d11 2 kfva lims proposal - agjencia e ushqimit dhe ... · 17 functional model of lims 17.1 main...

Technical assistance for the Animal Health Department of the KVFA and the Food and Veterinary Laboratory (Kosovo) - Deliverable 11.2 -

Consortium Agrotec SpA / IZSVe / NIRAS 1 / 50

EUROPEAN UNION The European Union IPA 2013 programme for Kosovo

KOSOVO

TECHNICAL ASSISTANCE FOR THE ANIMAL HEALTH DEPARTMENT OF THE KVFA AND THE FOOD AND

VETERINARY LABORATORY (KOSOVO)

REF: EuropeAid/133795/DH/SER/XK

Deliverable 11.2

Proposal for a LIMS system for KFVA

July 2015



This document has been produced with the financial

assistance of the European Union

The contents of this publication are the sole responsibility of

the author / contractor / implementing partner and are in no

way be taken to reflect the views of the European Union.



Deliverable11.2KFVALIMSproposal

Version 24.07.2015

CONTENTS

Abbreviations ................................................................................................................... 5

General remarks ............................................................................................................... 5

Current situation .............................................................................................................. 5

System Partners ................................................................................................................ 6

System Hosting ................................................................................................................. 6

Data Entry ........................................................................................................................ 6

The software system ......................................................................................................... 7

User rights and roles ......................................................................................................... 7

Use Case ........................................................................................................................... 8

History concept of data ..................................................................................................... 9

Network and data security ................................................................................................ 9

Multiple language capability ............................................................................................. 9

Usability requirements ..................................................................................................... 9

Contractor requirements .................................................................................................10

Warranty and support requirements ................................................................................10

Installation, testing and training requirements .................................................................10

Functional model of LIMS.................................................................................................10

Mainfunctions..................................................................................................................................................................10

Analysesrequestandsamplereception................................................................................................................10

Worksheetcreationandresultscapture...............................................................................................................11

Aliquots ..................................................................................................................................................................................... 11

Verification and publication ....................................................................................................................................... 11

Administration ................................................................................................................................................................. 11

Documentation ................................................................................................................................................................. 11

Workflow Diagram ......................................................................................................................................................... 12

Integrated laboratory equipment ............................................................................................................................ 13

Labelling ............................................................................................................................................................................. 13

Submission Form coding .............................................................................................................................................. 13

Sample coding .................................................................................................................................................................. 13

“Result Type” field values ............................................................................................................................................ 13

Reports ................................................................................................................................................................................ 14

Standard Reports ................................................................................................................................................................. 14

User Defined Reports .......................................................................................................................................................... 14

Entity Relationship Diagrams .................................................................................................................................... 15

Sample and testing data ................................................................................................................................................... 15



Users ........................................................................................................................................................................................... 16

Data tables ......................................................................................................................................................................... 16

Clients ........................................................................................................................................................................................ 17

Sample Submission Forms ................................................................................................................................................ 17

Samples ..................................................................................................................................................................................... 18

Distribution Forms .............................................................................................................................................................. 19

Analyses Sets ........................................................................................................................................................................... 19

Analyses Testing Methods Sets ....................................................................................................................................... 20

Tests ............................................................................................................................................................................................ 20

Test Reports ............................................................................................................................................................................ 21

Sample Types .......................................................................................................................................................................... 21

Sampling Programs............................................................................................................................................................. 22

Analyses .................................................................................................................................................................................... 22

Testing Methods .................................................................................................................................................................... 23

SOP Prices ................................................................................................................................................................................ 23

SSF to Analyses ...................................................................................................................................................................... 24

SSF to Testing Methods ...................................................................................................................................................... 24

Species ....................................................................................................................................................................................... 24

Laboratory Departments .................................................................................................................................................. 25

Parasites ................................................................................................................................................................................... 25

Bacteria .................................................................................................................................................................................... 25

Viruses ....................................................................................................................................................................................... 26

Findings Necropsy ................................................................................................................................................................ 26

Findings Histology ............................................................................................................................................................... 26

Findings Organoleptic ........................................................................................................................................................ 27

Municipalities ......................................................................................................................................................................... 27

Villages ...................................................................................................................................................................................... 27

Users ........................................................................................................................................................................................... 28

User Roles ................................................................................................................................................................................. 28

User Rights .............................................................................................................................................................................. 28

Modules ..................................................................................................................................................................................... 29

User Interface Mock-ups .............................................................................................................................................. 29

Sample registration............................................................................................................................................................. 30

Pending samples ................................................................................................................................................................... 31

Distribution Form ................................................................................................................................................................ 32

Distribution Form with aliquots.................................................................................................................................... 33

Approval of Distribution Form ....................................................................................................................................... 34

Test Report .............................................................................................................................................................................. 35

Annexes...........................................................................................................................36

Annex 1. “Request for Analysis” Form – Version A ........................................................................................... 37

Annex 2. “Request for Analysis” Form – Version B ........................................................................................... 38

Annex 3. “Distribution” Form ..................................................................................................................................... 39

Annex 4. „Report“ Form ................................................................................................................................................ 40

Annex 5. List of Tests – Food and Milk Analysis ................................................................................................. 41

Annex 6. List of Tests – Animal Health ................................................................................................................... 47

Annex 7. “KFVA Organogram” ................................................................................................................................... 49



1 Abbreviations

ADO ActiveX Data Objects

ASK Kosovo Statistics Office

API Application Programming Interface

CSV Comma Separated Values format

ELISA Enzyme-linked Immunosorbent Assay

HTTPS Secure Hypertext Transfer Protocol

ID Identifier

ISO International Organization for Standardization

JDBC Java Database Connectivity

KFVA Kosovo Food and Veterinary Agency

LAN Local Area Network

LIMS Laboratory Information Management Sysm

ODBC Open Database Connectivity

PCR Polymerase Chain Reaction

PDF Portable Document Format

PK Primary Key

PVP Private Veterinary Practitioner

SLA Service Level Agreement

SOP Standard Operating Procedures

VAT Value Added Tax

XML Extensible Markup Language, file format

2 General remarks

Laboratory Information Management System (LIMS) at Kosovo Food and Veterinary Agency (KFVA) will be a software based laboratory and information management system with functionality to support the running KFVA Laboratory. LIMS key features will be:

- Sample management

- Worksheet management

- Test management

- Quality assurance

- ISO 17025 compliancy

LIMS will be related to other system systems: - Animal Identification and Registration

- Veterinary Information System

- Approval, Registration and Control of Establishments

- Reporting System for Inspectors

LIMS will be a component of the planned Integrated KFVA system.

3 Current situation

KFVA laboratory is currently able to perform a number of different tests. Tests are divided into the two following groups:



- food safety and quality tests

- animal health tests

For more information about types of test conducted at KFVA please have a look at annexes 5 and 6. The following data forms currently used at KFVA are related to LIMS:

- Request for Analysis Form, type A and B

- Distribution Form

- Report Form

For more information please have a look at annexes 1, 2, 3 and 4. KFVA laboratory is divided into 6 sections:

- Microbiology

- Chemistry

- Milk Analysis

- Serology

- Bacteriology

- Histopathology

For more information please have a look at annex 7 “KFVA Organogram”.

4 System Partners

The KFVA LIMS will offer benefits to different organizations, institutions and animal keepers, so called system partners. Each system partner has to be considered by LIMS according to its role. The important system partners are:

- KFVA

- Animal keepers

- Private Veterinary Practitioners

- Abattoirs

- Livestock markets

- Food Processors

5 System Hosting

The LIMS will be hosted either by government agency, by KFVA or by a private company. The hosting organization will be responsible for the maintenance and availability of the system. Appropriate Service Level Agreement (SLA) will be required to determine the conditions of LIMS hosting. Users will connect to LIMS using LAN and Internet. It is important to note that Agency of Information Society (ASHI) under the Ministry of Public Administration of Kosovo offers free system hosting services to governmental institutions. By implementing this approach KFVA will be able to significantly reduce costs that are related to LIMS server hardware and hosting.

6 Data Entry

In most cases data entry will be done form within the KFVA laboratory. In some cases authorized users will be able to access LIMS from outside of KFVA laboratory through Internet.



7 The software system

The LIMS software will consist of three tiers: - Presentation layer

- Business logic layer

- Database

The LIMS must be accessible through a web client. The database has to be a relational database accessible with JDBC, ADO or ODBC.

8 User rights and roles

The system must include user rights and roles module. The LIMS will allow for definition and maintenance of:

- User roles

- Users’ access right to LIMS functions depending on their roles

- Access to data depending on user roles

Before any function or data is accessed by a user the LIMS will internally check the user’s rights and publish data according them. Based on current organizational structure of KFVA laboratory the following user types are envisaged:

- Head of KFVA

- Laboratory Director

- Head of Laboratory Section

- Laboratory Technician

- Receptionist

- Quality Manager

- LIMS Administrator

- Animal Health (access to relevant reports only)



9 Use Case



10 History concept of data

The LIMS will ensure that any information stored in the system is retrievable at any time. Instead of data deletion information is marked as archived. Only system administrators can delete data, after a backup has been created. Data management follows history concept:

- Each record in the database has a time stamp and status fields

- When record is changed then existing information is copied to a new record. The original

record is set to archived

- When record is deleted then it is marked as archived

11 Network and data security

When LIMS accessed over Internet secure communication protocol (HTTPS) should be used. Only authorized users should be able to work with LIMS data. Access to LIMS and database should always be protected by a password. Data managed by LIMS should be classified according to sensitivity and handled according to policies set out by Kosovo government and KFVA. KFVA laboratory LAN should be firewalled in order to protect it from unauthorized access to LIMS information. Data backup policy should be developed defining the type and frequency of data backups.

12 Multiple language capability

The LIMS user interface has be in Albanian and Serbian. It should be possible to compile reports and printouts in Albanian, Serbian and English.

13 Usability requirements

A number of codifiers are included in the LIMS proposal in order to improve usability. Codifiers are used to store values that are stored once and used many times. The following codifiers are defined:

- Sample types

- Test types

- Testing methods

- Species

- Parasites

- Bacteria

- Viruses

- Findings Necropsy

- Findings Histology

- Findings Organoleptic

In order to reduce data entry mistakes the following functionality is needed: - “Species to Analyses”: When user picks analyses then only the analyses relevant for the

sample species are displayed



- “Sample Type to Analyses”: When user picks analyses then only analyses relevant to the

sample type are displayed

- “Analyses Sets”: When user is entering requested analyses it should be possible to pick a set

of predefined analyses and testing methods

14 Contractor requirements

Below is included a sample list of requirements for contractor. The list will be finalized when LIMS financing is secured and specific requirements have been established. The contractor shall provide to KFVA:

- Unlimited usage license

- License to change and adapt the LIMS

- Source code

- Technical documentation

- Tools required to compile and/or use the LIMS

15 Warranty and support requirements

Below is included a sample list of requirements for warranty and support. The list will be finalized when LIMS financing is secured and specific requirements have been established. The contractor shall provide to KFVA:

- Technical support services (maintenance, hotline, upgrades) for the period of 3 years

- Monitoring of operation

- Functional upgrades in the amount of 100 developer man-hours

- Time-to-react in urgent cases is not more than 4 business hours, in non-urgent cases is not

more than 24 business hours

16 Installation, testing and training requirements

The LIMS will be installed at KFVA laboratory. The LIMS will be tested according to agreed testing plans. The contractor will provide necessary training to the LIMS users and administrators.

17 Functional model of LIMS

17.1 Main functions

KFVA LIMS main functions are: - Analyses request and sample reception

- Worksheet creation and results capture

- Verification and publication

- Administration

- Documentation

17.2 Analyses request and sample reception

When a sample arrives at the lab it is registered in the LIMS. Sample record is created with a unique ID and date of submission. Hard copy of “Request for Analysis Form” will be printed



out and signed by the client. Receipt will be printed for the client. During sample reception labels can be printed. If applicable, animal ear tag numbers will be entered. Quality Manager will verify each sample submission record. Following Quality Manager’s approval worksheets will be created automatically.

17.3 Worksheet creation and results capture

For each “Request for Analysis Form” one or more “Distribution Forms” will be created based on the analysis requested. Each “Distribution Form” corresponds to a KFVA laboratory section. After conducting the requested analyses the laboratory technicians will enter the test results on this form. The head of corresponding laboratory section will review and approve each distribution form before verification and publication can take place.

17.3.1 Aliquots

If requested analyses are part of a sampling program then number of aliquots will be defined. When entering results the number of result fields for each sample will correspond to the number of aliquots.

17.4 Verification and publication

After all “Distribution Forms” that are related to a particular “Request for Analysis Form“ have been filled with results and approved by corresponding heads of laboratory sections the Quality Manager will check the results and create a “Report Form”. The form will be printed out to be signed by the Quality Manager and Head of the KFVA laboratory. If applicable, invoice will be created by the laboratory receptionist based on testing methods used and their corresponding prices and quantities.

17.5 Administration

LIMS administrator will manage the system users and codifier tables.

17.6 Documentation

The documentation module will contain the following material: - Quality Manual

- Approved Procedures (20+)

- Worksheets (80+)

- Other documents

Quality Manager will be able to add and modify the documents in the Documentation module. Other users will be able view, download and print the materials.



17.7 Workflow Diagram



17.8 Integrated laboratory equipment

In order to automatically read test results from ELISA reader unidirectional interface software adapted to the ELISA kit used by the KFVA Laboratory will be developed. When sample throughput has increased sufficiently the interface software for PCR Realtime will be needed.

17.9 Labelling

LIMS should be able to print sample labels and barcodes when samples are registered. Label size will be 3.5 cm times 3.5 cm. The labels will be attached to 50 ml tubes, which are 3 cm in diameter. It is envisaged that Code 128 formatting (https://en.wikipedia.org/wiki/Code_128) will be used for barcodes.

17.10 Submission Form coding

When a new “Request for Analysis Form” is registered it is assigned a unique code in the following format: first two digits representing a year number followed by a slash symbol, then four digits represent a serial submission number. At the start of each year the submission number will start from “0001”. For example: “15/0001” represents first “Request for Analysis Form” in 2015.

17.11 Sample coding

When a new sample is registered it is assigned a unique code in the following format: “Request for Analysis Form” code followed by a slash symbol and then four digits representing the sample code within the submission. For example: “15/0001/0001” represents first sample on first sample submission form in 2015.

17.12 “Result Type” field values

Test can have different types of results. The result types are:

Type name Explanation

“PosNeg” Result can be either “negative” or “positive”

“PosValue” Result can be either “negative” or “positive”, in

case of a positive result a numeric value has to

be entered

“PosClass” Result can be either “negative” or “positive”, in

case of a positive result a class has to be

entered. The class will be saved in Test table

“Result Class” field

“ListParasites” Result can be either “negative” or “positive”, in

case of a positive result at least one value has to

be selected from Parasites table. The value(s)

will be saved in Test table “Result Findings” field

“ListBacteria” Result can be either “negative” or “positive”, in


be selected from Bacteria table. The value(s) will

be saved in Test table “Result Findings” field

“ListViruses” Result can be either “negative” or “positive”, in


be selected from Viruses table. The value(s) will

be saved in Test table “Result Findings” field



“FreeText” Result is entered as a free text

“LegalLimit” Result can be either “negative” or “positive”, in

case of a positive result the test result value has

to be above the value in the “Legal Limit” field

“FreeTextFindings” Result is entered as a free text, for quality

control user has to select at least one row from

“Findings” table. The value(s) will be saved in

Test table “Test Findings” field

“Quantitative” Result can be either “detected” or “not

detected”, in case of detected result the result

value has to be entered

17.13 Reports

LIMS will be able to produce two type of reports: predefined standard reports and user defined reports.

17.13.1 Standard Reports

Reports will be compiled using one or more of the following conditions: - Time period

- Sample type

- Test Type

- User

- Lab Department

- Turn-around time

- Sampling program

Reports should have two output forms selected by user: either summary or detailed. It should be possible to export reports into various formats (for example into CSV, PDF or Excel formats). Standard reports specification will be finalized when LIMS funding has become available.

17.13.2 User Defined Reports

User will have the possibility to define and save customized report templates. User will select data fields, filtering and grouping conditions and save it as a report template. Later user can retrieve and execute customized reports and export the date into the desired format.



17.14 Entity Relationship Diagrams

17.14.1 Sample and testing data



17.14.2 Users

17.15 Data tables

LIMS data will be stored in the following main data tables: - Clients

- Sample Submission Forms

- Samples

- Distribution Forms

- Tests

- Test reports

- Sampling programs

The following codifier data table will be used: - Laboratory departments

- Sample types

- Test types

- Testing methods

- SOP prices

- Species

- Parasites

- Bacteria

- Viruses

- Findings Necropsy

- Findings Histology

- Findings Organoleptic

Users’ data is stored in the following tables: - Users

- User Roles

- User Rights



17.15.1 Clients

Data Type Mandatory Checks Notes

Client ID Serial Yes Unique Automatic

Client Name Text Yes Minimum 2 characters

Only alphabetic and

numbers

Client

Municipality ID

Serial Yes References

Municipalities table

Client Village ID Serial Yes References Villages

table

Client Address Text

Client Type Text Yes “Private”, “Government

Veterinarian”, “PVPT”

Client Business

Number

Text Queried through API

available from Kosovo

Business Registration

Agency at

http://www.arbk.org

Client Email Text

Client Phone Text

Client VAT Text Value Added Tax

registration number

Client Bank

Account

Text Bank account number

Client Bank Name Text

Status Char Yes “Active” or “Archived”

Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp

DateTime Yes Automatic

Modified By Serial Yes References Users

table

Functionality: - For each sample a client record is referenced.

17.15.2 Sample Submission Forms


Sample

Submission Form

ID

Serial Yes Unique Automatic

Client ID Serial Yes References Clients

table

Delivered By ID Serial Yes References Clients

table

Sampling Date Date Yes -1 week <= x <= Today

Sample

Municipality ID

Serial Yes References

Municipalities table

Sample Village ID Serial Yes References Villages

table



Sampling

Program ID

Serial References “Sampling

Programs” table

Sample Type ID Serial References “Sample

Types” table

Field Boolean “Yes” or “No”

Quarantine Boolean “Yes” or “No”

Hard Copy Boolean “Yes” or “No”

Sample Condition Text Yes “Satisfactory” or “Non-

satisfactory”

Sample Refusal Text Yes, if

“Sample

Condition” =

“Non-

satisfactory”

Sampling Area

Description

Text

Species ID Serial Yes References “Species”

table

Notes Text

Received By Serial References Users

table


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - “Sampling Holding Code” references animal holding data from external Animal I&R system.

The following fields will be queried: holding name, location, type, keeper, owner. The data is

automatically retrieved after user enters the holding code in LIMS.

17.15.3 Samples


Sample ID Serial Yes Unique Automatic

Sample

Submission Form

ID

Serial References “Sample

Submission Forms”

table

Sample Print ID Text Yes Unique

Format: Year/5 digits

Example:

”15/1234”

Calculated

automatically

Holding ID Text Yes, for

registered

holdings

References external

I&R holding register

Ear Tag Text Yes, for

individually

identified

animals

Ear tag format is

“RKS01234567”



Analysis ID Serial References Analyses

Table; Reference to

additional analysis to

be conducted on this

particular sample

Testing Method

ID

Serial References “Testing

Methods” table;

Reference to

additional testing

method to be

conducted on this

particular sample


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - For each Sample Submission Form sample data is recorded

17.15.4 Distribution Forms


Distribution Form

ID


Sample

Submission Form

ID

Serial References “Sample

Submission Forms”

table

Approved QC Boolean “Yes” or “No”

Approved QC By Serial References User table

Approved Lab Boolean “Yes” or “No”

Approved Lab By Serial References User table


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - For each sample a number of tests can be prescribed

17.15.5 Analyses Sets


Analysis Set ID Serial Yes Unique Automatic

Name Serial Yes

Description Serial Yes




Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - For simplifying “Distribution Forms” data entry by allowing to combine two or more analyses

into one set

17.15.6 Analyses Testing Methods Sets


Analyses Testing

Methods Sets ID


Analysis Set ID Serial Yes References “Analysis

Sets” table

Analysis ID Serial Yes References Analyses

table

Testing Method

ID

Serial Yes References “Testing

Methods” table


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - Stores links between “Analyses Set” and Analyses and “Testing Methods”

17.15.7 Tests


Test ID Serial Yes Unique Automatic

Distribution Form

ID

Serial References

“Distribution Forms”

table

Test Type ID Serial Yes References “Test

Types” table

Test Done By Serial Yes References Users

table

Test Result Text

Legal Limit Number Yes, when

“Result

Type” =

“LegalLimit”

Result Class Text Yes, when

“Result

Type” =

“PosClass”



Result Findings Text List of values selected

from codifiers


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - For each sample received a number of tests is planned

17.15.8 Test Reports


Test Report ID Serial Yes Unique Automatic

Distribution Form

ID

Serial Yes Reference

“Distribution Forms”

table

Date Test

Completed

Date

Approved QC Boolean “Yes” or “No”

Approved QC By Serial References Users

table

Approved by

Head of KFVL

Boolean “Yes” or “No”

Approved Head

By

Serial References Users

table


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - For each distribution form a test report is issued to the customer

17.15.9 Sample Types


Sample Type ID Serial Yes Unique Automatic

Description Text Yes


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality:



- For each Sample Submission Form a sample type should be recorded

17.15.10 Sampling Programs


Sample Program

ID


Description Text Yes

Number of

Aliquots

Number 1, 5, 9 Number of aliquots

required by the

Sampling Program

Turn Around

Time

Number Target number of days

for producing the test

result for the Sampling

Program


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - For each Sampling Submission Form a sampling program can be selected

17.15.11 Analyses


Analysis ID Serial Yes Unique Automatic

Analysis

Description

Text Yes

Turn Around

Time



result for the Analyses

Lab Department

ID

Serial References

“Laboratory

Departments” table

Necrology Boolean “Yes” or “No” Analysis is related to

Necrology

Histology Boolean “Yes” or “No” Analysis is related to

Histology

Organoleptic Boolean “Yes” or “No” Analysis is related to

Organoleptic

Parasites Boolean “Yes” or “No” Analysis is related to

Parasites

Bacteria Boolean “Yes” or “No” Analysis is related to

Bacteria

Viruses Boolean “Yes” or “No” Analysis is related to

Viruses


Insert Time DateTime Automatic



Stamp

Modification

Time Stamp



table

Functionality: - For each test a corresponding test type should be selected

17.15.12 Testing Methods


Test Method ID Serial Yes Unique Automatic

Test Method

Description

Text Yes

Analyses ID Serial References Analyses

table

Result Type Text Yes “PosNeg”, “PosValue”,

“PosClass”, “ListParasites”,

“ListBacteria”,

“ListViruses”, “FreeText”,

“LegalLimit”,

“FreeTextFindings”,

“Quantitative”

Unit Text

Turn Around

Time



result for the testing

method


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - For each Test type different testing methods can be selected

17.15.13 SOP Prices


ID Serial Yes Unique Automatic


table

Testing Method

ID


Methods” table

Sample Type ID Serial References “Sample

Types” table

Price Number Price for given SOP


Insert Time DateTime Automatic



Stamp

Modification

Time Stamp



table

Functionality: - For each Test type different testing methods can be selected

17.15.14 SSF to Analyses



Sample

Submission Form

ID

Serial Yes References “Sample

Submission Forms”

table


table


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - Each Sample Submission Form might one or more analyses requested

17.15.15 SSF to Testing Methods



Sample

Submission Form

ID

Serial Yes References “Sample

Submission Forms”

table

Testing Methods

ID


Methods” table


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - Each Sample Submission Form might one or more testing methods requested

17.15.16 Species


Species ID Serial Yes Unique Automatic

Species Name Text Yes

Species Group Text e.g. “Ruminants”




Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - Each Sample Submission Form must have a species field filled

17.15.17 Laboratory Departments


Laboratory

Departments ID


Department

Name

Text

Manager Serial References Users

table


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - Each test type references a laboratory department

17.15.18 Parasites


Parasite ID Serial Yes Unique Automatic

Parasite Name Text


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - Parasites table is a codifier table used for test results data entry

17.15.19 Bacteria


Bacterium ID Serial Yes Unique Automatic

Bacterium Name Text


Insert Time

Stamp

DateTime Automatic



Modification

Time Stamp



table

Functionality: - Bacteria table is a codifier table used for test results data entry

17.15.20 Viruses


Virus ID Serial Yes Unique Automatic

Virus Name Text


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - Viruses table is a codifier table used for test results data entry

17.15.21 Findings Necropsy


Finding ID Serial Yes Unique Automatic

Finding Name Text


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - “Findings Necropsy” table is a codifier table used for test results data entry

17.15.22 Findings Histology



Finding Name Text


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - “Findings Histology” table is a codifier table used for test results data entry



17.15.23 Findings Organoleptic



Finding Name Text


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - “Findings Organoleptic” table is a codifier table used for test results data entry

17.15.24 Municipalities


Municipality ID Serial Yes Unique Automatic

Municipality

Name

Text Official ASK name

Municipality ASK

Code

Text Official ASK code


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - Lists all Kosovo municipalities according to Statistical Office (ASK) standard

17.15.25 Villages


Village ID Serial Yes Unique Automatic

Village Name Text Official ASK name

Village ASK Code Text Official ASK code


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - Lists all Kosovo villages according to Statistical Office (ASK) standard



17.15.26 Users


User ID Serial Yes Unique Automatic

User Full Name Text Yes

User Name Text Yes

User Password Text Yes Encoded

Job Title Text

Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - All LIMS users must be registered in this table

17.15.27 User Roles


User Role ID Serial Yes Unique Automatic

User ID Serial References Users

Table

Role Description Text Yes


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - List of roles, for example “Lab Director”, “Receptionist”, “Lab technician”

17.15.28 User Rights


User Rights ID Serial Yes Unique Automatic

User Role ID Serial Yes Reference “Users

Roles” table

List of privileges Text Yes View, Add, Edit,

Delete, Search

Module ID Serial Yes Reference to

“Modules” table


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality:



- List of privileges per LIMS module, for example (View-only “Sample registration”)

17.15.29 Modules


Modules ID Serial Yes Unique Automatic

Module name Text Yes


Insert Time

Stamp

DateTime Automatic

Modification

Time Stamp



table

Functionality: - List of LIMS module, for example “Sample registration”

17.16 User Interface Mock-ups

Mock-ups for main LIMS screens are included here: - Sample registration

- Pending samples

- Distribution Form

- Distribution Form with aliquots

- Approval of Distribution Form

- Test Report



17.16.1 Sample registration



17.16.2 Pending samples



17.16.3 Distribution Form



17.16.4 Distribution Form with aliquots



17.16.5 Approval of Distribution Form



17.16.6 Test Report



18 Annexes



18.1 Annex 1. “Request for Analysis” Form – Version A

REQUEST FOR ANALYSIS FORM Data/Datum/Date:__________________ NR.BR.No.SER.:_____________________________

Emri dhe adresa e Klientit: Ime i adresa klijenta: Name and address of customer:

Analiza e kërkuar : Trazena analiza: Requested analysis :

Qëllimi i marrjes së mostrës/Programi: Cilj uzorkovanja/Program: Aim of sampling/Program:

Mostra e sjellur nga: Uzorci donosi: Samples delivered by:

Emri i mostres dhe sasia : Naziv uzorka i iznos: Name and amount of sample:

Përshkrimi i kushteve dhe vendit të marrjes së mostrës: Opis uzorkovanja, podrucja i uslovi: Desciption of sampling area and conditions :

Raporti i testimeve duhet të dërgohet me: Test protocol treba poslati sa: Test protocol should be sent by:

□ Kopje fizike/Papiru/Hard copy

□ E-mail E-maili:

Gjendja e mostrës: Status uzoraka: State of the sample:

□ E rregullt/Redovan/Regular □ Jo e rregullt/Nepravilan/Irregular

Refuzimi i pranimit të mostrës: Odbijanje uzorka na prijemu: Refusal of sample:

_________________________________________________________________ Emri dhe nënshkrimi i klientit/Ime i potpis klienta/Name and signature of client

Plotësohet nga Laboratori/Ispunjeni od Laboratorij/Filled by Laboratory:

Data e pranimit/Datum prijema/Date of reception:

Kodi i mostrës/Kod uzorka/Sample code:

Nënshkrimi/Potpis/Signature:

Vërejtje/Primedba/Note:



18.2 Annex 2. “Request for Analysis” Form – Version B

KËRKESË PËR ANALIZË/ZAHTEV ZA ANALIZU/REQUEST FOR ANALYSIS KËRKESË PËR ANALIZË/ZAHTEV ZA ANALIZU/REQUEST FOR ANALYSIS

Data/Datum/Date:__________________ NR.BR.No.SER.:_____________________________

Të dhënat për klientin/Podaci klijenta/Client Information Emri dhe mbiemri/organizata : Ime i prezime/organizacija :

Name and surname/organization:

Adresa/Vendi/Fshati/Regjioni : Adresa/Mesto/Selo/Region:

Adress/Place/Village/Region:

Analiza që kërkohet: Potrebna analiza:

Analysis required:

Statusi Vaksinal: Vakcinacijom:

Vaccination status:

Të dhënat për mostrën/Podaci uzorka/Sample information Data e dorëzimit të mostrës: Datum podnosenja uzorka :

Date of submission of the sample:

Lloji i mostrës: Vrsta uzorka:

Sample type:

Lloji i kafshës: Vrsta zivotinje:

Kind of animal:

Numri i mostrave: Broj uzorka:

Number of samples:

Projekti: Projekat :

Project:

Terreni: Zemlja:

Field:

Karantina: Karantina:

Quarantine:

Raporti i testimeve duhet të dërgohet me: Test protocol treba poslati sa:

Test protocol should be sent by :

□ Kopje fizike/Papiru/Hard copy □ E-mail

E-maili:

Gjendja e mostrës: Status uzoraka:

State of the sample:

□ E rregullt/Redovan/Regular

□ Jo e rregullt/Nepravilan/Irregular

Refuzimi i pranimit të mostrës: Odbijanje uzorka na prijemu:

Refusal of sample:



18.4 Annex 3. “Distribution” Form

DISTRIBUTION FORM

TË DHËNAT E MOSTRËS

Kodi i mostrës:

Sektori: Lloji dhe numri i mostrave: Testi/Analiza që kërkohet: Data e pranimit: Kushtet e mostrës në pranim:

Programi: Zyrtari i Distribuimit:__________________________ (Emri, mbiemri dhe nënshkrimi)

Aprovoi: Urdhëresë për kryerjen e testeve: Menaxheri i Cilësisë: Udhëheqësi i Sektorit:

___________________ ___________________

Datë:_______________ Datë:_______________

RAPORTI I TESTIMIT

Kodi Parametrat Metoda e testimit

Rezultati Data Nënshkrimi

15/75/SB /1 15/75/SB /2 …. 15/75/SB /20

Raportin e testimit e aprovoi: Udhëheqësi i Sektorit:

___________________ Datë:_______________



18.5 Annex 4. „Report“ Form

REPORT FORM

RAPORT TESTIMI/TESTIRANJE IZVEŠTAJ/TESTING REPORT

Numri Serik: Serijski broj/ Serial number Emri dhe adresa e klientit: Ime i prezime klijenta/ Name and surname of Client Referenca e planit të marrjes së mostrave: Referenca plana uzorkovanja/Reference of sampling plan Data e pranimit të mostrës(ave): Datum prijema uzorka/Date of sample reception Mostra e sjellur nga: Uzorci donosi/Sample delivered by Materiali që testohet: Materijal testiran/Sample tested Data e kryerjes së testimit: Datum izvršenja testiranje/Date of test completion Përshkrimi i mostrës: E rregullt/Redovan/Regular Jo e rregullt/Nepravilan/Irregular

Opis uzorka/Sample description

Rezultatet e testimit / Rezultat testova / Test results -Rezultati vlenë për mostrën(at) e testuar(a). Rezultat odnosi na testiranom uzorku/Result is valid for sample(s) tested. -Raporti nuk lejohet të fotokopjohet dhe keqpërdoret. Izveštaj nije dozvoljeno da fotokopira i zlostavljana/Result is not permitted to be photocopied or abused.

Data e lëshimit të rezultateve: ___ / ___ / ______ Datum izdavanja rezultata: Date of issue of result:

Menaxheri i Cilësisë: Dejtori i LUV: Menager kualiteta/Quality Manager V.V. Direktor LHV/Director of FVL: ____________________________ ___________________________ (Fillojetë Rrustemaj) (Bafti Murati)


Consortium Agrotec SpA / NIRAS / IZSVe 41 / 50

18.6 Annex 5. List of Tests – Food and Milk Analysis

Testing Materials

Testing Parameter Methods Testing

Equipment Measurement range

Measurement accuracy

Status

Meat and meat products

Total number of aerobic microorganisms

ISO 4833:2003 Incubator Balance Thermometer

+30 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited


Escherichia coli ISO 16649-2:2001 Incubator Balance Thermometer

+42 �C 10 gr. – 25 gr. -50 - +300 �C

± 2�C ± 1.0 gr. ± 1�C

Accredited


Coagulase-positive staphylococci

ISO 6888-1:1999 Incubator Balance Thermometer

+36 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited


Salmonella spp. ISO 6579:2003 Incubator Balance Thermometer

+36 �C, +42 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited


Enterobacteriaceae


+36 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited


Listeria monocytogenes

ISO 11290-1:1996/Amd.1:2004

Incubator Balance Thermometer

+25 �C, +30 �C, +36 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited


Bacillus cereus ISO 7932:2004


+30 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited


Coliforms ISO 4832:2006 Incubator Balance Thermometer

+36 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited

Milk and milk products

Total number of aerobic microorganisms

ISO 4833:2003 Incubator Balance Thermometer

+30 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited


Escherichia coli ISO 16649-2:2001 Incubator Balance Thermometer

+42 �C 10 gr. – 25 gr. -50 - +300 �C

± 2�C ± 1.0 gr. ± 1�C

Accredited


Coagulase-positive staphylococci


+36 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited



Testing Materials




Status


Salmonella spp. ISO 6579:2003 Incubator Balance Thermometer

+36 �C, +42 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited


Enterobacteriaceae


+36 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited


Listeria monocytogenes

ISO 11290-1:1996/Amd.1:2004


+25 �C, +30 �C, +36 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited


Bacillus cereus ISO 7932:2004 Incubator Balance Thermometer

+30 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited


Coliforms ISO 4832:2006 Incubator Balance Thermometer

+36 �C 10 gr. – 25 gr. -50 - +300 �C

± 1�C ± 1.0 gr. ± 1�C

Accredited

Raw Milk Colony Forming Units of bacteria (CFU)

ISO 21187

BactoScanTM

FC Foss Integrator-IMT Nr.serik: 0209200504

235 deri ne 10 milion CFU/ml

10%

Accredited

Raw Milk Fat ISO 9622:2013 MilkoScan Nr.serik: 1702200601

0-60%

<=1.0% Accredited

Raw Milk Protein ISO 9622:2013 MilkoScan Nr.serik: 201702200601

0-15%

<=1.0% Accredited

Raw Milk Lactose ISO 9622:2013 MilkoScan Nr.serik: 1702200601

2 - 10%

<=1.0% Accredited

Raw Milk Total Solids ISO 9622:2013 MilkoScan Nr.serik: 1702200601

0-50%

<=0.8% Accredited

Raw Milk SnF (Solids Non-Fat)

ISO 9622:2013 MilkoScan Nr.serik: 1702200601

8 - 12%

<=0.8% Accredited

Raw Milk FPD (Freezing Point Depression)

ISO 9622:2013 MilkoScan Nr.serik: 1702200601

0.488 – 0.543°C

Accredited

Raw Milk Somatic Cells ISO13366-2.2006; ISO 3696

FossomaticTM

Minor Nr.serik: 1111200402

100.000- 2 million cells/ml

< 7 % në 100.000 cells/ml < 5 % në 300.000 cells/ml < 4 % në 500.000 cells/ml

Accredited



Testing Materials




Status


Organoleptic

Scientific paper ,,Teknologjia e prodhimeve Blegtorale “ Page 11, year 1996

Accredited


Fat%

ISO 488:2008 ISO 11870:2009 ISO 3433:2008

Bytyrometer Gerber

0-80% 0.01% Accredited


Proteins %

ISO KJELDAHL ( ISO 8968 – 1:2001)

UDK 142 Automatic Distillation Unit

N: 0.1-200 mg

0.1mg N Accredited


Determination of added water % in milk

ISO 5764:2009

CryoStar 0.0001°C-1.5000°C

0.002 °C Accredited


Determination of acidity

ISO 6092:1980

Byret O-50 SH 0.01SH Accredited


Determination of milk density g/cm

3

ISO 8967:2005

Laktodensimeter

1.020-1.040g/ cm

3

ne 20ºC

0.000g/ cm

3

Accredited


Determination of solid residues %

ISO 13580:2005

Balance Max 410 g 0.01%

Accredited


Determination of solid non-fat residues %

ISO 8851-3:2004

Balance Max 410 g 0.01%

Accredited


Fat% ISO 1444:1996

FoodScan-Type , model 78810-520027787

850 - 1050 nm

<0.01 nm Accredited


Humidity % ISO 1442:1997


850 - 1050 nm

<0.01 nm Accredited


Proteins % ISO 937:1978


850 - 1050 nm

<0.01 nm Accredited


Total solid residues

ISO 936:1998

Peshore Max 410 g 0.01%

Accredited


Proteins % ISO 937:1978

UDK 142 Automatic Distillation Unit

N: 0.1-200 mg

0.1mg N Accredited

Milk Determination of antibacterial residues

ISO 13969:2003 DSM Delvo Test SP-Nt

Balance 0.1mg-210g 0.01% Accredited

Meat Determination of antibacterial residues

R biopharm Premi test Cod 3925


Eggs Determination of antibacterial residues

R biopharm Premi test Cod 3925



Determination of afla M1

ISO 14675:2003 Tecna Aflatoxin Afla M1 ELISA kit Cod. MA418

Elisa Reader 450nm

±1.0% and ±0.010Abs

Accredited

Milk and powder milk

Determination of Chloramphenicol

Tecna Chloramphenicol ELISA kit Cod. AB630

Elisa Reader 450nm

±1.0% and ±0.010Abs

Accredited



Testing Materials




Status

Grains, animal feed

Determination of B1(mycotoxins )

Tecna Aflatoxin B1 ELISA kit Cod. MA220

Elisa Reader 450nm

±1.0% and ±0.010Abs

Accredited


*B1-Gentamicin Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Enrofloxacin Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Beta-Lactam Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Neomycin Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Oxytetracycline

Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Tetracycline Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Doxycycline Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Ampicillin Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Amoxicillin Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Streptomycin Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Tylosin Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Quinolone Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

*B1-Sulphonamide Elisa Reader 450nm ±1.0% and ±0.010Abs

Not Accredited

Eggs

*B1-Gentamicin Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Enrofloxacin Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Oxytetracycline

Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Tetracycline Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Tylosin Elisa Reader 450nm ±0.010Abs Not Accredited

*A6-Chloramphenicole


*B1-Sulphonamide Elisa Reader 450nm ±0.010Abs Not Accredited



Testing Materials




Status

Meat (Cattle)



*B1-Beta-Lactam Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Neomycin Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Oxytetracycline



*B1-Doxycycline Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Ampicillin Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Amoxicillin Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Streptomycin Elisa Reader 450nm ±0.010Abs Not Accredited


*A6-Chloramphenicole


*AOZ Elisa Reader 450nm ±0.010Abs Not Accredited

Liver (Cattle)

*A5-Clenbuterol Elisa Reader 450nm ±0.010Abs Not Accredited

*A5-Ractopamine Elisa Reader 450nm ±0.010Abs Not Accredited

Blood *A6-Chloram. Elisa Reader 450nm ±0.010Abs Not Accredited

Urine

*A4-Zeranol Elisa Reader 450nm ±0.010Abs Not Accredited

*A3-Trenbolone Elisa Reader 450nm ±0.010Abs Not Accredited

*A3-19-nortesto. Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Gentam. Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Tetra. Elisa Reader 450nm ±0.010Abs Not Accredited



Testing Materials




Status


*A5-Clenbut. Elisa Reader 450nm ±0.010Abs Not Accredited

*A5-Ractopa. Elisa Reader 450nm ±0.010Abs Not Accredited

*A1-DES Elisa Reader 450nm ±0.010Abs Not Accredited

*A6-Chloram. Elisa Reader 450nm ±0.010Abs Not Accredited

Fish *B1-Quinolone Elisa Reader 450nm ±0.010Abs Not Accredited

Honey



*B1-Beta-Lactam Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Oxytetracycline



*B1-Doxycycline Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Ampicillin Elisa Reader 450nm ±0.010Abs Not Accredited

*B1-Streptomycin Elisa Reader 450nm ±0.010Abs Not Accredited




18.7 Annex 6. List of Tests – Animal Health Testing Material

s Testing Parameter Methods Testing

Equipment

Measurement range

Measurement accuracy Status

Blood Serum

Antibodies against Leucosis

OIE Terrestrial Manual, 2012

Enzootic Bovine Leucosis

Chapter 2.4.11 Page 7,8

ELISA Reader Tecan

Nanoquant 450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Accredited

Blood Serum

Antibodies against BVDV (Bovine Viral Diharrhea

Virus)

OIE Terrestrial Manual, 2008 Bovine Viral Diarrhoea

Chapter 2.4.8 Page 702,703

ELISA Reader Tecan

Nanoquant 450 nm

For 0-2 OD < ± (1 % + 10

mOD) For 2-3 OD < ±

2.5%

Accredited

Blood Serum

Antibodies against CSFV(Classical Swine

Fever)


Clasiccal Swine Fever (Hog

Cholera) Chapter 2.8.3

Page 1100

ELISA Reader Tecan

Nanoquant 450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Accredited

Blood Serum

Antigen of CSF (Classical Swine Fever) virus


Clasiccal Swine Fever (Hog

Cholera) Chapter 2.8.3

Page 1100

ELISA Reader Tecan

Nanoquant 450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Accredited

Blood Serum

Antibodies against IBR (Infectious Bovine Rhinotracheitis)


Infectious Bovine Rhinotracheitis/

Infectious Postular

Vulvovaginitis Chapter 2.4.13

Page 10,11

ELISA Reader Tecan

Nanoquant 450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Accredited

Blood Serum

Antibodies against Brucella melitensis in small

ruminants


Bovine Brucellosis

Chapter 2.4.3 Page 10-16

ELISA Reader Tecan

Nanoquant 450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Accredited

Blood Serum

Antibodies against Brucella abortus in cattle


Bovine Brucellosis

Chapter 2.4.3 Page 10-16

ELISA Reader Tecan

Nanoquant 450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Accredited

Blood Serum

Bluetongue ELISA Reader

Tecan Nanoquant

450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Not Accred

ited

Blood Serum

Toxoplasmosis ELISA Reader

Tecan Nanoquant

450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Not Accred

ited



Testing Material

s Testing Parameter Methods Testing

Equipment

Measurement range

Measurement accuracy Status

Blood Serum

Q-fever ELISA Reader

Tecan Nanoquant

450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Not Accred

ited

Blood Serum

Chlamydiosis ELISA Reader

Tecan Nanoquant

450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Not Accred

ited

Blood Serum

Brucella abortus, ovis, caprine

Rose Bengal Not

Accredited

Blood Serum

Brucella abortus milk test ELISA Reader

Tecan Nanoquant

450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Not Accred

ited

Blood Serum

FMD (Foot and Mouth Disease)

ELISA Reader

Tecan Nanoquant

450 nm

For 0-2 OD < ± (1 % + 10

mOD)

For 2-3 OD < ± 2.5%

Not Accred

ited



18.8 Annex 7. “KFVA Organogram”

d11 2 kfva lims proposal - agjencia e ushqimit dhe ... · 17 functional model of lims 17.1 main...

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