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Caribbean Med Labs Foundation Newsletter Issue# 3

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    Gambling With Lives -Lets Do No Harm

    Every medical laboratory has a primary dutyand responsibility to DO NO HARM. This isnot an easy goal to achieve since laboratorytesting is exceedingly complex, involving manysteps, from taking a patient sample to usingthe result to effectively manage a patient.

    Laboratory errors are common. A recentUnited States study estimated that 2.9 millionerrors occurred annually,causing harm to morethan 160,000 patients.1 A truly frighteningstatistic!

    Millions of laboratory tests are conductedannually in the Caribbean. In the absence oflaboratory regulations or standards, to DO NOHARMbecomes exponentially more difcult.

    Keeping Focused on LabQuality the Ultimate QualityGoal of Accreditation

    A publication ofCaribbean Med Labs FoundationBy the Caribbean for the Caribbean

    Continued on Pages 4&5

    ISSUE #3 MAY 2013

    IN THIS ISSUE:

    Timing of Sample Crucial in Dengue

    Testing

    HIV Population In Focus at CCAS

    Meeting

    CARPHA from Vision to Reality

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    EDITORIAL

    Laboratory Medicine is changing. The changes aredriven by technology and changing clinical and publichealth requirements. We must respond and drivethe evolution of our services to meet this changingenvironment.

    New technology means that we have the potentialfor greater capacity but it also means that traditionallaboratory practice will become more threatened

    as point-of-care systems take up much of what wetraditionally did. The challenges we face includerepositioning traditional lab practice, keeping abreastof new knowledge and nding ways to apply it in ourlaboratory practice. We, traditionalists, must continueto increase the value we add to laboratory results.

    The development of a strong regional laboratorycommunity that shares knowledge is one strategyto help us. The Caribbean Med Labs Foundation iscommitted to strengthening the laboratory community,but each individual needs to get involved.

    Each of us needs to extend our alliances andpartnerships to benet from laboratory networks andservices within and outside our region. The foundation

    for this already exists but we must now make theeffort to build on it. In this regard, the start up ofthe Caribbean Public Health Agency (CARPHA) inJanuary, 2013, and the Caribbean Health LeadershipInstitute (CHLI) provide valuable opportunities to buildon our knowledge and strengthen alliances. We areencouraged by CARPHAs commitment to engage civilsociety as an equal partner in its work.

    The process of accreditation helps strengthen thesystems in the laboratory; this facilitates knowledgeacquisition and application. Laboratory accreditationalso helps to strengthen our dialogue and negotiationwith partners. Having been through two cycles oflaboratory accreditation, I can assure my laboratorycolleagues that accreditation has major internal

    benets; it is more than just a certicate on thewall. Accreditation is not something we should shyaway from or believe that we are not yet ready for;instead, we should embrace it. From the time youmake the decision to seek accreditation, the processof laboratory strengthening starts and there is acontinuing snow-ball effect.

    The laboratory is a critical player in the health careteam, but laboratory professionals must step forwardand get more involved in the daily clinical and publichealth policy discussions and decision making. It is notjust our results that the team needs. The health careteam needs our total engagement.

    Leading FromThe FrontDr Stephen King, Chairman, CMLF

    Dr King is an Independent Senator inthe parliament of St Lucia, LaboratoryDirector, and former Chief MedicalOfcer in St Lucia.

    On the 1st January 2013, the long awaitedCaribbean Public Health Agency (CARPHA)was established, with the challenge of creatingan integrated regional public health agency throughmerging the ve regional health institutions (RHIs),each with decades of valuable service CaribbeanEnvironmental Health Institute, Caribbean EpidemiologyCentre,Caribbean Food and Nutrition Institute,Caribbean Health Research Council, and CaribbeanRegional Drug Testing Laboratory.

    At the ofcial launch of CARPHA,in Trinidad and Tobago on 2nd July2013, Prime Minister of St. Kitts andNevis and CARICOM Lead for Human

    Resources, Health and HIV/AIDS, DrDenzil Douglas, described CARPHA as anexample of functional cooperation anda triumph of the spirit of regionalism.

    In his address at the ofcial opening, Executive Directorof CARPHA, Dr James Hospedales, gave thanks to theGovernment of Trinidad and Tobago for agreeing to hostthe new agency and provide support for a new facility,and to the many partner agencies including CanadasPublic Health Agency and Department of Foreign Affairsand International Trade,United States Centers forDisease Control and Prevention, European Union andPublic Health England.

    Dr. Hospedales noted that the regional challenges aremany. CARPHA will aim to reduce premature deathsfrom non-communicable diseases (NCDs), HIV/AIDSand injuries and violence by at least 25 per cent by2025 and will include this goal as part of its post-2015targets for the Caribbean.

    As a small Agency facing a large task, the CARPHAExecutive Director is clear that partnership andnetworking will be a key strategy and he committedto pursuing this approach, and to include civil societyas an equal partner. As a regional non-governmentalorganisation, we at the Caribbean Med Labs Foundationlook forward to developing a successful, collaborative

    and mutually supportive relationship with CARPHA.This will be consistent with the tradition of stronginternational NGOs which work with governmentalagencies and advocate for and support theimplementation of governmental policies.

    Dr. Hospedales ended his address by noting thatCARPHA has a rich tradition of the ve (5) former RHIson which to build. His priorities include the completionof the transition of 5 into 1, and crafting a new vision incollaboration with member states.

    Visit CARPHA at http://carpha.org

    CARPHA- fromVision to Reality

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    Its the rainy season again,and dengue fever is on therise in several countries inthe Caribbean. As usual,the laboratory, which is

    one of the most silent ofhealth support systems, isa key avenue for providingthe information requiredfor managing patients andguarding the publics health.

    >> What is Dengue?Dengue is an illness caused by infection

    with any of the four types of Dengue

    virus (DEN 1, 2, 3 and 4), which are

    transmitted by theAedes aegypti

    mosquito and affects an estimated 50

    million people in approximately 100countries every year. Infection by one

    DEN serotype confers long-term immunity

    to that serotype but not to the others,

    so persons can be infected by different

    serotypes at different times in their

    lifetime usually with increasing severity

    of symptoms.

    The majority of dengue infections (~75%)

    are asymptomatic. Testing for dengue

    infection can be somewhat bewildering

    because within a week to 10 days, this

    acute illness progresses from infection

    with the virus to production of antibodies

    against the virus by our immune system.

    The diagram belowillustrates whathappens during the course of dengue

    infection.

    During the acute febrile phase of the

    disease, the major symptoms are 2-7

    days of fever, with any of the following

    symptoms: retro-orbital pain, headache,

    bone, muscle and/or joint pain, rash, mild

    symptoms of bleeding (e.g. easy bruising,

    gum or nose bleeds, petechiae). As the

    fever subsides, the disease progresses to

    the critical phase which is characterized

    by a 24-48 hour period in which shock

    can occur due to increased capillary

    permeability and plasma leakage. The

    presence of these symptoms is now

    called severe dengue (formerly dengue

    haemorrhagic fever or dengue shock

    syndrome). Appropriate treatmentis critical at this stage as patients

    can be at risk of death. Additional

    symptoms at this stage include abdominal

    pain, vomiting, thrombocytopenia and

    mild bleeding symptoms. The nal

    convalescent phase of dengue lasts 4-7

    days.

    >> Testing for Dengue

    In a suspected dengue case, laboratory

    tests are important to determine infection

    and to analyse how severe the disease

    is. Measuring platelet counts gives

    an indication of severity a decrease

    indicates increased likelihood of bleedingand haemorrhagic symptoms. Doctors

    may monitor the patients platelet count

    and haematocrit (red cell volume) over

    time to see if there are any changes.

    >> How do we diagnosedengue in the laboratory?When the patient presents to the

    health care system, the timing of

    taking the sample to test for dengue

    is critical. Based on the diagram, it

    is clear that samples taken early in

    the acute febrile stage would contain

    circulating dengue virus. Assays suitable

    during this acute phase include those

    which detect dengue virus i.e. traditional

    virus isolation, or those which identify

    dengue RNA virus (Reverse Transcriptase

    Polymerase Chain Reaction RT PCR) as

    well as soluble antigen (i.e. NS1 antigen).

    Virus isolation is a relatively slow process

    (21 days), while PCR and soluble antigen

    detection are the more immediately

    available methods used today. Samples

    taken at day 2 to 4 in the course of the

    illness should be tested for dengue virus.

    With the exception of the NS1 antigen

    test, such tests are much more complex

    and expensive and are generally only

    done at reference laboratories where

    more sophisticated facilities and specially

    trained staff are available.

    Anti-dengue IgM antibody is produced

    during the acute phase of the disease

    and is detectable by ELISA 3-5 days after

    the onset of illness. A sample taken at

    day 3-5 or later in the course of the

    illness is the correct one for use with the

    commonly used rapid and ELISA tests that

    measure ONLY antibody. Even persons

    who have had previous infections with

    dengue cannot be reliably tested with

    antibody tests before 3-5 days after onset

    of disease. Newer dengue rapid tests

    that detect both antibody and antigen

    (e.g. NS1) are now available and make

    it possible to detect dengue much earlier

    (i.e. within the rst 3 days of illness)using simple technology.

    While it is not possible to rely on the

    more complex tests for testing every

    case of dengue infection, we need to do

    some amount of PCR testing and/or virus

    isolation because these tests provide

    information on the type of dengue virus

    causing the infection. It is important

    from an epidemiological point of view to

    track these circulating serotypes, as the

    incidence of severe dengue increases with

    changes in circulating serotypes.

    >> Interpretation of

    Dengue test resultsIn testing for dengue, the following things

    are critical:

    Knowledge of the date of onset ofsymptoms to determine whetherthe patient will have only virus orwhether they should already havestarted to produce antibody.

    Selection of the appropriatetest to ensure that the correctmethodology is used to measurethe virus or the antibody asappropriate to the timing ofsample taking.

    It is the laboratorys responsibility to

    validate that the selected tests work

    within the laboratory in the same way

    and under the conditions specied by the

    manufacturer and to ensure the quality of

    all results produced by the laboratory.

    The laboratory must also manage

    its resources to ensure appropriate

    utilisation. During a dengue outbreak,

    initially, samples from all patients

    exhibiting symptoms should be tested to

    identify the cause of the outbreak.

    LABORATORYS ROLE IN DENGUE TESTING

    Continued on Back Page

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    >> Laboratory Error HurtsThe avoidance of laboratory errors

    presents a multidimensional challenge.Even accreditation, if not appropriatelymanaged, may not guarantee thatincidents of lab error are avoided.

    The 2004 experience of MarylandGeneral Hospital (MGH) in the USA isinstructive in this regard.2 MGH was ahighly regarded laboratory, repeatedlyaccredited in 2001 and 2003 by theCollege of American Pathologists (CAP).In spite of this, a terrible preventablelaboratory incident resulted in HIVinfection of one staff member, over2000 clients having to be offered freeretests, the temporary closure of the

    laboratory and the convening of a USCongressional hearing at which it wasrevealed that the MGH was given highmarks in an accreditation assessmentprocess even while severe operationalproblems existed. Stakeholdersdiscovered that AccreditationandQualityare not always synonymous.

    In a more recent 2012 occurrence, acrime lab chemist in Massachusetts(Mass) was arrested on suspicion ofaltering or faking thousands of drug-related tests.3 As new informationemerges it seems that almost 200,000cases may have to be re-opened.Hundreds of persons may have beenincarcerated unfairly and even morealarming, hundreds of dangerouscriminals may have to be released dueto untrustworthy evidence. This lab,which was not accredited, has beenclosed as investigations continue.

    What do both of these cases have incommon? Their staff lost sight of theirprimary duty to DO NO HARMandfailed to either comply with standardquality requirements (MGH) or toimplement the required quality systems(Mass).

    >> Standards, QualitySystems and Accreditation

    as Strategic MotivationA laboratory seeking to DO NO HARMneeds to adhere to the tenets of anyquality-focused business operationi.e. identify an appropriate qualitystandard, implement appropriatequality structures and systems, worktowards full compliance and seekcredentialing of quality achievements.

    In 2004, Caribbean Governmentsagreed that the ISO 15189 Standardwould be the benchmark for medicaland related public health laboratoryoperations.4 Signicant resources

    have been invested in laboratoryimprovements and the lure ofaccreditation is giving impetus to thiseffort.

    >> How can accreditationwork for your lab andfor your clients?

    The accreditation processrequires specialist assessors toconduct a thorough evaluation ofsystems, people, infrastructure,equipment and client satisfaction.

    In order to maintain the integrity,credibility and trustworthinessof the accreditation process,a critical aspect must be thatAccreditation Bodies ensurethat assessors are competent toconduct evaluations and providesound feedback.

    Becoming accredited means havingappropriately skilled staff; maintainedequipment; efcient sampling; relevanttechnology; valid methodologies;

    effective recording and reportingprocedures; excellent customer serviceand of course competitive costing of

    services. Becoming accredited meansconsistently aiming to DO NO HARMand taking the continuous qualityimprovement path.

    Some laboratories preparefor accreditation without fullyengaging staff, management andkey stakeholders in the qualityimprovement effort. These laboratorieseventually experience signicant qualitysystems gaps that inevitably lead to

    error incidents and possibly to a loss ofaccreditation.

    No Accreditation Body canguarantee that a laboratorycomplies with standardrequirements on a continuousbasis or that every laboratorytest will be accurate. SomeAccreditation Bodies nowinclude this disclaimer in theirinstructions.4

    Continued from Cover

    GAMBLINGWITH

    LIVES

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    Accredited laboratories are expectedto comply with the quality and ethicalrequirements of the relevant standardon a day-to-day basis and tohonestlypresent all laboratory data.They are expected to be transparentabout possible conicts of interests andavoid entering into unethical nancialarrangements such as inducementsto clinicians to refer clients.4 Non-compliance with these requirements

    can damage the image and reputationof a laboratory, can result in unreliableservices, can diminish client condenceand above all, can erode trust in theaccreditation process.

    Laboratories with multi-sites MUSTensure that both the main facility ANDsatellite sites or service centres areassessed for accreditation and thattheir accredited scope of testing isclear. Clients have a responsibility tochoose their laboratory wisely.

    >> Selecting an

    Accreditation BodyISO 15189 accreditation certicatescan only be issued by accreditationbodies afliated with the InternationalLaboratory Accreditation Cooperation(ILAC). ILAC-afliated Bodies existworldwide. Several other non-ILAC afliated bodies also accreditlaboratories in conformance with theISO 15189.

    It is important to note that manynon-ILAC-afliated AccreditationBodies establish their ownstandards for medical and public

    health laboratories that may takea somewhat different approach tolaboratory improvement to thosepromoted by the ISO 15189Standard. Signicant differencesin requirements may exist andlaboratory assessments andaccreditations may differ in focusand expected outcomes.

    >> New RegionalAccreditation InitiativesRegional partners have recognized thechallenges and have drafted a StepwiseApproach to Quality Improvement.This will be further discussed in asubsequent edition of this Newsletter.

    Let us not gamble with the manylives we hold in our hands. Let

    us ensure that we DO NOHARMby implementing our

    quality systems, pursuing theaccreditation goal and ensuringthat laboratory qualityandaccreditation are synonymous.

    Wendy Kitson-Piggott, CMLF Laboratoryand Quality Systems Specialist.

    KEY:

    a. International Laboratory Accreditation Cooperation (ILAC)

    b. Trinidad & Tobago Laboratory Accreditation Service (TTLABS)

    c. Jamaica National Agency for Accreditation (JANAAC)

    d. Coordination Committee for Quality Assurance in Health Care Laboratories in the Netherlands (CCKL)

    e. Standards Council of Canada (SCC)

    f. College of American Pathologists (CAP)

    g. Joint Commission International (JCI)

    Visit the CMLF website cmedlabsfoundation.nefor a list of references for this article.

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    As the Deputy LaboratoryManager responsible foradvancing Quality Servicesat the Princess Margaret

    Hospital Laboratory (ThePublic Hospitals Authority) inThe Bahamas, we manageover 100 staff members,and a host of internal andexternal stakeholders. Weare expected to be effectiveleaders, focused on theorganizations vision andmission.

    The eleven-month learning offered by the Caribbean HealthLeadership Institute (CHLI) turned out to be another phase inmy process of life-long learning of the principles and practiceof leadership.

    The focus of the CHLI programme was to advance personaland professional development, with a view to strengtheningleaders who will, in turn, inuence the performance of workteams and contribute to the improvement of national andregional health systems. As the manager responsible fordriving the laboratory into accreditation, I recognized that itis not an easy process and that change is necessary

    During our rst retreat, in May 2012, each of the eightgroups was given an Action Learning Project.

    As we reected on our Action Learning Project, we adaptedthe eight steps in John Kotters book Leading Change:

    Step One: Creating a sense of Urgency; Step Two: Form aPowerful Coalition; Step Three: Create a Vision for Change;Step Four: Communicate the Vision; Step Five: Remove

    Obstacles; Step Six: Create Short-term Wins; Step Seven:Build on the Change and Step Eight: Anchor the Changes inCorporate Culture.

    The main learning period, which included web-basedseminars incorporating core curriculum, guided our reectionand contributed to strengthening our network.

    We were reminded that as we seek to enhance our leadershiskills, we must also understand ourselves; knowing our weakand strong areas was necessary. To accomplish this, manyinstruments were used, including:

    FIRO-B, which afforded ways to identify a set ofinterpersonal needs that is most comfortable for us, asleaders.

    THE CHANGE STYLE INDICATOR MODEL was used tomeasure our preferred style in approaching change anddealing with situations involving change.

    THE 360 DEGREE PROFILE allowed us to review our

    leadership prole through the eyes of those we lead, or worwith. Some of the responses were expected, others wereunexpected, but they were all good, because at the end of

    the day, it was all about change and positive development.

    As the Valedictorian for 2013, (CHLI Cohort Five) I cantruly say that my leadership skills were enhanced and Iwas reminded to let go of those things over which I haveno control. Within me, there is this desire to always lookfor opportunities to guide newcomers to the service and toshare something of what I learnt from the Caribbean HealthLeadership Institute, for it was truly a wonderful learningexperience. As a member of the Triple-L, CHLI Life-LongLeadership Alumni Network, I look forward to wherever thisleadership journey takes me.

    Caribbean Health Leadership Institute (CHLI) Cohort Five Valedictorian

    Ismae Whyms, Ph.D., Deputy Laboratory Manager, The Bahamas

    When Laboratory and other Public Health specialists meet inNassau, the Bahamas, from August 25th to 29th, 2013, theywill be working towards building on achievements in qualitylaboratory diagnostics, treatment and care for the Caribbean HIVpopulation.

    Thats the remit of the 2nd Joint meeting of the CaribbeanHIV/AIDS Regional Training Network (CHART), the CaribbeanCytometry and Analytical Society (CCAS) and the Caribbean MedLabs Foundation (CMLF). This meeting also doubles as the 10thCCAS HIV/AIDS International Workshop, successfully organisedby Professor Clive Landis and his team of dedicated volunteers atCCAS, initially as a means of educating laboratory professionalsabout technological advances in laboratory support for HIV/AIDS care and treatment. In subsequent years, the meeting wasexpanded with the participation of CHART, to address advancesin clinical care and treatment of HIV infected persons, and withCMLF to support strengthening of regional laboratory networks.

    A look at the programme for the Opening Ceremony provides aglimpse of the extent of the collaboration and support which thehost country is providing for this key event in the Caribbeanspublic health calendar. Not only will Bahamas representativesmake presentations at the meeting, but the Minister of Health,Dr Perry Gomez, will participate in the Opening Ceremony, alongwith a number of ofcials from the Public Hospitals Authority.

    Over 150 participants and presenters will come from the hostcountry, the wider Caribbean, United Kingdom, Canada, CostaRica and Mexico. Students of the University of the West Indiesand sponsors will be among the regional and internationaldelegates. Presenters will address themes such as: the PublicHealth Benets of Biological Prevention, Immunology and theFrontiers of Immunophenotyping including (for the rst time)

    alternative uses of ow cytometry; Strengthening LaboratoryNetworks in the Caribbean; Laboratory Quality ManagementSystems (QMS) and Monitoring and Evaluation in a changingEnvironment; and Strengthening Counselling and PsychosocialCare. Delegates will present country reports on the existingservices for laboratory support for HIV/AIDS care and treatmentand selected participants will provide updates on research beingdone into issues surrounding HIV/AIDS care and treatment withithe Caribbean and Latin America.

    The Opening Ceremony Distinguished Lecture will featureThomas Quinn, M.D., Professor of Medicine, Johns HopkinsBloomberg School of Public Health and Director, Johns HopkinsCenter for Global Health. Dr Quinn is well known for hisinvestigation on the epidemiology, pathogenesis, and clinicalfeatures of HIV/AIDS internationally; and the interaction betweeSTDs and tropical diseases on the natural history and spread ofHIV/AIDS in developing countries.

    CMLF team members will be contributing throughout the meetingand workshop. Director-Laboratory Management Specialist,Valerie Wilson, will be part of the opening ceremony, serve asa session chair and present on QMS Implementation Using aStepwise Approach. Immunologist and Laboratory InformationSystems Specialist, Dr Wayne Labastide, will present onLeukemia/Lymphoma and Flow Cytometry and introduce theCMLF Electronic Log Book. Laboratory and Quality Systems

    Specialist, Wendy Kitson-Piggott, will present on 21st CenturyEconomic Trends and Implications for Regional LaboratoryServices and A Costing Framework for QMS Implementation.

    A presentation from the Caribbean Public Health Agency(CARPHA) will outline a New Public Health Vision for theCaribbean.

    Improving care for the Caribbean HIV populationin focus at CHART-CCAS-CMLF Meeting

    Ismae Whyms

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    In the second issue of our CMLF Newsletter (January 2013),we presented the rst installment of an article in whichgraduates shared their views on a three-year trainingprogramme for laboratory managers conducted underthe umbrella of The Strengthening of Medical LaboratoryServices in the Caribbean (SMLS) Project. We also listedthe key success factors identied by the ve graduates whopresented views. The full article can be viewed on the CMLF

    website at www.cmedlabsfoundation.net

    In this issue of the CMLF Newsletterwe highlight the experiences, successesand challenges as reported by thegraduates from St Lucia and Suriname.

    Suriname: Haidi confessed that she had had mixed feelingsabout embarking on the Quality Management System(QMS) journey excited but also doubtful about her abilityto manage what seemed to be a huge task ahead.

    She admitted that her many years of experience in managinga laboratory and support from the regional network of

    laboratory colleagues, all struggling to implement quality,gave her comfort and helped her to manage her doubt.

    She reects on the lessons that she has learned as botha Laboratory Manager and in her capacity as the NationalQuality Coordinator at the Ministry of Health and advises thatlaboratories should ensure that the roles and responsibilitiesof the Quality Manager and the components of the QMS areclearly documented and understood.

    Like Rebeca, Haidi also emphasizes the absolutely criticalimportance of involving ALL staff in the quality improvementplanning and monitoring efforts, from the very beginning.Celebrating small successes and achievements proved tobe a useful motivational strategy for her. Managers, advisesHaidi, must role model professionalism and they also need toestablish their own peer support and de-stressing systems.

    It has taken some time, but on reection, Haidi says shehas observed the personal growth among technologists inthe Public Health laboratory and is proud of the growingawareness of the importance of a QMS by technologists inSuriname.

    St Lucia: As Chairperson of the St Lucia National LaboratoryAdvisory Council, Trudy used her SMLS preparation to inspirethe Councils quality improvement efforts. Her advocacyat this level, she admits, contributed to the Councilsaccomplishments that included adoption of the ISO 15189Standard as the benchmark for national medical laboratories,increased focus on human resource development at all levelsof laboratory operations and the introduction of standardizedmethods for safety and microbiology.

    At the same time Trudy, in her role as laboratory and qualitymanager of a private facility in St Lucia, established herquality goals and dedicated considerable energy and passionto implementing a quality management system (QMS). Shedescribes this experience as challenging but exciting anddemanding 100% staff involvement and commitment. Eventhough she migrated in 2009, Trudy was thrilled when, in2010, her St Lucia laboratory realised their dream of being

    the rst laboratory in the country to achieve accreditation.

    In 2009, Trudy moved on to a laboratory in Canada. Hereis a laboratory, she says, that lives and breathes continuousquality improvement (CQI) under the watchful eye ofa Department of Quality and Regulatory Affairs. Dailyreviews of quality indicators and team resolution of non-conformances are the norm.

    She says that she feels the same keen sense of excitementand interest that she remembers from her participation inthe SMLS project and observes that this new experiencehas served to reinforce the message that the accreditationjourney requires unrelenting attention to audits, externalquality assurance (EQA), validations, standard operatingprocedures (SOPs), revisions, turn-around-time (TAT)

    tracking and safety among the many other quality factors.Trudy quietly reects on how effectively she has beenprepared for her new challenges by both her SMLSexperience and the quality improvement effort in herprevious St Lucia laboratory. She acknowledges that hertraining as an advocate, a leader and most importantly, anactivist, has signicantly contributed to the condence shenow brings to her functions in this new and high qualityaccredited environment.

    Wendy Kitson-Piggott, Laboratory and Quality Systems Specialist,CMLF.

    Laboratory Champions

    Haidi Tjon Kon FatTrudy Leonce-Joseph

    Key Success Factors

    Admittedly the quality journey is fraught withongoing challenges -- time and resources beingmajor deterrents. But what do these regional QualityChampions see as the critical success factors forimplementing andsustaining laboratory quality?Recurring themes from these graduates have included:

    100% support from administrators and laboratorymanagement

    a clear institutional vision, shared by all

    fearless and visionary laboratory leadership

    thorough knowledge of the laboratory standard

    100% staff involvement

    responsibility, accountability, dedication andcommitment

    effective teamwork

    strong communication channels among staff,clients and stakeholders

    an effective staff recruitment process and structureand above all -

    a collective will and seriousness of purpose and aprimary focus on patient care and safety.

    Striving for a culture of sustainable laboratory quality inwhich doing the right thing the right way the frsttime and every time, has been the common goal forall of these laboratory managers who have truly becomeChampions of Laboratory Quality.

    7

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    Vision The regional champion for best practice in Medical Laboratory Services.

    Mission Promote and support the achievement of quality laboratory services inaccordance with appropriate standards, through advocacy, resource mobilisation,collaboration, research and education.

    63A Petra Street, Woodbrook, Port-of-Spain, Trinidad, W.I. | Telephone: 868 628 5911/4765 Fax: 868 628 4765Email: [email protected] Website: www.cmedlabsfoundation.net

    Valerie WilsonDirector

    Wendy Kitson-PiggottLaboratory andQuality SystemsSpecialist

    Wayne LabastideLaboratoryInformationSystems Specialist

    Louise MathuraAdministrative/Finance Assistant

    Cheryl ONeil, Editor Caribbean Med Lab News

    The CMLF Board Members:

    Dr. Stephen King, ChairmanIndependent Senator, Laboratory Director and former Chief MedicalOfcer, St. Lucia.

    Mr. Lawford Dupres, Deputy ChairmanFormer Director, Trinidad and Tobago Bureau of Standards and formerDirector, CARICOM Regional Organisation for Standards and Quality.

    Ms. Ingrid Lashley, TreasurerDirector, Trinidad and Tobago Mortgage Finance Co. Ltd.

    Mrs. Marvo Harper, SecretaryLegal Practitioner, Trinidad and Tobago.

    Dr. David PicouFormer Director, Caribbean Health Research Council.

    Dr. Farley CleghornSenior Vice President and Chief Technical Ofcer, Futures Group, USA.

    Dr. Paula BurnsProvost and Vice President (Academic), Northern Alberta Institute ofTechnology, Canada.

    Mr. Jones P. MadeiraManager of the Information and Protocol Division of the Judiciary ofTrinidad and Tobago.

    Dr. Sonia RoacheCaribbean College of Family Physicians, Private Practitioner, Trinidadand Tobago.

    That as a user of laboratoryservices you should:

    1. Choose your laboratory carefully

    2. Ask your referring doctor or the lab whether the labis accredited

    3. Ask the referring doctor or the lab what is done toensure consistently reliable results

    4. Ask the lab whether you can see their performancerecord for External Quality Assessments

    5. Politely ask to see the label or ID on your sample ofblood or other specimen to ensure its accurate

    6. Ensure that you understand the implications of yourtest results

    7. Talk to your doctor until you do understand

    8. Trust your instincts - suggest a re-test to your doctorif results are unexpected or alarming

    9. Get a second opinion if you feel that you should its

    your right10. Follow up with your doctor or lab. Do not assume

    that your results are negative or normal, if you dontget any feedback.

    11. Remember that laboratories have a duty to providea timely and reliable result to every client its yourright.

    The broad objectives of the CMLF include:

    Continued development of the supportive environmentfor the rapid expansion of high quality regional laboratoryservices

    Advocacy at the highest levels for the implementationof relevant laws, regulation and accreditation of regionallaboratories

    Mobilisation of resources for laboratory strengtheningefforts

    Mapping of a regional coordinating strategy to ensuresustained laboratory strengthening efforts.

    DID YOU KNOWLABORATORYS ROLEIN DENGUE TESTING

    However, as the outbreak progresses, focus should be placed

    on selecting samples from patients living in areas where

    dengue has not been previously detected, for PCR testing,

    and testing of persons exhibiting symptoms of severe dengue.

    Later, as the outbreak subsides, testing of all persons exhibiting

    symptoms resumes during the inter-outbreak period.

    In the context of dengue outbreaks, the laboratory plays a key

    role in:

    Conrming dengue and identifying circulating serotypes

    Monitoring of patients for severity of disease

    Ensuring the quality of all results they produce

    Providing information for guiding the sampling of testingsince it may not be possible to test all persons for dengueduring a large outbreak

    Providing surveillance information for epidemiologicalanalysis and to guide vector control activities.

    References:

    1. World Health Organisation , Dengue: Guidelines for

    diagnosis, treatment, prevention and control: 2009.

    2. Johnson, B.W., Russell, B. J., and Lanciotti, R. S. 2005. Serotype-specic detection of dengue viruses in a fourplex real-time reversetranscriptase PCR assay. J. Clin Micobiol 43:4977-4983.

    3. Peeling, R.W. et al. 2010. Evaluation of diagnostictests: dengue. Nat Rev Microbiol 8:S30-38.

    Valerie Wilson, CMLF Director-Laboratory Management Specialist

    Continued from Page 3


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