The Impact of COVID-19 Containment Actions on Extra-Analytical Phases of the Clinical Laboratory: A Case Report.

Laboratory information systems need to adapt to new demands created by the COVID-19 pandemic, which has set up new normals like containment measures and social distancing. Some of these have negatively impacted the pre- and postanalytical phases of laboratory testing. Here, we present an intriguing finding related to the generation of the accession number/specimen number on the investigation module of a hospital management information system and its impact on the dissemination of reports resulting in the wrong release of reports on a female patient amidst the background of COVID-19 containment measures. We analyze the situation that led to this false reporting and the importance of the proper customization of information software in laboratories along with a robust postanalytical framework of laboratory work culture to avert such untoward incidents. This introspection has made us realize that COVID-19 has been a scientific, medical, and social challenge. We need to redefine our priorities in the days to come because SARS-CoV-2 is here to stay.

Experience on how to implement a preanalytical and POCT unit in Madrid's IFEMA field hospital during this unprecedented COVID-19 emergency.

To fight the virus SARS-CoV-2 spread to Europe from China and to give support to the collapsed public health system, the Spanish Health Authorities developed a field hospital located in the facilities of Madrid exhibition centre (IFEMA) to admit and treat patients diagnosed with SARS-CoV-2 infectious disease (COVID-19). The Department of Laboratory Medicine of La Paz University Hospital in Madrid (LMD-HULP) was designated to provide laboratory services. Due to the emergency, the IFEMA field hospital had to be prepared for patient admission in less than 1 week and the laboratory professionals had to collaborate in a multidisciplinary group to assure that resources were available to start on time. The LMD-HULP participated together with the managers in the design of the tests portfolio and the integration of the healthcare information systems (IS) (hospital IS, laboratory IS and POCT management system). Laboratorians developed a strategy to quickly train clinicians and nurses on test requests, sample collection procedures and management/handling of the POCT blood gas analyser both by written materials and training videos. The IFEMA´s preanalytical unit managed 3782 requests, and more than 11,000 samples from March 27th to April 30th. Furthermore, 1151 samples were measured by blood gas analysers. In conclusion, laboratory professionals must be resilient and have to respond timely in emergencies as this pandemic. The lab's personnel selection, design and monitoring indicators to maintain and further improve the quality and value of laboratory services is crucial to support medical decision making and provide better patient care.

Routine Health Information System (RHIS) improvements for strengthened health system management.

BACKGROUND: A well-functioning routine health information system (RHIS) can provide the information needed for health system management, for governance, accountability, planning, policy making, surveillance and quality improvement, but poor information support has been identified as a major obstacle for improving health system management. OBJECTIVES: To assess the effects of interventions to improve routine health information systems in terms of RHIS performance, and also, in terms of improved health system management performance, and improved patient and population health outcomes. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE Ovid and Embase Ovid in May 2019. We searched Global Health, Ovid and PsycInfo in April 2016. In January 2020 we searched for grey literature in the Grey Literature Report and in OpenGrey, and for ongoing trials using the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov. In October 2019 we also did a cited reference search using Web of Science, and a 'similar articles' search in PubMed. SELECTION CRITERIA: Randomised and non-randomised trials, controlled before-after studies and time-series studies comparing routine health information system interventions, with controls, in primary, hospital or community health care settings. Participants included clinical staff and management, district management and community health workers using routine information systems. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed records to identify studies for inclusion, extracted data from the included studies and assessed the risk of bias. Interventions and outcomes were too varied across studies to allow for pooled risk analysis. We present a 'Summary of findings' table for each intervention comparisons broadly categorised into Technical and Organisational (or a combination), and report outcomes on data quality and service quality. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included six studies: four cluster randomised trials and two controlled before-after studies, from Africa and South America. Three studies evaluated technical interventions, one study evaluated an organisational intervention, and two studies evaluated a combination of technical and organisational interventions. Four studies reported on data quality and six studies reported on service quality. In terms of data quality, a web-based electronic TB laboratory information system probably reduces the length of time to reporting of TB test results, and probably reduces the overall rate of recording errors of TB test results, compared to a paper-based system (moderate certainty evidence). We are uncertain about the effect of the electronic laboratory information system on the recording rate of serious (misidentification) errors for TB test results compared to a paper-based system (very low certainty evidence). Misidentification errors are inaccuracies in transferring test results between an electronic register and patients' clinical charts. We are also uncertain about the effect of the intervention on service quality (timeliness of starting or changing a patient's TB treatment) (very low certainty evidence). A hand-held electronic device probably improves the length of time to report TB test results, and probably reduces the total frequency of recording errors in TB test results between the laboratory notebook and the electronic information record system, compared to a paper-based system (moderate-certainty evidence). We are, however, uncertain about the effect of the intervention on the frequency of serious (misidentification) errors in recording between the laboratory notebook and the electronic information record, compared to a paper-based system (very low certainty evidence). We are uncertain about the effect of a hospital electronic health information system on service quality (length of time outpatients spend at hospital, length of hospital stay, and hospital revenue collection), compared to a paper-based system (very low certainty evidence). High-intensity brief text messaging (SMS) may make little or no difference to data quality (in terms of completeness of documentation of pregnancy outcomes), compared to low-intensity brief text messaging (low-certainty evidence). We are uncertain about the effect of electronic drug stock notification (with either data management support or product transfer support) on service quality (in terms of transporting stock and stock levels), compared to paper-based stock notification (very low certainty evidence). We are uncertain about the effect of health information strengthening (where it is part of comprehensive service quality improvement intervention) on service quality (health worker motivation, receipt of training by health workers, health information index scores, quality of clinical observation of children and adults) (very low certainty evidence). AUTHORS' CONCLUSIONS: The review indicates mixed effects of mainly technical interventions to improve data quality, with gaps in evidence on interventions aimed at enhancing data-informed health system management. There is a gap in interventions studying information support beyond clinical management, such as for human resources, finances, drug supply and governance. We need to have a better understanding of the causal mechanisms by which information support may affect change in management decision-making, to inform robust intervention design and evaluation methods.

Pathologist Opinions about EPIC Beaker AP: a Multi-Institutional Survey of Early Adopters.

EPIC Systems Corporation provides a widely used electronic medical record. Beaker Anatomic Pathology is a newly developed laboratory information system (LIS) that has been implemented at a small number of academic pathology departments. Pathologist opinions of EPIC Beaker AP have not been well described in the literature. A 37-question survey was administered to pathologists and pathology trainees to assess overall satisfaction and efficiency of report generation using Beaker AP. Data about experience in pathology, signout responsibilities, Beaker AP usage, and the legacy LIS was also collected. Seventy-four pathologists (51 faculty, 23 residents) responded to the survey (overall response rate 29.7%). Overall pathologist satisfaction with Beaker AP showed high inter-institutional variability; institutions with legacy LISs with a graphical interface had a generally neutral to negative assessment of Beaker AP. The majority of respondents disagreed with the statement "Beaker AP is easy to use and designed for my needs". Pathologists felt that Beaker AP was useful for reviewing clinical information and billing; areas of weakness included searching for prior cases and grossing efficiency. Overall, pathologists had a neutral opinion of whether generating and signing out a complete report was faster in Beaker AP, with marked inter-institutional variation. This variability was likely due to a combination of the efficacy of the legacy LIS, familiarity with Beaker AP at the time of the survey, and institution-specific optimization efforts.

The Effect of Information Technology on the Information Exchange between Laboratories and Ambulatory Care Centers: A Systematic Review.

Laboratory services form an integral part of medical care in the decision-making of physicians, including those working at ambulatory care centers. Information exchange is essential between ambulatory care centers and laboratories. Inevitable errors have always existed in the exchange of such information on paper, which can be to some extent avoided by developing appropriate computer-based interfaces. Therefore, this review aimed to examine studies conducted to determine the effect of electronic communication between ambulatory care centers and laboratories. This systematic review was conducted on the basis of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Studies were searched in the PubMed, Embase, Cochrane, and Web of Science, and those written in English and published between 2000 and February 2019 with full texts available were selected. From a total of 3898 papers retrieved from the studied databases, 24 papers were eligible for entering this study after removing similar and nonrelated studies. Electronic exchanges between ambulatory care centers and laboratories can have numerous benefits in terms of financial, organizational, and quality. This evidence for the value of electronic communications is an important factor contributing to its local investment and adoption.

Operational Aspects of a Clinical Decision Support Program.

Clinical decision support tools that involve improving test utilization should be jointly overseen by a laboratory stewardship committee and the hospital informatics team. The roles of these groups vary by institution and may overlap. This is a team effort and collaboration is a must. The effectiveness of these efforts in an institution depends on the receptiveness of leadership and providers, as well as the effectiveness of the associated committees. Examples of the challenges and successes of laboratory stewardship interventions that have been operationalized at the Cleveland Clinic that use clinical decision support tools, as well as associated literature, are reviewed.

Training Aspects of Laboratory-Based Decision Support.

Pathology has a large role to play in the proper development, implementation, and optimization of clinical decision support (CDS). CDS training must be supported by an educational foundation in clinical and pathology informatics. Educational opportunities are currently limited, but expanding, in the pathology residency space with Pathology Informatics Essentials for Residents. The use of an educational version of electronic clinical systems is an important educational tool to support the needed outcomes-driven and exercise-based informatics and CDS training. With the multidisciplinary nature of informatics, it is advantageous to include laboratory professionals in the training exercises as appropriate.

Machine Learning and Other Emerging Decision Support Tools.

Emerging applications of machine learning and artificial intelligence offer the opportunity to discover new clinical knowledge through secondary exploration of existing patient medical records. This new knowledge may in turn offer a foundation to build new types of clinical decision support (CDS) that provide patient-specific insights and guidance across a wide range of clinical questions and settings. This article will provide an overview of these emerging approaches to CDS, discussing both existing technologies as well as challenges that health systems and informaticists will need to address to allow these emerging approaches to reach their full potential.

"SILAB for Africa": An Innovative Information System Supporting the Veterinary African Laboratories.

Introduction: To support African veterinary laboratory services, the Istituto Zooprofilattico Sperimentale dell'Abruzzo e del Molise puts in place an operational system called "SILAB for Africa" (SILABFA); this is a web application used by a laboratory information management system to support laboratory diagnostic activities and to meet the needs of various African countries. SILABFA was designed to collect and manage all necessary information on samples, tests, and test results.Methods: The system involves the entry of sample data on arrival, the tracking of samples through the various sections of the laboratory, and the collection of test results. It automates the generation of test reports and monitors outbreaks through data interrogation functions and eliminates multiple registrations of the same data on paper records. SILABFA is currently installed in Namibia, Botswana, Zambia, Zimbabwe, Tanzania, Uganda, Kenya, Ethiopia, and Cameroon, and installation in Senegal and Ivory Coast is planned for the next few months. After some years of SILABFA usage, it was natural to want to utilize more and more data collected in a homogeneous and consistent way for epidemiological purposes and to cover informative debts toward ministries and other organizations.Conclusion: To improve the availability of good, detailed, and reliable data, as the epidemiological information, SILABFA has been linked to the local animal identification, registration, and traceability system and other relevant national information systems.

Designing and evaluating functional laboratory information system requirements integrated to hospital information systems.

RATIONALE, AIMS, AND OBJECTIVES: Laboratory information sub-systems play an important role in diagnosis and treatment of patients. This study aimed to determine functional requirements of users and assess the existence of these requirements in the laboratory information system. METHOD: This descriptive cross-sectional study was conducted in 2016 in two phases. The first phase was done through three stages. First, based on an unsystematic review of related literature, an outline of functional laboratory information system requirements was identified. In the second stage, these requirements were identified in group meetings in the form of a semi-structured questionnaire and given to experts. Then, modified Delphi technique was used to reach agreement on each item. Then, based on experts' comments, the final version of the questionnaire was presented including 61 closed-ended items using Likert scale and an open-ended item. It was surveyed by 50 experts using Delphi technique. Responses were scored, and the requirements whose mean final score was 3 and above were finally confirmed. In the second phase, based on the confirmed requirements, a checklist comprising 68 requirements was prepared and adopted hospital information systems were evaluated through researcher observation. Data were analysed using descriptive statistics. RESULTS: The final list of functional laboratory information system requirements was prepared with 68 items. The results of the evaluation revealed that confirmed requirements existed in 58.8% of hospital information systems. CONCLUSION: Laboratory information system requirements were designed with 68 items. Evaluation results showed that the systems were moderate in terms of compliance with the requirements.

Automation and productivity in the clinical laboratory: experience of a tertiary healthcare facility.

Clinical laboratories for in vitro diagnostics are facing pressure to preserve cost control while providing better services through new initiatives. Laboratory automation is a partial answer to this problem, having come a long way from the early days of clinical laboratory testing. The journey and implementation of automation in the Singapore General Hospital's Clinical Biochemistry Laboratory has allowed for sustained performance in the light of increasing workload and service commitments amid an evolving healthcare environment. Key to realising predicted outcomes is the optimisation of workflow processes, reduction of errors, and spatial placement of specimen reception and analytical areas. This paper gives an overview of our experience with automation in the clinical laboratory and its subsequent impact on service standards.

Factors Influencing Laboratory Information System Effectiveness Through Strategic Planning in Shiraz Teaching Hospitals.

This study aimed to develop and test a research model that examined 7effective factors on the effectiveness of laboratory information system (LIS) through strategic planning. This research was carried out on total laboratory staff, information technology staff, and laboratory managers in Shiraz (a city in the south of Iran) teaching hospitals by structural equation modeling approach in 2015. The results revealed that there was no significant positive relationship between decisions based on cost-benefit analysis and LIS functionality with LIS effectiveness, but there was a significant positive relationship between other factors and LIS effectiveness. As expected, high levels of strategic information system planning result in increasing LIS effectiveness. The results also showed that the relationship between cost-benefit analysis, LIS functionality, end-user involvement, and information technology-business alignment with strategic information system planning was significant and positive.

Top ten challenges when interfacing a laboratory information system to an electronic health record: Experience at a large academic medical center.

BACKGROUND: Recent U.S. government regulations incentivize implementation of an electronic health record (EHR) with computerized order entry and structured results display. Many institutions have also chosen to interface their EHR to their laboratory information system (LIS). Reported long-term benefits include increased efficiency and improved quality and safety. In order to successfully implement an interfaced EHR-LIS, institutions must plan years in advance and anticipate the impact of an integrated system. It can be challenging to fully understand the technical, workflow and resource aspects and adequately prepare for a potentially protracted system implementation and the subsequent stabilization. OBJECTIVES: We describe the top ten challenges that we encountered in our clinical laboratories following the implementation of an interfaced EHR-LIS and offer suggestions on how to overcome these challenges. METHODS: This study was performed at a 777-bed, tertiary care center which recently implemented an interfaced EHR-LIS. Challenges were recorded during EHR-LIS implementation and stabilization and the authors describe the top ten. RESULTS: Our top ten challenges were selection and harmonization of test codes, detailed training for providers on test ordering, communication with EHR provider champions during the build process, fluid orders and collections, supporting specialized workflows, sufficient reports and metrics, increased volume of inpatient venipunctures, adequate resources during stabilization, unanticipated changes to laboratory workflow and ordering specimens for anatomic pathology. A few suggestions to overcome these challenges include regular meetings with clinical champions, advanced considerations of reports and metrics that will be needed, adequate training of laboratory staff on new workflows in the EHR and defining all tests including anatomic pathology in the LIS. CONCLUSION: EHR-LIS implementations have many challenges requiring institutions to adapt and develop new infrastructures. This article should be helpful to other institutions facing or undergoing a similar endeavor.

Estado de la certificación/acreditación de los laboratorios clínicos españoles: estudio inicial / State of certification/accreditation in Spanish clinical laboratorios: an initial study

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Acute kidney injury electronic alerts in primary care - findings from a large population cohort.

BACKGROUND: Electronic reporting of AKI has been used to aid early AKI recognition although its relevance to CA-AKI and primary care has not been described. AIMS: We described the characteristics and clinical outcomes of patients with CA-AKI, and AKI identified in primary care (PC-AKI) through AKI e-Alerts. DESIGN: A prospective national cohort study was undertaken to collect data on all e-alerts representing adult CA-AKI. METHOD: The study utilized the biochemistry based AKI electronic (e)-alert system that is established across the Welsh National Health Service. RESULTS: 28.8% of the 22 723 CA-AKI e-alerts were classified as PC-AKI. Ninety-day mortality was 24.0% and lower for PC-AKI vs. non-primary care (non-PC) CA-AKI. Hospitalization was 22.3% for PC-AKI and associated with greater disease severity, higher mortality, but better renal outcomes (non-recovery: 18.1% vs. 21.6%; progression of pre-existing CKD: 40.5% vs. 58.3%). 49.1% of PC-AKI had a repeat test within 7 days, 42.5% between 7 and 90 days, and 8.4% was not repeated within 90 days. There was significantly more non-recovery (24.0% vs. 17.9%) and progression of pre-existing CKD (63.3% vs. 47.0%) in patients with late repeated measurement of renal function compared to those with early repeated measurement of renal function. CONCLUSION: The data demonstrate the clinical utility of AKI e-alerts in primary care. We recommend that a clinical review, or referral together with a repeat measurement of renal function within 7 days should be considered an appropriate response to AKI e-alerts in primary care.

Orders on file but no labs drawn: investigation of machine and human errors caused by an interface idiosyncrasy.

In this report, we describe 2 instances in which expert use of an electronic health record (EHR) system interfaced to an external clinical laboratory information system led to unintended consequences wherein 2 patients failed to have laboratory tests drawn in a timely manner. In both events, user actions combined with the lack of an acknowledgment message describing the order cancellation from the external clinical system were the root causes. In 1 case, rapid, near-simultaneous order entry was the culprit; in the second, astute order management by a clinician, unaware of the lack of proper 2-way interface messaging from the external clinical system, led to the confusion. Although testing had shown that the laboratory system would cancel duplicate laboratory orders, it was thought that duplicate alerting in the new order entry system would prevent such events.