News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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There Ain’t No Such Thing as a Free Lunch (TANSTAAFL): Quality Costs Money

Wall Street has yet to grasp this essential truth of laboratory medicine-lab test quality comes with its own price tag

At this moment in time, Quest Diagnostics Incorporated‘s  (NYSE:DGX) advertised value proposition to other labs—”industry-leading quality and technical proficiency”—has diminished credibility with pathologists and lab industry executives. They are questioning how the nation’s largest lab company could allow systemic errors that caused it to report inaccurate Vitamin 25(OH) D test results to tens of thousands of patients for 18 months during 2007 and 2008.

These same pathologists represent an important source of reference and esoteric testing referrals to the nation’s largest lab company. Thus, the disclosure of systemic failures in its Vitamin D testing program may have implications for Quest Diagnostics over the long term. Many health systems, hospitals, and laboratories across the United States refer reference and esoteric tests to Quest Diagnostics. Quality and test result integrity are a primary buying motive for the pathologists and lab directors in these organizations. As scientists, they want confidence in the analytical integrity of the test results they provide to their own clinicians.

Two national reference laboratories with solid reputations for quality and lab test result integrity are ARUP Laboratories and Mayo Medical Laboratories. These reputations for quality and integrity are key assets at ARUP and Mayo. Both firms compete successfully against the two blood brothers because many referring laboratories believe the scientific integrity at ARUP and Mayo is not compromised in ways that may occur in publicly-traded lab companies. Of interest, both these laboratories earn adequate profit margins while competing effectively on price, service, and quality against the national lab companies.

Quest Diagnostics now finds itself facing a tough challenge in the reference/esoteric testing marketplace. Among its peers in the scientific and laboratory medicine communities, the quality and integrity of its lab test results will be seriously questioned. And because pathologists have long memories, this can be an issue for years into the future.

That has been the experience of Specialty Laboratories, Inc. During the 1990s, this was a go-go reference and esoteric testing laboratory. Fast-growing, it had a reputation for first-rank science and regularly introduced new proprietary assays to the medical community. But, in April, 2002, federal and state laboratory regulators yanked Specialty’s license to do business with Medicare. The story centered around internal whistleblowers and regulatory directives that were not fully addressed by Specialty’s executive team. There were questions about the integrity of test results for some lines of lab tests performed at Specialty. (“State, Federal Regulators Target Specialty Labs,” The Dark Report, April 22, 2002.)

Within a few months, Specialty Labs was able to reclaim its Medicare license after fixing deficiencies and passing its inspections. However, loss of its Medicare license was a body blow to Specialty Laboratories. Across the nation, pathologists and laboratory directors stopped sending specimens to Specialty Labs. Overnight, the company experienced a precipitous decline in specimen volume and revenue. Facing grim financial prospects, in January 2006 it was sold to AmeriPath. Ironically, Quest Diagnostics found itself the owner of Specialty Laboratories when it acquired AmeriPath last year.

The example of Specialty Labs illustrates why quality, integrity, and trust matter-a great deal! Pathologists and lab directors face personal liability if their laboratory delivers inaccurate results to patients and physicians. Their personal reputations ride on the performance of their laboratory. As physicians, they understand the consequences to patient care when a laboratory fails to report accurate test results. Their own laboratory must maintain its reputation for integrity and quality if it is to retain the trust of the clinicians and patients it serves.

Further, these same pathologists and lab directors regularly interview and hire scientists and medical technologists from both of the national laboratory companies. They hear lots of stories about the internal operations of these two billion-dollar lab companies. There are few secrets about events that unfold inside the two blood brothers. For example, lab scientists directing Vitamin D testing at their own labs quickly recognized, early in 2007, that Quest Diagnostics was struggling with its home brew mass spectrometry Vitamin D assay.

The lab community has watched both national labs continually cut costs over the past ten years. Competing labs conduct hiring interviews with the wave after wave of terminated employees hunting for jobs after each RIF (reduction in force) trims back staff to save money. Pathologists and lab directors understand the consequences of sustained cost cutting. Eventually, a laboratory’s cost cutting reaches a point where the resources, staff time, and operational capability required to sustain a high level of analytical accuracy and integrity can be compromised.

That is why many laboratory professionals are asking if the inaccurate Vitamin 25(OH) D results performed over an 18-month period on tens of thousands of patients is a sign that should not be ignored. Has Quest Diagnostics reached the threshold where further cost-cutting to satisfy Wall Street will undermine the quality and integrity of its lab test results?

Of all the customers of the two national laboratories, pathologists are the best informed about how constant budget reductions can undermine the quality and integrity of laboratory test results. They know that lab test quality is an expensive proposition.

Thus, no one should be surprised if, going forward, both national laboratories find it more difficult to expand the reference and esoteric business which comes to them from other laboratories across the nation. Should either firm experience even modest declines in the year-over-growth in this business segment, it will be a significant sign. Questions associated with test integrity may be motivating an important source of reference and esoteric testing to steer their specimens to other laboratory providers.

Should this happen, no one should be surprised. If a decade of sustained cost-cutting has finally reached the point where laboratory customers question the quality of the test results produced by major lab companies, it will only be the market imposing its discipline. The market will be reminding Wall Street investors that spending to sustain quality protects market share and profits. After all, as the libertarians say, “There ain’t no such thing as a free lunch (TANSTAAFL)”!

Related Information:

European LIS Competitor Eyes U.S. Market Via Lab Industry Survey

As healthcare becomes a global business, laboratory vendors from overseas are casting an envious eye on the market in the United States. After all, it is the world’s biggest and richest healthcare market, with more than $2 trillion in spending. Better yet, because healthcare in this country is organized around multiple payers and private providers, it provides competitive opportunities that don’t exist in many countries with single-payer health systems. (more…)

One Barrier to EMR Adoption May be “Close to Retirement” Doctors

As the nation’s healthcare system pursues the goal of a universal electronic medical record (EMR) and a paperless, all-electronic environment, one barrier to adoption may be the large number of physicians nearing retirement. That’s the opinion of a neurosurgeon in his recent testimony before a congressional committee.

Physicians within five years of retirement may not get a return on their investment, Philip Tally, M.D., a neurosurgeon in Bradenton, Florida, told a hearing on “Cost and Confidentiality: The Unforeseen Challenges of Electronic Health Records in Small Specialty Practices,” on July 31 before the House Committee on Small Business.

Just 4% of physicians have an extensive, fully functional EMR and only 13% have a basic system, Tally told the committee, citing an article, “Electronic Health Records in Ambulatory Care-A National Survey of Physicians,” in the July 3, 2008, issue of the New England Journal of Medicine. The committee hearing was on the unforeseen challenges faced by small specialty medical practices when installing an EMR system.

“If you’re not thinking about practicing more than five years, don’t bother because the transition and the cost and the time to make it proficient for you in a small practice is probably not worth it-with one exception and that would only be if you intend to sell your practice someday,” Tally told Modern Healthcare magazine. When selling a practice, the physician who buys the practice is likely to want the EMR, he added.

The American Medical Association’s Physician Characteristics and Distribution in the U.S., 2008 edition, shows how physician demographics are weighted toward approaching retirement. There are 921,900 physicians in this country, of which 343,200 (37.2%) are over age 54. Approximately 166,000 physicians are aged 55 to 64 and 177,200 are aged 65 and older.

Interestingly, Tally was speaking from experience. His three-physician practice of neurosurgeons installed an EMR in 1992, making the group just the fifth in the nation and the first neurosurgery group to do so. At the time, the practice spent $50,000 for the EMR and about $5,000 annually to maintain the system. Tally, who chairs the Florida Medical Association’s IT committee, the congressional hearing that his group spent about 1,000 hours to configure the system after it was installed. His medical office staff found the process challenging, as the staff turnover rate climbed to 30%. Tally did observe that the EMR system, once implemented, significantly increased productivity.

Accurately measuring the return on investment (ROI) that accrues to a physician group from implementing an EMR is complicated by many factors. These include: 1) savings from eliminating the need to maintain and store paper charts; 2) savings in time for physicians to see patients under the new EMR system versus the time it took under the old system; and, 3) savings from electronic data entry of laboratory tests results in the EMR. Perhaps most difficult to measure is physician and patient satisfaction with the new EMR system versus the old.

Tally has an overlooked perspective on why physician age is likely to be an impediment to EMR adoption. He points out that more than one in three physicians in this country are within a decade or less from retirement-and are thus likely to find the transition to an electronic medical records system to be both uneconomical and unwelcome. It may turn out that more financial incentives from federal and state government sources, along with private payer incentives, will be required to encourage smaller physician groups to implement an EMR system. Clinical laboratories will need to take these factors into consideration as they develop effective strategies for supporting to move to a fully-digital patient health record by their office-based physician clients.

Physicians in America (In round numbers)

Younger than age 35     141,500
35 to 44                        213,300
45 to 54                        223,900
55 to 64                        166,000
65 and older                 177,200
Total                             921,900

Source: American Medical Association’s Physician Characteristics and Distribution in the U.S., 2008 edition
Related Information:
Dr. Tally’s prepared remarks for the House Small Business Committee:

Committee Examines Costs and Challenges of Electronic Health Records to Small Medical Practices