Last data update: May 13, 2024. (Total: 46773 publications since 2009)
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Query Trace: Howerton D[original query] |
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Evaluation of the US COVID-19 Scenario Modeling Hub for informing pandemic response under uncertainty
Howerton E , Contamin L , Mullany LC , Qin M , Reich NG , Bents S , Borchering RK , Jung SM , Loo SL , Smith CP , Levander J , Kerr J , Espino J , van Panhuis WG , Hochheiser H , Galanti M , Yamana T , Pei S , Shaman J , Rainwater-Lovett K , Kinsey M , Tallaksen K , Wilson S , Shin L , Lemaitre JC , Kaminsky J , Hulse JD , Lee EC , McKee CD , Hill A , Karlen D , Chinazzi M , Davis JT , Mu K , Xiong X , Pastore YPiontti A , Vespignani A , Rosenstrom ET , Ivy JS , Mayorga ME , Swann JL , España G , Cavany S , Moore S , Perkins A , Hladish T , Pillai A , Ben Toh K , Longini I Jr , Chen S , Paul R , Janies D , Thill JC , Bouchnita A , Bi K , Lachmann M , Fox SJ , Meyers LA , Srivastava A , Porebski P , Venkatramanan S , Adiga A , Lewis B , Klahn B , Outten J , Hurt B , Chen J , Mortveit H , Wilson A , Marathe M , Hoops S , Bhattacharya P , Machi D , Cadwell BL , Healy JM , Slayton RB , Johansson MA , Biggerstaff M , Truelove S , Runge MC , Shea K , Viboud C , Lessler J . Nat Commun 2023 14 (1) 7260 Our ability to forecast epidemics far into the future is constrained by the many complexities of disease systems. Realistic longer-term projections may, however, be possible under well-defined scenarios that specify the future state of critical epidemic drivers. Since December 2020, the U.S. COVID-19 Scenario Modeling Hub (SMH) has convened multiple modeling teams to make months ahead projections of SARS-CoV-2 burden, totaling nearly 1.8 million national and state-level projections. Here, we find SMH performance varied widely as a function of both scenario validity and model calibration. We show scenarios remained close to reality for 22 weeks on average before the arrival of unanticipated SARS-CoV-2 variants invalidated key assumptions. An ensemble of participating models that preserved variation between models (using the linear opinion pool method) was consistently more reliable than any single model in periods of valid scenario assumptions, while projection interval coverage was near target levels. SMH projections were used to guide pandemic response, illustrating the value of collaborative hubs for longer-term scenario projections. |
Projected resurgence of COVID-19 in the United States in July-December 2021 resulting from the increased transmissibility of the Delta variant and faltering vaccination (preprint)
Truelove S , Smith CP , Qin M , Mullany LC , Borchering RK , Lessler J , Shea K , Howerton E , Contamin L , Levander J , Salerno J , Hochheiser H , Kinsey M , Tallaksen K , Wilson S , Shin L , Rainwater-Lovett K , Lemaitre JC , Dent J , Kaminsky J , Lee EC , Perez-Saez J , Hill A , Karlen D , Chinazzi M , Davis JT , Mu K , Xiong X , Piontti APY , Vespignani A , Srivastava A , Porebski P , Venkatramanan S , Adiga A , Lewis B , Klahn B , Outten J , Schlitt J , Corbett P , Telionis PA , Wang L , Peddireddy AS , Hurt B , Chen J , Vullikanti A , Marathe M , Hoops S , Bhattacharya P , Machi D , Chen S , Paul R , Janies D , Thill JC , Galanti M , Yamana T , Pei S , Shaman J , Reich NG , Healy JM , Slayton RB , Biggerstaff M , Johansson MA , Runge MC , Viboud C . medRxiv 2021 WHAT IS ALREADY KNOWN ABOUT THIS TOPIC? The highly transmissible SARS-CoV-2 Delta variant has begun to cause increases in cases, hospitalizations, and deaths in parts of the United States. With slowed vaccination uptake, this novel variant is expected to increase the risk of pandemic resurgence in the US in July-December 2021. WHAT IS ADDED BY THIS REPORT? Data from nine mechanistic models project substantial resurgences of COVID-19 across the US resulting from the more transmissible Delta variant. These resurgences, which have now been observed in most states, were projected to occur across most of the US, coinciding with school and business reopening. Reaching higher vaccine coverage in July-December 2021 reduces the size and duration of the projected resurgence substantially. The expected impact of the outbreak is largely concentrated in a subset of states with lower vaccination coverage. WHAT ARE THE IMPLICATIONS FOR PUBLIC HEALTH PRACTICE? Renewed efforts to increase vaccination uptake are critical to limiting transmission and disease, particularly in states with lower current vaccination coverage. Reaching higher vaccination goals in the coming months can potentially avert 1.5 million cases and 21,000 deaths and improve the ability to safely resume social contacts, and educational and business activities. Continued or renewed non-pharmaceutical interventions, including masking, can also help limit transmission, particularly as schools and businesses reopen. |
COVID-19 reopening strategies at the county level in the face of uncertainty: Multiple Models for Outbreak Decision Support (preprint)
Shea K , Borchering RK , Probert WJM , Howerton E , Bogich TL , Li S , van Panhuis WG , Viboud C , Aguás R , Belov A , Bhargava SH , Cavany S , Chang JC , Chen C , Chen J , Chen S , Chen Y , Childs LM , Chow CC , Crooker I , Valle SYD , España G , Fairchild G , Gerkin RC , Germann TC , Gu Q , Guan X , Guo L , Hart GR , Hladish TJ , Hupert N , Janies D , Kerr CC , Klein DJ , Klein E , Lin G , Manore C , Meyers LA , Mittler J , Mu K , Núñez RC , Oidtman R , Pasco R , Piontti APY , Paul R , Pearson CAB , Perdomo DR , Perkins TA , Pierce K , Pillai AN , Rael RC , Rosenfeld K , Ross CW , Spencer JA , Stoltzfus AB , Toh KB , Vattikuti S , Vespignani A , Wang L , White L , Xu P , Yang Y , Yogurtcu ON , Zhang W , Zhao Y , Zou D , Ferrari M , Pannell D , Tildesley M , Seifarth J , Johnson E , Biggerstaff M , Johansson M , Slayton RB , Levander J , Stazer J , Salerno J , Runge MC . medRxiv 2020 Policymakers make decisions about COVID-19 management in the face of considerable uncertainty. We convened multiple modeling teams to evaluate reopening strategies for a mid-sized county in the United States, in a novel process designed to fully express scientific uncertainty while reducing linguistic uncertainty and cognitive biases. For the scenarios considered, the consensus from 17 distinct models was that a second outbreak will occur within 6 months of reopening, unless schools and non-essential workplaces remain closed. Up to half the population could be infected with full workplace reopening; non-essential business closures reduced median cumulative infections by 82%. Intermediate reopening interventions identified no win-win situations; there was a trade-off between public health outcomes and duration of workplace closures. Aggregate results captured twice the uncertainty of individual models, providing a more complete expression of risk for decision-making purposes. |
Impact of SARS-CoV-2 vaccination of children ages 5-11 years on COVID-19 disease burden and resilience to new variants in the United States, November 2021-March 2022: a multi-model study (preprint)
Borchering RK , Mullany LC , Howerton E , Chinazzi M , Smith CP , Qin M , Reich NG , Contamin L , Levander J , Kerr J , Espino J , Hochheiser H , Lovett K , Kinsey M , Tallaksen K , Wilson S , Shin L , Lemaitre JC , Hulse JD , Kaminsky J , Lee EC , Davis JT , Mu K , Xiong X , Pastore y Piontti A , Vespignani A , Srivastava A , Porebski P , Venkatramanan S , Adiga A , Lewis B , Klahn B , Outten J , Hurt B , Chen J , Mortveit H , Wilson A , Marathe M , Hoops S , Bhattacharya P , Machi D , Chen S , Paul R , Janies D , Thill JC , Galanti M , Yamana T , Pei S , Shaman J , Espana G , Cavany S , Moore S , Perkins A , Healy JM , Slayton RB , Johansson MA , Biggerstaff M , Shea K , Truelove SA , Runge MC , Viboud C , Lessler J . medRxiv 2022 10 Background SARS-CoV-2 vaccination of persons aged 12 years and older has reduced disease burden in the United States. The COVID-19 Scenario Modeling Hub convened multiple modeling teams in September 2021 to project the impact of expanding vaccine administration to children 5-11 years old on anticipated COVID-19 burden and resilience against variant strains. Methods Nine modeling teams contributed state- and national-level projections for weekly counts of cases, hospitalizations, and deaths in the United States for the period September 12, 2021 to March 12, 2022. Four scenarios covered all combinations of: 1) presence vs. absence of vaccination of children ages 5-11 years starting on November 1, 2021; and 2) continued dominance of the Delta variant vs. emergence of a hypothetical more transmissible variant on November 15, 2021. Individual team projections were combined using linear pooling. The effect of childhood vaccination on overall and age-specific outcomes was estimated by meta-analysis approaches. Findings Absent a new variant, COVID-19 cases, hospitalizations, and deaths among all ages were projected to decrease nationally through mid-March 2022. Under a set of specific assumptions, models projected that vaccination of children 5-11 years old was associated with reductions in all-age cumulative cases (7.2%, mean incidence ratio [IR] 0.928, 95% confidence interval [CI] 0.880-0.977), hospitalizations (8.7%, mean IR 0.913, 95% CI 0.834-0.992), and deaths (9.2%, mean IR 0.908, 95% CI 0.797-1.020) compared with scenarios where children were not vaccinated. This projected effect of vaccinating children 5-11 years old increased in the presence of a more transmissible variant, assuming no change in vaccine effectiveness by variant. Larger relative reductions in cumulative cases, hospitalizations, and deaths were observed for children than for the entire U.S. population. Substantial state-level variation was projected in epidemic trajectories, vaccine benefits, and variant impacts. Conclusions Results from this multi-model aggregation study suggest that, under a specific set of scenario assumptions, expanding vaccination to children 5-11 years old would provide measurable direct benefits to this age group and indirect benefits to the all-age U.S. population, including resilience to more transmissible variants. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY 4.0 International license. |
Multiple models for outbreak decision support in the face of uncertainty
Shea K , Borchering RK , Probert WJM , Howerton E , Bogich TL , Li SL , van Panhuis WG , Viboud C , Aguás R , Belov AA , Bhargava SH , Cavany SM , Chang JC , Chen C , Chen J , Chen S , Chen Y , Childs LM , Chow CC , Crooker I , Del Valle SY , España G , Fairchild G , Gerkin RC , Germann TC , Gu Q , Guan X , Guo L , Hart GR , Hladish TJ , Hupert N , Janies D , Kerr CC , Klein DJ , Klein EY , Lin G , Manore C , Meyers LA , Mittler JE , Mu K , Núñez RC , Oidtman RJ , Pasco R , Pastore YPiontti A , Paul R , Pearson CAB , Perdomo DR , Perkins TA , Pierce K , Pillai AN , Rael RC , Rosenfeld K , Ross CW , Spencer JA , Stoltzfus AB , Toh KB , Vattikuti S , Vespignani A , Wang L , White LJ , Xu P , Yang Y , Yogurtcu ON , Zhang W , Zhao Y , Zou D , Ferrari MJ , Pannell D , Tildesley MJ , Seifarth J , Johnson E , Biggerstaff M , Johansson MA , Slayton RB , Levander JD , Stazer J , Kerr J , Runge MC . Proc Natl Acad Sci U S A 2023 120 (18) e2207537120 Policymakers must make management decisions despite incomplete knowledge and conflicting model projections. Little guidance exists for the rapid, representative, and unbiased collection of policy-relevant scientific input from independent modeling teams. Integrating approaches from decision analysis, expert judgment, and model aggregation, we convened multiple modeling teams to evaluate COVID-19 reopening strategies for a mid-sized United States county early in the pandemic. Projections from seventeen distinct models were inconsistent in magnitude but highly consistent in ranking interventions. The 6-mo-ahead aggregate projections were well in line with observed outbreaks in mid-sized US counties. The aggregate results showed that up to half the population could be infected with full workplace reopening, while workplace restrictions reduced median cumulative infections by 82%. Rankings of interventions were consistent across public health objectives, but there was a strong trade-off between public health outcomes and duration of workplace closures, and no win-win intermediate reopening strategies were identified. Between-model variation was high; the aggregate results thus provide valuable risk quantification for decision making. This approach can be applied to the evaluation of management interventions in any setting where models are used to inform decision making. This case study demonstrated the utility of our approach and was one of several multimodel efforts that laid the groundwork for the COVID-19 Scenario Modeling Hub, which has provided multiple rounds of real-time scenario projections for situational awareness and decision making to the Centers for Disease Control and Prevention since December 2020. |
Impact of SARS-CoV-2 vaccination of children ages 5-11 years on COVID-19 disease burden and resilience to new variants in the United States, November 2021-March 2022: A multi-model study.
Borchering RK , Mullany LC , Howerton E , Chinazzi M , Smith CP , Qin M , Reich NG , Contamin L , Levander J , Kerr J , Espino J , Hochheiser H , Lovett K , Kinsey M , Tallaksen K , Wilson S , Shin L , Lemaitre JC , Hulse JD , Kaminsky J , Lee EC , Hill AL , Davis JT , Mu K , Xiong X , Pastore YPiontti A , Vespignani A , Srivastava A , Porebski P , Venkatramanan S , Adiga A , Lewis B , Klahn B , Outten J , Hurt B , Chen J , Mortveit H , Wilson A , Marathe M , Hoops S , Bhattacharya P , Machi D , Chen S , Paul R , Janies D , Thill JC , Galanti M , Yamana T , Pei S , Shaman J , España G , Cavany S , Moore S , Perkins A , Healy JM , Slayton RB , Johansson MA , Biggerstaff M , Shea K , Truelove SA , Runge MC , Viboud C , Lessler J . Lancet Reg Health Am 2023 17 100398 BACKGROUND: The COVID-19 Scenario Modeling Hub convened nine modeling teams to project the impact of expanding SARS-CoV-2 vaccination to children aged 5-11 years on COVID-19 burden and resilience against variant strains. METHODS: Teams contributed state- and national-level weekly projections of cases, hospitalizations, and deaths in the United States from September 12, 2021 to March 12, 2022. Four scenarios covered all combinations of 1) vaccination (or not) of children aged 5-11 years (starting November 1, 2021), and 2) emergence (or not) of a variant more transmissible than the Delta variant (emerging November 15, 2021). Individual team projections were linearly pooled. The effect of childhood vaccination on overall and age-specific outcomes was estimated using meta-analyses. FINDINGS: Assuming that a new variant would not emerge, all-age COVID-19 outcomes were projected to decrease nationally through mid-March 2022. In this setting, vaccination of children 5-11 years old was associated with reductions in projections for all-age cumulative cases (7.2%, mean incidence ratio [IR] 0.928, 95% confidence interval [CI] 0.880-0.977), hospitalizations (8.7%, mean IR 0.913, 95% CI 0.834-0.992), and deaths (9.2%, mean IR 0.908, 95% CI 0.797-1.020) compared with scenarios without childhood vaccination. Vaccine benefits increased for scenarios including a hypothesized more transmissible variant, assuming similar vaccine effectiveness. Projected relative reductions in cumulative outcomes were larger for children than for the entire population. State-level variation was observed. INTERPRETATION: Given the scenario assumptions (defined before the emergence of Omicron), expanding vaccination to children 5-11 years old would provide measurable direct benefits, as well as indirect benefits to the all-age U.S. population, including resilience to more transmissible variants. FUNDING: Various (see acknowledgments). |
Projected resurgence of COVID-19 in the United States in July-December 2021 resulting from the increased transmissibility of the Delta variant and faltering vaccination.
Truelove S , Smith CP , Qin M , Mullany LC , Borchering RK , Lessler J , Shea K , Howerton E , Contamin L , Levander J , Salerno J , Hochheiser H , Kinsey M , Tallaksen K , Wilson S , Shin L , Rainwater-Lovett K , Lemairtre JC , Dent Hulse J , Kaminsky J , Lee EC , Perez-Saez J , Hill A , Karlen D , Chinazzi M , Davis JT , Mu K , Xiong X , Pastore YPiontti A , Vespignani A , Srivastava A , Porebski P , Venkatramanan S , Adiga A , Lewis B , Klahn B , Outten J , Orr M , Harrison G , Hurt B , Chen J , Vullikanti A , Marathe M , Hoops S , Bhattacharya P , Machi D , Chen S , Paul R , Janies D , Thill JC , Galanti M , Yamana TK , Pei S , Shaman JL , Healy JM , Slayton RB , Biggerstaff M , Johansson MA , Runge MC , Viboud C . Elife 2022 11 In Spring 2021, the highly transmissible SARS-CoV-2 Delta variant began to cause increases in cases, hospitalizations, and deaths in parts of the United States. At the time, with slowed vaccination uptake, this novel variant was expected to increase the risk of pandemic resurgence in the US in summer and fall 2021. As part of the COVID-10 Scenario Modeling Hub, an ensemble of nine mechanistic models produced six-month scenario projections for July-December 2021 for the United States. These projections estimated substantial resurgences of COVID-19 across the US resulting from the more transmissible Delta variant, projected to occur across most of the US, coinciding with school and business reopening. The scenarios revealed that reaching higher vaccine coverage in July-December 2021 reduced the size and duration of the projected resurgence substantially, with the expected impacts was largely concentrated in a subset of states with lower vaccination coverage. Despite accurate projection of COVID-19 surges occurring and timing, the magnitude was substantially underestimated 2021 by the models compared with the of the reported cases, hospitalizations, and deaths occurring during July-December, highlighting the continued challenges to predict the evolving COVID-19 pandemic. Vaccination uptake remains critical to limiting transmission and disease, particularly in states with lower vaccination coverage. Higher vaccination goals at the onset of the surge of the new variant were estimated to avert over 1.5 million cases and 21,000 deaths, though may have had even greater impacts, considering the underestimated resurgence magnitude from the model. |
Maternal Psychiatric Conditions, Treatment With Selective Serotonin Reuptake Inhibitors, and Neurodevelopmental Disorders
Ames JL , Ladd-Acosta C , Fallin MD , Qian Y , Schieve LA , DiGuiseppi C , Lee LC , Kasten EP , Zhou G , Pinto-Martin J , Howerton EM , Eaton CL , Croen LA . Biol Psychiatry 2021 90 (4) 253-262 BACKGROUND: This study aims to clarify relationships of maternal psychiatric conditions and selective serotonin reuptake inhibitor (SSRI) use during preconception and pregnancy with risk of neurodevelopmental disorders in offspring. METHODS: We used data from the Study to Explore Early Development, a multisite case-control study conducted in the United States among children born between 2003 and 2011. Final study group classifications of autism spectrum disorder (ASD) (n = 1367), developmental delays or disorders (DDs) (n = 1750), and general population controls (n = 1671) were determined by an in-person standardized developmental assessment. Maternal psychiatric conditions and SSRI use during pregnancy were ascertained from both self-report and medical records. We used logistic regression to evaluate associations of ASD and DDs (vs. population controls) with maternal psychiatric conditions and SSRI treatment in pregnancy. To reduce confounding by indication, we also examined SSRI associations in analyses restricted to mothers with psychiatric conditions during pregnancy. RESULTS: Psychiatric conditions and SSRI use during pregnancy were significantly more common among mothers of children with either ASD or DDs than among population controls. Odds of ASD were similarly elevated among mothers with psychiatric conditions who did not use SSRIs during pregnancy (adjusted odds ratio 1.81, 95% confidence interval 1.44-2.27) as in mothers who did use SSRIs (adjusted odds ratio 2.05, 95% confidence interval 1.50-2.80). Among mothers with psychiatric conditions, SSRI use was not significantly associated with ASD in offspring (adjusted odds ratio 1.14, 95% confidence interval 0.80-1.62). Primary findings for DDs exhibited similar relationships to those observed with ASD. CONCLUSIONS: Maternal psychiatric conditions but not use of SSRIs during pregnancy were associated with increased risk of neurodevelopmental disorders in offspring. |
Modeling of Future COVID-19 Cases, Hospitalizations, and Deaths, by Vaccination Rates and Nonpharmaceutical Intervention Scenarios - United States, April-September 2021.
Borchering RK , Viboud C , Howerton E , Smith CP , Truelove S , Runge MC , Reich NG , Contamin L , Levander J , Salerno J , van Panhuis W , Kinsey M , Tallaksen K , Obrecht RF , Asher L , Costello C , Kelbaugh M , Wilson S , Shin L , Gallagher ME , Mullany LC , Rainwater-Lovett K , Lemaitre JC , Dent J , Grantz KH , Kaminsky J , Lauer SA , Lee EC , Meredith HR , Perez-Saez J , Keegan LT , Karlen D , Chinazzi M , Davis JT , Mu K , Xiong X , Pastore YPiontti A , Vespignani A , Srivastava A , Porebski P , Venkatramanan S , Adiga A , Lewis B , Klahn B , Outten J , Schlitt J , Corbett P , Telionis PA , Wang L , Peddireddy AS , Hurt B , Chen J , Vullikanti A , Marathe M , Healy JM , Slayton RB , Biggerstaff M , Johansson MA , Shea K , Lessler J . MMWR Morb Mortal Wkly Rep 2021 70 (19) 719-724 After a period of rapidly declining U.S. COVID-19 incidence during January-March 2021, increases occurred in several jurisdictions (1,2) despite the rapid rollout of a large-scale vaccination program. This increase coincided with the spread of more transmissible variants of SARS-CoV-2, the virus that causes COVID-19, including B.1.1.7 (1,3) and relaxation of COVID-19 prevention strategies such as those for businesses, large-scale gatherings, and educational activities. To provide long-term projections of potential trends in COVID-19 cases, hospitalizations, and deaths, COVID-19 Scenario Modeling Hub teams used a multiple-model approach comprising six models to assess the potential course of COVID-19 in the United States across four scenarios with different vaccination coverage rates and effectiveness estimates and strength and implementation of nonpharmaceutical interventions (NPIs) (public health policies, such as physical distancing and masking) over a 6-month period (April-September 2021) using data available through March 27, 2021 (4). Among the four scenarios, an accelerated decline in NPI adherence (which encapsulates NPI mandates and population behavior) was shown to undermine vaccination-related gains over the subsequent 2-3 months and, in combination with increased transmissibility of new variants, could lead to surges in cases, hospitalizations, and deaths. A sharp decline in cases was projected by July 2021, with a faster decline in the high-vaccination scenarios. High vaccination rates and compliance with public health prevention measures are essential to control the COVID-19 pandemic and to prevent surges in hospitalizations and deaths in the coming months. |
Cost of rapid HIV testing at 45 U.S. hospitals
Pinkerton SD , Bogart LM , Howerton D , Snyder S , Becker K , Asch SM . AIDS Patient Care STDS 2010 24 (7) 409-13 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
Howerton D , Krolak JM , Manasterski A , Handsfield JH . Arch Pathol Lab Med 2010 134 (5) 751-8 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. |
Good laboratory practices for molecular genetic testing for heritable diseases and conditions
Chen B , Gagnon M , Shahangian S , Anderson NL , Howerton DA , Boone JD . MMWR Recomm Rep 2009 58 1-37; quiz CE-1-4 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. |
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