A Turning Point for Lipoprotein(a) Treatment: Are Clinical Laboratories Ready?

Clinical laboratories worldwide need to report IgE antibody results on clinical specimens as analytical results and not use differential positive thresholds

INTRODUÇÃO: O Controle Externo da Qualidade (CEQ) é uma ferramenta importante para a garantia da qualidade das análises laboratoriais, auxiliando o laboratório a avaliar a eficiência da fase analítica de seus processos. Um resultado errôneo de uma análise prejudica a conclusão do diagnóstico de uma enfermidade e a indicação correta do tratamento a ser tomado. As inspeções sanitárias em laboratórios clínicos (LCs) no estado do Rio de Janeiro são feitas com base no roteiro de inspeção sanitária publicado pela Portaria SES/CVS 743, de junho de 2006, na RDC 302/2005 e legislação vigente. Os resultados observados quanto ao CEQ, do total de 347 inspeções realizadas pelo Setor de Laboratórios de Análises Clínicas da Secretaria de Saúde e Defesa Civil (LAC-SESDEC) no decorrer dos anos pesquisados, são apresentados a seguir: em 2006, entre as 133 inspeções realizadas em Laboratórios de Análises Clínicas, 44% dos estabelecimentos não possuíam contrato com provedor de ensaios de proficiência (EPs); em 2007, entre as 95 inspeções realizadas em Laboratórios de Análises Clínicas, 38% não possuíam contrato com provedor de EPs; em 2008, entre as 119 inspeções realizadas em Laboratórios de Análises Clínicas, 35% não possuíam contrato com provedor de EPs. Dos 214 laboratórios clínicos inspecionados nos anos de 2007 e 2008, 62% (134 estabelecimentos) possuíam CEQ, entretanto, desses 134 estabelecimentos, 65% não registravam as ações corretivas relacionadas com as não conformidades detectadas em relatório emitido pelo provedor de EPs. MÉTODO: No presente estudo, foi avaliada a distribuição percentual dos resultados das inspeções sanitárias realizadas em LCs no estado do Rio de Janeiro de 2006 a 2008, cadastrados na Secretaria Estadual de Saúde e Defesa Civil (SESDEC), relacionando o número de LCs que não atendem às exigências sanitárias, item: "Controle Externo da Qualidade - CEQ da Portaria 743/2006", e a natureza e a iniciativa desses estabelecimentos: LC intra e extra-hospitalares (hospitais públicos ou privados, próprios ou terceirizados). OBJETIVO: Avaliação percentual do CEQ em LCs no estado do Rio de Janeiro ao longo do período analisado, com relação à natureza desses estabelecimentos.

Consensus Characterization of 16 FMR1 Reference Materials: A Consortium Study

Targeted Array CGH

Practices of clinical microbiology laboratories in reporting voided urine culture results

Monocyte volumetric parameters and lymph index are increased in SARS-CoV-2 infection.

Evaluation of a pulsed xenon ultraviolet light device for reduction of pathogens with biofilm-forming ability and impact on environmental bioburden in clinical laboratories.

Autoverification in a core clinical chemistry laboratory at an academic medical center

Future Role of the Clinical Lab in Population Health.

Much has been written recently about the remarkable transformation new DNA sequencing technologies are bringing to medicine, delivering vast amounts of genetic information speedily and with ever-decreasing cost. Glib references to ‘‘the $1,000 dollar genome’’ have emphasized the point that ‘‘soon’’ complete genomic analysis will be possible for less than the charge for a computed tomography scan of the chest, abdomen, and pelvis (current procedural terminology code 74178). Recent estimates indicate more than 68 million computed tomography scans are done in the United States each year. Cost estimates for genome analysis virtually never take into account the realities of the development and reimbursement strategies for novel clinical laboratory assays. Genomic-based clinical laboratory tests are increasingly common, and the processes that typically determine appropriate reimbursement for these tests are being challenged by their unique nature. In 2013, several expert working groups were commissioned by the American Medical Association Current Procedural Terminology (AMA CPT) Editorial Panel to develop CPT codes that describe genomic sequencing procedure (GSP) services, which will be provided by laboratory tests using genomic sequencing technologies. These codes were debated and accepted by the panel earlier this year and, although not perfect, represent an earnest attempt by knowledgeable stakeholders, including payers, to create useful and meaningful codes. On Monday, July 14, 2014, the Centers for Medicare & Medicaid Services (CMS) held the Annual Clinical Laboratory Fee Schedule Public Meeting in Baltimore, Maryland. During the first half of this meeting, several groups presented public commentary regarding the most ‘‘appropriate’’ pricing methodology (eg, gapfilling versus crosswalk; see Table) for new CPT codes. Discussion surrounded those codes accepted by the AMA CPT Editorial Panel for genomic sequencing-based assays (eg, 814XX, targeted genomic sequencing; see Figure), which are to be implemented by CMS on January 1, 2015. At this meeting, Roswell Park Cancer Institute) and multiple other groups (eg, Sequenom Laboratories, the American Society for Clinical Pathology, the American Clinical Laboratory Association, the Coalition for 21st Century Medicine, Foundation Medicine, and the American Society for Clinical Laboratory Science) recommended gapfill. Organizations including the Association for Molecular Pathology and the College of American Pathologists recommended crosswalk, in large part, motivated by the less-than-optimal implementation by CMS of the gapfill process for pricing the tier 1 and tier 2 molecular pathology procedure CPT codes in 2013. There remain many tests used clinically with accurate codes, which have not been priced by CMS or its contactors. Hence, various personalized medicine innovations are not available to many people. Although it is unknown whether crosswalking or gapfilling methodology will be adopted by CMS to determine reimbursement for next-generation sequencing–based tests, the outcome of this could be critically important to patient care for many years. Regardless of which methodology is used, individual groups concerned with cancer care, such as Roswell Park Cancer Institute, sense the urgency for this void to be filled. Remarkably, this debate is occurring in the shadow of the recent US House bill HR 4302 Protecting Access to Medicare Act of 2014 (PAMA; 113th Leg, Pub L No. 113-93), where there is language requiring the Secretary of Health, not later than July 1, 2015, to establish a permanent clinical laboratory advisory panel to assist CMS on coverage and payment matters related to clinical diagnostic laboratory tests. This panel, to be composed of individuals with expertise in clinicaland research-based molecular pathology and with appropriate expertise in laboratory science and health economics, will assist the Secretary of Health and CMS in the establishment of payment rates for new clinical

I am very pleased to comment such an article reviewing the book “Metodele laboratorului clinic” (title in English: “The Methods of the Clinical Laboratory”) (1) since I know one of the authors very well, as well as the importance of the book. Professor Ioan Manta was the Founder and for several decades the Chairman of the Department of Medical Biochemistry of the University of Medicine and Pharmacy in Cluj-Napoca, Romania. As other students in medicine, I was greatly impressed by Professor Manta’s outstanding lectures, in which the great importance of biochemistry and molecular biology for medicine (and for the clinical laboratory in particular) was emphasized. Some of his students decided to engage in research in his department during their medical studies. Professor Manta ensured an excellent environment for both teaching and research, was an excellent mentor, asking other staff members to introduce students to research programs within the department. Under the supervision of a very dedicated Lecturer, Dr. Adriana (Popesco) Hodârnau, and together with two colleagues, we pursued a project of research involving chromatography of amino acids that resulted in the publication of a paper in an international journal, which was well known at the time (2). Afterwards, Professor Manta made great efforts to help me to obtain several positions in his department (Ph D student, Lecturer, Senior Lecturer), and to obtain the approval to work as a Postdoc in England (I was later appointed to Chair of the new Department of Cell Biology). All of these steps were very difficult to pursue during the “Communist Regime”, which led to Professor Manta suffering a lot (he was even imprisoned for several years, during the Second World War after he undertook several visits to Germany, even though he was sent by the University to buy equipment and consumables for all laboratory departments). Professor Ioan Manta was the founder of Medical Biochemistry in Romania, devoting a lot of his time to practical problems of the clinical laboratory. This was all in a time when links with other countries were cut (first because of the War, then due to the “Communist Regime”). Consequently, it was extremely important for specialists working in medical laboratories (hematologists, chemists, biologists, and pharmacists) to have methods to use in their analyses upon which clinicians could base the diagnosis and treatment of patients. Professor Manta, along with another clinician, Alexandru Ciplea, took on the difficult task of writing a book on such methods. They successfully wrote an excellent book, which was on the benches of every for decades medical laboratory in Romania for decades; the users called it the “Manta-Ciplea book”. At some point, Professor Manta told us of a visit to a Romanian laboratory where he was introduced by the Head of a Clinic and one of the people in the lab said: “Ah, you are Mr. Manta-Ciplea!”. In 1974, while I was a Lecturer in his Department, Prof. Manta called me one morning and expressed his wish to produce another practical book for clinical laboratories, containing just biochemical methods, as in the meantime the medical (clinical) laboratory had been divided into several sub-specialties (hematology, biochemistry, microbiology, parasitology, immunology, etc.). He asked me to be a co-author of a new “methods” book and even gave me the task of identifying other coauthors. I felt honored and also very enthusiastic, and managed to find two other authors: Mircea Cucuianu (the Director of the best clinical laboratory in Cluj-Napoca, the First Medical Clinic; he later became the first Professor of Clinical Biochemistry and the founder of this discipline in Romania) and Adriana Hodârnau. Together, we produced a highly successful book: (“Metode biochimice in laboratorului clinic”, in English: “Biochemical Methods in the Clinical Laboratory” (3)), which was published in 1976. The book was used for many years in all clinical laboratories in Romania, before new analyzers were introduced (after 1990). To conclude, I agree that the book by Prof. Ioan Manta-Alexandru Ciplea was for decades a reference book and believe that it is important to pay tribute to such books and their authors.

This study investigates the application of 15 Quality Indicators (QIs) in clinical laboratories in Fujian Province, China, from 2018 to 2023. It identifies the main causes of laboratory errors and explores issues in the application of QIs, providing a reference for establishing provincial state-of-the-art and operational quality specifications (QSs). All clinical laboratories in Fujian Province were organized to submit general information and original QIs data through the online External Quality Assessment (EQA) system of the National Clinical Laboratory Center (NCCL) for a survey of 15 QIs. Data from 2018 to 2023 were downloaded for statistical analysis, and the current QSs for the 15 QIs in Fujian Province were compared and analyzed with those published by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Working Group on Laboratory Errors and Patient Safety (WG-LEPS). QIs data from 542 clinical laboratories were collected. The survey on data sources showed that the number of laboratories recording QIs data using Laboratory Information Systems (LIS) increased annually, but the growth was modest and the proportion was less than 50 %. Among the laboratories using LIS to record QIs data, 133 continuously participated in this survey for six years, reporting different QIs. Over the six years, all reported QIs showed significant improvement or at least remained stable. The best median Sigma (σ) metrics were for the percentage of critical values notification and timely critical values notification, reaching 6σ, followed by the percentage of incorrect laboratory reports, with σ metrics ranging from 4.9σ to 5.1σ. In contrast, the percentage of tests covered by internal quality control (IQC) (1.5σ-1.7σ) and inter-laboratory comparison (0.1σ) remained consistently low. Compared to the QSs published by IFCC WG-LEPS, the QSs for the 15 QIs in Fujian Province in 2023 were stricter or roughly equivalent, except for the percentage of incorrect laboratory reports (Fujian Province: 0-0.221, IFCC WG-LEPS: 0-0.03). 1. The application of QIs has significantly improved the quality of testing in clinical laboratories in Fujian Province, but the percentage of tests covered by IQC and inter-laboratory comparison remain low; 2. Effective application of QIs requires the establishment of comprehensive LIS, unified calculation standards, and other supporting measures.

Oversight of individual clinical and research laboratories is variable and site dependent. There are several regulating bodies, each with their own requirements, leading to confusion in the certification process and returning information to study participants. A literary and web-based review of research, clinical research, and clinical laboratories compared regulatory differences among different laboratory types and regulatory bodies. A research laboratory generally performs scientific investigations, whereas a clinical laboratory investigates safety, devices, diagnostics, or potential treatments and specifically uses human biospecimens for diagnosis, treatment, or disease prevention. The Occupational Safety and Health Administration, the US Food and Drug Administration, and individual institutions have published guidelines on good laboratory practices and safety, but there are no regulating bodies that govern research laboratory practice. Clinical laboratories are expected to follow good clinical laboratory practices, and if they perform human testing, certification through Clinical Laboratory Improvements Amendments (CLIA) is required. Historically, genetic testing may be pursued through clinical or research avenues. CLIA prohibits releasing test results obtained from research; however, research results are freely released in many countries. The Health Insurance Portability and Accountability Act privacy rule contains an exception that could allow participants to obtain their results from a non-CLIA research lab. Determining laboratory regulatory requirements can often be difficult for research and clinical laboratories. It would be beneficial for CLIA and others to consider individual oversight for preanalytic processes. Insurance coverage for genetic testing is still variable and limited, so research testing could offer a cost-effective alternative for those affected by genetic conditions if return of results to participants is appropriately sanctioned. It is still unclear as to who would be responsible for disseminating, explaining, and determining if any follow-up care or monitoring is required from research results. Further guidelines are needed to direct release of research results and secondary findings.

The state of the medical geneticist workforce: Findings of the 2003 survey of American Board of Medical Genetics certified geneticists

<h3>Abstract</h3> <h3>Importance</h3> The actual demand on SARS-CoV-2 diagnosis is a current challenge for clinical laboratories. Sample pooling may help to ameliorate workload in clinical laboratories. <h3>Objective</h3> to evaluate the efficacy of sample pooling compared to the individual analysis for the diagnosis of CoVID-19, by using different commercial platforms for nucleic acid extraction and amplification. <h3>Design and settings</h3> observational, prospective, multicentre study across 9 Spanish clinical microbiology laboratories including SARS-CoV-2 RNA testing performed in April 2020, during the first three days after acceptance to participate. <h3>Participants and Methods</h3> 3519 naso-oro-pharyngeal samples received at the participating laboratories were processed individually and in pools (351 pools) according to the existing methodology in each of the centres. <h3>Results</h3> We found that 253 pools (2519 samples) were negative, and 99 pools (990 samples) were positive; with 241 positive samples (6.85%), our pooling strategy would have saved 2167 PCR tests. For 29 pools (made out of 290 samples) we found discordant results when compared to their correspondent individual samples: in 24/29 pools (30 samples), minor discordances were found; for five pools (5 samples), we found major discordances. Sensitivity, specificity, positive and negative predictive values for pooling were 97.93%, 100%, 100% and 99.85% respectively; accuracy was 99.86% and kappa concordant coefficient was 0.988. As a result of the sample dilution effect of pooling, a loss of 2-3 Cts was observed for E, N or RdRP genes. <h3>Conclusion</h3> we show a high efficiency of pooling strategies for SARS-CoV-2 RNA testing, across different RNA extraction and amplification platforms, with excellent performance in terms of sensitivity, specificity, and positive and negative predictive values. We believe that our results may help clinical laboratories to respond to the actual demand and clinical need on SARS-CoV-2 testing, especially for the screening of low prevalence populations. <h3>Key points</h3> <h3>Question</h3> May clinical laboratories implement sample pooling as an efficient and safe strategy for SARS-COV-2 RT-PCR screening? <h3>Findings</h3> Sensitivity, specificity, positive and negative predictive values for pooling were 97.93%, 100%, 100% and 99.85% respectively; accuracy was 99.86% and kappa concordant coefficient was 0.988. <h3>Meaning</h3> Sample pooling can be used safely at clinical laboratories, especially for the screening of low prevalence populations.