Purpose of Internal Auditing in Medical Testing Facilities
Pre-transfusion testing refers to the laboratory testing required to ensure compatibility between the blood of the transfusion recipient and the blood product intended for transfusion. This process includes proper completion of the requisition, proper patient identification, collection and labelling of the blood sample from the patient, laboratory testing to determine the patient’s blood group and to identify the presence of red blood cell alloantibody, and compatibility testing1. Pre-transfusion testing is completed when a compatible blood product is identified for transfusion to the intended recipient. This report represents the performed audit on pre-transfusion testing using card technique. The following section will include the Deficiencies observed through the audit, Suggested improvement method and Well performed elements. The purpose of this audit is to improve the existing pre-transfusion testing though finding and addressing the deficiencies as well as providing appropriate recommendation for them.
Blood fridge temperature were read and recorded properly
The temperature of the refrigerator to store the Red Blood Cell properly should be from +2°C to +6°C, where the maximum tolerable point is +8°C2. In many cases, the lack of monitoring and maintenance of the temperature causes several dilemmas in screening and crosshatching antibody tests. As per the observation, the responsible personnel did not monitor or take the updated report of the refrigerator’s effective temperature. It can cause severe damage to the RBC and even can disable the RBC to react with the testing reagent chemicals. Therefore, a significant monitoring and recording section is missing from this excising Pre-transfusion testing process.
Expiring date of test cell reagents are not checked before using
Checking the expiring data of all the test cell reagents is essential before each use of reaction testing in screening test. The commercial antibody testing reagents have specific expiring date mentioned in its package. In the existing Pre-transfusion testing process, the responsible personnel are not checking the expiring date of the reagents properly. In this situation, an expired reagent can cause disputed test results and can waste the valuable RBC stock. Therefore, in the existing practice of using the test cell reagents is not appropriate for antibody screening tests, which needs sincere attention of the management.
Test cell reagents did not reach room temperature before being used
Before increasing the temperature up to 37 degree Celsius for 30 minutes for antibody reaction, the test cell reagents should reach the room temperature that is 25 degree Celsius3. The test cell reagents are stored in a very low temperature. Therefore, suddenly using them in a high temperature can block the reaction rate through an adiabatic reaction buffer during the antibody detection procedure. As per the audit observation, it has been found most of the the responsible personnel are increasing the temperature of the reagents up to 37 degree for AHG phase taking them directly from the refrigerator. In this situation, the antibodies can react differently with the reagent resulting a disputed report.
Deficiencies Observed during the Pre-transfusion Testing Audit
The following improvement procedures can be utilised to improve the quality of regular Pre-transfusion testing process:
- The blood/ red cell (RBC) storage should be monitored and recorded daily basis in order to ensure the optimum temperature that should be from +2°C to +6°C. In some specific situation, the temperature can go up to +8 degree Celsius. The management should develop an operational checklist for the responsible personnel that will help them to keep track the temperature of the blood/ red cell (RBC) storage refrigerator.
- The operational management should also ensure that the workers are checking the expiring data of all the test cell reagents before using them in each of reaction testing in screening test. The commercial antibody testing reagents have specific expiring date mentioned in its package. To maintain the regular practice the operator can have a notification attached on the reagent storage that will alarm the workers regarding the expiring data checking before any usage.
- The operational management should ensure that the test cell reagents are reaching the room temperature that is 25 degree Celsius before increasing the temperature up to 37 degree Celsius for 30 minutes for antibody reaction. In order to implements this new practice the operational management can execute several on job training programs to develop the new skills of perfection among the workforce.
- Event based training session could be effective, where the users will gain knowledge and sincerity regarding the negative outcomes of these negligence and disputed operations. Attractive and practical illustration about chemical reactions considering the external factors such as time and temperature can increase the essentiality of these essential operations to the responsible personnel.
- Both direct and indirect monitoring on the regular operation can help to collect all the information regarding how the trained personnel comply with all the essential consideration successfully. Checklist, awareness poster, code of conducts for successful operations can be also incorporated in regular system to remind the workforce all the necessary micro work procedure.
Appropriate PPE worn are provided regularly including lab coat, covered shoes and Google were Cleanliness of work area and equipment were noticeable and the waste bins are also present. Patient details on the request form are similar to the patient sample due to appropriate patient details recording system before doing tests. Exactly 0.8% red cell suspension prepared cell suspension is prepared by dispenseing 1mL diluent LISS in a tube and add 10μL of packed red cells as per the AABB standards. The cards are labelled with at least two patient full details and initials. At the 2 coombs card is positively labelled 1-11 and with the 12 well A, along with 50µL ID-panelCell added to the 1-11 labelled well. Apart from that, the ID-panel cells expiring dates checked and mixed thoroughly before being used and 50µL patient cell is added to well 12(A). In the process, 25µL of patient plasma is added to well 12(A) to check if the plasma fully dispensed in every wells. Only one drop(25µL) of confirmation reagent is added to the wells.
Additionally, the cards are incubated in 37C for 15minutes and also centrifuged for 10minutes to use new cell suspensions in order to get more accurate result. For this the responsible personnel make sure that the cards are balanced and spined for 10 minutes while the cards are inspected front and back for positive and negative reaction. The test validated based on colour change to blue/green (AHG cont cells/ confRgt) to be confirmed and validated by visualising colour change. The final results are graded and recorded (IAT) on the antigen composition sheet immediately after the testing where the negative results are also observed and considered first. The antibody identification is performed based on the IAT reading and the rule out method is used to identify the antibody with homozygous expression is considered as excluded. The RhK is card used for phenotyping the patient and 50µL of 0.8% Patient sample added to each well. The result is interpreted proficiently if there is a struggle interpreting the result.
The auditing process is well executed where each and individual testing materials was not altered for this process. I have also ensured that the responsible personnel of Pre-transfusion testing process are not informed about investigation or auditing procedure. It helped me to identify the actual problems in the regular activities performed by the workforce. I have also found that some mistakes are intentional and some are unintentional. Apart from that the major dilemmas are present in the pre testing phase where the temperature and expiry dates are required to be monitored carefully. I observed that the Blood Grouping, Antibody Detection Tests, Cross-matching Tests are performed effectively. However, more in depth inspection could analyse these phases more critically. IS-XM approach could be inspected with detail. The transportation procedure among different rooms can be inspected to monitor any sudden physical temperament to the storage system. The use of patient’s serum and suspended RBCs of the donor can be inspected to find any operational discrepancy. The AHG-XM and usage of anti-IgG could be inspected thoroughly. Including these inspection in the auditing checklist could help me to analyse the existing intermediary procedures as well. Moreover, in next audit phase the I will try to make the inspection checklist more specific, viable and precise to develop more effective audit report.
The critical control points:
- Donor details management
- Collection of preservation of blood
- ABO blood group determined by both forward and reverse methods4
- Evaluating the performance of blood grouping reagents5
- Screening for pre-Transfusion Transmissible infection
- Recording and documentation
Reference
- Weng Y, Chiu Y. Comparison of efficacy and safety of exchange transfusion through different catheterizations: Femoral vein versus umbilical vein versus umbilical artery/vein*. Pediatric Critical Care Medicine. 2013;12(1):61-64. doi:10.1097/pcc.0b013e3181dbeb78
- Roxby D. Current concepts in pre-transfusion serological compatibility testing. ISBT Sci Ser. 2012;6(2):265-269. doi:10.1111/j.1751-2824.2011.01499.x
- Aysola A, Duque M, Williams P, Alissa R. Comparison of heel stick sample with placental blood sample for pretransfusion testing. Transfusion. 2018;58(9):2227-2231. doi:10.1111/trf.14792
- Evanovitch D. A primer in pretransfusion testing. Transfusion and Apheresis Science. 2012;46(3):281-286. doi:10.1016/j.transci.2012.03.017
- Anstee D. Red cell genotyping and the future of pretransfusion testing. Blood. 2012;114(2):248-256. doi:10.1182/blood-2008-11-146860
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