Technological improvements have expanded the scope and complexity of laboratory testing. CMS should retain authority for determining what is an acceptable doctoral degree. In recent years, there has been discussion regarding who should determine what is an acceptable non- MD doctoral degree under CLIA. CMS has proposed expanding the role of nurses within CLIA, in part due to the shortage of laboratory personnel. 2. AACC recommends that Congress and CMS work together to ensure sufficient numbers of qualified MLS professionals. 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. Moderate Complexity Medical Decision-Making represents the cognitive labor “sweet spot” for most physicians. The agency should develop and circulate a consensus document to CMS regional offices to ensure uniformity. Individuals performing moderate and high complexity testing are expected to have a certain level of scientific knowledge and experience, understand how to troubleshoot problems, and be able to perform applicable quality control checks, among other skills needed to perform quality testing. Specifically, AACC hold the following positions: AACC holds the following positions to maintain the highest standards for MLDs: 900 Seventh Street, NW Suite 400 requirements to perform moderate or high complexity tests. This training is essential to providing MLS students with a complete education necessary for ensuring accurate patient results that contribute to positive patient outcomes. U.S. Given this, CMS has generally accepted doctoral scientists that, in addition to the required coursework, have successfully completed a written dissertation that includes a strong independent original research component that advances scientific knowledge. 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. AACC uses Cookies to ensure the best website experience. Selected. 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. Each innovation has created new opportunities and challenges in the delivery of quality healthcare. The American Association for Clinical Chemistry (AACC) supports federal funding to increase the number of Medical Laboratory Scientists (MLS) who are vital to performing and ensuring quality patient testing. They consult with clinical colleagues on issues of test utilization and interpretation and determine the optimum instrumentation to efficiently meet clinical needs and effectively reduce the cost of care. One is restoring federal funding for MLS training programs through Title VII of the Public Health Services Act. with performing physician, Independent You can change these settings at any time, but that may impair functionality on our websites. Complexity, Low 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. Problems, Diagnostic Advocacy & Outreach One suggestion is to let each of the CMS-approved certifying bodies determine what is an acceptable degree. With more funding, these programs could train more students and reduce the growing shortage. One contributing factor to this shortage is the decline in MLS programs. These facilities perform nearly 13 billion tests annually (1). In the example above, the clinical problems would be scored as follows: The data points for the above encounter are scored as follows: Problem Doctoral or Master’s degree in a chemical, physical, CMS should not equate a bachelor’s degree in nursing as equivalent to a bachelor’s degree in the biological sciences under CLIA. In 1990, there were 720 MLS training programs. AACC urges the following actions to ensure the continued integrity of CLIA moderate and high-complexity testing. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988. Additionally, MLS students are required to participate in full-time clinical rotations during training, which are becoming more difficult to arrange. AACC.org A doctoral scientist degree under CLIA should, in addition to its coursework, include independent original research intended to advance scientific knowledge, and a completed and approved written dissertation of the original work. Elected officials should allocate funding to support the clinical rotation training of MLS students in hospitals and/or reference laboratories. Board certification along with the requisite continuing education requirements ensures a standardized knowledge base and reflects a broad, deep, and up-to-date understanding of laboratory medicine, which permits MLDs to educate and guide other healthcare providers, ensure the efficient use of resources, and maintain quality patient care. Proposed alternatives to this approach include permitting nurses to demonstrate proficiency through the completion of a CLIA-approved competency exam, POCT certification program, and/or a curriculum of laboratory courses. Non-waived (moderate and high complexity testing) personnel requirements can be found in subpart M of the CLIA regulations (CLIA Regulations – subpart M). The value of MLDs to the healthcare system is increasing as advances in testing contribute to more personalized, cost-effective care. The main purpose of performance testing is to identify and eliminate the performance bottlenecks in the software application. IBPS Clerk test is the first step that every candidate needs to take who is aspiring for banking jobs. Association Society for Clinical Pathology June 16, 2016 letter to CMS regarding Memorandum (S&C -16-18-CLIA). Board certification should remain a requirement for demonstrating the competency of MLDs in high complexity laboratories. The number of sites performing clinical laboratory testing in the United States has increased from 154,000 in 1993 to 266,000 in 2020. radiology test (except heart catheterization or echo), Review or order On January 24, 2003, the ... which involves the following activities: ... moderate complexity and high complexity testing are also the same. It is therefore critical that they have documented skill in the independent and critical assessment of research data. obtain old records, Review and medicine test (PFTs, EKG, cardiac echo or cath), Discuss test Currently, MLS programs do not produce enough graduates to fill existing vacancies. Another option is reimbursing hospitals and commercial laboratories to provide MLS students with required clinical experiences. Test Categorization (i.e., complexity) versus “Authorized Setting ” A. Performance Testing is a software testing process used for testing the speed, response time, stability, reliability, scalability and resource usage of a software application under particular workload. Once limited to hospital and reference laboratories, testing is now routinely performed at the hospital bedside, in ambulances, mobile clinics, doctors’ offices, and even the home. Lawmakers should provide Title VII funding to allied health training programs to expand their MLS training programs. According to the Bureau of Labor Statistics (BLS), 72,100 additional clinical laboratory personnel are needed by 2028 just to meet the growing demand for testing services (2). Testingof fingerst ick whole blood specimens is authorized for use at the Point of Care (POC), i.e., in patient care 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). IBPS Clerk Mock Test 2020. There are concerns that transferring this responsibility to private sector accrediting bodies may create financial incentives to accept less-rigorous degrees, resulting in lesser-qualified individuals serving as a high complexity MLD, a decision that could jeopardize patient care and unnecessarily increase healthcare costs. Washington, DC 20001 Decision-Making, Established problem, stable or improving, New problem, with no additional work-up planned (maximum of 1), New problem, with additional work-up planned, Review or order Position Statements The appropriate education, training, and experience of MLD is essential to ensuring high-quality patient care at all levels of service. Since then, the rules governing patient testing have largely remained unchanged. MLDs in high-complexity laboratories assume responsibility for all LDTs generated by their lab. Most programs cite insufficient and shrinking numbers of hospital laboratories willing to accept students and provide them with supervised and guided clinical experiences. 3. // Many in the laboratory community objected to this proposal, noting that nurses generally take only one-third of the coursework required for a biological sciences degree with little or no focus on clinical laboratory testing (5). Waived testing does not have any CLIA personnel requirements. The exam is scheduled in 3 different stages- the preliminaries, then the mains, and finally the interview round. Points, Data Unfortunately, there is a shortage of well-trained individuals to perform these tests. Phone // +1.202.857.0717 or 800.892.1400 complexity testing AND as of 04/24/1996 have at least 2 years of clinical laboratory training or experience, or both, in high complexity testing (either before or after completing the accredited or military medical laboratory training ) AND meet 1 of the following: – Have graduated from an approved or accredited medical Procedures, Management Options Finally, the creation of a loan forgiveness program for laboratory personnel willing to work in underserved areas for a specified period could incentivize individuals to enter the field. // Waived Testing Moderate Complexity Testing High Complexity Testing Not Applicable 1. summation of old records, Presenting The Medical Services Advisory Committee (MSAC) is an independent non-statutory committee established by the Australian Government Minister for Health in 1998. The requirements are based on the complexity of the test and not the type of laboratory where the testing is performed. 2MD, DO, or DPM with a current medical license with at least 1 year of training and/or experience in nonwaived testing in the designated specialty/subspecialty area; OR 2. Complexity Medical Fax // +1.202.887.5093, © 2020 American Association for Clinical Chemistry. clinical lab tests, Review or order Most of these tests are performed in hospitals and commercial laboratories. 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. There are several actions that could address the shortage of qualified laboratory personnel. Moderate and High Complexity Personnel In addition, the association backs alternative pathways to qualify individuals to serve as testing personnel if they can demonstrate equivalency with the current requirements. 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. 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. With over 12000 vacancies, the IBPS clerk exam opens several doors of opportunities for the applicants. the requirements to perform high, moderate or waived complexity tests. 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. The CLIA standards require that these individuals either: (a) have a doctoral degree in a chemical, physical, biological, or clinical laboratory science and be certified by a board approved by the Department of Health and Human Services; (b) be a doctor of medicine or doctor of osteopathy and meet certain regulatory requirements; or (c) previously served as an MLD prior to February 24, 2003. You may not be surprised to learn that Moderate MDM is required for a "routine" encounter like a level 2 hospital progress note , but you may not have realized that it also represents the cognitive labor requried for a level 4 office visit with an established patient . A person serving as an MLD should have a broad knowledge of laboratory operations, analytical theory and processes, and an understanding of the pathophysiology of disease. Modernization of CLIA: Moderate and High Complexity Testing. AACC is concerned that there are not sufficient laboratory professionals to perform quality testing. review of image, tracing, or specimen, Decision to Now there are 608—a reduction of 15 percent (3). AACC urges policymakers to retain the existing standards for high complexity Medical Laboratory Directors (MLDs) who continue to play a critical and unique role in evaluating and developing new technologies and approaches to meet emerging healthcare needs. Continuing without changing Cookie settings assumes you consent to our use of cookies on this device. The complexity of these problems affects the evaluation of the DAP and illustrates the need for multiple approaches to its interpretation. MLDs oversee all clinical, scientific, and business aspects of the laboratory. The Centers for Medicare and Medicaid Services (CMS) developed and implemented the regulations between 1990 and 1995. Scientific advances have also led to the development of new, complex laboratory tests that can more precisely identify a medical condition, leading to earlier diagnosis and treatment, better patient outcomes, and more effective use of limited healthcare resources (e.g., SARS-CoV-2). Points, Straightforward Failure to accurately perform a test can cause incorrect results to be reported and acted upon by a physician, potentially placing patients at risk for harm. AACC urges the following actions to ensure the continued integrity of CLIA moderate and high-complexity testing. The agency recommended that a nursing degree be deemed equivalent to a medical laboratory professional degree, which would allow nurses to perform moderate and high complexity testing without obtaining prior laboratory training as well as serve in a supervisory capacity (4).
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