Clinical governance: implications for point-of-care testing

2002 ◽  
Vol 39 (5) ◽  
pp. 421-423 ◽  
Author(s):  
Danielle B Freedman
Keyword(s):  
Point Of Care ◽  
Clinical Governance ◽  
Management Support ◽  
Point Of Care Testing ◽  
Financial Perspective ◽  
National Guidance ◽  
In Vitro Diagnostic ◽  
The Uk ◽  
Based Medicine

With the introduction of clinical governance in the UK during 1997 and the shift in focus from a purely financial perspective to one of quality, it has become even more important that laboratories become involved with in vitro diagnostic devices (IVDs) used outside the laboratories by non-laboratory personnel, namely, point-of-care testing (POCT). The demand for POCT is increasing and its growth will continue with advances in technology, increasing pressure to shorten patient length of stay and requirements to decrease turnaround times, alongside the national initiatives to consolidate laboratories. However, clinical governance is about practising evidence-based medicine, and both the clinical and cost-effectiveness of POCT continue to be debated. Accountability and leadership are pivotal in the implementation of clinical governance. Thus, the onus is on laboratories to take the lead for POCT and ensure that there is a robust risk management strategy to protect not only the staff, but, importantly, the patient. A rigorous POCT policy and national guidance must be adhered to. For a high quality POCT service to be delivered, fulfilling the requirements of clinical governance, a multidisciplinary local group must be established with recognized accountability, appropriate resources and, importantly, management support.

Current nursing practice of point-of-care laboratory diagnostic testing in critical care units

1995 ◽  
Vol 4 (6) ◽  
pp. 429-434 ◽  
Author(s):  
Lamb LSJr ◽  
RS Parrish ◽  
SF Goran ◽  
MH Biel
Keyword(s):  
Critical Care ◽  
Patient Care ◽  
Laboratory Testing ◽  
Point Of Care ◽  
Diagnostic Testing ◽  
Critical Care Nurses ◽  
Point Of Care Testing ◽  
Critical Care Units ◽  
In Vitro Diagnostic

BACKGROUND: The development of user-friendly laboratory analyzers, combined with the need for rapid assessment of critically ill patients, has led to the performance of in vitro diagnostic testing at the point of care by personnel without formal laboratory training. OBJECTIVES: To determine the range of laboratory testing performed by critical care nurses and their attitudes toward this role. METHODS: A survey of critical care nursing consultants was conducted, using a modified Likert scale, to assess objective measures of point-of-care testing practice in critical care units and to determine nurses' attitudes toward the practice of point-of-care testing. Statistical analysis was performed to determine significant trends in responses. RESULTS: Of the units responding to the survey, 35% used critical care nurses exclusively to perform point-of-care testing, 32.5% used laboratory technicians and critical care nurses, and 25% used other personnel. Of critical care nurses performing laboratory testing, 95.5% performed blood glucose analysis; 18.7%, arterial blood gas analysis; 4.5%, electrolyte analysis; 4.5%, hematology profiles; and 22.7%, other testing. Most agreed that stat tests were not reported promptly, thereby necessitating bedside testing. Respondents indicated that they would prefer that laboratory personnel operate in vitro diagnostic equipment and that requirements for critical care nurses to perform laboratory testing detracted from other patient care duties. CONCLUSIONS: Most nurses who perform point-of-care testing responded that it was necessary and helpful in patient management. However, they would prefer, because of their other patient care responsibilities, that laboratory personnel take this responsibility.

Laboratory Quality Control and Accreditation

2019 ◽  
Author(s):  
Anthony R. Oliver
Keyword(s):  
Clinical Laboratory ◽  
Point Of Care ◽  
Competent Authority ◽  
Internal Audit ◽  
Laboratory Practice ◽  
Iso 15189 ◽  
Certification Testing ◽  
In Vitro Diagnostic ◽  
The Uk

According to the International Organization for Standardization (ISO), the ‘Medical laboratories—Requirements for quality and competence (ISO 15189:2012) BS EN ISO 15189:2012’ accreditation is defined as ‘a procedure by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks’. Accreditation is delivered by the ‘competent authority’ based on a set of defined standards and the continual internal audit of the laboratory processes and infrastructure against these standards to achieve conformance. Additionally, the ‘competent authority’ periodically undertakes assessments to ensure compliance with the standards. These assessments vary in frequency and nature depending upon the assessment body. In some instances (e.g. UK Accreditation Service, UKAS), the assessments are annual and based on a four- year cycle covering the whole laboratory repertoire and infrastructure. The HSE is responsible for the inspection and licencing of microbiological containment level 3 and 4 facilities. The HTA is responsible for legal registration of laboratories that process and store human tissue, and is mainly histology related. The MHRA provides guidelines on good laboratory practice, good clinical practice, good clinical laboratory practice, and good manufacturing practice, largely around clinical trial work. It is also responsible for accreditation of blood transfusion laboratories. Finally, it provides guidance on the In Vitro Diagnostic Medical Device Directive (IVDMDD, 98/ 79/ EC) and the regulation of medical ‘devices’ including diagnostic devices, where a ‘device’ is defined as including reagent kits and analytical platforms. EFI provides guidance and standards for transplantation and tissue typing laboratories across Europe. Until 2009, CPA provided accreditation for the majority of UK pathology services. CPA was acquired by the UK Accreditation Service in 2009. UKAS is a government- appointed national accreditation body for the UK that is responsible for certification, testing, inspection, and calibration services, and is the competent authority for all ISO standards, not just pathology. It covers various sectors, including healthcare, food production, energy supply, climate change, and personal safety. The majority of UK pathology services will be UKAS ISO15189 accredited by 2018, including transitional ‘dual’ CPA standards/ ISO15189 accreditation between 2015 and 2018. It also provides ISO22870:2006 accreditation that is point of care specific, as well as ISO17025:2005, which applies to calibration standards.

Point-of-care testing for C-reactive protein in acute cough presentations in primary care

2020 ◽  
Vol 12 (1) ◽  
pp. 1-7
Author(s):  
Simon Searle-Barnes ◽  
Peter Phillips
Keyword(s):  
Primary Care ◽  
Point Of Care ◽  
Point Of Care Testing ◽  
C Reactive Protein ◽  
Acute Cough ◽  
Reactive Protein ◽  
The United Kingdom ◽  
Viral Aetiology ◽  
Prescription Rates ◽  
The Uk

Acute cough is one of the most common illnesses in the UK, with an estimated 48 million cases per annum. The majority of these presentations are thought to be of viral aetiology and self-limiting in nature, yet some studies report antibiotic prescription rates of approximately 65% in the UK. Clincians' decision-making process can be influenced by both patient expectations and difficulty in differentiating between viral and bacterial aetiologies by clinical examination alone. This article will consider the feasibility, efficacy, benefits and limitations of using point-of-care testing of C-reactive protein within primary care in the United Kingdom to help inform management of acute cough.

scholarly journals Proceedings of the First Workshop on Standards for Microfluidics

2019 ◽  
Vol 124 ◽  
Author(s):  
Darwin R. Reyes ◽  
Henne van Heeren
Keyword(s):  
Point Of Care ◽  
Lab On A Chip ◽  
In Vitro Diagnostics ◽  
Point Of Care Testing ◽  
Future Developments ◽  
Exciting Opportunity ◽  
Micro Total Analysis Systems ◽  
Advance Research ◽  
Total Analysis

In the last two decades, the microfluidics/lab-on-a-chip field has evolved from the concept of micro total analysis systems, where systems with integrated pretreatment and analysis of chemicals were envisioned, to what is known today as lab-on-a-chip, which is expected to be modular. This field has shown great potential for the development of technologies that can make, and to some extent are making, a big difference in areas such as in vitro diagnostics, point of care testing, organ on a chip, and many more. Microfluidics plays an essential role in these systems, and determining the standards needed in this area is critical for enabling new markets and products, and to advance research and development. Our goal was to bring together stakeholders from industry, academia, and government to discuss and define the needs within the field for the development of standards. This publication contains a summary of the workshop, abstracts from each presentation, and a summary of the breakout sessions from the National Institute of Standards and Technology Workshop on Standards for Microfluidics, held on June 1–2, 2017. The workshop was attended by 46 persons from 26 organizations and 11 countries. This was a unique and exciting opportunity for stakeholders from all over the world to join in the discussion of future developments towards standardization in the microfluidics arena.

Effects of Different Hematocrit Levels on Glucose Measurements With Handheld Meters for Point-of-Care Testing

2000 ◽  
Vol 124 (8) ◽  
pp. 1135-1140 ◽  
Author(s):  
Zuping Tang ◽  
Judith H. Lee ◽  
Richard F. Louie ◽  
Gerald J. Kost
Keyword(s):  
Glucose Concentration ◽  
Point Of Care ◽  
Point Of Care Testing ◽  
Extreme Caution ◽  
Design Changes ◽  
Glucose Meter ◽  
Clinical Risks ◽  
Value Changes ◽  
Simultaneous Change

Abstract Objectives.—To determine the effects of low, normal, and high hematocrit levels on glucose meter measurements and to assess the clinical risks of hematocrit errors. Design.—Changes in glucose measurements between low and high hematocrit levels were calculated to determine hematocrit effects. The differences between glucose measured with meters and with a plasma glucose method (YSI 2300) also were compared. Setting.—Six handheld glucose meters were assessed in vitro at low (19.1%), normal (38.5%), and high (58.3%) hematocrit levels, and at 6 glucose concentrations ranging from 2.06 mmol/L (37.1 mg/dL) to 30.24 mmol/L (544.7 mg/dL). Results.—Most systems, regardless of the reference to which they were calibrated, demonstrated positive bias at lower hematocrit levels and negative bias at higher hematocrit levels. Low, normal, and high hematocrit levels progressively lowered Precision G and Precision QID glucose measurements. Hematocrit effects on the other systems were more dependent on the glucose concentration. Overall, Accu-Chek Comfort Curve showed the least sensitivity to hematocrit changes, except at the lowest glucose concentration. Conclusions.—We strongly recommend that clinical professionals choose glucose systems carefully and interpret glucose measurements with extreme caution when the patient's hematocrit value changes, particularly if there is a simultaneous change in glucose level.

scholarly journals Measurement of Circulating Forms of Prostate-specific Antigen in Whole Blood Immediately after Venipuncture: Implications for Point-of-Care Testing

2001 ◽  
Vol 47 (4) ◽  
pp. 703-711 ◽  
Author(s):  
Timo Piironen ◽  
Martti Nurmi ◽  
Kerttu Irjala ◽  
Olli Heinonen ◽  
Hans Lilja ◽  
...  
Keyword(s):  
Physical Exercise ◽  
Prostate Specific Antigen ◽  
Whole Blood ◽  
Point Of Care ◽  
Prostate Gland ◽  
Specific Antigen ◽  
Point Of Care Testing ◽  
Blood Samples ◽  
Whole Blood Samples

Abstract Background: The purpose of this study was to validate the use of whole-blood samples in the determination of circulating forms of prostate-specific antigen (PSA). Methods: Blood samples of hospitalized prostate cancer and benign prostatic hyperplasia patients were collected and processed to generate whole-blood and serum samples. Three different rapid two-site immunoassays were developed to measure the concentrations of total PSA (PSA-T), free PSA (PSA-F), and PSA-α1-antichymotrypsin complex (PSA-ACT) to detect in vitro changes in whole-blood samples immediately after venipuncture. The possible influence of muscle movement on the release of PSA from prostate gland was studied in healthy men by measuring the rapid in vitro whole-blood kinetics of PSA forms before and after 15 min of physical exercise on a stationary bicycle. Results: Rapid PSA-T, PSA-F, and PSA-ACT assays were designed using a 10-min sample incubation. No significant changes were detected in the concentrations of PSA-T, PSA-F, and PSA-ACT from the earliest time point of 12–16 min compared with measurements performed up to 4 h after venipuncture. Physical exercise did not influence the concentrations of the circulating forms of PSA. Hematocrit-corrected whole-blood values of PSA-T and PSA-F forms were comparable to the respective serum values. Calculation of the percentage of PSA-F (PSA F/T ratio × 100) was similar irrespective of the sample format used, i.e., whole blood or serum. Conclusions: We found that immunodetectable PSA forms are likely at steady state immediately after venipuncture, thus enabling the use of anticoagulated whole-blood samples in near-patient settings for point-of-care testing, whereas determinations of PSA (e.g., PSA-T, PSA-F, or PSA-ACT) performed within the time frame of the office visit would provide results equivalent to conventional analyses performed in serum.

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