Select Committee on Science and Technology Written Evidence

Memorandum by Focus Technologies Inc



  Focus Technologies is a company, based in the United States, with experience in the establishment of electronic surveillance networks in 10 countries, including the United Kingdom.

  A number of barriers to implementation with direct relevance to the broader surveillance of infectious disease have been encountered. Some issues have been encountered in other countries—the lack of standardised nomenclature and the diversity of computer connections required while others are specific to the United Kingdom being a direct result of historical under-investment in microbiological testing.


1.1  Approaches to surveillance

  In broad terms, two models have been widely used for the surveillance of bacterial populations and their susceptibility to anti-microbial agents.

1.1.1  Central laboratory testing (ex. TRUST, SENTRY, Alexander Project)

  Clinical microbiology laboratories select clinical isolates which correspond to the study specifications and send them by courier to a central laboratory where they are re-tested using standardised techniques.

1.1.2  De-centralised testing (ex. TSN, EARRS, RGSD)

  Clinical microbiology laboratories send identification and susceptibility test results to a central repository for collation.


2.1  TSN concept and principles

  The Surveillance Network (TSN<eptm<rs) is a de-centralised surveillance system. Data are collected at regular intervals, usually daily, from hospitals and private laboratories in 10 countries. TSN participation is voluntary. No financial relationship exists between participating laboratories and Focus Technologies. In return for data, Focus Technologies provides data management services and makes consolidated databases available to participants thus providing benchmarks against which participants may compare their local findings. Participants gain access to TSN data by connecting to an Internet site ( This site provides a set of tools designed specifically for the performance of queries upon TSN data.

2.2  Current status of TSN networks
CountryParticipants Institutions[55] ResultsStrains Patients
USA128284 57,872,9694,396,6432,668,082
Canada3287 19,410,5171,975,4281,184,493
Australia20103 16,243,3312,215,2931,332,967
Italy2750 5,232,930338,528216,941
Spain1721 4,318,757265,852145,780
United Kingdom960 6,021,038758,711401,303
France3664 16,027,943879,949541,852
Germany23174 15,912,6601,048,175510,788
The Netherlands312 551,41968,75035,970
Greece66 622,00230,56024,530
All TSN Databases301861 142,213,56611,977,889 7,062,706

  Table 1 TSN Database Statistics July 2002

  Focus Technologies first began recruiting participants in the United States in 1993. Upon installation, most participants have been able to provide three years of historical data. Most TSN databases include reliable data from 1998 onwards.

2.3  Electronic collection of surveillance data

2.3.1  Selection of participants

  In order to provide a balanced sample, the geographical location, size, type (ex. general hospital, teaching hospital, private laboratory, etc.) and methods used to perform antibiotic susceptibility tests are taken into account when selecting participants.

  To ensure the reliability of the sample, only sites with acceptable microbiology practices and quality control procedures are invited to participate. Preference is given to participants who are able to provide antibiotic susceptibility results in a quantitative format. Quantitative data allows more sophisticated quality control procedures to be implemented and can provide a more detailed view of the evolution of resistance.

2.3.2  Sample size

  With TSN Focus Technologies aims to collect in each country a sample size of between 10 per cent and 15 per cent of all susceptibility tests performed. This sample size adequate to provide reliable information to participants and the pharmaceutical industry concerning the trends in antibiotic resistance. The industry makes use of the data in the registration of antibiotics, in making strategic decisions to develop new products and in the marketing of existing ones. In some countries, the TSN database significantly exceeds this target sample size. The collection and management of the quantity of data this presents is made possible only through the use of electronic data transfer and a high degree of automation.

2.3.3  Data extraction

  Data extraction requires a program to interrogate the participant's Laboratory Information System (LIS). Development of this program is performed by the manufacturer of the LIS, by the participant if the necessary competence is available or by Focus Technologies.

2.3.4  Data collected
Data fieldComments
Antibiotic testedThe name of the antibiotic
Qualitative resultSusceptible, Intermediate or Resistant
Quantitative resultMIC or Zone size where available
Isolate identificationGenus and species or a code
Patient identifierRequired to enable removal of duplicate results
Month and year of birthAntibiotic resistance is strongly correlated with age
GenderMale, female or unknown
Patient locationIn-patient, Out-patient or Intensive care
Ward or serviceFor local use only
Specimen typeUrine, blood-culture
Specimen identifierRequired to enable removal of duplicate results
Laboratory codeCode to identify participating laboratory
InstitutionInstitution where the patient is being treated
RegionInstitution's geographical region
Test MethodAntibiotic susceptibility testing method used  Encryption of identifiers to protect patient confidentiality

  The patient and specimen identifiers are encrypted before transmission using a key known only to the participating institution. For additional security, all data fields are further encrypted and compressed using commercial system, PGP. The participant retains the PGP public key.

2.3.5  Data transmission

  In most cases, participants transmit their data via the Internet using File Transfer Protocol (FTP). Where local security arrangements forbid this kind of transmission, the data are sent as an electronic mail attachment.

2.3.6  Data processing

  Data processing activities are centralised at Focus Technologies' head office in Herndon, Virginia in the United States.  Normalisation

  Normalisation would not be required if all laboratories adhered to the same nomenclature for organisms, antibiotics and specimen descriptions. This is the position of ONERBA, the organisation that oversees the surveillance of antibiotic susceptibility data in France. At present there is no rigid standardisation of nomenclature, apart from that introduced passively through the use of automated systems, so in order that data from diverse sources may be compared, Focus Technologies has defined a standard nomenclature for organisms, antibiotics, specimen types, gender and patient locations. Participants are not required to use this standard nomenclature when transmitting data, instead conversion tables are established with each participant before data transmission begins. The data are automatically converted to the standardised nomenclature on receipt. If a previously un-encountered data item is received, it is referred back to the participant for interpretation and the conversion tables updated.  Detection of unusual resistance

  Once normalised, data then pass through a rule-based expert system. This program detects uncommon resistances. The rules for each country are defined in collaboration with an advisory board comprising local experts in antibiotic resistance. Many of these rules will be common between countries (ex. resistance to vancomycin in Staphylococcus aureus) however where a local frequency of resistance is typically very low or very high, this will be taken into consideration. Participants are notified of any result considered to be rare or unlikely and are asked to confirm by re-testing if they have not already done so. In the case of extremely rare occurrences, participants are requested to send the strain to a local reference laboratory for confirmation. Data, which cannot be verified in this way, are excluded from the database thereby maintaining database quality.  Removal of duplicate results

  In order to avoid bias from multiple transmission or repeated testing, duplicate results are prevented from entering the TSN database. A duplicate is defined as a second occurrence within five days of the same organism from the same patient with the same susceptibility pattern.

2.3.7  Quality control procedures

  Data are added to the TSN databases on a monthly basis. Before being released to the participants, the updated databases are compared statistically to the previous version.

2.4  Access to surveillance data

2.4.1  Prevention of unauthorised access

  The TSN servers are protected by a key-card access system. Essential computer operations personnel from the Focus Technologies Information Systems team alone are provided with key-cards.

2.4.2  Participant access

  Individuals designated by participating laboratories are provided with passwords allowing access to TSN data via the Internet. They may view their own data and the consolidated national and regional databases. They may not examine data from an individual institution other than their own.

2.4.3  Third-party access

  Advisory Board members are granted access to the national and regional databases. Subscriptions are commercially available.

2.4.4  Publication of TSN data

  TSN data is now frequently quoted in peer-reviewed journals, conference presentations and posters. Participants are encouraged to publish their experiences.


3.1  Pertinent source of information

  Clinical microbiology laboratories provide an excellent source of surveillance information dedicated as they are to the isolation and study of disease-causing micro-organisms. TSN attempts to capture all susceptibility results for all isolates unlike other studies which tend to focus on a narrow range of organisms and antibiotics. The reason for this is simple. It is difficult to predict which organisms and antibiotics will be concerned when future resistance threats arise. Many susceptibility results for yeasts and mycobacteria are also received. The lack of standardisation in these areas precludes the use of this data at present.

3.2  Data volumes

  Electronic data transfer and automated handling allows for a much larger sample than would be possible with a central laboratory testing or paper report approach.

3.3  Trending capability

  TSN networks are based upon a fixed core of participating laboratories. Automatic data transmission provides a consistent flow of information. A stable group of participants allows reliable trending.

3.4  Real-time data availability

  Data are processed in monthly batches. Data remain in quarantine for a month while quality control procedures are performed. The delay between data collection and availability is between one and two months.

3.5  Interaction with laboratories

  When issues arise, they are discussed with the laboratory concerned. Frequently this leads to improvements in laboratory practice. Over time this interaction is expected to improve the reliability of TSN databases.

3.6  Detection of "alert" organisms

  TSN's expert rule system provides a means of rapid detection of rare or previously unencountered resistance. Often these occurrences occur through misidentification of the organism concerned or other technical error. The resolution of these incidents may also lead to improvements in laboratory practice.


  Despite the enthusiasm clinical microbiologists have shown for the project, the implementation of TSN in the United Kingdom has proved more difficult than in other countries.

4.1  Data quality

  The primary reason for generating antibiotic susceptibility results is to treat patients suffering from infectious disease. The consolidation of this information for epidemiological analysis, outside of their institution, has not been a consideration for most clinical microbiology laboratories in the United Kingdom.

4.2  Laboratory practice

4.2.1  Identification of isolates

  Identification of micro-organisms to the level of species is common practice in most developed countries. It is considered important to the correct interpretation of susceptibility tests. Manual and automated test systems for the identification of bacterial and fungal isolates have been available for more than 25 years and are widely used. In the United Kingdom the precise identification of bacterial isolates, in particular Gram-negative rod-shaped bacteria from urine samples, is commonly considered to be unnecessary. These organisms are frequently grouped together under the pseudo-classification "coliforms" for which no standard definition exists. The collection and analysis of this data is of dubious value since the strains termed "coliforms" may have widely varying susceptibilities to antibiotics.

4.2.2  Antibiotic susceptibility testing

  Automation in susceptibility testing has been adopted more slowly in the United Kingdom than in other countries through unwillingness or inability to invest in new technology. The impact on surveillance is twofold.
TSN DatabaseAntibiotics Tested
United States13
The Netherlands8

  Table 2 Average number of antibiotics tested per strain—TSN databases July 2002  Few antibiotics tested

  Instruments such as the Microscan, Vitek or Phoenix systems that test minimum inhibitory concentrations employ standard test-panels of between 12 and 20 antibiotics. Automatic inhibition zone readers are widely used in France where pairs of large square agar plates, each with a capacity of nine antibiotics are commonly used. The testing of large numbers of antibiotics permits the recognition of patterns of resistance. These patterns allow the detection of a number of the mechanisms employed by bacteria to evade or counteract the anti-bacterial effects of the antibiotic. Knowledge of the resistance mechanisms present can provide useful information to support the choice of therapy. Expert systems are widely used to automatically perform these analyses. In the United Kingdom, the tradition has been to test each bacterium isolated against fewer antibiotics. The source of data is therefore less rich and the choice of molecules chosen by each laboratory to represent each class of antibiotics is more varied. This has an adverse effect upon the ability to consolidate and perform inter-laboratory comparisons.  Qualitative results only

  Most automated techniques provide quantitative as well as qualitative results. Quantitative results allow more detailed analyses of microbial populations and are therefore of value to surveillance programmes. Few laboratories in the United Kingdom are currently able to supply quantitative susceptibility results.

4.3  Testing standards

  In the absence of a European Union standard for susceptibility testing, laboratories in the United Kingdom apply the British Society for Antimicrobial Chemotherapy (BSAC) or the American National Committee for Clinical Laboratory Standards (NCCLS) recommendations. Some laboratories continue to use the method devised by Stokes. This lack of standardisation complicates surveillance because results obtained by different methods cannot be combined to provide an overall statistic.

4.4  Information system incompatibility

  The automation of data extraction from laboratories in the United Kingdom has been greatly assisted when laboratories have in-house computer expertise. Experience with participants whose computer support is provided by external consultants has been less favourable. There is little standardisation between laboratory information systems. Recent consolidation among suppliers of laboratory information systems may come greater harmonisation. Where participants have adopted automated tests producing quantitative results, it is frequently the case that their laboratory information system is not designed to accept and store them.

October 2002

55   An Institution is a hospital or clinic for which the participating laboratory performs all microbiological analysis. Back

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