A survey of clinical laboratory instrument verification in the UK and New Zealand

2019 ◽  
Vol 56 (2) ◽  
pp. 275-282
Author(s):  
Matthew Hand ◽  
Andrea Crampton ◽  
Annette Thomas ◽  
Eric S Kilpatrick
Keyword(s):  
New Zealand ◽  
Clinical Laboratory ◽  
Clinical Biochemistry ◽  
Laboratory Medicine ◽  
Medical Laboratory ◽  
Clinical Samples ◽  
Acceptance Criteria ◽  
Measuring Range ◽  
Laboratory Instrument ◽  
The Uk

Background Clinical laboratory instrument verification testing is often an accreditation requirement. However, it is not known what verification procedures are in routine use or how often the process identifies problems which need addressing prior to testing clinical samples. Objective To investigate which standards are currently being used for laboratory verification in UK and New Zealand (NZ) clinical laboratories and to help establish if the activity justifies the effort required. Methods A survey of verification of clinical laboratory instrumentation was distributed to members of the Association for Clinical Biochemistry and Laboratory Medicine and New Zealand Institute of Medical Laboratory Scientists. The survey consisted of questions on the verification elements used and whether acceptance criteria were met. Results Nineteen of 72 (26%) of responders only used organization-developed protocols for verification, 20/72 (28%) solely used national/international guidelines, while 16/72 (22%) used a combination. Manufacturers’ claims were partly or entirely used as acceptance criteria for imprecision (89%), accuracy (64%) and analytical measuring range (94%), with these being met on 61%, 67% and 93% of occasions, respectively. For patient comparison and linearity, acceptance criteria were met by 71% and 91%. Only 27–36% undertook any troubleshooting before accepting a failed component of verification. Conclusions Laboratories in the UK and NZ are currently using a variety of verification standards and acceptance criteria for instrument verification. It is common for instruments to fail, especially following the assessment of imprecision and accuracy. While this suggests the process is warranted, only a minority address failed elements before accepting verification.

scholarly journals THE PROFESSIONAL STANDARD OF A SPECIALIST IN CLINICAL LABORATORY MEDICINE AND ITS EVALUATION BY MEDICAL LABORATORY STAFF

2017 ◽  
Vol 25 (3) ◽  
pp. 63-68
Author(s):  
P. N. Zolotaryov
Keyword(s):  
Higher Education ◽  
Clinical Laboratory ◽  
Laboratory Medicine ◽  
Study Data ◽  
Medical Laboratory ◽  
Laboratory Research ◽  
Laboratory Diagnostics ◽  
Professional Standard ◽  
Laboratory Staff ◽  
Wide Range

The issue of improving the personnel service in clinical laboratory diagnostics is topical, since specialists, having modern knowledge in laboratory research, can not stay aside from active participation during their appointment and interpretation. Training of specialists of this level requires revision of the regulatory framework, namely, the development of professional standards for specialists in clinical laboratory medicine. The survey involved 83 specialists with higher education working in clinical diagnostic laboratories of various forms of ownership in the Samara Region (Russia). In the course of the study, data were obtained reflecting the readiness to perform a number of generalized labor functions of the professional standard. Prior to the evaluation of the criterion of attention paid to the labor function in each group of respondents, we expected to obtain values of 9-10 units. However, in the course of the study, we found that this indicator in various groups of respondents fluctuated in a wide range. We believe that the training of professional stuff with higher education in laboratory medicine should be implemented in parallel with the introduction of the professional standard.

scholarly journals Applicability of the AGREE II Instrument in Evaluating the Development Process and Quality of Current National Academy of Clinical Biochemistry Guidelines

2012 ◽  
Vol 58 (10) ◽  
pp. 1426-1437 ◽  
Author(s):  
Andrew C Don-Wauchope ◽  
John L Sievenpiper ◽  
Stephen A Hill ◽  
Alfonso Iorio
Keyword(s):  
Clinical Laboratory ◽  
Clinical Biochemistry ◽  
Guideline Development ◽  
Stakeholder Involvement ◽  
Laboratory Medicine ◽  
Quality Of Reporting ◽  
Agree Ii ◽  
Strongly Agree ◽  
Agree Ii Instrument

Abstract BACKGROUND Laboratory medicine practice guidelines (LMPGs) are an important part of clinical laboratory medicine. The Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument has been developed to evaluate the process of practice-guideline development and the quality of reporting. We assessed the applicability of AGREE II in assessing the National Academy of Clinical Biochemistry (NACB) LMPGs. METHODS The NACB website was searched for all available LMPGs up to December 2011. Two independent appraisers used the AGREE II instrument to assess each LMPG identified by the search. Quality was assessed across 6 domains (scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence), comprising a total of 23 items and 2 overall assessments, each scored on a 7-point scale (1, strongly disagree, to 7, strongly agree). All scores were expressed as AGREE II calculated percentages (100% indicates that all items scored 7 by all appraisers). RESULTS Eleven LMPGs were identified. All of the LMPGs provided some information seen as applicable to clinical practice by the appraisers. Only 5 of the LMPGs had overall scores ≥50%, with a median score of 42% (range: 8%–92%). Individual domain scores varied considerably from 0% to 100%. One guideline achieved a very high score on the instrument. CONCLUSIONS The AGREE II instrument is applicable and useful to evaluate LMPGs. All domains were evaluated as being useful to assess LMPGs, some were addressed well (e.g., clarity of presentation), whereas others could be improved (e.g., applicability).

scholarly journals Increasing Trends in Unhealthy Practices of Clinical Laboratory Medicine Service in Nepal

2017 ◽  
Vol 5 (1) ◽  
pp. 33-48 ◽  
Author(s):  
Satyam Prakash
Keyword(s):  
Clinical Laboratory ◽  
Diagnostic Value ◽  
Laboratory Medicine ◽  
Medical Laboratory ◽  
Contributing Factors ◽  
Laboratory Service ◽  
Legal Provisions ◽  
Medicine Service ◽  
Geographical Regions ◽  
The Government

 The medical laboratories are increasing significantly with striking challenges in ensuring praiseworthy public health service in Nepal. Quality medical laboratory service provision is important in order to enhance diagnostic value and save lives. Poverty, poor infrastructure, unskilled manpower and incompetency are major contributing factors leading to inefficient provision of health services in developing countries. Nepal has been increasing its network of clinical health laboratories in the Government and private sectors that are scattered in various geographical regions. The quality of service remains a growing concern even as medical diagnostic laboratories are undergoing the process of accreditation for quality services in line with WHO standards. But, still the status of clinical laboratory practice regarding quality assurance, skilled manpower, standard labs and cost effective quality service remains challenging due to different loopholes in policy making. The regulatory bodies and legal provisions seem to be in non-functional state. The malpractices in clinical laboratory medicine service are increasing exponentially. Therefore, this review draws attention towards unhealthy practices in clinical laboratory services and critically examines different factors affecting the healthy practice in medical laboratory science.  Janaki Medical College Journal of Medical Sciences (2017) Vol. 5(1): 33-48

scholarly journals Comparison of regression for blood ALP levels using methods of the Japan Society of Clinical Chemistry and the International Federation of Clinical Chemistry and Laboratory Medicine in bovine, canine, feline, and human testing

PLoS ONE ◽  
2021 ◽  
Vol 16 (6) ◽  
pp. e0253396
Author(s):  
Akihisa Hata ◽  
Noboru Fujitani ◽  
Masahiro Takeshita ◽  
Chie Tanaka ◽  
Noriko Matsuda ◽  
...  
Keyword(s):  
Veterinary Medicine ◽  
Clinical Laboratory ◽  
Clinical Chemistry ◽  
Animal Health ◽  
Laboratory Medicine ◽  
International Federation ◽  
Medical Laboratory ◽  
Japan Society ◽  
Medical Laboratories ◽  
Laboratory Technology

Livestock and companion animal health have a direct impact on human health. Research on clinical laboratory technology for veterinary medicine is as important as that on human laboratory technology. Reagents and analysis equipment for human medical laboratory tests are often used in veterinary medicine. Medical laboratories in Japan utilize the Japan Society of Clinical Chemistry (JSCC) method for blood alkaline phosphatase (ALP) analysis. The International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) method is used worldwide for ALP catalytic concentration measurement. When the IFCC method is used, human blood ALP activity is approximately one-third of the JSCC method’s activity. The JSCC method for ALP measurement was switched to the IFCC method in medical laboratories in Japan in April 2020 for global standardization purpose. It is uncertain whether conventional JSCC method reagents will continue to be supplied. In veterinary medicine, the relationship between the JSCC and IFCC methods in terms of ALP measurement is almost unclear. This study investigated the regression between JSCC and IFCC methods measuring ALP in bovine, canine, feline, and human. The regression formulas for bovine, canine, feline, and human ALP values using the conventional JSCC (x) and IFCC (y) methods are y = 0.379x + 0.124, y = 0.289x + 8.291, y = 0.358x + 0.432, and y = 0.337x + 2.959, respectively. These results suggested that the IFCC method measurement could be estimated by approximately one-third of the JSCC method measurement in animal species such as bovine, canine, and feline. By applying the conversion factors proposed in this study, a very good correlation could be obtained between the two methods for each animal.

scholarly journals International best practice: Understanding the core difference between medical laboratory science and clinical laboratory medicine in Nigeria

2021 ◽  
Vol 30 (2) ◽  
pp. 145
Author(s):  
Felix Archibong ◽  
Udeme Asibong ◽  
IfeyinwaE Okoye ◽  
TonyJude Onyia ◽  
Annette Legogie ◽  
...  
Keyword(s):  
Best Practice ◽  
Clinical Laboratory ◽  
Laboratory Medicine ◽  
Medical Laboratory ◽  
Medical Laboratory Science ◽  
Laboratory Science ◽  
The Core

scholarly journals Diagnostic amyloid proteomics: experience of the UK National Amyloidosis Centre

2020 ◽  
Vol 58 (6) ◽  
pp. 948-957 ◽  
Author(s):  
Diana Canetti ◽  
Nigel B. Rendell ◽  
Janet A. Gilbertson ◽  
Nicola Botcher ◽  
Paola Nocerino ◽  
...  
Keyword(s):  
Simple Algorithm ◽  
Enzymatic Digestion ◽  
The Body ◽  
Clinical Samples ◽  
Correct Identification ◽  
Pathogenic Variants ◽  
Amyloidogenic Protein ◽  
Patient Database ◽  
Serious Disease ◽  
The Uk

AbstractSystemic amyloidosis is a serious disease which is caused when normal circulating proteins misfold and aggregate extracellularly as insoluble fibrillary deposits throughout the body. This commonly results in cardiac, renal and neurological damage. The tissue target, progression and outcome of the disease depends on the type of protein forming the fibril deposit, and its correct identification is central to determining therapy. Proteomics is now used routinely in our centre to type amyloid; over the past 7 years we have examined over 2000 clinical samples. Proteomics results are linked directly to our patient database using a simple algorithm to automatically highlight the most likely amyloidogenic protein. Whilst the approach has proved very successful, we have encountered a number of challenges, including poor sample recovery, limited enzymatic digestion, the presence of multiple amyloidogenic proteins and the identification of pathogenic variants. Our proteomics procedures and approaches to resolving difficult issues are outlined.

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