The Centers for Disease Control and Prevention commissioned a report on the status of laboratory medicine.  Recently made available, the 2007 draft report is open for comments through May 30, 2008.
 
The report examines several aspects of laboratory medicine:  value; market profile; workforce; quality and the total testing process; quality systems and performance measurement; laboratory information systems; federal regulation; and reimbursement. 
 
Among the 2007 findings, CDC estimates that approximately 6.8 billion laboratory tests are performed in the United States, with revenue totaling approximately $52 billion.  Clinical pathology is the largest sector compromising 66% of all laboratory tests.  Anatomic pathology and cytology assume 23% of the market, and molecular and esoteric testing combines 8% of current laboratory production.  Due to limited research, the report notes that it is difficult to demonstrate ultimately the value of laboratory medicine.
 
Recommendations were interspersed throughout the report.  Noting the growing shortage of laboratory professionals, the report suggests that the laboratory sector "redefine staffing qualifications and workforce level requirements."  To improve quality, the report advises expansion of laboratory consultation services for clinicians; development of quality control, performance evaluation and test reproducibility standards for anatomic pathology; employment of graphical displays in reporting results for proteomic and genetic tests; standardization of  data elements and report formats for all laboratory tests; training operators in the use of point-of-care testing devices; and increased use of quality management systems among laboratories.  The report recommends a concentrated focus on improvements and standardization in the pre- and post-analytical phases of testing.
 
In the area of information technology, the report notes that differences in data interchange and terminology standards must be resolved before laboratory data may be fully integrated into clinical practice.  Due to technological advances and volume demands, laboratory information systems must have capacity to store and retrieve large quantities of data.  Also, to accommodate whole-tissue-processing, digital pathology systems need to grow capacity for high-power computation, data storage, image formatting, and processing algorithms.
 
The report provides an overview of federal regulation for laboratories, including a look at the Clinical Laboratory Improvement Amendments of 1988 (CLIA).  While noting that laboratory performance has improved under this oversight, some problems remain.  To remedy concerns, evaluation protocols for quality control and validation are under development.  Actions taken by the Centers for Medicare and Medicaid Services to improve CLIA were examined.  The report suggests that CLIA may be insufficient to ensure quality for genetic testing, but notes that recent guidance documents by the Food and Drug Administration may assist in the oversight of laboratory-developed tests.
 
Regarding reimbursement, the report suggests that a redesign of the Medicare payment system for laboratory services is needed.  The lack of reliable data on the relationships among current production costs, technological changes, economies of scale, and historical costs is problematic, and studies evaluating the appropriateness of payment rates have not been completed.  Wide variation among multiple fee schedules and archaic coding methods were also suspect in the concern over reimbursement rates.  The report recognizes that private payers often follow the lead of Medicare payment practices.
 
Appendix B of the report provides a matrix of quality indicators for performance measurement from the College of American Pathologists along with additional indicators.  It demonstrates where efforts have been made to study or develop quality indicators and where there may be opportunities for future study.  The CDC hopes to use this report as a springboard for "transforming laboratory medicine over the next decade."