Biosafety

Mobile Biological Laboratories

an overview of this program:

ORLANDO Systems Inc. presents:

Mobile Medical Analysis Laboratories  

INTRODUCTION

  Increased Epidemiological appearances with high virulence danger (SARS, Birdflu/Avian and Asian flues, Cholera, Tuberculosis, Bioterror Agents, 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 modern 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 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 global community, particularly at the

Peripheral level.

ORLANDO SYSTEM Inc., USA (with its division in Europe, ORLANDO Telecom SRL) which developed this Mobile Monitoring project, is proposing a Programme for a MOBILE MEDICAL and BIOLOGICAL LABORATORY - 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 Epidemics Monitoring Network in the Developing Countries. 

The Strategy of ORLANDO 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 or in the end-user countries. 

FUNCTIONS

The Primary functions of the Mobile Laboratory are to assist in early and reliable diagnosis, investigate and monitor outbreaks of disease, collect reliable surveillance data for effective disease control and participate in the national immunization programmes. Such information can then be distributed to the appropriate world organizations for further action and study.

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 Mobile Laboratory 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 to be monitored are: SARS, HIV, Variola, Malaria, Cholera, Hepatitis, Anthrax, Ebola, Botullinic Toxin, etc.  Control of epidemic conditions like 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 SARS (as of April 27^th, 2003 and 2004) are met. Avian flu H types are also considered.

Mobile Medical Laboratory networks should be an integral part of local National Health Services, 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 (in-out HEPA filtering). 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 RAPID TESTING as a simple, reliable, reproducible, and cost - effective procedure 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 , SARS, Avian Flu H2, H5, H7, etc ;

-        Pathogens with potential use in bioterrorism - Anthrax, Ebola, Variola, Bottulin, 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).  

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 Inc 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 available.

-        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.  

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.   

RECORD KEEPING

This is an essential and required procedure for an efficient activity of the Mobile Laboratory, regardless of the BSL level - proper registers or electronic destination of data [dates, name, age, sex of patients, clinical diagnosis, results of tests, etc.]. 

IMMUNIZATIONS and SURVEYS

Mobile laboratory should participate in national immunizations and monitoring vaccinations programmes and in surveys organized by intermediate, state / provincial and central laboratories or health care authorities. 

COMMUNICATIONS

The Mobile Medical and Biological Laboratory have a proper communication system, satellite and conventional, for voice, data, video - and GPS - with the fixed, higher-level laboratories with regards to data collection, supervision and quality assurance.

STAFF                 

The staff in the Mobile Laboratory / Peripheral level includes 2 persons - 1 technologist/technician and 1 laboratory assistant/attendant/driver. The Mobile Laboratory extended peripheral [intermediate] level must include also - qualified pathologist / microbiologist / biochemist. 

 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

STANDARD OPERATIONAL 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 ;

LABORATORY MANUALS

Mobile Laboratories TECHNICAL SPECIFICATION

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

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 Biological Lab is containerized, can be installed on self-supporting trailer with air-shocks or can be transferred to Transit type, 3.500kg 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 ORLANDO Systems inc, NY, Mobile Medical and Biological Laboratories are also available with Positive or Negative pressure, Bio-Safety Level II Hood or a GLOVEBOX BSL3, with fresh air HEPA filtering, it can provide a Level II or III BioSafety level for the occupants and samples. The Mobile Medical Clinics for doctor examinations, diagnosis and some treatment are similar in technology, size and scope. 

OTHER FACILITIES

 Other facilities include a supply of safe water, a reliable source of energy like a generator, Battery and solar cells. The systems also include sterilization/ incineration and possible chemical disinfections facilities.

There is also included 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).

CONCLUSION

Copyrights 2001-2006,

ORLANDO Systems Inc.,

ORLANDO Telecom SRL

108 South Franklin Ave, Suite #10, VALLEY STREAM, NY 11580, USA

T: (516)-593-3480, F: (516)-593-3481, Mob: 1-908-416-6272

Certified ISO 9001:2000

www.birdflulabs.com    www.orlando-systems.com

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Reduced size material:

POSTER- EBSA- Prague Congress, May 12-14^th, 2004

 Title: APPLICATION OF MOBILE LABORATORIES FOR EPIDEMOLOGICAL EMERGENCIES FIELD INTERVENTIONS

T.Basch, Orlando Systems, USA, and D.Butur, National Institute for Research and Development in Microbiology and Immunology “Cantacuzino”, Bucharest, Romania. theo@orlando-systems.com, dbutur@cantacuzino.ro

Backround: Increased Epidemological appearances with high virulence danger (SARS, Asian flues, Bioterror Agents, etc) requires increased intervention mobility directly in the infected areas, while respecting Biosafety rules and protecting fixed labs and facilities

Functions: To assist in early and reliable diagnosis, investigate outbreaks of disease, collect reliable surveillance data for effective disease control, participate to immunization national programmes, control the quality of water and food, control 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. 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. Identifiable diseases: SARS, HIV, Variola, Hepatitis, Anthrax, Ebola, Botullinic Toxin.

Technical: Mobile 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). Lab is containerized, self-supporting on trailers or on  small trucks with min 2,000kg loading capacity. A large tent is available on the right side, with 220VAC and 12VDC power outlets, an Autoclave and Decontamination unit. Available with Positive or Negative pressure, Bio-Safety Level II Hood or a GLOVEBOX BSL3, with fresh air HEPA filtering, it can provide a Level II or III BioSafety level for the occupants and samples.

Other facilities include a supply of safe water, a reliable source of energy like generator, Battery and solar. Also includes sterilization/incineration , chemical disinfections facilities.

Conclusion: Mobile Biological laboratories are of great use in Epidemological situations requiring Biosafety in sample collection and analysis.