Opinions...Cytyc or Tripath(thinprep or surepath)

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Anonymous said:
Only the NEGATIVE slides count as .5, an abnormal slide is counted as 1.5!
Who is still counting all slides as .5 only?
Click to expand...

No. In California you may read 80 manually screened slides per day and a maximum of 200 negative imaged slides per day. (Thanks to Cytic) This means that 10 manually screened slides equals 25 imaged slides. One manually screened slide equals 2.5 imaged slides. Conversely, one imaged slide equals .4 or 40% of a manually screened Pap. Therefore an abnormal imaged slide counts as 1.4 manually screened slides.

Large labs are doing way over 100 imaged slides. Working the Cytotech to an early death.

Because the counting is so tedious, the large corporate labs have set 130+ slides as a limit on the imaged only screened slides. When the counting of negative and abnormal slides are done for the day, the count should not go over 200 imaged or when converted, 80 manually screened slides.
 






Anonymous said:
wow thanks for the press release i forgot about that one. You are an idiot to think roche will eat my lunch. They will get a piece but i suggest you do your homework before speaking. Genprobe aptima hpv is the gamechanger and they will eat your butt

nothing else you can say
Click to expand...

Apparently you did not know this:
http://www.roche-diagnostics.us/press_room/2005/021605.htm

or this:
http://www.businessweek.com/news/2011-04-29/gen-probe-said-to-seek-buyer-hire-morgan-stanley.html

Read and weep.
 






Anonymous said:
No. In California you may read 80 manually screened slides per day and a maximum of 200 negative imaged slides per day. (Thanks to Cytic) This means that 10 manually screened slides equals 25 imaged slides. One manually screened slide equals 2.5 imaged slides. Conversely, one imaged slide equals .4 or 40% of a manually screened Pap. Therefore an abnormal imaged slide counts as 1.4 manually screened slides.

Large labs are doing way over 100 imaged slides. Working the Cytotech to an early death.

Because the counting is so tedious, the large corporate labs have set 130+ slides as a limit on the imaged only screened slides. When the counting of negative and abnormal slides are done for the day, the count should not go over 200 imaged or when converted, 80 manually screened slides.
Click to expand...

Where do you know this from? DO you have any idea what labs are doing it? Do they have quotas?
 












What labs arent requiring over 100 cases a day now is a better question. Many labcorp, quest and bioreference labs are. Look at all the techs that have been laid off in recent years due to the increased productivity. The ones still employed are scared to talk. Hopefully teh field will die soon so a bunch of women dont die. It would be better to do HPV testing at this point since the quality of screening is so bad.
 






Anonymous said:
No. In California you may read 80 manually screened slides per day and a maximum of 200 negative imaged slides per day. (Thanks to Cytic) This means that 10 manually screened slides equals 25 imaged slides. One manually screened slide equals 2.5 imaged slides. Conversely, one imaged slide equals .4 or 40% of a manually screened Pap. Therefore an abnormal imaged slide counts as 1.4 manually screened slides.

Large labs are doing way over 100 imaged slides. Working the Cytotech to an early death.

Because the counting is so tedious, the large corporate labs have set 130+ slides as a limit on the imaged only screened slides. When the counting of negative and abnormal slides are done for the day, the count should not go over 200 imaged or when converted, 80 manually screened slides.
Click to expand...

This is absolutely incorrect in California, and sounds like a Cytyc line.

The counting is not tedious nor confusing, sounds like a LabCorp line. This is not advanced calculus, it is using units of .5, 1.0, or 1.5.

Counting any Negative Imaged slide as .4 in California or anywhere else is wrong and directly goes against the recommendations that the FDA published for the Imager in July 2010.

In California 80 is the maximum. Cytyc made the recommendations from a federal standpoint (ie most states screen 100 maximum, therefore 200 Maximum Imaged slides WHEN ONLY 22 FIELDS OF VIEW ARE LOOKED AT ONLY!!!!) The maximum number of NEGATIVE Imaged slides that can be screened IN California is 160 (80x2). As abnormal slides are detected during the day, the Cyto must make their worth as 1.5, because they are looking at ALL of the fields of the ThinPrep...not just 22 fields.

It was obvious in the product insert and it is obvious now, the 200 number was only meant for Negative slides. You move to a Full Manual Review then you count it as 1.5 - Check the recent FDA recommendations (and the Hologic press release that they were forced to make).
How Cytyc lives with themselves for using this bogus clinical data and greasing every politician and organization's hands is beyond me.
So if a cyto in CA screens 130 Imaged slides, just looks at 22 Fields of View on the slide, the maximum number of Abnormal slides (all fields of view) they can have is 15! They have to stop screening to follow the law!
(130/2 = 65, + 15 is the equivalent of 80 manually screened slides.)

In a maximum 100 state (FL, TX, etc), for example, a cytotech can screen 180 Imaged Negative slides, but can only have 10 Abnormals out of the 180! (180/2 + 10 = 100)
For all you CTs you know this is virtually impossible. And I hope to God that there is not pressure out there to "let cases go" to "increase productivity". No Cytotech should ever consider doing that, benign reactive changes or not! The Imager will miss cases of HSIL and only show reactive examples on the 22 Fields of View. Protect yourself and scan these cases and count them as 1.5! Your job is to save lives, not to increase productivity.

This is the way it has always been, LabCorp chose not to follow the FDA regulations as they were written. They saw they could get away with it and they did. They convinced the professional organizations that it was confusing and tedious, and like lambs they all fell for it and didn't want to question the deep pockets of LabCorp and the donations made by Cytyc/Hologic.

So who knows how many cases have been missed in the YEARS of making cytos screen too many? When will we see those cases? I hope it wasn't my mom, or sister, or friend that happen to be slide number 179 on a tough day.

If you are a cyto and think you are screening too many slides per day, you probably are and LabCorp will blame you if you are overworked and miss a case.

If anyone wants to contact me off this site about the calculations, please email me at:
DSanonymousCT@gmail.com
 






Anonymous said:
This is absolutely incorrect in California, and sounds like a Cytyc line.

The counting is not tedious nor confusing, sounds like a LabCorp line. This is not advanced calculus, it is using units of .5, 1.0, or 1.5.

Counting any Negative Imaged slide as .4 in California or anywhere else is wrong and directly goes against the recommendations that the FDA published for the Imager in July 2010.

In California 80 is the maximum. Cytyc made the recommendations from a federal standpoint (ie most states screen 100 maximum, therefore 200 Maximum Imaged slides WHEN ONLY 22 FIELDS OF VIEW ARE LOOKED AT ONLY!!!!) The maximum number of NEGATIVE Imaged slides that can be screened IN California is 160 (80x2). As abnormal slides are detected during the day, the Cyto must make their worth as 1.5, because they are looking at ALL of the fields of the ThinPrep...not just 22 fields.

It was obvious in the product insert and it is obvious now, the 200 number was only meant for Negative slides. You move to a Full Manual Review then you count it as 1.5 - Check the recent FDA recommendations (and the Hologic press release that they were forced to make).
How Cytyc lives with themselves for using this bogus clinical data and greasing every politician and organization's hands is beyond me.
So if a cyto in CA screens 130 Imaged slides, just looks at 22 Fields of View on the slide, the maximum number of Abnormal slides (all fields of view) they can have is 15! They have to stop screening to follow the law!
(130/2 = 65, + 15 is the equivalent of 80 manually screened slides.)

In a maximum 100 state (FL, TX, etc), for example, a cytotech can screen 180 Imaged Negative slides, but can only have 10 Abnormals out of the 180! (180/2 + 10 = 100)
For all you CTs you know this is virtually impossible. And I hope to God that there is not pressure out there to "let cases go" to "increase productivity". No Cytotech should ever consider doing that, benign reactive changes or not! The Imager will miss cases of HSIL and only show reactive examples on the 22 Fields of View. Protect yourself and scan these cases and count them as 1.5! Your job is to save lives, not to increase productivity.

This is the way it has always been, LabCorp chose not to follow the FDA regulations as they were written. They saw they could get away with it and they did. They convinced the professional organizations that it was confusing and tedious, and like lambs they all fell for it and didn't want to question the deep pockets of LabCorp and the donations made by Cytyc/Hologic.

So who knows how many cases have been missed in the YEARS of making cytos screen too many? When will we see those cases? I hope it wasn't my mom, or sister, or friend that happen to be slide number 179 on a tough day.

If you are a cyto and think you are screening too many slides per day, you probably are and LabCorp will blame you if you are overworked and miss a case.

If anyone wants to contact me off this site about the calculations, please email me at:
DSanonymousCT@gmail.com
Click to expand...

Sorry, Correct Email is: DSanonymousCT85@gmail.com
 






arent cytyc reps still telling labs that the 200 limit is ok?
how do they get away with that as far as liability?
and are they telling labs that calling an abnormal slide equals 1.4?
 












FDA Home> Medical Devices> Databases
MAUDE Adverse Event Report

This is only one example of how Cytyc squirms out of responsibility - by saying "no delay in patient prognosis" because the missed case happened to be a QC case:

HOLOGIC, INC. THINPREP IMAGING SYSTEM AUTOMATED MICROSCOPE FOR CYTOLOGY Back to Search Results

Event Date 01/12/2010
Event Type Other Patient Outcome Other;
Event Description
Possible false negative. No delay in pt diagnosis. Abnormal cells found outside 22 fields of view (fov) during qc. Cas agreed no trigger cells seen in fov to prompt an autoscan.

There is a list of such examples on the FDA Maude Adverse Event Report (I cut and pasted from that site).
 






How Laboratorians Can Safely Calculate Workload for FDA-Approved Semi-Automated Gynecologic Cytology Screening Devices
The purpose of this communication is to clarify for laboratories how workload should be calculated when using currently FDA-approved semi-automated gynecologic cytology screening devices. This communication is intended for cytotechnologists, technical supervisors, and laboratory managers using these systems and addresses how to count fields of view (FOV) and full manual slide reviews (FMR), as well as establishing maximum workload limits. Exceeding the designated maximum workload jeopardizes the ability of device users to detect precancerous and cancerous lesions of the cervix and is a public health risk.

What are the current issues with workload recording and maximum workload limits?
It has been brought to our attention that the current product labeling regarding workload recording for these devices has been difficult to interpret, resulting in variability and lack of standardization in counting methods.

In addition, individual maximum daily workload limits are not being established by the technical supervisor as mandated by CLIA’88. The maximum daily limit specified in each of the device product labeling is only an upper limit and should never be used as an expectation for daily productivity or as a performance target.

How can laboratorians safely calculate workload for FDA-approved semi-automated cytology screening device?
To ensure the safety and effectiveness of these devices, given their importance as women’s health screening tests, the FDA has determined that laboratorians should use the following method when calculating workload. The calculation method applies to both semi-automated cytology screening systems currently on the market (Hologic’s ThinPrep® Imaging System and Becton Dickinson’s Focal Point™ Guided Screening System):

All slides with full manual review (FMR) count as 1 slide (as mandated by CLIA’88 for manual screening)
All slides with field of view (FOV) only review count as 0.5 or ½ slide
Then, slides with both FOV and FMR count as 1.5 or 1½ slides
Use these values to count workload, not exceeding the CLIA maximum limit of 100 slides in no less than an 8-hour day.
FMR = 1 slide

FOV = 0.5 slide

FMR + FOV = 1.5 slides

Upper Limit = 100 slides


Note: ALL laboratories should have a clear standard operation procedure for documentation of their method of workload counting and for establishing workload limits.

The following are examples of different counting scenarios that a cytotechnologist may encounter:
Cytology slide count equivalents

Non-gynecologic cytology:

One smear = 1 slide
One slide preparation which results in cell dispersion over one-half or less of the total available slide area = 0.5 slide
Gynecologic cytology:

One conventional Pap smear slide = 1 slide
One manually screened (non-automated) liquid based cytology preparation = 1 slide
One FOV (Field of View) slide screened by the automated method = 0.5 slide
One FMR (Full manual review) slide screened by the automated method = 1 slide
Then, FOV + FMR screened by the automated method = 1.5 slides
Note: If an FMR slide is rescreened manually as part of 10% QC, it should be counted as 1 slide because it is assumed that this slide will not undergo an FOV review a second time.

Scenario 1:

Cytotechnologist screens non-gynecologic and automated gynecologic slide preparations in the same laboratory

Non-Gyn:

15 smears = 15 slides

10 cytospin slides = 5 slides (10 x 0.5)

Gyn:

50 FOV only (automated screening) = 25 slides (50 x 0.5)

20 FOV + FMR (automated screening) = 30 slides (20 x 1.5)

5 QC (manual screening) = 5 slides

TOTAL NUMBER OF SLIDES SCREENED = 80 slides

Scenario 2:

Cytotechnologist screens gynecologic slide preparations both manually and by automated screening device in the same laboratory

15 conventional Pap smears = 15 slides

20 liquid based cytology slides (manual screening) = 20 slides

60 FOV only slides (automated screening) = 30 slides (60 x 0.5)

20 FOV + FMR slides (automated screening) = 30 slides (20 x 1.5)

TOTAL NUMBER OF SLIDES SCREENED = 95

Scenario 3:

Cytotechnologist screens gynecologic slide preparations both manually and by automated screening device in different laboratories on the same day

Lab #1:

Hours worked = 4

10 Conventional pap smears = 10 slides

30 liquid based cytology slides (manual screening) = 30 slides

Total slides screened in Lab #1 = 40

Lab #2:

Hours worked = 4

50 FOV only slides (automated screening) = 25 slides (50 x 0.5)

15 FOV + FMR slides (automated screening) = 22.5 slides (15 x 1.5)

Total slides screened in Lab #2 = 47.5

TOTAL NUMBER OF SLIDES SCREENED = 87.5

***Note: CA screens only the equivalent of 80 Full Manual Review,most other states are 100. Only scenario 1 is valid for California labs. http://www.fda.gov/MedicalDevices/S...s/TipsandArticlesonDeviceSafety/ucm220292.htm
 












All slides with full manual review (FMR) count as 1 slide (as mandated by CLIA’88 for manual screening)
All slides with field of view (FOV) only review count as 0.5 or ½ slide
Then, slides with both FOV and FMR count as 1.5 or 1½ slides
Use these values to count workload, not exceeding the CLIA maximum limit of 100 slides in no less than an 8-hour day. FMR = 1 slide

FOV = 0.5 slide

FMR + FOV = 1.5 slides

Upper Limit = 100 slides (80 slides in California)

Note: ALL laboratories should have a clear standard operation procedure for documentation of their method of workload counting and for establishing workload limits.
 


















Anonymous said:
Are you serious. Of course we have quotas. The max every day or try to find another job that does not. There aren't any.
Click to expand...

I agree that they are all the same. But the real question is that quota falling withing the FDA regulations. If they are, then it is just a crappy job that doesn't care about its people and there is choice.
If there are still labs who think they can slide by and make their own rules as far as workload limits, then that is something else.
Those people who are in that situation need to speak up, contact someone who will listen. Let them know they cant treat everyone like slave machines demanding the same amount of work everyday.
 






Anonymous said:
arent cytyc reps still telling labs that the 200 limit is ok?
how do they get away with that as far as liability?
and are they telling labs that calling an abnormal slide equals 1.4?
Click to expand...

Yes, that is what I was talking about.Even though we know that the slide should count as 1.5, cytic reps, like S. Harner, who I cannot believe used to be a cytotech herself, is advising labs to use the 1.4 count. Who do they listen to? the FDA guidelines or cytic? CYTIC!!!

So the fact is that Quest and other California labs do not follow the guidelines if they are aware that they exist. When I tried to explain this at my lab, I was treated like a trouble maker, so in a market where there are no jobs, and everyone else keeps their mouths closedl, I don't need to be made an example of. I was told the S. Harner gave them the guidelines. Believe it or not.
 






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