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Learning Center
Coagulation Corner
Monday, May 4, 2009
Quality in Coagulation
"Quality means doing it right when no one else is looking"
Henry Ford
We have Quality Assurance, Six Sigma, Quality Control, Proficiency Testing, CAP, JCAHO, Quality Management and we have our conscience. April brought the Quality Testing workshop sponsored by the Mayo Clinic. Here experts from the coagulation field get together to present the latest updates on issues that have been in our field for years. How do you handle issues, but more importantly how do you improve them? What do you use? Tell me - what's in your lab? What processes do you use so you know you can ensure quality when no one else is looking? Surprise inspections are the way it is supposed to be- can an inspector walk into your coagulation laboratory today and be assured you are performing quality results? Let's face it; everyone has that expired box of 'something' somewhere in their laboratory, that doesn't hinder quality, unless of course you use it... So where are the hot spots in the coagulation laboratory?
We know we need quality, where do you get help?
Guidelines: These are the best things since sliced bread, use them! CLSI guidelines are a How to for laboratories. Want to know how to perform a reference range? Method comparison? Issues with the PT and APTT? Platelet Aggregation? These published guidelines are established by input from both industry and hospitals to help standardize and ensure established processes. Use them! Read them-
Proficiency testing: Great stuff, lots of work, this is established material that is peer evaluated, sometimes by method, others by reagents, as well as all methods/reagents. Having instrument trouble, not sure if your factors are running high, get some of that material and run it, will give you a ton of information. When you get back the results, read them, carefully, look to see what is the most frequent result? If this is a standard, how close are your results? Does your test run higher? Is the material patient plasma or adulterated material? Remember with the complexity of coagulation testing and antibodies used, you may have a different answer than other methods with adulterated material, how do you compare with your own method? Are the CV's tight? This is great stuff! But remember - this doesn't test the quality of the laboratory, or pre- and post analytical steps, it doesn't test laboratory efficiency. But, what it does do it help laboratories to improve quality in detecting their own errors and have a mechanism to correct those errors.
Quality Control: So tell me what are you doing here? How many controls do you run? Do they reflect your patient population? Do you know the defined use of run for coagulation controls are every 8 hours? (Unless of course you have to make new reagents) but you really only need to run them once a shift. And while it is very nice to run the controls for the next shift, I think it is important for each shift to run their own controls so they know how the analyzer is performing. More importantly, know what those results mean. To get the most quality out of your QC have established rules, and know the action to take when they fail those rules. When should they be run, or when they are acceptable, there is your quality.
Are you rolling your eyes yet? I know this I have 3 children (Happy Mother's day, by the way to all moms!) So what about in the coagulation laboratory? How do you keep the bar high when you are dealing with pre-analytical variables, unstable enzymes, complex testing and overworked technologists? Wine or whine? Both work. You do your best to control what you can and have good processes in place to catch what you can't. Let's discuss-
So you are running QC, most are lyophilized in coagulation testing; this is the first step of your testing and can make or break your day. How is that water you are using? Was it sitting on a lab bench or is it fresh? Type 1? Or distilled? Remember you are beginning a shift, this can make or break your day, and you can control it, go get fresh water. Should not sit in a beaker more than 1 hour, pour it on the plants. What about the pipette- been calibrated, sure 6 months may be okay for other labs, but lets face it, something that gets used every day, to check the QUALITY of your analyzers might warrant a 3 month check.
Loading that calibrator? Are you sure it has the correct calibration value? I know the analyzers read the barcodes, etc, but techs are smart, and analyzers at times have a mind of their own, takes 2 seconds, verify that you have the correct lot, and calibrator value.
Reagents, are you running factors? Might want to use fresh ones, may be a waste, but sometimes the costs saved in time is more important. Can you use ones that are on board, absolutely - but again if you are having trouble every morning, its not your calibrator, controls work on other assays, might be those reagents.
Running von Willebrand assays? First do not refrigerate whole blood for testing, it can cause in vitro proteolysis of vWF and result in falsely decreased vWF activity. Also, when these samples come into the laboratory, if you batch test them, get them spun and frozen ASAP. If they sit the activity can decrease, the antigen be stable and look like a Type II deficiency (decreased activity and normal antigen) This is a tough assays, automation helps, still- if running frozen samples, run controls FIRST, make sure your assay is working, then thaw the samples at 37 degrees C for 5 minutes, Mix the samples well, and DO NOT PUT THE SAMPLES on ice, keep at room temperature. Remember, you can falsely decrease vWF, possibly due to cold induced binding of vWF to platelets. Now you may test. Seems like a bit of a project, trust me the time you invest will surpass the time you save.
Proficiency testing for coagulation, this is complex stuff- your variables are only the reagents, factor deficient plasma, calibrators, analyzers, buffers and even the calcium chloride! What do you do? Treat these samples the same as patients, I know that is hard to do, but what are we looking for- we are looking to see how we perform with peer analysis. Have different techs perform the assays, make sure that you run patients with the proficiency testing. Use these as blind samples to assess competency. Review the outcomes, READ the summaries, see how your lab performs, how your assay performs with other people using that assay and with the total group. How is that for quality?
Learning about quality is important, but having the tools to help give you that quality is key!
Donna Castellone
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About the Author
Donna Castellone,
MS, MT(ASCP)SH
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