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1Special Edition
LabAfrica
EQA Programs
Lab Humour
Keton Official Launch
ESfEQA programs are Dakks accredited
Laugh at various memes and jokes from around the world
First year in business story
Edition 1
Keton Quality Perspective Magazine 2019/2020
Keton Scientific ConferenceStrengthening laboratory medicine practice globally
2LABAFRICA MAGAZINE
ANTONY JACCODUL - Editor in Chief
ANTONY JACCODUL - Editor in Chief
EDITORIAL
EDITORIAL
DESIGNED BY - JDT. ([email protected])
©Copyright 2019 Keton Limited. No part of this magazine may be reproduced in any form or stored on a retrieval system without prior knowledge or permisson of the publisher. While every effort is made to ensure the content of LabAfrica are accurate at the time of going to press, the publisher cannot accept respon-sibility for any errors that may appear, or for any consequence of using the information contained herein.
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ForewordQuality resides in prominence on endless development and system enhancement as an avenue of
accomplishing client satisfaction to guarantee firm’s long-term achievements. With this in mind, research must be as continuous and deliberate as much as possible since the patients needs also
keep evolving . Keton is therefore here to fill the void of our desires in quality through great collaboration with reputable life sciences organization in Europe and North America.
We believe our patients deserve the best and so do our medical laboratories that strive to provide an-swers to questions marks of our clinicians every single day. Our suite of products understand today’s laboratory because we have worked and walked from the lowest to highest level of laboratories providing answers and solutions regardless of size.
Our EQA services is present in over 30 countries including Kenya, Uganda, Tanzania, Zimbabwe, Zambia, Ghana, Nigeria India, Italy, United Arab Emirates, China, Turkey, Serbia, Romania, Portugal, Pakistan, Ger-many, Malaysia, Israel, Jordan, Iran, Greece, Georgia, Egypt, United Kingdom, France, Croatia, Costa Rica, Chile, Belgium . The suite services provided are duly accredited to ISO 17043:2010 by German Accreditation Body Gmbh (DAKKS). The training programs are most sought after in the region having trained over 1000 personnel in various lab programs and the numbers keep growing.
We hope our third party controls for hematology, chemistry, infectious diseases have helped labs fulfil various requirements of the ISO 15189:2012 standard specifically clause 5.6.
Quality is king and we shall continue providing avenues for sharing experiences such as the recently held Keton Scientific Conference which dwelt on laboratory discourse.
We also intend to fill the void in provision of quality RDT products for fecal bacteria and virus such as H.pylori, Campylobacter, Salmonella, Rotavirus, Adenovirus, Astrovirus and norovirus.
Microscopy remains a cornerstone in laboratory medicine practice and the reason we wish to bring col-laborative approach in microscopy through a collaborative HDMI enabled camera microscopes from Hol-land.
Hold our hand and get the best from the experts and sure enough our patients will smile through better and breakthrough solutions.
ANTONY JACCODUL - CEO Keton Group
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ContentsISSUE
05 KETON’S Profile 25 Calendar 2020
06 European Society for External Quality Assessment (ESfEQA) Programs
26 - 27 PICTORIAL
09 1st KETON Scientific Conference
11 Scientific Conference Presentations
13 KETON’S Official Launch
14 Lab Humour
15 KETON’S Award Ceremony Awardees
17 Method Verification
18 Third Party Controls
20 Euromex Microscopes
22 Vitassay Rapid Kits
24 Lab safety PPEs
IN THIS
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ProfileKeton Consulting is a leading proficiency testing and biomedicine consulting firm grounded on creating com-munities where people continually expand their capac-ity to create the results they truly desire, where new and expansive patterns of thinking are nurtured, where collective aspiration is set free, and where people are continually learning to see the whole together. We val-ue professionalism, mutual respect, results orientation, excellence, continuous learning and social responsibility.
Our expertise anchors heavily in implementation of ISO Accreditation and Certification Standards; ISO/IEC15189:2012, ISO/IEC17025:2017, ISO/IEC, 17043:2010, ISO13528, ISO19011, ISO9001:2015, ISO/IEC 17011:2017, ISO/IEC17034:2016 among Others.
ABOUT US
KETON’S
ESfEQAEuropean Society for External Quality Assessment
Assessment is very critical to laboratory quality management. It is usually done in several ways and the most commonly used method is that of External Quality Assessment. A suc-cessful performance of the EQA program reflects on the effectiveness of the laboratory’s
quality management, this also allows for the recognition of the laboratory quality by the external groups.
KETON is a regional collaborator of Europe-an Society for EQA with presence in over 30 countries Nigeria, Botswana, Kenya, Uganda, Tanzania, Zimbabwe, Zambia, Ghana, India, It-aly, United Arab Emirates, China, Turkey, Ser-bia, Romania, Portugal, Pakistan, Germany, Malaysia, Israel, Jordan, Iran, Greece, Georgia, Egypt, United Kingdom, France, Croatia, Costa Rica, Chile, Belgium. Accredited to ISO 17043:2010 by German Accreditation Body Gmbh (DAKKS).
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EXTERNAL QUALITY ASSESSMENTESFEQA WORKFLOW
ESFEQA REPORT STATISTICS Z-SCORE
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ESFEQA PROGRAMS
Biochemistry ProgramsBlood Gas and Electrolytes
Cardiac Marker
Clinical ChemistryCoagulation
Drugs of AbuseEthanol
Fecal Occult Blood
Glycated Hemoglobin
LipidsQualitative Urine Analysis (Urine stick)
Therapeutic Drugs
Urine Chemistry
BIO
CH
EM
IST
RY
Immunology ProgramsAllergology Inhale Allergens
Allergology Food Allergens & Insect PoisonAllergens,
HormonesSpecific Hormones
Tumor Marker
Tumor Marker/ Hormones
Microbiology ProgramsHematology ProgramsAdenovirus
Aspergillus Fumigatus Bacteriology
BorreliaBrucellaChagas
MIC
RO
BIO
LO
GY
Chlamydia Pneumoniae
Chlamydia Trachomatis
Coxsackievirus
ECHO-Virus Enterovirus
Epstein-Barr Virus Hepatitis A Virus Hepatitis B VirusHIV-1 RNA Viral LoadHIV DNHTLV I/II
Infectious Disease Combination Control
LeptospiraInfluenza B Virus
Measles Mosquito Transmitted DiseasesMalaria MicroscopyMalaria RDTMybacteria tuberculosis Microscopy
Parvovirus B19Parasitology Microscopy
Q-Fever Respiratory Syncytial Virus
Syphilis ToRCHTB Molecular –Gene Xpert and Hain Varicella Zoster Virus
Erythrocyte Sedimentation Rate Alifax
Erythrocyte Sedimentation Rate
Basic HematologyHematology 3 Part DifferentialHematology 5 Part DifferentialPeripheral Blood FilmSickle Cell
Parainfluenza Virus
Influenza A Virus
HEMATOLOGY PROGRAMS
IM
MU
NO
LO
GY
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KETONScientific Conference
Keton Scientific Conferences are meant to strengthen laboratory medicine practice globally.
Keton Scientific Conferences are meant to strengthen laboratory medicine practice globally through the bottoms up approach of skills transfer that ensures the human resource at the base of the pyramid is well equipped to tackle today’s challenges through innovation
and knowledge management. This was in tandem with our story of dedication to advancement of Quality Diagnosis in our Laboratories, of simple strategic small steps,of seeing quality from the eye of the customer, of continuous learning from our environment, of creating changes in our generation that matters; because today’s scientist may be the patient tomorrow.
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The theme for the 1st Keton Scientific Conference was: “Quality Laboratory Diagnosis for Improved Patient Outcomes”.With this in mind, it is important to note that the greatest anchor in evidence-based medicine is the quality laboratory services and knowledge management that form the foundation of quality that we aspire every day in our test results. Poor quality leads to the death of millions ev-ery year and costs countries mil-lions of dollars hence the need to protect the patient. A mixture of presentation, panel discus-sions, participants’ caucuses and benchmarking formed the crust of the conference.
The impactful and topical dis-cussion for the two days cap-tured; Method Validation and Verification, EQA Statistics, Risk Management, Monitoring IQC, Current Trends in Tumors, Root Cause Analysis & CAPA, Clinical Decision Areas, Malaria Diagno-sis Techniques, Third Party Con-trols and Automated Workflow Processes among others. The conference was also meant to structure the conversation on several establishments of vari-ous guidelines meant to improve African laboratories especially on decision making hence the open forum for such discussions before the conclusion of the conference. This conference was surely an eye-opener, that Afri-ca is finally ripe for take-off in Laboratory medicine practice.
Keton Scientific Conference was held at Pride Inn West-lands Nairobi on the 25th and 26th July 2019. The 1st Keton Scientific Conference attract-ed 100 participants from all areas in the medical field and it was a successful and im-pactful conference for all the attendees.
Booths and Exhibitions formed an integral part of the conference linking the par-ticipants to vendors, manu-facturers of medical equip-ment and products, External Quality Assessment, Calibra-tion, and Third-Party Controls products and services.
“Quality Laboratory Diagnosis for
Improved Patient Outcomes”.
Location
Poor quality leads to the death of millions every year and costs countries mil-lions of dollars.
“
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The presenters handled their presentations effectively and the participants had the chance to raise their questions and be responded to in the panel discussion sessions which took place after 2-3 sub topical presentation.
Presentations1st Keton Scientific Conference
Calibration Verification Guidelines and regulations Mario Gatellum Micro Audit MicroCon-trols USA
ISO 15189:2012 Accredita-tion Perspectives and Experience from KENAS
Ms. Doris MueniAss. Director of Health and Safety KENAS
Verifying Qualitative Methods
Arthy Yongo of Global Implementation Solutions
Laboratory Accreditation Perspectives and Experience from CAP
John WaigwaQuality Manager Aga-Khan University Hospital Nairobi
Qualifying Medical DevicesThomas Gachuki Deputy Director NPHLS Kenya
Anti-Microbial Testing - Techniques, EUCAST GUIDELINES vs. CLSI Guidelines & The Root Cause Analysis Process Dr. Evelyne Mulwa Scan Lab
SUB-TOPICAL PRESENTATION TITLES AND PRESENTERS
Kindly reach out to us via mail and we shall be able to provide you with the presentations for your reference. [email protected] & [email protected]
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Guidelines on Malaria DiagnosisMs. Rosebella Kiplagat National Malaria Refer-ence Laboratory
Competency in Malaria Detection, Species Identification, Staging, and QuantificationSila Otieno AMREF Health Africa
How does EQA Support You to Evaluate, Keep and Improve the Quality in your Laboratory?
Dr. Dieter Groche – European Society for EQA ESfEQAGermany
Importance of Continuous Quality Monitoring in Your Laboratory through EQA
Antony Jaccodul Keton Consulting
Managing Bacterial EpidemicsMs.Caroline Mbogori National Mcrobiology Reference Laboratory Kenya
Current Trends in Tumor Markers
Dr. Jamila RajabUniversity of Nairobi
Documenting CAPA and Monitoring its Effective-ness
Ms. Susan Musau
Impact of risk Management Program at Kendu Adven-tist Hospital Laboratory on Accreditation Process
Shadrack Wechuli and Claudius Odhiambo Kendu Adventist Hospital Laboratory
Importance of Using Third-Party Controls toMonitor Quality
Robert Njuguna KENAS
Reviewing IQC; What to Look For?
Ms. Caroline Wambua Pathcare Laboratories Kenya
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Keton Group Official Launch
Keton marked its First year in business and it was officially launched on the 26th of July 2019. This was marked by a celebratory event. A reflection of the milestones achieved thus far and looking to the future with hope and determination. This event was graced by the guests, Keton Management and Staff and Keton Board of Advisors. This was the last highlight of the day and concluded the event with closing remarks from the C.E.O Antony Jaccodul and thereafter an in-teractive session with the participants, guests and the exhibitors marked the end of the 2 day conference.
Celebrating the beginning
Lab HumourLab Humour
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AwardeesKeton Award Ceremony
1 The EQA awards were first awarded in the inaugural Keton Scientific Conference
9 The number of awardees for the different categories
4The EQA awards categories
KE7711b, they only missed to receive three certificates out of a total of 51 measured ana-lytes over three cycles (up to 18 analytes per cycle) COAST PROVINCIAL GENERAL HOSPITAL (PGH)
AWARDEESThe following are the awardees;
For Clinical Chemistry
A. FOR QUANTITATIVE DETERMINATION.
KE0467, they only missed to receive one certificate (MID %) out of a total of 24 measured analytes over two cycles (12 analytes per cycle) - AAR HEALTHCARE LTD MOUNTAIN MALL LABORATORY
For HEM3D
KE5815a, they missed no certificate out of a total of 22 measured analytes - Nakuru Provincial General Hospital (PGH)
For HEM5D
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B. FOR SEMI-QUANTITATIVE DETERMINATION (US): (TIE)
KE5914a, all results correct in both cycles - AAR HEALTHCARE LTD SARIT CENTRE LABORA-TORY
KE5914a, all results correct in both cycles - AAR HEALTHCARE LTD SARIT CENTRE LABORA-TORY
(Analyzing all the results, the labs have a tie).
C. FOR QUALITATIVE DETERMINATION: (TIE)
KE2055a, participated in most surveys (SYP, MALM, TB Microscopy, CRYAG, TB GENE XPERT, ABO) with very good results, excluding only MALM - EDARP KENYA - CARDINAL OTUNGA LAB
UG8639a, participated in SYP, INF, and ABO, with all results correct - ARUA REGIONAL BLOOD BANK.
C. FOR QUALITATIVE DETERMINATION: (TIE) Cont’d
UG6812a, participated in SYP, INF, and ABO, with all results correct- GULU REGIONAL BLOOD BANK
(Analyzing all the results, the labs have a tie).
D. THE MOST IMPROVED LABORATORY
KE6812a, they had 9 wrong results in the first cycle and all results correct in the second and third cycle, with 24 analytes per cycle. - BOMU MEDICAL HOSPITAL (CHANGAMWE).
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Made Easy
Method Verification
Verification provides evidence (test results) that the design outputs (actual product) meet the design inputs (product re-quirements and design specifi-cations). Depending on the item being verified, a test case or test suite would be run, or an inspec-tion or analysis done to provide the required evidence. Outlining experiments like accuracy, preci-sion, linearity will help to prove that an analytical method is acceptable or fit for its intend-ed purpose for clinical labora-tories before being put into use for testing patient samples. Cal-ibration Verification essential-ly checks the Calibration of the analyzer by confirming that the test system is able to provide accurate results throughout the Analytical Measurement Range of the instrument for that par-ticular analyte. Linearity As de-fined by CLSI’s (formerly NCCLS) EP06-A guideline: ). The ability (within a given range) to provide results that are directly pro-portional to the concentration (amount) of the analyte in the test sample.
Why do we do calibration verification?
To detect hook dose effect
Test method calibrators may not span the instrument’s report-able range
Daily Quality Controls gener-ally do not challenge lower and upper limits
It is possible to have “Pass-ing” Daily QC, but “Failing” Calibration Verification since controls may not span entire analyzer range
Best Practices in Method VerificationLabs must perform every 6 months or more frequently if specified in the test sys-tem’s instructions
There is a change in reagent lot numbers for a particular analyte—unless the labora-tory can show that the new lot of reagent does not affect the range of the patient test results and that daily quality control re-sults are not adversely af-fected by changing reagent lots.
There is major preventative maintenance or replace-ment of critical instrument components which may af-fect test patient results.
Quality control materials begin to shift or are out of the laboratory’s acceptable limits and other methods of checking the accuracy of the control results are not able to ascertain and resolve the problem
Document each time Cali-bration Verification is per-formed
The laboratory must also be able to verify calibration on factory-calibrated instru-ments that cannot be cali-brated by the end userVerification provides evi-
dence that the design out-puts meet the design in-puts
“
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ControlsThird Party
Controls which are not designed or optimised for use with any one specific test or equipment and as such they mirror the performance of patient samples and provide an unbiased, independent assessment of analytical performance.
Products for CalibrationVerification.
What ISO 15189:2012 Clause 5.6.2.2 says.
Audit –Linearity samples for clinical chemistry
Linearity samples for heamatology with data reduction software
Quality control materials The laboratory shall use quality con-trol materials that react to the examining system in a manner as close as possible to patient samples
Quality control materials The laboratory shall use quality con-trol materials that react to the examining system in a manner as close as possible to patient samples
NOTE 1 The laboratory should choose concentrations of control materials, wherever possible, especially at or near clinical deci-sion values, which ensure the validity of decisions made
NOTE 2 Use of independent third party control materials should be considered, either instead of, or in addition to, any control materials supplied by the reagent or instrument manufacturer. Also FDA and CLSI
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Benefits of Third Party Controls
Values assigned using a large number of independent laboratories ensuring statistically valid Targets
Most have meteorological trace-ability to Internation-al Reference Laboratories
Highly consolidated controls allow for space, time, and ultimately, cost savings
Boosted shelf life ensures continuity of supply and re-duced costs
Reduced preparation times by removing the need for multiple instrument controls
Allows for easy method/instrument comparability since these controls can be run on multiple equip-ment –ISO 15189-2012-5.6.4
Most 3rd Party QC producers provide inter-laboratory comparison platforms and other data analysis ser-vices
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Microscopy goes high-tech for better diagnosis
The bScope microscope is high-tech and comes with a camera that is very quick to attach us-ing the tube provided and an USB 2.0 cable that attaches to an optical mouse that is used to control the image on the screen It has a HDMI cable that can be attached to a display device e.g. Laptop, Television or a projector. This is very efficient as it allows for better view of the slide and also works well as a teaching mi-croscope for demonstrative pur-poses It is also equipped with a storage disc that can store pic-tures of the fields of view taken
Euromex bScope Microscope
Versatile and evolutive!
by the user and serve as a refer-ence when stored.
The microscope really is a joy to use. The eyepieces are “high-fo-cus” which gives a greater work-ing distance – this reduces the chances of accidentally touching the glass and marking it or eye-lashes getting in the way.
This higher-end microscope also comes with Kohler illumination which helps to improve contrast. Set up is easy and is a very effi-cient microscope to use in the laboratory.
The microscope really is a joy to use. The eyepieces are “high-fo-cus” which gives a greater work-ing distance – this reduces the chances of accidentally touching the glass and marking it or eye-lashes getting in the way.
This higher-end microscope also comes with Kohler illumination which helps to improve contrast. Set up is easy and is a very ef-ficient microscope to use in the laboratory.
It has an excellent ergonomical design; these robust and attrac-tively priced microscopes are available in several configura-tions with HWF 10x/20 mm eye-pieces and objectives for bright field and phase contrast. The design of the bScope is both er-gonomic and evolutive.
Height adjustable eyepieces and low stage controls minimize fa-tigue during long working ses-sions and therefore providing more comfort for microscopists. The robust and compact size of the bScope with its Cable Stor-age System allows more working space, safer operation and easy storage.
EUROMEX MICROSCOPES
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Brightfield models
Phase contrast models
CSS – Cable Storage System
Carrying Grip
Cordless Use Anti-Theft Slot
Package Content
E-Plan, Plan, E-plan IOS in-finity corrected, Plan IOS infinity corrected 4x/0.10, 10x/0.25, 20x/0.40, S40x/0.65, S60x/0.85 and S100x/1.25 oil immersion objectives.
E-plan Phase, E-plan Phase IOS infinity corrected, Plan Phase IOS infinity corrected 10x/0.25, 20x/0.40, S40x/0.65 and S100x/1.25 oil immersion objectives. All S40x, S60x and S100x oil immersion ob-jectives are spring loaded. All optics are anti-fungus treated and anti-reflection coated for maxi-mum light throughout.
The optional rechargeable batteries turn the bScope into a cordless.
At the back of the microscopea Kensington Security Slot isplaced, which can be used tosecure the instrument from theft.
Smart Styrofoam packaging ensures a low environmental footprint while maintaining maximum safety during trans-port. Supplied with power cord, dust cover, a spare fuse, white filter, user manual and 5 ml immersion oil.
Allows users to easily stowaway excess cable lengthinto the back of the instru-ment during operation andto roll up the power cable foreasy storage
Double coaxial, low-posi-tioned coarse and fineadjustments with 180graduations. Precision1.11 μm, 200 μm per rotation,
total travel ap-proximately19 mm. Supplied with an adjustable rack stop to prevent dam-age to sample and objectives.The coarse adjustmentis equipped with frictioncontrol.
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FECAL TESTS AVAILABLE WITHVITASSAY
BACTERIA Shigella Single Card
SING
LE
Shigella Single Card
Salmonella typhi Single Card
GDH Single Card
Salmonella Single Card
Campylobacter Single Card
E. coli Single Card
H. pylori Single Card
H. pylori + Transferrin Double Card
EHEC VT1+VT2 Double CardSalmonella typhi + paratyphi Double CardYersinia enterocolitica O:3+O:9 Double Card
DO
UB
LE M
ULTI
A + B Three in one Card
V ITASSAY
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PARASITES
Crypto Single CardGiardia Single CardEntamoeba Single Card
SING
LE
Crypto + Giardia Double Card
DO
UB
LE M
ULTI
Crypto+Giardia + Entamoeba
Three in one
VIRUSES
Adenovirus Single CardRotavirus Single CardAstrovirus Single CardNorovirus Single CardEnterovirus Single CardHAV Single Card
SING
LE Rotavirus + Adenovirus Double CardNorovirus GI + GII Double CardRotavirus + Norovirus Double Card
DO
UB
LE
Rotavirus+Adenovirus+AstrovirusThree in oneRotavirus+Adenovirus+Astrovirus+Norovirus Four in oneRotavirus + Adenovirus + Norovirus Three in one
MU
LTI
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BODYwear
ReflectiveVest
Rain coat
Among the items you will find in our on body protection are; Reflective vests, Biosafety Kits,Lab coats, Overalls & Rain suits and coats.
LAB SAFETYPPEs
HEAD, EYE & EARwear
Among the items you will find in our head protection include; V- guard safety helmets,Jsp Model safety helmets, HDPE safety helmets, Face shields
BODYwear
ReflectiveVest
Rain coat
Among the items you will find in our on body protection are; Reflective vests, Biosafety Kits,Lab coats, Overalls & Rain suits and coats.
LAB SAFETYPPEs
HEAD, EYE & EARwear
Among the items you will find in our head protection include; V- guard safety helmets,Jsp Model safety helmets, HDPE safety helmets, Face shields
26 LABAFRICA MAGAZINE
Keton’s 1st Scientific Conference Pictorial
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Quality Management . Training . Advisory . Mentorship . Biosafety Products
Keton Consulting Limited . Blessed House, Thika Road . 1st Flr Suite 111
e-mail: [email protected] . www.ketonconsulting.com
office: 0779 865 372/0734 565 975
Remodelled Calibration Laboratory - Mansa Zambia
Health Consultancy
