Analysis of trends of post-analytical quality indicators in Clinical Bacteriology laboratory: A pilot study from a tertiary care teaching hospital in Uttarakhand, India.

CONTEXT: Implementation of quality management system (QMS) which encompasses various quality indicators (QIs), can serve as a stepping stone for continuous improvement & help in achieving globally accepted quality standards in a diagnostic laboratory. AIMS: To generate preliminary data on trends of post-analytical QIs in Bacteriology section. SETTINGS AND DESIGN: A pilot study was conducted at a tertiary care teaching hospital located in Rishikesh, Uttarakhand. METHODS AND MATERIAL: Data of the following four quality indicators pertaining to aerobic culture and sensitivity testing of various clinical samples received in Clinical Bacteriology laboratory was compiled and retrospectively analysed: (i) Rate of reporting errors; (ii) Rate of re-dos; (iii) Percentage of reports correlating with clinical diagnosis; (iv) Percentage of adherence to safety precautions by employees working in diagnostics. STATISTICAL ANALYSIS USED: Descriptive statistics like mean and frequency distribution plots. RESULTS: The mean reporting error rate was 0.12 per 1000 tests. It was consistently low from July 2018 to May 2019, after which an overall increasing trend was observed. The mean rate of re-dos was 2.79 per 1000 tests. An overall decreasing trend was observed with maximum rates during the months of December 2017 and January 2018. On an average only 7.86% of the reports co-related with clinical diagnosis. Almost 100% adherence to safety precautions was observed with the exception of two instances of needle stick injuries (NSIs). CONCLUSIONS: Commitment of laboratory personnel in adopting, maintaining and analysing QMS data will lead to further strengthening of our existing healthcare system.

A Feasible Laboratory-Strengthening Intervention Yielding a Sustainable Clinical Bacteriology Sector to Support Antimicrobial Stewardship in a Large Referral Hospital in Ethiopia.

Background: Access to clinical bacteriology in low resource settings (LRS) is a key bottleneck preventing individual patient management of treatable severe infections, detection of antimicrobial resistance (AMR), and implementation of effective stewardship interventions. We sought to demonstrate the feasibility of a practical bundle of interventions aimed at implementing sustainable clinical bacteriology services at Tikur Anbessa Specialized Hospital in Addis Ababa, Ethiopia, and report on cost and intensity of supervision. Methods: Starting in Dec 2015, an intervention based on the CLSI QMS01-A guideline was established, consisting of (i) an initial needs assessment, (ii) development of key standard operating procedures, (iii) adaptation of processes for LRS, (iv) training and supervision of laboratory staff via consultant visits and existing online resources, and (v) implementation of a practical quality systems approach. A guiding principle of the bundle was sustainability of all interventions post implementation. Outcomes and challenges: An initial investment of ~US$ 26,200 for laboratory reagents, and a total of 50 visit-days per year from three Canadian and Norwegian microbiologists were committed. Twelve SOPs, including antimicrobial susceptibility testing, were adapted, and an automated blood culture platform was donated (bioMerieux). In the first 18 months of implementation of the intervention, the average volume of specimens analyzed in the lab went from 15/day to 75/day. The number of blood cultures tested increased from an average of 2/day to over 45/day. Antimicrobial susceptibility testing was introduced and cumulative antibiograms were generated for the institution. Quality control was implemented for all procedures and quality assurance tools implemented included external quality assurance and proficiency testing of six technologists with longitudinal follow-up. The laboratory is on the path toward SLIPTA accreditation by the African Society for Laboratory Medicine. Reagent costs, staff training and retention, and engagement of clinical personnel with the lab proved to be manageable challenges. Key external challenges include in-country supply-chain management issues, lack of competition among distributors, and foreign-currency exchange distortions. Conclusions: Using a relatively low-intensity intervention based on existing training tools and accreditation schemes, we demonstrate that establishment of reasonable-quality clinical bacteriology is not only within reach but also a critical step toward assessing the burden of AMR in settings like this one and implementing effective stewardship strategies.

Introducing the concept of the isonym into the International Code of Nomenclature of Prokaryotes.

There are various ways in which the names of prokaryotes can be duplicated in the literature. An examination of the various ways that this may happen under the International Code of Nomenclature of Prokaryotes indicates that a concept is missing, namely the one that refers to the same name based on the same nomenclatural type published in the International Journal of Systematic Bacteriology/International Journal of Systematic and Evolutionary Microbiology, by the same or different authors in different manuscripts or in the Validation Lists. To cater for such instances it would be appropriate to introduce the concept of the isonym and to regulate how they are to be dealt with.

Proposed modifications to Rule 40d of the International Code of Nomenclature of Prokaryotes.

The wording of Rule 40d was discussed at the XIIth International (IUMS) Congress of Bacteriology and Applied Microbiology, Istanbul in 2008 and some changes were made to clarify how the authorship of names covered by this rule were to be cited. However, a key topic that was raised and discussed was the issue of wording that either automatically creates a subspecies name or whether an automatic consequence of the rule was that a subspecies name based on the nomenclatural type of the corresponding species was required, but must be validly published in accordance with the Rules of the International Code of Nomenclature of Prokaryotes. The differences are subtle, but important.

Clinical bacteriology in low-resource settings: today's solutions.

Low-resource settings are disproportionately burdened by infectious diseases and antimicrobial resistance. Good quality clinical bacteriology through a well functioning reference laboratory network is necessary for effective resistance control, but low-resource settings face infrastructural, technical, and behavioural challenges in the implementation of clinical bacteriology. In this Personal View, we explore what constitutes successful implementation of clinical bacteriology in low-resource settings and describe a framework for implementation that is suitable for general referral hospitals in low-income and middle-income countries with a moderate infrastructure. Most microbiological techniques and equipment are not developed for the specific needs of such settings. Pending the arrival of a new generation diagnostics for these settings, we suggest focus on improving, adapting, and implementing conventional, culture-based techniques. Priorities in low-resource settings include harmonised, quality assured, and tropicalised equipment, consumables, and techniques, and rationalised bacterial identification and testing for antimicrobial resistance. Diagnostics should be integrated into clinical care and patient management; clinically relevant specimens must be appropriately selected and prioritised. Open-access training materials and information management tools should be developed. Also important is the need for onsite validation and field adoption of diagnostics in low-resource settings, with considerable shortening of the time between development and implementation of diagnostics. We argue that the implementation of clinical bacteriology in low-resource settings improves patient management, provides valuable surveillance for local antibiotic treatment guidelines and national policies, and supports containment of antimicrobial resistance and the prevention and control of hospital-acquired infections.

Schnelltest-Diagnostik sexuell übertragbarer Infektionen in niedrigschwelligen Einrichtungen : Gemeinsame Stellungnahme des RKI, PEI und der DSTIG.

On February 5th, 2016 an expert meeting on rapid diagnostic tests (RDT) for sexually transmitted infections (STI) was held in Berlin at the Robert-Koch-Institute. The aim of the conference was to update a former evaluation of RDTs for diagnosis of HIV, HBV, HCV, T. pallidum, C. trachomatis and N. gonorrhoeae in low-threshold counseling services for STI that had been published after the previous meeting in 2012. According to the strategy to control HIV, hepatitis B and C and other STI, recently adopted by the German Government, there is a lack of test capabilities and a demand for more testing services as well as improved access to testing. Using RDTs as low-threshold test services in counseling centers or even for testing at home may provide an important option to lower the barrier of testing. Based on performance data evaluated in clinical trials some RDTs for HIV, HCV and syphilis are quite well suited as a point-of-care Test (POCT). In contrast, sufficient diagnostic accuracy for detection of C. trachomatis and N. gonorrhoeae can only be achieved by PCR-based POCTs. In Germany the use of POCTs is subjected to legal stipulations of IfSG and MPG. Of importance, it is not allowed to deliver HIV tests to private persons for home testing (§ 11, MPG). Furthermore, both assessment and communication of infectious diseases are reserved to the physician and must not happen as remote diagnostics (§ 24, IfSG). In addition, like all laboratory tests, RDTs are subject to quality assessment according to guidelines of the German Medical Association.

[Analysis of the results of the SEIMC External Quality Control Program. Year 2014]. / Análisis de resultados del Programa de Control de Calidad Externo SEIMC. Año 2014.

The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) include controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most relevant conclusions and lessons from the 2014 controls. As a whole, the results obtained in 2014 confirm the excellent skill and good technical standards found in previous editions. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. Once again, the results of the SEIMC program highlighted the need to implement both internal and external controls in order to assure the maximal quality of the microbiological tests.

Laboratory automation in clinical bacteriology: what system to choose?

Automation was introduced many years ago in several diagnostic disciplines such as chemistry, haematology and molecular biology. The first laboratory automation system for clinical bacteriology was released in 2006, and it rapidly proved its value by increasing productivity, allowing a continuous increase in sample volumes despite limited budgets and personnel shortages. Today, two major manufacturers, BD Kiestra and Copan, are commercializing partial or complete laboratory automation systems for bacteriology. The laboratory automation systems are rapidly evolving to provide improved hardware and software solutions to optimize laboratory efficiency. However, the complex parameters of the laboratory and automation systems must be considered to determine the best system for each given laboratory. We address several topics on laboratory automation that may help clinical bacteriologists to understand the particularities and operative modalities of the different systems. We present (a) a comparison of the engineering and technical features of the various elements composing the two different automated systems currently available, (b) the system workflows of partial and complete laboratory automation, which define the basis for laboratory reorganization required to optimize system efficiency, (c) the concept of digital imaging and telebacteriology, (d) the connectivity of laboratory automation to the laboratory information system, (e) the general advantages and disadvantages as well as the expected impacts provided by laboratory automation and (f) the laboratory data required to conduct a workflow assessment to determine the best configuration of an automated system for the laboratory activities and specificities.

Illustrating microorganisms: Sir William Watson Cheyne (1852-1932) and bacteriology.

Sir William Watson Cheyne is largely known to medical history as Lord Lister's 'trusted assistant'.1 He spent a lifetime defending Joseph Lister's (1827-1912) antiseptic principle in the wake of scepticism and misunderstanding. However, his main contribution to Lister's work was in the embryonic field of bacteriology in the 1870s-1890s, which brought him into contact with continental researchers, particularly Robert Koch (1843-1910). In this field, Cheyne built an independent reputation as an assessor, chronicler and promoter of continental laboratory methodology. He pioneered bacteriological training in British teaching hospitals and incorporated laboratory testing into case notes as standard procedure. This paper reconsiders Cheyne's contribution to the development of bacteriology in British medicine at the end of the 19th century. It examines his motives in promoting new laboratory techniques and the methods he used to embed them in hospital procedure. It also considers how he continued to use bacteriological arguments to keep the Listerian antiseptic principle on the medical agenda well after Lister withdrew from active involvement in the field.

[Analysis of the results of the SEIMC External Quality Control Program. Year 2009]. / Análisis de resultados del Programa Externo de Control de Calidad SEIMC. Año 2009.

The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. In this article, the most important conclusions and lessons from the 2009 controls are presented. As a whole, the results obtained in 2009 confirm the excellent skill and good technical standards found in previous editions. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. The results of this program highlight the need to implement both internal and external controls in order to ensure maximal quality of microbiological tests.

[Evaluation of the methodological quality of the Rémic (microbiology guidelines - bacteriology and mycology) of the Société française de microbiologie]. / Évaluation de la qualité méthodologique du Rémic (référentiel en microbiologie médicale - bactériologie et mycologie) de la Société française de microbiologie, 3(e) édition (2007).

We have evaluated the methodological quality of the Rémic (microbiology guidelines - bacteriology and mycology) of the Société française de microbiologie (edition2007), using to AGREE criteria, which are consensual at an international level, in particular at the the World Health Organisation (WHO) and at the European Union. The methodological quality of the Rémic appears to be sub-optimal. These shortcomings in quality are mainly observed in AGREE domain n° 5 (applicability), in AGREE item n° 5 (patients' opinions were not considered), and in AGREE item n° 23 (conflicts of interest were not declared). The users of the Rémic must be aware of these few methodological shortcomings in order for them to be careful before they put its recommendation in practice. In conclusion, we advise the editors of the Rémic to insert at least a methodological chapter in their next edition.

[Analysis of the results of the SEIMC External Quality Control Program, 2007]. / Análisis de resultados del Programa Externo de Control de Calidad SEIMC. Año 2007.

The External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC) includes controls for bacteriology, serology, mycology, parasitology, mycobacteria, virology and molecular microbiology. This article presents the most important conclusions and lessons drawn from the 2007 controls. As a whole, the results obtained in 2007 confirm the excellent skill and good technical standards found in previous years. However, erroneous results can be obtained in any laboratory and in clinically relevant determinations. A few deviations were observed in some controls, calling for critical reflection. Once again, the results of this program highlighted the need to complement internal with external controls, such as those offered by the SEIMC program.

Rejection of the genus name Methanothrix with the species Methanothrix soehngenii Huser et al. 1983 and transfer of Methanothrix thermophila Kamagata et al. 1992 to the genus Methanosaeta as Methanosaeta thermophila comb. nov. Opinion 75.

The Judicial Commission of the International Committee on Systematics of Prokaryotes has decided to place the genus Methanothrix with the species Methanothrix soehngenii Huser et al. 1983 on the list of nomina rejicienda, based on the fact that it is not represented by an axenic culture and contravenes Rule 31a of the International Code of Nomenclature of Bacteria. The species Methanothrix thermophila is transferred to the genus Methanosaeta as Methanosaeta thermophila (Kamagata et al. 1992) Boone and Kamagata 1998 comb. nov.

Status of strains that contravene Rules 27 (3) and 30 of the International Code of Nomenclature of Bacteria. Opinion 81.

Based on a list of 205 names proposed in original articles in the International Journal of Systematic and Evolutionary Microbiology or cited in Validation Lists from January 2001 that are not in accordance with Rules 27(3) and 30 of the International Code of Nomenclature of Bacteria (the Code), the Judicial Commission rules that names contained in lists 2-4 are to be considered to be validly published and that deposit in more than one collection in different countries is documented. Names included in list 1 are only to be considered validly published if evidence is presented that the strains have been deposited in additional collections, as laid down by Rules 27 (3) and 30 of the Code.

The type strain of Lactobacillus casei is ATCC 393, ATCC 334 cannot serve as the type because it represents a different taxon, the name Lactobacillus paracasei and its subspecies names are not rejected and the revival of the name 'Lactobacillus zeae' contravenes Rules 51b (1) and (2) of the International Code of Nomenclature of Bacteria. Opinion 82.

The Judicial Commission affirms that typification of Lactobacillus casei is based on ATCC 393, that ATCC 334 is a member of a different taxon and that the publication rejecting the name Lactobacillus paracasei (and its included subspecies) together with the revival of the name 'Lactobacillus zeae' contravenes Rules 51b (1) and (2) of the International Code of Nomenclature of Bacteria.