

    Guideline:               Guideline Effective Date:                   Revision Date:
 QCAI.002(Rev2.0)                   DDMMMYY                                01JAN05

             8.1.3.   The investigation of the incident should include determination of
                      the following information:

                      •   The length of time the blood products have been outside the
                          acceptable temperature.

                      •   If the blood products should be discarded or should remain in
                          inventory. See guideline QCAI.010 Temperature Check of
                          Blood and Blood Components.

                      •   Alternative storage arrangements of acceptable blood
                          products.

                      •   The cause of the unacceptable temperature.

                      •   Corrective action to be taken.

                      •   Review of corrective action resolution.

      8.2.   Exposure of blood products to ambient temperatures outside the
             acceptable range will necessitate the measurement of the actual
             temperature of each product to determine whether or not to discard.

             8.2.1.    Exposure to ambient temperatures outside 1-10 o C does not
                       necessarily render blood unsuitable for transfusion.

                       If units reach a temperature outside the 1-10 o C range, products
                       should be discarded.

             8.2.2.    Exposure to ambient temperatures outside the 20-24 o C does
                       not necessarily render platelet concentrate unsuitable for
                       transfusion.

                       If units reach a temperature outside the 20-24 o C range,
                       products should be discarded.

             8.2.3.    Exposure to ambient temperatures above –20 o C or the
                       manufacturer’s recommended storage temperature does not
                       necessarily render frozen blood products unsuitable for
                       transfusion.

                       If units reach a temperature above the recommended
                       temperature products should be discarded.



                                                                                QCAI.002(Rev2.0)
               Technical Resource Manual for Hospital Transfusion Services
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Temperature Documentation of Blood Product Storage
                  Equipment

    Guideline:               Guideline Effective Date:                   Revision Date:
 QCAI.002(Rev2.0)                   DDMMMYY                                01JAN05

             8.2.4.    Exposure to ambient temperatures outside recommended
                       manufacturer’s guidelines does not necessarily render
                       fractionation products unsuitable for transfusion.

                       The product insert should be referenced to determine the
                       acceptable length of time that product may be stored at the
                       incorrect temperature.

      8.3.   If the temperature of the internal thermometer(s) and the continuous
             recording device and/or the digital readout do not agree within 1 o C, the
             following steps may be required.

             8.3.1.    Calibrate the internal thermometer(s). In the interim, replace
                       the thermometer(s) with replacement calibrated thermometer(s)
                       and allow the thermometer to equilibrate for one hour and re-
                       read and record the temperature.

             8.3.2.    Determine whether the chart is recording correctly.

             8.3.3.    Determine whether the digital read-out is functioning correctly.

9.0 References
      9.1.   Canadian Society for Transfusion Medicine. Standards for hospital
             transfusion services, version 1. Ottawa: Canadian Society for Transfusion
             Medicine, 2004: D1.6, D4.1, D5.1, D5.3, D5.4, D5.5.2, D5.5.4, D5.6.2,
             D7.1.1, E1.4, E4.1, E5.1, E5.2, E6.1, E7.1, E8.1, Appendix A.

      9.2.   Canadian Blood Services. Circular of information for the use of human
             blood and blood components. Ottawa: Canadian Blood Services,
             November 2002.

      9.3.   Canadian Standards Association. Blood and blood components
             (CAN/CSA Z902-04). Mississauga, Ontario: Canadian Standards
             Association, 2004: 7.5.1.4, 7.6.1, 7.6.3.1, 7.6.4.3, 7.7.4, 7.8.2, 9.4.2, 9.4.3,
             9.4.4, 9.4.6, 9.4.7, 11.1.2.5, 19.6.4.1, Table 4.




                                                                                QCAI.002(Rev2.0)
               Technical Resource Manual for Hospital Transfusion Services
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    Temperature Documentation of Blood Product Storage
                      Equipment

         Guideline:                    Guideline Effective Date:                   Revision Date:
      QCAI.002(Rev2.0)                        DDMMMYY                                01JAN05



   Facility endorsement if guideline is used as a Standard Operating
                            Procedure (SOP)

Approved By:
                                                                  (Senior Management)


                                                                  (Senior Management)

Facility effective date:                                               DDMMYY
                                                                (Date of implementation)


                                   Change Log
                       Change Description                                              Effective Date
Original
                                                                                         01 April 2000
Revision 1
2.3 addition of Draft Standards for Blood Safety requirement
2.5. added as per Draft Standards for Blood Safety
5.2. - deleted                                                                           01 April 2002
6.1.2., 6.2.3., 6.2.6., 6.2.7., 6.2.9. – deleted
8.5 - revised

Revision 2
Changed “patient to “recipient”, “must” to “shall” and updated to CAN/CSA
Z902-04 in all cases where applicable
2.2: Changed “able” to “designed and validated” (CSTM D5.5.4)
2.2.1: Changed “should” to “shall”
2.2.3: Old 2.2.3 replaced with granulocyte storage temperature.
2.2.4 (was 2.2.3): Changed storage of plasma components intended for
freezing to ≤ –20 o C (CAN/CSA Z902 #7.6.1) Added note about storage                    01 January 2005
temperature of cryosupernatant plasma (CAN/CSA Z902 #7.6.4.3)
2.3: Deleted
2.4 (was 2.6): The frequency requirement for storage devices with
continuous monitoring systems to record the temperature changed from
every 4 hours to every 8 hours. (CAN/CSA Z902 #9.4.6) Changed “shall have
a system for continuous temperature monitoring” to “should” (CAN/CSA
Z902 #9.4.6)




                                                                                           QCAI.002(Rev2.0)
                         Technical Resource Manual for Hospital Transfusion Services
                                                                                                 Page 8 of 9
    Temperature Documentation of Blood Product Storage
                      Equipment

         Guideline:                    Guideline Effective Date:                   Revision Date:
      QCAI.002(Rev2.0)                        DDMMMYY                                01JAN05

2.4.1: Added “In storage equipment that is not continuously monitored, the
temperature shall be checked manually with a calibrated thermometer and
recorded at least once every 4 hours.” (CAN/CSA Z902 #9.4.7)
2.4.2 (was 2.5.1): Added “manually using a calibrated thermometer and
documented”
2.5 (was 2.7): Changed “minimum of 5 years from the date of product use or
expiry, whichever comes first, or …” to “minimum of 5 years from the date of
last temperature recording or….” (CAN/CSA Z902 #19.6.4.1; Table 4)
2.6: Revised and becomes 2.4 (CAN/CSA Z902 #9.4.6)
2.6 (was 2.8): Changed “Refrigerators used for reagent or specimen storage
shall be maintained at a temperature between 1 o and 8 o C” to “Refrigerators
for reagent storage shall be maintained as per manufacturer’s
recommendations. Refrigerators for specimen storage shall be maintained at
a temperature between 1 and 6o C. Temperature checks shall be performed
and documented daily.” (CAN/CSA Z902 #11.1.2.5; CSTM D7.1.1) Deleted
information on freezers used for reagent or specimen storage.
5.1: Changed “Freezers for frozen product storage: –30o C or colder” to
“Freezers for frozen plasma component storage: ≤ –20 o C” (CAN/CSA Z902
#7.6.1). Changed “Refrigerators for reagent and specimen storage: 1 to 8 o C”
to “1 to 6 o C” (CAN/CSA Z902 #11.1.2.5)
5.3: Changed “minimum of 5 years from the date of product use or expiry
whichever comes first, or as outlined in provincial acts/rules and
regulations” to “minimum of 5 years from the date of last temperature
recording “(CAN/CSA Z902 #19.6.4.1, Table 4)
6.1: Added “If the temperature is outside the acceptable range, see
procedural notes 8.1 and 8.2”.
6.2.1: Added “and the internal thermometer(s)”. Added: “Move the internal
thermometer to the next lower shelf (move to top shelf if on bottom).”
6.2.2: Revised to include recording temperatures of both the recording
device (chart) and the internal thermometer;
Moved “Ensure that the temperature has remained within an acceptable
range since the last documented record of temperature.” (was 6.2.1).
6.2.3: Deleted (combined with 6.2.2)
8.2.3: Added “or the manufacturer’s recommended storage temperature”
and deleted –30 o C
9.0: Deleted references 9.3, 9.4; added new reference 9.3
Updated Job Aid, form (QCAI.002F), and Competency Companion
(QCAI.002D, QCAI.002E)




                                                                                          QCAI.002(Rev2.0)
                         Technical Resource Manual for Hospital Transfusion Services
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