Evaluation of reagent shipments for acceptable performance

Transcription

1 Created Lisa Senzel Asst. Prof. - Clinical 6/20/2012 Path Revised Bruce Kube Day Heme Tech 1 8/23/2012 Reviewed Jay Bock M.D. 6/27/2012 Approved Lisa Senzel Asst. Prof. - Clinical Path HEM /23/2012 Evaluation of reagent shipments for acceptable performance I. PRINCIPLE In cases where a lot of reagent is verified but the lot is sequestered and its receipt is spread over several shipments, it is possible for reagent effectiveness to become compromised during shipment. In order to ensure that reagent shipments are not compromised a mechanism was developed to monitor the efficacy and keep track of reagent shipments. This procedure applies only to reagents that have sequestered lots with multiple shipments. II. PROCEDURE Reagent shipments: 1. Upon receipt of a new shipment from the sequester of a previously evaluated lot of reagents the following is to occur. 2. On the next regular dayshift (M-F holidays excluded) 1 bottle of the newly received shipment of reagent is to be obtained and if necessary, reconstituted. 3. The reconstituted reagent is to be placed into the refrigerator (2-8 o C) until it can be placed on the analyzer. 4. As soon as practicable after the reagent is ready, remove the current in use reagent bottles from the coagulation analyzer and replace them with the reagents from the new shipment. 5. Run all controls associated with that method and when resulting the controls, append with the code NRSHP. This translates to NEW REAGENT SHIPMENT EVAL 6. Choose a recent previously analyzed patient (within 1 hour if possible) that will utilize all of the reagents from the new shipment and repeat the analyses. 7. Record the results in the table in the shipment evaluation of the coagulation analyzer logbook and indicate acceptable. 8. If the results are outside of acceptable limits, repeat the procedure with a new sample. If this fails consult senior personnel.

2 Control Shipments: 1. Upon receipt of a new shipment from the sequester of a previously evaluated lot of controls the following is to occur. 2. On the next regular dayshift (M-F holidays excluded) 1 bottle of the newly received shipment of control is to be reconstituted. 3. One of each test that is monitored for each control will be performed and the results evaluated for acceptability (within established 2SD range). 4. performed, shipment date and the results of the acceptability of each analysis will be recorded on the appropriate chart. 5. Result all of the controls in the LIS and append the code NCSHP this translates to NEW CONTROL SHIPMENT EVAL. Hematology Analyzer reagent handling: When a new lot of reagent is placed into use for the hematology analyzer the following procedures are to be followed to ensure proper evaluation of the new lot has occurred and acceptable results can be recovered. 1. Record the new lot information on the log sheet in the Hematology reagent verification log book. 2. Replace the container on the analyzer and enter the lot specific information into the workstation 3. After replacing the container and entering the lot specific information, perform a start-up cycle to flush the old reagent from the analyzer and replace it with new. 4. When the start up cycle is complete verify that the background is acceptable and print out the startup log. 5. If replacing reagents that affect the CBC run the 5C controls (3 levels) or if replacing retic reagents run the Retic-C controls (3 levels). 6. Print out the results for each control run and attach them to the startup log 7. File the results in the Hematology Reagent verification logbook in front of the previous filings but behind the log sheet (the last entry in the log sheet should match the first set of printouts) It is not necessary to perform this task with each analyzer only once when the lot is originally put into use. III. QUALITY CONTROL For each reagent evaluated 3 levels of control will be analyzed and evaluated for acceptability. IV. RESULTS All QC analyzed is within 2SD of the mean established for the reagent Patient sample replicates must fall within the following tolerance limits

3 o PT - 15% o Aptt - 15% o Fg - 20% o DD- 25% University Hospital Medical Center % difference is calculated as follows where reference is the original patient value and repeat is the value obtained with the new reagent. Example: reference = 23.6, repeat = 24.0 = 1.7% acceptable V. LIMITATIONS In some instances repeat results heparinized can vary as time elapses. When repeating samples suspected of being heparinized, try to allow as little time as possible to pass.

4 Reagent Recombiplastin- 2G Exp Lot # Shipment Received QC OK Prothrombin Time PT Old PT % New diff OK QC OK Fibrinogen Fg Old Fg New % Diff OK Initials Acceptable limits o PT - 15% o Aptt - 15% o Fg - 20% o DD- 25%

5 Reagent Synthesil Exp Lot # Shipment Received QC OK PTT Old PTT New Aptt % diff OK Initials Acceptable limits o PT - 15% o Aptt - 15% o Fg - 20% o DD- 25%

6 Reagent D-Dimer Test Kit Exp Lot # Shipment Received QC OK DD Old D-Dimer DD New % diff OK Initials Acceptable limits o PT - 15% o Aptt - 15% o Fg - 20% o DD- 25%

7 Reagent D-Dimer Controls Exp Lot # Performed Shipment Received Result D-Dimer High Control Within 2 SD D-Dimer Corrective Action Result Within 2 SD D-Dimer Low controls Corrective Action Indicate acceptability by placing a Y in the box Y indicates control is within established 2SD range Indicate all corrective actions if unacceptable results are obtained.

8 Control Level LOT # Expiration date Normal Abnormal Low Abnormal High Shipment Received Normal Abnormal Low Abnormal High PT PTT FG PT PTT Fg PT PTT Initials Indicate acceptability by placing a Y in the box Y indicates control is within established 2SD range

9 Control Level LOT # Expiration date Low fibrinogen Shipment Received Low Fib control Fib-RP Fib-C Initials Indicate acceptability by placing a Y in the box Y indicates control is within established 2SD range

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