Events at blood collection area due to nonconforming blood bags and plateletpheresis kits: need for timely corrective and preventive actions.
BACKGROUND
Good blood banking practice requires that every effort should be made to detect any deviation or defect in blood bank products and to identify any potential risk to blood donor or recipient(s). We report the findings of an exercise that provide an insight into why feedback from the user side is crucial.


METHODS
Various events involving blood bags and plateletpheresis kits and the corresponding appropriate actions instituted for remedial measures were recorded. These scattered events were recorded for 6 months following the use of a new batch of improved blood bags with add-on features. Several events related to plateletpheresis kits from three different manufacturers were also recorded for 1 year.


RESULTS
The affected blood bags were utilized with no untoward incident. The complaint was closed following satisfactory response from the blood bag manufacturing company that acted in a timely manner in addressing the root causes of the problems. However, corrective and preventive actions (CAPA) could not be implemented for plateletpheresis kits. The rate of undesirable events was higher with plateletpheresis kits as compared with whole blood bags (1.75% vs. 0.06%).


CONCLUSIONS
As defects or deviations that trigger the need for CAPA can stem from numerous sources, it is important to clearly identify and document the problems and level of risk so that appropriate investigations can be instituted and remedial actions can be taken in a timely manner. This study demonstrates the usefulness of a quality initiative to collate and analyze blood product faults in conjunction with blood product manufacturers.
Department of Transfusion Medicine, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, India. aver2211@gmail.com
Anupam
A
Verma
Deepti
D
Sachan
Priti
P
Elhence
Hem
H
Pandey
Anju
A
Dubey
D000062:Accidents, Occupational / Q000517:prevention & control / Q000706:statistics & numerical data; D000465:Algorithms; D001771:Blood Banks / Q000331:legislation & jurisprudence / Q000458:organization & administration / Q000592:standards* / Q000706:statistics & numerical data; D058731:Blood Safety / Q000295:instrumentation* / Q000379:methods / Q000592:standards; D001800:Blood Specimen Collection / Q000295:instrumentation* / Q000592:standards / Q000706:statistics & numerical data; D004868:Equipment Failure / Q000706:statistics & numerical data*; D006301:Health Services Needs and Demand / Q000592:standards; D006801:Humans; D016272:Occupational Health / Q000592:standards; D010983:Plateletpheresis / Q000295:instrumentation* / Q000379:methods / Q000592:standards / Q000706:statistics & numerical data; D011364:Professional Practice / Q000592:standards / Q000706:statistics & numerical data; D058996:Quality Improvement; D011933:Reagent Kits, Diagnostic / Q000592:standards; D012308:Risk Management; D013997:Time Factors
D011933:Reagent Kits, Diagnostic