This effect was particularly evident in moving from three or four indicators to six, but less so when transitioning from six to eight indicators. Sites performing Point-of-care testing (POCT) must obtain Clinical Laboratory Improvement Amendments of 1988 (CLIA) certification prior to testing. and responsibilities for a technical consultant for moderate If you have comments or suggestions on how to improve the www.ecfr.gov website or have questions about using www.ecfr.gov, please choose the 'Website Feedback' button below. Confirmatory factor analysis for applied research. 14, 1990, unless otherwise noted. Dolan C, van der Sluis S, Grasman R. A note on normal theory power calculation in SEM with data missing completely at random. Prior work suggests that researchers must consider if missing data are missing at random versus missing completely at random, as this distinction will likewise affect statistical power and sample size requirements (Davey & Salva, 2009a; Dolan et al., 2005). Each panel shows the minimum sample size required for each permutation of each type of model that was evaluated. (a) The technical consultant must possess a current license issued by the State in which the laboratory is located, if such licensing is required. 1National Center for PTSD at VA Boston Healthcare System, Boston, MA, USA, 2Boston University School of Medicine, Boston, MA, USA, 3Center for Biomarker Research and Personalized Medicine, School of Pharmacy, Virginia Commonwealth University, Richmond, VA, USA. 493.1406 Standard; Laboratory director qualifications on or before February 28, 1992. This content is from the eCFR and is authoritative but unofficial. Centers for Medicare and Medicaid Services, February 6, 2014, Federal Register, Final Rule, pages 7290-7316, CLIA program and HIPAA Privacy Rule: Patients Access to Test Reports, U.S. Bureau of Labor Job Outlook for Clinical Laboratory Technologists and Technicians Job Projections for 2018-2028. 493.1365 Standard; PPM testing personnel responsibilities. Readers are also referred to Paxton, Curran, Bollen, Kirby, and Chen (2001), who provide a useful step-by-step discussion of conducting Monte Carlo analyses. This information should not be considered complete, up to date, and is not intended to be used in place of a visit, consultation, or advice of a legal, medical, or any other professional. We next evaluated the effects of missing data on sample size requirements for one CFA and the latent mediation model. Maxwell SE. Evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient . C, 3., D The laboratory verifies and documents that the applicant has the education and experience required by the job responsibilities. However, the minimum sample size increased to 260 with 5% and 10% missing data per indicator and to 320 with 20% missing data per indicator because of errors that occurred at smaller sample sizes. 493.1411 Standard; Technical consultant qualifications. Structural equations with latent variables. Laboratories Performing High Complexity Testing ( 493.1441 - 493.1495) Testing meditational models with longitudinal data: Questions and tips in the use of structural equation modeling. Over the past quarter century, however, medical care and the laboratory environment have evolved considerably, necessitating a review of the CLIA standards to ensure they remain current and assure high quality patient care. MLDs in high-complexity laboratories assume responsibility for all LDTs generated by their lab. We specified that the most discrepant mean parameter estimate in a model had to be within 5% of the population value. The requirements differ substantially for personnel who perform moderate- and high-complexity testing and thus are defined separately. Such rules are problematic because they are not model-specific and may lead to grossly over-or underestimated sample size requirements. Staff performing COVID-19 testing need to meet the CLIA personnel requirements applicable to the assay the laboratory is performing and as designated in the EUA and by the manufacturer. Moderate means violations that result in negative outcome and actual or potential harm for a resident. Elevated blood lead level means a level of lead in blood that is any of the following: Barrier Level means the Barrier Level as specified in 1 of the Product and Underlying Data. As a library, NLM provides access to scientific literature. For example, the model in which the direct effects accounted for 16% of the variance in the dependent variable required greater than 2.4 times more participants to achieve adequate statistical power relative to the model in which 45% of the variance was explained (i.e., n = 440 vs. 180). // Labs doing moderate or high complexity tests (also called "non-waived tests") must be licensed and inspected every 2 years. CMS should not equate a bachelors degree in nursing as equivalent to a bachelors degree in the biological sciences under CLIA. The value of MLDs to the healthcare system is increasing as advances in testing contribute to more personalized, cost-effective care. (a) The laboratory director must possess a current license as a laboratory director issued by the State in which the laboratory is located, if such . A complete description of the requirement is located at http://www.cdc.gov/clia/Regulatory/default.aspx, Education Requirements For Moderate Complexity Testing, Multistix Urine Chemistries (Specialty Clinic Use), BinaxNOW COVID-19 Ag Card (Specialty Clinic Use Only), Rapid HIV 1/2 STAT-PAK Assay (Specialty Clinic Use), http://www.cdc.gov/clia/Regulatory/default.aspx. We used several criteria to evaluate the minimum sample size required to achieve minimal bias, adequate statistical power, and overall propriety of a given model, following recommendations by Muthn and Muthn (2002). The Code of Federal Regulations (CFR) is the official legal print publication containing the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. This document is available in the following developer friendly formats: Information and documentation can be found in our This approach does not address the power of the overall modelit provides estimates of power and bias for individual effects of interest (i.e., individual factor loadings, correlations, or regressive paths). The department shall periodically update the tests authorized under this subsection (1)(d) based on changes made by the federal clinical laboratory improvement amendments program; and (B) Moderate complexity tests if the medical assistant- certified meets standards for personnel qualifications and responsibilities in compliance with federal . If reanalysis with a new seed number reveals bias in a primary parameter estimate, it may warrant choosing the most conservative sample size estimate, whereas a single error resulting from reanalysis may not warrant increasing the sample size. AACC is concerned that there are not sufficient laboratory professionals to perform quality testing. You can change these settings at any time, but that may impair functionality on our websites. AACC recommends that Congress and CMS work together to ensure sufficient numbers of qualified MLS professionals. Models with 20% missing data per indicator necessitated, on average, nearly 50% increase in sample size requirements (due to problems with error and bias). 57 FR 7172, Feb. 28, 1992, unless otherwise noted. The Office of the Federal Register publishes documents on behalf of Federal agencies but does not have any authority over their programs. Federal government websites often end in .gov or .mil. Finally, as recommended by Muthn and Muthn (2002), we tested the stability of the results by running the analyses again with a new, randomly selected seed number (i.e., so that data generation began at a different point, resulting in a different set of 10,000 data sets compared to the analysis with the initial seed number). Penetrant does not include Multi-purpose Lubricants that claim to have penetrating qualities, but are not labeled primarily to loosen bonded parts. Use of popular rules-of-thumb for such purposes may be quick and handy, but they are insufficient. The eCFR is displayed with paragraphs split and indented to follow Acceptable standard error estimates also had to be within 5% of the population standard error. Models based on larger samples (Boomsma, 1982; Gagn & Hancock, 2006; Velicer & Fava, 1998), with more indicators per factor (Gagn & Hancock, 2006; Marsh, Hau, Balla, & Grayson, 1998), and with larger factor loadings (Gagne & Hancock, 2006) are more likely to converge properly. Enders CK, Bandalos DL. These facilities perform nearly 13 billion tests annually (1). The reliability of each of the variables was specified in the data simulation phase of the analysis. Each individual performing moderate complexity testing must, (a) Possess a current license issued by the State in which the laboratory is located, if such licensing is required; and. TESTING NAMED IN THE CLIA REQUIREMENTS? 493.1451 Standard: Technical supervisor responsibilities. Position Statements (NIST SP 800-115). Centers for Medicare and Medicaid Services, January 9, 2018, Federal Register, Request for Information, pages 1004-1009, Revisions for Personnel Regulations, Proficiency Testing Referral, Histocompatibility Regulations, and Fee Regulations under the Clinical Laboratory Improvement Amendments of 1988. Currently, MLS programs do not produce enough graduates to fill existing vacancies. We also evaluated a three-factor latent variable mediation model with regressive direct and indirect paths between factors (i.e., implying directional relationships) and varied the variance explained in the dependent variable. The impact of nonnormality on full information maximum-likelihood estimation for structural equation models with missing data. Personnel Requirements by Test Complexity: Testing Personnel: Waived Testing: Moderate Complexity Testing : High complexity Testing: Not Applicable: 1. AACC urges the following actions to ensure the continued integrity of CLIA moderate and high-complexity testing. The https:// ensures that you are connecting to the MacCallum et al. We observed somewhat greater instability of results, however, with respect to the reanalysis of the best solutions using a new seed number. 493.1423 D6066: Standard; testing personnel qualifications: (b4ii) Have documentation of training appropriate for the testing performed prior to analyzing patient specimens. Careers, Unable to load your collection due to an error. Marsh HW, Hau KT, Balla JR, Grayson D. Is more ever too much? Additional details and script for conducing Monte Carlo analyses in MPlus can be found in Muthn and Muthn (2002), Muthn and Asparouhov (2002), and Muthn (2002). Most of these tests are performed in hospitals and commercial laboratories. There are several actions that could address the shortage of qualified laboratory personnel. Aquatic plant means a plant, including the roots, which typically floats on water or requires water for its entire structural support, or which will desiccate outside of water. Maxwell SE, Kelley K, Rausch JR. 493.1462 General supervisor qualifications on or before February 28, 1992. We hope this will help researchers better understand the factors most relevant to SEM sample size determinations and encourage them to conduct their own Monte Carlo analyses rather than relying on rules-of-thumb. This is consistent with prior work suggesting that increasing the number of indicators per factor may be one way to compensate for an overall small sample size and preserve statistical power (Marsh et al., 1998). In these cases, sample sizes were relatively unchanged, or in some cases decreased, with the addition of the third factor. Ind = indicator; CFA = confirmatory factor analysis. Tests after Completion means the tests (if any) which are specified in the Contract and which are carried out in accordance with the Specification after the Works or a Section (as the case may be) are taken over by the Procuring Entity. Over the next ten years, clinical laboratories need approximately 7,000 laboratory professionals annually, but the MLS programs graduate only 6,000 students a year, leaving a sizeable deficit (3). The US Food and Drug Administration (FDA) classifies tests as waived (simple), provider performed microscopy procedures (PPMP), moderate or high complexity, depending on how difficult the tests are. // If you work for a Federal agency, use this drafting In addition, the association backs alternative pathways to qualify individuals to serve as testing personnel if they can demonstrate equivalency with the current requirements. First, we evaluated (a) the degree of bias in the parameter estimates, (b) the degree of bias in the standard error estimate, and (c) the 95% confidence interval for the parameter estimates. Note. Gagn P, Hancock GR. 493.1409 Condition: Laboratories performing moderate complexity testing; technical consultant. In the paragraphs that follow, we describe our results with respect to the broad lessons learned from this study. While many of these test systems are waived under CLIA and therefore largely exempt from direct regulatory oversight, many others are classified as moderate or high complexity, subjecting them to personnel, quality control, and proficiency testing standards. sharing sensitive information, make sure youre on a federal developer resources. Evaluation of confirmatory factor analytic and structural equation models using goodness-of-fit indices. The agency should develop and circulate a consensus document to CMS regional offices to ensure uniformity. Kim KH. contact the publishing agency. We set the sample size of a given model and then adjusted it (upwards or downwards) based on whether the results met our criteria for acceptable precision of the estimates, statistical power, and overall solution propriety, as detailed below. Prior work has arrived at this same general conclusion (Cole & Maxwell, 2003), although to our knowledge, no prior study has systematically evaluated and compared sample size requirements with respect to statistical power, bias, and solution propriety under varying parameter conditions across latent-variable and single-indicator models. Qualified Technical Supervisor. When reevaluated with the new seed number, 41% of the CFA models, 67% of the SEM models (note that there were only three total), and 75% of the missingness models required a change in sample size. For example, as shown in Figure 3 (Panels AC) and Supplemental Tables 13, sample size requirements at least doubled when comparing the simplest possible one-factor, four-indicator model, which required a sample of 190, 90, and 60 participants at factor loadings of .50, .65, and .80, respectively, relative to the simplest possible two-factor model (with three indicators per factor), which required a minimum sample of 460, 200, and 120, respectively. The standardized magnitude of the three direct paths in the model was set to .40, and the total variance of each variable was set to 1.0 (and all means to 0). Attending to potential sources of bias and error is important for ensuring the validity of the results and their interpretation. MacCallum RC, Widaman KF, Zhang S, Hong S. Sample size in factor analysis. Models with missing data invoked full information ML estimation for cases with missingness as this approach performs well when data are missing completely at random or missing at random (Enders & Bandalos, 2001). Over the past few decades, technological advances and improved portability of devices have expanded the types of settings in which laboratory testing can be performed. CLIA personnel requirements for High and Moderate complexity testing are presented in a clear and concise way. Comments or questions about document content can not be answered by OFR staff. The results of this study demonstrate the great variability in SEM sample size requirements and highlight the problem with a one size fits all approach, consistent with the observations of MacCallum et al. A standard error may also be biased if it is under- or overestimated (which increases the risk of Type I and II errors, respectively). Bentler PM, Chou CH. Laboratories Performing Moderate Complexity Testing 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director. One suggestion is to let each of the CMS-approved certifying bodies determine what is an acceptable degree. 493.1495 Standard; Testing personnel responsibilities. Many of these tests are developed or adapted by highly educated, experienced, and trained individuals who serve as the MLD of a high complexity testing facility. The latter approach is a post hoc method that is limited by the quality of the existing data and may lead to unwarranted confidence in the stability of the results or the appropriateness of the sample for the planned analyses. The appropriate education, training, and experience of MLD is essential to ensuring high-quality patient care at all levels of service. Refer to A Guide to the Evaluation of Educational Experience in the Armed Services. Schiphol - Arriving and departing, Transfers, Layovers and Luggage storage. Washington, DC 20001 Recent years have seen a large increase in SEMs in the behavioral science literature, but consideration of sample size requirements for applied SEMs often relies on outdated rules-of-thumb. No amount of increasing the sample size in a single-indicator model will compensate for inadequate reliability of the measures. The relative performance of full information maximum likelihood estimation for missing data in structural equation models. Power is dependent on (a) the chosen alpha level (by convention, typically = .05), (b) the magnitude of the effect of interest, and (c) the sample size. We hope that researchers will find the examples in this study relevant to their own work and use them to help arrive at initial estimates for sample size that are then evaluated fully through additional analyses matched to the researchers specific study. switch to eCFR drafting site. 493.1361 Condition: Laboratories performing PPM procedures; testing personnel. 2. Thus, a model in which any one of the parameters of interest fell below 80% power would be rejected (this approach is conceptually similar to the all-pairs power approach described by Maxwell, 2004). Further, the association is troubled by ongoing efforts to redefine the educational requirements of high complexity MLDs, which could result in lesser qualified individuals serving in this capacity. M, R. A, 6. (11) Ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results; Results of this study also highlight problems with not accounting for missing data in determining sample size requirements. Each individual must have documentation of training applicable to the types and complexity of testing performed. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel. However, this effect also leveled as the transition from six to eight indicators did not result in as dramatic a decrease in sample size (i.e., this dropped from 60 to 50 when increasing from six to eight indicators in the one-factor model with factor loadings of .65) and, in some instances, yielded no reduction in minimum sample size (i.e., both the six- and the eight-indicator one-factor model with loadings of .50 were associated with a minimum sample size of 90). Note. This training is essential to providing MLS students with a complete education necessary for ensuring accurate patient results that contribute to positive patient outcomes. This implies that researchers need to carefully consider these parameters when planning an SEM and to keep in mind that having large effects, while associated with generally improved statistical power, yields new concerns about parameter bias that may ultimately result in increased sample size requirements in order to obtain sufficiently accurate estimates. Furthermore, rather than increasing linearly with number of estimated parameters or number of variables, we found that sample size requirements actually decreased when the number of indicators of a factor increased. Penetrant means a lubricant designed and labeled primarily to loosen metal parts that have bonded together due to rusting, oxidation, or other causes. When contemplating sample size, investigators usually prioritize achieving adequate statistical power to observe true relationships in the data. Marcoulides GA. Modernization of CLIA: Moderate and High Complexity Testing, The Journal of Applied Laboratory Medicine, Advancing Personalized Precision Medicine, Modernization of CLIA Moderate and High Complexity Testing, Newborn Screening and Improving Childrens Health, Pediatric Lab Results the Need for Normal, https://www.govinfo.gov/content/pkg/FR-2014-02-06/pdf/2014-02280.pdf, https://www.bls.gov/ooh/healthcare/clinical-laboratory-technologists-and-technicians.htm#tab-6, https://www.aacc.org/publications/cln/articles/2015/november/the-laboratory-workforce-shortage-demands-new-solutions, https://www.govinfo.gov/content/pkg/FR-2018-01-09/pdf/2017-27887.pdf, Commission on Accreditation in Clinical Chemistry. Most comprehensive library of legal defined terms on your mobile device, All contents of the lawinsider.com excluding publicly sourced documents are Copyright 2013-, Quality Surveillance Engineer / Inspector. Background and more details are available in the NIHMS661496-supplement-Supplemental_Material.pdf, Paxton, Curran, Bollen, Kirby, and Chen (2001), Hertzog, von Oertzen, Ghisletta, & Lindenberger, 2008, http://www.statmodel.com/download/webnotes/mc1.pdf, http://www.statmodel.com/download/webnotes/mc2.pdf. Educ Psychol Meas. American Council on Education, Washington, D.C. (b4) Have earned a high school diploma or equivalent; and. Regulation Y Essentially, this is the assumption of a single indicator analysis, as measurement error is not removed from the variance of the measure and the indicator is treated as if it is a perfect measure of the latent construct. Specifically, we set observed variable reliability to .42, .81, or .90, which, in the case of the use of completely standardized factor loadings, is equivalent to factor loadings of .65, .90, and .95, respectively.4 After specifying the degree of indicator reliability for data generation, we then purposefully misspecified the model by setting the reliability of the indicators to 1.0 in the data analysis phase. will bring you to those results. (b2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or, (b3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medial Laboratory Specialist (Laboratory Technician); or. However, the model that explained 75% of the variance in the dependent variable actually required more participants than the model that explained 45% of the variance. Muthn LK, Muthn BO. High Complexity When categorizing a test, the FDA considers: Knowledge needed to do the test Training and experience needed to do the test Reagents and materials preparation Operational steps characteristics Calibration, quality control, and proficiency testing materials 1Throughout this article, we refer to the term bias in its broadest sense (i.e., a systematic misrepresentation of a parameter estimate or statistic due to methodological problems such as insufficient sample size or poor measurement psychometric characteristics). site when drafting amendatory language for Federal regulations: Failing to focus on the magnitude of the indirect effect could lead to a study with insufficient sample size. Marcoulides GA, Saunders C. PLS: A silver bullet? Monitoring well means a water well intended for the purpose of determining groundwater quality or quantity. Inclusion in an NLM database does not imply endorsement of, or agreement with, For example, we did not evaluate the effects of nonnormal data (see Enders, 2001), or of the use of categorical, count, censored, or item parceled data (see Alhija & Wisenbaker, 2006). 493.1423 Standard; Testing personnel qualifications. The model is fit in each subsample and the resulting parameter estimates and fit statistics are then examined across all the random draws. Note. While the number of indicators in a model had an inverse effect on sample size requirements (i.e., models with more indicators per factor required fewer cases), other types of increases to the complexity of the model necessitated increased sample size requirements. The simulated data were dimensional (i.e., continuous) and normally distributed. Board certification should remain a requirement for demonstrating the competency of MLDs in high complexity laboratories. The difference in sample size requirements when evaluated with different seed numbers was sometimes quite meaningfulin one instance, there was a discrepancy of 50 cases across the two simulations. 1 This guide provides summary information and helpful links to assist you in navigating the CLIA requirements for performing moderate complexity tests.
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