Kaiser Plans Widespread Use For Pap Technology

Actual clinical experience with AutoPap System in QC and primary screening proves encouraging

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WITHIN THE HMO INDUSTRY, Kaiser Permanente is highly respected for its thorough research into the clinical efficacy and economic cost of new healthcare technologies.

That is the reason why Kaiser’s decision to adopt NeoPath, Inc.’s automated cytology technology for primary screening of Pap smears is getting widespread attention within the laboratory community.

Coupled with a similar decision by SmithKline Beecham Clinical Laboratories (SCBL), the clinical and the competitive environment for Pap smear testing is shifting in fundamental ways.

Moreover, Kaiser has a different relationship to patients than a commercial laboratory like SmithKline. Kaiser is a closed HMO and truly offers “cradle to grave” care for its beneficiaries. As the largest non-profit HMO in the United States, it does over 1.4 million Pap smears per year just inside its own system.

Early Detection

Because Kaiser has total responsibility for a beneficiary’s health, it is motivated to spend money on early detection which could reduce downstream costs. It will offer preventive tests that government and other private health plans may not currently pay for. More importantly, it is constantly looking for ways to simultaneously improve healthcare outcomes while lowering the overall cost of care.

Curious about what Kaiser might know about this technology that would be useful to clients of THE DARK REPORT, an exclusive interview was arranged with Gene Pawlick, M.D., Director, Regional Laboratory for Kaiser Permanente-Northern California.

New Discoveries

Dr. Pawlick is an active participant in Kaiser’s various evaluations of different automated cytology technologies. “Kaiser is keenly interested in new discoveries which promise to improve current cytology practices,” said Dr. Pawlick. “For that reason, we have participated in many clinical studies and trials for the various automated cytology technologies.

“Kaiser-Northern California did a joint study with Kaiser-Southern California soon after the FDA approval in 1995 of NeoPath’s system for quality control,” he noted. “We were impressed with its performance. We asked to be a field site in the clinical studies needed to support NeoPath’s FDA application for approval as a primary screener.

“For that reason, we have a lot of direct clinical experience with this instrument,” continued Dr. Pawlick. “NeoPath’s automated primary screening system has increased the sensitivity of the Pap smear screening process. The published clinical studies in which we participated document the specific levels of improvement we experienced within the Kaiser laboratories.

“In fact, the increased sensitivity came thundering out of the laboratory at us,” he added. “No one could ignore it. The science was beautiful and the impact on patient care was obvious.”

Technology Standard

“That is why we have chosen NeoPath as our technology standard at the program-wide level,” said Dr. Pawlick. “The details on a national purchasing contract have been hammered out and the plan is for all Kaiser operations to convert their Pap smear screening to this technology within 24 months.

“In the meantime, we are beginning to share the clinical information with our physicians,” noted Dr. Pawlick. “Across the Kaiser system, the gynecological community is interested in a more sensitive technology which can improve early detection.”

Technology Was Coming

As at SBCL, cytotechnologists within the Kaiser laboratories greeted the AutoPap Systems with some apprehension. “Realistically, most cytotechs have watched the development of various Pap smear products during the last six years. Everyone knew it was coming,” observed Dr. Pawlick. “What many cytotechs did not anticipate was that professional skills are needed to keep these instruments operating accurately.

“This is not like a toaster, where you buy it, bring it home, and you can turn the dial to make the toast light or dark,” he explained. “ These instruments require cytotechs who understand how the machine operates, understand cytology, and apply both skills to keep the instrument finely-tuned.

“In fact, I predict that cytotechs who embrace this technology and learn to blend their cytology skills with the machine’s capability will have tremendous career opportunities that don’t exist today,” added Dr. Pawlick. “Everyone here is still learning what these instruments can do and how they require interaction with cytotechs to maximize the sensitivity and specificity, whether screened automatically or manually.”

For an organization built upon data, exhaustive research, and frequent clinical studies, the ability of NeoPath’s instrument to electronically capture data, process it and store it has not gone unnoticed at Kaiser.

Liquid Prep: Is The Jury Still Out?

Along with NeoPath’s AutoPap QC and Primary Screening Systems, there is another emerging cytology product. It is Cytyc Corporation’s ThinPrep® monolayer system.

During THE DARK REPORT’S interviews with executives at Kaiser Permanente and SBCL, there was little discussion pro or con about ThinPrep or other liquid monolayer Pap smear preparation products.

The key question which surrounds the monolayer Pap smear is cost versus clinical benefit. This was addressed in the Blue Cross/Blue Shield study of new cytology technology, which concluded that monolayer Pap smears did not offer a sufficient clinical improvement for the additional cost, given its current technology.

Certainly Kaiser and SBCL have made strategic decisions to pursue automated screening on a system-wide basis before adopting monolayer preparation products across their national organizations. It may be that monolayer preparation technology will evolve on the heels of automated screening.

If that proves to be true, then today’s generation of monolayer preparation technology is possibly still somewhat ahead of its time.

Information Capability

“There are two aspects to AutoPap’s data and information capability which excite me,” said Dr. Pawlick. “First, its artificial intelligence can be improved over time. That means we can continually raise the bar over current standards of practice. If the instrument delivers in this area, there should be substantial clinical benefit, accompanied by worthwhile reductions in the cost of care.

“Second, we in Northern California want to create a data base of our own patient population,” he explained. “As a cervical pathology subspecialist, I would love to capture more than just the diagnosis. I believe that if we could look at more detailed clinical information and match that against other clinical data, it would result in some very worthwhile discoveries.”

Collectively, Dr. Pawlick’s comments indicate that Kaiser Permanente found the clinical benefits to be, as he put it, “impressive.” As with SBCL, Kaiser found further validation about AutoPap’s cost effectiveness in the Blue Cross/Blue Shield study released last April.

Kaiser, as a non-profit HMO, has a different business mindset than SBCL, which is a for-profit commercial laboratory. But both organizations tell a consistent story about significant improvement in sensitivity and specificity. Each acknowledges a certain level of operational benefits also expected from NeoPath’s automated primary screening technology.

Willing To Move Ahead

It is a strong endorsement for this technology that Kaiser, responsible for its own reimbursement, is willing to move ahead after careful consideration of clinical benefits weighed against additional costs. Kaiser’s actions should certainly cause other laboratories to reconsider their position on automated screening versus manual screening.

What Makes The AutoPap Instrument Tick?

ONE CRITICAL COMPONENT to the AutoPap instrument is its software algorithms.

“Mathematical morphology” is the design philosophy. This deals with the dynamics of shapes. It is a branch of mathematics which allows shapes to be divided by shapes. (Think of a wine glass divided by a kitchen plate.) It is a segment of mathematics which is non-commutative, non-additive, non-linear and difficult to comprehend.

AutoPap uses mathematical morphological algorithms to analyze normal versus abnormal cell structure. It produces no “graphic” in the true sense. Rather, it produces measurements of what is in the image. It is these measurements that provide the basis for future data set comparisons with other clinical information.

Processing speed is another strength of AutoPap. The average mammogram contains seven megabytes of data. The average Pap smear contains four giga-bytes of data!

In seven minutes, Auto-Pap can analyze one Pap smear. It requires a computation rate of 15 billion instructions per second (BIPS). Compare this with a desktop computer, which operates in millions of instructions per second (MIPS).

Fifteen Morpho computers (each with ten chips) come packed inside every AutoPap instrument. Each Morpho computer handles 1 billion instructions per second. That’s how AutoPap gets enough crunch-power to speedily process a single Pap smear!


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