Complaint investigations for  all survey organizations are unannounced. Validation reviews are one of  CMS’s primary oversight tools. 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, such as identifying the proportion of labs  with condition-level deficiencies. Limited Data Are Available on the Quality of Labs Inspected by State Survey Agencies

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. Proficiency Testing Results Suggest that Quality Has Not Improved at Hospital Labs in Recent Years

Although CMS noted that proficiency testing trend data show a decrease in  failures for labs as a whole, the data suggest that lab quality may not have  improved at hospital labs for the period 1999 through 2003. Proficiency  testing is an important oversight tool for survey organizations because it is  an objective indicator of a lab’s ability to consistently produce accurate  test results and is conducted more frequently than surveys—three times a  year versus once every 2 years. Survey weaknesses include:   (1) inspections that most organizations announce ahead of the visit, which  allows labs to prepare for their inspections and portray themselves in a  manner that may not accurately reflect their day-to-day quality assurance  processes; (2) variability in the proportion of labs with condition-level  deficiencies in 2004, which suggests surveys are not conducted in a  consistent manner; and (3) the goal of educating lab workers during  surveys taking precedence over, or precluding, the identification and  reporting of deficiencies. Announced Surveys May Result in Unrealistic Picture of Lab Quality

Because labs can and do prepare for surveys, CMS regional office officials  and most of the state survey agencies acknowledged that announced  surveys may not always provide a realistic picture of lab quality. For example, according to officials from a state survey agency we  interviewed, surveyors prefer not to cite condition-level deficiencies. Lab Workers Who File Complaints About Quality Problems in Lab Testing Not Afforded Whistle- blower Protections

Some lab workers may not be filing complaints about quality problems at  their labs because of anonymity concerns or because they may not be  familiar with filing procedures. Finally, CMS does not adequately use data, such as the results of  surveys, to monitor survey organization activities and processes. CLIA requires that proficiency testing be conducted “on a quarterly basis,  except where the Secretary determines for technical and scientific reasons  that a particular examination or procedure may be tested less frequently  (but not less often than twice per year).” The committee report on the bill  that forms the basis for much of CLIA indicated that “proficiency testing  should be the central element in determining a laboratory’s competence,  since it purports to measure actual test outcomes rather than merely  gauging the potential for accurate outcomes.”
In CMS’s 1992 rule implementing CLIA, the agency provided a rationale for  reducing the frequency of proficiency testing, but did not provide a  technical and scientific basis for reducing the frequency for particular  procedures or tests. For example:    Accrediting organizations provide labs more advance notice about  upcoming surveys than CMS allows state survey agencies to give to the  labs they inspect. Many CMS Validation Reviews Lack Independence and Reviews Skip Some State Survey Agencies

CMS validation reviews that are intended to evaluate lab surveys  conducted by both states and accrediting organizations do not provide  CMS with an independent assessment of the extent to which surveys  identify all serious—that is, condition-level or condition-level equivalent— deficiencies. Without  validating at least some surveys in each state, CMS is unable to determine  if the states are appropriately identifying deficiencies. CMS Use of Data for Oversight of CLIA Program Is Limited

CMS does not routinely collect and analyze data essential for effective  oversight of the CLIA program but has initiatives to automate some  available data to make them more accessible for analysis. CMS is  developing, and plans to launch, a complaints database in March 2006. Allow the CLIA program to utilize revenues generated by the program to  hire sufficient staff to fulfill its statutory responsibilities. COLA said that our recommendations to improve CMS oversight of survey  organizations had merit. JCAHO said that our recommendation  that all survey organizations develop and require labs to prominently  display posters that instruct lab workers on how to file anonymous  complaints was too narrow and prescriptive and may inadvertently limit  organizations from using other, more effective ways to educate lab  workers on this topic.
Why GAO Did This Study

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) strengthened and extended 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 either a state or one of six private accrediting organizations. CMS oversees implementation of CLIA requirements and the activities of survey organizations. GAO was asked to examine (1) the quality of lab testing; (2) the effectiveness of surveys, complaint investigations, and enforcement actions in detecting and addressing lab problems; and (3) the adequacy of CMS's CLIA oversight.

What GAO Found

Because of limited comparable data from CMS and survey organizations, too little is known about the quality of lab testing. For example, a standardized assessment of lab quality across survey organizations is not possible because of different definitions of what constitutes a serious quality problem. One survey organization had no systematic way of identifying the problematic labs it inspects. However, GAO's analysis of an indicator that measures a lab's ability to consistently produce accurate test results suggests that lab quality may not have improved at hospital labs in recent years. Based on an analysis of available data and interviews with CMS and survey organizations, real and potential lab quality problems are masked by survey, complaint, and enforcement weaknesses. Because most survey organizations announce the timing of biennial surveys, allowing labs to prepare for inspections, surveys may not provide a realistic picture of lab quality. Although two survey organizations that generally inspect hospital labs plan to begin unannounced surveys in 2006, they may not be possible at physician office labs that have irregular hours. Survey organizations that typically inspect such labs, however, provide more advance notice about upcoming inspections than CMS allows states to provide. Several other factors suggest that surveys and complaints do not present a realistic picture of lab quality. Interviews with officials from a sample of states confirmed that some survey organizations do not cite all serious deficiencies, as evidenced by variability in the limited available lab survey data. Officials said that surveyors may be reluctant to cite deficiencies because they view their role as educational, not regulatory; moreover, CMS has instructed state surveyors not to cite some deficiencies for over 2 years after implementing new lab requirements. Finally, lab workers may file complaints infrequently because of concern about retaliation and a lack of understanding about how to file a complaint. CMS rarely imposes sanctions, even for labs with the same repeat deficiencies, a reflection of the educational focus of the CLIA program. CMS does not require labs to participate in a key quality assurance test as frequently as CLIA requires. Although funded by lab fees, CMS officials indicated that the program has not been allowed to hire sufficient staff to carry out the agency's oversight responsibilities. Moreover, CMS's principal oversight tool, intended to determine if all serious deficiencies were identified, lacks independence because many oversight reviews are conducted simultaneously with survey organizations. CMS's presence may make surveyors more attentive to survey tasks than when they are not being observed. Compared to independent reviews, simultaneous reviews rarely identify missed deficiencies. Furthermore, CMS does not collect and analyze data on serious deficiencies identified by each survey organization and thus, is unable to assess whether lab quality is improving or declining. Nor does CMS effectively analyze other key data such as the use of sanctions. To improve oversight, CMS is establishing a nationwide complaints database. CMS is also instituting annual survey organization performance reviews.