IT WAS A BUSY TIME LAST WEEK on the lab industry meeting circuit. THE DARK REPORT made the rounds and uncovered some valuable intelligence for lab directors and pathologists.
First on the meeting tour was Philadelphia, site of the American Association of Clinical Chemistry (AACC) annual convention, held July 21-25. The number of exhibitors and the size of the exhibit hall was equal to earlier conventions. However, in contrast to past years, the AACC did not regularly announce the number of attendees over the public address system. Speculation was that attendance was down this year. The most obvious cause may be concerns over terrorism and the Middle East situation which discouraged international travel to Philadelphia.
Looking For New Trends
Nonetheless, as many as 15,000 attendees and vendors were present, along with lots of interesting new technology and products. Taken together, it was an opportunity to identify new trends and validate existing trends.
On the laboratory automation front, diagnostic manufacturers again emphasized modular or workstation solutions. In response to lab buyer’s needs, vendors are concentrating on automating specific aspects of the testing process. For example, Ortho-Clinical Diagnostics (OCD) unveiled its Ortho ProVue™ instrument, which automates tests done in blood banks.
In the evolving battle between “open” and “closed” TLA systems, one emerging winner may be LabInterlink. At the AACC, a number of the major diagnostic vendors showed LabInterlink equipment engineered specifically to connect their instruments to an automated line meeting the NCCLS clinical laboratory automation standards.
New Interest In Automation
Talk at the AACC meeting indicates that some of the nation’s largest laboratories are telling their instrument vendors that they will only buy instruments compatible with open laboratory automation standards. That gives these labs the ability to “plug and play” any combination of instruments, by any vendor, into their lab’s specific automation configuration.
“Closed” automation systems will continue to be sold. But there is growing evidence that the laboratory marketplace prefers “open” system solutions. If those vendors now selling closed automation systems expand their offering of open instruments, it will be confirmation that the lab marketplace definitely supports the open option.
There is another trend in lab automation that will be relevant to lab directors and pathologists. THE DARK REPORT believes that the patient safety movement will increase interest in laboratory automation solutions. As labs come under pressure to eliminate errors and reduce variation in specific work processes, automation can be one solution to achieve both goals.
Less Errors And Variation
Manual work processes are one source of errors in the laboratory. Mechanization and automation of manual work processes is a proven way to reduce both errors and variability. For example, OCD’s new Ortho ProVue instrument, mentioned above, was designed to help blood banks achieve both those goals by eliminating the manual steps required to test blood products.
It is an interesting change to the way lab administrators view automation. In the mid-1990s, automation was judged primarily by its ability to lower costs and increase lab capacity. In recent years, lab automation has increasingly become a labor-substitution solution, allowing labs to move medical technologists to higher-value uses. Now lab automation will also be viewed as a tool that helps labs reduce errors, reduce variability, and improve turnaround times and lab test quality.
CAP’s Management Confab
In Chicago, the College of American Pathology’s (CAP) “Pathology Practice Management 2003” was conducted on Saturday, July 26. This annual one day meeting covers the full range of trends in the pathology marketplace, legislative updates, and information on evolving legal, billing, coding, and malpractice issues.
On the legislative front, there are several interesting issues which are not known to most of the lab industry. In her presentation, Denise Bell, Director of Federal and State Legislative Affairs for CAP, noted that the pharmacy trade association was involved in a nation-wide effort to get individual states to pass legislation that would change the scope of practice and allow pharma- cists to “order, perform, and in some cases, interpret laboratory tests.” To expedite this effort, the pharmacy profession has model legislation it pro- vides to state legislatures.
Turning to the pending Medicare legislation now in the House-Senate conference committee, Bell identified a provision passed by the House which has received little attention, but which could have considerable impact on the lab industry. The version of the Medicare drug benefit bill passed by the House includes a provision which supports the move away from ICD-9 and toward ICD-10. The objective is to develop a national code which would also supplant the CPT code system.
Next HIPAA Deadline
Bell also called attention to the fact that, effective October 16, all providers must comply with HIPAA requirements for electronic transactions and code sets. “This is a big event,” she declared. “However, CMS (Centers for Medicare and Medicaid Services) will use a carrot and stick approach in enforcement.
“CMS will respond to complaints about non-compliance. If the non-compliant provider is making reason- able efforts to achieve compliance, CMS will not take immediate action. But if that provider, after some number of months, has not achieved compliance, CMS indicates it will take action to enforce compliance.”
During her presentation on the legal issues of Part A clinical pathology professional agreements, attorney Jane Pine Wood of McDonald Haber revealed a new legal issue involving the responsibilities of the laboratory medical director. In the South, several hospital laboratories shared lab test proficiency data by telephone, violating CLIA regulations. This came to the attention of CMS, which investigated the matter and made an unexpected ruling.
Potential Legal Exposure
“It was a single pathology group serving the hospital labs involved,” noted Wood. “Because the contract for medical directorship of the several hospital labs was held in the name of the pathology group practice, CMS ruled that all the pathologists who were members of that group were at risk for violating CLIA regulations.
“CMS has not issued a final ruling in this case, but its declared position is an unanticipated interpretation of the CLIA regulations,” added Wood. “Any pathology group holding a similar hospital contract to provide medical director services to multiple hospital labs will find it prudent to review this situation. One solution may be to hold laboratory directorships in the name of individual pathologists—not the group practice itself.”
Each of the insights gleaned from both the AACC meeting and the CAP program and presented on these pages represent valuable business intelligence for lab administrators and pathologists. Collectively, they identify issues which either need direct attention, or will shape the strategic thinking of laboratory leaders.
The issues highlighted on these pages also demonstrate that a wide range of outside influences continue to impact the laboratory industry.
Clinicians Pulling Tests Out of the Core Lab
ONE CONSEQUENCE OF THE MOVEMENT to provide standardized care to all patients is that more testing will migrate from core labs into near-patient and point- of-care (POC) settings.
Evidence of this came at a press conference conducted by Beckman Coulter Corporation at the AACC meeting in Philadelphia last week. The topic was the laboratory’s role in reducing patient errors and supporting higher clinical outcomes.
The press conference featured a panel that included THE DARK REPORT, Baptist Hospital of East Tennessee (which reported on how automation reduced variation and improved TAT and other clinical outcomes), and an emergency room specialist from the University of Massachusetts Medical Center (UMMC) in Worcester, Massachusetts.
Djiby Diop, M.D. discussed the recently established standards for cardiology care. From the moment the patient appears at the ER door, the ER has 30 minutes to start blood-thinning drugs and 90 minutes to get the patient into the cath lab, as appropriate to the patient’s symptoms.
The 30-minute and 90-minute standards mean that most hospital core laboratories cannot deliver lab test results fast enough to support these standards. To meet this challenge, UMMC’s emergency department has begun a point-of-care cardiology testing program within the ER.
In deciding to do POC cardiology testing in the ER, there was little debate within UMMC about issues of higher cost-per-test, quality of test results, and similar arguments put forth by lab managers wanting to keep tests in the core lab. What drove this decision was the need to support the ER’s ability to meet the 30-minute and 90-minute standards for appropriate patient care. Like at UMMC, clinicians will begin to pull testing out of the core lab as a way to improve outcomes and meet standards.