Colleen,
I acknowledge your 18 years of lab experience. I expect you have seen the entire spectrum of subjective rather than objective categorizations of Bethesda parameters. Yet isn't the Bethesda system where the fault partially lies? It requires the impossible......objectivity. How do you maintain a quantitative and qualitative standard by all diagnosing clinicians?? As you are well aware, objectivity goes out the window when there is a distraction, a runny nose, an unhappy relationship, a full bladder, an ill child at home. Ask three people the color of a new car and you will probably get three varied answers. Interpretation is at the heart of the PAP test as your anecdotes confirm.
Couple that with the inherent nature of the slides...a multitude of cells, mucous, blood and it is amazing that the 50 year old PAP smear has lasted as long as it has. You said.... Patients are being overtreated because techs and pathologists are grossly overcalling. Yes...medical insurance providers are increasingly bearing the brunt of these "safe calls". It is a litigious world we live in. Yet everyone making safe calls increases the costs to society in doing so. It is no small wonder the sensitivity rate of PAP smears is diminished in comparison to yesteryear. The NeoPath system as a primary screener will not eliminate these systemic problems...it may momentarily lessen them until boredom and complacency resurface. But at what costs and how many ravaged lives in the interim?
Are you aware there is an FDA approved Hybrid Capture HPV DNA Assay for the detection of HPV (the primary cause of cervical cancer)? This DNA Assay is "currently" only approved as an adjunct to the PAP smear but is undergoing clinical trials for use as a primary screener.
This Hybrid Capture DNA/RNA assay test has its own CPT Code and is FDA approved with Cervical specimens collected with a broom collection device and rinsed in Cytyc PreservCyt Solution, among others.
Considering the traditional PAP smear test does not overtly detect HPV and the DNA HPV Assay (made by Digene (DIGE) ) detects some 95% of HPV, it appears that the PAP smear may eventually become a relic.
The 50 year old PAP smear (with a marginal detection rate) may ultimately give way to this new method should the HPV DNA Assay procedure receive "primary screening approval". It would also seem that responsible labs must eventually embrace this new technology or suffer the consequences of failing to provide truly objective screening for cervical abnormalities or the absence there-of. Medical coverage providers have a multitude of reasons to embrace it.
When and if the NeoPaths AutoPap system is eventually approved, it will still require a considerable initial lab expenditure and reimbursable rate. A slide usage fee will still increase costs, albeit hopefully with a certain higher qualitative analysis. In the end we will still have copious rescreens and a human element trying to maintain objectivity within the parameters of the Bethesda system.
Now look at the DNA/RNA Hybrid Capture Assay...with its minimal base capital requirements it provides totally objective automated screening and classification for various forms of HPV. The DNA Assay seems to provide the answer that insurance providers are looking for. A process that can cost effectively screen for latent abnormalities before they become visible under a microscope. A process that requires no massive amount of optics and gears and algorithms and neural network databasing. A system that eliminates the "speed bumps" of visual acuity. A process that eliminates an average of $1200 worth of colposcopy, and follow up treatments for false positives. A system where results are easily interpreted and automatically objective and accurate (92% compared to the 70% average sensitivity rate for the PAP smear). A system where false negatives are significantly reduced. And last but not least... a system that extends cervical exams visits and tests for non-risk inherent patients with a commensurate cost savings.
Colleen your own anecdotal statements of the problems that your profession faces will not be cured by the introduction of a NeoPath primary screener. Your own statement suggests that the calls will get more challenging:
<<I am predicting that when the autopap signs out the easy slides, mediocre techs will either have to sharpen skills or leave the profession. Their work will be consistently more challenging. Hopefully, the autopap will also remove some of the epidemic paranoia in my profession. We techs will no longer have to worry about tiny cancer cells being totally missed by human eyes.>>
Sounds to me like complacency is already rampant in this redundant, tedious, and paranoid area of a Labs work load.The price tag of employing the AutoPap Screener, which increases a labs cost by $314,000 (per 100,000 slides) or the price of 5.6 cytotechs (OR) 2.09 Pathologists (based on annual salary) is only going to be a an expensive substitute scapegoat.
No true improvements will be garnered until the human subjectivity element is totally removed from the screening process. The AutoPap may be a first step in the right direction but from an Industrial Engineering standpoint it still leaves a lot to be desired. Of course your comments and others are expected and welcome.
|
