AcT Diff AcT Diff 2 CHS Medical Group utilizes the Beckman Coulter Hematology Analyzers to perform CBCs, AcT Diff or the AcT Diff 2 Analyzer. After completion of this module, personnel should know the following: Acceptable Startup and Quality Control Procedures and appropriate documentation to file Acceptable Logs to use for documentation How to mix Control Material and Patient Samples Acceptable Mode to test Control Material and Patient Samples Appropriate sample type What Patient information is entered into the Hematology Analyzer before performing the test 1 P a g e
How to change reagents Flagged results must be addressed before reporting How to contact Aramark for Service on the analyzer Everyone operating the analyzer must be able to perform the following tasks: Start-up Shut-down Run controls Enter Patient ID numbers Run Patient Samples Change Reagents Participate in Proficiency Testing for CBCs How to call for Service File all appropriate documentation - Start-ups (including those that may Fail - Maintenance Logs - Corrective Action Logs - Proficiency Testing Printouts - Service Reports Daily Morning Procedures that must be performed before patients are tested: 1. Start-up Passed save printout from the analyzer, initial, and file in the Hematology Accordion Folder. Each morning the analyzer must go through the Start-up procedure. At the end of the Start-up, the background information is printed and Passed or Failed is indicated. All parameters must Pass before you can proceed with performing controls. If the Start- 2 P a g e
up fails to Pass after several attempts you may need to contact Service. Document any issues on the Corrective Action Log with any necessary reference numbers from Service. 2. 3 levels of Quality Control (Coulter 4C Plus) have been run and at least 2 out of the 3 levels are within acceptable range (+/- 2SD). Document any control issues on the Corrective Action Log. Reference the Beckman Coulter Routine Operation Easy Reference Guide for complete Step-by-Step guidelines including ICONS pictures. o Gloves must be worn when performing testing. o Make sure Quality Control Material is not expired: o Control material must be taken out of the refrigerator and allowed to warm for 15 minutes. o Gently mix each vial before testing by using the 8x8x8 rule according to the package insert. o Save printouts from the analyzer until the End-of-the-Month summary has been printed, initial and file in the Hematology Accordion Folder. 3 P a g e
3. Documentation on the Beckman Coulter AcT Diff Maintenance and Reagent Log. Every day the clinic is open, the AcT Diff Maintenance and Regent Log must have documentation. The appropriate documentation for each day includes: initials for Daily Startup, AM Controls, and Daily Shut-down. 4 P a g e
4. Documentation on CHS Medical Group Corrective Action Log for any issue with Start-up, performing controls, and Service contacts including a brief description of the problem and a reference number. A Corrective Action Log should be filed with each month s Quality Control Documentation. 5 P a g e
Running Patient Samples: (Reference the Beckman Coulter Routine Operation Easy Reference Guide) 1. Make sure you are wearing gloves 2. Make sure you are testing in the Whole Blood Mode AcT Diff AcT Diff 2 3. Make sure you have the appropriate sample that has been labeled correctly: o Sample type is EDTA (lavender tube or bullet) 4. Make sure the sample is mixed appropriately by the 8x8x8 rule 5. Select the appropriate patient range by touching the Patient Range Icon (selecting either 1,2, or 3) 6. Make sure you enter the patient s MRN as the patient ID (at the End-of-the- Month, a Patient Data Summary will be printed for review and the patient s MRN is how they are identified). 7. Make sure you verify the patient results Review all Flags before reporting patient results. (Reference Handling Flags on Beckman Coulter AcT Diff Printouts located in your Procedure Manual) o Examples of types of Flags include: 6 P a g e
1. Replacement Flags No results will be shown (+++++) indicates the value is higher than the analyzer can count (XXXXX) indicates one or more of the monitored criteria, for aperture alert, has failed the internal limits. There may be clogs in the apertures that must be removed and samples must be re-mixed and rerun. 2. Non-Replacement Flags Results will be shown with flag (X) Aperture Alert - indicates one criteria has failed, results must be reviewed. There may be clogs in the apertures that must be removed and samples must be re-mixed and rerun. (+) indicates the value is higher than the analyzer can measure accurately, sample must be sent out (*) Results must be reviewed refer to the Procedure Manual for action to be taken (1,2,3,4,M) Diff flags that means there is an abnormal cell that has tripped the alert. These flags should be reported in Canopy to let the Provider know there are abnormal cells present. A manual diff is needed if ordered by the physician. When entering patient results into the POL, be sure to indicate any flagged parameters so the Provider is aware and has complete test results. When sending specimens to the Reference lab for validation or to request a differential, please follow the written protocol for referring CBCs. End of Day Procedures that must be performed: 1. Perform Shutdown everyday this allows the AcT Rinse to cycle through the analyzer to maintain performance. 2. Document on the Beckman Coulter AcT Diff Maintenance and Reagent Log. 7 P a g e
Additional Information: Changing Reagents: All staff members that perform CBCs must know how to change reagents and the expiration dates associated with them. The AcT Diff PAK and the AcT Diff Tainer both have a reagent management card, insert the new card into the analyzer when opening a new reagent. Save the old reagent management card as this will be used to download IQAP data at the end of the month. Prime any necessary reagent added. o Record Lot #s and Expiration Dates on the Maintenance Log. o Documentation of Open Expiration Dates are also required to be written on the reagent with a Sharpie Marker: AcT Diff Pak - 60 days AcT Diff Tainer 30 days Participating in Proficiency Testing Samples: All staff members that perform CBCs are required to participate in Proficiency Testing. They must complete all samples for the same event. example, if 5 samples come in one Proficiency Testing event, then the same staff member must complete all 5 samples. All printouts from the analyzer must be saved and initialed. Repeat samples only if you would normally repeat and document why you repeated it on the printout. 8 P a g e
Service for the Beckman Coulter Analyzers: When Service needs are determined please contact Aramark, not Beckman Coulter: ARAMARK SERVICE REQUESTS: Effective 1/1/14 management of the service on these analyzers has been moved to Aramark. The process for requesting service is as follows. Call 704 446 6161 and select option 2 (Clinical Engineering). You will be asked for the asset number of the unit (if there is not one please provide the serial number), a description of the problem and your contact number. If the unit is not functioning please request a Priority 1 for the request. If this is to schedule a PM please select a Priority 2. This will log the request and begin the tracking process. Aramark s office or one of the technicians will call the person listed on the request within 1 hour between 8 and 5. After hours calls will be responded to within 2 hours by phone. If you have not received a call back please reach out to us at the numbers above. Service performed outside the coverage hours is billable back to the facility. After the Aramark Representative comes and services your analyzer, please save all Service Reports as these are to be filed in your Hematology Notebooks, normally with the Calibrations. Be sure to read the Service Report to make sure you do not need to perform a calibration. If you are not sure or the Aramark tech tells you to do something that contradicts what you have been instructed to do by your Technical Consultant or the procedure manual, contact your Technical Consultant or the Primary Lab Contact at your clinic. 9 P a g e