CRITICAL CONTROL POINTS IN COMPONENT PREPARATION by Ptcu8g

VIEWS: 0 PAGES: 31

									CRITICAL CONTROL
POINTS IN
COMPONENT
PREPARATION
OBJECTIVES   • To understand the critical control points
               in unit processing.
             • To assess quality and efficacy of
               components processed.
CRITICAL CONTROL POINTS


      •   Work area
      •   Equipment
      •   Pre-processing check
      •   Sorting
           • Quarantine of Products
           • Discard of unsuitable units
      •   Processing
      •   Release Procedure
      •   Labeling
      •   Quality of products
      •   Inventory
      •   Documentation
WORK AREA:




      Adequate space
      Appropriate temperature
      Good lighting
      Proper bench for work
      Cleanliness
EQUIPMENT


      • Maintenance
      • Calibration
      • Cleanliness
Fridges & Freezers

• Continuous monitoring
• Audible & visual alarm check
PRE-PROCESSING CHECK


   •   Temperature of blood box
   •    Thermometer
   •   Time of collection & arrival at the blood bank
   •   Identification of bags & sample tubes
   •   Accept or reject
   •   Documentation
   •   What to do in case of deviation
SORTING
• Batch according to ABO blood Group
• Weigh bags and decide what component/s to process
• Decide suitability for processing
   – Unsuitable (quarantine)
   – Process blood if suitable
QUARANTINE OF PRODUCTS


 • At appropriate temperature
 • Separate from blood inventory
PROCESSING

•   Equipment – maintenance
•   Work instruction on each component
•   Speed of centrifugation
•   Time of centrifugation
LABELLING



     •   Name of Component
     •   ABO/Rh Type
     •   Serial # or Bar Code #
     •   Extraction and Expiration Date
     •   Result of TTI’s and Antibody Screening
     •   Name of BSF
RELEASE PROCEDURE


    •   Authorized personnel
    •   Testing results
    •   Check each bag against result
    •   Check by second authorized personnel
    •   Post screen label
    •   Transfer into blood stock inventory
DOCUMENTATION


• Standard Operating Procedure
• Record all discarded units
INDICATORS




 •   QC of blood components:
 •   Are the standard specification met?
 •   Labels
 •   No. of unsuitable units for processing
CALIBRATION OF
REFRIGERATED CENTRIFUGE
FOR COMPONENT
PREPARATION

 1. Perform a platelet count. Platelet count below 133, 000/mL
 should not be used.

 Formula:
 Platelets/uL x 1000 x mL of Whole Blood(WB)
 = # of platelets in WB
2. Prepare a platelet rich plasma( PRP) at a selected speed and time.
3. Perform a platelet count on PRP.
  Formula:
  # of platelets in PRP = Platelets/uL x 1000 x mL of PRP
4. Calculate percent yield
   Formula:
    # of platelets in PRP x 100 = % yield
      # of platelets in WB
5. Repeat the above process using 3 different donor samples at
   different speed and time of centrifugation.
6. Select the shortest time and lowest speed with the highest % yield
   of platelets.
Procedure for Platelet Concentrate Calibration


  1. Centrifuge the PRP at selected time and speed.
  2. Express the platelet poor plasma into the
       satellite bag.
  3. Agitate the PC for one hour.
  4. Mix its content well by stripping the tubing
       several times.
  5. Perform a platelet count on the segment.
  Formula:
  # of platelets in PC= platelets/uL x 1000 x mL of PC
7. Calculate % yield
      Formula:
              # of platelets in PC x 100= % yield
              # of platelets in PRP
8. Repeat steps 1-7 using different donors with different
      speed and time of centrifugation.
9. Select the shortest time and lowest speed with the
      highest % yield.
contains all blood
elements


after 24hr storage
becomes red cells
suspended in
protein liquid plasma




Whole Blood
After light / soft spin




                          platelet rich plasma




                               red cells
platelet rich plasma




      pRBC
                       platelet rich plasma
                       platelet poor plasma
platelet concentrate
Quality Control of Blood
      Components
Whole Blood
• Life span and storage
•        CPD-A1 : 35 days at +2ºC to +6ºC                  CP2D   : 42 days at +2ºC
  to +6ºC
         SAG-M : 45 days at +2ºC to +6ºC
• Volume : 450 mL + 10% volume excluding the anticoagulant
• Hemoglobin : 45 g/ unit
• There should be no hemolysis
  (upon expiry: <0.8% of red cell mass)
• Frequency : 1% of all units with a minimum of 4 units / month
Packed Red Blood Cell
• Life span and storage
        CPD-A1          : 35 days at +2ºC to +6ºC
        CP2D            : 42 days at +2ºC to +6ºC
        SAG-M           : 45 days at +2ºC to +6ºC
• Volume                : 280 + 50 mL
• Hematocrit : 0.65 – 0.75
• Hemoglobin            : 45 g/unit
• Plasma                : 20 – 35%
• Dosage effect         :1 unit = Hct: 30% or Hgb: 1 g
• There should be no hemolysis
  (upon expiry: <0.8% of red cell mass)
• Frequency : 1% of all units with a minimum of 4 units / month
Platelet Concentrate
• Life span and Storage          : 5 days (AABB) at
                                 +20ºC to +24ºC
•   Volume                       : 50-70 mL
•   Platelet count               : >5.5 x 1010/ L
•   Residual leukocytes : <0.2 x 109/L
•   pH                           : 6.4-7.4
•   Dosage effect                : 5,000 – 10,000 per unit
•   Frequency                    : 1% of all units with a minimum
                                 of 10 units per month
•   Note                         : Platelet concentrates must
                                 demonstrate “platelet ribbon” &
                                 “swirling phenomenon”
    blood unit/s collected more than 15 minutes should not be processed
    into components
Fresh Frozen Plasma
 • Life span and storage : -30ºC or colder for 12 months
 • Volume                         : 150 -250mL
 • Content                        :All coagulation factors except
                                  platelet
                                  :400mg fibrinogen
 • Factor VIIIc                   : >70% of the value of the freshly
                                  collected plasma unit
 • Residual cells                 : RBC: <6.0 x 109/L;
                                  platelets : <50 x 109/L
 • Visual changes                 : no abnormal color / no clots
 • Thawed at +37ºC and stored at ref temp for a maximum of 24 hrs
 • Frequency                      : every 3 months,
                                  10 units in the 1st month of storage

 Note: Plasma must be processed within 8 hrs of
 collection and must be frozen immediately
FROZEN COMPONENTS STORAGE TIME

   Storage Temperature   Maximum Storage Time


     -65oC or below            7 years


     -40oC to -64oC           24 months


     -30oC to -39oC           12 months



     -25oC to -29oC            6 months



     -20oC to -24oC            3 months
Cryoprecipitate

  • Life span and storage : -30ºC or colder for 1 year
  • Volume                 : 30-40mL
  • Factor VIIIc           : 80-150 IU
  • Fibrinogen             : 150-250 mg
  • Factor XIII            : 20-30% of WB level
  • vWF                    : 40-70% of WB level
  • Thawed at +37ºC for 15 mins and stored at room temp
    for 6 hrs
  • Frequency              : every 2 months using pool of
                                  6 units
CONTRIBUTING FACTORS TO A GOOD BLOOD COMPONENT




     1. Validated and periodically monitored
        equipment
     2. Trained and competent staff
     3. Properly collected whole blood

								
To top