Establishing laboratory-specific reference intervals for TSH and fT4 by use of the indirect Hoffman method

Background The results of examinations of laboratory parameters are the basis of appropriate medical decisions. The availability of reliable and accurate reference intervals (RIs) for each laboratory parameter is an integral part of its appropriate interpretation. Each medical laboratory should confirm their RIs. Up-to-date reference intervals for thyroid function hormones are still a matter of ongoing controversy. The aim of the study was the application of the indirect Hoffman method to determine RIs for TSH and fT4 based on the large data pools stored in laboratory information systems and the comparison of these RIs to generally used RIs. Material and methods The TSH and fT4 routine examination results of hospitalized and outpatient populations were collected over five years (2015–2019), and reference limits were established by the improved Hoffmann method after the exclusion of outliers. Comparative verification of established RIs was conducted with the RIs values provided by test manufacturers and literature data. Results Various RIs were observed in different age groups in the examined populations. For TSH, RIs varied between different age groups, with a narrower range of RIs in the studied adult population and a shift of both reference boundaries toward higher values in comparison to manufacturers’ data among children. RIs estimated for fT4 were very similar to the manufacturer and literature data. Conclusion Thyroid hormone levels change during a person’s lifetime and vary between sexes, but this difference does not always influence the clinical interpretation of laboratory results in the context of RIs. The use of indirect methods is justified due to the ease and low cost of their application.

Online patológiai vizsgálatkérő felület létrehozása a Semmelweis Egyetemen

Összefoglaló. Bevezetés: Az I. Patológiai és Kísérleti Rákkutató Intézet – a Semmelweis Egyetemen belüli diagnosztikai szolgáltatásnyújtás mellett – kiterjedt külső partneri hálózattal (vizsgálatmegrendelővel) bír. Az Intézet a napi működése során párhuzamosan használja az egyetem központi informatikai rendszerét, valamint belső, folyamattámogató alkalmazását (workflow management). A külsős partnerek hozzáférése vizsgálatfeladásra az egyetemi központi informatikai rendszerhez nincs biztosítva. A vizsgálatok rendelése papíralapú, a minta érkeztetésekor a klinikai adatok rögzítése manuális, kifejezetten humánerőforrás-igényes. Célkitűzés: Célunk volt a patológiai minták regisztrációjának egyszerűsítése és felgyorsítása, az adminisztratív folyamatok hatékonyságának javítása. Módszer: A kitűzött célt a minőségfejlesztésből ismert Plan-Do-Check-Act (Tervezés-Cselekvés-Ellenőrzés-Beavatkozás) ciklus módszereit alkalmazva kívántuk elérni, online, a mintavétel helyén elérhető, a meglévő belső folyamattámogató alkalmazáshoz kapcsolódó, szakterület-specifikus vizsgálatkérő felület kifejlesztésével. Eredmények: A vizsgálati minták regisztrációjának átlagos ideje 65%-kal csökkent az online vizsgálatkérő rendszerhez csatlakozott klinikai partnerek körében. Megbeszélés: Az elmúlt években tapasztalható volt, hogy kisebb, nem hatékonyan működtethető patológiai osztályok megszűntek, részben vagy egészben beolvadtak nagyobb diagnosztikai egységekbe. A humánerőforrás-problémák (elöregedő szakma a patológia) a fenti folyamatot minden bizonnyal tovább erősítik. Várható, hogy a nagyobb patológiai osztályokon a következő években a mintaszám tovább növekszik, a vizsgálatkérések egyre nagyobb hányada érkezik majd intézményen kívülről. Következtetés: A patológiai informatika fejlesztésekor figyelembe kell venni, hogy szükséges már a mintavétel helyén biztosítani az informatikai támogatást a minta nyomon követéséhez, nem elégséges csak a laboron belüli folyamatok kiszolgálása. Orv Hetil. 2021; 162(49): 1962–1967. Summary. Introduction: The 1st Department of Pathology and Experimental Cancer Research, Semmelweis University (Budapest, Hungary) has a broad network of clinical partners, many of which are non-university hospitals. A separate hospital information system and a local laboratory workflow management system is used at the Department. University clinics use the hospital information system for electronic requesting of tests. Non-university partners have no access to the systems, requesting tests is paper-based, registration of the requests at the pathology lab is manual and laborious. Objective: Our main objective was to improve the efficiency of the sample registration step of the pathology workflow. Method: Applying the Plan-Do-Check-Act procedure, a quality improvement project has been carried out and an online, subspecialty-based requesting application tool, interfaced with the current laboratory information system, was developed. Results: The average sample registration time improved with 65% among the early user partners. Discussion: The past years have shown smaller, inefficient pathology labs decreasing in number and integrated into larger regional diagnostic centers. Both issues of efficiency and quality assurance and problems rooted in human resources are drivers of further centralisation. The numbers of test requests and samples from non in-house partners are expected to be increased in the pathology labs in the future. Conclusion: Efficient and safe sample tracking has to start at the site of sample acquisition. State of the art laboratory information systems should support this expansion of competence. Orv Hetil. 2021; 162(49): 1962–1967.

Establishing Laboratory-Specific Reference Intervals for TSH and fT4 by use of the Indirect Hoffman Method

Background: The results of examinations of laboratory parameters are the basis of appropriate medical decisions. The availability of reliable and accurate reference intervals (RIs) for each laboratory parameter is an integral part of its appropriate interpretation. Each medical laboratory should confirm their RIs. Up to date reference intervals for thyroid function hormones are still a matter of ongoing controversy. The aim of the study was application of the indirect Hoffman method to determine RIs for TSH and fT4 based on the large data pools stored in laboratory information systems, and the comparison of these RIs to generally used RIs.Material and methods: The TSH and fT4 routine examination results of a hospitalized and outpatients population over five years (2015-2019) were collected, and reference limits were established by the improved Hoffmann method after the exclusion of outliers. Comparative verification of established RIs was conducted with the RIs values provided by test manufacturers and literature data.Results: The various RIs in different age groups in examined populations were observed. For TSH RIs varied between different age groups, with a narrower range of RIs in the studied adult population, while for children, a shift of both reference boundaries toward higher values in comparison to manufacturers' data was observed. RIs estimated for fT4 were very similar to the manufacturer and literature data.Conclusion: Thyroid hormone levels change during a person's lifetime and vary between sexes, but this difference does not always influence the clinical interpretation of laboratory results in the context of RIs. The use of indirect methods is justified due to the ease and low cost of their application.

ANALYSIS AND DEVELOPMENT OF LABORATORY INFORMATION SYSTEMS (CASE STUDY : INFORMATICS ENGINEERING LABORATORY, BHAYANGKARA UNIVERSITY, SURABAYA)

At first information systems do not have to be associated with information technology, but with the development of the times,nowadays an information system can not exist without the use of information technology. A system is needed to facilitate the affairs of an organization. The effecctiverss of the system will affect the success of the organization under it. The development of Web-based Information Systems is an effort to develop the implementation of practice and in order to improve the quality of services to students that are effective, efficient and transparent, and directed to achieve the establishment of information networks and service transactions to qualified students without restrictions on partition and space. The end goal is the development of Laboratory Information System is expected to accommodate the concept, the essence and the nature of service to students with excellenees. The results of the test based on questionnaire data. Presentase conformity system reach 92%, where the system runs in accordance with the wishes of responden. While the system discrepancies reach 8%.

Pathology Informatics Education during the COVID-19 Pandemic at Memorial Sloan Kettering Cancer Center (MSKCC)

<p>This review details the development and structure of a four-week rotation in pathology informatics for a resident trainee at Memorial Sloan Kettering Cancer Center (MSKCC) in New York City so that other programs interested in such a rotation can refer to. The role of pathology informatics is exponentially increasing in research and clinical practice. With an ever-expanding role, training in pathology informatics is paramount as pathology training programs and training accreditation bodies recognize the need for pathology informatics in training future pathologists. However, due to its novelty, many training programs are unfamiliar with implementing pathology informatics training. The rotation incorporates educational resources for pathology informatics, guidance in the development, and general topics relevant to pathology informatics training. Informatics topics include anatomic pathology related aspects such as whole slide imaging, laboratory information systems, image analysis, and molecular pathology associated issues such as the bioinformatics pipeline and data processing. Additionally, we highlight how the rotation pivoted to meet the department’s informatics needs while still providing an educational experience during the onset of the COVID-19 pandemic.</p><p><strong>Conclusion</strong>. As pathology informatics continues to grow and integrate itself into practice, infor- matics education must also grow to meet the future needs of pathology. As informatics programs develop across institutions, such as the one detailed in this paper, these programs will better equip future pathologists with informatics to approach disease and pathology.</p>

Error Evaluation in the Laboratory Testing Process and Laboratory Information Systems

Introduction: The laboratory testing process consists of five analysis phases featuring the total testing process framework. Activities in laboratory process, including those of testing, are error-prone and affect the use of laboratory information systems. This study seeks to identify error factors related to system use and the first and last phases of the laboratory testing process using a proposed framework known as total testing process-laboratory information systems. Materials and Methods: We conducted a qualitative case study in two private hospitals and a medical laboratory. We collected data using interviews, observations, and document analysis methods involving physicians, nurses, an information technology officer, and the laboratory staff. We employed the proposed framework and Lean problem-solving tools namely Value Stream Mapping and A3 for data analysis. Results: Errors in laboratory information systems and the laboratory testing process were attributed to failure to fulfill user requirements, poor cooperation between the information technology unit and laboratory, the inconsistency of software design in system integration, errors during inter-system data transmission, and lack of motivation in system use. The error factors are related to system development elements, namely, latent failures that considerably affected the information quality and system use. Errors in system development were also attributed to poor service quality. Conclusion: Complex laboratory testing process and laboratory information systems require rigorous evaluation in minimizing errors and ensuring patient safety. The proposed framework and Lean approach are applicable for evaluating the laboratory testing process and laboratory information systems in a rigorous, comprehensive, and structured manner.

Laboratory information systems in internal quality control of a cardiac surgery hospital

Introduction. In recent years, laboratory information systems (LIS) have become an element of medical institutions’ work, providing high quality and efficiency of clinical activities. Laboratory diagnosis plays a vital role in treating and preventing all known diseases, which requires compliance with specific quality criteria. Material and methods. A study was conducted with the historical control of the laboratory tests’ conditiona-lity before and after introducing LIS in the A.N. Bakulev National Medical Research Center of Cardiovascular Surgery. During 2018, quarterly an analysis of the reappointments of the following groups of laboratory tests was carried out: hematological test, immunochemical analysis, biochemical blood test, hemostasis system (coagulogram), platelet aggregation with ADP. Unfounded recognized studies assigned more than once for 48 hours in the absence of clinical justification. Results are provided using standard descriptive statistics methods. Results. After the work carried out in the fourth quarter, there was a decrease in the total number of appointments by 20% and a decrease in studies performed in terms of one patient. Conclusion. The introduction of LIS made it possible to obtain a tool for quantitative and qualitative analysis of the validity of the purpose of laboratory research and conduct an economic analysis of the results. The data obtained were subsequently used to develop laboratory profiles, allowing to continue the optimization of this area and the implementation of lean technologies in the clinic. Also, the data obtained made it possible to evaluate the knowledge and application of clinical recommendations to manage patients with various pathologies. During the verification of the results and analysis of the doctors’ explanatory notes, the laboratory process’s most compromised stages were identified.

Assessing the Quality of Reporting to China’s National TB Surveillance Systems

(1) Background: The reliability of disease surveillance may be restricted by sensitivity or ability to capture all disease. Objective: To quantify under-reporting and concordance of recording persons with tuberculosis (TB) in national TB surveillance systems: the Infectious Disease Reporting System (IDRS) and Tuberculosis Information Management System (TBIMS). (2) Methods: This retrospective review includes 4698 patients identified in 2016 in China. County staff linked TB patients identified from facility-specific health and laboratory information systems with records in IDRS and TBIMS. Under-reporting was calculated, and timeliness, concordance, accuracy, and completeness were analyzed. Multivariable logistic regression was used to examine factors associated with under-reporting. (3) Results: We found that 505 (10.7%) patients were missing within IDRS and 1451 (30.9%) patients were missing within TBIMS. Of 171 patient records reviewed in IDRS and 170 patient records in TBIMS, 12.3% and 6.5% were found to be untimely, and 10.7% and 7.1% were found to have an inconsistent home address. The risk of under-reporting to both IDRS and TBIMS was greatest at tertiary health facilities and among non-residents; the risk of under-reporting to TBIMS was greatest with patients aged 65 or older and with extrapulmonary TB (EPTB). (4) Conclusions: It is important to improve the reporting and recording of TB patients. Local TB programs that focus on training, and mentoring high-burden hospitals, facilities that cater to EPTB, and migrant patients may improve reporting and recording.

High-resolution pediatric reference intervals for 15 biochemical analytes described using fractional polynomials

Objectives Assessment of children’s laboratory test results requires consideration of the extensive changes that occur during physiological development and result in pronounced sex- and age-specific dynamics in many biochemical analytes. Pediatric reference intervals have to account for these dynamics, but ethical and practical challenges limit the availability of appropriate pediatric reference intervals that cover children from birth to adulthood. We have therefore initiated the multi-center data-driven PEDREF project (Next-Generation Pediatric Reference Intervals) to create pediatric reference intervals using data from laboratory information systems. Methods We analyzed laboratory test results from 638,683 patients (217,883–982,548 samples per analyte, a median of 603,745 test results per analyte, and 10,298,067 test results in total) performed during patient care in 13 German centers. Test results from children with repeat measurements were discarded, and we estimated the distribution of physiological test results using a validated statistical approach (kosmic). Results We report continuous pediatric reference intervals and percentile charts for alanine transaminase, aspartate transaminase, lactate dehydrogenase, alkaline phosphatase, γ-glutamyl-transferase, total protein, albumin, creatinine, urea, sodium, potassium, calcium, chloride, anorganic phosphate, and magnesium. Reference intervals are provided as tables and fractional polynomial functions (i.e., mathematical equations) that can be integrated into laboratory information systems. Additionally, Z-scores and percentiles enable the normalization of test results by age and sex to facilitate their interpretation across age groups. Conclusions The provided reference intervals and percentile charts enable precise assessment of laboratory test results in children from birth to adulthood. Our findings highlight the pronounced dynamics in many biochemical analytes in neonates, which require particular consideration in reference intervals to support clinical decision making most effectively.