scholarly journals ASCLS Annual Meeting 2017: Official Abstracts of Submitted Papers, Case Studies and PostersEffective Incorporation of Performance Standards in Quality Control SystemsSubmandibular ZygomycosisRisk Management and Quality Control in Mass SpectrometryThe Significance of the Laboratory in the Work Up and Monitoring of Seemingly Independent Illnesses That In Fact Were InterrelatedThe Education Gap in Clinical MicrobiologyValidation of an Allelic Discrimination Assay for Drug MetabolismDevelopment of a High Resolution Melt Curve Assay to Detect Sickle Cell DiseasePhytochemical Effects on Bacterial BiofilmField Evaluation of Onsite Monitors for Surface Contamination by 5-fluorouracilComparison of Test Results for IHC, FISH and NGS when Screening for Molecular MarkersSevere Factor VII Deficiency in a NewbornValidation of Vysis LSI ALK and ROS1 Break Apart FISH ProbesA Prospective Study of Patients Diagnosed with Sarcoidosis: Nutrition, Health Assessment and Environmental ExposuresAssessment of Intake of Cinnamon Supplements on Hemoglobin A1c Levels in Pre-DiabeticsNGS Testing Helps to Identify New Treatment Opportunities for Advanced Solid Tumor Cancers Driven by Molecular AlterationsCause and Concern for Patients with B- cell Lymphoproliferative DisordersOral Presentation AbstractsInpatient Utilization of Point of Care Glucose Concomitant TestingWhat is That Bug in My Blood?Effects of Blood Banking Advanced Technology Practice Prior to Clinical Rotations on Clinical Laboratory Science Student OutcomesPlanting Your Lab Garden with Your OWN Seeds: A Novel Approach to the Laboratory Professional Shortage

2017 ◽  
Vol 30 (3) ◽  
pp. 161-170
Author(s):  
Selom Agboyi ◽  
Sean Ahrens ◽  
Zoe C. Brooks ◽  
Demetra Castillo ◽  
Ryan Cordner ◽  
...  
Keyword(s):  
Quality Control ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Health Assessment ◽  
Performance Standards ◽  
Advanced Technology ◽  
Factor Vii ◽  
High Resolution Melt ◽  
Allelic Discrimination Assay ◽  
Allelic Discrimination

scholarly journals Unique Approach to Quality Assurance in Viscoelastic Testing

2020 ◽  
Vol 5 (6) ◽  
pp. 1228-1241 ◽  
Author(s):  
Nicole H Leadbetter ◽  
Thomas B Givens ◽  
Francesco Viola
Keyword(s):  
Quality Control ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Central Laboratory ◽  
Control Plan ◽  
Coagulation Function ◽  
Core Technology ◽  
Unique Approach ◽  
New Generation ◽  
Precision Testing

Abstract Background The Quantra QPlus System is a novel viscoelastic testing (VET) device designed for the management of coagulation function in critical care settings. The system is indicated and approved for use at the point-of-care and designed for use by nonlaboratory personnel. Methods We describe the comprehensive set of internal QC checks implemented in the Quantra and demonstrate the system’s unique capabilities made possible by its ultrasound core technology. Single- and multisite precision testing were performed following Clinical Laboratory Standards Institute guidelines and included multiple days of testing, multiple instruments, multiple lots of cartridges and controls, and multiple operators. Results Percent CVs for total imprecision were 3.6% to 8.0% for all measured parameters. CVs for replicate imprecision (“repeatability”) were 2.7% to 7.7% for all measured parameters. Replicate imprecision was the largest component of variability for most parameters. Conclusions The Quantra QPlus System is a new-generation cartridge-based VET device that can operate with reduced oversight from the central laboratory while easily integrating into the Individualized Quality Control Plan framework.

Quality Control of Test Systems Waived by the Clinical Laboratory Improvement Amendments of 1988

2000 ◽  
Vol 124 (8) ◽  
pp. 1122-1127 ◽  
Author(s):  
Kathleen M. LaBeau ◽  
Marianne Simon ◽  
Steven J. Steindel
Keyword(s):  
Quality Control ◽  
Home Health Care ◽  
Error Detection ◽  
Test Performance ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Ease Of Use ◽  
Test Systems ◽  
Physician Office ◽  
Clinical Laboratory Improvement Amendments

Abstract Context.—Recent advances in laboratory testing technology have resulted in a rapidly increasing number of test systems targeted for physician office, point-of-care, and home health care settings. With enhanced error detection mechanisms and unitized reagents, these new systems simplify the testing process and the assessment of analytical test performance. Many also meet the criteria set by the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to qualify as waived test systems, and laboratories using only waived tests are subject to very limited regulatory oversight. Objective.—To evaluate use patterns and perceptions about quality control requirements with respect to waived testing. Design and Setting.—Survey of a network of 431 hospital, independent, and physician office laboratories in the US Pacific Northwest. Results.—Responding laboratories (n = 221) were taking advantage of the availability of waived tests and using them to make definitive diagnoses. We found considerable differences between quality control practices and the laboratories' perceptions of quality control requirements. Most respondents were performing traditional quality control on waived tests, influenced by their interpretation of regulations, the intended use of the test, and the testing personnel employed. Conclusions.—Technology optimized for alternate quality control can represent an improvement in ease of use while meeting expectations for accuracy and providing relief from regulatory burdens. However, laboratory personnel exhibit confusion in applying new quality control systems.

scholarly journals Cardio-Pulmonary Sequelae in Recovered COVID-19 Patients: Considerations for Primary Care

2021 ◽  
Vol 12 ◽  
pp. 215013272110237
Author(s):  
Zouina Sarfraz ◽  
Azza Sarfraz ◽  
Alanna Barrios ◽  
Radhika Garimella ◽  
Asimina Dominari ◽  
...  
Keyword(s):  
Primary Care ◽  
Primary Infection ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Case Reports ◽  
Case Series ◽  
Infectious Complications ◽  
Care Physician ◽  
Cross Sectional ◽  
Infection Period

Background: Current literature lacks characterization of the post-recovery sequelae among COVID-19 patients. This review characterizes the course of clinical, laboratory, radiological findings during the primary infection period, and the complications post-recovery. Primary care findings are presented for long-COVID care. Methods: Adhering to PRISMA guidelines, 4 databases were searched (PubMed, Embase, CINAHL Plus, Scopus) through December 5, 2020, using the keywords “COVID-19 and/or recovered and/or cardiovascular and/or long-term and/or sequelae and/or sub-acute and/or complication.” We included published peer-reviewed case reports, case series, and cross-sectional studies providing the clinical course of COVID-19 infection, and cardiopulmonary complications of patients who recovered from COVID-19, while making healthcare considerations for primary care workers. Results: We identified 29 studies across 9 countries including 37.9% Chinese and 24.1% U.S. studies, comprising 655 patients (Mean Age = 45) with various ethnical backgrounds including Asian and European. Based on the WHO COVID-19 severity classification scale, initial disease severity was mild for 377 patients and severe for 52 patients. Treatments during primary infection included corticosteroids, oxygen support, and antivirals. The mean value (in days) for complication onset after acute recovery was 28 days. Complete blood counts and RT-PCR tests were the most common laboratory results described. In 22 of the studies, patients showed signs of clinical improvement and were prescribed medications such as anticoagulants or corticosteroids. Conclusion: Post-recovery infectious complications are common in long-COVID-19 patients ranging from mild infections to life-threatening conditions. International thoracic and cardiovascular societies need to develop guidelines for patients recovering from COVID-19 pneumonia, while focused patient care by the primary care physician is crucial to curb preventable adverse events. Recommendations for real-time and lab-quality diagnostic tests are warranted to establish point-of-care testing, detect early complications, and provide timely treatment.

scholarly journals POS-020 QUALITY CONTROL RESULTS FROM STATSENSOR XPRESS TM POINT OF CARE CREATININE METER UNDER REAL WORLD USAGE

2021 ◽  
Vol 6 (4) ◽  
pp. S9
Author(s):  
M. FREDLUND ◽  
M. Nyawo ◽  
A. Hamilton ◽  
M. Rocco ◽  
B. Cullis
Keyword(s):  
Quality Control ◽  
Real World ◽  
Point Of Care

Quality assurance and quality control to ensure durability

2021 ◽  
Author(s):  
B. C. Roy ◽  
Tanmoy Guha ◽  
R. Ekambaram
Keyword(s):  
Quality Control ◽  
Quality Assurance ◽  
Service Life ◽  
Performance Standards ◽  
Full Compliance ◽  
Design Build ◽  
Adequate Quality ◽  
Structural Failures ◽  
High Level ◽  
Fundamental Requirement

<p>High level of quality during design, design-build and construction stages is a fundamental requirement to ensure that structure serves its intended purpose. Establishment of a quality assurance manual is prime necessity. Lack of quality control during design, review and approving design drawings are major reasons for structural failures. Designers and design checkers need to work in tandem to ensure more adequate Quality Assurance &amp; Control (QA/QC).</p><p>In structural design Durability is a key parameter and becomes critical for service life of 100/120 years. In design build and construction stages controlling work quality is important to maintain performance standards. Tailor made quality plan for Design-build Contract is essential. Quality procedures, inspection and testing needs implementation in practice to verify full compliance and prevent occurrence of faults and defects towards durability and service life. This paper deals with Quality with special emphasis on durability in design and construction through case studies of design build contracts.</p>

POCT errors can lead to false potassium results

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Antonio Buño ◽  
Paloma Oliver
Keyword(s):  
Decision Making ◽  
Clinical Decision Making ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Clinical Intervention ◽  
Clinical Decision ◽  
Whole Process ◽  
Severe Hyperkalemia ◽  
Wrong Diagnosis ◽  
Critical Patients

Abstract Point-of-care-testing (POCT) facilitates rapid availability of results that allows prompt clinical decision making. These results must be reliable and the whole process must not compromise its quality. Blood gas analyzers are one of the most used methods for POCT tests in Emergency Departments (ED) and in critical patients. Whole blood is the preferred sample, and we must be aware that hemolysis can occur. These devices cannot detect the presence of hemolysis in the sample, and because of the characteristics of the sample, we cannot visually detect it either. Hemolysis can alter the result of different parameters, including potassium with abnormal high results or masking low levels (hypokalemia) when reporting normal concentrations. Severe hyperkalemia is associated with the risk of potentially fatal cardiac arrhythmia and demands emergency clinical intervention. Hemolysis can be considered the most frequent cause of pseudohyperkalemia (spurious hyperkalemia) or pseudonormokalemia and can be accompanied by a wrong diagnosis and an ensuing inappropriate clinical decision making. A complete review of the potential causes of falsely elevated potassium concentrations in blood is presented in this article. POCT programs properly led and organized by the clinical laboratory can help to prevent errors and their impact on patient care.

Achieving Quality Reproducible Results and Maintaining Compliance in Molecular Diagnostic Testing of Human Papillomavirus

2003 ◽  
Vol 127 (8) ◽  
pp. 978-983 ◽  
Author(s):  
Jacqueline M. Seabrook ◽  
Roger A. Hubbard
Keyword(s):  
Quality Control ◽  
Human Papillomavirus ◽  
Method Validation ◽  
Proficiency Testing ◽  
Laboratory Testing ◽  
Clinical Laboratory ◽  
Laboratory Accreditation ◽  
Medical Laboratory ◽  
Molecular Diagnostic ◽  
High Complexity

Abstract Laboratories contemplating either the addition of new molecular tests or modifying methods approved by the Food and Drug Administration for human papillomavirus testing should be aware of a variety of procedural, performance, and regulatory issues surrounding such activity. Diagnostic medical laboratory testing in the United States is regulated by the Centers for Medicare and Medicaid Services, an agency formerly known as the Health Care Finance Administration. The regulatory vehicle of the Centers for Medicare and Medicaid Services is manifested in the Clinical Laboratory Improvement Amendments (CLIA). The CLIA program has put into place specific regulations for laboratory quality control, which includes specific recommendations for method validation. Regulations that must be followed regarding personnel, quality control, quality assurance, method validation, and proficiency testing depend on the complexity category of the individual test. All molecular diagnostic tests, including those for human papillomavirus, are considered high complexity. The Centers for Medicare and Medicaid Services retains the authority to allow private, national accreditation organizations to “deem” that a laboratory is compliant with CLIA '88 requirements. Accreditation organizations, such as the Joint Commission for Accreditation of Hospitals, the Commission on Office Laboratory Accreditation, and the College of American Pathologists (CAP), as well as several state medical laboratory–accrediting agencies, possess the authority to deem laboratories as “CLIA-approved.” The CAP, through its Laboratory Accreditation Program, has promoted standards for laboratory performance and method validation. In general, guidelines set forth in the CAP Laboratory Accreditation Program checklists specify that all clinical laboratory testing must essentially meet those requirements defined for high-complexity testing under CLIA '88, including test validation standards, reportable/reference ranges, performance criteria, and proficiency testing.

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