External quality assessment providers' services appear to more impact the immunohaematology performance of laboratories than national regulatory and economic conditions.

OBJECTIVES: Medical laboratories may, at their own discretion, exceed but not undercut regulatory quality requirements. Available economic resources, however, may drive or hinder eagerness to exceed minimum requirements. Depending on the respective scopes of regulatory and economic framework conditions, differing levels of quality efforts to safeguard laboratory performance can be anticipated. However, this has not yet been investigated. METHODS: Immunohaematology external quality assessment (EQA) results collected by 26 EQA providers from their participant laboratories in 73 countries from 2004 to 2019 were evaluated. Error rates were aggregated in groups according to the respective national regulatory and economic framework conditions, to whether or not expert advice was provided in case of incorrect results, and the frequency of EQA samples. RESULTS: These representative data indicate no association between national regulatory (mandatory participation in EQA, monitoring of performance of individual laboratories by authorities, financial consequences of incorrect results) and economic (level of national income, share of national health expenditure) conditions to the quality performance of medical laboratories in immunohaematology. However, EQA providers' support for laboratories in the event of incorrect results appear to be associated with lower error rates, but a high EQA sample frequency with higher error rates. CONCLUSIONS: Further research into the impact of introducing or changing services of EQA providers is needed to confirm the results found in this first of its kind study.

Internal quality control for HIV testing of blood donors - Dried tube specimen as a cost-effective alternative.

BACKGROUND: An important aspect of ensuring blood safety is the performance of mandatory serological testing for transfusion transmissible infections. The practice of internal quality control (IQC) in blood banks in India is nonuniform, especially the use of third-party materials. Cited reasons are cost, lack of access to control materials, and need for deep-freezers for storage, if prepared in-house. OBJECTIVE: Validation of dried tube specimen (DTS) from HIV-positive plasma as a low-cost, stable material for use as IQC material in blood banks. METHODS: Fresh-frozen plasma (FFP) prepared from four HIV-positive blood-donors were pooled. Equal numbers of seronegative FFPs were pooled. Twenty microlitre aliquots of plasma were made in micro-centrifuge tubes and air-dried overnight at room-temperature. These were stored in 2-8°C refrigerators and tested once weekly for 6 months on multiple platforms with different detection principles: Rapid tests, second-generation enzyme-linked immunosorbent assay (ELISA), fourth-generation ELISA, and fourth-generation Chemiluminescence immunoassay. The protocol was sustained over the next 6 months with decreased testing frequency to study the extended stability of DTS. RESULTS: A total of 139 positive-DTS and 139 negative-DTS were tested with 100% samples showing consistent results on all platforms over 1 year. There was mild deterioration in reaction strengths, which did not interfere in result interpretations. CONCLUSION: Plasma in form of DTS maintained stability when stored at 2-8°C for 1 year. This provides evidence that DTS can be a modality for the production of cost-effective, stable, in-house control material for resource-restricted countries.

Assessment of Performance of Blood Banks in India: A National Level Cross Sectional Study.

India lacks comprehensive information about blood transfusion systems, which could help ensure universal access to safe blood through evidence-based strategies and programs. We conducted the first national assessment of blood bank systems, services, practices, and performance in India. We conducted a cross-sectional survey of all 2626 blood banks and assessed the administrative, technical, and quality aspects in 2016. In addition to descriptive analysis, we compared the means of different variables using independent t-test or ANOVA and a generalized linear model. We performed linear regression analysis between the collection of blood per 100 people and the number of blood banks per million people. The disaggregated mean score of quality management system and overall performance are presented by different groups. Besides, we graded the performance based on tertile classification, as low, medium and high-performance blood banks. Of the 2493 blood banks that participated in the study, most were public (38%) or not-for-profit(38%), and 51% had component separation facilities. Of the 11.65 million units of blood collected annually, 72% was through voluntary blood donation. There were 2.2 blood banks per one million people, collecting around one unit per 100 persons annually with wide variation between states. The mean overall performance score was 62(95% confidence interval [CI]:61.6-62.5), and the mean quality management system score was 57.4(95% CI:56.8-58.0), with significant variation across different categories of blood banks. This assessment provides critical information for developing evidence-based policies, programs, and monitoring systems to improve the performance of blood transfusion services in India.

A national level estimation of population need for blood in India.

BACKGROUND: The population need for blood is the total volume required to transfuse all the individuals who need transfusion in a defined population over a defined period. The clinical demand will arise when people with a disease or condition who require transfusion, access healthcare services, and subsequently the clinicians request blood. Essentially, the conversion of need to demand must be maximum to avoid preventable mortality and morbidity. The study estimated the population need for blood in India. METHODS: The methodology included a comprehensive literature review to determine the diseases and conditions requiring transfusion, the population at risk, and prevalence or incidence; and Delphi method to estimate the percentage of people requiring transfusion, and the quantum. RESULTS: The estimated annual population need was 26.2 million units (95% CI; 17.9-38.0) of whole blood to address the need for red cells and other components after the separation process. The need for medical conditions was 11.0 million units (95% CI:8.7-14.7), followed by surgery 6.6 million (95% CI:3.8-10.0), pediatrics 5.0 million (95% CI:3.5-7.0), and obstetrics and gynecology 3.6 million units (95% CI:1.9-6.2). The gap between need and demand which depends upon the access and efficiency of healthcare service provision was estimated at 13 million units. CONCLUSION: The study brings evidence to highlight the gap between need and demand and the importance of addressing it. It cannot be just the responsibility of blood transfusion or health systems, it requires a multi-sectoral approach to address the barriers affecting the conversion of need to clinical demand for blood.

Assessment of two immunoassays for detection of IgM antibodies to scrub typhus using a serum panel.

Laboratory tests are necessary for diagnosis of scrub typhus (ST) especially in the absence of the distinctive eschar. Performance of an ELISA and ICT (immunochromatography) to detect IgM antibodies to scrub typhus was assessed using a panel of 346 sera chosen from healthy individuals, those with scrub typhus and scrub-typhus like illness. A sensitivity of 98.7% for ST IgM ICT and 97.4% for ST IgM ELISA was observed while specificity was 96.3% for ICT and 95.9% for ELISA. As excellent concordance (98.8%) was noted between the two assays, IgM ICT can be used for rapid diagnosis of scrub typhus. Abbreviations: ST IgM ELISA: Scrub typhus IgM ELISA; ST IgM ICT: Scrub Typhus IgM Immunochromatography, Rapid diagnostic test: RDT.

Lack of grading agreement among international hemostasis external quality assessment programs.

: Laboratory quality programs rely on internal quality control and external quality assessment (EQA). EQA programs provide unknown specimens for the laboratory to test. The laboratory's result is compared with other (peer) laboratories performing the same test. EQA programs assign target values using a variety of methods statistical tools and performance assessment of 'pass' or 'fail' is made. EQA provider members of the international organization, external quality assurance in thrombosis and hemostasis, took part in a study to compare outcome of performance analysis using the same data set of laboratory results. Eleven EQA organizations using eight different analytical approaches participated. Data for a normal and prolonged activated partial thromboplastin time (aPTT) and a normal and reduced factor VIII (FVIII) from 218 laboratories were sent to the EQA providers who analyzed the data set using their method of evaluation for aPTT and FVIII, determining the performance for each laboratory record in the data set. Providers also summarized their statistical approach to assignment of target values and laboratory performance. Each laboratory record in the data set was graded pass/fail by all EQA providers for each of the four analytes. There was a lack of agreement of pass/fail grading among EQA programs. Discordance in the grading was 17.9 and 11% of normal and prolonged aPTT results, respectively, and 20.2 and 17.4% of normal and reduced FVIII results, respectively. All EQA programs in this study employed statistical methods compliant with the International Standardization Organization (ISO), ISO 13528, yet the evaluation of laboratory results for all four analytes showed remarkable grading discordance.

Analytical performance specifications for external quality assessment - definitions and descriptions.

External Quality Assurance (EQA) is vital to ensure acceptable analytical quality in medical laboratories. A key component of an EQA scheme is an analytical performance specification (APS) for each measurand that a laboratory can use to assess the extent of deviation of the obtained results from the target value. A consensus conference held in Milan in 2014 has proposed three models to set APS and these can be applied to setting APS for EQA. A goal arising from this conference is the harmonisation of EQA APS between different schemes to deliver consistent quality messages to laboratories irrespective of location and the choice of EQA provider. At this time there are wide differences in the APS used in different EQA schemes for the same measurands. Contributing factors to this variation are that the APS in different schemes are established using different criteria, applied to different types of data (e.g. single data points, multiple data points), used for different goals (e.g. improvement of analytical quality; licensing), and with the aim of eliciting different responses from participants. This paper provides recommendations from the European Federation of Laboratory Medicine (EFLM) Task and Finish Group on Performance Specifications for External Quality Assurance Schemes (TFG-APSEQA) and on clear terminology for EQA APS. The recommended terminology covers six elements required to understand APS: 1) a statement on the EQA material matrix and its commutability; 2) the method used to assign the target value; 3) the data set to which APS are applied; 4) the applicable analytical property being assessed (i.e. total error, bias, imprecision, uncertainty); 5) the rationale for the selection of the APS; and 6) the type of the Milan model(s) used to set the APS. The terminology is required for EQA participants and other interested parties to understand the meaning of meeting or not meeting APS.

External quality assessment scheme for hemostasis in India.

Regular participation in an external quality assessment scheme (EQAS) is critical for ensuring acceptable laboratory performance. However, participation in such programs is uncommon for laboratories performing tests of hemostasis in developing countries. There are several reasons, including lack of awareness of its significance, absence of locally administered and easily accessible programs, and costs associated with some of the international schemes. To address this problem, we initiated an EQAS for hemostasis in India in the year 2000. This initially was limited to approximately 25 laboratories associated with the chapters of the Hemophilia Federation (India), with samples and analysis of results supported by United Kingdom National External Quality Assessment Scheme. This was converted to a national program in 2003, in association with the Indian Society of Haematology and Transfusion Medicine. Local manufacture of survey samples began in 2004, along with analysis of results. Currently, more than 100 laboratories are registered in the program. They receive samples three times a year for the following tests: prothrombin time, activated partial thromboplastin time, and factor assays. Some surveys also include samples for fibrinogen and von Willebrand factor assays. In recent surveys, 60 to 95% of laboratories had their clotting times and 57 to 77% of laboratories had their factor assays within consensus. The program has helped identify causes of unacceptable performance. The challenges ahead are to increase participation, improve reporting of results, and provide individualized support to laboratories to improve performance when necessary.