SCHIP

through SEDS. The CMS and the States consider the 21,000,0000 Medicaid enrollment figure to be a final estimate for 1997. This figure is also cited in the first annual report of the CMS-funded evaluation of SCHIP by Mathematica Policy Research (posted on the web at www.hcfa.gov/init/fy2000.pdf).

The 1998-2001 Medicaid enrollment counts presented are estimates based on interim data submitted by the States through SEDS and are therefore subject to change when edited HCFA-2082 data become available. In general, edited data for a fiscal year are available about two years after the end of the year.

States may eventually report all of their SCHIP and Medicaid data through the Medicaid Statistical Information System (MSIS). Reporting Medicaid data through MSIS is now required for all States; and we are working with States to help them use MSIS to streamline their Medicaid and SCHIP reporting and improve CMS's ability to analyze data across programs. However, there are significant time lags in collecting and editing these data through MSIS. Therefore, we will continue to rely on the States' quarterly and annual statistical report submissions through SEDS, with updates from edited HCFA-2082 data, as such data become available.

Verification and Validation: The program enrollment data that States submit through SEDS are reviewed by CMS personnel every quarter. These data also are subject to audit and are being reviewed and analyzed as part of a National Evaluation contract awarded to Mathematica Policy Research.

CMS will measure, to the extent possible, the unduplicated count of the number of children who are enrolled in any of the following programs: regular Medicaid; expansions of Medicaid through SCHIP; and separate SCHIP programs as reported by the States. While we consider an unduplicated count to be an appropriate measure for this goal and we can measure the unduplicated count within each program, some children may be enrolled in Medicaid at one point in the year and in SCHIP at another point, making it difficult to establish an accurate unduplicated count across all programs. Similarly, the SCHIP counts include some double counting of children in States that have combination programs. To the extent our data allow, we will closely monitor this issue.

The Clinical Laboratory Improvement Amendments of 1988 (CLIA) strengthen quality performance requirements under the Public Health Service Act and extend these requirements to all laboratories that test human specimens for health purposes. Currently 174,500 laboratories are registered with the CLIA program. Approximately 77 percent of these laboratories perform test methodologies that are so simple and accurate that the likelihood of erroneous results is negligible and, therefore, are not subject to proficiency testing (PT) or routine inspections. Workloads projected for FY 2004 include a five percent sample review of all 16,300 accredited laboratories and surveys of 20,800 non-accredited laboratories, State validation surveys of 800 accredited laboratories, and approximately 1,600 follow-up surveys and complaint investigations.

CLIA

Performance Results Discussion

Success in our PT program increases patient and physician confidence by producing a snapshot of laboratory's ability to perform tests accurately. It also reduces the need for repetitive testing, which will reduce overall costs of medical care related to diagnostic testing. We have exceeded our targets in FYS 1999 and 2000 to sustain improved testing accuracy with 91.9 percent of laboratories having no failures and 96.4 percent of laboratories properly enrolled in PT. We expect to receive final CY 2001 performance data for our CLIA goal in the first quarter of CY 2002, and based on the performance we have seen thus far, we anticipate continued success.

The CMS feels that we have reached peak performance with the percentage of laboratories enrolled in PT with no failures and with the percentage of laboratories properly enrolled and participating in PT. However, we feel that it is important to maintain these levels of laboratory testing accuracy and to continue to monitor and report on performance in these target areas. Documented experiences with previously regulated and voluntarily accredited laboratories indicate that PT performance can achieve these high levels, and our data now reflect that the previously unregulated laboratories can also accomplish this. The experiences also maintain that PT performance can be monitored and sustained to guarantee accurate and reliable testing and timely PT problem resolution.

Discussion: Congress passed the Clinical Laboratory Improvement Amendments
(CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the
accuracy, reliability and timeliness of patient test results regardless of where the test
was performed. CLIA specifies quality standards for proficiency testing (PT), which
provides CMS with a means of measuring laboratory performance. A laboratory's
performance of PT provides CMS surveyors, CLIA surveyors, inspectors of approved
accreditation organizations, and surveyors of approved State licensure programs with an
excellent overview of the laboratory's current ability to produce accurate patient test
results. Because of the continuous monitoring of PT by these individuals and the value
of PT in general, we decided to use PT enrollment and successful PT performance as
our target areas for improvement for this goal.

PT involves sending sample specimens with known properties to each laboratory three times per year, the results of which are not known to the laboratory. Laboratories' PT results are then evaluated for accuracy by CMS-approved private and State operated PT programs, following CLIA PT requirements. The PT testing is "blind," in that the laboratory staff members are not given any information about what they are expected to find. The CLIA regulation requires that the PT samples be tested in the same manner and by the same individuals as those performing patient testing.

Laboratory personnel, tests offered, and even laboratory size, location and environment are never constant. Because each can have a significant impact on test performance, we decided to set our initial goals at the highest realistic levels possible, taking into consideration that many laboratories had never been regulated before CLIA. Setting

CLIA

high initial targets (what we believed to be a maximum expectation for 38,000 laboratories, with no assurance they could be met) gave us true goals to strive for in our ever-changing health care environment, and we believed anything less stringent would not have been acceptable, considering the clinical impact of laboratory results on the beneficiaries of Medicare and Medicaid, as well as all other patients.

PT increases patient and physician confidence in a particular laboratory by producing a snapshot of the laboratory's ability to perform tests accurately according to objective standards. This enhanced confidence in laboratory test accuracy reduces the need or inclination for repetitive laboratory testing and thereby reduces the overall costs of medical care related to diagnostic testing. Typically, a laboratory that performs well on PT also provides accurate testing results for clinicians, which aids in rapid and appropriate patient diagnoses and therefore contributes to effective treatment. There is a well-documented educational value for the laboratory from PT because of the opportunity and incentive for the laboratory to learn from its PT performance.

There are approximately 174,500 CLIA certified laboratories. Seventy-seven percent of these laboratories perform test methodologies that are so simple and accurate that the likelihood of erroneous results is negligible and, therefore, are not subject to PT. The remaining 23 percent of the laboratories must perform PT on the required tests or analytes and are overseen directly by CMS, the State survey agencies, or private accrediting organizations. There are currently 86 tests or analytes (i.e., cholesterol, glucose, white blood cell count, etc.) for which laboratories must perform PT under CLIA. This list of 86 analytes is largely made up of diagnostic tests, which are commonly performed and whose results are important to health care treatment decisions. Each laboratory performs PT on the required analytes that are a part of its specific test menu.

Since PT data is only collected by calendar year, we are reporting in terms of calendar years. It is more accurate to report information for the same time frame, as opposed to having some information in calendar years and other information in fiscal years.

Coordination: The CMS works closely with State surveyors, CMS-approved accreditation organizations, PT programs, CMS-approved State laboratory licensure programs (CLIA-exempt laboratories) and professional advocacy groups in carrying out its CLIA activities.

Data Source(s): The primary data source is the Online Survey and Certification Reporting System (OSCAR). The PT enrollment rate is calculated using: (1) the number of laboratories in the OSCAR database that were subject to on-site survey and PT testing for at least one analyte, and (2) the number of laboratories cited as deficient for failing to be appropriately enrolled in PT. The rate at which enrolled labs perform successfully on PT is calculated using totals from the OSCAR database for: (1) the total number of tests performed for the year; and (2) the total number of failed scores received for the year.