Implementation of large-scale laboratory-based detection of COVID-19 in the Veterans Health Administration, March 2020 – February 2021

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) presented numerous operational challenges to healthcare delivery networks responsible for implementing large scale detection of Coronavirus Disease 2019 (COVID-19), the infection caused by SARS-CoV-2. We describe testing performance, review data quality metrics, and summarize experiences during the scale up of laboratory-based detection of COVID-19 in the Veterans Health Administration, the largest healthcare system in the United States.

During March 2020 to February 2021, we observed rapid increase in testing volume, decreases in test turnaround time, improvements in testing of hospitalized persons, changes in test positivity, and varying utilization of different tests. Though performance metrics improved over time, surges challenged testing capacity and data quality remained suboptimal.

Future planning efforts should focus on fortifying supply chains for consumables and equipment repair, optimizing distribution of testing workload across laboratories, and improving informatics to  Gentaur Equipment and Consumables accurately monitor operations and intent for testing during a public health emergency.

Purpose: To evaluate the cost-utility of wide-field imaging (WFI) as a complementary technology for retinopathy of prematurity (ROP) screening from the Brazilian Unified Health System’s perspective. Introduction: ROP is one of the leading causes of avoidable childhood blindness worldwide, especially in middle-income countries. The current ROP screening involves indirect binocular ophthalmoscopy (IBO) by ROP expert ophthalmologists. However, there is still insufficient ROP screening coverage. An alternative screening strategy is the combination of WFI with IBO.

Methods: A cost-utility analysis was performed using a deterministic decision-tree simulation model to estimate incremental cost-utility for ROP care.

Two screening strategies were compared: (1) IBO and (2) combination of WFI of all eligible preterm infants and IBO for type 2 ROP or worse and for non-readable images. Eligible population included preterm infants <32 weeks of gestational age or birth weight equal to or <1,500 g. The temporal horizon was a lifetime. Visual outcome data was converted to utility, and the health benefits were estimated on quality-adjusted life-years (QALY). Incremental cost per QALY gained was calculated from the health system perspective.

Costs were estimated considering equipment, maintenance, consumables, and staff. A micro-costing approach was used for WFI. Two technician nurses were trained for imaging execution and had their time evaluated. Two ROP expert ophthalmologists had their time evaluated for imaging reading. One-way sensitivity analysis and probabilistic sensitivity analysis were performed.

Results: Combined screening strategy resulted in a cost-effective program considering 90% ROP screening coverage. Costs per examination: (1) screening with IBO: US dollar (US $) 34.36; (2) screening with combination: US $58.20; (3) laser treatment: US $642.09; (4) long-term follow-up: ranged from US $69.33 to 286.91, based on the infant’s visual function. Incremental cost per QALY gained was US $1,746.99/QALY per infant screened with the combination strategy. One-way sensitivity analysis resulted in cost-effectiveness for all parameters. Probabilistic sensitivity analyses yielded a 100% probability of combination being cost-effective in a willingness-to-pay threshold of US $1,800/QALY.

Conclusion: The combined strategy for ROP screening was cost-effective. It enhances access for appropriate ROP care in middle-income countries and diminishes opportunity costs for ophthalmologists.

Blood analysis and detection plays an important role in diagnosis, monitor of curative effect and prevention of disease. Blood analysis and detection system has been widely used in the laboratories of centers of disease control and prevention and hospitals, and standardized application is an important prerequisite to ensure the quality of blood analysis.

Based on the core content of blood analysis and detection system application in laboratories, especially in primary medical laboratories

and referring to relevant documents such as national laws and regulations, national standards, industry standards, guidelines and specifications, the Grassroots Inspection Technology Standardization Branch of China Health Care International Exchange Promotion Association formulates this consensus.

And the consensus focus on the personnel management, equipment, reagents and consumables management and use, the whole process of test, quality control, result report and other related elements involved in the application of blood analysis system, so as to guide the primary medical laboratories to improve the quality management system, standardize the application of blood analysis and testing system, and improve the quality of blood analysis and testing.

Background: Antenatal Care (ANC) is one of the key care-packages required to reduce global maternal and perinatal mortality and morbidity OBJECTIVES: To identify the essential components of ANC and develop signal functions SEARCH STRATEGY: MESH headings for databases including Cinahl, Cochrane, Global Health, Medline, PubMed, and Web of Science SELECTION CRITERIA: Papers and reports on content of ANC published from 2000-2020 DATA COLLECTION AND ANALYSIS: Narrative synthesis of data and development of signal function through 7 consensus-building workshops with 184 stakeholders

MAIN RESULTS: A total of 221 papers and reports are included from which 28 essential components of ANC were extracted and used to develop 15 signal functions with the equipment, medication and consumables required for implementation of each. Signal functions for the prevention and management of infectious diseases (malaria, HIV, tuberculosis, syphilis and tetanus) can be applied depending on population disease burden. Screening and management of pre-eclampsia, gestational diabetes, anemia, mental and social health (including intimate partner violence) are recommended universally.

Three signal functions adress monitoring of foetal growth and wellbeing and identification and management of obstetric complications. Promotion of health and wellbeing via education and support for nutrition, cessation of substance abuse, uptake of family planning, recognition of danger signs and birth preparedness are included as essential components of ANC.

Identification of semen and spermatozoa is crucial in the forensic investigation of alleged sexual assault cases. In cases of alleged sexual assault where there is a long time gap between the incident and sample collection, or in cases of low sperm count, current methods have limitations of specificity, in the case of presumptive tests for semen, or the problem of recording spermatozoa by microscopy if they are few in number.

A 3-plex MSRE-PCR (methylation-sensitive restriction enzyme-PCR) assay using a spermatozoa-specific DNA methylated marker to identify spermatozoa has been reported previously by our laboratory. A key advantage over current methods is the increased sensitivity and specificity. A transition from a research tool to operational use requires blind trial testing and inter-laboratory trials.

We report on a collaborative exercise where reagents of the 3-plex MSRE-PCR were sent to six participating laboratories. Each laboratory used their own equipment, consumables, and the presumptive reagents conventionally for body fluid (such as acid phosphatase or PSA), DNA extraction, and quantification in practical casework.

The reagents and protocol for the 3-plex MSRE-PCR assay and 9 samples were provided by the organizing laboratory. The participating laboratories were requested to fill in the questionnaire after testing. The reported results from all the six participating laboratories were concordant and the expected correct results for the presence of spermatozoa. These outcomes verified the reproducibility and feasibility of the 3-plex MSRE-PCR assay. The results also indicated that the 3-plex MSRE-PCR assay was readily accessible to forensic laboratories for integrating it into current forensic casework processes.