The quality assurance of HIV (HBsAg etc) testing in the bloodscreening laboratories has three layers: test kit evaluation, quality control and proficiency assessment. Test kit evaluation is a premarketing activity performed by a national reference laboratory. Only in case a test kit is passing the criteria it can be market in the country. In addition to the premarketing evaluation a ongoing monitoring of the kit results is a option. Quality control is a ongoing activity of the bloodscreening laboratory and HIV testing laboratories. Available QualityControl (QC) samples with a know value are used in every run and the result can be used to confirm that the test results are accurate and reliable. QC samples are commercial available or can be produced by a national reference laboratory. Proficiency assesements programs are used as a independent external assessment of the laboratory testing process. By supplying a sample with a unknown value and instructions to process the sample according to the standard procedure the complete testing process can be assessed. Results are reported anonymous.

Situation in most developing countries

The bloodbanks and/or blood transfusion service in developing countries are not using (systematically) the three layers in the quality assurance for HIV testing. Some bloodbank have a ISO certification but there is a big difference between a ISO certification and the continuously monitoring of the quality of the HIV screening. Also the HIV testing laboratories do not have a form of accreditation of there testing activities. In most countries you need a accreditation to performing HIV testing, only if you have passed the accreditation criteria including the participation in external proficiency test programs and other criteria

Project description for bloodscreening laboratories 2 December 2001

The complete internet based service (see service description) can be of interest by setting up a regional or national reference laboratory for the quality assurance of bloodscreening laboratories. The service is direct available for use for every bloodbank or transfusion service with a access to internet. Access to the internet is preferably ones a day. The service supplies a information service only. A group of bloodbanks, a National or regional reference laboratory, a research group can use the service to set up a proficiency program or use the service for monitoring the outcome of runcontrols of a group of bloodscreening laboratories. Because the economy of scale your costs are reduced to a minimum, no IT staff and infrastructure is involved, no additional software is required, no investments in money and IT projects. The only requirements are a internet connection and a standard web browser. You can deploy the application in a national or international context direct from the start.

Currently we are active in setting up a project in INDIA involving several bloodbanks (see the description blow ). The project named AIDSINDIA is in the starting up phase and is using the service (see project description below) The goal of the project is to monitoring the quality of the bloodscreening by plotting the outcome of the runcontrols from the blood screening markers in a classical "Shewart Control Chart" and "Cumulative distribution" format. Because the multicenter setting you are able to observe the observations of the participants while maintaining the anonymity and the source of the data. Global Quality Services maintains a international accessible database for bloodscreening laboratories. By the law of large numbers ( Chebyshev's inequality) the period between the start of the deviation and the moment of detecting and signalling a deviation will decrees. GQS has added data entry screens for nearly suppliers of reagents.

1-Project description AIDS INDIA project

1.1 Goal:

Monitoring the quality of the bloodscreening by plotting the outcome of the runcontrols from the screening markers in a classical "Shewart Control Chart" and "Cumulative distribution" format. Because the multicenter setting you are able to observe the observations of the participants while maintaining the anonymity and the source of the data. Global Quality Services maintains a international accessible database for bloodscreening laboratories. GQS has added data entry screens for nearly all suppliers of reagents.

1.2 Methods:

QC samples from the manufacturer or prepared by the laboratories are included in every run. Results obtained from the QC samples including lotnumbers are entered in a international accessible database and plotted in the classical Stewart control chart on a daily basis. Plotting the QC data allows to observe trends towards a change in performance of the assay alerting them to potential problems.

1.3 Results

By a daily monitoring of all the runcontrols of all the assays of the routine screening of donors the laboratories are able to detect a deviations in a early stage. For example a field upgrade of a laboratory instrument, the introduction of a new lot of reagents etc. can effect the results. By the law of large numbers a change will be detected in a early stage. By a systematic comparison of the bias and variation in the assay results of the participating laboratories the organization is able to detect the source of the bias and or variability in relationship with method used, instrument, reagent and procedure while maintaining the anonymity and the source of the data. Sharing of the information with a direct feedback including charts will stimulate the awareness of quality

1.4 Discussion

To develop a own information service for this purpose is very difficult. While lack of understanding is one reason, there is also the question of resourcing of funds, training and staffing. A internet based service for Quality Control my overcome the basic problems and the availability of the results can stimulate the quality of the bloodscreening processes and funding of improvement programs. Implementation or development of a national or regional reference laboratory can be stimulated. Because the economy of scale your costs are reduced to a minimum, no IT staff and infrastructure is involved with the exception of internet connection, no investments in money and IT projects. You can deploy the application in a national or international context direct from the start. If necessary the service can be implemented as a complete in-house application. Because it is a multicenter set up you can see your observations between the observations of the other laboratories while maintaining the anonymity and the source of the data. You are able to study the outcome of the runcontrol in relationship with reagents-lotnumbers, runcontrol-lotnumer and or/instruments. By the law of large numbers ( Chebyshev's inequality) the period between the start of the deviation and the moment of detecting and signalling a deviation will decrees. You are able to start your own quality control circle. At membership processing you are able to define a new group or you request a membership of a existing group. A proficiency test provider or National Reference or regional reference laboratory can start his own group and can use the service to collect the data from the participating bloodscreening laboratories. In addition he can using GlobalQualityServices to automate his complete business process starting with the invitation to his customers to participate in a proficiency program to the online statistical analysis and billing. The statistical request are direct executed and the Shewart Control Chart and performance chart are online direct available.

1.5 Assumptions:

-Global Quality Services is only in the role of information service provider and facilitator of the process
-Participants are the organizers and carry out the process and are getting other participants involved

1.6 Organization

-Laboratory involved in blood screening for transfusion are organized in quality circles.
-Participants are active seeking contacts to get others involved

1.7 Runcontrols

QC samples from the manufacturer or prepared by the laboratories are included in every run. Results obtained from the QC samples including lotnumbers are entered in a international accessible database. On request of the participant a "Control Chart" and/or "performance chart" is generated. A quick start is the use of the runcontrol of the manufacturer of the test assay or the material of a national reference organization.

1.8 Data entry templates

Data entry templates are available for : Abbott, Avicenna, Boehringer, Fujirebio, Innogenetics, Murex, Organon Teknik, Ortho, Sanofi Pasteur Monolisa, BAG, Biomerieux, Biotest AG, etc. For a complete list of 200 data entry templates access our product catalogue. On request we ill add new templates to cover all suppliers of reagents.

1.9 The role of the participants

Participants are active seeking contacts to get others laboratories involved. Participants are organised in regional quality circles Each circle is responsible for the distribution of the runcontrol/reference material. The use of the runcontrol of the supplier of the reagent or the use of the reference material of a national organization is a option. You can start using the service in-house

1.10 Costs involved

The information service for this project is in the start up phase free a off any charges. In the long term we will seek funds from the EU or other organizations for the cost recovery and seeking other posibilities. As a starting point you can use the service for your own local blood bank. In this case there are no out of pocket costs involved with the exception of the costs you already made for the reference sample you prepared by yourself or received from the manufacturer of the reagents. External reference material is also (commercial) available from National reference laboratories or commercial organization's. In case you start a quality circle you have to take in account some out of pocket costs for the distribution of the reference sample. The distribution costs involve: transportation and packing material. In case you use external (commercial) reference samples you have to take those cost into account to

1.11 Logistical details

The obtaining, production, administration and distribution of reference samples are the responsibility of the members of the quality circle. Starting with a single bloodbank and scaling up to two or more will give time to build a distribution network. GlobalQualityServices contains the procedures and product catalogue for the ordering of the reference material from national or commercial organizations.

1.12 Statistical details "Shewart Control Chart"

The control chart is a simple graphical device which is useful in keeping track of production quality. "Control" implies that some static condition exist. If the quality does improve or change significantly we say we have no longer control, and we depend upon our control chart to detect the change. On the vertical axis we have a scale for observed values of the variable. On the horizontal axis we have a scale for days, or time at which the sample was taken. A solid horizontal line is drawn through the expected (assumed) value, and two parallel lines are drawn, one above and one below the solid line. We plot the observed value of the sample and plot it in the chart. If the point is between the parallel lines we say that the process is in control and take no further action. If the point is above the upper or below the lower line we say that the procedure is out of statistical control, and we attempt to find the factor which is causing the extreme observation. We wish the chance of asserting lack of control to be very small when the static condition still exists. We control this chance by the distance between the parallel lines, the so called Upper Control Limit and Lower Control Limit. In practice it is customary to use 3*Sigma / square (N) as control lines. For a normal distribution these control lines give a 0,27% chance of deciding erroneously that there is a lack of control. The statistical method's applied have as a goal to detect systematic deviations from deviations witch occur by chance. The control value's are calculated from the sample in the case that they are not supplied by the user. Besides the statistical upper and lower control limits you can specify a technical control limits. The technical control limits are determined based on technical or economical criteria and must be supplied by the user.

1.13 Performance chart

The performance chart is a cumulative distribution chart of all observations. Your observations are plotted against all other observations. The percentile score of the average value of your observations is marked.

1.14 Current status

Until now we have 8 reactions out of INDIA for our bloodscreening project (see project description). This is a very good start for a long term blood screening quality project. Until now we have questions about the following aspects: -costs involved, -logistical details,-statistical details.

1. 15 Invitation to participate

In case you are involved in the bloodscreening for transfusion you are invited to start using this services free of any charges. To start using this service register at http://www.GlobalQualityServices.com <http://www.globalqualityservices.com/> and within 24 hours you can order a data entry template out of the online product catalogue (free of any charges). You are able to start using the service for your own bloodbank and in addition you can use the service with more added value in a regional or national context. The service is available in nearly all countries. We have now 8 members and 3 users starting to build the AIDS INDIA bloodscreening database. In case you are active involved in the screening of blood donations in a developing countries please register free of any charges at http://www.GlobalQualityServices.com. You will receive a username and password and access to the database. To get used to the service, access to a demo version is supplied to.

2 Description of the service www.GlobalQualityServices.com

A complete new internet enabled application for the proficiency test provider, monitoring of runcontrols (external) variables and/or collecting data for research is available on the internet as a standard service:

-Portal infrastructure, a dynamic personalized website tailored to the need of the user
-Workflow processing, the complete business process of the provider captured in workflow steps
-Data entry, users can order a catalogue item including the data entry template's he/she needs
-Publications, after the publication date users can query the data base including charts

Using this service you are able to collect data rapidly over the internet and distribute and publish the results on line in a statistical chart and/report. Do you need a national or regional monitoring system for your indicators in the field of healthcare, here it is easy to use and no complicated IT project involved. Do you need a data collection system for your research project or routine monitoring of runcontrols, her it is easy to use and you can design your own data entry template direct for use.

2.1 The functions of the service include for example:

-user registration / ballot committee
-order processing (sample material, run controls, reagents and data entry templates and keys)
-processing of order/invoice
-workflow management (including standard letters and workflow, e-mail lists and e-mail response)
-production of labels for manual mail, material distribution and workorders
-data entry and validation and personalization
-log of the input to the database
-data collecting (upload from your lims)
-distribution (download a selection formatted for your own application)
-on line statistical analysis and reports including charts (summary,control charts, cum control chart, distribution, performance etc)
-processing of extreme cases and outliners
-early warning alerts
-publishing of inclosures
-discussion forum
-on-line form design
-integration with your own website

2.2 Requirements

The only requirements are a PC and a standard web browser. No additional software at the client site is necessary. The services is designed for a 17" monitor resolution 1024 by 768 and tested with internet explorer version 4 and netscape navigator version 3 and higher the only thing you need is a internet connection and a 28 kb modem or higher. The extreme low requirements of using this service makes it possible to use this service in the developing countries to. We deliver this service in the start up phase to the bloodbanking community free of any charges.

2.3 Demonstration database

The service as available now contains all the functions necessary for (national) proficiency testing, monitoring of runcontrols (external) variables, research studies, calibration and qc of equipment and reagents and technical support in the field. As a provider you are able to offer this service to your customers integrated with your own website. You are able to try it out by ordering a data entry template and use it in the demonstration database named National Reference Laboratory (NRL). The demonstration database is a example in the field of bloodscreening laboratories and contains predefined data entry templates for all suppliers of reagents. Using the demo database you are able to enter data and add data points and to generate real-time a sheward control chart and performance chart.

2.4 Management summary

Global Quality Services is a high quality cross industry services in the field of benchmarking /quality assurance, quality control. You are able to benchmark a product, service or organization in a national or international context. Global Quality Services is consolidating the measurable quantitative aspects of quality knowledge in your organization and makes the knowledge available to all the participants. The service is direct available for use. You can deploy the application in a national or international context direct from the start. There is no need for additional software at the client site. A standard up to date web browser will do the job. The cost of ownership for you and your customers is reduced to a minimum. Global Quality Services is a cross industry solution. Global Quality Services is active in the different fields or industry sectors like food, pharmaceuticals, manufacturing, blood banking, transfusion, medicine, agricultural, mineral and petrol , management and hospitals. This combined knowledge is to your advantage. The standard service is global available. The service is based on the knowledge collected in different sectors and industries. Using this information service you are able to speed up your quality assurance and control projects in the field of bloodscreening laboratories. In combination with the availability of commercial available reference samples from several sources you are able to set up a national qc program. Global Quality Services supplies only a information services. Using the model of Application Service Provider the service is direct available for use. Because the economy of scale your costs are reduced to a minimum, no IT staff and infrastructure is involved, no investments in time, money and IT projects. You can deploy the application in a national or international context direct from the start. Global Quality Services as a specialized internet portal can compete with the generic statistical products available to day. VisionFactory develops and implement complete innovative e-business solutions based on Lotus Domino, the Lotus SmartSuite and IBM WebSphere and if necessary is working with respected partners.

3 Implementation plan

Setting up a national quality assurance/control program needs a proper foundation. To building the support for a regional or national program we can follow the following steps:

-Discuss the need of a quality assurance control program based on a value belief of the quality of the blood transfusion system in your country. To get a agreement/consensus you need to discuss this in your regional/national organization. The purpose of this first step is to get a proper foundation for all steps to follow

-Next develop a vision and aims in relation with the quality assurence program including the role of a national reference laboratory with the following tasks (-setting standards and guidelines, -organization of the external assessment program, -organiszation of the quality control program, -production/purchasing of reference material, -Implementing a quality control program etc). Develop this vision/aims and get consensus in your regional/national organization

-Next plan the set up of the regional/national reference laboratory and plan all the projects you need to set up your QA and QC programs

Because you have already a consensus the implementation and funding will follow as a logical result of the program. The steps as described will take time but I think you need tho follow them to get the support you need. In parallel you can set up a pilot project to get the support and build expertise and trust.

3.1 Project plan template

Implementing a monitoring system based on runcontrols in a quality circle of bloodscreening laboratories

To anticipate potential problems and/or unexpected statistical results, which is very likely, you have to implementing a monitoring system for bloodscreenings laboratories step by step. To collect relevant information the first step of the bloodbank in the role of a regional reference laboratory's is to execute a internal project and as a second step the reference laboratory can start up a pilot project with other bloodbanks as participants. After the pilot project you can scale up to your local needs.
The project group must contain as a minimum four diciplines: laboratory technician, quality control and statistical expertise, external relationship, computer information systems. In some situations one person can manage two or more disciplines.

3.1.1 Runcontrol

Multimarker or single marker runcontrols are mostly filled off in 5.0 ml or 1.0 ml volumes test tubes, which can be plased at random positions between the test tubes. The expected response values for different test kits and testmethods appropriately diluted to operate at low Sample Cutoff (S/Co) ratios are shown in the product description. In case your test kit method is
not in the product description the suppliers can design the runcontrol specific for your test kit and method by applying the appropriate dilution factor. Samples must be stored by the specified temperature -70, to -4°C depending on the manufacturer. Examples of suppliers are Boston Biomedica Inc US, the National Serology Reference Laboratory, Australia and the
Central Laboratory of the Dutch Red Cross in the Netherlands.

3.1.2 Quality circle

Some homogeneity in the quality circle in respect to the used test method, reagents, runcontrols is preferable. The scale you can start is depending on your experiancy with runcontrols and proficiency testing. The role of the regional reference laboratory. The quality circle consist out of a number of bloodscreening laboratories of with one is in the role of a regional reference laboratory. The role of the regional reference laboratory can for example consist of, but not limited to the following tasks:

-Plan and execute a pilot project and monitoring all aspects of the pilot project see description of the pilot project below

-Coordinate the selection of one or more suppliers of runcontrols in relation with the current test methods and reagents used

-Routinely purchase a new stock of runcontrols preferable from the same batch/lot as the previous batch/lot

-Take care of the distribution of the runcontrols to the bloodbanks according to the needs and special requirements

-Organize a periodic evaluation meeting with the members of the quality circle. Points for the agenda are for example : handling of runcontrols, stock levels of runcontrols, interpretation of statistical results, use of the information system, introduction of new test, equipment

-Coordinate the introduction of new bloodbanks into the quality circle

-Coordinate some information system aspects: new users, inital values of system tables

3.1.3 Pilot project

Planning a pilot project is a crucial part. You start to make a list of all of testmethods (reagents, lotnumbers, runcontrols and lotnumbers, instruments and serial number) used in the quality circle. From there you select one or more common testmethod used within the quality circle. Select and purchase the reference material in a amount for a defined period for
example one month. Perform a training in the data entry procedure of the information system. Distribute the runcontrol to the participants, enter the daily results into the information system and evaluate the statistical results. In the pilot all the participants can get used to the procedures and the primarily statistical results. Participants need room/space to make
mistakes and adjust the working methods according to the results. After the adjustments made based on the primarily results the participants can add other testmethods into the quality circle and scale up all aspects.

3.1.4 Internal pilot.

To asses potential problems, to train the laboratory personal to get used to all aspects of the project and to test the different aspects of the information system it is advisable for the regional reference laboratory to perform a internal pilot project within the bloodbank itself. To excecute this internal pilot it is advisable to prepare a team containing the following expertise: (laboratory technician, external relationship, quality control and statistical expertise and some information system expertise).
The internal pilot contains as a minimum the following steps:

-Select one or more testmethod

-Setup of the inital values of the information system for example users, reagents, instruments and perform a system test using a test set with real live data.

-Purchase the reference material

-Use the runcontrols in the daily routine

-Enter the results in the information system

-Evaluate the results

3.1.4 Time line

-Internal pilot 2-3 months, pilot project including bloodbanks 4-6 months,
scaling up and adjustments 3 months
Sincerely,

John M Nivard
VisionFactory/GlobalQualityServices
Grote Oost 67
1621 BS Hoorn NH
The Netherlands
tel:+31653537046
email jnivard@hotmail.com