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Subject: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

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1.  FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 16 days ago
No replies, thread closed.
CBC is a high complexity test, and the abnormals require a peripheral blood smear to be read for a differential, morphology review,etc.
How can the FDA say that this is a low complexity test that untrained people can do.

I say we organize and get this reversed!!!

Diane Deutsch-Keahey, Ph.D, MT(ASCP)SH


2.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 16 days ago
No replies, thread closed.
Hi Diane,

The FDA made the announcement yesterday. Determinations and approvals by the FDA are not the same as promulgation of rules, that require publication and open comment periods.

The rules for CLIA and what is required of a waived test have not changed, so the FDA would have had to determine that this machine met the existing requirements.

From the news reports, which are fairly sketchy, and the FDA notice, it appears there may be restrictions on its use, but it's very hard to tell by what was published.

Opening it up to the group, does anyone know anything about this device?

Regards,

Jim

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Jim Flanigan, CAE
Executive Vice President
American Society for Clinical Laboratory Science (ASCLS)
1861 International Drive, #200 McLean, VA 22102
o: 571-748-3746 | m: 708-359-5721
jimf@ascls.org | @jimflanigancae
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3.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 16 days ago
No replies, thread closed.
This is the FDA summary on this instrument. It is NOT supposed to be used for monitoring already diagnosed disease states. Has factory calibration. Do not use on children under 2. It is a Sysmex instrument. "Untrained" personnel can operate it. Good luck POLS and clinics. Waived labs don't have to be inspected.!?

https://www.accessdata.fda.gov/cdrh_docs/reviews/K143577.pdf

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Bonnie Jo Taylor, MHS, MT(ASCP)SH
Retired
Shreveport LA
talor27@bellsouth.net
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4.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 16 days ago
No replies, thread closed.
Thank you Bonnie,

The Government Affairs Committee is reviewing this right now.

Jim

------------------------------
Jim Flanigan, CAE
Executive Vice President
American Society for Clinical Laboratory Science (ASCLS)
1861 International Drive, #200 McLean, VA 22102
o: 571-748-3746 | m: 708-359-5721
jimf@ascls.org | @jimflanigancae
------------------------------



5.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 16 days ago
No replies, thread closed.
With the FDA announcement I am sure I join thousands of VERY concerned clinical laboratory professionals over a 'waived' CBC.
Summary of my initial thoughts....
  • I am not currently knowledgeable of this specific instrument & the manufacturer website as of a few minutes ago does not list the XW-100 instrument to all review of the instrument manual, instructions, etc.
  • I am very concerned with the FDA announcement that states 'It (XW-100) is not intended to diagnose or monitor patients with primary and/or secondary hematologic diseases, including oncology and critically ill (what is the definition of critically ill?) patients'
    • does this only allow testing for screening purposes?  will it require that results outside of certain ranges 'be confirmed' (this will be a nightmare!)
    • if therapy is initiated from results, wouldn't this be considered as using results to diagnose?
  • Waived test =s follow manufacturer instructions, no proficiency testing, no CLIA accreditation reviews (unless site happens to be in the selected few for onsite visit by CLIA), etc.  (yikes!)
  • As professionals and as an organization, my hope is that we do not remain silent on this
  • From a couple of presentations by CMS/CLIA and following Q&A sessions with their leaders... they have verbalized grave concern with waived CBCs

If anyone needs the URL for the FDA release: https://www.fda.gov:80/FDAgov/NewsEvents/Newsroom/PressAnnouncements/ucm583997.htm  

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Lezlee Koch

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6.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 16 days ago
No replies, thread closed.
We need to organize for not only this latest indignity where our lab skills are underappreciated and dismissed, but also many other issues such as nurse equivalency. The ASCLS has a lobbyist, perhaps we need more than one. Perhaps it's time for every state to push for licencing all levels of skilled laboratory personnel. At least that would give us some legitimacy in the eyes of other health care professionals, in turn giving credibility to our voices and our skills.

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Helen Wand
Director Clinical Lab Assistant Program
Clackamas Community College
Milwaukie OR
(503) 594-0694
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7.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 14 days ago
No replies, thread closed.
Closing the loop on this discussion, ASCLS is drafting communication with the FDA on the subject. While the agency appears to have followed the existing rules for approval of a device like this, it's clear that the rules are woefully inadequate and outdated for advances in technology that make this kind of device possible. The ruling goes well-beyond what the FDA has traditionally approved and highlights the need for the process to address the pre- and post-analytical phases of providing quality laboratory services.

We will alert the membership and share the communication when it is complete.

Have a great weekend,

Jim

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Jim Flanigan, CAE
Executive Vice President
American Society for Clinical Laboratory Science (ASCLS)
1861 International Drive, #200 McLean, VA 22102
o: 571-748-3746 | m: 708-359-5721
jimf@ascls.org | @jimflanigancae
------------------------------



8.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 13 days ago
No replies, thread closed.
Thanks Jim.

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Drona Pandeya, M.S., MLS (ASCP)CM
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9.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 12 days ago
Edited by Susan Edralin 12 days ago
No replies, thread closed.
An automated result is by nature "moderate complex"  as with this device http://www.sysmex-ap.com/products/diagnostics/hematology/xp-series/ .  Should the instrument flag requiring a manual smear, the manual result is "high complex".  In states like California that differentiate MLT and MLS work inside the lab, this would mean the MLT can run the machine and make the smear, but the MLS would have to report out the manual comments and or manual differential results.

-SE


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Susan Edralin,DBA,MBA,MLS(ASCP)
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10.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 8 days ago
Edited by Susan Edralin 8 days ago
No replies, thread closed.
An Important point is that we are talking about the Sysmex  XW-100 instrument (not the XP).
The instrument is cleared by the FDA11/06/2017 for used in waived settings (Dr. offices)

1.) WHITE COUNT with lymph/neutrophil percent and absolute
2.) RBC COUNT with MCV
3.) PLT COUNT on patients OVER 2 years old from VENOUS blood VENOUS blood (no fingersticks, so phleb or nurse draw).


A Sysmex disclaimer states the instrument is "not intended to diagnose or monitor patients hematologic disease, oncology, or critically ill."

My questions for Sysmex is:
a.)  Is this flow cytometry technology?
b.)  What is Correlation Coefficient with XE
c.)  What do MFG instruction say regarding ANY FLAG on ANY TEST?  Does the instrument provide the end user with a result with a FLAG
or does the instrument say 'unable to determine' - The safety manual says that results are suppressed if sample is compromised to prevent erroneous results. 
d.)  What changed on this instrument from 10/22/2015 to 11/6/2017 to cause the FDA to ammend their classification?
e.) What maintenance is required?  QC every 8 hours of use, QC with each new reagent, lock out if QC out of range, lock of QC expiration date



FDA clearance announcement here:
       https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583997.htm
Search for any device complexity here:
        https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm
Update from FDA on status change dated 11/13/2017:
       https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/results.cfm

Sysmex SAFETY announcement:
       http://pages.sysmex.com/XW-100_Waived_CBC_landing2.html



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Susan Edralin,DBA,MBA,MLS(ASCP)
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11.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 8 days ago
No replies, thread closed.




What is the process to request a recall of this decision?

CBC is not a low complexity, simple test, and should not qualify for fast-tracked CLIA waiver approval.

Why wasn't there requests for comments from professional laboratorians and our organizations.

This is tantamount to permission for malpractice. Untrained personnel can do more harm than good.  This test is too important.

Let them wait (24 hours) for the test results, and get accurate and complete test results, rather than get results that may be flagged and resulted by untrained staff who do not know how to do the reflex testing required when the tests are flagged.  What about critical results? What is the policy on critical results in a CLIA waived testing facility?  There is too much at stake here.

Is call for a RECALL.  Return the CBC to a non-CLIA waived status.

What can we do about this?

Contact FDA

1 (800) 638-2041
(301) 796-7100
Information-Medical Devices / Radiation Products

Division of Industry and Consumer Education

CDRH-Center for Devices and Radiological Health

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993


















w

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Diane Deutsch-Keahey
Assistant Professor
York College CUNY
Jamaica, NY
(718) 262-2811
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12.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 11 days ago
No replies, thread closed.
Dear Friends & Fellow Clinical Laboratory Professionals:

Full Disclosure:  I am proud to be a licensed Clinical Laboratory Technologist, and employed by Sysmex America. The opinions expressed here are my own.  Sysmex is a great supporter of our profession, MLS and MLT education and is dedicated to high quality healthcare.

As I read the posts on this blog regarding the Sysmex XW-100, I understand how this innovation can seem threatening to our profession. The current discussions remind me of the anxiety surrounding automation of WBC Differentials 30 years ago.  Back then there was much concern about an automated instrument proposing to provide results as good as a skilled morphologist.  And yet now, most of us can't imagine being without an instrument able to provide WBC Differentials, NRBC enumeration, Reticulocyte % and Reticulocyte # counts and other Advanced Clinical Parameters.  Abnormal specimens still require review, but the ability to provide quicker, accurate CBC results for the majority of patient specimens allows Clinical Laboratorians to focus on the true abnormal specimens and improve patient care.

You may not have seen this, so I'd like to share a statement to Clinical Laboratory Professionals from Andy Hay, the Chief Operating Officer of Sysmex America. He posted this on the Hematology Interest Group on Facebook.  "Sysmex was delighted by the announcement this week of the first CLIA-waived hematology instrument, the Sysmex XW-100.  We understand some of the concerns raised on social media about the impact of this to quality or patient results, and to the clinical laboratory profession as a whole.  More information will be coming soon.  Be assured that Sysmex is dedicated to the provision of safe hematology results at all levels of healthcare.  Thank You, Andy Hay"

The automation of WBC Differentials did not detract from our professionalism.  We should not assume that today's innovation - the first CLIA-waived hematology instrument, will hurt our profession or healthcare quality.  On the contrary, these innovations move us forward and enhance patient care.




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Sharon Johnson, MBA, DLM(ASCP)
Group Manager, Hemostasis
Sysmex America
Tacoma WA
2245439336
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13.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 11 days ago
No replies, thread closed.
Thank you for sharing this Sharon. I had not seen the message from Andy Hay, but I'm sure everyone is happy that the concerns being raised have reached the leadership of Sysmex. It is impressive that Sysmex is listening.

Everyone would appreciate getting additional information as it becomes available.

ASCLS's concerns are with the regulatory process and whether the FDA is prepared and whether the regulations are sufficiently advanced to accommodate innovations coming from industry. As industry invests in advancing the capabilities of the laboratory, it's critical that there is an appropriate framework.

If there is anything ASCLS can contribute to the dialogue with Sysmex, we stand by willing to help.

Regards,

Jim

------------------------------
Jim Flanigan, CAE
Executive Vice President
American Society for Clinical Laboratory Science (ASCLS)
1861 International Drive, #200 McLean, VA 22102
o: 571-748-3746 | m: 708-359-5721
jimf@ascls.org | @jimflanigancae
------------------------------



14.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 10 days ago
No replies, thread closed.
With all due respect to you, I disagree with making a CBC a CLIA waived test.  This is not a low complexity test, but a high complexity test, and it does, despite what Sysmex told the FDA require advanced training to produce quality results.  I am a Medical Technologist and a Specialist in Hematology, and I teach intro and advanced hematology to MLS students, future professionals in lab medicine that are well-trained...they have to learn why an MCHC might be over 37 and how to trouble shoot that and when the can and cannot report a result.  I once had a student who reported, on a lab report, a value that was incompatible with life, and I asked him why; he said "that's what the machine said".  MLTs and MLSs are trained to know if the results are accurate.  They are trained to do the reflex testing when a CBC printout is abnormal, in reading and grading abnormal RBC, WBC, and Platelet morphologies, and in doing a manual differential, which is more than an automated instruments 3- or 5-part diff.  I worked with Coulter and Sysmex analyzers and they are great.  But, and I mean but, there are techs for a reason.  Can your instrument XW-100 report a diff with band counts, metamyelocyte, myelocyte, atypical lymphocytes, blast counts?  I will answer for you, NO.

I understand WHY there is a demand for quick results, and I understand the rationale for Sysmex to want to sell more instruments and reagents and enhance their business bottom line.  I do not agree with undermining the professional integrity of a test that is a major screening test and of a profession that is hidden, but is still the "eyes of the doctor" and the "medical detectives" and upon whose work leads to quality lab results that lead to diagnoses.  Why cut out the certified personnel (as in trained laboratorians, licensed and/or certified) in this equation.  It is a mockery to propose that the test will be equivalent without a trained tech.  Do you want it fast, or do you want it right?  You can have both, but not this way.

I still don't understand how the FDA let this pass without comments from the Lab Professionals certification and licensing organizations, could have a say.  I recommend a recall of this CLIA waiver for the CBC.

I think this is a slap in the face, by Sysmex, to laboratory professionals and laboratory science.

Ddr. Diane Deutsch-Keahey, Ph.D, MT(ASCP), SH(ASCP)
Assistant Professor Clinical Laboratory Science, Specialist in Hematology





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Diane Deutsch-Keahey
Assistant Professor
York College CUNY
Jamaica, NY
(718) 262-2811
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15.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 9 days ago
No replies, thread closed.
I totally agree Diane. I do not think that the disagreement surrounding with the FDA approval of this new CBC CLIA waived instrument can be equated with the "anxiety" lab professionals had over automated diffs 30 years ago. It is not the same thing. There were laboratory professionals certified/licensed who made decisions around the new automated diff technology, however, this new CBC analyzer does not require that. I agree this is undermines our profession and the quality of laboratory testing.

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Dr. Teresa Mortier MT(ASCP)
Assistant Professor, Medical Laboratory Science Program
Ypsilanti MI

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16.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 8 days ago
No replies, thread closed.
I believe that this dialogue is good for the profession and the industry.  It signifies the health of our profession.  But we have to be careful to get our facts straight.  A "CBC" has since the beginning of CLIA '88 test categorization been both a moderate and highly complex test.  Many, many clinics, including all of the clinics in my organization (about 60 physician office labs) are in a moderately complex environment.  The testing is performed by a variety of MLTs and CMAs.  Obviously in a moderate complexity environment, they have MLS and pathology oversight (but not on-site at all times).  They perform proficiency testing and they are accredited either by COLA or CAP.  The CBCs they perform become highly complex based on result and flags that are produced on their instruments.  In those cases they go to a highly complex lab site to be reviewed and reported by MLTs, MLSs and pathologists.  The majority, by far, of the CBC in the ambulatory environment, are performed in this moderate complexity environment.  As I stated in an earlier post, I don;t currently have any waived labs.  But am I willing to let this waived product introduction run its course to see what is possible. (Yes, many of you are screaming at me right now).

I was at a meeting in Albuquerque earlier this week, with about 50 laboratory leaders and pathologists.  There were also vendor sponsors at the meeting, one of which was Sysmex.  A number of seated together during lunch were with a high level Sysmex individual.  We had the opportunity to ask questions for an hour and to listen.  Am I completely sold?  NO.  But I am significantly closer to being sold based on what I heard about the many quality applications and fail safes built in to the instrument and understanding what it can and can't do.  I am not a big fan of a 3 part diff, but many, many clinic based labs already report a 3 part diff in a moderate complexity environment.  We have made a decision in our organization to require a 5 part auto diff that can reflex to a manual diff.  But, even without the diff, the ability to get a WBC and a platelet with a hemoglobin in a waived environment might have significant value.

Right now we are against this instrument based on many long, held principles  I do not minimize those principles, but I am also open to innovation.

Finally, as I stated in an earlier post, I am not going to be down on Sysmex.  They are doing what a for profit company is meant to do.  They also are playing by the rules currently in place by the FDA.  They have been working with the FDA on this specific product for almost 10 years.  They didn;t just dumb down their moderate complexity instruments.  They developed something new and put many, mnay controls in place.  Maybe that won;t be enough, but I am going to likely be willing to give it a try in a few of my smaller clinics staffed by CMAs for lab.

Respectfully, Rick Panning, MBA, MLS(ASCP)CM

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Rick Panning
Senior Administrative Director
HealthPartners
Bloomington MN
6512805909
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17.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 8 days ago
No replies, thread closed.

What are their safeguards? What training IS required for whoever is reporting the CBC results? Critical values calling? Sending to a licensed lab with non-CLIA waived trained techs to do a manual differential (if and WHEN)?  This is what I do, and do well.  I have 25 years experience and ASCP certification both as a MT and SH, and I CANNOT work in a NYC lab doing any lab work (without a NYS license). And I know what I am doing. So, how come a high school graduate with no training can read my CBC in a doctors office (anywhere in the country, including NYC?).  I am all about accuracy. I was taught that the work and results I release should be good enough (as if they were) for my mother or someone I love dearly.  This cannot be the case when there are only partial results.  I say, if you want the "top", just the CBC without the diff, maybe it is okay to make it  a CLIA waived test, but not a CBCD.

Somethings are worth waiting for, and accurate and complete results, reported by trained techs and QC'ed and problem solved and reviewed and assessed results prior to release are worth waiting for.  Also, if they are run by untrained personell and the test is not a full test, with reflex manual diff as needed and slide review for RBCM as needed, they should get a discount fee and a half-test.  It would be better to not allow this partial test. with a 3-part diff, and no manual diff, and no trained tech.  The FDA is wrong to go against the procedure manual of every lab everywhere for a CBCD procedure.  I say we APPEAL as a profession.  Where is ASCP and ASCLS leadership on this?



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Diane Deutsch-Keahey
Assistant Professor
York College CUNY
Rego Park NY
(718) 262-2811
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Best Answer
18.  RE: FDA approval of CLIA waived CBC using Sysmex XP100...how did we (ASCLS, ASCP, lab professionals) let this happen?!?

Posted 8 days ago
No replies, thread closed.
Some points for clarification.
  • ASCLS leaders, including the Government Affairs Committee are gathering information trying to understand the FDA's decision. Approvals of products and devices do not require public comment through the formal rule-making process. ASCLS was made aware of the approval at the same time everyone else was last week.
  • ASCLS will take into account the thoughts and insights of all the members before formulating a strategy moving forward.
  • The model number in the subject of this thread is incorrect. The model that was approved is the XW-100, not the XP-100. They are different devices. We all need to be careful to be as precise as possible on a topic this technically complex.

This thread has moved to:

http://connect.ascls.org/communities/community-home/digestviewer/viewthread?GroupId=637&MessageKey=85f2f35e-2f91-4449-91af-53fee5e226c0&CommunityKey=9648e19f-9394-4654-959c-ed8c8655343b&tab=digestviewer

Some additional details have been provided by Sysmex there. Some excellent questions are raised in this thread and we will be contacting those posters to move those questions to the new thread.


------------------------------
Jim Flanigan, CAE
Executive Vice President
American Society for Clinical Laboratory Science (ASCLS)
1861 International Drive, #200 McLean, VA 22102
o: 571-748-3746 | m: 708-359-5721
jimf@ascls.org | @jimflanigancae
------------------------------