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									                                                Laboratory networking in Republic of Georgia




        Consultancy Mission Report to Republic of Georgia
                        3/12/04-21/12/04




                        Dr Antoine Pierson (WHO/CSR/Lyon)

                                   Consultant
                                    PHRplus




       “Implementation of a laboratory network in Georgia”




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Table of contents
Table of contents .......................................................................................................................................2
Table of figures:.........................................................................................................................................3
Table of tables: ..........................................................................................................................................4
Introduction ................................................................................................................................................5
    i- Terms of reference of the consultation .............................................................................................................. 5
    ii- Acronyms used in the report ............................................................................................................................. 5
    iii- People met during the visit ............................................................................................................................... 6
    iv- Other projects linked to laboratory issues in Georgia ...................................................................................... 6
    v- Why implementing a laboratory network? ......................................................................................................... 7
       Isolated (i.e. non-linked into a network) laboratories status: ................................................................................................. 7
       Exchanges between levels: .................................................................................................................................................. 7
       Mission of the national laboratory network: .......................................................................................................................... 8
    vi- International Health Regulations (IHR) and laboratory confirmation ................................................................ 8
    vii- Key Georgian institutions involved during laboratory network implementation ............................................... 9
    viii- Several steps when implementing a laboratory network ................................................................................ 9
    ix- Rapid assessment of several laboratories in Gori ............................................................................................ 9
    x- Refinements of the ToRs ................................................................................................................................ 11
1- Normative step ................................................................................................................................... 12
    1-1 Agreement on definitions: ............................................................................................................................. 12
    1-2 Laboratory tutelary authority at the level of MoH .......................................................................................... 12
    1-3 Laboratory license criteria ............................................................................................................................ 13
    1-4 Inspection of laboratories ............................................................................................................................. 13
    1-5 Links with health insurance .......................................................................................................................... 14
    1-6 Analysis nomenclature ................................................................................................................................. 14
    1-7 Biosafety standards ...................................................................................................................................... 15
    1-8 Sampling requirements ................................................................................................................................ 15
    1-9 Signature requirements ................................................................................................................................ 15
    1-10 Reagents and supply registration ............................................................................................................... 15
    1-11 Equipment characteristic determination...................................................................................................... 16
    1-12 Organization of EQC .................................................................................................................................. 16
    1-13 National quality assurance programme ...................................................................................................... 17
2- Organization of laboratories, level of laboratories, number of laboratories ....................................... 18
    2-1 Existing types of public (non private) laboratories ........................................................................................ 18
    2-2 Organization of the laboratories at district level ............................................................................................ 19
       Summary of different laboratories at district level: .............................................................................................................. 19
       Proposed modification at district level: ............................................................................................................................... 20
    2-3 Existing relations between laboratories ........................................................................................................ 20
       At district level:................................................................................................................................................................... 21
       At regional level: ................................................................................................................................................................ 21
       At national level: ................................................................................................................................................................ 21
3- Analysis to be done at each level ...................................................................................................... 23
4- Technical details for all analysis chosen by level .............................................................................. 23
5- Equipment needed at each level ........................................................................................................ 24
6- Staff needed at each level ................................................................................................................. 24
7- Quality assurance .............................................................................................................................. 25
8- Implementation of the system ............................................................................................................ 26
9- Costing of all future activities ............................................................................................................. 27
10- Main recommendations .................................................................................................................... 29
APPENDIXES ........................................................................................................................................ 31
Appendix 1: Assessment of Gori Hospital Bacteriological laboratory .................................................... 32
Appendix 2: Photographs of laboratories assessed in Gori ................................................................... 33
Appendix 3: analysis by level ................................................................................................................. 34
    3-1 Sampling ...................................................................................................................................................... 36
    3-2 Cytology-hematology .................................................................................................................................... 36
    3-3 Hemostasis................................................................................................................................................... 36
    3-4 Immuno-hematology ..................................................................................................................................... 37
    3-5 Bacteriology.................................................................................................................................................. 37


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   3-6 Mycology ...................................................................................................................................................... 38
   3-7 Parasitology.................................................................................................................................................. 38
   3-8 Immunology .................................................................................................................................................. 38
   3-9 Virology ........................................................................................................................................................ 38
   3-10 Dynamic trials ............................................................................................................................................. 39
   3-11 Hormons ..................................................................................................................................................... 39
   3-12 Enzymes..................................................................................................................................................... 40
   3-13 Proteins ...................................................................................................................................................... 40
   3-14 Vitamins...................................................................................................................................................... 40
   3-15 Tumor markers ........................................................................................................................................... 41
   3-16 Biochemistry (blood, urine, CSF…) ............................................................................................................ 41
   3-17 Gazometry .................................................................................................................................................. 41
   3-18 Drug & toxic ................................................................................................................................................ 41
   3-19 Molecular biology ....................................................................................................................................... 42
Appendix 4: Equipment by level of laboratories ..................................................................................... 43
Appendix 5: Other programmes and partners working in the field of laboratories ................................. 46
      1- TADR/DTRA/high dangerous pathogens........................................................................................................................ 46
      2- World Bank project on primary health Care .................................................................................................................... 46
      3- European Union project on PHC in Kakheti region ......................................................................................................... 47
      4- Tuberculosis programme ............................................................................................................................................... 48
      5- Disease surveillance/USAID/Curatio .............................................................................................................................. 49
   6- Malaria network .............................................................................................................................................. 50
      7- HIV/AIDS ....................................................................................................................................................................... 50
      8- WHO/CSR strengthening programme ............................................................................................................................ 50
Appendix 6: Details on costing issues.................................................................................................... 52
   Price of equipment and sampling consumables ................................................................................................. 52
   Price of training................................................................................................................................................... 53
   Use of the Costing Tool for Laboratories ............................................................................................................ 53
Appendix 7: Documentation provided/gathered during consultation ..................................................... 55
Appendix 8: list of procedures to be developed for QA .......................................................................... 56
   Premises and generic procedures ...................................................................................................................... 56
   Staff management & organization procedures.................................................................................................... 56
   Sample procedures ............................................................................................................................................ 56
   Sample transportation procedures...................................................................................................................... 56
   Sterilization, hygiene & security procedures ....................................................................................................... 56
   Staining procedures............................................................................................................................................ 56
   Media procedures ............................................................................................................................................... 56
   Reagent procedures ........................................................................................................................................... 57
   Sample culture procedures ................................................................................................................................. 57
   Identification of a micro-organism ....................................................................................................................... 57
   Antibiotic susc. testing procedures ..................................................................................................................... 57
   Quality assurance procedures ............................................................................................................................ 57
   Data management procedures ........................................................................................................................... 57
   Disease specific procedures ............................................................................................................................... 57



Table of figures:
Figure 1: exchanges between levels .........................................................................................................7
Figure 2: laboratories present at district level ........................................................................................ 19
Figure 3: proposed modification of the lab number at district level ........................................................ 20
Figure 4: summary of the sample/data transportation ........................................................................... 26
Figure 5: budget for each level of sample transportation ....................................................................... 27
Figure 6: graphic representation of the budget for sample transportation ............................................. 28
Figure 7: directions of work of the DTRA project ................................................................................... 46
Figure 8: map showing organization of specimen collection for TB ....................................................... 48
Figure 9: VPDs quality assurance manual ............................................................................................. 49
Figure 10: details on sampling equipment and consummables costing ................................................ 52
Figure 11: training costs ......................................................................................................................... 53
Figure 12: screenshot of the tentative laboratory network tentative costing tool (WHO/CSR/Lyon) ..... 54



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Table of tables:
Table 1: summary of Gori bacteriology laboratory assessment ............................................................. 10
Table 2: List of terms related to laboratory activity requiring clear definition ......................................... 12
Table 3: staff number by level of laboratories ........................................................................................ 25
Table 4: budget categories for sample transportation ............................................................................ 28
Table 5: Details of the Gori computerized assessment ......................................................................... 32
Table 6: provisory list of analysis by level developed by the license unit and NGO “Genesis” ............. 35
Table 7: detailed list of analysis by level to be filled in........................................................................... 42
Table 8: list of equipment by level to be filled in .................................................................................... 44
Table 9: Example list of equipment by level (used by VPDs surveillance programme)......................... 45




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Introduction
          i- Terms of reference of the consultation
“Help develop a realistic model for the network of bacteriological and serological laboratories in
Georgia
Provide recommendations on
      the ideal number of such labs in the country
      their categorization by level
      minimum standards in terms of staffing, equipment, biosafety and quality control
      referral system and functional links to other health care institutions
Provide an estimate of how much it would cost the Government to run this model: implications in terms
of fixed and variable costs, and suggestions for the financial sustainability plan.”
                     rd
 This is the 3 consultation done for abt associates/PHRplus in the Republic of Georgia, after 2 other
        1
missions :
    in 2002: assessment of laboratories in Georgia in the focus of VPDs
    in 2003: writing a laboratory quality assurance manual for the VPDs diagnosis


          ii- Acronyms used in the report
                                      Agence Française de Sécurité Sanitaire et des Produits de Santé
            AFSSAPS
                                      (French Agency for Health Safety and Healths products)
            AST                       Antibiotic Susceptibility Testing
            ATCC                      American Type Culture Collection
            CCHF                      Congo Crimea Hemorrhagic Fever
            CIF                       Curatio International Foundation
            CDC                       Center for Disease Control (Atlanta, USA)
            CSR                       Communicable disease Surveillance and Response
            EQC                       External Quality Control
            EU                        European Union
            FDA                       Food & Drug Administration
            GTZ
            IDS                       Integrated Disease Surveillance
            IQC                       Internal Quality Control
            LAT                       Laboratory Assessment Tool
            MoLHSA                    Ministry of Labor, Health and Social Affairs
            NCDC                      National Center for Disease Control
            NRL                       National Reference Laboratories
            PCU
            PHL                       Public Health Laboratories
            PHR                       Public Health Reform
            PHRplus                   Partners for Health Reform plus Project
            QA                        Quality Assurance
            SCL                       Structure in Charge of Laboratories
            SOP                       Standard Operating Procedure
            TADR/DTRA                 Threat Agent Detection & Response
            TBE                       Tick Borne Encephalitis

1
    See appendix 5 for more details



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         US                      United States
         VPD                     Vaccine preventable disease
         WHO                     World Health Organization
         WRARI                   Walter Reed Army Research Institute


       iii- People met during the visit
MoH
Dr. Levan Baramidze          Head of Public Health Department
Dr. Rima Beriashvili         Director of the Standardization, Accreditation & Licensing unit
Dr. Paata Imnadze            Director of National Center for Disease Control
Dr. Shota Tsanava            Deputy Director, NCDC
Dr. Tamar Tchogovatze        Head of the malaria unit, NCDC
Dr. Tamar Zardiashvili       Epidemiologist, Biosafety & Threat Reduction Department, NCDC
Mr. Benjamin Kakavadze       Head of the Equipment unit
Mr. Giorgi Tvalavatze        Head of the Quality Control Inspection unit
Dr. Tina Bukia               Head of clinical lab department, medical academy
High Dangerous pathogens programme
Dr. Bonnie L. Smoak          Director of the Division of Preventive Medicine, US Army
Dr. Edmond F. Maes           Associate Director for Science, Epidemiology Program office, CDC
Dr. Robert F. Fagan          Surveillance systems, CDC
Dr. Timothy P. Endy          Director; Communicable Diseases, WRARI
Dr. Jason Paragas            United States Army Institute of Infectious Diseases
World Bank/PCU
Dr. Nino Moroshkina          Act. Director, Georgia Health/Social Projects Implementation Center
Dr. Irma Khonelidze          Georgia Health and Social Projects Implementation Center
Tuberculosis Project
Dr. Rusudan Aspindzelashvili Head of the Central Mycobacteriological Laboratory, Tbilisi
Dr. Shalva Gamtsemlidze      Project Coordinator, Tuberculosis Control, GTZ
Dr. Maia Kavtaradze          Project Coordinator, Tuberculosis Control, GTZ
Gori laboratories
Dr Donara Antadze            Director Gori Hospital bacteriology laboratory
HIV/AIDS
Dr. Tengiz Tsertsvadze       National AIDS coordinator, Infectious diseases Research Centre
Dr. Kathy Shermadini         Epidemiologist
USAID
Dr. Tamara Sirbilatze        Project manager
Dr. Gegi Mataratze           Project manager
European Union
Dr. John Gillespie           Health Management Consultant for the EU
Dr. Zaza Samadashivili       project manager, social & health assistance programmes
United Nations
Dr. Rusudan Klimiashvili     WHO liaison officer
Dr. Andrei Mosneaga          WHO medical officer, Tuberculosis/South Caucasus

       iv- Other projects linked to laboratory issues in Georgia
Eight major partners are having project with one or several components linked to laboratory
strengthening:
    1. TADR/DTRA/high dangerous pathogens
    2. World Bank project on primary health Care
    3. European Union project on PHC in Kakheti region
    4. Tuberculosis programmes
    5. Disease surveillance/USAID/Curatio
    6. Malaria network



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   7. HIV/AIDS
   8. WHO/CSR strengthening programme
Details about theses programmes can be found in appendix 5

        v- Why implementing a laboratory network?
Isolated (i.e. non-linked into a network) laboratories status:
        Lack of coordination,
        Lack of standardization
        Low quality analysis, low reproducibility
        Regular overlaps and duplication with other structures
        Dispersion of efforts and resources
        No centralization for:
             o Reagents and supplies
             o Quality assurance implementation
             o Waste management
        Limitation of the resources in general

                         Implementing a laboratory network will allow Georgia to increase the
                                           quality/cost/efficiency ratio:
        Quality:
              o Centralized supply of quality controlled reagents
              o National quality assurance programme
              o Staff refreshed on critical issues
              o National data management system
        Cost:
              o Reorganization of the laboratories  optimization of all working conditions, workload
                  and analytical processes  economy
              o Centralized supply of reagents  economy of scale
              o Preventive maintenance policy  increased equipment lifespan
        Efficiency:
              o Sample transportation instead of patient transportation (if any)
              o Improved data management
              o Improved links between laboratories and disease surveillance systems
              o Improvement of the prescription/interpretation of medical analysis


Exchanges between levels:

Usually, 3 levels of laboratories
are recommended in a country:
    1. „central‟             level:
        reference laboratories
    2. „intermediate‟        level:
        regional laboratories
    3. „peripheral‟          level:
        district laboratories
         th
 A 4 level can also be
defined at PHC level, when
some laboratory activities are
performed (usually limited to
very basic screening tests, in                        Figure 1: exchanges between levels
addition to specimen shipment
associated)




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Different types of exchange can be observed, as shown on figure 1.


Mission of the national laboratory network:
Providing quality and timely services, at the right place, responding to the needs of:
     The patient
     The community
     The healthcare system staff:
            o Clinicians
            o Epidemiologists
            o Sanitary engineers
     Deciders and politicians

       vi- International Health Regulations (IHR) and laboratory confirmation
The purpose of the International Health Regulations is to ensure the maximum security against the
international spread of diseases with minimum interference with world traffic. Its origins date back to
the mid-19th century when cholera epidemics overran Europe between 1830 and 1847.
In 1951 WHO Member States adopted the International Sanitary Regulations, which were renamed the
International Health Regulations in 1969. The regulations were modified in 1973 and 1981. The IHR
were originally intended to help monitor and control six serious infectious diseases: cholera, plague,
yellow fever, smallpox, relapsing fever and typhus. Today, only cholera, plague and yellow fever are
notifiable diseases.

The world is changing and very few urgent public health risks stay solely within national boundaries.
Coupled with increases in global traffic and trade, new microbes have appeared and old diseases have
re-emerged. The World Health Assembly has responded to these changes:
     In the early 1990s the return of old epidemics such as cholera in South America and the
       emergence of new infectious agents such as Ebola hemorrhagic fever resulted in a resolution
       calling for the revision at the 1995 World Health Assembly.
     The recent outbreak of SARS, the growing threats linked to avian influenza, all human and
       economical consequences linked to these outbreak did accelerate the process
     In 2001, the World Health Assembly adopted a resolution on Global health security: epidemic
       alert and response in which WHO was to support its Member States identifying, verifying
       and responding to public health emergencies of international concern.
     In January 2004, the WHO Executive Board decided to convene the Intergovernmental
       Working Group on the Revision of the International Health Regulations in November 2004.

What will change in the new IHR?
                                      (Bolded are part of IHR new regulations linked to surveillance/laboratory network)

1) Updating existing measures of the current IHR
     Guide on Ship Sanitation
     Guide on Hygiene and Sanitation in Aviation
     Guide to Early Warning Systems in Disease Surveillance.
2) Proposed key changes and benefits to Member States
     Real time event management system (including disease diagnosis)
     National core surveillance capacities: IHR requirements of detecting, reporting and
        responding to public health emergencies of international concern.
     Notification for public health emergencies of international concern

In conclusion:
All member States will have to improve their surveillance system, including laboratory confirmation
component, crucial for early identification and characterization of any causative agent, making further
rapid notification possible



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The deadline of May 2010 has been proposed for this new IHR implementation: all member states
should be able to rely on a functional and quality controlled surveillance network at this stage

Implementation of IHR (compulsory) can be the ideal moment to reform, review and reorganize the
global laboratory system in Georgia, including IHR specific diseases (mostly epidemic prone diseases)
but also all the other diseases or programmes needing laboratory confirmation or information

       vii- Key Georgian institutions involved during laboratory network
       implementation
Several institutions are involved:
    Ministry of Health
             o License, norms and standards unit
             o Reference laboratories (NCDC, TB reference lab, other reference labs)
             o Equipment unit
             o Quality control inspection unit
    Other ministries:
             o Ministry of Agriculture
             o Ministry of Defense
             o Ministry of Foreign Affairs
    Helped by different partners (see iv)

       viii- Several steps when implementing a laboratory network

Different steps:
     1. Normative step (laws, decrees, standards)  global frame of the lab work
     2. Organization of the labs (number/levels…)
     3. Package of analysis by level
     4. Methodology for each analysis (level-dependent)
     5. Equipment needed to perform the analysis following the methodology chosen
     6. Staff needed to perform the analysis using the methodology
     7. Quality assurance (procedures, maintenance, training of the staff…)
     8. Relations between laboratories (specimen flow/data flow)
     9. Costing of all activities
     10. Practical implementation of the network, how to organize activities

All these different steps will be developed in this report that will follow exactly this order

       ix- Rapid assessment of several laboratories in Gori
During a previous mission to Georgia (July 2002), several laboratories have been already assessed:
     Tbilisi (NCDC, Infectious Disease Hospital laboratories, Cito private laboratory)
     Batumi (PHL, Infectious Disease Hosp.)
     Kutaisi
     Rustavi (sanitary lab., Infectious Disease Hosp)
A paper questionnaire has been developed in collaboration with WHO/CSR/Lyon and used for the
purpose of these evaluations.

Since this time, CSR/Lyon developed a computerized laboratory assessment tool (called „LAT‟),
allowing the user to automatically generate indicators when filling-in the tool during assessment.
Indicators are been grouped into 10 different modules representing 10 key-laboratory activities.
In order to have a precise idea on how a Georgian intermediate laboratory would go through such
assessment, it has been decided to use LAT when assessing the Gori bacteriology hospital

5 laboratories have been visited in Gori:



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        Hospital bacteriology laboratory  detailed assessment using WHO LAT
        Hospital clinical laboratory
        Children hospital clinical laboratory
        Tuberculosis centre laboratory
        Public health “sanepi” laboratory

Summary of the LAT: (detailed results can be found in appendix 1), done 15/12/05


                       General indicator                                   37%

                       Average number of daily specimens                      1

                       1-building facilities and utility service           61%
                       2-biosafety, hygiene and security                    8%
                       3-specimen collection and recording                 45%
                       4-equipment                                         48%
                       5-reagents and supply                               47%
                       6-analysis and test performed                       71%
                       7-laboratory staff & working time                   53%
                       8-total quality                                     14%
                       9-reporting, analysis & communication               19%
                       10- outbreak participation                           0%
                                  (<50%: red, 50-85%: yellow, >85%: green)
                          Table 1: summary of Gori bacteriology laboratory assessment

Some comments about all laboratories visited: (photographs of the visited laboratories can be
found in appendix 2)

 Key points:
    Laboratory workload is very small (average 1-2 sample/day in bacteriology). Such amount of
      work doesn‟t allow laboratory staff to keep their proficiency within the time
    Laboratory staff is too numerous for the workload
    Laboratories are too numerous in the area (see 2-1 and 2-2)
    Laboratories are not well equipped, in quantity (only one microscope available in Gori
      Bacteriology laboratory) and in quality (monocular solar microscope instead of electrical
      binocular one, as example), equipment is not well maintained
    Cold chain is not monitored
    Very limited level of QA: no procedures, no IQC (no reference strains), no EQC
    Very low level of biosafety
    Very little commitment from central level: no supervision, no recommendation, no continuous
      training, no promotion of quality assurance, no provision of quality material…
    No central reagent registration unit  each lab has the possibility to buy non controlled
      reagents (as antibiotic discs, sold in Tbilisi already expired, see picture in appendix 4)
    No trust of the laboratory results by the clinicians
    Little knowledge of the clinicians on how to analyze and interpret laboratory results
    No communication between the 5 laboratories visited in the same town

Details about the different solutions proposed in order to strengthen the laboratory component in
Georgia can be found in 2-1 & 2-2


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        x- Refinements of the ToRs
Due to:
         Differential diagnosis of VPDs, that need to enlarge the initial spectrum of diseases targeted
         This future World Bank project
         This High Dangerous pathogens project and these new laboratories being built in the country
         The future implementation of IHR (NCDC is focal point)
         Common needs of several programmes (communicable and non communicable diseases) for
          sample transportation
         Common needs for laboratory staff training
         Common need for a National Laboratory Quality Manual

In accordance with MoH and CIF staff, it has been decided to extend the scope of the initial
ToRs in order to cover all laboratories activities in the country




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1- Normative step
This part will address the entire frame that should be implemented prior to the laboratory network. It will
also address some key-issues that should be solved

       1-1 Agreement on definitions:
The licensing unit should provide the laboratories a set of definition concerning all the major terms
used in the field of laboratories, in order to reach an agreement between all lab specialists.
As example, some confusion seems to remain when using terms such as „licensing‟, „certification‟ and
„accreditation‟:
     A „license’ is an authorization delivered from a licensing unit allowing you to open your
         laboratory if some national norms are respected
     Once open, you can decide to obtain a „certification’ that can be obtained in a specific domain
         of activity (viral serology, mycobacteriology, haemostasis…) or for all types of activities.
         International laboratory specific standards have to be respected (as ISO 17025 for example)
     If the laboratory is part of a bigger structure (usually hospital), this structure can try reach the
         „accreditation’ level. A global norm (from the ISO 900X type of norms) will be followed and the
         entire institution will be accredited. These norms are not laboratory specific, but cover any type
         of service-providing activities
 Having a set of very precise definition in Georgian language is a prerequisite for laboratory
networking

Here is a tentative and non limitative list of terms requiring a clear definition:

                     Accreditation                                  Licensing
                     Analysis                                       Procedure
                     Analysis report                                Qualification
                     Analytical system                              Quality
                     Assessment/evaluation                          Quality assurance
                     Certification                                  Reference values
                     Confidentiality                                Request form
                     External quality control                       Sample/specimen
                     Internal quality control                       Sampling
                     Laboratory                                     Transferability/reproducibility
                     Laboratory staff (all categories)              Validation

                    Table 2: List of terms related to laboratory activity requiring clear definition

       1-2 Laboratory tutelary authority at the level of MoH
There is no structure especially in charge of laboratories/laboratory science at the level of the MoH.
The existence of such coordination structure is also one of the prerequisite for a functioning laboratory
network. A “Laboratory office” or “laboratory coordination team” or “laboratory bureau” has to be
created at the level of MoH
Depending on the countries, laboratories are either:
      Alone in their unit
      Joined with drugs/pharmacy
      Joined with radiology
Terms of reference of such laboratory coordination office have to be very precisely defined as well as
its relations with the licensing unit; NCDC, other reference laboratories and all the other entities linked
to laboratories and laboratory science (including education)




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Nevertheless, an association of laboratory specialist has been created. This association is quite active
and regularly collaborates with the licensing unit, in order to insure laboratory visits/inspections and
various other expertise missions. One of the leading people of this association is named Dr Tina Bukia;
professor of biochemistry at the State Medical Academy. Till now, she visited 4 laboratories in two
different sets (last time was summer 04)

       1-3 Laboratory license criteria
Several licenses can be distributed to the laboratories, depending on the spectrum of analysis they are
carrying out:
     Bacteriology
     Virology
     Immunology
     Clinical diagnosis (hematology)
     Biochemistry
     Serology
     Cytology (cellular level)
     Histopathology (tissue level)
     Toxicology
     Cytogenetical analysis

For each of these components, several criteria are entering in the licensing process:
      Building and space
      Staff
      Equipment
      Diseases
      Tests
      Tests volume
There is no specific checklist designed to help the assessor to perform the job, only criteria for each
activities. Dr Bukia found the criteria to be at high level

Nevertheless, there are no specific requirements in these very important fields:
    Biosafety (NCDC is working in this field and will issue standards soon)
    EQC: no participation to an EQC programme is neither required nor compulsory in the country
       (we are only talking about participation and not about successful participation)
    Procedures/quality assurance: no basic quality assurance policy and procedures are required,
       no analytical procedures are required prior to licensing

In addition, once awarded, the license duration is permanent, and a licensed laboratory doesn‟t have to
require license renewal. In addition, laboratories licensed with the precedent norm (less restrictive)
don‟t have to go through a new visit and can use their old license forever.
Such fact will not push laboratories to respect or maintain standards once licensed, and should be
changed. 3 years seems to be a reasonable period for license validity

When licensing, on-site visit is compulsory and the accordance of the lab to the existing standards is
checked. As this visit is done without a standardized checklist; the quality of the visit will only depends
on the expert appointed for the occasion
No independent scoring system for each lab can be obtained this way; no improvement of the
laboratory quality can be monitored within the time

       1-4 Inspection of laboratories
Prior any inspection, authorization by court is required, and official permit has to be shown to the
inspected laboratory. Inspections are not considered as a way to improve the overall quality of
laboratory activity, but much more as “police operations”, only leading to fines and restrictions.



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They are not done on a regular basis, preventing improvement to become a regular movement. Once
again the problem of lack of checklist is a problem for inspectors, but also for the targeted laboratory
(no guidance before inspection).
As seen in 1-12, no EQC activity is performed in addition to inspections. The only way of control
remain very “static” (only conditions are checked), when EQC is very “dynamic” (real laboratory
performances are checked)

        1-5 Links with health insurance
There are no specific links between laboratories, license department and health insurance.
There are no official price lists for laboratory analysis usable in all the public structures of the country.
All laboratories are fixing their prices (free establishment of prices for all structures). This mean that
prices can vary very much depending on the structure.

Some federal programmes are free of charge for the patient (TB, cancer…) and laboratories are being
reimbursed by these vertical programmes. Anyway, the reimbursement allowed to the laboratories
performing these tests are very low, even bellow the reagents cost associated to the analysis. When
looking at the prices of private laboratories for similar analysis, they usually are between 10 to 100
times bigger than the one reimbursed by the programmes.

This system has some limits:
When a patient is suspected to develop a tuberculosis, he goes to the TB centre, performs lung
radiography and bacilloscopy. He has to pay for both (radiography is around 15 laris) and will be
reimbursed if one of these tests is positive. This advance of funds really limits the impact of these
programmes, and at least laboratory investigation for such diseases should be free of charge, incitating
people to perform the diagnosis.
The links with health insurance, the federal public health programmes and the laboratories should be
strengthened.

However, some analyses are free of charge in NCDC and in Tbilisi PH laboratory (as investigation of
meningitis case for example)

        1-6 Analysis nomenclature
A list of analyses that should be performed at each laboratory level is available in Georgia (see
appendix 3 for more details):
     Strengths of the list:
            o Its existence. Such list are rarely available in a lot of countries
            o Try to address several level of laboratories, grouped around 4 levels
            o Try to sort the analysis by family and precise some technical aspects (linked to a
                specific analysis) that are required for some laboratory level

      Weaknesses of the list:
            o All the analysis are not covered
            o Little precision about the analytical method that should be used to perform it. Little
                difference between screening and confirmation
            o Important analysis not available in the country are not planed (where to send, how to
                send, what to expect back)
            o Too many types of laboratories should be performing the same type of analysis 
                diminution of the number of laboratory types in order to simplify
            o No cost or cost range linked to analysis.
            o Still not officially validated by the Georgian MoH
More details about analysis by level can be found in section 3 and in appendix 3

Note about analysis prices:
Prices are free in Georgia, but a common price could be awaited in all the public facilities. This price
could also be an indication for patients and private laboratories.


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                                                                      Laboratory networking in Republic of Georgia



It is recommended to express the price using a coefficient (C), for example, glucose measurement
would cost 5C, HIV serology 20C, etc. If 1C = 20 tetri (fictitious number), this mean glucose analysis
would cost 1 lari and HIV serology 4 laris.
This coefficient can be revised on an annual basis, without having to republish the entire list of prices.
In addition, this coefficient can be a good and simple way to monitor the activity of a laboratory, when
summing up all analysis done expressed in number of coefficient

       1-7 Biosafety standards
Today, there are not clear biosafety standards in Georgia. NCDC is working to issue a list of standards,
but they are not close to release right now. These standards should include:
      Vaccination policy for laboratory staff: (already existing)
      Sterilization standards
      Disinfection & disinfectant standards
      Laboratory safe work standards
      Dangerous good transportation (national)
      Waste disposal standards
Once the standards established, the question will remain on who will be checking their real application
inside each laboratory

       1-8 Sampling requirements
No specific sampling diploma or attestation is required. This may not facilitate the national
standardization of specimen sampling, standardization of sample identification and standardization of
sample container and eventual transport media associated to the sampling itself
In addition, the field of responsibility of the sampler is also not clearly specified if any problem happens.
We just would like to remind that a good sampling (and a good sampling strategy) is the basis of a
good analysis. When sampling is correctly performed, 30% of the analysis is done. In addition, even
the best laboratory will never be able to get a good result with a bad sample.
The development of a basic certificate would allow this standardization, indispensable in a laboratory
network. A basic training

       1-9 Signature requirements
No laboratory can be opened in the country without a medical doctor in the staff. He is usually in
charge of the signature of the analysis result form.
In small facilities, when this single doctor is away from laboratory (meetings, vacations, illnesses…),
the signature responsibility is transferred to the lab technician. The transfer of signature responsibilities
has to be précised, as well as all the other responsibilities linked to this transfer of authorities:
     Respect of the procedures
     Equipment preventive maintenance
     Security issues
     Results validation
     Results transmission

       1-10 Reagents and supply registration
No specific agency for reagents registration is available today in Republic of Georgia. This allows the
commercialization of low quality reagents:
      Low sensitivity
      Low quality control before release
      Expired reagents
When implementing a laboratory network, the needs for analysis standardization also include the need
for reagent standardization.




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                                                                      Laboratory networking in Republic of Georgia



In addition to the lack of reagent registration standards, no central supply unit is available for laboratory
items. No specific custom rates for laboratory duties have been established (several countries are
using specific low custom rates for drugs, laboratory and radiology supplies).
The creation of such unit would allow:
     General decrease of all supply costs
     Control of the quality and registration of the kits
     Easy standardization among laboratories
     Decrease of shortages at peripheral level

          1-11 Equipment characteristic determination
The equipment unit has been totally changed in the past years and a large staff turnover has
happened. New norms are being redefined, and the responsible of the unit really lack guidance in
establishing these norms.
In addition to norms for each type of equipment, they have to work on the maintenance issues, always
critical for equipment lifespan (availability of specialist in the country, spare parts importation,
preventive maintenance schemes, basic training of end-user…)
A positive list of manufacturer should be issued, on the basis on their quality system process. Only
these manufacturers should be considered for public tenders.
In addition to the better quality of equipment, this will simplify maintenance issues in decreasing the
number of different model for the same equipment (different microscopes, centrifuges, photometers…)

          1-12 Organization of EQC
Objectives of EQC schemes:

Laboratory oriented objectives:
   1. Identifying possible deficiencies in laboratory practice, and guiding participants in any
       corrective actions to be taken for improvement;
   2. Identifying the reliability characteristics of particular methods, materials and equipment under
       routine conditions and suggest corrective actions as appropriate;
   3. Assessing and monitoring the impact of training; help for the preparation of future trainings

Public health oriented objectives:
   1. Providing the basis for the comparability of results during epidemiological surveillance and
        disease control
   2. Collecting information on laboratory measurements (intra- and inter-laboratory) to alert
        professionals and/or government bodies about problems related to traceability and
        harmonization of results, and establish limits of acceptability of results as appropriate for a
        given purpose;
   3. Collecting information for the purpose of licensing or accreditation of laboratories;

There is no organism specifically in charge of EQC/EQA programmes. Some surveys are being
organized by the national “laboratory bureau” and a specific unit should be created.
Two organisms have little experience in organizing schemes:
     Genetic Ecological Centre, that organized a couple of survey in biochemistry
     NCDC, that just begun to launch a programme in bacteriology
                                                                       2

Usually, EQC organizers are linked to reference laboratories. These laboratories should be already
participating to one or several EQC programmes before becoming organizer.

In addition, there is no clear policy specifying that all the Georgian have to participate to the National
EQC programme. These programmes shouldn‟t be punitive, at least during the first years. At the
beginning, only participation is compulsory. Before EQC programme becomes stricter, support can be
provided allowing a real improvement.


2
    In collaboration with WHO/CSR/Lyon unit



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On the same model of the license provided to laboratories, different programmes can be organized. A
laboratory owning 5 licenses (biochemistry, immunology…) will have to participate into 5 programmes.
In order to impact on the analyses a result, a minimum of 2 surveys per year per programme has to be
organized, ideally 3. Once again, participation should be compulsory. Usually, the programme is free
for public laboratories, and charged for private ones.

Important note: in addition to the programme itself, EQC programme are a very good way to begin a
laboratory network. A laboratory network needs regular activities and should be a clear benefit to its
members. Such programmes initiate communication, are performed on a regular basis and are
followed by corrective actions.

          1-13 National quality assurance programme
Surrounding the EQC programme, a national quality assurance programme has to be promoted. It
should be in charge of:
     National Quality Assurance Manual development
     Reference material provision
     Laboratory assessments
     External quality control organization
     Internal quality control promotion
     Training sessions coordination and evaluation
                                                    3




 All the issues considered in this first “Normative step” section will really condition the sustainability
of the future network.




3
    In collaboration with the medical university and adequate responsible



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                                                                       Laboratory networking in Republic of Georgia




2- Organization of laboratories, level of laboratories, number of
laboratories
        2-1 Existing types of public (non private) laboratories
“Public” laboratory definition is quite imprecise and may better be defined by excluding the pure
“private” laboratories. A large difference is made between “bacteriology” laboratories (direct
microscopy, culture and AST) and “clinical” laboratories (hematology, biochemistry and sometimes
blood grouping). Different types of public laboratories in the country:

        Primary Health Care laboratories
             o Polyclinics: few have a laboratory component
             o Ambulatory: very few have a laboratory component
              In these 2 cases, if existing the laboratory is mostly “clinical” with basic biochemistry
             and hematology tests

        District laboratories
             o Public health laboratories (originally “sanepi” laboratories), divided in two:
                        Inside centre of public health, including parasitology/malaria diagnosis
                            laboratory
                        Sanitarian laboratory, performing mostly food and water analysis (bacteriology
                            and physicochemical components), but also some stool analysis
             o Blood bank laboratories, almost all 66 districts have blood banking services, they are
                  usually also in charge of serology
             o STD laboratories, linked to IST consultation centre. They are existing in most of the
                  districts (not in districts close to large urban area)
             o Laboratories linked to women consultation centres

        Hospital laboratories
            o District hospital (bacteriology/clinical)
            o Children hospital (bacteriology/clinical), sometimes divided between in/out patients
            o City hospital (bacteriology/clinical), in the big towns

        Regional laboratories
            o Laboratories heading one of the 12 regions of the country
            o Not really developed except in Batumi, where NCDC has a branch lab
            o Sometimes a larger district laboratory considered as regional as in Kutaisi
            o In Kutaisi, Poti and Batumi, regional hospitals are existing, also equipped with
               laboratories

        Reference laboratories
            o NCDC
                     Diphtheria
                     Polio
                     Malaria
            o Tuberculosis laboratory
            o AIDS laboratory
            o Oncology/hematology (oncology centre)
            o Other?

        Other laboratories:
            o Railroad healthcare system
            o Army (ministry of defense)
            o Ministry of internal affairs, ministry of intelligence



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Note about reference laboratories:
Usually a laboratory is a reference for a limited number of diseases/disease families. The reference
doesn‟t seem to exist for all types. In addition, the reference status is not always clearly officially
declared (through decree or official publication).
Official notification would allow:
      Complete coverage
      Clear mission and objectives
      Clear resources allowed to reference laboratories
      Communication between levels and disciplines

2-2 Organization of the laboratories at district level
Summary of different laboratories at district level:


          Regular laboratories                                                 “Extra” laboratories



                                                                                            City hosp.
     District                    Sanitary            CPH lab.                                  lab.
    hosp. lab.                     lab.              parasit.                               C            B
   C            B



  Safe blood            “Women”             Tuberculosis           STD                        Children
  & HIV lab.              lab.                  lab.               lab.                        hosp.
                                                                                            C            B



        8 labs                                 Ambulantory
                                                  lab.
                                                                        Polyclinic
                                                                          lab.
                                                                                           4 labs
                           “B” and “C” mean “Bacteriology” and “Clinical” laboratories
                                   Figure 2: laboratories present at district level

As seen in 2-1 and in ix (Gori laboratories assessment), laboratories are too numerous. This doesn‟t
allow a good support to all of them in term of:
      Staff
      Equipment
      Reagents and supply
      Training
      Building conditions
In addition, the current system is not cost effective. Separation doesn‟t allow laboratories to buy bigger
equipment (chemistry auto-analyzer, automated cell counting, haemostasis analyzer, ELISA systems,
blood culture analyzer, and automated antibiotic susceptibility testing…)




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                                                                        Laboratory networking in Republic of Georgia



Proposed modification at district level:




    Arrows color :
     Specimens/Results                                        Regional &
                                                                National
     Supervision/QA                                         reference level


                                                                                                   Clinical
             Safe blood &
               HIV lab.                                                                           Bacterio

                                                               District                             STDs
                                                              hosp. lab.                           Parasit.
             Tuberculosis
                 lab.                                                                             Sanitary
                                                                                                   Women

     Sputum
  collection site                                            Primary health
                                                                care labs
                       Figure 3: proposed modification of the lab number at district level

The ultimate goal would be to have ONE STRONG POLYVALENT LABORATORY in each district. As
shown on the right part of the figure 2, this laboratory would be structured in different units:
     Clinical analysis (biochemistry, hematology, haemostasis)
     Human bacteriology analysis
     Sexually transmitted diseases analysis (except HIV and hepatitis issues)
     Parasitology analysis (including stool parasites and malaria)
     Food and water analysis (microbiology as well as physicochemical analysis)
     Analysis linked to Mother and child care
A night shift service has to be implemented inside the “clinical” unit of the laboratory, in order to get at
least one laboratory per district able to function 24/24 hours.

In addition to this large central laboratory, two other laboratory should complete the organization at
district level:
      Safe blood and HIV laboratory, in charge of ALL serologies for the district (linked to blood
          banking issues as well as for other purpose such as measles). This separation of serological
          issues will allow better equipment for the blood bank unit
      Tuberculosis laboratory. Depending on the district considered, either a sputum collection site
          or a real TB diagnosis laboratory is available. Due to the specificity and the biohazardous
          character of TB diagnosis centres, due to the existing links and programmes with different
          partners (as shown in appendix 5) and the existing network, it seems relevant to keep this
          separation.


       2-3 Existing relations between laboratories
Relations between laboratories have been described on the figure 1.
3 levels will be considered:



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                                                                                 Laboratory networking in Republic of Georgia



       District:
            o Central district laboratory
            o Safe blood & HIV laboratory
                                                     4
            o Tuberculosis laboratory (if available)
            o Other little laboratories from PHC/clinics located at the periphery of the district
     Regional
                  5

            o Central regional laboratory (larger district lab)
            o Safe blood & HIV laboratory (if available)
     National
            o Sample dispatching unit
            o Reference laboratories
As shown in figure 2, the future central district laboratory will be the heart of the district level
organization:

At district level:
        Reception of the samples from:
            o Other hospitals  analysis (eventually referred to upper level if exceeds possibilities)
            o PHC dispensaries/clinics  analysis (eventually referred to upper level if exceeds
                possibilities)
            o Safe blood & HIV laboratory  referred to upper level for safe blood and HIV (regional
                or national)
            o Tuberculosis laboratory  referred to upper level for tuberculosis (national only)
        Reception of results and data from regional/national level  transmission of the results:
            o Inside the hospital
            o To other hospitals
            o To safe blood & HIV laboratory
            o To tuberculosis laboratory
            o To PHC/clinics

 Even for TB and safe blood & HIV laboratories, the communication of sample between a district and
regional/national level will be done through this large district laboratory in order to simplify
transportation relays

At regional level:
Note: this model implies that regional laboratories are functional and are able to perform a bigger
analysis package than at district level. The regional polyvalent laboratory plays also the role of district
lab (no duplication inside the same town)
The regional polyvalent laboratory:
      Receive samples from lower level laboratories (district laboratories and PHL from their area) 
        analysis (eventually referred to upper level if exceeds possibilities)
      Receive results/data from national level  transmission inside regional laboratories and to
        district level
      Receive results from national Tuberculosis and Safe blood/HIV national laboratories 
        transmission to regional safe blood/HIV laboratory (if any) and to district level TB and safe
        blood/HIV laboratories
      Resend empty boxes ice bags and ice packs to the correct district laboratory

At national level:
Note: this model implies that a clear reference level has been established
A dispatching unit should be created in Tbilisi, in charge of receiving all samples from the periphery.
This unit could be ideally located inside one of the reference centre (NCDC, infectious disease
hospital, TB reference laboratory…). Roles of this unit:
4
 Sputum collection centre are not considered, as aprt of the regular TB network
5
  A regional level for tuberculosis diagnosis has not been planed in Georgia up today, diagnosis activities are split between
district and reference level, the sputum collection level is the real peripheral level



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                                                                   Laboratory networking in Republic of Georgia



        Receiving all the samples from periphery
        Receiving all the results from reference laboratories
        Receiving documents and data from different authorities (laboratory bureau, surveillance unit,
         reference laboratories…)
        Coordinating cold chain and transportation supplies for all network
        Sending samples to correct reference laboratory (depending on the specificities)
        Sending results/data to correct regional laboratory
        Resend empty boxes ice bags and ice packs to the correct regional laboratory
        Maintain a global database for disease referring and disease confirmation  excellent tool for
         epidemiologists and disease surveillance




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                                                                                 Laboratory networking in Republic of Georgia




3- Analysis to be done at each level
The determination of the list of analysis to be performed at each of the laboratory level is one of the
activities that will condition the future network of laboratory

In appendix 3, two different tables can be found:

        A table, summary of a book just issued by both Georgian license unit and NGO “Genesis” (end
         2004). This table shows, depending on the level of laboratory (3 levels defined) which analysis
         should be performed and which techniques linked to these analyses should be available
         (sampling, staining, observing…). Any time you climb a level, all the analyses of the lower level
         should also being performed (not shown in the table in order to avoid useless repetition)
        A second table, developed for the purpose of this report, containing 19 parts and trying to list a
                                                          6
         large variety of analysis that could be available .

The summary of the current standards is a very good beginning and the efforts of the team that
developed this book have to be highlighted.

In section 1-6 (analysis nomenclature), main strengths and weaknesses of this tentative list of analysis
by level have been already addressed.


 The second table in appendix 3 should be filled-in by a working group or by the newly created
laboratory bureau

Note: the VPDs surveillance project (Curatio International) developed a quality assurance manual
where the analysis linked to VPDs have been already linked to laboratory levels (See appendix 5)


4- Technical details for all analysis chosen by level
Simple question:
          “How should each analysis be performed? Which methodology should be used?”
A good compromise between the cost and the quality of the result has to be found.

The methodology can be different depending on the lab level considered, schematically:
     screening-oriented at district level
     first row confirmation at intermediate level
     definitive confirmation/full characterization at reference level
In any case, we have to keep in mind that the adequate technology should be used, and not high level
technology.

Example with Hepatitis B diagnosis:
    Ag HbS screening test  rapid test, no specific equipment required. QA requirements are
      existing but are little)
    Ag HbS confirmation  ELISA machine (with good QA level), reagents management (including
      cold chain)
    Other Antigens or Antibodies (biological follow-up of the disease)  ELISA machine (ideally 2)
      with full quality assurance policy, large reagents management, specialists for interpretation,
      involvement in the National EQA system …


6
 Due to their specificity, both Histopathology analysis and analysis linked to reproduction and medically assisted procreation
have not been included in this table.



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                                                                      Laboratory networking in Republic of Georgia



Example with blood sugar determination:
    Glucose estimation with dipsticks  rapid test, no specific equipment required. QA
      requirements are existing but are little
    Glucose home determination with glucometer (auto-control for diabetic people)  improved
      rapid test, need of the equipment. QA requirements are bigger, yearly maintenance/checking
      visit remain an issue
    Glucose routine determination with colorimeter (hospital routine method). Usually glucose
      oxydase method is used (GOP/POD) with a colorimeter. Reagent management is simple. QA
      requirements are high, regular maintenance, IQC and EQC participation are required.
    Glucose specific determination with precise 37° spectrophotometer using Hexokinase method
      (no other “oses” than glucose will interfere), usually for slight hyperglycemia confirmation,
      glucose one-day follow-up (6 samples/24 hours). This method requires very strict QA level,
      very well maintained equipment, good reagent management (3 times more expensive than
      glucose oxydase).

These small examples show the importance of the methodology and all the consequences it will
condition.

5- Equipment needed at each level
Once analysis by level defined (including methodology that should be used depending on the level), a
list containing all types of laboratory equipment should be filled-in. This has to be done for each
laboratory level. This list should give laboratories the possibility to perform the set of analysis planed,
using the methodology planed

In appendix 4, the table 8 provides this equipment list. It is recommended to fill each of the 4 levels.

Table 9 shows such a list developed for the specific purpose of VPDs in 2003 following a workshop
gathering several key persons from the country (MoH, NCDC, WHO…) but only including 3 levels of
laboratories (without PHC level). This list only covers VPDs needs (no biochemistry or hematology
activities are included)

6- Staff needed at each level

Once analysis, methodology and equipment have been defined, it is possible to estimate the amount of
staff needed in all the laboratories of the network in order to run the system.
A rapid survey should be performed in order to estimate:
      The existing workload in the different laboratories
      If low, the main reasons:
            o Quality of analysis performed?
            o Range of analysis proposed?
            o Quality of prescription and interpretation?
            o Geographical factors (access, weather…)
            o Financial factors?
            o Other factors?
      What could become this workload if a large central district laboratory is created?

Once workload roughly estimate, it is possible to match this workload with an appropriate number of
staff needed. Several staff categories have to be considered. As for equipment, a range mini/opti
(minimal and optimal number by level) can be used for the number required.
If any, night shifts have to be considered in the staff repartition.




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                                                                                Laboratory networking in Republic of Georgia


                                                         7
Once established, and if able to guess the cost of each staff category, it will be possible to know how
much the staff component of the network cost.

                                                      PHC                      district               intermediate
                                                     RANGE                     RANGE                     RANGE
    Director
    Senior specialist
    Technician
    Janitor/cleaner/driver/guard
    Technician assistant
    Secretary, administrator
    Logistician/stock manager
    Electrician/equipment maintenance
                                 total
                                   Table 3: staff number by level of laboratories



7- Quality assurance
As said several time in this report, Quality Assurance should be one of the factors leading this future
network. The concept of quality assurance can be broadened in order to include all laboratory activity
                                   8
in a concept called “Total Quality” . Total quality includes:

          Laboratory assessment
          Equipment issues (registration, inventory, preventive maintenance, curative maintenance…)
          Cold chain issue (control, monitoring…)
          Staff management
          Premises management
          Quality assurance manual / SOPs
          Internal quality control
          External quality control
          Norms, certification and accreditation

In addition to these topics, several other activities should be developed in Georgia:

          Reagents and supply registration
          Preparation of training needs for staff

The emergency in the field of Quality Assurance is the development of a National Quality Assurance
manual that should be used in all the Georgian laboratories. The VPD manual (see appendix 5) could
be completed to cover all laboratory activities:
           o Creation of a QA committee
           o Definition of the list of procedures needed
           o Creation of several working groups to write these procedures
           o Validation of these procedures
           o Distribution list

In appendix 8, a tentative list of procedures, only covering the needs of communicable diseases is
available. It can be used as the basis to develop the list of procedures needed.

7
 Including taxes, advantages, pension, training, EQA, housing, health insurance…
8
 WHO/CSR/Lyon developed a one week training module on “total quality”, already available in French, and available end of May
2005 in English (first English speaking session in June 2005 in Bordeaux, France)



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WHO/CSR/Lyon did provide several lectures on how to write a quality assurance manual, and the
NCDC staff trained in Lyon should be involved into the working group.

For networking purpose, special attention should be put on all the procedures concerning liaison
between laboratories (transportation, results…)

8- Implementation of the system
Note: on the CD-rom provided with this report, a set of documents useful for network implementation
can be used (section “Other documents”), the list can also be seen in appendix 7.

Schematically, 4 levels of laboratories can be defined:
    PHC
    District/Rayon (66)
    Region (11 + Tbilisi)
    Reference (not précised till today)

All the links between these labs have to be planed. We decided to include 8 PHC laboratories per
district, as average number. 61 districts have been also included (5 urban districts are not in the global
system, as they will only have inter-urban relations). 11 regions are also included. See also section 2-3
for more details about relations between levels

Primary Health Care level  Rayon level:
Once a week, samples will be transported by local buses from PHC to Rayon level. Results will be
brought back the following week by the same transporter.

Rayon level  Regional level:
Twice a week, samples will be transported by local buses from Rayon to Regional level. Results will be
brought back with the following transport.

Regional level  reference level:
Tree times a week, samples will be transported by local buses from Regional to Reference level
(sample dispatching unit). Results will be brought back with the following transport.

Figure showing relations between laboratories:




                                 Figure 4: summary of the sample/data transportation

Needs for this sample/results system:
    Transportation boxes, strong triple package are recommended in order to follow the
       international legislation and in order to be able to re-use boxes during 4 years (normal turn
       around time)
    Cold chain supplies: cold boxes, cold pack
    Little guideline for sampling/sample preparation/sample transportation
    Training of staff, every 2 years this number of staff should be trained in sampling:
            o 3 people per regional labs (3X11 = 33 people)
            o 2 people from rayonal/district lab (2X61 = 122 people)
            o 1 people from PHC (488X1 = 488 people)


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               This training should be done as “training of trainers” in order for them to be able to re-
              train colleagues when back in their laboratories

Turnaround times:
     Every two years for new training
     Every four years to renew transportation supplies

At district level, results and specimens are centralized by the district laboratory before dispatching to
adequate recipient laboratory

9- Costing of all future activities
Note: all tables and graphs (included in this report as pictures) are also available in MS Excel® format.




                             Figure 5: budget for each level of sample transportation

Figure 5 provide details about transportation costs of such system, sorted by area (PHCRayon,
Rayon  Region, Region  Reference)
Details about training costs and sampling equipment costs can be found in appendix 6.
Table 4 and figure 6 are summarizing all the costs for a basic but reliable system for sample
transportation. As seen, the costlier part is the transportation from all PHC to district laboratory




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                             Transportation PHC-district                $ 79 056
                             Transportation district-region             $ 39 528
                             Transportation region-reference            $ 16 200
                             Sampling equipment                         $ 16 134
                             Training issues                            $ 15 945
                             Overheads 6%                               $ 10 012
                                                      TOTAL yearly      $ 176 875

                             Cost/PHC                                    $      162
                             Cost/district                               $      648
                             Cost/region                                 $     1 473
                                 Table 4: budget categories for sample transportation



                           $10 012
                $15 945


                                                                         transp. PHC-district
         $16 134
                                                                         transp. district-region
                                                        $79 056
                                                                         transp. region-reference
                                                                         sampling equipment
        $16 200                                                          training issues
                                                                         overheads 6%



                     $39 528

                    Figure 6: graphic representation of the budget for sample transportation

In appendix 6, a tool newly developed by WHO/CSR/Lyon has been used in order to cost the entire
national Georgian network.




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10- Main recommendations

 About the global frame in which the network will be implemented:

1. Definitions of the terms
2. A laboratory bureau has to be created at the level of MoH

 About license and inspection

3. License criteria refinement, include a time component in the validity
4. Develop a national checklist for laboratory inspection, include biosafety, EQC and quality
   assurance in the inspection checklist
5. Include a time limited duration for the license once awarded

 About norms & standards

6. Review the different types of laboratory in order to come out with 4 clear levels of labs
7. Review the list of analysis that should be performed at each level, including a price coefficient, and
    the recommended method that should be used to perform the analysis
8. Develop a reasonable pricelist covering main analysis that should be available in public labs
9. Provide guidance to the equipment unit in order to help them finalizing the new equipment norms,
    maintenance issues and manufacturer recommendation
10. Finalize the biosafety standards being drafted by NCDC; plan their progressive introduction into the
    license requirements
11. Promote the national standardization of specimen sampling in developing a „sampling certificate‟
    each sampler should own prior to working
                                                                                   9
12. Development of minimum standards allowing reagents registration in Georgia .

 About several indirect units useful for the network implementation:

13. Promote a health economy survey about the relevancy of a national laboratory supply unit,
    eventually joined to other existing structures (drugs, medical supplies, radiology)
14. Create a specimen dispatching unit in Tbilisi inside one of the reference laboratory

 About global policy for laboratories and quality assurance

15. Implementation of a global quality assurance programme including
           1. Quality assurance manual
           2. Reference material provision
           3. External quality control organization
           4. Internal quality control promotion
           5. Training sessions organization

 About the network

16. Write a proposal and contact funding agencies checking for their interest in network creation
    participation
17. Organize the network




9
  As this issue seems an emergency when looking at some kits sold in Tbilisi, it is recommended to adopt as soon as possible
temporary standards based on existing one (EEC, French, FDA…) waiting for the National one to be developed



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APPENDIXES




    1. Assessment of Gori hospital bacteriology laboratory (15/12/04)

    2. Photographs of laboratories assessed in Gori

    3. Analysis by level

    4. Equipment by level of laboratories

    5. Other programmes and partners working in the field of laboratories

    6. Details on costing issues




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  Appendix 1: Assessment of Gori Hospital Bacteriological laboratory
                                             General indicator: 37%
1-building facilities and utility service          61%           Availability of screening tests               100%
Building conditions                                50%           Global indicator on availability of reagents  96%
Fluids conditions (Water supply conditions)        48%           AST availability                              50%
% of benched room utilized                         100%          Availability of identification                60%
Number of benched rooms (level dpt)                50%           Availability of high level identification       '
Communication                                      20%           Availability of very specific tests           50%
Communicable diseases coverage                     100%         7-laboratory staff & working time              53%
2-biosafety, hygiene and security                   8%           Presence of a senior staff                    100%
Use of safety equipments                           30%           % of senior staff                             100%
Availability of safety procedures                   0%           Presence of cleaning staff                    100%
Level of safety trainings                           0%           Availability of staff training                 0%
Safety conditions                                  25%           Availability of formal training                0%
Disinfection/sterilization of equipments            0%           Analysis decision                             100%
Availability of waste disposals                     0%           Working hours and days of work                25%
Availability of biosafety documentation             0%           Critical thinking outside working hours        0%
3-specimen collection and recording                45%          8-total quality                                14%
Quality of samples received                        80%           Availability of technical procedures          67%
Sampling procedures                                 0%           Availability of IQC                            0%
Quality of sampling request form                    0%           Availability of EQC                            0%
Critical thinking when handling samples             0%           Availability of temperature charts            33%
Quality of the logbook                             67%           Performing of preventive maintenance           0%
Macroscopic examination                            50%           Performing of equipment adjustments            0%
Specimen storage                                   100%          Availability of documentation/spare parts      0%
Quality of the specimen tracking                   60%          9-reporting, analysis & communication          19%
4-equipment                                        48%           Availability of disease reporting             20%
% of mini funct. Equipment available               55%           Availability of activity recording            50%
% of opti funct. Equipment available               28%           Availability of electronic activity recording   '
% of basic mini funct equipment available          71%           Availability of sample referring               0%
% of basic opti funct equipment available          39%           Laboratory supervision                         0%
5-reagents and supply                              47%           Availability of lab/lab collaboration         25%
Reagents preparation from powder                   50%          10- outbreak participation                      0%
Quality of reagent management                       0%           Involvement during outbreaks                   0%
Availability of funds for reagents                 50%           Specific outbreak supply                       0%
Use of expired reagents                             0%           Outbreak participation                         0%
Availability of basic staining reagents*           50%           Specific outbreak guidelines                   0%
Availability of special staining reagents*            '          Specific outbreak procedures                   0%
Availability enteric transp./culture media*        67%           Critical thinking with outbreak specimens      0%
Availability menin. transp./culture media*         100%            * no value mean that these analysis are not
Availability other transport/culture media*        100%            applicable (not needed in the lab), 0% mean
Availability AST reagents/culture media*           25%             that no reagents are available but should be
Availability of specific antisera*                 25%             present
Availability of serology reagents*                    '            „ mean that question is non applicable
6-analysis and test performed                      71%
                                  Table 5: Details of the Gori computerized assessment




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Appendix 2: Photographs of laboratories assessed in Gori
        Hospital bacteriology laboratory




Microscopy facility (monocular solar microscope); expired reagents (1993) bought the month before in
Tbilisi; wooden stock for heating (-5° the day of assessment) stored in bacteriology room.
      Hospital clinical laboratory




Biochemistry bench; sampling room; electrical wires (centrifuge)
     Children hospital clinical laboratory
                                                                        Hematology bench

                                                                        Old spectrophotometer (but still
                                                                        functioning)




        Tuberculosis centre laboratory
                                                                        Tuberculosis diagnosis cabinet

                                                                        Stain and chemicals




        Public health “sanepi” laboratory
                                                                        Benches

                                                                        Physico-chemical             analysis
                                                                        room




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       Appendix 3: analysis by level
       This first table is a summary of a book just issued by both license unit and the NGO “Genesis” at the
       end of 2004. This tables shows, depending on the level of laboratory (3 levels defined) which analysis
       should be performed and which techniques linked to these analyses should be available (sampling,
       staining, observing…). Any time you climb a level, all the analyses of the lower level should also being
       performed (in order to avoid useless repetition

       Note: the book was only available in Georgian language, and a rapid translation was kindly performed
       on the occasion by Dr. T. Zardiashvili. Some little imprecision or terminology may remain not very
       accurate.

LEVEL      TYPE OF MEDICAL UNIT                           ANALYSIS                                          METHODS
                                                     Clinical laboratories
  I        * ambulatory                  blood general analysis                          obtaining blood from finger
                                                                                         blood processing and microscopy in liquid
                                         Hemoglobin                                      condition
                                                                                         blood smear fixation/staining, hemato/cyto-
           * ambulatory, day hospital    N of erythrocytes                               diagnostics
                                         N of leucocytes                                 urine processing and microscopy
           * primary health care         N of platelet                                   stool processing and microscopy
                                         rate of erythrocytes sedimentation              phlegm smear fixation/staining, hemato- and cyto-
           * district hospital           blood coagulation and bleeding time             diagnostics
                                         microscopy smears for malaria identification
                                         urine general
                                         determination of proteins in urine
                                         determination of glucose in urine
                                         determination of bile pigments in urine
                                         stool general analysis
                                         stool research for latent bleeding
                                         phlegm mucous) general lab. Research
                                                       Biochemical analysis
                                         determination of glucose in urine               obtain blood (venous and capillary)
                                         prothrombin index determination                 isolation of plasma

LEVEL      TYPE OF MEDICAL UNIT                            ANALYSIS                                         METHODS
                                                      Clinical laboratories
           * district (municipal
  II       hospital)                     reticulocytes determination in blood            sampling and research of duodenal contents
                                         cytological determination of fetal hemoglobin   sampling and research of gastric juice
           * public health care centre   blood group and rhesus                          genital samples lab-diagnostics
                                         ketone and nitrites in blood                    CSF lab research
           * medical-social hospital     rate of haemturia
                                         nepichenko rule (shaped elements in urine)
                                         Zimnitski assay
                                         Ben-Jones albumen determination in
                                         stool research for helminthes & helminthes
                                         eggs
                                         stool research for protozoa identification
                                         CSF bacteriology
                                         lab research of duodenal contents
                                         determination of gastric juice acidity
                                         cytobacteriology of skin and mucous
                                         membranes
                                         cytobacteriology of eye swab
                                         cytobacteriology of vaginal swab
                                         cytobacteriology of urethral swab
                                         swab bacteriology to detect gonococcus
                                                      Biochemical analysis




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                                        total protein in blood
                                        creatinin in blood
                                        urea in blood
                                        Thymol trial
                                        glucose determination in blood
                                        B lipoproteins determination in blood
                                        total cholesterol in blood
                                        total bilirubin
                                        direct bilirubin
                                        Iron
                                        rheumatic factor
                                        C reactive protein in blood
                                        direct bilirubin
                                        diphenylamine trial
                                        antistreptolyzine determination in blood
                                                            Haemostasis
                                        Coagulogram
                                        blood coagulation time by lvy
                                        time of serum recalcification
                                        fibrinogen concentration determination
                                        thrombin time
                                        fibrinolysis activity determination

LEVEL      TYPE OF MEDICAL UNIT                           ANALYSIS                                            METHODS
                                                     Clinical laboratories

           * regional (republic)
 III       hospital                     hematocrit determination in blood                 lab research of serosity
                                        osmotic resistance of erythrocytes
                                        determination of mean diameter of
           * specialized hospital       erythrocytes
                                        cytological determination of fetal hemoglobin
           * clinical hospital          puncture sample cytological research
                                        catheter (from cavity organs) cyto-bacteriology
           * dispensary                 sperm cytobacteriology
                                        vagina purity rate
                                        direct fluorescence for Chlamydia, virus etc
           * polyprofile dispensary     detection,
                                        prostate juice lab research
           * polyclinic                 various pathologic material research for BK

           * maternity welfare
           centre/clinic                            Biochemical analysis

                                        Triglycerides
                                        HDL cholesterol
                                        LDL cholesterol
                                        aspartate aminotransferase ASAT
                                        alanine aminotransferase ALAT
                                        gamma-glutamyl transferase GGT

               Table 6: provisory list of analysis by level developed by the license unit and NGO “Genesis”




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This second table is a list of all analysis, grouped by discipline. It should be filled in before initiating the laboratory network

                                                                                            Hematocrit
          3-1 Sampling
                                                                                            hemoglobin electrophoresis
                    Analysis name                  PHC    DIS    REG     REF     ABR        hemoglobin F measurement
blood (capillary)                                                                           hemoglobin measurement (total)
blood (veinous)                                                                             hemoglobin solubility (itano)
CSF                                                                                         hemopathy diagnosis
Ear                                                                                         hemopathy follow-up
Ganglion                                                                                    Medullogramme
induced expectorations                                                                      research of Heinz particles
Medullar                                                                                    research of sickle cells
Mycology                                                                                    reticulocyt count
Nose                                                                                        Splenogramme
overflow (dropsy, pleural, articulation…)                                                   thrombocyte count
Skin
                                                                                                     3-3 Hemostasis
Sputum
STDs samples                                                                                                      Analysis name               PHC    DIS     REG      REF      ABR
Stool                                                                                       antithrombin III determination
Throat                                                                                      beta thromboglobulin
Uretral                                                                                     bleeding time
Vaginal                                                                                     cephalin activated time
Wound                                                                                       circulating anticoagulant research
                                                                                            differential II, VII, IX, X
          3-2 Cytology-hematology
                                                                                            euglobulin lyse test
                    Analysis name                  PHC    DIS    REG     REF     ABR        F IX determination
Adenogramme                                                                                 F VIII determination
auto-hemolysis test                                                                         F XI
blood hemogramme (complete)                                                                 F XII
blood protoporphyrin determination                                                          F XIII
cyto-chemical analysis                                                                      FDP determination
determination CD4 CD8 CD3                                                                   fibrinogene determination
ESR determination                                                                           fibrinopeptid A


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LMW heparin measurement                                                       CSF cyto-bacteriology
protein C determination                                                       dropsy overflow cyto-bacteriology
protein S determination                                                       eye sample cyto-bacteriology
prothrombine time                                                             genital cyto-bacteriology (cytology + ID)
standard heparin measurement                                                  Hemoculture
thrombin time                                                                 MIC determination
thrombocytic factor 4                                                         miscellaneous overflow cyto-bacteriology
thromboxan B2                                                                 nose-ear-throat cyto-bacteriology
Willebrand factor determination                                               pleural overflow cyto-bacteriology
                                                                              pus cyto-bacteriology
        3-4 Immuno-hematology
                                                                              research of bacterial toxin
                     Analysis name              PHC   DIS   REG   REF   ABR   research of Chlamydia
ABO grouping                                                                  research of diphtheria
direct compatibility test                                                     research of mycobacteria (ZN stain + culture)
direct Coombs test                                                            research of mycobacteria (ZN stain)
irregular antibody research                                                   research of mycobacteria species (biochemistry)
other RBC antigen determination                                               research of mycoplasma
Rhesus factor determination                                                   research of pertussis
Rhesus phenotype determination                                                research of rickettsia
thrombocyt grouping                                                           research of specific aerobic bacteria
                                                                              research of specific anaerobic bacteria
        3-5 Bacteriology
                                                                              research of specific bacteria (immunofluorescence)
                     Analysis name              PHC   DIS   REG   REF   ABR   research of spirochetes
anal cyto-bacteriology (cytology + ID)                                        serology borrelia
antibiotic seric concentration determination                                  serology brucella
antibiotic susceptibility testing (1 germ)                                    serology Chlamydia
antigen detection Yersinia                                                    serology coxiella burnettii
antituberculosis sensitivity testing                                          serology francisella
articulation overflow cyto-bacteriology                                       serology leptospira
basic sample cytology (microscopy + staining)                                 serology pasteurella
broncho alveolar washing cyto-bacteriology                                    serology streptococcus
broncho pulmonary cyto-bacteriology                                           serology syphilis
catheter cyto-bacteriology                                                    serotyping of bacterial strain


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skin cyto-bacteriology                                                               antigen detection leishmania
sperme cytobacteriology                                                              antigen detection toxoplasma
stool cytobacteriology                                                               antigen detection trichinella
urinary cyto-bacteriology (AS + cytology + ID)
                                                                                             3-8 Immunology
urinary strip analysis (2 parameters)
urinary strip analysis (full parameters)                                                                  Analysis name                     PHC    DIS     REG      REF      ABR
wound cyto-bacteriology                                                              antiDNA soluble antibodies determination
                                                                                     antiDNAn antibodies determination (IF)
        3-6 Mycology
                                                                                     antihistones antibodies determination
                       Analysis name                   PHC   DIS   REG   REF   ABR   antimitochondry antibodies determination
dermatophytes identification                                                         antineutrophil antibodies determination
exotic fungi identification                                                          antinuclear antibodies determination (IF)
filamentous fungi identification                                                     antiphospholipid antibodies determination
fungi microscopy                                                                     IgE specific determination
fungi sensitivity testing                                                            IgE total determination
Malassezia furfur identification                                                     rhumatoid factor determination (Waaler-Rose)
yeast identification
                                                                                             3-9 Virology
        3-7 Parasitology
                                                                                                          Analysis name                     PHC    DIS     REG      REF      ABR
                       Analysis name                   PHC   DIS   REG   REF   ABR   antigen detection adenovirus
stool parasite research (microscopy)                                                 antigen detection rotavirus
stool parasite research (microscopy + concentration)                                 antigen detection rotavirus
parasitic stool larva identification                                                 antigen detection RSV
malaria diagnosis (microscopy)                                                       serology adenovirus
malaria diagnosis (immunological)                                                    serology arbovirus
other blood borne parasites diagnosis                                                serology cytomegalovirus
derma/skin parasites diagnosis                                                       serology EBV
antigen detection aspergillus                                                        serology enterovirus
antigen detection candida                                                            serology H delta V
antigen detection Cryptococcus                                                       serology HAV
antigen detection distomatosis                                                       serology HBV
antigen detection echinococcus                                                       serology HCV
antigen detection histoplasma                                                        serology HEV


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serology HIV                                                         cortison
serology HSV (1&2)                                                   CRH
serology HTLV                                                        desoxycortisol
serology influenza                                                   DHA
serology measles                                                     E2
serology mumps                                                       E3
serology parvo B19                                                   erythropoietin
serology rabies                                                      FSH
serology RSV                                                         gastrin
serology rubella                                                     GH
serology VZV                                                         glucagon
viral culture diagnosis (generic)                                    GRH
                                                                     insuline
           3-10 Dynamic trials
                                                                     LH
                       Analysis name   PHC   DIS   REG   REF   ABR   LHRH
creatinine clearance                                                 melatonin
induced hyperglycemia                                                osteocalcin
urea clearance                                                       P substance
urine concentration trial                                            parathormon
urine dilution trial                                                 plasmatic cathecolamin
                                                                     plasmatic CGH
           3-11 Hormons
                                                                     pregnenolone
                       Analysis name   PHC   DIS   REG   REF   ABR   pro insulin
17 OH corticosteroids                                                progesteron
17 OH pregnenolone                                                   prolactin
25 OH D3                                                             PTH
ACTH                                                                 renin
ADH                                                                  serotonin
androstendiol                                                        T3, FT3, total T3
C peptide                                                            T4, FT4, total T4
calcitonin                                                           TBG
corticosteron                                                        testosteron
cortisol                                                             transcortin


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trypsin                                                             apoprotein B
TSH                                                                 beta 2 microglobulin
urinary 17-cetosteroids                                             C3
urinary 6 beta OH cortisol                                          C4
urinary aldosteron                                                  CRP
urinary CGH (pregnancy)                                             cryoglobulin research
urinary estrogens                                                   electrophyoresis of proteins
urinary free cortisol                                               ferritin
urinary OH indol acetic acid                                        fructosamin
urinary total catécholamin                                          haptoglobin
urinary vanylmandelic acid                                          HbA1c
                                                                    hemolytic complement 50
          3-12 Enzymes
                                                                    hemopexin
                      Analysis name   PHC   DIS   REG   REF   ABR   hyaluronic acid
5' nu                                                               Lp (a)
aldolase                                                            monoclonal dysglobulinemia diagnosis
ALP                                                                 myoglobin
amylase                                                             orosomucoid
CKMB                                                                prealbumin
CPK                                                                 procalcitonin
G6PD                                                                total IgA
GGT                                                                 total IgG
GO                                                                  total IgM
GP                                                                  total proteins
LDH                                                                 troponin
lipase
                                                                               3-14 Vitamins
          3-13 Proteins
                                                                                        Analysis name              PHC    DIS     REG      REF      ABR
                      Analysis name   PHC   DIS   REG   REF   ABR   folic acid
albumin                                                             vitamin A
alpha 1 antitrypsin                                                 vitamin B1
alpha 2 macroglobulin                                               vitamin B12
apoprotein A1                                                       vitamin B2


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vitamin B6                                                                       sodium
vitamin E                                                                        triglycerids
vitamin P                                                                        urea
                                                                                 uric acid
          3-15 Tumor markers
                                                                                           3-17 Gazometry
                      Analysis name                PHC   DIS   REG   REF   ABR
AFP                                                                                                  Analysis name           PHC    DIS     REG      REF      ABR
CA 125                                                                           2-3 diphospho glycerate
CA 15-3                                                                          carbon monoxyde
CA 19-9                                                                          methemoglobin/hemoglobin
CA 50                                                                            pCO2
CEA                                                                              pH
PSA                                                                              pO2
                                                                                 SaO2
          3-16 Biochemistry (blood, urine, CSF…)
                                                                                           3-18 Drug & toxic
                      Analysis name                PHC   DIS   REG   REF   ABR
ammoniac                                                                                             Analysis name           PHC    DIS     REG      REF      ABR
bicarbonats                                                                      alcool
bilirubin (tot., free, conj.)                                                    amikacin
calcium                                                                          aspirin
chlore                                                                           barbiturics
cholesterol                                                                      benzen
copper                                                                           benzodiazepin
creatinin                                                                        canabis
glucose                                                                          carbamazepin
iron                                                                             ciclosporin
iron fixation capacity                                                           cocain
lactic acid                                                                      digoxin
lithium                                                                          INH
magnesium                                                                        lead
osmolarity (measured)                                                            methotrexate
phospore                                                                         morphin/morphinics
potassium                                                                        paracetamol


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phenytoin                                                                  Chlamydia
theophyllin                                                                HBV, viral DNA
tricyclic drugs                                                            HCV, viral RNA
vancomycin                                                                 HIV viral load
                                                                           mycobacteria
        3-19 Molecular biology
                                                                           SARS virus diagnosis
                  Analysis name   PHC   DIS   REG      REF     ABR
CCHF



                                         Table 7: detailed list of analysis by level to be filled in




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Appendix 4: Equipment by level of laboratories

Minimal and optimal quantity of equipment that should be available in the different types of laboratory
are listed bellow in table 8
Please note that this list covers bacteriology, virology, serology, parasitology, biochemistry,
hematology and molecular biology

Once analysis by level defined (including methodology that should be used at different level), this list
should be filled in order to give laboratories the possibility to perform the set of analysis planed, using
the methodology planed

“mini” and “opti” refer to the MINImal stock that thould be available to perform the analysis decided for
the considered level, when OPTImal will show the comfortable amount of stock that should be provided
to the considered lab.

                                          PHC             district         intermed.           reference
                                      mini  opti        mini   opti       mini   opti         mini   opti
autoclave, 120 litres
autoclave, 60 litres
automated cell counter
automatic pipetters 0-20 µl
automatic pipetters 200-1000 µl
automatic pipetters 20-200 µl
biochemistry autom. analyzer
blood gas analyzer
blood grouping plates
candle jar for culture
centrifuge basic
centrifuge cooled
centrifuge hematocrit
CO2 incubator
coagulometer
computer (complete)
electrophoresis equipment
ELISA equipment (W/I/R)
ESR system
flame photometer
freezer-20°
freezer-70°
fridge
gel pulse electrophoresis
glassware kit, set *
heated magnetic agitator
immunoanalysis autom. analyzer
incinerator basic
incinerator large
incubator, 30°
incubator, 37°
incubator, 42°
Internet connection (year)



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laboratory information system
mallassez cell + dil. pipette
manipulation box
McFarland photometer
McFarland scale
media dispenser
microscope binocular
microscope fluorescence
microscope inverted
nephelometer/turbidimeter
oven
pH meter
photometer, basic
pressure cook, 12 litres
printer (laser)
protective Plexiglas screen
rotative agitator
safety cabinet class II
safety cabinet class III
scale basic (0,1 g)
scale precision (0,1 mg)
slide stainer (hematek)
spectrophotometer
thermocycler
vortex agitator
water distiller
waterbath
                                 Table 8: list of equipment by level to be filled in

For the specific purpose of VPDs, a list has been defined in 2003 following a workshop gathering
several key persons from the country (MoH, NCDC, WHO…) but only including 3 levels of laboratories
(without PHC level). This list only covers VPDs needs (no biochemistry or hematology)


                                                    Level III            Level II              Level I
                     Equipment                    laboratories        laboratories          laboratories
                                                 min.       opt.      min.       opt.      min.        opt.
         autoclave                                3           5        2          3         1           2
         basic scale                              1           2        1          1         0           1
         binocular microscope                     5          10        3          5         2           3
         candle Jar                               3           5        1          3         0           0
         clothes washing machine                  1           1        0          1         0           0
         CO2 incubator                            1           2        0          0         0           0
         computer+printer                         2           4        1          2         0           1
         diluter                                  1           2        0          1         0           0
         dryer                                    2           3        1          1         0           1
         electrophoresis equipment                1           2        0          0         0           0
         ELISA equipment (W/I/R)                  2           3        1          2         0           0
         emergency power supply                   1           1        1          1         0           0
         fluorescence microscope                  1           2        1          1         0           0
         freezer -20°                             3           5        1          2         0           1
         freezer -70°                             1           2        0          1         0           0
         fridge                                   4           8        2          5         1           2



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         gel pulse electrophoresis             1        1         0          0           0         0
         glassware kit                         1        1         1          1           1         1
         heated magnetic agitator              1        2         1          1           0         0
         incubator, large sized                2        4         0          1           0         0
         incubator, small sized                3        5         1          2           0         0
         Internet connection                   1        1         1          1           0         1
         manipulation box                      0        0         1          2           0         1
         Mc Farland photometer                 1        2         1          1           0         0
         media dispenser                       1        2         1          1           0         0
         oven                                  2        3         1          2           1         1
         photographic equipment                1        1         0          0           0         0
         plexiglass screen                     3        5         2          4           1         2
         precision scale                       1        2         1          1           0         0
         rotative agitator                     1        2         1          1           0         0
         safety cabinet class II               2        4         0          1           0         0
         safety cabinet class III              1        2         0          0           0         0
         slide dryer                           1        3         0          1           0         1
         thermocycler                          1        3         0          0           0         0
         vortex                                3        3         1          2           0         1
         washing machine                       1        1         0          1           0         0
         water distiller                       2        2         2          2           1         1
         waterbath                             2        4         1          2           1         1
             Table 9: Example list of equipment by level (used by VPDs surveillance programme)




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Appendix 5: Other programmes and partners working in the field of
laboratories
1- TADR/DTRA/high dangerous pathogens
The Biological Weapons Threat Agent Detection and Response (TADR) Surveillance System is a
programme run by the US Ministry of Defense, aiming at:
     Establishing an integrated, secure and sustainable disease surveillance system in Central Asia
         (Uzbekistan and Kazakhstan are also part of this project)
     Ensure Biosecurity and Biosafety of biological facilities.
     Support human, environmental, and veterinary disease monitoring.
     Promote potential for integration into a regional disease surveillance system
This will be done through:
     Construction of several high security laboratories in the country
     Modern, standardized, reliable diagnostics methods, as PCR-based diagnostics, ELISA.
     Improved Communications, transport, and integration e.g. computerization
     Data analysis and sharing
 In addition to activities strengthening epidemiology and disease surveillance in general.

This project is focusing on a limited number of diseases:
     Endemic plague
     Brucella
     Anthrax
     CCHF
     TBE
     Unique viruses (Tomdy, Barmody, Sadavaria Valley Fever, Karshi)
     Camelpox
     HFRS




                                 Figure 7: directions of work of the DTRA project

2- World Bank project on primary health Care
The main project development objective is to improve coverage and utilization of quality primary health
care (PHC) based on a model of family medicine/general practice, with an emphasis on reaching the
poor and disadvantaged. In the long-run, strengthening PHC services is expected to have a beneficial
impact on the health status of the Georgian population through prevention, early detection and the


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treatment of diseases responsible for a high burden of disease in the population (e.g. cardiovascular
diseases, tuberculosis, and acute respiratory infections). Implementation of PHC is also expected to
have a positive impact on the quality, cost-effectiveness and efficiency of health service delivery in
Georgia. 3 components of this project have been defined, bellow is a summary of these components.
Bolded and detailed are the issues related to laboratory:

    COMPONENT 1: PHC SERVICE DELIVERY (Estimated Costs: US$ 15.23 million total)

        Sub-Component 1.1: Establishing PHC Clinics in Urban and Rural areas The purpose of this
         sub-component is to develop PHC services in up to 74 rural and high mountain areas. The
         Project would support: (i) civil works for refurbishing the PHC clinics; (ii) basic office,
         diagnostic, therapeutic and laboratory equipment for all PHC clinics; (iii) vehicles in areas
         where the terrain is rough; and (iv) packet radio communication in selected locales.
        Sub-Component 1.2: PHC Referral Pilot: The objective of this sub-component is to test how
         the referral mechanism will work for maternal and child health services from PHC clinics in
         rural and high mountain areas to the Regional Hospital level. This pilot will be carried-out in the
         Imereti Region, and will link PHC clinics to the Kutaisi MCH Center. The Project will support: (i)
         partial rehabilitation of Kutaisi Maternity and Pediatric Hospital to establish the perinatal center;
         (ii) office, diagnostic, therapeutic and laboratory equipment for the center; (iii) training
         workshops for PHC teams in the latest international protocols for MCH; and (iv) local
         technical assistance for monitoring and evaluation of the pilot.
        Sub-Component 1.3: Community-based Information, Education and Communication (IEC).

    COMPONENT 2 - INSTITUTIONAL DEVELOPMENT (Estimated Costs: US$ 7.29 million total)

        Sub-Component 2.1 - Capacity-building for PHC Training: The purpose of this sub-component
         is to support training capacity in PHC. The proposed project will support: (i) civil works for
         rehabilitation of up to five Regional Family Medicine Training Centers (RFMTC) and selected
         office space for the Family Medicine Faculty; (ii) basic office, diagnostics, therapeutic and
         laboratory equipment for the RFMTC and office equipment for the Postgraduate Faculty; (iii)
         stipends for doctors and nurses undergoing the training of trainers (TOT) and for trainees
         undergoing retraining in family medicine/general practice; (iv) international and local technical
         assistance for developing a family medicine residency program curriculum and a business plan
         for the Family Medicine Faculty; and (v) workshops and study tours for staff of the Family
         Medicine Faculty to help build capacity in the management of family medicine residency
         programs, continuing education for family doctors and accreditation and licensing of family
         doctors. During Phase I, two RFMTCs will be developed in Kutaisi and Batumi for Western
         Georgia
        Sub-Component 2.2 - Capacity-building in the Management of PHC Services: The objective of
         this sub-component is to build the capacity of the Public Health Department within the
         MoLHSA for policy-making, planning and regulation of PHC services.
        Sub-Component 2.3: Strengthening Health Management Information Systems for PHC: The
         objective of this sub-component is to strengthen the design and implementation of a health
         management information system (HMIS) for primary health care.
        Sub-Component 2. 4: Support for PHC Health Care Financing Reforms: The objective of this
         sub-component is to build health care financing policy-making capacity in Georgia.

    COMPONENT 3 - PROJECT MANAGEMENT SUPPORT (Estim. costs US$ 1.24 million total)


3- European Union project on PHC in Kakheti region

The European Commission will support the Primary Health Care reform undertaken by the Georgian
Government with a total grant of € 7.5 million for a period of three years (2003-2006). The project
provides technical assistance at national and regional level in the areas of capacity building and reform
of the health care finance system (allocation of € 2.5 million). It also foresees investments in Kakheti


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region in terms of provision of equipment and refurbishment of existing Primary Health Care
infrastructure and related water and energy supplies, training of doctors, nurses and practice
managers, and addressing information, education and communication needs of health professionals
and the population (€5 million).
Before refurbishing, constructing and equipping Primary Health Care facilities and Family Medicine
services in Kakheti region, the Government decided that an inventory and needs assessment of the
existing health infrastructure and resources should be conducted. The European Union supported this
decision and a data collection exercise (September-November 2003), data processing and mapping
with GIS (Geographical Information System) was conducted in joint efforts with Geographics Company
supported by DFID. Subsequently, a criteria based approach has been applied by a team of European
experts to prioritize the allocation of funds for refurbishment, construction, equipment and staffing to
assist the MoH in developing a more effective and optimal system for allocation of health care
resources toward PHC in Kakheti region.

In the field of laboratory, several PHC/polyclinics will be reequipped and re-supplied in reagents and
consumables. The analysis package will be limited to a basic list (level IV in the laboratory
classification). The possibilities of also refurbishing a regional Kakheti laboratory are being considered
by the implementation responsible
Important note: the responsible of disease surveillance in MoH should rapidly consider the issues of
package of analysis by level (and equipment related to it) as this EU granted project will need such
documents very soon and this could be the ideal situation to field test these packages at a large scale

4- Tuberculosis programme
Several partners are involved in TB surveillance/diagnosis
When only considering the diagnosis aspect, USAID and Merlin are involved in re-equipping several
diagnosis centres (In Tbilisi for USAID, in the Gori area for Merlin).
The work performed is appropriate, and a basic-but reliable laboratory has been rapidly visited in Gori
hospital. See photographs in appendix 2

Another programme, GTZ-funded, was also focusing on diagnosis:
After a couple of TB laboratory assessment, it was evident that the number of TB diagnosis
laboratories in Georgia was bigger than the needs. As example, some labs were having an average
number of 0,5 per day.
It has been decided to close some of the laboratories and to strengthen the remaining ones. Closed
laboratories have been transformed into “sputum collection sites” able to collect, register and ship
specimens to the next TB laboratory. Today, around 35 collection sites and 35 TB laboratories are
available




                       Figure 8: map showing organization of specimen collection for TB




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The map above shows how the system is organized

The transportation is done on a weekly basis, using local buses. Special boxes are used to transport
the specimens. Results are brought back with another bus (2 directions). The yearly cost to run the
transportation issues only is around 800-1000 USD per month:
                          35 transports X 4.5 weeks X 2 = 315 transportations.

The system comes out with a final price around 3 USD. This amount is very reasonable.

Strengths of the system:
     The organization
     The rationalization of TB diagnosis in the country (balance between labs & collection sites)
     The use of local transportation systems  reliable and sustainable
     The low cost of the system  sustainable

Weaknesses of the system:
    Funded by an external agency  what about the transportation costs after the project?
    Very good system at district level, but no communication between the peripheral TB lab and
      the central reference one  very few sputum referred for TB culture (only done at reference
      level)
    Transportation is not following international security standards (triple package, labeling,
      security, confidentiality management…)

 This system is really a good example of specimen transportation/laboratory networking. Without the
lack of communication with the central level, it would have been an ideal system. As for Safe blood and
HIV laboratories (see bellow), TB responsible would also be very interested in participating into a
common network for samples and specimens transportation.


5- Disease surveillance/USAID/Curatio
A large project on health information and disease surveillance
has been implemented by National NGO “Curatio
International” (2002-2005). Several aspects have been
considered:
     Strengthening immunization MIS
     Strengthening VPD surveillance
     Improving management capacities

The importance of laboratory confirmation has been
highlighted when beginning VPD surveillance. A global
assessment of several laboratories has been carried out in
July 2002 (see ix), and a laboratory quality assurance manual
for VPD diagnosis has been issued in 2004. Laboratory QA
manuals issued in Georgian language are not numerous and
such tools really impact on the way analysis are performed
(see photograph of the manual)


                          Figure 9: VPDs quality assurance manual

Laboratories networking together usually share the same quality assurance manual, covering all tasks
and procedures used in a laboratory. The VPD quality manual only could ideally be the basis of a more
comprehensive manual able to cover at least all communicable disease diagnosis.




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          6- Malaria network
                                                                     The map on the left shows the districts with
                                                                    reported cases of malaria in 2000.

                                                               Georgia is the only European country that
                                                               submitted a proposal to The Global Fund that
                                                               received a positive answer from them. This
                                                               proposal will really allow them to improve the
                                                               management of Malaria in the country.
                                                               Prior to this project, each district is supposed to
                                                               have a parasitology laboratory (half of the
                                                               former soviet “sanepi” system that is in charge
                                                               of diagnosis. With differences from on lab to
another, they are mostly not reaching satisfactory levels.
The future project (1,125 Mill. USD including 0,8 Mill. USD from Global Fund) will allow the malaria
responsible to strengthen the existing national programme for effective Malaria prevention and control.
Six different strategies will be used together:
     1. Strengthening institutional capacities of the National Malaria Control Programme (NMCP) and
          the general health care services;
     2. Improvement of national capacities for and access to early diagnosis and adequate
          treatment of Malaria;
     3. Promotion of cost effective and sustainable vector control;
     4. Strengthening of the country surveillance mechanism;
     5. Improvement of community awareness and participation in malaria control and prevention, and
     6. Enhancing intersectional collaboration.
In the field of laboratories, different activities will be carried out:
               Provision of 80 microscopes
               Provision of adequate stain and consumables
               Refreshing of the microscopists
Through this programme, a future malaria-specific laboratory network will be promoted soon.

7- HIV/AIDS
35 Transfusion laboratories are present in the country. They insure blood safety in performing HIV and
Hepatitis serologies. Few of them have ELISA machine available for serology. Most of them are using
rapid tests.
A very good serology/virology laboratory is located in the infectious disease hospital in Tbilisi, and is
able to confirm any abnormal result. Around 10 sera are referred to them monthly for HIV confirmation.
Two other larger laboratories are available in Batumi and in Zugdidi.
When peripheral laboratories are referring samples, they usually freeze the serum and pack it with ice-
pack into a cool bag. The bag is then carried to Tbilisi by one of the laboratory technician, either by
road or by car. The system works well for this small amount of samples but is not cost-effective (cost of
the technician transportation and fees) and doesn‟t allow regular surveys to be performed.

Dr. Tengiz Tsertsvadze, National AIDS coordinator, expressed his interest for a global multi-disease
network for laboratory specimen transportation that may allow each vertical programme to facilitate the
confirmation of some important diseases.

8- WHO/CSR strengthening programme
                                                                                        10
A two year training and mentoring programme for 8 Eastern and Central European countries begun
early 2003. The aim of this programme is to strengthen disease surveillance in:
     Involving actively laboratories in the surveillance system
     Providing refreshing in good laboratory practices

10
     Belarus, Bulgaria, Georgia, Moldova, Romania, Russia, Turkey, Ukraine



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      Providing strong training in biosafety and quality assurance
      Begin the creation of a national laboratory network
      Help to write a national plan of action for laboratory activities
Two high level people from NCDC attended this programme and are actively involved in these
           11
activities

In addition to this mentoring programme, several tools and training sessions have been developed by
WHO/CSR/Lyon:
     A laboratory assessment tool
     An Internet resource portal for public health laboratories
     A costing tool for laboratory network (still being developed, see its field-test in Georgia in
         appendix 6)
     Quality assurance programmes (regional & national)
     Training modules for laboratories (biosafety, quality assurance, samples management during
         outbreaks




11
     Details can be found at www.who.int/csr/labepidemiology



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Appendix 6: Details on costing issues

Note: all tables and graphs (included as pictures) are also available in MS Excel® format.

       Price of equipment and sampling consumables
Figure 8 shows the details about:
      Price of small equipment (included in the network budget)
      Price of sampling consumables (not included in the network budget as included in the
         hospital budget)
This sampling equipment represents quite a large amount of money, and is regularly a limiting factor of
sampling quality and quantity. It has not been included into the yearly budget, as already supported by
a large variety of programmes and institutions




                     Figure 10: details on sampling equipment and consummables costing




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       Price of training




                                        Figure 11: training costs

       Use of the Costing Tool for Laboratories
The Costing Tool for Laboratories (CTL) is a tool being developed by WHO/CSR/Lyon. It will help in
the development of a global budget to support national public health laboratory systems in their basic
laboratory surveillance activity.

This CTL is designed for various professionals including:
     Policy-makers
     Health Economists
     Administrators
     MoH Representatives
     Laboratory Coordinators
     Reference Laboratory Directors

The CTL can be used by the aforementioned professionals to:
    Calculate global costs for a laboratory network organization in their country
    Calculate costs for a specific disease syndrome



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        Calculate costs for a specific type of laboratory
        Calculate costs for a specific type of analysis

In addition, this CTL can be used in the development of a national strategic plan that explores the
following:
      How to screen/diagnose/confirm a specific disease
      How to organize and manage a laboratory network in a country
      How to determine the type of analysis that should be available at each level of the laboratory
         network
      How to determine the number of staff required at each laboratory level
      How to determine the amount of equipment needed at each laboratory level

This tool can be used in two different ways:

    1-    The rapid method uses automated calculations with no or few refinements in the calculations.
    2-    The precise method refines several of the indicators used for calculations when completing
         the tool. This method is more accurate; however, it is also more time-consuming process.

Important note: this tool is still under development and Georgia was one of the first countries for field
testing of the tool. We are only providing a screenshot of the result




     Figure 12: screenshot of the tentative laboratory network tentative costing tool (WHO/CSR/Lyon)

Once this tool finalized, it will be possible to include all country parameters in order to get a very
precise estimate.




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Appendix 7: Documentation provided/gathered during consultation
Documentation provided:

Note: a CD-rom containing a large amount of documentation has been burnt and left to the Director of
the License unit.

        WHO/CDC Manual for the Laboratory Identification and Antimicrobial Susceptibility Testing of
         Bacterial Pathogens of Public Health Importance in the Developing World (English), 3
         examples left (NCDC, Infectious Disease Hospital, Curatio International)
        Summary of the norm ISO 17025 (English), as official document is not for free distribution
        Questionnaire for microbiology laboratory certification, French Committee for Antibiogramme
         (English & French)
        French Norms for Antibiogramme (English and French), free distribution
        Links to NCCLS (US standards), as not free distribution
        Different types of Georgian maps (with regions, with districts, with both…), provided by the
         Health Mapping unit (WHO/Geneva)
        French “GBEA” (Guide de Bonne Execution des Analyses, Guide for good execution of
         analysis), small 25 pages summary of French norms for laboratories
        Moldovan policy for “National External Quality Control Scheme in Bacteriology” (English)
        Policies and procedures of the WHO/NHLS external quality control for African laboratories of
         43 countries (125 pages, in English)
        French nomenclature of analysis (free distribution)
        French official tests:
              o “Décret relative au contrôle de qualité des analyses de biologie médicale”, décret 94-
                  1049, 02/12/1994 (decree related to QC of analysis), decree that made compulsory
                  participation to National EQC programme (in French)
              o “Missions et competences de l‟AFSSAPS”, missions and objectives of the French FDA
                  (in French)

Documentation gathered:

        “Organization of TB laboratory network and sputum transportation project in Georgia”, with
         narrative, map and laboratory list
        Presentation PowerPoint of the DTRA project/training week in Georgia
        “PHC Service Model for Kakheti region”
        World Bank Primary Health Care Development Project: “Project Appraisal Document” (94
         pages)
        VPDs Quality assurance manual (only in Georgian up today)
        Georgian norms for laboratories (printed by NGO Genesis, only in Georgian up today)
        Georgian railroad time table (useful for regular train transportation)


Note: an interactive CD-rom for network implementation is also available




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Appendix 8: list of procedures to be developed for QA
                                                             47. Portagerm media
         Premises and generic procedures                     48. Other transport media
                                                             49. Particular cases: HIV, hepatitis, poliomyelitis,
    1.  QA responsible designation procedure
                                                                 haemorrhagic fever …
    2.  Global map of the laboratory
    3.  Restricted areas procedures
    4.  Electrical, watery, gas and other fluids pathway        Sterilization,       hygiene        &     security
    5.  Arrows, signs and labels in the laboratory              procedures
    6.  Thermal area procedures (air conditioning,
        heater, cold rooms)                                  50. Sterilization by the dry heat
    7. Emergency evacuation procedure                        51. Sterilization by the wet heat
    8. Procedures in case of fire, chemicals problem,        52. Chemical cold sterilization
        electrical hazard, biohazard                         53. Disinfectants, disinfections
    9. Cold chain procedures                                 54. Vaccination required for laboratory staff
    10. Decrees or official texts ruling the laboratory      55. Clothes required in the laboratory
    11. List of analysis performed in the laboratory         56. Lab-coat, napkins & tissues washing
    12. Restrictive list to be performed at night &          57. Hand washing
        weekend                                              58. Laboratory washing, including floor & benches
                                                             59. Safe manipulation procedure
                                                             60. Procedures in case of injury (chemical, wound,
         Staff management             &    organization          burning)
         procedures                                          61. Procedure in case of biohazard injury (incl. HIV+
                                                                 exposure)
    13. List of the staff, including flow chart &
        responsibilities
    14. One page by staff: address, background, initial         Staining procedures
        training, continuous training attended & to be
        attended, job description, acting person if absent   62.   Smears, films & slides performing
    15. Working hours & workload                             63.   Quality control of staining methods
    16. Daily organization procedure                         64.   Methylene blue staining
    17. Night shift & weekend shift procedures               65.   Gram staining
    18. Communication procedures between staff               66.   Ziehl Nielsen staining
        (notes, regular meetings …)                          67.   India ink staining
                                                             68.   Giemsa staining
                                                             69.   May Grünewald Giemsa / field staining
         Sample procedures                                   70.   Lugol staining
                                                             71.   Trichrome staining
    19.   Sampling rooms
                                                             72.   Lactophenol blue staining
    20.   Sampling material
                                                             73.   Weber staining
    21.   Sample rejection or acceptation criteria
                                                             74.   Gomori Grocott staining
    22.   Blood sampling (peripheral & capillary)
    23.   Stool sampling
    24.   Urine sampling                                        Media procedures
    25.   Vaginal sampling
    26.   Urethral sampling                                  75.   Media ordering procedures
    27.   STD sampling                                       76.   Media location in the laboratory
    28.   Sputum sampling                                    77.   General procedure on media preparation
    29.   Induced expectoration sampling                     78.   General procedure on media conservation
    30.   Wound sampling                                     79.   Culture media decontamination & elimination
    31.   Ear sampling                                       80.   Incorporation of ATB into Used culture media
    32.   Nose sampling                                      81.   Conservation and control of culture media
    33.   Throat sampling                                    82.   Non selective agar
    34.   Dropsy overflow sampling                           83.   Hektoen culture media
    35.   Pleural overflow sampling                          84.   Salmonella Shigella culture media
    36.   CSF sampling                                       85.   BCYE culture media
    37.   Ganglion sampling                                  86.   Blood agar culture media
    38.   Mycological sampling                               87.   Chocolate culture media
    39.   Medullar sampling                                  88.   Mc Conkey culture media
                                                             89.   Sabouraud culture media
                                                             90.   TCBS culture media
         Sample transportation procedures                    91.   Chapman culture media
                                                             92.   Kliegler culture media
    40.   Transport media general procedure
                                                             93.   Simmons citrate culture media
    41.   International transportation rules (IATA/other)
                                                             94.   Löwenstein Jensen culture media
    42.   Sending specimen procedure
                                                             95.   Coletsos culture media
    43.   Receiving specimen procedure
                                                             96.   Basic nutritive broth
    44.   Cary-Blair media
                                                             97.   Brain heart broth
    45.   Alcalin pepton water media
                                                             98.   Schaedler broth
    46.   TransIsolate media



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       Reagent procedures                                          149. Archiving EQC results
                                                                   150. Corrective actions to be taken following a bad
     99.    Reagent ordering procedures                                 EQC result
     100.   Reagent stock management
     101.   Reagent global use, quality control and storage
     102.   Reagent location in the laboratory                        Data management procedures
     103.   Reagent fabrication                               Recording & computerized procedures
                                                                  151. Legal frame on what should be recorded for
       Sample culture procedures                                       each patient
                                                                  152. Global recording procedures
     104.   Stool culture                                         153. Availability of the manual of the computerized
     105.   Urine culture                                              laboratory management software (CLMS)
     106.   CSF culture                                           154. Pre-analytical edition: working number, labels,
     107.   Blood culture                                              working sheets
     108.   Swab specimen culture                                 155. Results filling & technical validation procedures
     109.   Sputum culture (general)                              156. Criteria for re-analyzing an abnormal result
     110.   Sputum culture (tuberculosis research)                157. Access restriction for patient modification, result
     111.   Overflows culture                                          modification, biological validation
     112.   Culture for mycological research                  Archiving procedures
                                                                  158. Global organization of archiving: what, where,
       Identification of a micro-organism                              how
                                                                  159. Archives access restriction
     113.   Identification of a gram positive cocci               160. Backup & copies of archived data
     114.   Identification of a gram positive rods                161. How long to archive data, logbooks and reports
     115.   Identification of a gram negative cocci           Reporting procedures
     116.   Identification of a gram negative rods
     117.   STDs diagnostics & culture                                Disease specific procedures
       Antibiotic susc. testing procedures                    For each disease
                                                                   162. (some parts are not relevant for all the disease)
     118.   Media preparation, control & use                       163. Causative organism
     119.   AST general procedure                                  164. Specimen used
     120.   AST special feature procedure                          165. Collection, storage and transport. of specimens
     121.   MIC procedure                                          166. Material needed
                                                                   167. List of analysis to be performed, useless analysis
                                                                   168. Macroscopic examination of the specimens
       Quality assurance procedures                                169. Staining procedures, microscopic examination
General QA procedures                                              170. Analysis procedures
     122. Location of QA manual and documentation                  171. Serodiagnostic and other immunological tests
     123. Update of QA manual                                      172. Other significant organisms isolated from the
     124. Procedure flow inside the laboratory                          same specimen
Equipment procedures                                               173. Differential diagnostic, false positives, false
     125. General acquisition procedure                                 negatives
     126. General resp. & organization toward equipment            174. Quality control
     127. Centrifuge use, control & maintain                       175. Antimicrobial susceptibility testing
     128. Microscope use, control & maintain                       176. Presumptive identification
     129. Incubator use, control & maintain                        177. Further analysis to be sent out of the laboratory
     130. Laminar flow use, control & maintain                     178. Reporting of the results, units of the results
     131. Water bath use, control & maintain                       179. Referral, links with Public Health authorities
     132. Agitators use, control & maintain                        180. Biosafety, waste elimination
     133. Fridge use, control & maintain
     134. Freezer use, control & maintain                     Proposed list of disease
     135. Scale use, control & maintain                           181. Cholera
     136. ELISA chain use, control & maintain                     182. Shigella
     137. Colorimeter use, control & maintain                     183. Salmonella
     138. Spectrophotometer use, control & maintain               184. Diphtheria
     139. Turbidimeter use, control & maintain                    185. Typhoid fever
     140. Autoclave use, control & maintain                       186. Pyogenic meningitis
     141. Oven use, control & maintain                            187. STDs
     142. Dryer use, control & maintain                           188. Plague
     143. Washing machine use, control & maintain                 189. Tuberculosis
     144. Water distiller use, control & maintain                 190. Other respiratory diseases
Internal quality control procedures                               191. Malaria
     145. What IQC is to be performed                             192. Viral hemorrhagic fever
     146. Archiving IQC results                                   193. Hepatitis
     147. Corrective action to be taken following bad IQC         194. HIV/AIDS
          results                                                 195. Fungal infections
External quality control procedures                               196. Parasitic digestives infections
     148. What EQC is to be performed                             197. …




Dr. Antoine Pierson, Feb. 2005                                                                                    57/57

								
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