Opening a new lab
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Does anyone have any experience opening a new lab? Our hospital is opening up a Stand-alone Emergency Room and we will have a lab within it. I am getting the POC devices ready and am having trouble figuring out how I can correlate the iSTAT with the Lab analyzers if we have no patient sample yet?
I would love any suggestions anyone may have!
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I started a small accredited laboratory in 2018 for moderate gas testing. I would be happy to talk with you and try to answer what I can.
Erika Deaton-Mohney BS, MT(ASCP), CPP
Point of Care and Compliance
Bronson Laboratory, POC
601 John Street Box: 37
Kalamazoo, MI 49007
269-341-8846
deatone@bronsonhg.org
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Hi Amanda
Since I personally did not handle setting up a new lab, I can't jump in but am willing to forward specific questions to someone on our POC team who was Tech Supervisor at the time she did the set up.
Email me privately in case I can't get to this platform in a timely manner - whatever would be helpful for you to know. If you post specific questions, just copy that into an email to me!
pmann@utmb.edu
Hi Amanda,
We've recently opened 2 freestanding ED UC sites, with a third one opening this year and possibly one more to come. The sites are doing quite a bit of POCT; so far about 5000 tests/month at each site--more than some of our smaller hospital labs. We're anticipating they'll only get busier now that flu is in full swing. I'm happy to talk with you about how we validated everything. Email me at kathleen.david@tricore.org
The important thing to note is that the validation studies must be performed at the new location, not at the main lab and then transported. Also all competency assessments need to be performed at the new location. We took blood from the main lab and ran the validations between the point of care analyzers and the satellite lab analyzers. Luckily the sites weren't too far apart.
Hi Kathleen, the multiple ED and UC sites and the high test volume is interesting.
What are the tests and platforms used?
Are the different sites independent from each other or some how connected, especially in terms of LIS result reporting and storage?
Hi Amanda,
You don’t really need ‘fresh” samples for a correlation. I use samples that have already been completed in the lab. Do you have a lab nearby that you could borrow samples?
As long as you sample them about the same time it doesn’t matter how old the sample is. As long as your results match each other. They certainly won’t match the original result, but it doesn’t need to .
I have also asked for “volunteers” to donate blood for validations. Ask your coworkersJ
Good luck
Kathy Andrews
MLT, RT
Point of Care Coordinator /
Coordinatrice des Analyses Hors Laboratoire
Moncton & Miramichi Area /
Régions de Moncton et Miramichi
Horizon Health Network / Reseau de Sante Horizon
Tel: (506)-857-5315 Fax: (506) 857-5325
kathy.andrews@horizonnb.ca
Happy New Year 2020 to you!
Wishing this year brings to you the warmth of love and illuminates your path of life
towards a positive direction.
From: Amanda Miller via POCT Listserv (Groupsite) [mailto:users+1247715@poct.groupsite.com]
Sent: January-02-20 2:58 PM
To: Andrews, Kathy (LAB) (HorizonNB)
Subject: [POCT Listserv] Opening a new lab
ATTENTION! External email / courriel externe.
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We are using:
Sysmex XN 550 for CBC/diff
i-STAT for blood gas, lactate, Troponin, BNP
Piccolo for liver panel with amylase
Triage for D-dimer and urine drug screen
Hemachron for PT-INR
Clinitek for UA and Upreg
Liat for flu A/B, RSV, and Group A strep
We also use Inform II for glucose, mono kit, Stool occult blood and pH paper, as well as a breath alcohol analyzer (not strictly POCT)
We also got specimens from our hospital lab for most of the tests.
The sites are all affiliated with the Presbyterian Health Services, and owned and staffed by Pres. We oversee the POCT stuff. They initially thought that the people caring for the patients could also do the lab testing, but soon discovered that they needed to hire people (EMT-B) to staff the lab as their only function. They take care of ordering all their own supplies. We have a technical consultant who oversees all the non-waived testing, doing QC review and 6 month studies. Presbyterian has an educator who is qualified as a TC who does training and competency assessments.
It was a nightmare to bring up, as it was very different from anything else in place. I think after opening the first 2, we've finally got a template so hopefully the next 2 will be smoother.
Thank you, Kathleen. Your experience is great and your detailed response is much appreciated.
Thank you all for your responses, my concern is I can only run whole blood on the iSTAT. So I cant take samples from another lab if they are already spun down. If I do it that way then I wont be correlating with the same process as an actual patient. My question I guess is, is it necessary to do a correlation if the chemistry analyzer is also just now being validated and hasn't been used on patients yet either?
I use Venous blood gas samples that are in Lithium Heparin. That way I can run them on my POC devices then I centrifuge and run on the analyzer.
Kathy Andrews
MLT, RT
Point of Care Coordinator /
Coordinatrice des Analyses Hors Laboratoire
Moncton & Miramichi Area /
Régions de Moncton et Miramichi
Horizon Health Network / Reseau de Sante Horizon
Tel: (506)-857-5315 Fax: (506) 857-5325
kathy.andrews@horizonnb.ca
Happy New Year 2020 to you!
Wishing this year brings to you the warmth of love and illuminates your path of life
towards a positive direction.
From: Amanda Miller via POCT Listserv (Groupsite) [mailto:users+1247715@poct.groupsite.com]
Sent: January-03-20 9:40 AM
To: Andrews, Kathy (LAB) (HorizonNB)
Subject: [POCT Listserv] Re: Opening a new lab
ATTENTION! External email / courriel externe.
------- Horizon Health Network Disclaimer -------
This e-mail communication (including any or all attachments) is intended
only for the use of the person or entity to which it is addressed and may
contain confidential and/or privileged material. If you are not the intended
recipient of this e-mail, any use, review, retransmission, distribution,
dissemination, copying, printing, or other use of, or taking of any action in
reliance upon this e-mail, is strictly prohibited. If you have received this
e-mail in error, please contact the sender and delete the original and any
copy of this e-mail and any printout thereof, immediately. Your
co-operation is appreciated.
Le présent courriel (y compris toute pièce jointe) s'adresse uniquement à
son destinataire, qu'il soit une personne ou un organisme, et pourrait
comporter des renseignements privilégiés ou confidentiels. Si vous n'êtes
pas le destinataire du courriel, il est interdit d'utiliser, de revoir, de
retransmettre, de distribuer, de disséminer, de copier ou d'imprimer ce
courriel, d'agir en vous y fiant ou de vous en servir de toute autre façon.
Si vous avez reçu le présent courriel par erreur, prière de communiquer
avec l'expéditeur et d'éliminer l'original du courriel, ainsi que toute copie
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reconnaissants de votre collaboration.
If this is a freestanding ED, then it has its own CLIA, correct? The requirements for validating devices per CLIA, CAP, and COLA are: accuracy, precision, reportable range of the test, and verifying patient normal reference intervals. I verified this with all 3 of those agencies; sorry I don't have any non-waived with TJC so not sure about them. This means it is not necessary to compare your devices with any other devices (unless you have more than one of them at the site).
Also, for i-STAT, some of the tests (Troponin is one of them) can be done on whole blood or plasma, so you could compare with the lab for those tests. I would contact Abbott to see what those are if you are interested.
That being said--we did do a lot of correlating to the nearest lab (30 minutes away), and for some of the tests that are more stable, no problem. Even though it's not required for regulations, our medical director did want to compare. For our normal range studies, we just collected blood from volunteers and ran on POCT devices then brought to lab to spin and compare.
To use the same process as patient testing--that's a pipe dream for POCT. Just look at the proficiency samples. Couldn't be farther away than patient samples!