WS/T 550-2017Guidance on Blood Quality Monitoring for Whole Blood and Ingredients (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

Drafting organizations of this standard. Shanghai Blood Center, Beijing Red Cross Blood Center, Tianjin Blood Center.

1 Scope

This standard specifies the monitoring methods for the quality of whole blood and blood components, and the principles of analysis and utilization of inspection results.

This standard applies to the monitoring of the collection, preparation and storage of whole blood and blood components at blood stations.

2 Normative references

The following documents are indispensable for the application of this document. For dated reference documents, only the dated version applies to this document.

For undated references, the latest version (including all amendments) applies to this document.

Pharmacopoeia of the People's Republic of China GB 18469 Whole blood and blood component quality requirements National Clinical Laboratory Procedures

3 Terms and definitions

The following terms and definitions apply to this document.

Whole blood and blood component quality monitoring is the activity of sampling whole blood and blood component and checking its quality characteristics.

4 Monitoring method

5 Analysis and utilization of inspection results

5.1 When analyzing the results of sampling of whole blood and blood components, the indicators that are caused by individual differences in blood donors and do not affect blood safety, such as If the inspection compliance rate is >=75%, it can be considered that the blood collection, preparation, and storage processes are controlled.

5.2 When the results of sampling compliance rate do not meet the standard, the frequency and quantity of sampling should be increased, and the quality of the whole blood or blood components involved should be evaluated.

Perform systematic analysis of the cause of the bid, and take corrective and preventive measures.

5.3 Trend analysis. The blood station should regularly analyze the trend of blood quality monitoring results. When an abnormal trend occurs, respond to the various factors involved in the process.

Make an assessment, analyze the reasons, and take corrective and preventive measures when necessary.

Appendix A

(Normative appendix) Blood chyle level detection method A.1 Materials Appearance is more than 2 parts of light yellow transparent normal plasma, one clean glassware, physiological saline, 5mL disposable hard with uniform texture Several plastic test tubes, one 1mL pipette, and pictures for turbidity.

A.2 Detection method A.2.1 Mix equal amounts of more than 2 parts of normal plasma in clean glassware to prepare standard plasma, and take at least 2 mL in a test tube as normal Standard tube.

A.2.2 Take at least 2 mL of the plasma or supernatant separated by centrifugation of chyloblood into a tube.

A.2.3 Take the sample of chyle blood to be tested and add it to the test tube quantitatively, and then take the same amount of normal saline to dilute the sample, and take the samples with different dilution ratios.

The quality control and the standard tube are juxtaposed and closely attached to the turbidity picture, placed in a bright place, and the operator faces the light source to make the brightness of the light received by the two tubes consistent.

And the two tubes are transposed on the left and right, and the comparison is repeated, and the clarity of the graphics on the picture of the two tubes is visually checked to determine whether the sample tube is the same as the standard tube.

Therefore, if the sample tube to be tested at a certain dilution is mixed with the standard tube, compare the sample tube with a higher dilution to the standard tube until the picture on the picture after the two tubes the clarity of the graphics is the same.

A.2.4 The dilution factor is used as the chylo index to evaluate the degree of blood chylo. The greater the chylo index, the heavier the degree of blood chylo. Chyle index Chylemia <=2 is defined as mild chylo, 2< chyle index <=5 is defined as moderate chylo, and chylo index>5 is defined as severe chylo.

A.3 Other

Other validated methods can be used to detect the degree of blood chylo.

Appendix B

(Normative appendix) Capacity detection method B.1 Method Use a weighing instrument with a minimum scale of 0.1g to weigh the whole blood or blood components, and calculate the volume according to formula B.1.

B.2 The proportion of whole blood and blood components refer to the "Relative Density Determination Method" of the Four General Principles of the "Pharmacy of the People's Republic of China" to determine the proportion of whole blood and blood components. Or according to the following ratio Re-calculate whole blood and component blood volume.

a) Specific gravity of whole blood. 1.050;

b) Plasma specific gravity. 1.027;

c) Specific gravity of platelet concentrate and apheresis. 1.030.

Appendix C

(Normative appendix) Other quality inspection items detection methods C.1 Sterility test refer to the "Law of Sterility Test" in the three general provisions of the "Pharmacopeia of the People's Republic of China" If sterility test is performed with a bacterial culture apparatus, refer to Manufacturer's instructions.

C.2 pH at the end of the storage period Samples were taken during the last 24h of the platelet storage period. The detection method refers to the three appendix "pH determination method" of "The Pharmacopoeia of People's Republic of China.

If the pH meter is used for measurement, please refer to the manufacturer's instructions.

C.3 Hemoglobin content refer to "Determination of Hemoglobin" in "National Clinical Laboratory Procedures". If you use a blood cell analyzer for measurement, you should refer to the manufacturer Use instructions for operation. The calculation method of hemoglobin content is shown in formula C.1.

C.4 Hematocrit

Refer to "Determination of Hematocrit" in "National Clinical Laboratory Procedures". If you use a blood cell analyzer for measurement, you should refer to the manufacturer Use instructions for operation.

This test item can be used for the detection of the "red blood cell mixed volume" in the method of apheresis granulocyte quality inspection.

C.5 Platelet content refer to "Platelet Count" in "National Clinical Laboratory Procedures". If you use a blood cell analyzer for measurement, you should refer to the manufacturer for use Instructions for operation. The calculation of platelet content is shown in formula C.2.

C.6 The amount of red blood cells mixed refer to "Red blood cell count" in "National Clinical Laboratory Procedures". The calculation method of the amount of red blood cells mixed is shown in formula C.3.

VRBCCRBC x=...(C.3)

C.7 Leukocyte mixing volume refer to "White blood cell count" in "National Clinical Laboratory Procedures". If using a blood cell analyzer for measurement (the number of white blood cells must be the detection range of the blood cell analyzer is within the linear range), please refer to the manufacturer's instructions. The calculation method of leukocyte mixing amount is shown in formula C.4.

C.8 VIII factor content refer to "National Clinical Laboratory Procedures" "Coagulation factor VIII (FVIII. C), IX (FIX. C), XI (FXI. C), XII (FXII. C) the activity determination (one-phase method)". If you use a blood coagulometer for determination, please refer to the manufacturer's instructions.

C.9 Plasma protein content refer to "Determination of Serum Total Protein" in "National Clinical Laboratory Procedures".

C.10 Fibrinogen content refer to "Determination of Plasma Fibrinogen Content" in "National Clinical Laboratory Procedures". If the coagulometer is used for measurement, the manufacturer should refer to Instructions for use.

C.11 Neutrophil content refer to "White Blood Cell Count" and "White Blood Cell Classification Count" in "National Clinical Laboratory Procedures". If measured by a blood cell analyzer, the manufacturer's instructions should be consulted.

Appendix D

(Normative appendix) Hemolysis rate detection method D.1 Detection time the washed red blood cells with a storage period of 24 hours are sampled during the storage period, and whole blood and other blood components are sampled during the last week of the storage period.

D.2 Detection method D.2.1 Calculation formula D.2.2 Hemoglobin test refer to "Determination of Hemoglobin" in "National Clinical Laboratory Procedures". If you use a blood cell analyzer for measurement, you should refer to the manufacturer's Instructions for use.

D.2.3 Detection of free hemoglobin content refer to "Determination of Free Hemoglobin" in "National Clinical Laboratory Procedures". Or use other proven methods.

D.2.4 Hematocrit test refer to "Determination of Hematocrit" in "National Clinical Laboratory Procedures". If you use a blood cell analyzer for measurement, you should refer to the manufacturer Instructions for use.

Appendix E

(Normative appendix) Leukocyte residual quantity detection method