Clinical laboratory regulation under the Clinical Laboratory Improvement Amendments of 1988: can it be done?

1990 ◽  
Vol 36 (12) ◽  
pp. 2027-2035 ◽  
Author(s):  
K M Peddecord ◽  
H C Hammond
Keyword(s):  
Laboratory Testing ◽  
Clinical Laboratory ◽  
The United States ◽  
Conventional Approach ◽  
Medical Decision ◽  
Test Quality ◽  
Public Expectations ◽  
Federal Authority ◽  
Fail Safe ◽  
Clinical Laboratory Improvement Amendments

Abstract This report examines logical but not yet widely recognized ramifications of the Clinical Laboratory Improvement Amendments of 1988 (CLIA'88), federal legislation that will require certification of all laboratories examining human specimens. Examination of the CLIA'88 committee reports and committee hearings suggest that more than the conventional approach to laboratory standards will be needed to meet the public's expectations as articulated by our elected representatives. The conventional approach to clinical testing standards seeks to assure quality by regulating the laboratory analytical process. However, little empirical evidence is available to support or refute this model, which has been used during the past 25 years. One alternative paradigm for laboratory standards is an approach that examines the total laboratory testing process, including the selection, ordering, and interpretation of the test as well as the laboratory analysis per se. The history of controversy over laboratory standards--especially personnel standards, the glacial federal regulatory rulemaking process, public expectations of fail-safe technology, among other factors--suggests the implementation of CLIA'88 will be a lengthy and vigorously debated contest. The risk of a test is seldom inherent in the test itself, but rather is a function of the context in which the test is being used to provide information for medical decision making. Our premise is that diagnostic tests must be examined in the context of the laboratory testing situation. We suggest that now is the appropriate time for laboratory professionals, practicing physicians, and the public to abandon conventional thinking regarding clinical laboratory standards. We believe that CLIA'88 reflects a shift in public expectations toward fail-safe laboratory testing and the need for additional government oversight in laboratory test quality. If these new expectations persist, CLIA'88 represents a potential landmark in the course of federal authority and the practice of medicine in the United States.

scholarly journals Detection of Influenza A and B Viruses and Respiratory Syncytial Virus by Use of Clinical Laboratory Improvement Amendments of 1988 (CLIA)-Waived Point-of-Care Assays: a Paradigm Shift to Molecular Tests

2018 ◽  
Vol 56 (7) ◽  
Author(s):  
Marwan M. Azar ◽  
Marie L. Landry
Keyword(s):  
Respiratory Syncytial Virus ◽  
Antiviral Therapy ◽  
Influenza A ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
The United States ◽  
Nucleic Acid Amplification ◽  
Molecular Tests ◽  
Syncytial Virus ◽  
Clinical Laboratory Improvement Amendments

ABSTRACT An accurate laboratory diagnosis of influenza, respiratory syncytial virus (RSV), and other respiratory viruses can help to guide patient management, antiviral therapy, infection prevention strategies, and epidemiologic monitoring. Influenza has been the primary driver of rapid laboratory testing due to its morbidity and mortality across all ages, the availability of antiviral therapy, which must be given early to have an effect, and the constant threat of new pandemic strains. Over the past 30 years, there has been an evolution in viral diagnostic testing, from viral culture to rapid antigen detection, and more recently, to highly sensitive nucleic acid amplification tests (NAAT), as well as a trend to testing at the point of care (POC). Simple rapid antigen immunoassays have long been the mainstay for POC testing for influenza A and B viruses and respiratory syncytial virus (RSV) but have been faulted for low sensitivity. In 2015, the first POC NAAT for the detection of influenza was approved by the Food and Drug Administration (FDA), ushering in a new era. In 2017, the FDA reclassified rapid influenza diagnostic tests (RIDTs) from class I to class II devices with new minimum performance standards and a requirement for annual reactivity testing. Consequently, many previously available RIDTs can no longer be purchased in the United States. In this review, recent developments in Clinical Laboratory Improvement Amendments of 1988 (CLIA)-waived testing for respiratory virus infections will be presented, with the focus on currently available FDA-cleared rapid antigen and molecular tests primarily for influenza A and B viruses and RSV.

The Cost of Implementation of the Clinical Laboratory Improvement Amendments of 1988—The Example of Pediatric Office-Based Cholesterol Screening

PEDIATRICS ◽  
1995 ◽  
Vol 96 (2) ◽  
pp. 230-234
Author(s):  
Andrew M. Tershakovec ◽  
S. Diane Brannon ◽  
Michael J. Bennett ◽  
Barbara M. Shannon
Keyword(s):  
Proficiency Testing ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
High Volume ◽  
Chemistry Laboratory ◽  
Screening Process ◽  
Cholesterol Screening ◽  
Low Volume ◽  
The Cost ◽  
Clinical Laboratory Improvement Amendments

Objective. To measure the additional costs of office-based laboratory testing due to the implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), using cholesterol screening for children as an example. Methods. Four-to ten-year-old children who received their well child care at one of seven participating pediatric practices were screened for hypercholesterolemia. The average number of analyses per day and days per month were derived from the volume of testing completed by the practices. Nurses and technicians time in the screening process were measured and personnel costs were calculated based on salary and fringe benefit rates. Costs of supplies, analyzing control samples, instrument calibration, and instrument depreciation were included. Costs estimates of screening were then completed. CLIA '88 implementation costs were derived from appropriate proficiency testing and laboratory inspection programs. Results. In six practices completing a low volume of testing, 2807 children (5 to 6 children per week) were screened during the observation period, while 414 (about 25 children per week) were screened in one high-volume practice implementing universal screening over a 4-month period. For the six low-volume practices, the cost of screening was $10.60 per child. This decreased to $5.47 for the high-volume practice. Estimated costs of CLIA '88 implementation, including additional proficiency testing and laboratory inspection, added $3.20 per test for the low-volume practices, and $0.71 per test for the high-volume testing. Conclusions. Implementation of CLIA adds significantly to the cost of office-based chemistry laboratory screening. Despite these additional expenses, the cost of testing is still within a reasonable charge for laboratory testing, and is highly sensitive to the volume of tests completed.

scholarly journals Validation of immunohistochemical tests performed on cytology cell block material: Practical application of the College of American Pathologists’ guidelines

CytoJournal ◽  
2019 ◽  
Vol 16 ◽  
pp. 6 ◽  
Author(s):  
Swati Satturwar ◽  
Renuka Malenie ◽  
Ann Sutton ◽  
Ding Dai ◽  
F. Zahra Aly
Keyword(s):  
Clinical Laboratory ◽  
The United States ◽  
Cell Block ◽  
Laboratory Staff ◽  
Academic Center ◽  
Formalin Fixed Paraffin ◽  
Formalin Fixed Paraffin Embedded ◽  
Validation Set ◽  
Clinical Laboratory Improvement Amendments

The advent of fiberoptic endoscopy with biopsy has revolutionized procurement of specimens from deep sites. This has translated into more cytologic specimens whereby the material is limited and best handled by cytology laboratory staff. While the diagnosis of the pathologic process is of utmost importance, there is increasing expectation that the diagnosis be specific and accurate as not to require additional biopsy for initiation of treatment. This expectation has driven demand in immunohistochemical (IHC) and molecular studies conducted specifically on material processed as cytology specimens. The Clinical Laboratory Improvement Amendments of 1988 requires laboratories in the United States of America to verify the performance of patient tests. Due to varying laboratory practices with respect to validation of IHC assays, the College of American Pathologists introduced guidelines for analytic validation of IHC tests. These guidelines address how to perform validation by recommending the number of cases in the validation set, comparator concordance, and when to revalidate. The main thrust of the guidelines is based on formalin-fixed paraffin-embedded tissue with only one expert consensus opinion referring to validation of IHC tests on cytology specimens which delegates to the medical director, the determination of number of positive and negative cases to be tested. This article will outline how an academic center approaches validation of IHC studies performed on cytology cell block specimens using the College of American Pathologists guidelines. A stepwise approach from selection of antibodies to validate followed by building the validation panel and evaluating the stain results for concordance against the gold standard of histology tissue specimen will be described. A rationale for dealing with discordant results and future innovations will conclude the report.

National Inventory of Clinical Laboratory Testing Services (NICLTS)

2000 ◽  
Vol 124 (8) ◽  
pp. 1201-1208 ◽  
Author(s):  
Steven J. Steindel ◽  
William J. Rauch ◽  
Marianne K. Simon ◽  
James Handsfield
Keyword(s):  
Public Health ◽  
United States ◽  
Health Care ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
The United States ◽  
High Complexity ◽  
Specimen Type ◽  
The Us ◽  
Clinical Laboratory Testing

Abstract Context.—A statistically valid inventory of the distribution, both geographic and by laboratory type, of clinical and anatomical laboratory testing in the United States is needed to assess the impact of the Clinical Laboratory Improvements Amendments of 1988 and to provide information for other health care and public health policy decisions. Objective.—To present initial US laboratory testing volume data compiled by the National Inventory of Clinical Laboratory Testing Services. Design.—Stratified random sample of laboratories performing testing in 1996 with data on the number of laboratory tests performed, identified by method and analyte. Data were collected by field tabulators (moderate- or high-complexity laboratories) or through a mail/telephone survey (waived or provider-performed microscopy laboratories) for each site. Participants.—Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing during 1996. Main Outcome Measure.—Laboratory testing distribution for 1996 in the United States by analyte, method, and specimen type. Results.—An overall response rate of 79% provided data from 757 moderate- or high-complexity laboratories and 1322 waived or provider-performed microscopy laboratories. The estimated total US testing volume for 1996 was 7.25 ± 1.09 billion tests. Laboratories performing complex testing, defined as greater than 16 method/analyte/specimen type combinations, comprised 16% of the US laboratories by survey site, but performed 80% (95% confidence limits, 43% to 100%) of the testing volume. Glucose analysis was the most frequently performed test. Automated hematology and chemistry analyzers were the most frequently used methods. Conclusions.—A statistically valid, consistent survey of the distribution of US laboratory testing was obtained. Simple analysis of these data by laboratory type and geographic region can provide insights into where laboratory testing is performed. The study design allows extensions that will facilitate collection of additional data of importance to public health and medical care delivery.

Adherence to Choosing Wisely Campaign Guidelines at Three Health Systems

2021 ◽  
Vol 156 (Supplement_1) ◽  
pp. S119-S119
Author(s):  
A K Windham ◽  
M Whitted ◽  
B Brimhall ◽  
J Buckley ◽  
G Nichols ◽  
...  
Keyword(s):  
Health System ◽  
Health Systems ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Cost Savings ◽  
The United States ◽  
Choosing Wisely ◽  
Variable Cost ◽  
Clinical Laboratory Testing ◽  
Unnecessary Testing

Abstract Introduction/Objective With rising healthcare costs in the United States, there has been a push for lab stewardship to improve the quality of patient care while reducing costs. To optimize the use of clinical laboratory testing, the ASCP working with other medical specialty organizations, developed the Choosing Wisely Campaign to promulgate evidence-based guidelines to optimize clinical laboratory testing. Methods/Case Report We examined adherence to three Choosing Wisely guidelines over a four-year period (2017- 2020), through queries of internal cost accounting databases to return aggregate volumes as well as variable and total costs at three large academic health systems. We measured concurrent orders for: 1) erythrocyte sedimentation rate (ESR) with C-reactive protein (CRP), 2) serum/plasma amylase with lipase, and 3) free thyroxine (FT4) and/or total triiodothyronine (TT3) with thyroid stimulating hormone (TSH) when the TSH is within the reference range (using an frequency estimate of 85% based on other studies). We also examined another guideline for concurrent orders for serum aldolase with creatine kinase (CK). We also quantified aggregate variable costs for the non-recommended test in each Choosing Wisely guideline (amylase, ESR, FT4 and/or TT3), and for serum aldolase when ordered with CK. Results (if a Case Study enter NA) Over the four-year period, there were 322,853 unnecessary tests based on these four guidelines (120,587 ESR and CRP, 30,444 amylase and lipase, 164,818 FT4 and/or TT3 with TSH, and 7,004 aldolase). Overall, unnecessary testing decreased between 2017 and 2020 for amylase with lipase, remained essentially unchanged for aldolase, and increased for the other two test guideline scenarios. The largest changes were concurrent orders for amylase and lipase at one health system (38% decrease), and orders for TT3 with a normal TSH result at another health system (324% increase). The four-year variable cost of these unnecessary tests was $1,215,309 ($303,827 mean annual cost), resulting in potential annual variable cost savings of $101,276 for each health system for the four guidelines we examined. Variable costs for unnecessary testing increased by 16.5% ($45,571) over the four-year period. Conclusion Guideline-based unnecessary testing remains as a target to improve laboratory diagnostic testing. There is potential to realize significant achievable cost savings if guidelines are implemented and maintained.

The Impact of New Regulations on Laboratory Testing in Physicians' Offices

1992 ◽  
Vol 38 (7) ◽  
pp. 1273-1279
Author(s):  
D J Loschen
Keyword(s):  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Practice Group ◽  
Laboratory Services ◽  
Educational Processes ◽  
Trained Personnel ◽  
Related Group ◽  
Organized Medicine ◽  
The Impact ◽  
Clinical Laboratory Improvement Amendments

Abstract The reaction of the clinician to the specter of regulation of any part of his or her practice mirrors the reaction of the laboratorian to the implementation of Medicare and Clinical Laboratory Improvement Amendments legislation in 1965 and 1967, respectively. Whether the regulatory burdens that will be visited upon these laboratories are justified or necessary is arguable; the fact of the upcoming regulation is not. The volume and breadth of testing in physicians' office laboratories (POLs) has increased exponentially since passage of the Diagnosis Related Group legislation by Congress in 1983, an increase made possible by remarkable developments in technology. State regulatory initiatives and private accrediting agencies have been perceived as being inadequate to prevent the proliferation of poorly controlled testing in the nontraditional laboratory environment. The testing menu of a given POL varies according to the scope of clinical services offered; the size of the practice group; the funding available for equipment and personnel acquisition; and the general availability of hospital, reference, and consultative laboratory services. Physicians who offer laboratory services as part of their practices must now prepare their laboratories to meet whatever requirements are mandated by regulation. This will include acquisition of trained personnel, improvement of instrumentation and methodologies, participation in proficiency testing, establishment of comprehensive quality-assurance programs, and adequate documentation of laboratory services. Organized medicine should devote its energies to assisting with needed educational processes to assure the survival of POLs.

scholarly journals Multi-Health System Comparison of Diagnostic Testing in Hospitalized Sepsis Patients

2021 ◽  
Vol 156 (Supplement_1) ◽  
pp. S120-S121
Author(s):  
B Brimhall ◽  
M Whitted ◽  
A Windham ◽  
A Podichetty ◽  
S Shifarraw
Keyword(s):  
Health Systems ◽  
Laboratory Testing ◽  
Laboratory Tests ◽  
Clinical Laboratory ◽  
Diagnosis Related Groups ◽  
Diagnostic Testing ◽  
The United States ◽  
Hospital Length Of Stay ◽  
Imaging Studies ◽  
Imaging Utilization

Abstract Introduction/Objective Comparisons of diagnostic testing across multiple health systems over multiple years are uncommon. Such comparisons would quantify variations in test use between health systems. Methods/Case Report Using the Vizient Clinical Database, we compared clinical laboratory and imaging utilization for hospitalized adult sepsis patients (N = 69,035) over three years (2017-2019) at 19 large academic-affiliated health systems across the United States. We used Medicare Severity Diagnosis Related Groups (MSDRG), employed by the US Centers for Medicare and Medicaid Services (CMS), and identified sepsis patients (MSDRG triplet 870/871/872). We stratified hospitalized sepsis patients by severity of illness (SOI) into high severity (MSDRG 870), moderate severity (MSDRG 871), and low severity (MSDRG 872) groups. SOI further categorizes patients within a diagnostic group, quantifying the extent of comorbid conditions and complications. We measured hospital length of stay (LOS), number of laboratory tests (CPT codes 80000-89999), and number of imaging studies (CPT codes 70000-79999). We divided the number of laboratory tests and radiology studies by mean hospital LOS (in days) to calculate laboratory tests and imaging studies per hospital day. Results (if a Case Study enter NA) Between health systems, lowest and highest values for laboratory and imaging utilization ranged from 50.1 to 141.3 tests per hospitalization and 1.4 to 7.2 studies per hospitalization, respectively. Differences in laboratory tests between health systems persisted after adjusting for SOI with low to high laboratory tests per hospitalization ranging from 127.8 to 405.7, 51.0 to 144.7, and 31.9 to 78.2, for high, moderate, and low SOI groups. Utilization ranges were smaller for imaging studies. After adjusting for hospital LOS, laboratory testing differences between health systems were more pronounced and with low and high laboratory test per day utilization of 6.5 to 24.3, 6.1 to 18.5, and 6.0 to 17.1, for high, moderate, and low SOI groups. Differences in radiology studies were not as pronounced after adjusting for LOS. Conclusion There is considerable variation among health systems in laboratory and radiology resource utilization for hospitalized sepsis patients. This variation persists, especially for laboratory testing, after adjusting for SOI and LOS.

scholarly journals Simulation Analysis and Comparison of Point of Care Testing and Central Laboratory Testing

2019 ◽  
Vol 4 (1) ◽  
pp. 238146831985630
Author(s):  
Reed Harder ◽  
Keji Wei ◽  
Vikrant Vaze ◽  
James E. Stahl
Keyword(s):  
Laboratory Testing ◽  
Simulation Analysis ◽  
Point Of Care ◽  
Patient Flow ◽  
Productivity Loss ◽  
The United States ◽  
Central Laboratory ◽  
Point Of Care Testing ◽  
Test Quality ◽  
Clinical Scenarios

Background. In response to demand for fast and efficient clinical testing, the use of point-of-care testing (POCT) has become increasingly common in the United States. However, studies of POCT implementation have found that adopting POCT may not always be advantageous relative to centralized laboratory testing. Methods. We construct a simulation model of patient flow in an outpatient care setting to evaluate tradeoffs involved in POCT implementation across multiple dimensions, comparing measures of patient outcomes in varying clinical scenarios, testing regimes, and patient conditions. Results. We find that POCT can significantly reduce clinical time for patients, as compared to traditional testing regimes, in settings where clinic and central testing areas are far apart. However, as distance from clinic to central testing area decreased, POCT advantage over central laboratory testing also decreased, in terms of time in the clinical system and estimated subsequent productivity loss. For example, testing for pneumonia resulted in an estimated average of 27.80 (central lab) versus 15.50 (POCT) total lost productive hours in a rural scenario, and an average of 14.92 (central lab) versus 15.50 (POCT) hours in a hospital-based scenario. Conclusions. Our results show that POCT can effectively reduce the average time a patient spends in the system for varying condition profiles and clinical scenarios. However, the number of total lost productive hours, a more holistic measure, is greatly affected by testing quality, where POCT often is at a disadvantage. Thus, it is important to consider factors such as clinical setting, target condition, testing costs, and test quality when selecting appropriate testing regime.

Characterization of Microorganism Identification in the United States in 1996

2001 ◽  
Vol 125 (7) ◽  
pp. 913-920
Author(s):  
Steven J. Steindel ◽  
Marianne K. Simon
Keyword(s):  
Public Health ◽  
United States ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Direct Methods ◽  
The United States ◽  
Test Method ◽  
Confidence Limits ◽  
Public Health Importance ◽  
Microorganism Identification

Abstract Context.—The National Inventory of Clinical Laboratory Testing Services (NICLTS) was designed to give an unbiased estimate of all patient testing performed by laboratories registered under the Clinical Laboratory Improvement Amendments in 1996. Objective.—Survey data were used to develop a profile of laboratory testing primarily intended to identify microorganisms or antibodies to these microorganisms. Design.—Estimates of the extent of microorganism identification were derived from the NICLTS database by identifying associated tests and methods. The volumes for tests performed at locations that primarily prepared blood components for distribution were excluded. Organisms of public health importance were identified from the National Notifiable Disease list maintained by the Centers for Disease Control and Prevention. Participants.—Laboratories that were enrolled in the 1996 Online Certification Survey and Reporting System, maintained by the US Health Care Finance Administration, and that performed laboratory testing in 1996. Outcome Measure.—Estimated volumes and associated confidence limits by test, method, specimen type, public health importance, and testing location. Results.—Excluding testing of the blood supply, 315 million tests (95% confidence limits, 280–354 million tests) were performed in the United States for microorganism identification. Those tests for which public health consensus requires national reporting represented 38% of this total. Although hospitals performed 46% of all microorganism identification, they only performed 33% of the testing for microorganisms of public health importance. Independent and specialty laboratories performed 38% of all testing but 65% of the testing for microorganisms of public health importance. Direct methods (methods not involving culture) were used in 77% of the tests for microorganisms of public health importance and in 42% of all identification tests. Conclusions.—The distribution of microorganism identification testing found using NICLTS data is consistent with plans to modernize the public health surveillance system in the United States.

CDC and Clinical Laboratory Partners: Analysis of Biosafety Gaps Revealed During the Ebola Outbreak

2019 ◽  
Vol 152 (Supplement_1) ◽  
pp. S139-S139
Author(s):  
Nancy Cornish ◽  
Sheldon Campbell ◽  
Elizabeth Weirich
Keyword(s):  
Patient Care ◽  
Health Care Providers ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
The United States ◽  
Future Research ◽  
Competency Assessment ◽  
Care Providers ◽  
Clinical Laboratories ◽  
Clinical Laboratory Testing

Abstract Objectives Patient care and public health in the United States depend on timely and reliable clinical laboratory testing. A third of the roughly 500 million yearly patient visits to health care providers involve at least one laboratory test, and approximately 70% of medical decisions are based upon test results. However, the performance of clinical laboratory testing could be compromised by patient specimens potentially contaminated with highly infectious materials. The importance of biosafety in clinical laboratories was highlighted during the 2014 Ebola crisis, where fears about safety resulted in some institutions refusing or delaying tests on patient specimens, which resulted in delayed diagnoses and contributed to patient deaths. Methods In collaboration with subject matter experts from academia, medical centers, and federal institutions, the Centers for Disease Control and Prevention has reviewed the capability of clinical laboratories to safely test patient specimens potentially contaminated with highly infectious materials, like Ebola. Current biosafety guidance for clinical laboratories has been largely based on biosafety practices in research laboratories, so the guidelines do not always correspond to clinical laboratories and may be incomplete or occasionally inconsistent. While essential to patient care, clinical laboratories are also unique environments with specialized equipment, processes, and therefore distinct challenges. Here we discuss the complexity of clinical laboratories and describe how applying current biosafety guidance to clinical laboratories may be difficult and confusing at best or inappropriate and harmful at worst. We describe biosafety gaps and opportunities for improvement in the areas of ethics; risk assessment and management; automated and manual laboratory disciplines; specimen collection, processing, and storage; test utilization; waste management; laboratory personnel training and competency assessment; and accreditation processes. Conclusion These identified gaps in knowledge and practice could inform future research and education in clinical laboratory biosafety.

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