Lab Soft News

Cleveland Clinic TV Advertisement: Get a Second Opinion in Cardiology

I recently viewed a TV commercial for the Cleveland Clinic on MSNBC. One of the major themes of it was: Get a second opinion if you have a diagnosis of a cardiology condition. There is nothing surprising about a tertiary care center like Cleveland Clinic promoting second opinions. I have been a strong advocate for this in selected cases and have blogged about the idea many times (see: Seeking A Second Opinion as a Partial Solution to the DCIS Controversy; Fourteen Ways to Avoid Getting Screwed by the U.S. Healthcare System; Some Tips for Selecting a "Good" Doctor and a "Good" Hospital; Cleveland Clinic Use of Multidisciplinary Teams; Salaried Physicians Deemed Essential). What strikes me as different about this national advertising campaign is that the need for a second opinion is being planted in the minds of a large number of healthcare consumers. Here is a list of reasons why a patient should seek a second opinion from the Wikipedia article on this topic (see: Second opinion):

1. Physician recommends surgery.
2. Physician diagnoses patient with serious illness (such as cancer).
3. Physician recommends a treatment for the patient other than what the patient believes is necessary.
4. When physician recommends elective surgery, it may be required by the insurance plan. In other cases, insurance will not pay for a second opinion.
5. Patient believes he/she has a condition that the physician diagnosed incorrectly or failed to diagnose.
6. The physician himself/herself recommends a second opinion.

This is a good list to use as a starting point. I would add one more reason which is closely related to the list but not directly stated: to take advantage of special knowledge or diagnostic services that may not necessarily be available in the patient's home environment. I hasten to add that such services in cardiology would be available in numerous tertiary care systems other than the Cleveland Clinic.

For me, the most important reason for seeking a second opinion is the the patient has been diagnosed with a serious disease such as cancer, option #2 above. This closely follows from the idea stated in the previous paragraph because the treatments for various types of cancer are changing rapidly. Therefore, a patient with an aggressive cancer is best served by an oncologist who is familiar with all such options.

I want to list one more comment about the need for a second opinion as to the need for surgery (option #1 above). Indications for surgery can vary and some surgeons may be more inclined to operate than others. I also think that it's a good idea to consult with a second physician or surgeon who lacks a financial incentive to operate or perform a particular medical procedure.

Why Is It So Hard to Promote Meaningful Changes in EHRs?

A recent article in the JAMA network discussed what the authors termed "evolutionary pressures" being placed on EHRs and provided a critique of some of the shortcomings of these systems in the delivery of healthcare (see: Evolutionary Pressures on the Electronic Health Record). For me, the key quote from the article was the following: Bloated records, devoid of meaning and full of cut-and-paste content, are leading some to call for adopting a “less is more” strategy that prioritizes relevant information. The authors of the article then went on to make the following point: 

At present, the spectacular effects of computers in science and in the secular world are not reflected in the EHR, which for physicians remains burdensome, all-consuming, and far from intuitive; this is not surprising, when the dominant EHRs are designed for billing and not primarily for ease of use by those who provide care. In fact, a measure of successful EHR evolution may be that physicians spend much less time with the EHR than they do now. Deimplementing the EHR could actively enhance care in many clinical scenarios.

I was struck their use of the term "evolutionary pressures" in the article. I interpret this as being synonymous with pressure to make EHRs better adaptive to the needs of healthcare providers. How can this be the case when the suggestion is made in the article that "reimplementing" them could serve to enhance many clinical scenarios? In a Darwinian world, poorly adaptive species are destined to disappear.

Generally speaking and in a free market economy, buyers of a product usually have a major effect on the quality of goods being bought. In short, customers don't buy poorly designed or manufactured goods so vendors vie for business by constantly improving them. It seems to me that there are seven major reasons why we are then burdened by EHRs that don't serve us well:

• EHRs are large and monolithic rather than modular. Many have at least some very old code at their core that was developed many years ago. All of this makes it difficult to deploy meaningful improvements of them.
• Even for those vendors motivated to greatly improve their systems, their monolithic and complex status makes major revisions difficult to achieve.
• EHRs have been designed, as the article above emphasizes, mainly for purposes of efficient billing rather than optimizing the delivery of clinical services by healthcare professionals. 
• Hospital executives are much more concerned with the financial status of their hospitals than the efficiency of healthcare professionals who work in these settings. Moreover, few if any of the executives have clinical assignments or work "in the trenches" so they do not experience first-hand the inefficiencies of the "bloated" EHRs.
• There is a quasi-monopoly enjoyed by vendors of EHRs, particularly at the high end, so the market is not a very competitive one. There is thus little pressure for vendors to improve or modify their products.
• Because of the quasi-monopolistic nature of the EHR industry, hospitals clients are unable to exert meaningful pressure on EHRs vendors who exercise a high level of client control over hospitals.
• The federal government, believing that "automation" of healthcare is inherently beneficial, has put pressure on hospitals to deploy EHRs, creating a large and lucrative market for them.

Capturing Value from Remnant Serum and Tissue Specimens by the Delaware HIE

Health information exchange (HIEs) have been struggling since their inception to stay afloat. At the regional or state level, they serve the function of integrating health information generated for patients across the various providers in an area. One of the major problems that bedevils them is developing a successful financial model. Although their mission is critical and despite the fact that vast amount of money are spent on healthcare in the U.S, clinical data integration is not a high priority for many hospitals. The Delaware HIE has come up with a new source of revenue (see: Delaware HIE Teaming Up with iSpecimen to Turn Remnant Clinical Pathology Laboratory Specimens into Cash). Below is an excerpt from an article on this topic: 

The Delaware Health Information Network (DHIN) has entered into a novel collaboration that may help address the medical research community’s growing need for clinical specimens. At the same time, this agreement will also provide a much-needed new revenue stream for participating medical laboratories and hospitals. With Medicare and health insurers reducing reimbursements for laboratory tests, medical laboratories and pathology groups are facing uncertain financial times. However, DHIN’s new partnership with iSpecimen of Massachusetts highlights the potential value of remnant clinical specimens—samples that otherwise would be discarded once patient testing is complete....DHIN is the first data aggregator in the iSpecimen network, which today includes more than 50 hospitals and commercial lab, 400 clinics and practice groups, 10 biorepositories, and a large blood center. Delaware Health Information Network CEO Jan Lee, MD, believes her organization’s collaboration with iSpecimen not only will benefit the medical research community but also will reduce the fees paid to DHIN by member hospitals and medical laboratories that take part in the initiative....[She] believes her organization’s collaboration with iSpecimen not only will benefit the medical research community but also will reduce the fees paid to DHIN by member hospitals and medical laboratories that take part in the initiative....."We have data from every hospital and every commercial lab in Delaware. If they used our data source to identify the specimens of interest, they will get a higher hit rate.” ....DHIN will credit 75% of the transaction fees it receives from iSpecimen back to the hospital or laboratory that donated the clinical specimen. iSpecimen generates its revenue by charging participating researchers for the matching service. Patients must provide informed consent to have their specimens used in an active research project, a requirement that has muted enthusiasm for the joint venture among some DHIN members.

Remnant serum, blood, or tissue samples by themselves are almost worthless. However, linked to a patient's clinical history and deidentified, they becomes extremely valuable for researchers in general and certainly for support drug company researchers. As noted in the excerpt quotes above, two of the major limiting factors for the sale of remnant serum and tissue by hospitals has been (1) obtaining informed consent from the patients and (2) the possibility of pushback from patients concerning such sales even if the specimens are deidentified. It's possible that moving the sales process one step away from the hospitals to an organization like the Delaware Health Information Network/iSpecimen might cause less distress for patients. Moreover, I think that a convincing argument could be made by the hospitals to their patients that such sales help to support the non-profit DHIN and thus support patients by making their integrated health record readily available across multiple facilities. 

Allscripts Launches a Subsidiary, 2bPrecise, Focusing on Genomic Testing

One of the major challenges for EHR vendors like Allscripts is that their strategy and focus has been on reproducing the paper medical record. EHRs have thus been generally incapable of analyzing or interpreting clinical information in a meaningful way or providing advice about sophisticated test ordering. It now appears that at least one of these companies is trying to remedy this problem. Allscripts has launched a subsidiary focusing on optimizing the ordering of genomic tests (see: NIH and Allscripts subsidiary 2bPrecise launch cloud-based genomic technology to boost precision medicine). Below is an excerpt from the article announcing this new company:

2bPrecise, a wholly owned subsidiary of Allscripts Healthcare, has launched an early adopter program at the National Institutes of Health.The NIH, a longtime Allscripts Sunrise EHR client, will deploy a cloud-based genomics and precision medicine platform designed by 2bPrecise. 2bPrecise uses advanced methods in clinical-genomic ontology and data harmonization and returns merged, semantically harmonized knowledge in a machine-readable and structured format.... Medical researchers can combine genomic data with clinical and environmental information in a way that enables statistical analysis and pattern detection. The 2bPrecise EHR-agnostic technology will make it possible for NIH physicians and researchers to use genomic information in their existing Allscripts Sunrise workflow. The goal is to simplify and optimize the complex process of finding, selecting, ordering and receiving genomic tests. Using the 2bPrecise genomics and precision medicine tools, results of genomic sequencing tests will be made available at the point of care through Allscripts Sunrise EHR. Genomic medicine experts from NIH will be the early adopters and include physicians and researchers at the National Human Genome Research Institute, the National Cancer Institute and the NIH Clinical Center. “2bPrecise will soon be able to take a big step toward bringing an easy-to-use, clinical-genomic solution into the mainstream," 2bPrecise General Manager Assaf Halevy said in a statement. He added the offering soon would be available to any provider, integrated delivery network or payer organization to help unlock new insights of molecular diagnostics and new treatments.

Obviously, ordering the most appropriate genomic tests for a patient demands sophisticated computer support. All of this sounds like a good start on a deep learning initiative for one EHR vendor. Just so we are on the same page, here's a good definition for deep learning from Wikipedia (see: Deep learning): 

Deep learning is part of a broader family of machine learning methods based on learning representations of data. An observation (e.g., an image) can be represented in many ways such as a vector of intensity values per pixel, or in a more abstract way as a set of edges, regions of particular shape, etc. Some representations are better than others at simplifying the learning task (e.g., face recognition or facial expression recognition[10]). One of the promises of deep learning is replacing handcrafted features with efficient algorithms for unsupervised or semi-supervised feature learning and hierarchical feature extraction.

One aspect of this announcement seems to me to be particularly important. EHR vendors that embrace new technology like deep learning as a component of their overarching strategy would be well advised, like Allscripts, to create new companies to execute this new strategy. Not to do so would jeopardize the strategy. The best deep learning experts would probably not be attracted to an EHR company that has historically worked mainly with older technology. In general, healthcare IT is far behind the national curve. Perhaps these companies like 2bPrecise will help to reverse this trend.

Employer Medical Clinics; New Opportunity for Lab Outreach?

It's clear that the portion of the outreach business based on private physician offices is declining as the number of such practices decreases (see: Bureaucrats are killing private medical practice). However lab outreach is still big business as the profits of LabCorp (see: LabCorp 3Q Profit Rises 17% Amid Cost Controls) and Quest (see: Quest Diagnostics revenue beats and profit up 67%) can attest. The Dark Daily recently came up with one new possibility for the lab outreach business: employer medical clinics (see: Continuing Popularity of Employer Medical Clinics Brings New Opportunities for Medical Laboratory Outreach). Below is an excerpt from this article:

Employers have a big stake in lowering the cost of healthcare. That is one reason why more employers are incorporating employee wellness programs into their health benefit offerings....Today, employers are going beyond simple wellness programs, creating on-site or near-site clinics to save their employees a trip to their local doctor, urgent care, or hospital....As this expansion continues, so will the potential opportunities for outside service providers to fill demand and provide services.....In a 2015, Willis Towers Watson...conducted a survey that polled 137 U.S. employers representing 4.6-million employees. Willis determined that 75% of employers found that investing in on-site clinics helped to boost productivity. Two-thirds found on-site clinics an ideal way to increase access to affordable healthcare for their employees.... More than one-third of businesses plan to increase on-site clinic access by 2018....This is a prime opportunity for pathology groups and clinical laboratories, as they are uniquely positioned to bridge the gap between hospitals and on-site clinics by consolidating information and helping to form personalized treatment plans, organize screening routines, and help employers to optimize their offerings based on the health needs of their workforce.....Because the majority of employers cite “convenient access” as a leading reason for developing on-site options, local medical laboratories and  providers offer accessibility—along with an ability to tailor services to the needs of the employee population—that most national providers find difficult to match.

I think this idea of lab testing is a good one for large employer clinics with high patient volume that offer more complex tests. However, I suspect many of these clinics probably function as the equivalent of a physical office laboratory (POL), performing relatively few simple tests on-site with occasional send-outs. I had not heard much about POLs lately but did know that CLIA regulations and POLs were closely intertwined. Below is an excerpt from a Wikipedia article on POLs (see: Physician office laboratory):

On January 1, 1987, the Health Care Financing Administration ruled physicians must accept assignment for performed in-office Medicare lab testing, significantly cutting physician revenues. This, combined with plans from third-party to reduce POL payments and increased pressure on Congress to regulate POLs like other clinical laboratories, led to suggestions of physicians banding together into limited partnerships to start their own reference labs. That pressure on Congress led to the signing into effect of the Clinical Laboratory Improvement Amendments (CLIA) on October 31, 1988. 

It seems, however, that POLs continue to have some market share nationally (see: Physician office laboratory):

In July 2015, the Centers for Medicare and Medicaid Services (CMS) reported nearly half of all CLIA-certified laboratories in the United States (122,189) were physician office laboratories. Additionally, 61.3% of the POLs in the United States today are running Clinical Laboratory Improvement Amendments (CLIA) waived tests, and 22.7% hold provider performed microscopy (PPM) certificates. However, in late 2010, POLs were estimated to be processing only about eight percent of all clinical laboratory tests. That number went up to nine percent in late 2014.

I personally think that there will be a growing demand for point-of-care (POC) instruments, both for small labs located in employer clinics, decentralized hospital locations, and perhaps walk-in drug store clinics (if they emerge post-Theranos). What is also clear at this time is that the lab test data generated in these locations must always be integrated into patient EHR records. This can be a challenge, particularly about what EHR records are involved.

API/Sunquest Pathology Informatics Lectures Now Available On-Demand

The Association for Pathology Informatics (API) and Sunquest Information Systems have collaborated for two years to provide free one-hour lectures on pathology informatics topics. The 2016-2017 series will begin next month. Details about these upcoming presentations will be provided in Lab Soft News as well as on API and Sunquest web sites.  

All of the 2015-2016 lectures are now available on-demand at a webinar index page (see: Sunquest and API On-Demand Webinars). Each lecture is identified by an image of the title slide, the date of the presentation, and the name of the presenter. You will appreciate that the presenters are all well-known experts in the field of pathology informatics.

Just click the "view recording" button to launch each of the lectures or click the arrow in the middle of each lecture title slide. There is no paywall but you will be asked to provide some identification information. This will be used only to provide you with notices about upcoming webinars in the  series. Feel free to use the "comment" feature of this blog to ask questions, discuss any of these previous lectures, or suggest possible topics for the upcoming ones.

Janet Kreizman, CEO of AACC, Responds to Previous Blog Notes about Theranos

I posted a note yesterday showing the close association of previous AACC executives to the Theranos Scientific and Medical Advisory Board  (see: Theranos Scientific and Medical Advisory Board Tightly Linked to the AACC). This was in addition to my two previous notes about this same topic (see: Major Miscalculations by the AACC Regarding Elizabeth Holmes and Theranos; Conflict-of-Interest Disclosure for Society Members Who Plan Conferences?). This morning I received an email from Janet Reizman, CEO of AACC, which I have copied in its entirety below, boldface emphasis mine.

As an aside, I count myself among what I would call "old school" in terms of lab professionals. In this regard, I do feel nostalgic for the old days when pathology and lab medicine societies were primarily represented by their presidents who held scientific and medical credentials; nary a CEO in sight. It's also of interest that this email came from CEO Janet Kreizman and not from the AACC president, Patricia Jones, Ph.D.

Dear Bruce:

I have read with interest your recent series of blog posts about the Theranos session at the 68th AACC Annual Scientific Meeting. We at AACC appreciate the feedback of the laboratory medicine community and are always interested in hearing from stakeholders.

I do want to clear up some of the misinformation and/or insinuations that have been communicated in your posts. Theranos did not offer AACC a donation in return for the invitation to speak, nor did the company purchase a booth at the Clinical Lab Expo. The only agreement for this session was that Elizabeth Holmes explain the Theranos technology and answer attendees' questions.  

I want to be clear that no one on the AACC Board of Directors has any kind of financial agreement with Theranos, nor do those on the organizing committee for the meeting. You have noted that four of AACC’s past presidents are members of Theranos’ Scientific and Medical Advisory Board. This is true, but it is certainly not news, since media outlets have been reporting this fact since April. These past presidents -- while respected members of the association -- hold no decision-making authority at AACC and did not have any impact on the decision to have Elizabeth Holmes speak about Theranos’ technology at the AACC Annual Scientific Meeting. This decision was made by the current leadership at AACC.

If you have any further questions, please feel free to contact me, rather than speculating publicly about some wrongdoing that never occurred.

Sincerely,

Janet B. Kreizman

Chief Executive Officer, AACC 

For me, this letter provides some very important insights. Regarding Elizabeth Holmes' lecture at the recent AACC annual conference, the decision to invite her was solely made by the current leadership at AACC. I am not a member of the organization, but I would think that the following questions might arise in the current members' minds and perhaps be put to Janet Kreizman and the members of the conference planning committee:

• What exactly was accomplished by the appearance of Elizabeth Holmes at the annual meeting to further the scientific goals of the AACC as they relate to laboratory medicine?
• Given the amount of national publicity given to her appearance, in what ways did the scientific reputation or financial status of the AACC benefit from her presentation?
• Are any changes to the conference planning process warranted for future years based on this experience?

Theranos Scientific and Medical Advisory Board Tightly Linked to the AACC

In two previous notes (see: Major Miscalculations by the AACC Regarding Elizabeth Holmes and Theranos; Conflict-of-Interest Disclosure for Society Members Who Plan Conferences?), I raised the issue of possible links between the AACC and Theranos. I raised this possibility because I thought that it was a possible explanation for the extraordinary AACC invitation to Elizabeth Holmes, founder of Theranos, to speak at the AACC annual meeting. Her lecture occurred after she had been barred for two years from the lab industry by federal regulators (see: Elizabeth Holmes of Theranos Is Barred From Running Lab for 2 Years). To restate the obvious, Holmes appearance before one of the major clinical lab professional societies did not seem appropriate. Rather than hash over details about her apparently failed previous analyzer called Edison, she then proceeded to introduce in her lecture a new analyzer, MiniLab, which is only in the early development stage (see: Theranos' Highly-Anticipated Defense of Its Tech Is Called a 'Bait-and-Switch').

A reader of Lab Soft News read my notes and suggested to me that I take a look at the membership of the Theranos Scientific and Medical Advisory Board for possible conflicts-of-interest with regard to the AACC. Interestingly enough, there were four of the eight members with tight links to the AACC. They are listed below:

Susan A. Evans, PhD, FACB

Dr. Evans has over 30 years of experience in diagnostics and health technology companies. She served as President, Secretary, and member of the Board of Directors for the American Association for Clinical Chemistry (AACC)....Dr. Evans also served as a member of the Board of Directors and President of the National Academy of Clinical Biochemistry (NACB), now the Academy of the AACC.

Ann M. Gronowski, PhD, DABCC

....She is a past President of the American Association of Clinical Chemistry (AACC) and a past President of the American Board of Clinical Chemistry (ABCC)....

Larry J. Kricka, D. Phil, FRCPath

....He is a Fellow of the Royal College of Pathologists, and a member of the Editorial Board of Clinical Chemistry, and Analytical Biochemistry, and past editor-in-chief of Luminescence. He was President of the American Association for Clinical Chemistry (AACC) in 2001....

Jack Ladenson, PhD, DABCC

....He has been active in a number of professional organizations and has served as President of the American Association for Clinical Chemistry (AACC) and the Academy of Clinical Laboratory Physicians and Scientists (ACLPS). He is also a past chair of the Editorial Board of the journal Clinical Chemistry.....

So, there may be a ready explanation for the favoritism shown toward Elizabeth Holmes by the AACC. There is not much daylight between four of the eight members of the Theranos Scientific and Medical Advisory Board and the AACC. Four of them served as president of the organization. Dr. Evans was also a president of the NACB which is part of the AACC. Both Drs. Kricka and and Ladenson have editorial connections to the journal Clinical Chemistry which is published by the AACC.

In yesterday's note, I suggested that the members of conference planing committees of professional societies post conflict-of-interest (COI) statements regarding their remunerative or investment relationships with companies serving the clinical lab industry. In light of this new information, I would now suggest the same recommendation apply to both past and present officers of the various lab and pathology medical societies. 

Conflict-of-Interest Disclosure for Society Members Who Plan Conferences?

In response to my recent note about the miscalculations in the relationship between Elizabeth Holmes and Theranos with the AACC (see: Major Miscalculations by the AACC Regarding Elizabeth Holmes and Theranos), I received the following two reader comments with the same response: 

Well said. I agree completely. I wonder how many of the AACC decision makers have received remuneration from Theranos?

Well said. Look for the $! Very damaging to the AACC.

For me, the favoritism that the AACC leadership and planners of the annual meeting have shown toward Holmes is inexplicable. Although the incentive for the Holmes invitation could be attributed solely toward stimulating registration for the annual meeting, I think that there may be an additional explanation. In my blog note, I wrote the following: There also needs to be some additional investigation of the remuneration, if any, the AACC received in exchange for inviting her to speak. 

As the two reader comments above suggest, it's possible that some member(s) of the organization may have had some "special" relationship with Theranos or that Theranos provided some financial remuneration to the AACC to pave the way for the Holmes invitation. I have no idea whether this is a the case but the comments cited above do raise the question of what constitutes conflict-of-interest (COI) for members of professional societies when they participate in the selection of speakers for a conference.

I need to first state that nearly all lab professionals who volunteer to work with societies on various activities and meetings have some sort of relationship with vendors of lab products and services but most often without financial remuneration. Most will be customers of some of the conference exhibitors. Hence, it would be impossible to exclude volunteer participation in the conference planning process on this basis. Currently, all professional societies require disclosure of vendor relationships by conference faculty if a company or its product are addressed in the faculty member's lecture. 

I don't know if these faculty COI rules are enforced by societies regarding members of planning committees. If in force, such rules would probably require disclosure of all remunerative or investment relationships with companies in conference brochures and other materials. I use the word all here because planning committee members will be responsible for selecting conference faculty members. Unlike the latter, they have relatively little control over the content of the faculty lectures. Therefore, disclosure of all remunerative or investment relationships for them would be necessary.

Major Miscalculations by the AACC Regarding Elizabeth Holmes and Theranos

This is not another note about the machinations of Theranos and Elizabeth Holmes per se. I have covered this topic in depth in the past. It's more about the recent invitation for her to lecture at the recent AACC annual meeting. Her appearance has been covered well by the Dark Daily (see: Theranos CEO Elizabeth Holmes Presents Scientific Data to Clinical Laboratory Chemists and Pathologists at AACC in Philadelphia) and Bloomberg (see: Expecting Data From Theranos, Lab Experts Get New Product). Here's an excerpt from the Dark Daily article:

Theranos is known to embellish any links it might have with credible parties. To ensure no misunderstanding on the point about an AACC endorsement, when AACC President Patricia Jones, PhD, introduced Holmes, she took extra effort to declare that, in providing a forum for Theranos to present scientific data, AACC was not endorsing the company. Jones added the additional disclaimer that in no way was the association validating the data and technologies that were to be discussed by Holmes. However, when Holmes stepped up to the podium and began to speak, she delivered a curve ball to the audience. She did not present scientific data about the much-ballyhooed proprietary technology that her company has bragged about in recent years. Instead, Holmes introduced a new lab test product [MiniLab], along with data produced from recent correlation studies involving that lab testing device.

There is no possible justification for Elizabeth Holmes to have been invited to speak at the AACC which is a scientific organization for clinical laboratory professionals. Prior to her appearance, she had been sanctioned by CMS and barred from the industry for two years. What possible good could have come out of this appearance before lab professionals? Appropriately, her presentation has sparked serious infighting among some of the AACC members (see: Theranos founder’s conference invitation sparks row among scientists). Below is an excerpt from this second article:

A prestigious scientific organisation has descended into infighting over a decision to invite Elizabeth Holmes, founder of blood-testing group Theranos, to deliver a presentation at its annual conference this week, with at least two members of the association threatening to resign. The American Association for Clinical Chemistry invited Ms Holmes to deliver a 90-minute talk in front of 3,000 scientists...despite protests from some scientists responsible for organizing the conference, who argued that a series of damaging scandals at Theranos should disqualify the company. Ms Holmes had been expected to use the session to present scientific data in defence of her company’s proprietary blood-testing technology, including a tiny finger-prick vial or “nanotainer” that she claims can generate accurate test results without traditional needles or venous draws. However, Ms Holmes, whose company is under Federal criminal investigation, sidestepped past controversies and used her appearance to unveil a completely new machine, the MiniLab, which she said could enable small samples of blood to be analyzed remotely using cloud computing....Several scientists on the committee responsible for organising the meeting opposed the decision to invite Ms Holmes for fear that it would lend credibility to her company, while others decided to boycott the presentation in protest. They believe the association invited Ms Holmes to generate publicity.

In my opinion, AACC president Patricia Jones and other members who went along with this invitation have made two serious errors regarding Elizabeth Holmes. The first was inviting her to speak in the first place at a time when her reputation and that of Theranos was already in tatters. It was an inexcusable publicity grab and not worthy of the organization. The second mistake was not having gained some knowledge about the material she was actually going to present from the podium. The lecture turned out to be the promotion of a new analytic device which is not available in the market and has not been reviewed by the FDA. No other IVD company would have been allowed to take such liberties. These actions have resulted in the AACC becoming an object of national ridicule with damage to its reputation. There also needs to be some additional investigation of the remuneration, if any, the AACC received in exchange for inviting her to speak. I have the feeling that there was more at stake here than a mere interest in providing her a forum in the name of fair play.