CLIA established an  approval process to allow states and private accrediting organizations to  use their own requirements to survey labs. Deficiencies are also characterized as standard- or condition-level  based on the requirement in which the deficiency occurs. Insufficient Data Exist to Identify Extent of Serious Lab Quality Problems

The extent of serious quality problems at labs is unclear because CMS has  incomplete data on condition-level deficiencies identified by state survey  agencies prior to 2004. We also found that the lack of a  straightforward linkage between CLIA requirements and the CLIA- equivalent requirements of some survey organizations makes it virtually  impossible to assess lab quality in a standardized manner. Limited Quality Data for Labs Inspected by State Survey Agencies Suggest Survey Inconsistencies

CMS’s OSCAR database contains limited data on the quality of labs  inspected by state survey agencies and, as a result, it is not possible to  analyze changes in the quality of lab testing over time. In January 2004,  CMS implemented revised CLIA survey requirements and modified the  existing OSCAR data—state survey agency findings—to reflect the  changes. As a result of the data modifications, the  findings for surveys conducted prior to 2004 no longer reflect all key  condition-level requirements in effect at the time of those surveys. Because exempt-state programs and accrediting organizations do  not classify inspection requirements and related deficiencies with the  same criteria used by state survey agencies—as either standard- or  condition-level—they cannot easily identify the proportion of surveyed  labs with condition-level deficiencies. CMS Use of Data for Monitoring Lab Quality Is Limited

CMS does not effectively use available data, such as the results of surveys  and proficiency testing data, to monitor and assess lab quality. Proficiency testing is an important indicator of  lab quality because it is an objective assessment of a lab’s ability to  produce accurate test results and is conducted more frequently than  surveys—three times a year versus once every 2 years. Although  CMS’s analysis of proficiency testing data showed improvements over  time, our analysis of proficiency testing data for 1999 through 2003  suggests that there has been an increase in proficiency testing failures for  labs inspected by CAP and JCAHO, which generally inspect hospital labs,  and a decrease in such failures for labs surveyed by state survey agencies  and COLA, which tend to inspect physician office labs. CLIA Program Oversight Is Inadequate

Oversight by CMS and survey organizations is not adequate to ensure that  labs meet CLIA requirements. For example, the goal of educating lab  workers during surveys takes precedence over the identification and  reporting of deficiencies, while the use of volunteer rather than staff  surveyors by one accrediting organization raises questions about  appropriate levels of training and the appearance of a conflict of interest. The significant increase in complaints since CAP took steps to help ensure  that lab workers know how to file a complaint suggests that some quality  problems at labs inspected by some survey organizations may not be  reported. In addition, sanctions are not being used effectively as an  enforcement tool to promote labs’ compliance with CLIA requirements, as  evidenced by the relatively few labs with repeat condition-level  deficiencies on consecutive surveys from 1998 through 2004 that had  sanctions imposed. Furthermore, CMS is not meeting its responsibility to  determine that accrediting organization and exempt-state program  requirements and processes continue to be at least equivalent to CLIA’s. According to CMS, this  educational focus allows labs and their staff to become familiar with the  proficiency testing program; however, it is important to note that there  was about a 13-year time lag between the 1992 regulations that  implemented CLIA and the 2005 implementation of Pap smear proficiency  testing. Our work demonstrated that  the oversight of clinical labs needs to be strengthened in several areas. More broadly, CMS and survey  organization oversight of the lab survey process is not adequate to enforce  CLIA requirements.
Why GAO Did This Study

Today's hearing focuses on oversight of clinical labs. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) strengthened quality requirements for labs that perform tests to diagnose or treat disease. About 36,000 labs that perform certain complex tests must be surveyed biennially by a state survey agency, a state CLIA-exempt program, or a private accrediting organization. CMS oversees implementation of CLIA requirements, which includes determining the CLIA equivalency of the inspection requirements used by exempt states and accrediting organizations. GAO was asked to discuss (1) the quality of lab testing and (2) the adequacy of CLIA oversight. To examine these issues, GAO analyzed data on lab performance and reviewed the procedures used by CMS and survey organizations to implement CLIA and oversee lab performance. This testimony is based on the GAO report, Clinical Lab Quality: CMS and Survey Organization Oversight Should Be Strengthened, GAO-06-416 (June 16, 2006).

What GAO Found

In summary, insufficient data exist to identify the extent of serious quality problems at labs. When CMS implemented revised CLIA survey requirements in 2004, it modified historical state survey agency findings and, as a result, data prior to 2004 no longer reflect key survey requirements in effect at the time of those surveys. The limited data available suggest that state survey agency inspections do not identify all serious deficiencies. In addition, the lack of a straightforward method to link similar requirements across survey organizations makes it virtually impossible to assess lab quality in a standardized manner. Furthermore, CMS does not effectively use available data, such as the proportion of labs with serious deficiencies or proficiency testing results, to monitor lab quality. Proficiency testing is an objective measurement of a lab's ability to consistently produce accurate test results. GAO's analysis of proficiency testing data suggests that lab quality may not have improved at hospital labs in recent years. Oversight of clinical lab quality is not adequate to ensure that labs are meeting CLIA requirements. Weaknesses in five areas mask real and potential quality problems at labs. First, the balance struck between the CLIA program's educational and regulatory goals is sometimes inappropriately skewed toward education, which may result in understatement of survey findings. For example, even though the initial test failure rates were high, CMS instructed state survey agencies not to cite deficiencies during the first two years of required Pap smear proficiency testing to allow labs and their staff to become familiar with the program. Second, the manner in which one accrediting organization structures its survey teams raised concerns about appropriate levels of training and the appearance of a conflict of interest that could undermine the integrity of the survey process. Third, concerns about anonymity and lab workers' lack of familiarity with how to file a complaint suggests that some quality problems are not being reported. Fourth, based on the large number of labs with proposed sanctions from 1998 through 2004 that were never imposed--even for labs with the same serious deficiencies on consecutive surveys--it is unclear how effective CMS's enforcement process is at motivating labs to consistently comply with CLIA requirements. Finally, CMS is not meeting its requirement to determine in a timely manner the continued equivalency of accrediting organization and exempt-state program inspection requirements and processes, nor has the agency reviewed changes to accrediting organization and exempt-state program inspection requirements before implementation.