Mobile Veterinarian, Medical and Food Safety BSL2+ and BSL3 Laboratories for AVIAN Flu, FMD Foot and Mouth Disease and many other Agents, with Integrated INFRARED Detection Systems
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INTRODUCTION

Increased Epidemiological appearances with high virulence danger (EBOLA, SARS, AVIAN FLU, Asian flues, Cholera, Variola, Bioterror Agents, FMD Foot and Mouth Disease, etc) requires increased intervention mobility directly in the infected areas, while respecting Biosafety rules and protecting fixed labs and facilities. One of the WHO priorities in the 3-rd Millennium is to improve and promote essential Health technologies applicable at the primary health care level. 

Primary health care is conceived as a key approach to achieving health for all and must be implemented especially in the developing countries.

These strategies represent a comprehensive approach by the health sector to the promotion of health, prevention of disease, appropriate diagnosis, adequate treatment and measures for rehabilitation. For these strategies - preventive, promotive, diagnostic, therapeutic and rehabilitative components of health care, proper surveillance with a sound and efficient network of laboratories is essential. At present, Laboratory support at the Primary Health care level is not fully developed in the most developing countries and the programmes for continuous medical education and quality control are limited. In the case of emergencies like the present one in Asia , it is simply non adequate. 

At the same time, several communicable diseases and especially new several emergent diseases are prevalent in these countries, in relation to which early diagnosis and well - defined laboratory - based epidemiological information could yield favorable results for the patient as well as the community, particularly at the peripheral level.

ORLANDO SYSTEM Inc., USA, member ABSA and EBSA, (with its division in Europe, ORLANDO Telecom SRL) , which developed this project, is proposing a Programme for a network of MOBILE MEDICAL and BIOLOGICAL LABORATORIES - Containerized [medical laboratory - standard and extended], independent, towed or installed on a 4 WD truck, boat or any other platform + as a part of a Mobile Laboratories Network in the Developing Countries and other areas. 

The Strategy of the ORLANDO group is also to implement a Programme for training of the laboratory technologists and technicians for these Mobile Medical Laboratories, in the spirit of Good Laboratory Practice and Quality Assurance, up to BSL3 level. Such training can be accomplished in Hungary or Romania in a high level training, approved facility. For Mobile Labs for HEALTH applications, also BSL3, please visit our other website http://www.orlandomedsys.com.

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FUNCTIONS
The Primary functions of the Mobile Laboratory are to assist in early and reliable Diagnosis, investigate outbreaks of disease, collect reliable Surveillance and Monitoring data for effective disease control and participate in the National Immunization Programmes of end-user nations.

The level of the Mobile laboratory must be equivalent in the "Standard version" to the Peripheral laboratory, and in its "Expanded version" to the Intermediate laboratory. Usage of Rapid Tests in the Mobile Peripheral laboratories will allow prompt patient management and better disease surveillance as primary health care.

The OSI Mobile Laboratories and Clinics will also support the control of the quality of water and food, the environmental pollution and its hazards and, if possible, monitor the various vertical national health programmes. One of the special tasks of Mobile laboratory is to participate to the control of bioterrorism - diagnosis and collection of specimens from area concerned by bioterrorism.

Some of the Identifiable diseases are: EBOLA, SARS, HIV, Variola, Malaria, Cholera, Tuberculosis, Polio, West Nile , Hepatitis, Anthrax, Ebola, Botullinic Toxin, etc.  Control of epidemic conditions like EBOLA, SARS, as far as human or animal farm infections are fully considered as part of this project, started in November 2001. The present requirements for protections re EBOLA, SARS (as of April 27 th , 2003 and 2004) are met. Avian flu H types are also considered.

The Mobile Medical Laboratory networks should be an integral part of National Health Service, and should be developed within its framework, in the pyramidal structure of laboratory network from the developing countries.

The level of the Mobile Medical Laboratory must be equivalent in the "Standard variant" to the peripheral laboratory, and in its "Expended variant" to the intermediate laboratory . Our lab project has gone a step further and raised the Safety Level to BSL2 as far the Hood and as some functions of the Lab itself. A low cost Level BSL3 model is also available.

In the organization of the Mobile Laboratory priority should be given to the appropriate technology and tests of clinical relevance, applicable to the local circumstances and conditions. Conventional laboratory tests, though sensitive and specific, are often time-consuming, difficult to perform and need many reagents and much and expensive equipments.

Therefore, there is a clear need to introduce more RAPID TESTING as simple, reliable, reproducible, and cost - effective via a Mobile delivery method. The introduction of RAPID TESTING in the Mobile Peripheral laboratories will allow prompt patient management and better disease surveillance, which will be a great support for primary health care.

Common diseases for which laboratories at this level can help include:

•Parasitic infections - malaria, filariasis, vaginal trichomoniasis, amoebiasis and other intestinal parasites;
•  Bacterial infections - tuberculosis, leprosy, gonorrhea, meningitis, skin infections with phylogenic organisms;
•  Fungal infections - candidiasis , superficial mycoses
•  Viral infections - HIV , hepatitis viruses , EBOLA, SARS, Avian Flu H2, H5, H7, etc ;
•  Pathogens with potential use in bioterrorism - anthrax, Ebola, etc.;
•  Noncomunicable diseases - anaemia , diabetes , eclampsia, etc
•  New emergent pathogens;

For same of the infections, if facilities and reagents are limited, only sample collection and dispatch to intermediate/central laboratories will be possible, but only under SAFE conditions for workers and sample conservation alike (like fresh air HEPA intake/outtake filtering).
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DIAGNOSIS
Diagnostic procedures available at this level depend on the resources, manpower and policies of the health services as well as the prevalent communicable and noncommunicable diseases. Appropriate technologies, need - based and comprehensively evaluated by the local health care services, should be used wherever possible.
ORLANDO Systems LLC general offer for the Mobile Medical and  BIOLOGICAL Laboratory network project is

- "standard variant"
- a " plain vanilla " system, with standard equipment and reagents (BSL1), about 3 to 3.5 meters, but with a limited cost; And an;
•  " Extended variant " - longer, 3.5 to 4 meters, with a built-in Sample entry and Decontamination room, with optional equipments and reagents, with BSL2 and 3, with Negative pressure, HEPA air filtering available, etc.
•  The applications are: for Human and/or Veterinarian use, Vaccinations, etc,  

Basic microscopic examinations at the standard level may include the following

- Faeces for exudates [amoebic/bacillary dysentery], trophozoites, ova and cysts;
- Vaginal swabs - wet preparations for Trichomonas and Gram stained smears for candidiasis;
- Urethral discharge - Gram stained smears for gonococci;
- Sputum - Ziel Neelsen stained smears for acid fast bacilli;
- Skin - Ziel Neelsen stained smears for acid fast bacilli [AFB] and direct wet preparations for fungi;
- Nasal smears for AFB [Ziel Neelsen stain];
- Blood films for malarial parasites and microfilaria [Romanowsky stain];
- Urine deposits for cells, casts and parasites;
- Pus and exudates - Gram smears for bacteria;
- Cerebrospinal fluid [CFS] - Gram stained smears for bacteria, wet preparations for parasites and cell count in counting chambers:
- Semen examinations;

Clinical chemistry examinations should include the following:

•  Urine examination for glucose, protein, ketones, bile pigments and salts; and pregnancy tests;
•  Faeces for occult blood;
•  Blood examination for glucose, protein, bilirubin, creatinine, etc

  Hematology examinations should include the following

•  Hemoglobin estimation;
•  Total leukocyte counts;
•  Differential white cells counts;
•  Erythrocyte sedimentation rates [ESR];
•  Packed - cell volume [PCV];
•  Platelet counts;
•  Raeticulocyte counts;
•  Peripheral blood smears for cells morphology.

Serology for indirect identifications of infection, by means of determinations of antigens and / or antibodies, by rapid tests [including ELISA], for:

•  Viral, bacterial and parasitic infections.

Additional examinations include those for water, food and environmental contaminations.

In some infections, referral to higher-level laboratories should include:

•  Dispatch of faecal samples, for cultures, in suitable transport medium in cases of cholera, dysentery, diarrhea, etc.;
•  Serum / blood samples for culture and serology;
•  Water, food and environmental samples for analysis and culture;
•  Dispatch of appropriate samples during outbreaks. Technicians at the periphery must be trained to respond rapidly and appropriately in cases of outbreaks.

All the above procedures require adequate training and experience in the standard procedures for collection, storage and transport of samples.
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TESTS
Reliable, sensitive, specific, cost - effective and easily as well rapidly performed tests are particularly needed for the Mobile Laboratory activity. Newer techniques - latex agglutinations, co agglutinations, dipstick and conventional ELISA would be use. 
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RECORD KEEPING
This is essential for an efficient activity of the Mobile Laboratory - proper registers or electronic destination of data [dates, name, age, sex of patients, clinical diagnosis, results of tests, etc.]. In disaster areas, lost records need to be replaced, health maps and antibiotic resistance needs to be tested and recorded. Notebooks are suggested, with easy back-up, network and Communications connectable ports.
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IMMUNIZATIONS and SURVEYS
Mobile Laboratories should participate in national immunizations and monitoring vaccinations programmes and in surveys organized by intermediate, state / provincial and central laboratories or health care authorities. 
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COMMUNICATIONS
The Mobile Medical and Biological Laboratories shall have a proper communication system, GSM, Radio, Satellite and conventional, for voice, data, video  - as well as a GPS unit - with the fixed, higher-level laboratories with regards to data collection, supervision and quality assurance. International connections will speed up help requests for diagnosis and verification.
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STAFF
The staff in the Mobile Laboratory / Peripheral level should have at least 2 people - 1 technologist/technician and 1 laboratory assistant/attendant/driver. The Mobile Laboratory extended peripheral [intermediate] level must include also - qualified pathologist / microbiologist / biochemist. 
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EQUIPMENTS / SUPPLIES
Some of the Necessary equipments and supplies (as recommended by our experts, but to be revised by the local end-users) can include:

•  1 binocular microscope with in built light ;
•  1 dark field microscope ;
•  1 centrifuge for vacutainers ;
•  1  hemoglobin meters ;
•  1 ESR stand ;
•  1 hemoanalyzer - 8/18 parameters [ optional ] ;
•  1 minianalyzer for chemical chemistry [ soft for 30-40   analyses ] - optional
•  1 reader ,1 washer and 1 incubator for  ELISA serology - optional ;
•  4 automatic pipettes [ 20 + 50+ 250 m monocanal + multicanal 250 m ] and devices for pipeting ;
•  1 micro analyzer for radiation - optional;
•  1 micro analyzer for chemical weapons - optional;
•  1 laminar flow cabinet ; Bio Safety Level II, or mobile BSL3- optional
•  1 Refrigerator - for samples ;
•  1 Refrigerator - for reagents and for vaccines - optional 2 ;
•  1 freezer - for samples ;
•  air conditioned system + filters for dust and BIOLOGICAL / chemicals - optional;
•  1 computer [laptop] - optional
•  reagents and kits for - microbiology , hematology , serology [Conventional , rapid and ELISA tests ] ;
•  reagents and kits for - water , food and environmental analysis [ bacteriological and chemical assurance ];
•  vaccines for National immunization programmes
•  special supplies for sample collection , transport and storage ;
•  culture and transport media for microbiology ;
•  laboratory materials for single use ;
•  sterilized syringes and needles [ single use ] ;
•  sterile collection bottles and tubes for water, food and environmental  analysis ;
•  deionized / distilled water [ bottles ] ;
•  PCR and ELISA tests equipment. Locally recommended supplies
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STANDARD OPERATION PROCEDURES
•  collection samples ;
•  processing of samples ;
•  storage samples ;
•  all types of analysis ;
•  epidemiological surveys ;
•  investigation of outbreaks ;
•  immunizations and monitoring vaccine response ;
•  collection of data ;
•  record keeping ;
•  equipment maintenance ;
•  laboratory maintenance ;
•  decontamination / biosafety ;
•  waste and contaminated / decontaminated disposal ;
•  organization of quality assurance / internal quality control / external quality assessment ;
•  guidelines for bio-safety ;
•  Etc.
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LABORATORY MANUALS
LM should include organization, staff , laboratory techniques , preventive maintenance of equipment, quality assurance , biosafety, specimen collection and packaging, record keeping , ordering supplies, communication system and logistic support , safe management of environment, biosafety programmes, methods for identifying and correcting faults and difficulties, WHO standards, etc.
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Mobile Laboratories
TECHNICAL SPECIFICATIONS
Typical Lab Working SPACE:
Standard: 2.00mH x 2.00mW x 3.00/3.50m Length
Expanded: 2.00mH x 2.00mW x 3.50/4.00m + Length


Technical Data

MBL-3000

MLEE-3500

MLBSL2-3500

MNBCL-4000

Length

3000mm

3500mm

4000mm

Width

2000mm

2000mm

2000mm

Weight

1700kg

2000-2500kg

2500-3000kg

Special Missions

Basic Medical, Biological Tests

Epidemiological Interventions, High Risk, Bioterror

Level BSL-2 and 3,

Also NBC/2 rooms


Mobile Medical and BIOLOGICAL Laboratories available are defined by size (3-6m long, 2x2m wide and tall), Biosafety Level 1-3 (Single and Dual rooms) and applications (Human and/or Veterinarian use, Vaccinations, etc).

The ORLANDO Mobile Medical and Biological Laboratories are containerized, can be installed on self-supporting trailer with air-shocks or can be transferred to Transit type, 2 - 2.500kg capacity small trucks, ships, etc. It also has an optional large tent on the right side, with access to the 220VAC and 12VDC power outlets, as well as the Autoclave and Decontamination unit.

The Mobile Laboratories are also available with Positive or Negative pressure, Bio-Safety Level II Hood or a GLOVEBOX BSL3, with fresh air Bio HEPA filtering and can provide a Level II or III BioSafety level for the occupants and samples. The Mobile Medical Clinics for doctor examinations, diagnosis and some basic treatments are similar in technology, size and scope.
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OTHER FACILITIES
 Other facilities include a supply of safe Purified water, a reliable source of energy like a generator, Battery and solar cells. The systems also include sterilization/incineration and possible chemical disinfections facilities. Also included are transport and optional communication facilities between the Mobile laboratory and the higher-level laboratory for referral of samples and patients procurement of supplies and personal discussions (portable refrigerators).
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CONCLUSION
Mobile BIOLOGICAL Medical and Veterinarian Laboratories are of great use in Epidemiological or Bioterror situations requiring Biosafety in sample collection and analysis.
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