Point-of-care testing: inspection preparedness

Perfusion ◽  
2000 ◽  
Vol 15 (2) ◽  
pp. 137-142 ◽  
Author(s):  
John Bennett ◽  
Cindy Cervantes ◽  
Scott Pacheco
Keyword(s):  
Clinical Laboratory ◽  
Point Of Care ◽  
Health Care Financing ◽  
Well Being ◽  
Regulatory Agencies ◽  
Human Beings ◽  
Point Of Care Testing ◽  
Human Specimen ◽  
Testing Site ◽  
Clinical Laboratory Improvement Amendments

Point-of-care testing (POCT) in the operating room has changed dramatically since the implementation of the Clinical Laboratory Improvement Amendments (CLIA ‘88), which became effective in September 1992. With the implementation of CLIA ‘88, the Health Care Financing Administration (HCFA) mandated that human specimen testing ‘for the purpose of diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of human beings’, must be performed by a certified laboratory or testing site. To attain and maintain accreditation, the need for more stringent and comprehensive documentation has become imperative. The Joint Commission for the Accreditation of Hospitals (JCAHO), the College of American Pathologists (CAPS), HCFA, and state regulatory agencies require data such as staff credentialling, staff training/competency, procedure manuals, quality control logs, quality assurance/corrective action plans, correlation studies, proficiency testing results, and equipment maintenance logs to assure specimens are analyzed in a reliable manner by competent personnel so as not to jeopardize the safety and well being of the patient. Developing a comprehensive, ongoing survey readiness plan that includes a pre-survey checklist of all the documentation required and having this documentation in order and up to date well in advance of the survey will greatly enhance the probability of a successful survey conducted by the various regulatory agencies.

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.

Letter to the Editor

PEDIATRICS ◽  
1994 ◽  
Vol 93 (1) ◽  
pp. 154-154
Author(s):  
Alejandro Hoberman ◽  
Ellen R. Wald
Keyword(s):  
Private Practice ◽  
Occupational Safety ◽  
Clinical Laboratory ◽  
Regulatory Agencies ◽  
Health Administration ◽  
Safety And Health ◽  
Effective Care ◽  
Laboratory Procedures ◽  
The One ◽  
Clinical Laboratory Improvement Amendments

Dr Murray correctly points out that the concerns of office-based pediatricians regarding regulations imposed by the Clinical Laboratory Improvement Amendments (CLIA) and Occupational Safety and Health Administration (OSHA) greatly affect the likely implementation of "new laboratory procedures" within the private practice sector. Although these regulatory agencies, on the one hand, intend to assure quality control when evaluating specimens and on the other hand, safety for patients and employees, they are often perceived as obstacles to effective care.

Limitations of Proficiency Testing Under CLIA '67

1992 ◽  
Vol 38 (7) ◽  
pp. 1237-1244 ◽  
Author(s):  
R H Laessig ◽  
S S Ehrmeyer ◽  
B J Lanphear ◽  
B J Burmeister ◽  
D J Hassemer
Keyword(s):  
Health Care ◽  
Quality Assurance ◽  
Proficiency Testing ◽  
Clinical Laboratory ◽  
Health Care Financing ◽  
Clinical Laboratories ◽  
Regulatory Strategy ◽  
Clinical Laboratory Improvement Amendments ◽  
Quality Improvement Tool

Abstract Proficiency testing (PT), recognized as a quality-assurance (QA) and quality-improvement tool, also has become the cornerstone of the Health Care Financing Administration's (HCFA) regulatory strategy under the revised Clinical Laboratory Improvement Act of 1967 (CLIA '67) and the proposed Clinical Laboratory Improvement Amendments of 1988 (CLIA '88). Use of PT as a regulatory tool corrupts it for things it can do better. PT as a primary regulatory strategy has severe limitations. We explore the nature of these limitations and their implications for clinical laboratories as they impact on the long-term success of HCFA's approved regulatory PT programs in 1991 and beyond, and CLIA '88 PT, which is to be implemented in 1994.

scholarly journals Point-of-care testing in the cardiovascular operating theatre

2006 ◽  
Vol 44 (9) ◽  
Author(s):  
Urs E. Nydegger ◽  
Erich Gygax ◽  
Thierry Carrel
Keyword(s):  
Healthcare Professionals ◽  
Cardiovascular Surgery ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Operating Table ◽  
Standard Laboratory ◽  
Rapid Progress ◽  
Point Of Care Testing ◽  
Laboratory Procedures ◽  
Major Equipment

AbstractPoint-of-care testing (POCT) remains under scrutiny by healthcare professionals because of its ill-tried, young history. POCT methods are being developed by a few major equipment companies based on rapid progress in informatics and nanotechnology. Issues as POCT quality control, comparability with standard laboratory procedures, standardisation, traceability and round robin testing are being left to hospitals. As a result, the clinical and operational benefits of POCT were first evident for patients on the operating table. For the management of cardiovascular surgery patients, POCT technology is an indispensable aid. Improvement of the technology has meant that clinical laboratory pathologists now recognise the need for POCT beyond their high-throughput areas.Clin Chem Lab Med 2006;44:1060–5.

Evaluation of point-of-care testing in critically unwell patients: comparison with clinical laboratory analysers and applicability to patients with Ebolavirus infection

Pathology ◽  
2015 ◽  
Vol 47 (5) ◽  
pp. 405-409 ◽  
Author(s):  
Jen Kok ◽  
Jimmy Ng ◽  
Stephen C. Li ◽  
John Giannoutsos ◽  
Vineet Nayyar ◽  
...  
Keyword(s):  
Clinical Laboratory ◽  
Point Of Care ◽  
Point Of Care Testing

scholarly journals Quality Management for Point-Of-Care Testing of Pathogen Nucleic Acids: Chinese Expert Consensus

2021 ◽  
Vol 11 ◽  
Author(s):  
Xi Mo ◽  
Xueliang Wang ◽  
Zhaoqin Zhu ◽  
Yuetian Yu ◽  
Dong Chang ◽  
...  
Keyword(s):  
Public Health ◽  
Nucleic Acid ◽  
Quality Management ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Conventional Polymerase Chain Reaction ◽  
Laboratory Medicine ◽  
Expert Consensus ◽  
Nucleic Acid Detection ◽  
Point Of Care Testing

COVID-19 continues to circulate globally in 2021, while under the precise policy implementation of China’s public health system, the epidemic was quickly controlled, and society and the economy have recovered. During the pandemic response, nucleic acid detection of SARS-CoV-2 has played an indispensable role in the first line of defence. In the cases of emergency operations or patients presenting at fever clinics, nucleic acid detection is required to be performed and reported quickly. Therefore, nucleic acid point-of-care testing (POCT) technology for SARS-CoV-2 identification has emerged, and has been widely carried out at all levels of medical institutions. SARS-CoV-2 POCT has served as a complementary test to conventional polymerase chain reaction (PCR) batch tests, thus forming an experimental diagnosis platform that not only guarantees medical safety but also improves quality services. However, in view of the complexity of molecular diagnosis and the biosafety requirements involved, pathogen nucleic acid POCT is different from traditional blood-based physical and chemical index detection. No guidelines currently exist for POCT quality management, and there have been inconsistencies documented in practical operation. Therefore, Shanghai Society of Molecular Diagnostics, Shanghai Society of Laboratory Medicine, Clinical Microbiology Division of Shanghai Society of Microbiology and Shanghai Center for Clinical Laboratory have cooperated with experts in laboratory medicine to generate the present expert consensus. Based on the current spectrum of major infectious diseases in China, the whole-process operation management of pathogen POCT, including its application scenarios, biosafety management, personnel qualification, performance verification, quality control, and result reporting, are described here. This expert consensus will aid in promoting the rational application and robust development of this technology in public health defence and hospital infection management.

scholarly journals Hemoglobin A1c Point-of-Care Assays; A New World with a Lot of Consequences!

2009 ◽  
Vol 3 (3) ◽  
pp. 418-423 ◽  
Author(s):  
Erna Lenters-Westra ◽  
Robbert J. Slingerland
Keyword(s):  
Nurse Practitioners ◽  
Hemoglobin A1c ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Care Center ◽  
Venous Blood ◽  
Coefficients Of Variation ◽  
Rapid Result ◽  
Performance Results ◽  
Clinical Laboratory Improvement Amendments

Background: Point-of-care instruments for the measurement of hemoglobin A1c (HbA1c) may improve the glycemic control of people with diabetes by providing a rapid result if the performance of the instruments used is acceptable. A 0.5% HbA1c difference between successive results is considered a clinically relevant change. With this in mind, the In2it from Bio-Rad and the DCA Vantage from Siemens were evaluated according to Clinical and Laboratory Standards Institute (CLSI) protocols. Methods: The CLSI protocols EP-5 and EP-9 were applied to investigate precision, accuracy, and bias. The bias was compared with three certified secondary reference measurement procedures. Differences between capillary and venous blood were investigated by an end-user group consisting of nurse practitioners at a diabetes care center. Results: At HbA1c levels of 5.1 and 11.2%, total coefficients of variation (CV) for the In2it were 4.9 and 3.3%, respectively, and for the DCA Vantage were 1.7 to 1.8% and 3.7 to 5.5% depending on the lot number of the cartridges. Method comparisons showed significant lot number-dependent results for the In2it and the DCA Vantage compared with the three reference methods. No overall difference was observed between capillary and venous blood for both methods. Conclusion: Performance results of the In2it and the DCA Vantage showed variable and lot number-dependent results. To maintain the interlaboratory CV of 5% for HbA1c, the Clinical Laboratory Improvement Amendments rules for waived point-of-care instruments should be revised. An obligation for participating in external quality schemes and taking adequate action should be considered for POC instruments that perform poorly.

scholarly journals Types of Assays for SARS-CoV-2 Testing: A Review

2020 ◽  
Vol 51 (5) ◽  
pp. e59-e65 ◽  
Author(s):  
Marie C Smithgall ◽  
Mitra Dowlatshahi ◽  
Steven L Spitalnik ◽  
Eldad A Hod ◽  
Alex J Rai
Keyword(s):  
Patient Care ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Direct Patient Care ◽  
Point Of Care Testing ◽  
Clinical Laboratories ◽  
Novel Coronavirus ◽  
Outpatient Settings ◽  
Clinical Laboratory Testing

Abstract Clinical laboratory testing routinely provides actionable results, which help direct patient care in the inpatient and outpatient settings. Since December 2019, a novel coronavirus (SARS-CoV-2) has been causing disease (COVID-19 [coronavirus disease 2019]) in patients, beginning in China and now extending worldwide. In this context of a novel viral pandemic, clinical laboratories have developed multiple novel assays for SARS-CoV-2 diagnosis and for managing patients afflicted with this illness. These include molecular and serologic-based tests, some with point-of-care testing capabilities. Herein, we present an overview of the types of testing available for managing patients with COVID-19, as well as for screening of potential plasma donors who have recovered from COVID-19.

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