The Lewin Group and Battelle Memorial Institute
3130 Fairview Park Dr.
Falls Church, VA 22042
Dear Mr. Liebow:
We are writing to commend The Lewin Group and its contracted entity, Battelle Memorial Institute, on the May 2008 publication of the comprehensive report “Laboratory Medicine: A National Status Report” prepared for the Division of Laboratory Systems, National Center for Preparedness, Detection, and Control of Infectious Diseases, Centers for Disease Control and Prevention. The Committees on Professional Affairs and Laboratory Practices of the American Society for Microbiology (ASM) reviewed the key findings outlined in the Executive Summary of the National Status Report. The document is an insightful and thought provoking report that categorizes the unique contributions of the laboratory profession to healthcare as well as identifying the many opportunities for enhancing value and the obstacles in the current healthcare climate to realizing those enhancements.
The ASM is the largest, single life sciences society dedicated to the advancement of the microbiological sciences and their application for the common good. The Society represents approximately 42,000 microbiologists, including scientists and science administrators working in a variety of areas, including biomedical, environmental, and clinical laboratory fields. Many of our members have primary involvement in clinical laboratory medicine including individuals directing clinical microbiology or immunology laboratories, individuals licensed or accredited to perform such testing, industry representatives marketing products for use, and researchers involved in developing and evaluating the performance of new technologies. Thus, as a society, we are dedicated to the recognition of the importance and value of laboratory medicine in healthcare.
Our specific comments for consideration are as follows:
The Value of Laboratory Medicine to Healthcare
Considering that laboratory medicine accounts for healthcare expenditures of only ~2%, yet is stated to influence 70-80% of clinical decision making, demonstrates the profound influence on healthcare. What may be underappreciated in the report is the extent to which laboratory medicine has an impact on healthcare beyond that accrued to individual patients. That additional impact, which is difficult to quantify, is on public health and well being. Particularly in the field of medical microbiology, the specific etiologic diagnosis of a communicable disease can have a profound impact on mitigating clinical, financial and psychosocial consequences of additional, uncontained spread to other susceptible populations. Laboratory testing algorithm and best practice design, must take into account the potential public health benefit of testing.
Market Profile of the Laboratory Medicine Sector
It is anticipated that revenue, spending, and test volume in US healthcare will continue to grow due to changing demographics as well as emerging technology and innovation. This trend will be particularly evident in infectious and immune based chronic diseases where not only are new diseases continuously emerging and resurging, but understanding of the pathogenesis of these diseases is leading to new approaches for diagnosis, prognosis, and monitoring therapy. The greatest challenge will be to appropriately allocate resources to meet the evolving needs of an expanding population with expanding test capabilities.
With this in mind, one major concern the ASM Committees on Professional Affairs and Laboratory Practices have is with definitions used in the report. Molecular diagnostics is a term that applies to a methodology that detects molecular analytes, most commonly nucleic acids. Molecular diagnostics are quite often used to detect microbial analytes. However, the report tends to use this term interchangeably with “genetic testing” which more often implies use of molecular diagnostics for the purpose of detecting genes or genetic elements associated with the human genome. It is strongly recommended that the report distinguish between molecular tests for infectious agents and molecular tests used to characterize human genetic factors.
In addition, the report demonstrates a lack of clarity in distinguishing different levels of testing as defined by the Clinical Laboratory Improvement Amendments (CLIA). Waived tests are distinct from non-waived tests, physician performed microscopy is a unique category distinct from waived tests, and among non-waived tests, there is a distinction between moderate and high complexity tests. The latter becomes very important in requirements for molecular testing methods. In addition, consumer directed testing may fall into any category, and performance requirements are largely determined by state regulations.
We agree strongly with the concept that public information on quality in laboratory medicine in all categories of practice environments is limited, and would strongly encourage and hope to participate in any new initiatives designed to assess quality objectively through programs similar to other Centers for Medicare & Medicaid Services (CMS) approved or consumer “watchdog” group quality reporting initiatives. The now disbanded Institute for Quality in Laboratory Medicine provided a promising, but unfortunately unfunded, approach to this issue.
Laboratory Medicine Workforce
Even as volumes of patients and laboratory medicine testing increase, the availability of newly and highly trained laboratory professionals is decreasing. Many studies document a significant workforce shortage emerging, and the sophistication of emerging technologies does not obviate the need, rather it accentuates the looming crisis. Steps must be taken to encourage young people to enter the field, while assuring that the salary levels for degreed individuals are commensurate with the rigorous training required to meet demanding certification requirements. It is of note that a coalition of laboratory medicine professional groups, the Coordinating Council on Clinical Laboratory Workforce, has already developed several initiatives to address this alarming trend.
Quality and the Total Testing Process
As previously stated, the ASM strongly supports any reasonable initiatives to standardize quality monitoring processes at all stages of testing, preanalytical, analytical, and postanalytical. Further, such monitors should be in place in all laboratory medicine environments. There is no justification to evaluate quality of testing performed in any environment differently; that is, physician office laboratories, and Point-of-Care-Testing (POCT) should be subject to the same scrutiny as hospital and independent laboratories as should testing performed when consumer directed.
One particular issue of key importance to ASM’s clinical members regarding quality systems pertains to consultation by laboratory professionals. There are in fact several barriers to the provision of consultative reports by subject matter experts: First, is the failure of clinicians to acknowledge the need for interpretation of complex tests, both in the preanalytical (ordering) and postanalytical (reporting) stages. It is widely recognized that practical pathology and laboratory medicine training is inadequate in most medical school curricula, thus it is increasingly important for laboratory professionals to play a role in providing expert consultations. For many infectious and immunologic conditions, a doctoral level scientist is fully capable to play a key role in assuring appropriate test utilization. However, the failure of payers to acknowledge that expertise and reimburse accordingly is an impediment to both provision of key services as well as to encouraging young scientists to enter the field of laboratory medicine. The recent addition of a CPT code (96040) for provision of genetic counseling services by trained non-physician genetic counselors clearly establishes a precedent for recognizing the unique contributions of non-physician scientists in quality testing for individual patients.
Quality Systems and Performance Measurement
Again, the ASM would strongly support any reasonable initiative to improve appraisal of quality systems in laboratory medicine. Too often at present, laboratories are subjected to arbitrary and proprietary benchmarks imposed by consulting firms using approaches gleaned from industry. However, it must be emphasized that laboratory medicine is not an industry, rather a healthcare profession, and as such, quality should be assessed using performance monitors established through a consensus process in a manner similar to those defined for hospitals and physicians. A nationally defined and uniform set of monitors that encompasses all aspects of the testing process, including preanalytical, analytical, and postanalytical as well as more general monitors that evaluate customer satisfaction, including both patients and physicians as customers is clearly desirable. Further, it is clearly recognized that some degree of data standardization is an important element of establishing such a system. The ASM recommends that a consensus process by appropriate stakeholders be used in any attempt to standardize data elements for the purpose of quality monitoring.
Laboratory Information Systems
Harmonization of data elements is also of key importance for effective use of laboratory information systems. Not only is this a key component of devising uniform quality monitoring systems, but for public health purposes, it is critical that electronic data sharing on a real-time basis be a reality if outbreaks and emerging diseases are to be recognized in a timely manner for effective intervention. Further, to avoid unnecessary duplication of testing and conservation of resources, it is critical that patient specific electronic medical records that include recent laboratory test results be readily available across all providers in a secure manner.
Federal Regulatory Oversight of Laboratory Medicine
While CLIA has provided a reasonable model for oversight of laboratory processes, there remain areas for improvement. Harmonization of requirements and inspection approaches between CMS and entities having deemed status with CLIA would facilitate quality monitoring and implementation of best-practices defined by consensus processes.
Particularly important is the need to harmonize expectations for validation and verification for both Food and Drug Administration (FDA) evaluated products and laboratory developed tests. The FDA and CMS should work closely together to ensure that CLIA regulatory requirements that emanate from each entity are in conformance.
Reimbursement for Laboratory Medicine
CLIA and FDA factors also influence reimbursement for laboratory testing. Particularly for emerging technologies, processes should be in place to assure adequate reimbursement for laboratory tests determined to be appropriate through best-practice analysis. The ASM is aware that the Department of Health and Human Services Office of Inspector General/Office of Evaluations is currently revisiting the existing approach to reimbursement for laboratory services, and ASM would urge CDC to facilitate this evaluation, long overdue since recommended by the Institute of Medicine Report on Medicare Payment Policy issued in 2000.
The ASM also wishes to reaffirm its strong and already-on-record opposition to both competitive bidding and co-payments as a means to further reduce payment levels. Rather, the emphasis should be on evaluation of the appropriateness and equity of the current approaches to payment for laboratory services prior to implementing any drastic revisions to payment policies.
Again, we strongly commend the CDC and its contracted entities, the Lewin Group and Battelle Memorial Institute for undertaking such an extensive analysis of the “state-of-laboratory testing.” Certainly the profession is facing key challenges, but equally certainly, laboratory medicine has an absolutely critical role to play in provision of healthcare to individuals and in promoting and protecting public health and safety. We would be pleased to be part of any future discussions or groups designed to begin to evaluate each component of the critical analysis provided in this report. The importance of emerging infectious diseases and the emerging recognition of the role of infection in many chronic diseases render the expertise available within ASM key to any such future endeavors to improve upon the already significant value of laboratory medicine as well as the recognition of that critical value within the total healthcare sector. Please do not hesitate to contact Suzy Leous in ASM’s Office of Public Affairs at 202-942-9262 or firstname.lastname@example.org if we can be of further assistance.
Vickie S. Baselski, Ph.D., Chair, Committee on Professional Affairs
Susan E. Sharp, Ph.D., Chair, Committee on Laboratory Practices