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Test Number : P2070-053
Test Name : IBM FileNet P8 Product Fundamentals Technical Mastery Test v1
Vendor Name : IBM
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IvfOPEN: advanced Egg, Sperm, And Embryo Identification For A Safer IVF industry. | P2070-053 Q&A and PDF Download

earlier this month, a bunch of leaders from the world’s in vitro fertilization (IVF) community and a bunch of engineers from IBM convened a digital assembly to focus on defense; in specific, the deserve to cut back misidentification of IVF specimens to zero the usage of an answer referred to as ivfOPEN. 

To location the magnitude of positive specimen identification into standpoint, accept as true with the names Jessica and Jennifer Smith.

in keeping with Social safety administration facts, about two and 1 / 4 p.c of feminine babies born in the united states within the 1990’s had been named Jessica or Jennifer. all over that identical decade, probably the most usual final name turned into Smith, which accounted for 1% of all toddlers. That ability that there are about four,500 Jessica or Jennifer Smiths between 20 and 30 years historical within the u.s.. 

within the coming decade, if they observe a 15% incidence of infertility, 675 of these women could need IVF. Assuming a generous 50% success price per IVF cycle in the coming decade, these women could account for 1350 cycles. each cycle will produce between three and six various kinds of tissue that may need storage for the later use (eggs, embryos, semen, trophoblast, testicular biopsy, ovarian biopsy), that means that the 1350 cycles might produce an mixture eight,one hundred samples, all labeled Jessica Smith or Jennifer Smith. depending on the penmanship of the labeler, it may be elaborate to inform one grownup’s specimens from a further’s. more alarming: every of those eight,100 samples generates straws for eggs (count on 12 per egg freezing cycle), one or greater sperm vials when sperm is frozen, straws for embryos (count on 4-6 per cycle), and one vial per embryo when biopsied for PGT. every of these is a potential labeling error, as are the assorted dish and other vessel-labeling steps. In sum, the 675 Jessica and Jennifer Smiths may symbolize tens to a whole lot of hundreds of separate situations the place a specimen may be mislabeled or transferred to one other patient.

We comprehend that patients swap clinics and that their frozen sperm, eggs and embryos go back and forth with them, so they can not tell for certain how these eight,100 samples could be allotted between the 450 or so IVF clinics in the country. Nor do they understand what number of Jessica or Jennifer Smith specimens may be shipped to the us from different countries.

however they will count on that as the number of kept specimens continues to rise, the possibility of mistaking one Jessica or Jennifer Smith’s specimen for a different Jessica or Jennifer Smith’s specimen in a given IVF lab will upward thrust too.

 There are loads of general names; there are virtually as many Ashley Smiths as Jessica Smiths, and there are more Emilys, Sarahs, and Samanthas collectively than there are Jessicas and Ashleys. And Smith is far from the only regular remaining identify. Census information indicates that in 1990, .8% of babies were Johnsons, .7% have been Williams, and .6% Jones and .6% Brown. Add Davis and Miller and they are close to 5% of the inhabitants. And as IVF cycle volumes raise for infertility, fertility maintenance in oncology, genetic ailment prevention, LGBTQ fertility administration and proactive management of risk for future infertility through the use of egg freezing and storage, specimen mixups will boost for these names too. 

Mistakenly fertilizing eggs with a stranger’s sperm, transferring an extra patient’s embryo to a girl expecting her personal genetically-linked embryo, or having to destroy a specimen as a result of uncertainty of origin may still be in no way movements, like amputating the incorrect leg or working on the inaccurate side of the mind. alas, besides the fact that children, a Google seek “IVF mix-up” yields 349,000 outcomes. 

And ivfOPEN aims to repair that. How? Some background first. 

IVF and computer systems

The information age arrived just a few years too late for IVF. 

Mary Louise Brown, the primary IVF baby, become born in 1979 into a global of typewriters, clipboards, pencils and erasers. IVF laboratory information over lots of the next decade consisted of a number of simple numbers (variety of eggs, awareness of sperm) that all and sundry understood, and descriptions that supposed whatever thing a bit diverse to each person who encountered them. One embryologist’s “doable day two embryo” turned into an additional’s “mildly fragmented asymmetric four-cell embryo” and yet an additional’s “grade AB-.” however seeing that nobody else saw the records, it didn’t in reality remember how they recorded it.

in the early years of IVF, they accumulated sperm and eggs and made embryos, which were all either used or discarded within a number of weeks. Some embryos became into time period pregnancies. Over time these pregnancies accrued identities: names and numbers and pictures. Embryos that arrested within the lab or did not increase after transfer left a legacy of a couple of lines of obscure, arbitrary textual content, scribbled into the affected person’s chart.

just before 1979, they already knew a way to freeze, save and thaw sperm. Over the next two-and-a-half decades, they discovered a way to do the equal for embryos, and later for eggs. Then they learned how to query the eggs and embryos, to verify for genetic advice. These new talents coincided with gradual, constant growth in the price of a hit being pregnant for every embryo transferred, an effectivity that resulted in transferring fewer embryos per cycle, which in flip resulted in more embryos that may be saved for future use.

This new talent created a new challenge, although, that of developing a standard language to precisely and continually describe, music, inventory and pleasant handle what became a big worldwide stock of embryos, eggs and sperm, a collection it truly is becoming at expanding prices, and has steadily overwhelmed the rudimentary methods which have been developed piecemeal from one remoted IVF core to the subsequent.

we've yet to conquer that challenge.

acquainted with monitoring results of whole cycles, each as a legacy of the early, pre-freezing IVF era and to agree to influence reporting necessities of the united states centers for disorder handle (CDC), IVF clinics’ techniques for information assortment, nice manage, and stock management on the particular person specimen level dissimilar from health center to sanatorium, or modified with alterations in laboratory leadership. 

we've always been respectable at answering “pregnant: yes or no?” 

We’re now not amazing at “egg or embryo: first rate, bad, or what? And why?”

So while their science has improved, permitting us to function intracellular and intra-embryonic surgery, to deduce ever stronger amounts of information from the eggs and embryos that they shop, and make viable one-embryo-at-a-time efficiency, their statistics assortment is still in an suggestions wasteful previous. 

This relative forget of specimen stage facts analysis changed into exacerbated by the character of the data itself, which remains descriptive and subjective, far from ultimate for standardization, rigorous evaluation and rational choice making.

In a fantastic world, their skill to retrieve and store statistics concerning the eggs and embryos that they preserve frozen in laboratories would have been developed at a similar pace because the bioengineering that created these new sources of statistics. unluckily, they have not yet transitioned from the analog/descriptive/sample attention/I understand it after I see it language of the 20th century.

And this haphazard strategy to retaining song of sperm, eggs and embryos is causing issues on the most basic stage: protecting tune of what’s the place and what belongs to whom.

Enter ivfOPEN: the idea

The aggregate of a massive and rapidly becoming variety of frozen and stored specimens spread among lots of IVF labs and storage amenities worldwide, labeled inconsistently, lacking a most desirable practices formulation for inventory management or protocol for specimen and label transfer from one web site to the subsequent aspects to 1 very primary and glaring solution: an industry-large equipment to generate a special identifier for every specimen at its aspect of beginning, producing a universally queryable source of true id that follows the specimen anyplace on earth, and not using a opportunity of identifier duplication.

shifting IVF checklist-preserving from the cycle stage to the specimen stage may still be the first, and arguably the most important, step in removing specimen identification mistakes and the “in no way error” that observe these blunders.

but how do they put into effect this?

earlier than considering a solution, what’s most super about the want for a robust identifier and tracking system, a “single source of fact” concerning specimen identity, is that this theory has been in existence in a single form or a different, all the way through industry, public fitness and executive, for many years. the primary social security numbers had been assigned in 1936. VIN numbers for automobiles had been delivered in 1954. ISBN numbers for books begun in 1970. the first UPC grocery scan turned into carried out in 1974 on a pack of gum in Troy, Ohio. How do they justify now not enforcing a single source of certainty device for IVF?

That referred to, how can they implement this?

Enter IBM, and blockchain.

entertaining specimen tagging and tracking is not new; it has been effectively carried out in plenty larger industries; food is a brilliant illustration. Bacterial infection within the produce aisle of a new Jersey grocery store will also be straight away traced to a lettuce box in California and every transport vehicle in between, using a gadget designed by using IBM, part of an usual protection and surveillance infrastructure that identifies and data voluminous records about their food deliver, however that limits entry to sensitive statistics via an unimpeachable permissions structure. IBM additionally lately piloted an analogous system with the FDA the use of blockchain to music prescription remedy in the US. (perform a Google search for IBM and blockchain for a tons extra thorough dialogue of blockchain and how it works to arrange and give protection to the integrity and confidentiality of big datasets.)

IVF procedures include dozens of strategies and interventions, most of which involve some degree of identity investigate. by using replacing handwritten labels or sharpie-generated petri dish identification programs that may additionally depend on some aggregate of affected person identify, date of procedure, or beginning date; inputs in order to basically certainly trigger duplication error as the sheer number of specimens increases and that they circulate from one lab or storage facility to an extra ― by way of replacing these with a pc generated and electronically tracked (suppose bar codes or RFID tags) identification system they will rationally engineer the removal of specimen disposition errors.

This digitalization of IVF specimen identification, applied right through the IVF ecosystem, is the vision of ivfOPEN. Implementation will contain advent of a point-of-specimen introduction system for entertaining identifier project, and software/verification of that identifier at each step in specimen contact, in addition to administration of the records generated and manage of access to these information through a strict permission constitution. 

imperative to the success of ivfOPEN is conserving its slim scope. IVF is a series of interventions, performed with the aid of a consortium of experts, service suppliers, medication, reagent, machine and gadget producers and managers. Ideally, ivfOPEN will enrich the efficiency of each and every step of this operations chain, enhancing the safety and sure bet of all of them with out competing with any of them.

Naturally, a cooperative plan like this raises questions.

not each sanatorium writes patient names on sticky notes. Some have computerized programs already. the place does ivfOPEN healthy there?

ivfOPEN would integrate with the present gadget to generate the identifiers themselves, insuring that no two specimens any place in the world had the same picking out label. The ivfOPEN equipment may still be value-added to any latest labeling or witnessing gadget.

is this yet another IVF cycle “add-on” if you want to raise fees to sufferers?

fairly the contrary. The plan for now, pending prison and engineering advice, is to make the ivfOPEN a non-profit. After an preliminary build-out period paid for by way of business-leading organizations, the gadget will guide itself with tiny costs (likely $1 or less) each and every time the device is used for an identification verification (the equal of the usage of an iPhone to scan a bar code.)

Why would companies make investments in this technology in the event that they do not own it?

The short reply is that these companies make the most of the growth of the IVF business. I actually have modeled the united states IVF underlying demand for IVF to be neatly over a million cycles per year; at present they do under 300,000. recently, enlargement in corporation-based mostly IVF assurance insurance for IVF and egg upkeep, expanded use of IVF to keep away from genetic disorder, hold fertility for oncology patients and broaden family unit building in the LGBTQ group collectively presage an acceleration in IVF demand. To the extent that this multiplied demand can be met efficiently, and — greater importantly — safely, heading off specimen loss and accidents from specimen identification mistakes, the usage of innovation, then that innovation can be supported with the aid of business incumbents.

How concerning the docs and embryologists? What's in it for them?

Three benefits instantly come to mind: 1) possibility mitigation. whether or no longer the security advantage stemming from precision specimen identification translate into actuarial tables and coverage savings, they're going to in the reduction of the risk of rare catastrophic pursuits that may wreck a health center’s acceptance and influence in lawsuits 2) the ivfOPEN system will exchange a legacy specimen identification gadget that changed into no longer designed to dispose of duplicate identifiers from specimens transferred in from other amenities and 3) the device might be engineered for speedy and seamless workflow (take into account the iPhone - bar code comparison.)

What about privacy considerations?

As we've discovered from IBM, the combination of “scrubbing” of the identities underlying the identifiers and setting up a strict, non-tamperable permissions architecture in order that the most effective queries which are viable are people who keep the integrity of the information.

So how can they make this happen?

probably the most critical features: simplicity and humility.

ivfOPEN should still remedy one issue: design the most beneficial system for assigning wonderful identifiers to specimens bought or created all the way through IVF and serve the complete IVF group: sufferers, doctors, scientists, team of workers and organizations, in a price-introduced style that doesn't intrude with or compete with their dreams; to facilitate a way forward for safe and attainable IVF.

disclosure: The writer is co-chair of ivfOPEN.

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