Value-added laboratory medicine in an era of managed care

1995 ◽  
Vol 41 (8) ◽  
pp. 1256-1262 ◽  
Author(s):  
J M McDonald ◽  
J A Smith
Keyword(s):  
Managed Care ◽  
Technology Assessment ◽  
Clinical Laboratory ◽  
Point Of Care ◽  
Care Service ◽  
Value Added ◽  
Outcome Analysis ◽  
Total Quality ◽  
Clinical Consultation ◽  
Healthcare Quality Assurance

Abstract Clinical laboratory consultants (M.D.s and Ph.D.s) must add value and medical relevance to the healthcare system to earn and maintain their roles in an era of managed care. Service opportunities include new and expanded roles in system-wide (a) managing of point-of-care testing, (b) informatics and information systems, (c) clinical consultation, (d) resource management, (e) management of utilization, (f) improving healthcare quality assurance, and (g) technology assessment and implementation. Hypothesis-driven research focused on the linkage between the laboratory and outcome analysis, clinical practice guidelines, total quality improvement, technology assessment, and healthcare policy provides major opportunities to complete for expanding research support. Changes in clinical laboratory consultant training are necessary to provide the knowledge, skills, and experience required to provide value-added and medically relevant services. Clinical laboratory consultants with Ph.D. degrees should initially be trained broadly in all areas of the laboratory, with emphasis on system-wide issues, and then trained as specialized scientists.

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.

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.

Health Technology Assessment in the Era of Managed Care

2004 ◽  
pp. 401-412
Author(s):  
Laura Sampietro-Colom ◽  
Shawna Jackson ◽  
Erin Williams ◽  
Frank J. Papatheofanis
Keyword(s):  
Managed Care ◽  
Health Technology Assessment ◽  
Technology Assessment ◽  
Health Technology

PP120 Health Technology Assessment Framework To Capture The Full Value Of Value Added Medicines

2017 ◽  
Vol 33 (S1) ◽  
pp. 128-129
Author(s):  
Mondher Toumi ◽  
Cecile Remuzat ◽  
Adam Plich
Keyword(s):  
Health Technology Assessment ◽  
Technology Assessment ◽  
Drug Repositioning ◽  
Value Added ◽  
Health Technology ◽  
Access To Medicines ◽  
Deliberative Process ◽  
Study Objective ◽  
Healthcare Needs ◽  
Patient Reported

INTRODUCTION:Value added medicines (VAM) are medicines based on known molecules that address healthcare needs and deliver relevant improvements for patients, healthcare professionals and/or payers through drug repositioning, drug reformulation or drug combination (1-3). Recently, the European Commission, through the Safe and Timely Access to Medicines for Patients (STAMP) program, considered the issue of VAM development and regulatory process. Current Health Technology Assessment (HTA) tools may not fully capture the benefits of VAM, which could lead to obstacles for patient access to VAM in several European countries (1). The study objective was to identify how HTA frameworks should evolve to reflect VAM value.METHODS:HTA expert interviews were performed as a preparatory step to an advisory board meeting. The following topics were addressed: (i) Eligibility for HTA and early HTA dialogues; (ii) Attributes that should be considered in HTA; (iii) HTA methodology; and (iv) Involvement of stakeholders in HTA.RESULTS:VAMs bring additional benefit to patients and society. Therefore, the possibility for VAM assessment on a voluntary basis and within the appropriate assessment patterns/tools should be, in principle, included into HTA frameworks, as well as into early HTA dialogues. HTA should be patient-centric, and attributes such as patient preference, adherence, and patient reported outcomes should be considered where relevant. Unmet patient needs and disease burden should be used in a transparent and reproducible deliberative process. All these attributes should be used as explicitly and meaningfully weighted appraisal modifiers. HTA methodology should be comprehensive and should integrate societal perspectives. Patient representatives should take part in the decision-making process.CONCLUSIONS:Current HTA frameworks should evolve to enhance VAM value recognition and encourage industry investment in medicines with high potential value for society.

scholarly journals Implementing Lean Management Techniques at a Radiation Oncology Department

2018 ◽  
Vol 18 (3) ◽  
pp. 362
Author(s):  
Mustafa M. Al-Balushi ◽  
Zahid Al-Mandhari
Keyword(s):  
Radiation Oncology ◽  
Healthcare Sector ◽  
Lean Management ◽  
Total Quality ◽  
Royal Hospital ◽  
Value Stream ◽  
A Value ◽  
Healthcare Quality Assurance ◽  
Management Techniques ◽  
Value Stream Map

Objectives: Lean management (LM) principles were first developed by a Japanese manufacturing company to maximise value and minimise waste in the automotive industry. However, these principles can also be applied in the healthcare sector. This study aimed to illustrate the process of implementing LM principles in a radiation oncology department to streamline workflow and identify and reduce waste. Methods: This study took place in the Department of Radiation Oncology, Royal Hospital, Muscat, Oman, in December 2016. A value stream map (VSM) was created for the chain of processes followed in the department. A waste analysis was conducted to determine which processes did not add value for the patient or healthcare provider. Results: Based on the VSM analysis, only six out of 13 steps were found to be of value. Necessary and unnecessary non-value-adding activities were identified. Sources of waste included parking and registration. In addition, variabilities in workload were noted. Conclusion: Overall, LM principles improve workflow, reduce waste and enhance patient and staff satisfaction. In the current study, the application of LM principles helped to improve value in a radiation oncology department.Keywords: Health Services Administration; Healthcare Quality Assurance; Total Quality Management; Organization and Administration; Efficiency; Oman.

scholarly journals Individualized Quality Control Plan (IQCP): Is It Value-Added for Clinical Microbiology?

2015 ◽  
Vol 53 (12) ◽  
pp. 3719-3722
Author(s):  
Susan E. Sharp ◽  
Melissa B. Miller ◽  
Janet Hindler
Keyword(s):  
Quality Control ◽  
Clinical Microbiology ◽  
Clinical Laboratory ◽  
Value Added ◽  
Control Plan ◽  
It Value ◽  
Link Type

The Center for Medicaid and Medicare Services (CMS) recently published their Individualized Quality Control Plan (IQCP [https://www.cms.gov/regulations-and-guidance/legislation/CLIA/Individualized_Quality_Control_Plan_IQCP.html]), which will be the only option for quality control (QC) starting in January 2016 if laboratories choose not to perform Clinical Laboratory Improvement Act (CLIA) [U.S. Statutes at Large 81(1967):533] default QC. Laboratories will no longer be able to use “equivalent QC” (EQC) or the Clinical and Laboratory Standards Institute (CLSI) standards alone for quality control of their microbiology systems. The implementation of IQCP in clinical microbiology laboratories will most certainly be an added burden, the benefits of which are currently unknown.

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.

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