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1.
Br J Community Nurs ; 27(3): 150, 2022 Mar 02.
Article in English | MEDLINE | ID: covidwho-1753985
2.
Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz ; 65(3): 327-334, 2022 Mar.
Article in German | MEDLINE | ID: covidwho-1694625

ABSTRACT

The importance of quality assurance (QA) and quality management (QM) in medical laboratories has been a topic in many political and public discussions, especially since the beginning of the SARS-CoV­2 pandemic. Uniform standards are required in order to create comparability not only among medical laboratories in Germany, but also across national borders. There are two leading systems in Germany: The Guideline of the German Medical Association (Rili-BÄK) and accreditation according to DIN EN ISO 15189.This article is intended to raise awareness of quality in medical laboratories to ensure patient safety through competent diagnostics on the patient. A literature search was carried out, including legal texts, standards, and further QM documents and publications. Furthermore, empirical values from representatives of various institutions are considered.A comprehensive QM system significantly supports work in medical laboratory diagnostics. Maintaining trust in the efficiency of medical laboratories and the facilities that support them is of great importance for the best possible care for the population. The additional effort associated with accreditation is justified with regard to patient safety but should not experience any additional bureaucracy.


Subject(s)
COVID-19 , Laboratories , Germany , Humans , Quality Assurance, Health Care , Risk Assessment , SARS-CoV-2
3.
PLoS One ; 17(2): e0263736, 2022.
Article in English | MEDLINE | ID: covidwho-1674020

ABSTRACT

Sudden emergence and rapid spread of COVID-19 created an inevitable need for expansion of the COVID-19 laboratory testing network across the world. The strategy to test-track-treat was advocated for quick detection and containment of the disease. Being the second most populous country in the world, India was challenged to make COVID-19 testing available and accessible in all parts of the country. The molecular laboratory testing network was augmented expeditiously, and number of laboratories was increased from one in January 2020 to 2951 till mid-September, 2021. This rapid expansion warranted the need to have inbuilt systems of quality control/ quality assurance. In addition to the ongoing inter-laboratory quality control (ILQC), India implemented an External Quality Assurance Program (EQAP) with assistance from World Health Organization (WHO) and Royal College of Pathologists, Australasia. Out of the 953 open system rRTPCR laboratories in both public and private sector who participated in the first round of EQAP, 891(93.4%) laboratories obtained a passing score of > = 80%. The satisfactory performance of Indian COVID-19 testing laboratories has boosted the confidence of the public and policy makers in the quality of testing. ILQC and EQAP need to continue to ensure adherence of the testing laboratories to the desired quality standards.


Subject(s)
COVID-19 Testing/standards , COVID-19/diagnosis , Clinical Laboratory Techniques/standards , Laboratories/standards , Mass Screening/standards , Quality Assurance, Health Care/standards , Reverse Transcriptase Polymerase Chain Reaction/standards , COVID-19/epidemiology , COVID-19/genetics , COVID-19/virology , Humans , India/epidemiology , Quality Control , SARS-CoV-2/genetics , SARS-CoV-2/isolation & purification , Specimen Handling/methods
5.
Int J Lab Hematol ; 44(2): 407-413, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1528379

ABSTRACT

INTRODUCTION: The high incidence of thrombotic events in patients with COVID-19 affects health care worldwide and results in an increased workload in haemostasis laboratories due to more frequent testing of D-dimer, haemostatic parameters and anti-Xa tests. However, the impact of this increase in assay requests on the quality of performance in haemostasis laboratories remains unclear. In this study, the impact of the COVID-19 pandemic on the quality of performance and management of haemostasis laboratories was evaluated. METHODS: The impact on the quality of performance was studied using external quality assessment data from 2019 to 2020 derived from ECAT surveys. A questionnaire was sent to Dutch haemostasis laboratories to identify challenges and management strategies. Furthermore, the number of assays performed in 2019 and 2020 was supplied by four Dutch hospitals, located in regions with different disease incidence. RESULTS: No differences in response rate nor the quality of the measurements were observed between the EQA surveys in 2019 and 2020. The questionnaire results showed a large increase of >25% in the number of test requests for anti-Xa, D-dimer and fibrinogen assays in 2020 compared to 2019. Extreme peaks in test requests were also observed in the four evaluated hospitals. Additionally, 84% of the respondents indicated that they had experienced increased work pressure, and increased sick leave was observed in 71% of the participating laboratories. CONCLUSIONS: The enormous increase in test requests, especially for D-dimer assays and anti-Xa activity, did not affect the quality of performance within haemostatic laboratories during the COVID-19 pandemic.


Subject(s)
COVID-19 , Blood Coagulation Tests , COVID-19/epidemiology , Hemostasis , Humans , Laboratories , Pandemics , Quality Assurance, Health Care
7.
Br J Nurs ; 30(15): 938-939, 2021 Aug 12.
Article in English | MEDLINE | ID: covidwho-1357666

ABSTRACT

Emeritus Professor Alan Glasper, from the University of Southampton, discusses recent changes to the way in which the Care Quality Commission (CQC) conducts its health and social care inspections.


Subject(s)
Quality Assurance, Health Care , State Medicine , Humans , Quality Assurance, Health Care/organization & administration , State Medicine/standards , United Kingdom
8.
PLoS One ; 16(8): e0256086, 2021.
Article in English | MEDLINE | ID: covidwho-1357436

ABSTRACT

BACKGROUND: Quality water, sanitation, and hygiene facilities act as barricades to the transmission of COVID-19 in health care facilities. These facilities ought to also be available, accessible, and functional in temporary treatment centers. Despite numerous studies on health care facilities, however, there is limited information on the status of WASH facilities in such centers. METHODS: The assessment of health care facilities for the COVID-19 response checklist and key informant interviews, were used for data collection. 35 treatment centers in Southern Ethiopia were surveyed. Eightkey informants were interviewed to gain an understanding of the WASH conditions in the treatment centers. The Quantitative data was entered using EPI-INFO 7 and exported to SPSS 20 for analysis. Results are presented using descriptive statistics. Open Code 4.02 was used for the thematic analysis of the qualitative data. RESULTS: Daily water supply interruptions occurred at 27 (77.1%) of the surveyed sites. Only 30 (85.72%) had bathrooms that were segregated for personnel and patients, and only 3 (3.57%) had toilets that were handicapped accessible. 20(57.2%) of the treatment centers did not have a hand hygiene protocol that satisfied WHO guidelines. In terms of infection prevention and control, 16 (45.71%) of the facilities lacked adequate personal protective equipment stocks. Between urban and rural areas, there was also a significant difference in latrine maintenance, hand hygiene protocol design and implementation, and incineration capacity. CONCLUSION: The results reveal crucial deficiencies in the provision of WASH in the temporary COVID-19 treatment centers. Efforts to improve WASH should offer priority to hygiene service interventions to minimize the risk of healthcare-acquired infections. The sustainable provision of hygiene services, such as hand washing soap, should also be given priority.


Subject(s)
COVID-19/epidemiology , Health Facilities/statistics & numerical data , Hygiene , Quarantine/statistics & numerical data , Sanitation/statistics & numerical data , Water Quality , COVID-19/prevention & control , Ethiopia , Health Facilities/standards , Humans , Quality Assurance, Health Care , Quarantine/standards , Sanitation/standards
9.
Clin Chem Lab Med ; 59(11): 1878-1884, 2021 10 26.
Article in English | MEDLINE | ID: covidwho-1341521

ABSTRACT

OBJECTIVES: Numerous analytical systems, rapidly made available on the market throughout the SARS-CoV-2 pandemic, aim to detect COVID-19, and to continuously update and improve the same systems. Medical laboratory professionals have also developed in-house analytical procedures in order to satisfy the enormous volume of requests for tests. These developments have highlighted the need control the analytical procedures used in order to guarantee patient safety. The External Quality Assessment (EQA) Scheme, an important quality assurance tool, aims to guarantee high standard performance for laboratory and analytical procedures. The aim of the present study was to report on the results collected in an experimental EQA scheme for the serological diagnosis of SARS-CoV-2. METHODS: All qualitative results collected in the different EQA surveys were summarized in order to identify the percentage of laboratory results in relation to typology of antibodies, results and samples. RESULTS: A total of 4,867 data sets were collected. The analysis of EQA data made, demonstrates a better agreement among laboratories results for total Ig than single immunoglobulins (IgG, IgM, IgA) in the case samples positive for SARS-CoV-2, and a wide divergence between IgM results for positive samples (only 34.9% were correct). Results for negative controls and specificity controls demonstrated a better overall agreement than results for positive samples. CONCLUSIONS: Working in collaboration with the IVD manufacturers, laboratory professionals must strive to achieve harmonization of results, and to develop well-defined protocols complying with the ISO 15189 requirements.


Subject(s)
Antibodies, Viral/immunology , COVID-19/diagnosis , SARS-CoV-2/immunology , Serologic Tests/methods , Antibodies, Viral/blood , COVID-19/immunology , Humans , Immunoglobulin A/blood , Immunoglobulin A/metabolism , Immunoglobulin G/blood , Immunoglobulin G/metabolism , Immunoglobulin M/blood , Immunoglobulin M/metabolism , Pilot Projects , Quality Assurance, Health Care , Retrospective Studies , Sensitivity and Specificity , Severity of Illness Index
10.
Am J Public Health ; 111(S2): S101-S106, 2021 07.
Article in English | MEDLINE | ID: covidwho-1328027

ABSTRACT

Objectives. To examine age and temporal trends in the proportion of COVID-19 deaths occurring out of hospital or in the emergency department and the proportion of all noninjury deaths assigned ill-defined causes in 2020. Methods. We analyzed newly released (March 2021) provisional COVID-19 death tabulations for the entire United States. Results. Children (younger than 18 years) were most likely (30.5%) and elders aged 64 to 74 years were least likely (10.4%) to die out of hospital or in the emergency department. In parallel, among all noninjury deaths, younger people had the highest proportions coded to symptoms, signs, and ill-defined conditions, and percentage symptoms, signs, and ill-defined conditions increased from 2019 to 2020 in all age-race/ethnicity groups. The majority of young COVID-19 decedents were racial/ethnic minorities. Conclusions. The high proportions of all noninjury deaths among children, adolescents, and young adults that were coded to ill-defined causes in 2020 suggest that some COVID-19 deaths were missed because of systemic failures in timely access to medical care for vulnerable young people. Public Health Implications. Increasing both availability of and access to the best hospital care for young people severely ill with COVID-19 will save lives and improve case fatality rates.


Subject(s)
COVID-19/mortality , Clinical Coding/standards , Forms and Records Control/standards , Quality Assurance, Health Care/standards , Adolescent , Aged , COVID-19/epidemiology , Cause of Death , Child , Child, Preschool , Humans , Male , Middle Aged , Minority Groups/statistics & numerical data , Quality Control , Sex Distribution , United States , Young Adult
11.
Ann Ig ; 33(5): 513-517, 2021.
Article in English | MEDLINE | ID: covidwho-1317344

ABSTRACT

Abstract: Starting from the minimum requirements indicated by Lombardy Region, a validation checklist has been developed by experts in design, healthcare layout planning, hygiene and public health, planning and compliance, in order to provide managers of COVID-19 massive vaccination centers with a useful and easy-to-use tool to ensure quality, safety and efficiency of the different activities performed.


Subject(s)
COVID-19 Vaccines , COVID-19/prevention & control , Community Health Centers/organization & administration , Mass Vaccination/organization & administration , SARS-CoV-2 , Validation Studies as Topic , COVID-19 Vaccines/supply & distribution , Checklist , Community Health Centers/standards , Efficiency, Organizational , Facility Design and Construction , Humans , Hygiene , Italy , Patient Safety , Quality Assurance, Health Care , Quality Indicators, Health Care
12.
Clin Chem Lab Med ; 59(10): 1735-1744, 2021 09 27.
Article in English | MEDLINE | ID: covidwho-1286880

ABSTRACT

OBJECTIVES: External quality assessment (EQA) schemes provide information on individual and general analytical performance of participating laboratories and test systems. The aim of this study was to investigate the use and performance of SARS-CoV-2 virus genome detection systems in Austrian laboratories and their preparedness to face challenges associated with the pandemic. METHODS: Seven samples were selected to evaluate performance and estimate variability of reported results. Notably, a dilution series was included in the panel as a measure of reproducibility and sensitivity. Several performance criteria were evaluated for individual participants as well as in the cohort of all participants. RESULTS: A total of 109 laboratories participated and used 134 platforms, including 67 different combinations of extraction and PCR platforms and corresponding reagents. There were no false positives and 10 (1.2%) false negative results, including nine in the weakly positive sample (C t ∼35.9, ∼640 copies/mL). Twenty (22%) laboratories reported results of mutation detection. Twenty-five (19%) test systems included amplification of human RNA as evidence of proper sampling. The overall linearity of C t values from individual test systems for the dilution series was good, but inter-assay variability was high. Both operator-related and systematic failures appear to have caused incorrect results. CONCLUSIONS: Beyond providing certification for participating laboratories, EQA provides the opportunity for participants to evaluate their performance against others so that they may improve operating procedures and test systems. Well-selected EQA samples offer additional inferences to be made about assay sensitivity and reproducibility, which have practical applications.


Subject(s)
COVID-19/diagnosis , Genome, Viral , Quality Assurance, Health Care , SARS-CoV-2/isolation & purification , Austria/epidemiology , COVID-19/virology , Humans , Laboratories , Molecular Diagnostic Techniques/methods , Pandemics , SARS-CoV-2/genetics , Sensitivity and Specificity
13.
Biochem Med (Zagreb) ; 31(2): 020712, 2021 Jun 15.
Article in English | MEDLINE | ID: covidwho-1278715

ABSTRACT

INTRODUCTION: Effective implementation and continual compliance with ISO 15189:2012 require ongoing commitment and active involvement of laboratory staff. Our aim was to assess attitudes regarding accreditation implementation by conducting a survey in three Croatian accredited medical laboratories. MATERIALS AND METHODS: An anonymous survey consisting of 34 questions was distributed either electronically or in a paper form a week prior to scheduled annual audits. Distributions of answers regarding age, work experience, laboratory workplace, and education level and according to the respective laboratory were compared. RESULTS: The overall response rate was 76% (225/297). Preference towards working in an accredited laboratory and a positive attitude were revealed by 70% and 56% participants, respectively, with better process documentation as the main advantage. Only 14% of responders considered themselves completely familiar with ISO 15189:2012. Total of 68% of responders felt that accreditation increases the usual workload, with excessive paperwork as the main contributor. Half of the responders declared partial agreement that accreditation requirements and expectations were clearly explained and claimed that their suggestions were taken into account only occasionally, which was especially emphasized by technical staff. The vast majority (89%) completely follow the prescribed protocols. Only 27% consider turnaround time monitoring useful. Competence assessment is considered efficient by 41% of responders. The majority (73%) prefer an online audit in times of COVID-19. CONCLUSIONS: Despite an overall positive attitude towards accreditation, further efforts are needed in providing better education about ISO 15189:2012 for technical staff and modifying formats of competence assessment, in order to achieve better adherence to ISO 15189:2012 requirements.


Subject(s)
Accreditation , Attitude of Health Personnel , Laboratories, Hospital/standards , Adult , Croatia , Female , Humans , Male , Quality Assurance, Health Care , Surveys and Questionnaires
14.
Ann Ig ; 33(5): 513-517, 2021.
Article in English | MEDLINE | ID: covidwho-1266915

ABSTRACT

Abstract: Starting from the minimum requirements indicated by Lombardy Region, a validation checklist has been developed by experts in design, healthcare layout planning, hygiene and public health, planning and compliance, in order to provide managers of COVID-19 massive vaccination centers with a useful and easy-to-use tool to ensure quality, safety and efficiency of the different activities performed.


Subject(s)
COVID-19 Vaccines , COVID-19/prevention & control , Community Health Centers/organization & administration , Mass Vaccination/organization & administration , SARS-CoV-2 , Validation Studies as Topic , COVID-19 Vaccines/supply & distribution , Checklist , Community Health Centers/standards , Efficiency, Organizational , Facility Design and Construction , Humans , Hygiene , Italy , Patient Safety , Quality Assurance, Health Care , Quality Indicators, Health Care
15.
Front Health Serv Manage ; 37(4): 17-27, 2021 Jul 01.
Article in English | MEDLINE | ID: covidwho-1243551

ABSTRACT

SUMMARY: While the term systemness has been used in the healthcare sector for decades, its definition varies from organization to organization. Still, the goals are consistent: to improve patient experience, lower costs, reduce risk, and provide insights into a wide range of care and management issues. Most health systems face similar challenges, such as margin enhancement, quality improvement, increased access, and fending off disruptive competition. Systemness is a way to address these challenges while improving the overall interdependence of the organization. Although embraced by and advantageous to healthcare organizations, systemness efforts often fail. The obstacles are surmountable when organizations thoroughly analyze the achievable scale of systemness, community resources, and current mindset regarding the good of the whole. Leaders must play a vital role in promoting systemness by providing education and a routine review of day-to-day organizational activities. Sometimes, systemness requires a change in leadership or an updating of leadership skills.Organizations must recognize and assess their culture as it relates to principles of independence versus interdependence, and refocus clinical standardization through best-practice protocols and policies as COVID-19 affects the already-fractured healthcare sector. Fortunately, current and developing artificial intelligence, wearables, at-home testing, and improved technologies promise to provide a needed break for a contracting physician field and fatigued front line, and they present an opportunity for those organizations poised to meet the systemness challenge.


Subject(s)
COVID-19/diagnosis , COVID-19/therapy , Delivery of Health Care/organization & administration , Intersectoral Collaboration , Patient-Centered Care/organization & administration , Quality Assurance, Health Care/organization & administration , Quality of Health Care/organization & administration , Humans , Organizational Culture , Organizational Objectives , SARS-CoV-2
16.
J Clin Lab Anal ; 35(6): e23804, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1241506

ABSTRACT

BACKGROUND: Before public health emergencies became a major challenge worldwide, the scope of laboratory management was only related to developing, maintaining, improving, and sustaining the quality of accurate laboratory results for improved clinical outcomes. Indeed, quality management is an especially important aspect and has achieved great milestones during the development of clinical laboratories. CURRENT STATUS: However, since the coronavirus disease 2019 (COVID-19) pandemic continues to be a threat worldwide, previous management mode inside the separate laboratory could not cater to the demand of the COVID-19 public health emergency. Among emerging new issues, the prominent challenges during the period of COVID-19 pandemic are rapid-launched laboratory-developed tests (LDTs) for urgent clinical application, rapid expansion of testing capabilities, laboratory medicine resources, and personnel shortages. These related issues are now impacting on clinical laboratory and need to be effectively addressed. CONCLUSION: Different from traditional views of laboratory medicine management that focus on separate laboratories, present clinical laboratory management must be multidimensional mode which should consider consolidation of the efficient network of regional clinical laboratories and reasonable planning of laboratories resources from the view of overall strategy. Based on relevant research and our experience, in this review, we retrospect the history trajectory of laboratory medicine management, and also, we provide existing and other feasible recommended management strategies for laboratory medicine in future.


Subject(s)
COVID-19 Testing , COVID-19/diagnosis , Clinical Laboratory Services , Clinical Laboratory Techniques/standards , Laboratories , Clinical Laboratory Services/organization & administration , Clinical Laboratory Services/standards , Humans , Laboratories/organization & administration , Laboratories/standards , Point-of-Care Testing , Public Health , Quality Assurance, Health Care
18.
Br J Nurs ; 29(13): 727, 2020 07 09.
Article in English | MEDLINE | ID: covidwho-1229479
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