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Health Surveillance and Disease Management / Communicable Diseases / Antimicrobial Resistance

Recommendations of a Group of Experts: Standards for the Use of Automated Identification Systems for Bacteria and Susceptibility to Antimicrobials

(Brasilia, Brazil, 26–28 October 2004)

laboratory

Full Text (in Spanish, 15 pp, PDF, 296 Kb; chapter headers translated for user orientation)
- Introduction
- Objectives
- Summary of the Discussion
- Prerequisites for the Utilization of Automated Equipment
- Recommendations
- Essential Elements of the Quality Management System
- External Performance Evaluation: Modalities
- Evaluation
- General Report to Send to Participating Laboratories
- Individual Report
Annex I: Short Guide for Technical Evaluation Visits to Automated Systems Used to Identify and Test Antimicrobial Susceptibility
Annex II: List of Participants

PAHO Antimicrobial Resistance Page

- WHO Drug Resistance Page
- WHO Pharamaceutical Products Page

General objective of the Expert Committee: Define the processes that guarantee the quality of the information generated by automated systems for identifying bacteria and testing susceptibility to antimicrobial drugs.

Specific Objectives

  • Identify critical points and criteria for internal quality control.
  • Define a program for external performance evaluation.
  • Prepare a short guide for technical evaluation visits.

Introduction

In 1995, due to a regional alert on the importance of emerging and reemerging diseases, among which resistance to antibiotics is included, PAHO strengthened its activities in this area. Thus, a network of surveillance of the susceptibility was developed to antibiotics for isolations of Salmonella spp, Shigella spp, and Vibrio cholerae. These microorganisms are important etiologic agents of diarrheal diseases that could, sometimes, require antibiotic treatment. Its importance transcends its individual medical aspects, since its epidemic presentation transfers the problem to a public health dimension. Furthermore, the importance of food contamination, sometimes in the source itself due to infection of farm animals, transforms an individual medical problem into an epidemiological problem with economic and social serious implications. The same thing occurs when these etiologic agents cause outbreaks in countries that obtain resources from tourism. Thus, a problem is created with much broader economic and political impact than that of the original medical problem.

The surveillance network for the etiologic agents of enteric diseases sponsored by PAHO began to function in 1996, with the involvement of the National Reference Laboratories (NLRs) of Argentina, Brazil, Chile, Colombia, Costa Rica, Mexico, Peru, and Venezuela. Each of these laboratories would be the head of a local network in which several of the thousands of laboratories in the region would participate, for the purpose of carrying out microbiological analyses. After all, the activities of those laboratories depend on the isolation, identification, and determination of the susceptibility to antibiotics of the species subject to surveillance.

The participating countries concluded that, in order to have confidence in the results obtained, it would be necessary to strengthen the quality assurance of the internal practices of each laboratory and to establish a system to allow for periodic performance evaluation, both of the National Reference Laboratory and of the laboratories participating in every country's network. Hence, they accepted that their contribution to the network was conditional upon surveillance activities principlesin the national laboratories being carried out in accordance with quality assurance principles that ensured the veracity of the results obtained. Based on those results, greater rationalization could be achieved in terms of both the empirical treatment of the individual case and potential control measures of importance to the community.

The National Laboratory for Enteric Pathogens (LNPE) of Canada agreed to serve as the laboratory organizing the system, which was subsequently joined by laboratories from five Caribbean countries: Bahamas, Barbados, Jamaica, Saint Lucia, and Trinidad and Tobago in 1998, and Cuba in 1999. With support from the Agency for International Development of the United States of America (USAID), six more Latin American countries were also incorporated in the network in 1999: Bolivia, Ecuador, El Salvador, Guatemala, Nicaragua, and Paraguay.

The countries participating in the network are committed to providing ongoing support to the corresponding National Reference Laboratory (NLR). In turn, the NLR would function as the head of the network, compiling national information on the identification of the species isolated and their susceptibility to antibiotics. Furthermore, it would supervise the enforcement of principles of quality assurance in each laboratory in the network by means of supervisory visits and would be responsible for carrying out performance evaluations of each laboratory. In this way, the information could be used to the extent that it is reliable.

Subsequently, other community species were added to network monitoring: Streptococcus pneumoniae (invasive), Haemophilus influenzae (invasive) Neisseria meningitidis, and Escherichia coli (urinary infection), as well as species isolated in hospital-acquired infections, such as Staphylococcus aureus, Pseudomonas aeruginosa, Acinetobacter spp, Enterococcus spp (E. faecalis and E. faecium), Klebsiella spp and Enterobacter spp. Surveillance of these bacteria calls for an external performance evaluation program carried out by the National Institute of Infectious Diseases (Instituto Nacional de Enfermedades Infecciosas / INEI) of the Institute Carlos Malbrán, of Argentina.

Accordingly, it was agreed that the mission of the Latin American Network for Surveillance of Resistance to Antimicrobial Drugs would be to obtain reliable, timely, and replicable microbiological data to be used to improve patient care and strengthening surveillance with the establishment of sustainable quality assurance programs. The efficiency of the monitoring activities in each country depends on the increase in the geographical coverage of surveillance activities; the increase in the number of laboratories participating in the network (Sentinel Centers); the increase in the number of isolations; the improvement in the results of the external performance evaluation; the availability and dissemination of local, national and regional information; and the results of supervisory visits.

As complement to the criteria established by the Expert Committee that met in Santiago, Chile, from 24 to 26 February 2003 to define standards for performance evaluation using the Kirby-Bauer antibiogram (PAHO document Recommendations of an Expert Committee: Performance Evaluation Standards for the Kirby-Bauer Antibiogram [Areas of Inhibition or Interpretation]), we propose defining standards for the use of the automated systems of identification and antimicrobial susceptibility. The Expert Committee that met in Brasilia, Brazil, in October 2004, undertook this project, the product of which is this report.