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Posts posted by SMILLER
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Now that I think of it, perhaps the pathologist is simply offering to help ID a particular cell (they are not really reviewing the entire CBC) that a tech has an issue with. In that case, as long as the patient is not identified, I see no problem--other than the universal precautions thing.
Scott
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! Thanks for the head's up!
Scott
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On 5/10/2019 at 1:56 PM, TRabs10 said:
One of our sister sites was recently cited by HFAP for not following their Anti-D package insert (BioRad Seraclone Anti-D blend for tube testing). Their procedure is to interpret any obstetrical RH type that reacts 1+ or less at immediate spin NEGATIVE until they refer the sample for genotyping. A chartable comment is added to the result stating that the reaction was discordant and that the sample was referred for genotyping. If genotyping shows a Partial D, the interpretation stays as Negative. If the genotyping comes back as weak D 1, 2, 3, or D+ the interpretation is corrected to Positive and a corrected report sent. However, the BioRad package insert says "agglutination of red cells is a positive result". hence the citation. We realized that the "less than 2+" rule in the procedure refers to the FORMER Anti-D reagent (Immucor Series 4) and the SOP was left that way when they switched to BioRad. They aren't interested in changing the current process, because it has helped identify at least 3 partial D mothers who would not have received RhIG if the insert had been followed to a T. My question is, does anyone else follow a similar "less than 2+" rule, have you been cited, and what Anti-D reagent are you using? Do you result these patients at "Indeterminate", at least until genotyping is complete?
Thank you!
I am not sure about this, but just because the insert describes what a positive result looks like, I do not think that means they are trying to say the interpretation is necessarily positive. That's what your facilities' P&P is for, approved by your pathologist and based on whatever data you want to cite.
Scott
- Malcolm Needs and Ensis01
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2 hours ago, AMcCord said:
We've passed several CLIA inspections within the past 10 years.
Yay! But see CFR 493.1256 (d) (3) (ii) and get back to me on what you think that means.
Scott
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I agree. The check cells are not controls. They do not need to have a specific "semi-quantitative" result--they just need to have a positive reaction to show that the wash step was adequate and that AHG was added.
In your procedure you should just indicate that you get some arbitrary positive reaction: 1+, 2+/MF--whatever. Just be sure you are not writing up something that disagrees with the manufacturer'e IFU.
Scott
- John C. Staley, exlimey, Ensis01 and 1 other
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1 hour ago, James Spears said:
I'm assuming they meant a bachelors that isn't in Medical Technology/Laboratory Sciences.
Ah! Then the MLTs are getting screwed, and the facility may be breaking the law!
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I would agree with Mabel, above, where the point of the serial titres is to check if things are getting worse (as in a pregnancy). It seems like you would have to isolate it in all cases, including in the initial specimen, even if the titre is low. Otherwise, if on a subsequent specimen one does have a high enough titre to warrant "splitting" it out, you would have nothing to compare that specific antibodies titre to.
We never have had to deal with anything like this so I also would be interested in what others are doing.
Scott
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I agree with John in his last post. Either MLTs are getting more credit (and pay) than they are due, or the MTs are getting screwed.
Scott
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On regular UAs here (NOT being used for C&S screening), we do micros about 1/3 of the time.
The problem is with our UA/culture screens. We have to do a micro on each one to assess WBC and bacteria/yeast. So besides doing a lot of extra cultures, we do a lot of extra micros as well. This is our main problem (in my opinion) -- our screening protocol is too conservative.
Next year we will be getting a Urisys or equivalent. Our protocols are going to have too change.
Scott
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I was wondering what protocols others are using for urine culture screening. Currently we have two ways to order a UA: Urinalysis, and Urinalysis w Screen for Culture. (We also have a straight urine C&S order -- we just do those without scrteening.
If the latter is ordered, we look at the following from a UA: Esterase, Nitrite, and on microscopic: WBCs, and Yeast and/or bacteria. If any of these four things is positive or present, we do a C&S. If they are all negative, we cancel the C&S as "void per protocol".
Almost all of our UA orders now are Urinalysis w Screen for Culture. The presence of bacteria (or something that looks like bacteria) causes the C&S to be done, We get a lot of negative urine C&S s with this system.
Thanks,Scott
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23 hours ago, AMcCord said:
The FDA didn't have a problem with it when they were inspecting us.
The FDA is one thing. But in the US, you have to also follow the CLIA regs. Your inspection agency must, at a minimum, satisfy those in their standards. See the CFR for QC, and review your inspection agency's' standards. You will see what I mean.
Scott
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In the US, a MLS is the professional certification for a Medical laboratory Scientist. Besides a board exam, it first requires a B.S. in an accredited program. Is this what you mean?
Scorr
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28 minutes ago, AMcCord said:
CAP states that a positive and negative test should be run for all reagents, each day of use. However, there is always the bit about following manufacturers recommendations that's involved in meeting CAP requirements. If the manufacturer of the reagents your facility uses recommends running only positive controls daily and your SOP cites that, it's OK to do so. However, even if the package insert states that, your lab's policies may require more extensive QC for reasons specific to your department, facility or the supervisor's preferences. Can't hurt to ask your blood bank supervisor to explain the CAP requirements as they apply to the QC done.
I don't think that is correct about dumbing down to manufacturer's recommendations. I believe the regs read that at a minimum, manufacturer's requirements for things like QC be followed. CLIA/JCAHO/CAP regulations are often much more strict than what a particular manufacturer may suggest for their product.
If you choose to not run a pos and neg control, you better have a better reason than, "the manufacturer said it was OK."
Scott
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We get a couple a year here. The difference is, for our records, as to whether to document it as a cold anti-M or a NSC.
I just wondered what these are when they react as a M and the patient is M antigen positive. Some kind of auto-antibody I guess.
Scott
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A recent thread about homo- and hetero-zygous expression of the M antigen reminded me of something I have wondered about...
Why do so many Non Specific Cold antibodies, when tested with common antibody ID panels, "mimic" anti-M? Apparently there is some moiety present on RBCs that react with a NSC from patients that are often otherwise positive for the M antigen. Yet, the pattern ofr these looks like a M reacting antibody. These seem to be always only cold reacting (IgM), and not significant, but I just wondered what is going on here.
Thanks, Scott
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If documentation of proper blood handling for transfusion is not appropriate, I am pretty sure that the inspectors will not care whether it's happening in the Blood Bank in the Lab or in OR. This is healthcare, after all, and this is my hospital.
I do think it is worthwhile to try to correct deficiencies. It make seem like a sisyphean task at times, but one cannot just give up on this stuff just because we "are at the mercy of human beings". (We should all be used to that by now!)
I do think that efforts should be concentrated on making things as simple as possible, not only for ourselves, but for those other humans in all the other departments that we work with everyday. I do think its worth the effort.
Scott
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On 4/19/2019 at 1:56 AM, YorkshireExile said:
Smiller - When you say you have done a "recent" pos DAT workup, how do you define recent? What time frame?
Generally during the same patient stay.
Scott
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We do not have units in a fridge in OR (or anywhere else for that matter besides the BB). Our BB is just down the hall from OR, so our OR units are kept in the BB until needed for a specific patient Then they are issued in a cooler. Presumably the correct ID and read-back is done in the OR for each unit.
Scott
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22 hours ago, David Saikin said:
If I am qcing gel - I use the diluent as a neg control.
If I am qcing tube reagents, I only test a pos and neg w anti-D, otherwise, only positive qc.
(personally, I think that tubes should be qc'd pos and neg but it is not required in the US (FDA).
Hmmm. Here in Michigan, we are indeed doing negative controls for reverse cells (we just use albumin). We are FDA and JCAHO inspected.
Scott
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19 hours ago, YorkshireExile said:
And if not pregnant or not transfused within the last 3 months?
That caveat is used for inpatients who have a continuous stay. We cannot take the patient's word for it if they have been away from our facility.
However, we have an exception for pre-admit testing, which we will allow up to 10 days before the procedure IF the patient gives us info regarding pregnancy, transfusions and other hospital stays.
Also, in a similar vein, we generally will not repeat an eluate on a positive DAT if it has been worked up recently and the strength has not changed.
Scott
Communication between shifts
in All other topics
Posted
We have a communication log that we make notes on that sits in the center of the Lab near our schedule. Ideally a associate from the previous shift will go over what is on the log with the next shift. We usually have a half hour overlap between shifts tho.
Scott