BenchTech

I'm currently looking for anyone who maybe able to give me some feedback about CLIA regulations and the donor world. To explain I'm working for a research company that is setting up a laboratory with a Certificate of Compliance to perform CBC's on donors prior to the collection of MNC's. All my experience is clinical and I have never worked in the donor world before. I'm wondering how some of the CLIA regulations apply. For example having a physician order for the CBC. I have reached out to our state CLIA inspector multiple times with no response, which is frustrating enough and I'm looking for some guidance. Thanks

For those of you out there running TEG 6s instruments, since Haemonetics does not have 2 levels of commercial QC available how do you satisfy this requirement: HEM.20090 Alternative Control Procedures Phase II If the laboratory performs test procedures for which control materials are not commercially available, there are written procedures for an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be recorded. NOTE: "Performance" includes elements of accuracy, precision, and clinical discriminating power. Examples of alternative procedures may include split sample testing with another method or with another laboratory, the testing of previously tested patient specimens in duplicate, testing of patient specimens in duplicate, or other defined processes approved by the laboratory director. Evidence of Compliance: ✓ Written procedures for alternative quality control AND ✓ Records of alternative control procedures Thanks!!!

I'm curious if anyone outs there have any specific procedures for troubleshooting ECMO patient's and their wonky Coag pictures? What tests do they typically use and what instrument do you run? Thanks

We run 2 levels of body fluid controls every 24 hrs on the Sysmex XNs. It's a control specifically for body fluids as the XN treats body fluids differently than it does peripheral blood specimens. When we had the XE analyzers we did not run a specific QC but we also ran them specimens same way we ran whole blood specimens.

We prefer doing a plasma blank as opposed to saline replacement. A lot of times we can correct for Lipemia with a 1:5 dilution when we can't we do the following. Plasma Blank: If severe lipemia is present, spin an aliquot of the patient’s blood at 3400 rpm for 10 minutes. Remove the plasma to a small glass tube and run this “plasma blank” in manual mode to obtain the Hgb value for the plasma. Calculate the corrected Hgb: Corrected Hgb = Whole blood Hgb - ((1-Spun Hct) X Plasma Hgb) Use the corrected Hgb and original RBC result to recalculate the MCH and MCHC as required.

As we do our self inspection I have come across this new CAP requirement. **NEW** 08/17/2016 Alternative Control Procedures If the laboratory performs test procedures for which control materials are not commercially available, there are written procedures for an alternative mechanism to detect immediate errors and monitor test system performance over time. The performance of alternative control procedures must be recorded. NOTE: "Performance" includes elements of accuracy, precision, and clinical discriminating power. Examples of alternative procedures may include split sample testing with another method or with another laboratory, the testing of previously tested patient specimens in duplicate, testing of patient specimens in duplicate, or other defined processes approved by the laboratory director. I have a number of tests that do not have commercial QC, Gastrocult, Hansel Stain, Giemsa Stain, PFA, and HITs. My questions are: Does anyone know of any commercial QC for any these tests? Anytime we do a Wright or Giemsa stain we generally judge the quality as our QC. For Hansel we do stain a blood smear that has a high Eos count. Does anyone do anything different? Thanks!

I've used the the CA1500 for about 13 years at multiple different facilities and although it is a work horse with very few issues, the technology is very antiquated. We've been trying to upgrade for a number of years to the 2500 but no luck securing the money yet. If you're looking, don't even look at the CA1500 definitely look at the 2500 or something else.

Does anyone use the VIDAS for DDimers? How's the ease of use? How long do tests generally take? Are your physicians happy with it? Is it easy to calibrate? What's the reliability of the QC? Any issues? We are currently using the CA1500's Thanks!

How many places spin their urine QC and perform a microscopic exam? Do you do it daily? weekly? monthly? My big question though is this a CAP requirement. I can't find anywhere where it states that it is a requirement. I recently took over as supervisor and I don't know if we are doing this every day because we always have or because it's required. Thanks

How many places spin their urine QC and perform a microscopic exam? Do you do it daily? weekly? monthly? My big question though is this a CAP requirement. I can't find anywhere where it states that it is a requirement. I recently took over as supervisor and I don't know if we are doing this every day because we always have or because it's required. Thanks

Anyone out there reporting the XN automated differential for body fluids? If so how do the providers like it (do the insist on more than a 2 part diff)

Does anyone out there require that staff wear a face shield when performing a CBG or doing any type of capillary puncture?

Curious what people use. I'd love to get rid of the Hansel stain and make life easier on my Techs.

Thank you for the responses. It took over 6 months but we were finally able to get everything to work with full auto verification. Thanks!

Does anyone out there have the XN line, SP-10, and the DI60 Cellavision with SoftLab as their LIS? I'm looking to see what people's work flow and processing is. We're having trouble getting our interface built. Thanks!

All of our flags on the Xe-2100 are interpreted in our LIS (we use Soft). I am not familiar enough with the computer interfaces of any of these machines to give you any insight. Sorry.

I have used Advia's, Coulters and Sysmex machines and I would say Sysmex wins. They are easy to use, the online QC management program (insight) is great, I love getting an optical plt, %IG and automated NRBC count. We have 2 XE-2100's, a XS-1000i and a Poch-100i in our organization. We also have the XE-2100's set up on an automated line with a slide maker stainer that is wonderful!!!. Very easy to maintain, we have had almost no major issues with them. I dislike the Coulters because we always had problems with them ( I used the LH500 and LH750). I did not like the way they ran, and the software. The Advia's weren't bad but it always seemed like we were sucking clots into the guts of it and needing it replaced (a lot of that was user error I will admit). Hope this helps if you want more info just holler

We have 4 TEGS, 2 run in Hematology (for Plavix monitoring) in the lab and 2 run by our Perfusion department in the CVOR. They have had TEGs at the facility for about 6-8 years?? Long before I joined. They went a long way to reducing the amount of product that was transfused during CABGs and other cardiac surgeries. I don't know about their use in Trauma it is not a quick test by any means taking about 1.5 hours to run a Plavix profile and I would estimate at least 45 minutes for a basic TEG (this is once we get the specimen). It is a fascinating instrument but not an easy test by any means. It is time consuming to set up and not conducive to multitasking.

If you are looking for an small analyzer that is easy to use the Poch-100i is a great option but the 3 part differential does not correlate with the XE-2100s. The differences in testing methodology (Pochi measures solely by impedance) are far to different and it consistently does not pick up immature granulocytes, nucleated red, server left shifts, and counts a lot of monos as neutrophils. The other indices correlate beautifully. We use the analyzer at an Urgent Care Center but we do not report a differential. I have verified a plt count down to 7 BUT if there are any plt abnormalities it will error and not necessarily give an accurate count with out correlating it with smear review. We use the XS-1000i at an Oncology center and it is a great instrument, but it is not cheap and maybe overkill depending on how many specimens you run. Good luck! I have included and article for you from Medscape at http://www.medscape.com/viewarticle/509093_4 "The pocH-100i analyzer is a 3-part hematology analyzer recently approved by FDA. The instrument is designed for a laboratory running 20 or less samples a day. The operation of the instrument is fairly simple and user-friendly. It takes about 5 minutes to start up and 3 minutes to shut down, with an analysis time of approximately 148 seconds per sample. Both whole blood (15 B5L from 13 mm cap pierceable vial or 15 B5L from microtainer with 500 B5L sample) and prediluted blood (20 B5L whole blood into 500 B5L of pocH-100i diluent) can be used for testing. A lysate and diluent are the only reagents needed for testing and can be acquired as pocH-100i pack reagent from the vendor. A pocH-100i pack contains 2L diluent (x2, good for 60 samples) and 250 mL lysate (x2, good for 500 samples). Consumption per cycle is 40 mL diluent and 0.5 mL lysate. The instrument can store 20 patient samples and 100 quality control results. The analyzer prepares 2 dilutions: 1 lysed and the other unlysed. After the first dilution is measured, the white cells and hemoglobin values are displayed on the screen of the instrument, while the analyzer processes the second dilution, which measures RBC, HCT, MCV, and PLT. With the appropriate adaptor, the instrument can also analyze micro samples from pediatric units. Instrument A uses laser-based flow cytometry for cell analysis, while instruments B, C, and D use aperture-impedance method or the VCS (volume-conductivity-scatter) technology. Although instrument generated flags have been reported in the pocH-100i, we did not encounter any flags in abnormal specimens with blast cells, immature myeloid cells, and nucleated red blood cells. Identification of monocytes by automated instruments is difficult, especially when abnormal cells are present.[3] Our observation of reduced correlation with monocyte counts has been reported regularly in previous instrument evaluations.[4,5] In general, a peripheral smear review is necessary to validate the automated differential generated by the instrument. Our correlation study validates the only previously reported study of pocH-100i analyzer performance. The pocH-100i analyzer is capable of filling a niche in a market where there is a need for small compact analyzers that can generate accurate CBC values. While the analyzer is marketed for physician's offices it could just as easily be used as an inexpensive backup for any size laboratory. Indeed, its direct current (DC) capability can be used as a backup in situations of emergency power outage. In addition, if a primary analyzer is down for several hours, the pocH-100i can easily handle STAT CBC orders. Its small size also makes it ideal when instrument mobility might be needed. We were indeed very impressed by the ability to move it from laboratory to laboratory without excessive packaging. The pocH-100i could easily be used on a mobile cart when the primary analyzer is undergoing maintenance and transported for use in other locations as required. Keeping the pocH-100i plugged into an uninterrupted power supply (UPS), a laboratory is prepared to operate as a backup 24 hours a day, 7 days a week for small volume laboratories and/or as a backup in larger laboratories. The pocH-100i analyzer's compact size and ease of operation with cap-piercing capability make it an ideal primary instrument for low-volume laboratories. The operator of the pocH-100i analyzer primarily interacts with the instrument using a well designed touch-screen display. The menu options and pathways are straightforward and self-explanatory. A "pop-out" door provides easy loading and unloading of blood samples. However, the operator must initiate testing by pushing "run." If distracted, the operator may easily forget to push the "run" button because the instrument does not proactively prompt the technician to initiate a run or to remove previously tested samples. The cap-piercing needle system allows the operator to run samples without opening the tube, providing an outstanding safety feature in an instrument of this small size. The minor disadvantage of the analyzer includes limited data management for quality control (QC) and quality improvement (QI). Although the pocH-100i analyzer has a memory capacity for 100 QC results, technical personnel accustomed to Levey-Jennings (LJ) charts will not be able to view the LJ charts for shifts or trends, nor will they be able to use more than 1 lot number of control material at any given time. Validation of new lot numbers could be cumbersome. However, these minor pitfalls of the pocH-100i analyzer are essentially negligible, given that the instrument is intended for low-volume laboratories. The procedural manual provided with the instrument is easy to follow. The information and illustrations are adequate for a knowledgeable laboratory person to follow. However, inexperienced operators without a background in hematology need technical training, especially to understand histogram analysis. The advantages of compact size, low cost, minimal technical skills, and ease of operation make pocHi-100 analyzer highly suitable and ideal for low volume laboratories, and/or as a backup for larger laboratories. In summary, the pocHi-100 instrument is user friendly and capable of generating consistent and accurate CBC data." Laboratory Medicine. 2005;36(8):487-488. © 2005 American Society for Clinical Pathology

The place that I am at has been using TEG testing for quite awhile (6yrs-8yrs) and although I have not worked there that long they rave about the reduction in the usage of plts, cryo, and FFP. The perfusionists were in charge of the TEGs and the lab has recently got two additional machines as back up for the OR and for outpatient testing. They do TEGs on all OR cardiac cases and in certain other instances. Having run the machines, they are really cool and provide a ton of information once you learn how to interpret the graphs. They also use TEGs to determine if the bleeding post-OP is just from the procedure or if they are leaking and need to go back in to the OR.

Our Perfusion department has recently become concerned with the possible effect of cold agglutinins on their patients. As we test with Gel and use mostly computer cross matches they are looking at possibly having us do cold panels or other cold testing on their patients. We were curious as to how many other places do routine testing for colds on their cardiac patients with negative antibody screens? Thanks :0)

I can't even imagine in what universe that someone would think that this is okay!! So what happened? Please tell me that there were repercussions for everyone involved....

When I worked at a hospital that transfused neonates we transfused either AB or Type specific. If we could not get those we would wash them. We would never give out of type plasma to a child or neonate.

Sorry I should have explained it, TEG Testing or Thromboelastograph is a coag test that measures the whole clotting process and strength of the clot. By reading the graph it can tell where in the clotting process the patient is having difficulties and tell what products are indicated. We have been using TEGs for about 6 years but they have just recently come into the laboratory. They are really cute machines http://www.haemoscope.com/technology/index.html

If you read my QA labeling post you know we have an upcoming QA meeting, in addition to the specimen labeling QA we are also being asked to present data on the amount of wasted units and the reasons why they are wasted. We are looking at number of units transfused in a year to the number wasted due to thawing with out using, returned outside 30 mins and other crappy excuses as to why it left the blood bank and the floors decided not to use them. Again if you have any data that you are willing to share I would be very appreciative. Also do you use TEG testing and if you do have you noticed a decrease in your product usage. Thanks and I hope everyone is well.