Cost of rapid HIV testing at 45 U.S. hospitals.

In 2006, the United States Centers for Disease Control and Prevention (CDC) recommended expanded and routine use of single-session rapid HIV tests in all health care settings to increase the proportion of persons who learn their HIV status. Limited empiric information is available regarding the costs of rapid testing and pre- and posttest counseling in health care settings. We surveyed 45 U.S. hospitals during 2005 through 2006 to assess the costs associated with rapid testing and counseling. Cost analyses were conducted from the provider (hospital) perspective, and results were expressed in year 2006 U.S. dollars. The mean per-test cost of rapid HIV testing and counseling was $48.07 for an HIV-negative test and $64.17 for a preliminary-positive test. Pre- and posttest counseling costs accounted for 38.4% of the total cost of rapid testing for HIV-negative patients. Counseling costs were significantly correlated with overall test costs. Many hospitals contained overall test costs by limiting time spent in pre- and posttest counseling or by using lower-paid personnel for counseling activities or both. Counseling costs constituted a significant proportion of the overall costs of rapid testing and counseling activities at study hospitals. Our data provide useful baseline data before implementation of the CDC's 2006 recommendations. Costs can be reduced by limiting time spent in pre- and posttest counseling or by using lower-paid personnel for counseling activities or both.

Proficiency testing performance in US laboratories: results reported to the Centers for Medicare & Medicaid Services, 1994 through 2006.

CONTEXT: Beginning in 1994, clinical laboratories performing nonwaived testing were required, under the regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA), to enroll and participate in a proficiency testing (PT) program approved by the Centers for Medicare & Medicaid Services. Successful PT performance is a requirement for maintaining CLIA certification to perform testing in certain specialties and subspecialties and for specific analytes. OBJECTIVE: To evaluate the PT performance from 1994 through 2006 of hospital and independent laboratories (HI) compared with all other testing sites (AOT) for selected commonly performed tests and analytes. DESIGN: Proficiency testing data, from 1994 through 2006, were electronically reported to the Centers for Medicare & Medicaid Services by approved PT programs as required by CLIA regulations. Approximately 16 million PT event scores from 36 000 unique testing sites were sorted into 2 groups based on the type of testing facility: HI or AOT. RESULTS: The PT performance scores for 15 of the most commonly performed tests demonstrated a decline in failure rates for both HI and AOT laboratory groups during 1994 through 2006 (analyte/test values reported in this article include alanine aminotransferase, amylase, bilirubin, cholesterol, digoxin, glucose, hemoglobin, leukocyte count, potassium, prothrombin time, theophylline, thyroxine, triglycerides, white blood cell differential, and uric acid). For most analytes, the difference in failure rates between HI and AOT was statistically significant. The AOT group started with higher failure rates, and remained higher for all analytes, during most years when compared with the HI group; although, over time, that difference diminished. The AOT group showed a greater decline in PT failure than the HI group. For all analytes, the AOT group performance improved during this period. CONCLUSIONS: The PT performance improved dramatically for the AOT group from 1994 through 2006 as measured by a decrease in the percentage of laboratories with unsatisfactory performance for 15 selected analytes. The PT performance in the HI group improved modestly for some analytes during this same period, whereas, for other analytes, the group showed no apparent improvement.

Provider-related barriers to rapid HIV testing in U.S. urban non-profit community clinics, community-based organizations (CBOs) and hospitals.

We examined provider-reported barriers to rapid HIV testing in U.S. urban non-profit community clinics, community-based organizations (CBOs), and hospitals. 12 primary metropolitan statistical areas (PMSAs; three per region) were sampled randomly, with sampling weights proportional to AIDS case reports. Across PMSAs, all 671 hospitals and a random sample of 738 clinics/CBOs were telephoned for a survey on rapid HIV test availability. Of the 671 hospitals, 172 hospitals were randomly selected for barriers questions, for which 158 laboratory and 136 department staff were eligible and interviewed in 2005. Of the 738 clinics/CBOs, 276 were randomly selected for barriers questions, 206 were reached, and 118 were eligible and interviewed in 2005-2006. In multivariate models, barriers regarding translation of administrative/quality assurance policies into practice were significantly associated with rapid HIV testing availability. For greater rapid testing diffusion, policies are needed to reduce administrative barriers and provide quality assurance training to non-laboratory staff.

Cost of OraQuick oral fluid rapid HIV testing at 35 community clinics and community-based organizations in the USA.

The US Centers for Disease Control and Prevention recommends the expanded use of rapid HIV antibody tests in community settings to increase the proportion of persons who are aware of their HIV status. The cost of providing rapid testing services in these settings is not known. We conducted a cost survey of non-profit community clinics and community-based organizations (CBOs). The final study sample for the cost analyses included 28 community clinics and seven CBOs that offered rapid HIV testing, all of which used OraSure's OraQuick oral fluid assay. Overall, the mean per-client rapid testing cost was 36.68 dollars for HIV-negative clients (2006 dollars, provider perspective) and 44.22 dollars for preliminary-positive clients. Personnel costs accounted for 55.6% of overall testing costs for negative clients and 63.2% for preliminary-positive clients. This study contributes unique empirical data about the costs of OralQuick rapid testing that can be used by clinic and CBO directors to assess the economic impact of implementing rapid testing at their sites. The findings also could be used to inform discussions regarding national and local HIV testing policies.

Good laboratory practices for molecular genetic testing for heritable diseases and conditions.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized as waived (from routine regulatory oversight) or nonwaived based on the complexity of the tests; tests of moderate and high complexity are nonwaived tests. Laboratories that perform molecular genetic testing are subject to the general CLIA quality systems requirements for nonwaived testing and the CLIA personnel requirements for tests of high complexity. Although many laboratories that perform molecular genetic testing comply with applicable regulatory requirements and adhere to professional practice guidelines,specific guidelines for quality assurance are needed to ensure the quality of test performance. To enhance the oversight of genetic testing under the CLIA framework,CDC and the Centers for Medicare & Medicaid Services (CMS) have taken practical steps to address the quality management concerns in molecular genetic testing,including working with the Clinical Laboratory Improvement Advisory Committee (CLIAC). This report provides CLIAC recommendations for good laboratory practices for ensuring the quality of molecular genetic testing for heritable diseases and conditions. The recommended practices address the total testing process (including the preanalytic,analytic,and postanalytic phases),laboratory responsibilities regarding authorized persons,confidentiality of patient information,personnel competency,considerations before introducing molecular genetic testing or offering new molecular genetic tests,and the quality management system approach to molecular genetic testing. These recommendations are intended for laboratories that perform molecular genetic testing for heritable diseases and conditions and for medical and public health professionals who evaluate laboratory practices and policies to improve the quality of molecular genetic laboratory services. This report also is intended to be a resource for users of laboratory services to aid in their use of molecular genetic tests and test results in health assessment and care. Improvements in the quality and use of genetic laboratory services should improve the quality of health care and health outcomes for patients and families of patients.

Scope of rapid HIV testing in urban U.S. hospitals.

OBJECTIVE: The present study examined the scope of rapid human immunodeficiency virus (HIV) testing in urban U.S. hospitals. METHODS: In a multistage national probability sample, 12 primary metropolitan statistical areas (three per region) were sampled randomly, with weights proportionate to acquired immunodeficiency syndrome (AIDS) populations. All 671 eligible hospitals within areas were selected. Laboratory staff from 584 hospitals (87%) were interviewed by telephone in 2005. RESULTS: About 52% reported rapid HIV test availability (50% in occupational health, 29% in labor and delivery, and 13% in emergency department/urgent care), and 86% of hospitals offering rapid tests processed them in the laboratory. In multivariate models, rapid test availability was more likely in hospitals serving more patients, and located in high-poverty, high-AIDS prevalence areas, and in the South or Midwest vs. West. It was less likely in hospitals serving areas with large percentages of people who were black/African American or Hispanic/Latino (p<0.05). CONCLUSIONS: Rapid HIV testing is increasing across urban U.S. hospitals, primarily for occupational exposure and in hospitals with greater resources and need. To achieve routine HIV screening, policies should encourage greater breadth of diffusion of rapid testing at the point of care, especially in smaller facilities, the West, and communities with racial/ethnic diversity.

Scope of rapid HIV testing in private nonprofit urban community health settings in the United States.

OBJECTIVES: We examined patterns of rapid HIV testing in a multistage national random sample of private, nonprofit, urban community clinics and community-based organizations to determine the extent of rapid HIV test availability outside the public health system. METHODS: We randomly sampled 12 primary metropolitan statistical areas in 4 regions; 746 sites were randomly sampled across areas and telephoned. Staff at 575 of the sites (78%) were reached, of which 375 were eligible and subsequently interviewed from 2005 to 2006. RESULTS: Seventeen percent of the sites offered rapid HIV tests (22% of clinics, 10% of community-based organizations). In multivariate models, rapid test availability was more likely among community clinics in the South (vs West), clinics in high HIV/AIDS prevalence areas, clinics with on-site laboratories and multiple locations, and clinics that performed other diagnostic tests. CONCLUSIONS: Rapid HIV tests were provided infrequently in private, nonprofit, urban community settings. Policies that encourage greater diffusion of rapid testing are needed, especially in community-based organizations and venues with fewer resources and less access to laboratories.

Good laboratory practices for waived testing sites: survey findings from testing sites holding a certificate of waiver under the clinical laboratory improvement amendments of 1988 and recommendations for promoting quality testing.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), simple, low-risk tests can be waived and performed with no routine regulatory oversight in physicians' offices and various other locations. Since CLIA was implemented, waived testing has steadily increased in the United States. Surveys conducted during 1999-2004 by the Centers for Medicare & Medicaid Services and studies funded by CDC during 1999-2003 evaluated testing practices in sites holding a CLIA Certificate of Waiver (CW). Although study findings indicate CW sites generally take measures to perform testing correctly, they raise quality concerns about practices that could lead to errors in testing and poor patient outcomes. These issues are probably caused, in part, by high personnel turnover rates, lack of understanding about good laboratory practices, and inadequate training. This report summarizes study findings and provides recommendations developed by the Clinical Laboratory Improvement Advisory Committee for conducting quality waived testing. These recommendations include considerations before introducing waived testing, such as management responsibility for testing, regulatory requirements, safety, physical and environmental requirements, benefits and costs, staffing, and documentation. They also cover good laboratory practices for the three phases of testing: 1) before testing (test ordering and specimen collection), 2) during testing (control testing, test performance, and result interpretation and recording), and 3) after testing (result reporting, documentation, confirmatory testing, and biohazard waste disposal). They are intended to be used by those who would benefit from improving their knowledge of good laboratory practices. Continued monitoring of waived testing, with a focus on personnel education and training, is needed to improve practices and enhance patient safety as waived testing continues to increase.