Lab Soft News

Job Description for a LabCorp Phlebotomist

In a previous note, I discussed what I perceived to be the large appetite for college graduate recruits by LabCorp (see: Leading Employers of College Students and Recent Graduates). I was therefore interested when I came across a web-based advertisement for a LabCorp phlebotomist in Monster.com. This is a full-time position in Arlington, Texas. I thought that such a posting would be of interest to readers of this blog. Below is the job description (boldface emphasis mine):

Phlebotomist with a minimum of two years experience.  Skill and comprehension level required for this category: Phlebotomy certification (where required) from an accredited agency, completion of an approved phlebotomy training course, or equivalent experience through previous employment. Minimum of two years verifiable phlebotomy experience.

Exhibit proficiency in all of the following: blood collection by venipuncture and capillary technique from patients of all age groups, urine drug screen collections, paternity collections, breath/saliva alcohol testing, LCM/Cyber Tools, TestCup, pediatric blood collections, difficult draws (patients in mental retardation facilities, long-term care facilities, drug rehabilitation facilities, prisons, psychiatric facilities, or similar facilities). Has comprehensive understanding of compliance and safety, and is able to effectively communicate the importance of compliance and safety to other employees. Possess the ability and skills necessary to provide orientation and training for patient service technicians.

License/Certification/Education: Normally requires a High School Diploma or equivalent w/2 years experience.
Meet all state & local requirements for Phlebotomist

Here is a description of the LabCorp Communication Manager (LCM) that is referred to above:

LabCorp Communications Manager (LCM) is a Windows-
based product that automates test ordering and information retrieval. This user-friendly software package directly links the physician’s office to LabCorp laboratories, allowing clients to create test request forms, receive laboratory results, and manage patient test records easily and efficiently.

I found this list of desired proficiencies required of newly hired phlebotomists to be very interesting for the following reasons:

• A phlebotomist in the labs where I work is usually viewed as an entry-level position and the assumption is that the department will train many of them. Based on the ad above, LabCorp will only accept candidates who are already trained. In addition, there is a requirement of proficiency in LCM/Cyber Tools. This appears to be proprietary software used by LabCorp. By requiring proficiency in its own proprietary software, the company seems to be restricting its search to personnel currently working for the company or those having worked for it in the recent past. This may save on training costs but is this the most effective way to recruit entry level positions?
• I was also interested in the reference to "difficult draws" above, defined as: patients in mental retardation facilities, long-term care facilities, drug rehabilitation facilities, prisons, psychiatric facilities, or similar facilities. This gives a whole new meaning to "difficult draws" which I have personally defined in the past as blood draws from pediatric patients and adults with small veins.
• Even though the educational requirement is high school or the equivalent for phlebotomists, these personnel have managerial responsibility for orienting and training the patient service technicians.

I have previously discussed my respect for phlebotomists in previous notes. I view them as the most important ambassadors for the lab and therefore personnel who need to be carefully selected and trained. In a previous note (see: Customer Criticises LabCorp for Bad Blood Drawing Experience), I discussed a blogger who had an unfavorable experience in a LabCorp patient service center. Unfortunately, her saga and interactions with the company continue. She reports that she received an email from Pamela Sherry, Senior Vice President of Corporate Communications at LabCorp, in response to her original blog note. She responded to this query. She then was then surprised to receive an anonymous and sarcastic note, presumably from a LabCorp employee. One gets the distinct impression that this is not a company that relishes or encourages customer feedback or criticism.

New Test Sought for Fragile X Syndrome

Quest and U.S. Genomics is attempting to develop a screening test for Fragile X Syndrome (FXS) (see: Quest Partners on Retardation Test). Below is an excerpt from the announcement:

Medical test maker Quest Diagnostics [has]...signed an agreement with privately held U.S. Genomics to develop a screening test for mental retardation....Under the agreement, the companies will jointly develop genetic testing technology for an advanced screening method for Fragile X Syndrome, or FXS, a genetic mutation on the X chromosome that is the most common form of inherited mental retardation. The companies plan to develop an automated test for widespread testing. Currently, doctors use two types of genetics tests for FXS that require a high level of technical expertise, take several days to complete and cannot be used to screen large populations.

Such early announcements of the intention to develop a test is usually directed more toward the financial community than to a scientific audience but I thought that this note would provide an opportunity to comment briefly about FXS. Here is a brief description of the syndrome from the home page of the National Fragile X Foundation:

Fragile X is a family of genetic conditions, which can impact individuals and families in various ways. These genetic conditions are related in that they are all caused by gene changes in the same gene, called the FMR1 gene. Fragile X includes: fragile X syndrome (FXS), the most common cause of inherited mental impairment. This impairment can  range from learning disabilities to more severe cognitive or intellectual disabilities....FXS is the most common known cause of autism or "autistic-like" behaviors.

Here is a description of the chromosomal defect of FXS (see: Fragile X Syndrome):

The genetic defect is dynamic and lies at the distal end of the long arm of the X chromosome. Careful examination of the karyotype of affected individuals' lymphocytes, cultured in a folate-depleted and thymidine-depleted medium, reveals a constriction followed by a thin strand of genetic material extending beyond the long arm at the highly conserved band Xq27.3. This constriction and thin strand produces the appearance of a fragile portion of the X chromosome, leading to the term fragile X.

The rapid diagnosis of FXS is obviously a very appealing goal for a molecular diagnostics company. Given highly variable nature of chromosomal defects, however, this can also be very elusive goal. Readers may want to refer to previous notes about some of the challenges of the detection of the BRCA1 and 2 genes by Myriad Genetics.

The proposed rapid test could be used to identify female carriers of the fragile X gene:

Females carrying one copy of the fragile X can transmit it to their sons or daughters; in this case each child has a 50% of chance of inheriting the fragile X. Sons who receive the fragile X are at high risk of intellectual disability. Daughters who receive the fragile X may appear normal or they may be intellectually disabled, usually to a lesser degree than boys with the syndrome.

Approximately 1 in 260 women carry a premutated FMR1 gene.

Firm Details About the GE Purchase of a Portion of Abbott Diagnostics

Some of the dust has finally settled on the purchase by GE of a portion of Abbott Diagnostics (see: GE snatches Abbott's core diagnostics unit). Below is an excerpt from one of the articles covering the story:

Determined to retain to retain its dominance over Siemens in healthcare technology, General Electric (GE) has bought Abbott's in vitro and point-of-care diagnostics businesses for $8.13bn... in cash.....GE entered the molecular diagnostic market in 2004 when it paid more than $9bn...for UK-based Amersham, a bioscience and medical diagnostic firm. The latest acquisition reflects the company's strategy of combining early diagnosis with information technology to enable a new 'early health' model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention....GE will also be acquiring Abbott's point-of-care unit which manufactures diagnostic products for blood analysis in order to provide health care professionals critical diagnostics information at the point of patient care. By divesting its core diagnostics businesses, Abbott has now chosen to focus on its molecular diagnostics and diabetes care (glucose monitoring) businesses. Although around two-thirds of Abbott's sales in diagnostics come from the immunochemisty products that are being divested, that part of the business has been underperforming compared to its diabetes unit, which grew 35% in fiscal 2004/05.

So GE is acquiring Abbott's IVD and POCT businesses and Abbot retains its molecular diagnostics and diabetes care properties. One source has told me that GE did not buy the molecular diagnostics portion of Abbott because, first, it was not for sale and, secondly, GE felt that its previous Amersham purchase provided sufficient coverage and expertise in this area. It's quite clear that GE has been closely following and emulating Siemens' recent IVD acquisitions that have been covered in detail here.

The article above emphasizes the early health model that is being pursued by GE (and also Siemens) through the combination of information technology with medical imaging and molecular diagnostics. I have posted a number of previous notes commenting about what I personally believe is the growing importance of the diagnosis of pre-symptomatic disease. I find it very interesting that press releases from these two companies frequently refer to this approach to diagnosis whereas the term is not as common in the medical literature. This leads one to wonder whether there will be some substance to it in the long run.

Additional Discussion About "Radiology Without Walls"

Dr. Hector Aldape has sent me a comment about a recent note (see: Radiology Without Walls). Listed below are a set of quotations from this blog note followed by his reactions to each:

Blog:...ultrasound examination frequently results in an immediate diagnosis, thus enhancing the quality-of-care.
Comment: When a nurse does a bedside glucose, this also results in an immediate diagnosis.

Blog:...ultrasound examination generates a professional fee whereas most lab procedures do not.
Comment: POCT lab procedures may not generate a "professional" fee, but they are certainly included in the overall hospital bill. I suspect the real answer is this: lab procedures need to be strictly controlled as to accuracy, precision, etc. Laboratorians understand this, nurses, do not. I see this time and time again when I inspect POCT areas.

Comment: Finally, I think we both we'll agree on this, an ER doc can read an EKG or an Ultrasound, BUT, not as well as a cardiologist or a radiologist. Right?

Hector raises a number of key issues that perhaps will launch additional discussions about the topic of labs without walls. Below are my responses plus additional ideas:

• It is correct that bedside inpatient glucoses can potentially generate a new diagnosis of diabetes but I believe that the vast majority of such tests are performed to monitor known diabetics. However, I have never questioned the fact that POCT results in a higher quality-of-care in various settings. I also believe that the migration of a large portion of testing to point-of-care and point-of-collection is inevitable, particularly as the cost of POCT decreases.
• Most of the physicians that I know have a higher level of interest in the professional fees that they personally generate than those procedures that increase the size of a patient's hospital bill. I believe that this is the major driver for the adoption of portable ultrasound by physicians outside radiology.
• I agree with Hector that most nurses are not adequately trained to understand many of the nuances of lab testing including POCT. Many, but not all, of them consider POCT as an additional burden to their already hectic professional lives. I believe that the only way to further professionalize POCT is to have such testing performed by personnel under the direct control of the clinical labs. Another option would be for lab professionals to offer additional training in lab testing to nurses, leading to some sort of certification.
• I agree that most ER physicians are probably not as skilled as cardiologists in interpreting EKGs nor as skilled as radiologists in interpreting ultrasound images at the present time. This does not mean that they are not trainable in these areas. Hence, the emergence of emergency medicine fellowships (see: Advocate Health Care and Palmetto Health as examples). The porosity of medical specialty boundaries hinges on the development of training opportunities in emerging technologies.
• Despite the best efforts of professional societies to establish legal and organizational barriers to protect their "guilds" from competition, I don't think that they will be able to enforce sch barriers in the long-run because the courts and healthcare consumers tend to resist arguments that favor monopolies whenever and wherever they occur.

Wide Array of Exhibitors to Participate in Lab InfoTech Summit

I recently posted a note commenting on the fact that 42 exhibitors are now scheduled to participate in Lab InfoTech Summit, a three-day conference on clinical lab IT that will take place on March 5-7, 2007, at the Venetian Resort Hotel in Las Vegas. Here is the complete list of these companies with links to their home pages:

Corporate Underwriters
Beckman Coulter
MediSolution
Middleware Solutions from Roche Diagnostics
Siemens Medical Solutions Diagnostics
Technidata America Medical Software
SCC Soft Computer

Exhibitors - Platinum
Atlas Medical Software
IMPAC Medical Systems
PathSync

Exhibitors - Gold
A & T Corporation
American Society for Clinical Pathology
Antek HealthWare
Apollo Telemedicine
Aspyra
bioMerieux
CareEvolve
Cerner Corporation
Clarient
Data Innovations
Dawning Technologies
De Novo Software
Eclipsys Corporation
Fletcher-Flora Health Care Systems
GE Healthcare Integrated IT Solutions
Healthcare Solutions from Roche Diagnostics
Hilgraeve, Inc.
KliniTek, Inc.
Labtest.com
McKesson
Misys Healthcare Systems
MITEM Corporation
NeoTool
NetLIMS
Nikon
Olympus America
Omnitech Labs
Orchard Software
Psyche Systems
Seacoast Laboratory Data Systems
SNOMED International
TELCOR
Wyndgate Technologies

This will be the 25th annual lab software conference that I have managed. The first 21 of them were held in Ann Arbor and sponsored by the University of Michigan -- the conference during those years was named AIMCL. For the past three years going on four, the conference, now called Lab InfoTech Summit, has been held in Las Vegas. It is now sponsored by the Pathology Informatics Consortium (PEC), a non-profit company focusing on pathology and lab education.

In the early days, the conference attracted about a dozen exhibitors, all of them selling classic LISs. Now, as you can see from the above list, there is a wide array of exhibitors and product offerings, including classic LISs, AP-LISs, middleware, digital imaging, lab portal software, and lab automation systems (LASs). We even have a vendor, De Novo Software, with a product in a new category -- software to support the flow cytometry lab. I don't even have a name for this category but I might suggest one here -- intramural lab software (ILS).

If you believe, as I do, that information technology is one of the most important value-adding set of products used in the clinical labs today, you might want to consider attending Lab InfoTech Summit, spending time with the company representatives listed above, and listening to the lectures. No other conference in the country offers a comparable experience.

Additional Discusssion About IVDMIAs

I have written multiple previous notes about In-Vitro Diagnostic Multivariate Indexed Assays (IVDMIAs), which is the term that the FDA uses to refer to panels of biomarkers plus the computer algorithms necessary to interpret the results of the biomarker panels. The FDA is considering the regulation of IVDMIAs and will hold a public meeting about this topic on February 8, 2007, in Gaithersburg, Maryland, to discuss the topic.

The Dark Daily recently covered this topic (see: FDA Hosts Meeting to Discuss Guidance for Multivariate Index Assays) and below is an excerpt from the article:

Lab directors and pathologists concerned about regulation of molecular tests will be interested to learn that the Food and Drug Administration (FDA), Office of In Vitro Diagnostic Device Evaluation and Safety (OVID), has announced a public meeting on the guidance document for IVDMIAs. This meeting is a public forum during which FDA will hear presentations and comments from interested stakeholders regarding its recently issued document entitled "Draft Guidance for Industry, Clinical Laboratories, and FDA Staff on In Vitro Diagnostic Multivariate Index Assays."....Dark Daily asked Dr. Paul W. Radensky of McDermott, Will & Emery to comment on why laboratory directors and pathologists should pay attention to this meeting.

Radensky... believes this new FDA initiative has the potential to affect most all hospital laboratories, stating, "The draft IVDMIA guidance represents a major policy shift for FDA regarding the regulatory requirements for laboratory-developed tests. Although FDA has indicated in public meetings that it intends to regulate only a few laboratories, as currently drafted, the guidance raises many questions about which tests are covered and, for those that may be covered, what elements comprise the medical device subject to FDA regulation versus the laboratory service regulated by CLIA and state laboratory licensing authorities."

Radensky suggests that laboratorians "review the draft guidance and consider carefully what is currently going on in their institutions to assess how the draft guidance or further expansion of FDA regulation over laboratory-developed tests might impact their operations. Does the laboratory—or do physicians managing patients at their institutions—combine laboratory data with other data using any mathematical or algebraic formulas to determine likelihood of disease or to predict likely outcome from treatment? Does the laboratory develop and validate any tests on its own?"

In my previous notes, I have concentrated on the FDA's interest in the algorithms used to interpret lab test results (referred to above as "mathematical or algebraic formulas"), concluding that regulatory oversight would stifle innovation in molecular diagnostics. However, knowledgeable observers have suggested to me that this FDA initiative is primarily focused on home-brew testing.

I have come to the conclusion that the FDA is interested in both home-brew testing and algorithms because the two are inextricably bound together. Put another way, I believe that most advanced molecular diagnostic tests from this time forward will consist of panels of multiple home-brew assays plus the algorithms necessary to interpret the test results. And to quote from my previous note (see: FDA and the Regulation of Lab Software and Algorithms):

The only LIS components that are now subject to FDA review are the blood banking software modules. Such regulatory oversight, in my opinion, has had a chilling effect on the development and evolution of blood banking software because of the regulatory burden that now hangs over it. My own view is that software and algorithms are inherently unregulatible.

::Update on 1/25/2007 @ 12:15 p.m.

Greg Vail, CEO of Data Innovations, has emailed me with a link to a company press release (see: Data Innovations Receives FDA Clearance for Instrument Manager) from which I will copy a portion below:

Data Innovations, Inc. is pleased to announce the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its flagship product, Instrument Manager™, for use in blood banking environments. The FDA designation allows Data Innovations to market Instrument Manager v8.05 for use in blood banks and transfusion centers in the United States.

Greg is on record in this blog as being enthusiastic about FDA regulation of lab software and I want to present a balanced view of this topic.

Leading Employers of College Students and Recent Graduates

I recently came across an article (see: Top/Biggest Employers of College Students and Recent Graduates) that lists the 543 leading employers of college students and recent graduates in the U.S. with the projected 2007 entry level hires. I was fascinated to find LabCorp in the number 50 position in the list, right up there with some of the biggies like GE and Pfizer (old number). Below is a shortened version of the list of the top 50 companies accompanied by the anticipated number of 2007 hires. You can navigate to the article to view the entire list.

1.  Enterprise Rent-A-Car: 8000
5.  Ernst & Young: 3525
7.  Target: 3035
9.  Teach For America: 3000
11. KPMG: 2800
12. Avis Budget Group: 2500
14. Hertz: 2500
16. Boeing: 2200
17. State Street: 2000
20. Intel: 1500
21. National Security Agency: 1500
23. Southwest Airlines: 1400
25. Jos. A. Bank Clothiers: 1300
26. Microsoft: 1300
27. Wal-Mart Stores: 1300
29. Farmers Insurance Group: 1200
31. U.S. Navy: 1200
32. Federal Bureau of Investigation: 1160
35. General Electric:1100
36. Johnson & Johnson: 1100
39. Internal Revenue Service: 1000
43. National Cancer Institute: 1000
44. Pfizer: 1000
47. U.S. Department of Labor: 1000
48. American Express: 850
50. LabCorp: 800

You may want to chalk this up to my naivete, but I never would have guessed that LabCorp would hire nearly as many college graduates as American Express or more than half the number of Wal-Mart or Microsoft. Interestingly enough, Wal-Mart hires 600,000 new employees per year so the 1,300 college graduate listed above constitutes a mere fraction of its yearly hires.

I would assume that the LabCorp phlebotomy and courier slots do not require a college degree. Similarly, I would assume that some, but certainly not all, of the company's technical personnel are college graduates. Perhaps some of the readers of this blog can enlighten me about what drives this demand for college graduates at LabCorp. Perhaps part of this demand for personnel is the ramp-up in response to the new UnitedHealth contract.

It's not relevant to the lab would, but who would have imagined that the National Security Agency would grab 1,500 new hires in 2007. By the way, isn't this classified information? How about the 8,000 yearly new hires for Enterprise Rent-A-Car. Are they using these people for crash dummies? For those of you, like me, who never leave their office and have never heard of State Street (2,000 hires), here's a link to the company's home page. These guys are not fooling around as evidenced by this brief description of the company below:

With $11.3 trillion in assets under custody and $1.6 trillion under management, State Street is the world's leading provider of financial services to institutional investors.

Reduced Registration Fee for Lab InfoTech Summit

A deadline is fast approaching to qualify for a reduced registration fee for Lab InfoTech Summit that will be held at the Venetian Resort Hotel Casino in Las Vegas on March 5-7, 2007. For those registering on or before February 1, 2007, the registration fee for the plenary conference is $550. After February 1, this fee increases to $625. Pathology residents and API members qualify for a registration fee of $450, which is only valid until February 1. In addition, the special room rate of $219 per night at the Venetian reserved for conference registrants may not be available after February 1. Here is the link to the conference on-line registration form and here is the link to the conference home page.

I will provide more details about this later, but a total of 42 exhibitors will be participating in the conference.  A total of 44 can be accommodated in the exhibitor space. This is a new record for Lab InfoTech Summit -- a total of 35 participated in the 2006 conference. There is no other laboratory conference in the U.S. with either this number of laboratory software exhibitors or this special laboratory product focus in one large space. This conference provides a unique opportunity in a highly desirable destination city to shop for a new information system or augment the functionality of an existing LIS.

eClinicalWorks President Responds to Rumors

I have written previous notes about a company called eClinicalWorks. The product is an office EMR that has had recent success because it is reasonably priced and seems to be relatively simple to operate and support. One also gets the sense that the developers pay attention to the needs of their customers -- office-based physicians. I have also been impressed by the way in which the company has taken the trouble to integrate the product with LISs and reference labs.

Mr. HIStalk posted a recent note about the company that was prompted by a comment from a reader published in an eClinicalWorks customer site. There was apparently a rumor circulating that GE had its eye on the company. Below is the response of the company president to the rumor (boldface emphasis mine):

President Girish Kumar responded to that reader in a way that makes me remember how self-confident and outspoken he was in my interview with him. Here's what he told his customer, pulling no punches when faced with the mighty GE: "It’s probably a post from the competition to get a rumor started....The rumor is totally untrue and without any merit....We are growing faster than GE and have a better product and probably higher EMR revenue figures. Our implementations are also at the standard 14 week mark that we like to have....We are a profitable and very well managed private company with ZERO debt, no venture capital and good profit margins and solid revenues (40 million dollars for 2006). Let the other legacy and debt ridden EMR public companies with lofty PEs worry about survival and debt....We are neither a speculative stock nor a legacy company with a diminishing customer base and inflated valuations that gets traded on the market. Our customers can bet on us being around for a long time as an independent private company."

Like Mr. HIStalk, I found Kumar's candid and factual response very refreshing. I am sure that it accomplished what was intended -- to provide assurances to his customers that they would not be jerked around as a result of its purchase by some larger company to "round out" its set of healthcare software offerings. The response also casts into bold relief the typical official mumbo-jumbo and ambiguous responses of publicly-held companies when they are put into play, either by rumor or actual facts.

Radiology Without Walls

I have been closely following some of the recent technology-driven changes in radiology because of the close analogies to lab medicine and pathology. One example is the development of portable ultrasound devices such that medical students are now being trained on their use, prompting a description of such devices as the new stethoscope. A recent article (see: The Incredible Shrinking Modality) discusses this topic in great detail. Below is an excerpt from the article (boldface emphasis mine):

Miniaturization of ultrasound technology—manifested in compact and highly portable systems—has created a robust subset of the modality’s market.....More recently, the technology has made inroads into the emergency department (ED), intensive care unit, and doctor’s office....The new paradigm [described] as the “Radiology without Walls” model—also incorporates affordability and premium capability....More and more, a variety of vendors—large and small, new and established—have focused on making ultrasound more applicable to new environments....Where it once represented a niche market, portable ultrasound technology has entered into new areas such as the ED and operating room. ....Vendors have been able to place the power of large, cart-based systems into hand-carried devices without compromising quality. At the same time, they’ve made these innovations more affordable.

Manufacturers of portable ultrasound devices have created whole new markets for their devices (e.g., ED, physician office, operating room) by reducing their size and cost without compromising functionality. This portability has weakened the hold exerted by radiologists on the technology, thus prompting the use of the term "radiology without walls" which could also be interpreted as "radiology without radiologists."

These circumstances invite comparisons with point-of-care testing (POCT), which also could be referred to as labs-without-walls. However, this analogy prompts an additional question: why are POCT programs in hospitals generally under the control of lab personnel, with the support of nursing personnel, whereas clinicians have enthusiastically seized control over portable ultrasound? I suspect that the answer to this question is twofold. First, ultrasound examination frequently results in an immediate diagnosis, thus enhancing the quality-of-care. Secondly, ultrasound examination generates a professional fee whereas most lab procedures do not. If ultrasound procedures become too commonplace, however, the healthcare payers may seek to change this situation.