in this issue ukas answers your questions getting up to speed

In this issue

UKAS AnswersYour Questions

Getting Upto Speedwith theNew UKASAssessments

Focus 2015Head toCardiff Bay

Even MoreCrosswordHoliday Tips

The Association for Clinical Biochemistry & Laboratory Medicine | Issue 613 | May 2014

ACBNews

About ACB NewsThe Editor is responsible for the finalcontent. Views expressed are not necessarily those of the ACB. EditorDr Jonathan BergDepartment of Clinical BiochemistryCity HospitalDudley RoadBirmingham B18 7QHTel: 07973-379050/0121-507-5353Fax: 0121-507-5290Email: [email protected]

Associate Editors Mrs Sophie BarnesDepartment of Clinical Biochemistry12th Floor, Lab BlockCharing Cross HospitalFulham Palace RoadLondon W6 8RFEmail: [email protected]

Mr Ian HanningDepartment of Clinical BiochemistryHull Royal InfirmaryAnlaby RoadHull HU3 2JZEmail: [email protected]

Dr Derren Ready Microbial DiseasesEastman Dental Hospital University College London Hospitals (UCLH) 256 Gray’s Inn Road London WC1X 8LD Email: [email protected]

Mrs Louise TilbrookDepartment of Clinical BiochemistryBroomfield HospitalChelmsfordEssex CM1 5ETEmail: [email protected]

Situations Vacant AdvertisingPlease contact the ACB Office:Tel: 0207-403-8001 Fax: 0207-403-8006Email: [email protected]

Display Advertising & InsertsPRC Associates Ltd1st Floor Offices115 Roebuck RoadChessingtonSurrey KT9 1JZTel: 0208-337-3749 Fax: 0208-337-7346Email: [email protected]

ACB Administrative OfficeAssociation for Clinical Biochemistry & Laboratory Medicine130-132 Tooley StreetLondon SE1 2TUTel: 0207-403-8001 Fax: 0207-403-8006Email: [email protected]

ACB PresidentProfessor Eric KilpatrickDepartment of Clinical BiochemistryHull Royal InfirmaryAnlaby RoadHull HU3 2JZTel: 01482-607-708Email: [email protected]: @ACBPresident

ACB Home Pagehttp://www.acb.org.uk

Printed by Swan Print Ltd, BedfordISSN 1461 0337© Association for Clinical Biochemistry &Laboratory Medicine 2014

ACBNews

General News page 4

Microbiology News page 13

Practice FRCPath Style Calculations page 15

Quality Matters page 16

Meeting Reports page 20

ACB News Crossword page 22

Situations Vacant page 23

Issue 613 • May 2014

The monthly magazine for clinical science

Issue 613 |May 2014 | ACB News

Front cover: Julie Evans, Pervaz Mohammed, Nicola Barlow, David Burnett and Deon Coley-Grant admiring David’s new book onaccreditation

EuroLabFocus

The Patient &Laboratory MedicineLiverpool, UK • 7-10 October 2014

RCPath Research AwardsThe Royal College of Pathologists’ ResearchCommittee is pleased to announce the launchof the 2014 Research Medal Awards. ThisAward is open to Trainees who are first authoror first joint author on a single originalpublished research paper. Research for thesubmitted paper must have been undertakenand published whilst the candidate wasregistered as a Trainee. There is an overview on the Research

Medal Awards at: www.rcpath.org/research/specialty-research-medalsFull details of the submission process and

eligibility criteria are available at:www.rcpath.org/research/specialty-research-medals/submission-process.htm �

National ClinicalBiochemistry Audit Group Website The National Clinical Biochemistry Audit Groupis seeking a new member with responsibilityfor maintaining content on the audit sectionof the ACB website. This would require liaisonwith the ACB Office and regional audit leads.Interest from all grades of staff and all regionswould be welcomed. To apply please contactAnnette Thomas ([email protected])with a brief overview of 200 words maximumon how you would improve the website anddisseminate audit reports. �

National Institute for Health ResearchFellowshipsManaged by the NIHR Trainees CoordinatingCentre, the fellowship is designed to supportvarious health professionals including alliedhealth professionals. The aim is to helpdevelop careers which combine research andcontinued clinical practice in support of theNHS. Fellowships are available at three levelsincluding doctoral, post-doctoral and seniorclinical lectureships. Further details can befound at www.nihrtcc.nhs.uk �

4 | General News

ACB News | Issue 613 |May 2014

SudokuThis month’s puzzle

Lastmonth’ssolution

MHRA Alert MDA/2014/012Medical Device Alert: Laboratory reagentsrequiring manual handling for use incombination with Roche cobas c502The issue is regarding level sensing function ofthe cobas c502 laboratory analyser not beingactivated for tests requiring manual reagenthandling. The use of insufficient volumes ofreagent may lead to a false negative result anda missed diagnosis, such as syphilis. It is possibleto obtain ‘valid’ but inaccurate results whenthere is no reagent remaining in the Rochecassette. Since MHRA issued a notice in February 2012 (MDA/2012/004) the settings forlevel sensing have not been correctly encoded insome REC files, therefore level sensing may nothave been correctly performed on Cobas c502analysers. Further details can be found on theMHRA website: www.mhra.gov.uk �

6 | General News


The full audited accounts of the ACB are now completed and as in previous years areavailable in the Annual Report provided tomembers at the AGM and on the website. The ACB does not hold a political fund nor wasany salary paid to, or benefits provided by, theunion to, or in respect of, any member of theExecutive, the President and the GeneralSecretary.That document provides for you:

� The total income and total expenditure ofthe union for the period to December last.

� The amount of the union’s total income forthat period that consisted of payments inrespect of membership.

� The name and address of the auditor whoaudited the accounts contained within theannual return and the full audit report.

A member who is concerned that someirregularity may be occurring, or have

occurred, in the conduct of the financial affairsof the union may take steps with a view toinvestigating further, obtaining clarificationand, if necessary, securing regularisation ofthat conduct. The member may raise any suchconcern with such one or more of thefollowing as it seems appropriate to raise itwith: the officials of the union, the trustees ofthe property of the union, the auditor orauditors of the union, the Certification Officer(who is an independent officer appointed bythe Secretary of State) and the police.

Where a member believes that the financialaffairs of the union have been or are beingconducted in breach of the law or in breach of the rules of the union and contemplatesbringing civil proceedings against it the union or responsible officials or trustees, he should consider obtaining independentlegal advice. �

Trade Union StatementStatement to Members issued in connection with the

Union’s Annual Return for period ended 31st December 2013 as required bySection 32A of Trade Union and Labour Relations (Consolidation) Act 1992

ACB West MidlandsScreening and the Right StuffWednesday 11th June 2014 11.00-15.30University Hospitals Coventry and Warwickshire, Coventry

A Scientific Meeting to Celebrate the Career of Dr Steve Smith

11.00 Arrival and CoffeeChair: Neil Anderson11.15 Training Biochemists for the Future Dr Frances Boa11.45 Steve’s Trainee: Genetic Markers of Postnatal Depression Amy Frank12.00 Steve’s Trainee: Building a Faecal Calprotectin Service Claudia Tomkins12.15 Solving Paediatric Mysteries Dr Heather Stirling12.45 Lunch and NetworkingChair: Dimitris Grammatopolous13.30 What Does the Future Hold for Working in Laboratory Medicine? Professor Eric Kilpatrick 14.00 Bowel Cancer Screening – The Future Looks Even Brighter! Professor Stephen Halloran14.30 Laboratory-Based Screening for Fetal Anomalies Dr Dave Worthington15.00 Reconfiguration: More than ‘Rearranging the Deckchairs’! Neil Anderson15.30 Meeting close

Meeting registration fee: Trainees £10, ACB Members £20, Non-ACB Members £30. Further registration details from: [email protected]

8 | General News


The ACB is delighted to announce that Focus 2015 will be hosted in Wales. The ACBAnnual Conference will be held in theprestigious Wales Millennium Centre in Cardiff Bay from 8th-11th June 2015.The iconic Wales Millennium Centre is an

impressive purpose built arts centre housingtheatres for musicals, opera, ballet and dance,however, for three weeks a year it is availablefor conference hire and the ACB has beenlucky to secure the venue for Focus next year. The Centre is conveniently located withinwalking distance of the vibrant and livelyCardiff City centre and is well served by publictransport in an area which has undergonesignificant development in recent times. Thisincludes many hotels, bars and restaurants as well as the National Assembly for Wales, the Sennedd, which is housed next door. The Centre boasts amazing views across

sparkling waters of Cardiff Bay, formed fromthe confluence of the rivers Taf and Ely, theCardiff Barrage and beyond. Keen televisionviewers will recognise the Millennium Centrefrom its numerous appearances in film andtelevision including Dr Who and Torchwood.Dr David Cassidy has kindly agreed to Chair

the meeting and is currently working hard topull together an Organising Committee fromthe members in and around Wales. Dr AndrewDay and his team from the South West andWessex Region will be organising the scientificprogramme.On behalf of the ACB we look forward to

welcoming you to Wales in 2015. Furtherinformation will follow in the coming monthswith an official invitation to participateenvisaged to be issued at EuroLabFocus inLiverpool in October. �

Focus 2015Creoso i Gymru; Welcome to Wales

National Training Course No. 4 University of South Wales, Pontypridd29th June – 1st July 2014Aimed at all Clinical Scientist and Medical Trainees within Clinical Biochemistry to teachsubjects that are not easily found withintextbooks as preparation for the FRCPathexamination.

Key topics:

� Paediatric Metabolic Biochemistry� Biochemistry of Pregnancy� Biochemistry of Newborn� EQA Interpretation and Workshop� CPA/UKAS� Quality Management Systems� Clinical Cases� Essay Writing – Analytical Techniques

The Trainees Evening will take place in theMansell Hall at Llancaiach Fawr Manor onMonday 30th June 2014, leading on to a historical tour around the Manor House followed by a 3 course evening meal.

ACB Members: £200pp (Residential – 2 nights); £235pp (Residential – 3 nights if required for the Tuesday night); £135pp (non-residential)

Non-ACB Members: £350pp (Residential – 2 nights); £385pp (Residential – 3 nights if required for the Tuesday night); £285pp (non-residential)

For further information and/or to register please visit the meetings page of the ACB website:www.acb.org.uk

10 | General News


Sense About Science will be holding a Standingup for Science media workshop at thePhysiological Society, London on Friday 13thJune. This full day event is free and for earlycareer researchers in all sciences, engineeringand medicine (PhD students, post-docs orequivalent in first job).

During the workshop discussion about science-related controversies is combined withtraining in media reporting with practicalguidance and tips for how to deal with the

media. Please find further information at:www.senseaboutscience.org

These workshops are very popular andplaces are limited. To apply send a CV and short cover letter explaining your reasons forapplying to Victoria Murphy at:[email protected] ACB partners this workshop and holds

five priority places. Closing date forapplications is Friday 30th May. �

Media Training Workshop

General News | 11


Dr Suzy Lishman has been elected President ofThe Royal College of Pathologists by Fellows.Suzy is the College’s second female Presidentand the youngest in its 52-year history. ArchiePrentice, President of The Royal College ofPathologists said: “I am delighted to announcethat Suzy Lishman has been duly elected asCollege President to serve for a three yearterm which will take effect from the College’sAnnual General Meeting in November”.Speaking of her election Suzy comments

that “it is an honour to have been electedPresident of the Royal College of Pathologists,particularly as this is the first time that allFellows have had the opportunity to vote”.Suzy is a Consultant Histopathologist atPeterborough City Hospital, where she is Headof Department and lead for gastrointestinalpathology. Dr Lishman has been an officer ofThe Royal College of Pathologists since 2005 and is responsible for the development of the College’s public engagementprogramme, introducing National Pathology

Week in 2008. Since then over2000 pathology-related events forschools and thepublic have beenheld in the UK andbeyond. NationalPathology Week in 2014 (November 3rd-9th) will, forthe first time, include anInternational Pathology Day on 5th November.In its inaugural list of the fifty mostinspirational women in healthcare in 2013 theHealth Service Journal described Dr Lishman asthe “Public face of pathology” and “the mostoutward facing person from that specialism”.Many will know Suzy from her Twitter feed

with more than 10,000 Tweets under her beltmany done on the train coming home fromCollege business this has got to be worth afollow now! �

College Elects Lishman as President

Christie Pathology Moves to synlab UK

12 | General News


After some years in the United Kingdom theUK arm of the German independent providerof pathology services synlab has secured itsfirst major NHS contract. The Christie NHSFoundation Trust has entered into apartnership with synlab UK Limited, to providepathology services at Manchester’s specialistcancer centre.The “Christie Pathology Partnership” joint

venture will allow the Trust to further developits pathology service for provision ofdiagnostic and monitoring services for cancerpatients undergoing chemotherapy,radiotherapy and surgery. The partnershipaims to deliver financial benefits to the Trustthrough significantly improved procurementterms, efficiency gains through improvedprocesses and growth in third party activitythrough increased provision of specialistoncology pathology services.The new partnership begins on 1st June with

staff, equipment and facilities of The Christie’spathology laboratories transferring to thejoint venture. The Christie PathologyPartnership will draw on the Europeanexpertise of synlab combined with theestablished cancer expertise at The Christie.Roger Spencer, Christie Chief Executive,commented that “The Christie PathologyPartnership reflects our vision to be a world-leading comprehensive cancer centre”.Hugh Risebrow, MD of synlab UK, feels that

the “Christie brand and reputation combined

with synlab’s operational excellence will createa pathology partnership that will support The Christie’s sustainable development,maintain its independence and assist in TheChristie being internationally recognised asone of the world’s leading comprehensivecancer centres that will deliver high qualityand increasingly sophisticated diagnostictechniques to help patients receive the bestpossible cancer treatments.” On-site pathology services will remain at

The Christie and the contract length is 10years. ACB News can report that all staff inpathology transfer to the joint venture exceptthe pathology medical staff and ConsultantClinical Scientist who remain employees of theTrust. �

Hugh Risebrow, Chief Executive of synlab UK andJoanne FitzPatrick Finance Director at The Christiesigning the contract


Microbiology News | 13

Each year, the ACB Scientific Committeeawards financial support to young scientists inthe profession undertaking relevant research. I am a third year Infection Sciences STP traineebased in Clinical Microbiology, NottinghamUniversity Hospitals NHS Trust and this year I have been fortunate to receive a ScientificScholarship for my research into variabilitywithin the hepatitis B surface antigen and theassociated diagnostic and clinical impact.

Immune CyclesThe persistence of hepatitis B virus (HBV)infection for more than 6 months is referred toas chronic hepatitis B (CHB). Worldwide, it isestimated that 350 million people suffer fromCHB and that annually up to 1.5 million deathsoccur from complications of CHB such ascirrhosis and hepatocellular carcinoma. The natural history of CHB is a complex anddynamic process which cycles through episodesof immune tolerance, immune clearance,immune control and immune escape. The immune clearance and immune escapephases are associated with inflammation andprogressively lead to liver damage. Althoughtreatment regimens are effective insuppressing HBV replication and preventingliver damage, they fail to eradicate the virusand long term therapy is necessitated. As such,patient monitoring is an essential componentof CHB therapy.

Differing HBsAG ProductionThe hepatitis B surface antigen (HBsAg) isconsidered to be the serologic hallmark ofHBV infection and its presence in a serumsample is a fundamental diagnostic marker inclinical practice. The loss of HBsAg (HBsAg-seroconversion) is considered tantamount to a“cure” for this disease and the ideal end-pointof therapy is sustained, off-therapy HBsAgabsence, which is associated with an improvedlong-term outcome. Although CHB patients

persistently produce HBsAg throughout thecourse of their infection, there is evidence tosuggest that the amount of HBsAg produceddiffers significantly across the different phasesof infection. This suggests that HBsAg mayhave a role in the individualisation andmonitoring of patient therapy. For example asignificant reduction in HBsAg early intreatment is a good indicator of a sustainedvirological response and conversely patientsconsistently demonstrating a high HBsAg titre following three months of therapy (non-responders) can be switched toalternative treatment regimes.

Possible Ambiguous DataSensitive and specific diagnostic assays are anessential prerequisite to monitoring patientresponse to therapy via the HBsAg marker, yetto date only two quantitative assays arecommercially available. Previous research hasindicated that mutations within the preS/Sgenes which encode the HBsAg maycontribute to the persistence of CHB and resultin the failure of routine laboratory tests todetect and quantify HBsAg in clinical samples.Unfortunately, little knowledge exists on thecorrelation between the presence anddistribution of nucleotide polymorphisms inthe preS/S genes and HBsAg quantification. As such, it is not fully understood whetherexisting HBsAg quantification assays are ableto detect unusual HBV strains such as low copyvariants or those with mutations in the HBsAg,which may affect detection by commercialassays. Therefore the likelihood exists thatclinical judgements on CHB management mayrest on ambiguous data.

Our Current ResearchIn order to evaluate the clinical significance ofthe association between sequence variationwithin the preS/S gene and HBsAgquantification we aim to compare the results

Overcoming Ambiguous Data onChronic Hepatitis BGemma Clark, Nottingham University Hospitals

14 | Microbiology News


A Trent Region Trainees networking eveningtook place on Tuesday 1st April. The idea ofthe event was to give Trainees in the regionthe opportunity to meet one another,particularly those from different disciplines,listen to a topical lecture from a local expert,to find out more about the ACB from me, their local representative, and DonnaFullerton, Regional Tutor for Biochemistry, and most importantly to have an enjoyableevening!

IT Issues Allow NetworkingNineteen Trainees from as far afield asMansfield and Leicester congregated at theCanal House in central Nottingham. This is anunusual pub in that it has part of the adjacentcanal extending inside the building, alongwith its very own narrow boat! Trainees frombiochemistry, immunology and microbiologyhad plenty of time to network at the start ofthe event due to some unforeseen issues withthe IT equipment and projector. We wereunable to get the projector working butfortunately the barmaid was able to lend usher personal laptop and a second laptop wassourced, so the audience was to be foundhuddled snugly together to receive thelecture.

Viral Causes of HepatitisProfessor Will Irving, an Honorary Consultantin Clinical Virology at Nottingham UniversityHospitals NHS Trust and Professor of Virologyat the University of Nottingham gave us astimulating lecture on viral causes of hepatitis.He described the clinical presentation andlaboratory diagnosis of these very differentviruses and he illustrated his talk with someinteresting case studies. We also learnt aboutthe plethora of antiviral agents targetinghepatitis C that are in development which willrevolutionise the management of patientswith hepatitis C infection. Treatment hasevolved from a protracted course withinjectable agents, significant side effects and a1 in 10 chance of cure in the 1980s to a muchshorter, oral treatment with a predicted curerate of more than 70%. After the talk, we tucked into the buffet

and had a further chance to mingle beforeheading back home for the night. Thank youto the Trent, Northern and Yorkshire Regional ACB Committee who kindlysponsored by the event, Will for giving anexcellent lecture, Donna for giving up her time for us and to all the Trainees forattending. �

Cross Discipline Networking in TrentZoe Aiken, Nottingham University Hospitals

from a reliable, sensitive HBsAg quantificationassay along with high quality sequence datafrom a deep sequencing platform atNottingham University Hospitals. It isanticipated that the findings of thisinvestigation will enhance our knowledge ofHBsAg as a diagnostic marker for HBVmanagement, with the aim of developing a

robust, individualised platform for themonitoring of CHB therapy.

� The full title of Gemma’s project is: ACB Scientific Scholarship 2013 – The effectof genetic variability within the hepatitis Bsurface antigen on quantification: an evaluation of diagnostic and clinicalimpact. �

Practice FRCPath Style Calculations | 15


A 62-year old woman has diabetes insipidus and loss of thirst sensation. Following a hotfortnight, she is admitted to the Emergency Department with dehydration. She is knownnormally to weigh 62 Kg. On admission, she is found to have a serum sodium concentration of156 mmol/L. Estimate her water deficit.

FRCPath, Spring 2013

Assume that reduced fluid intake and increased urinary losses (due to decreased waterreabsorption owing to ADH deficiency) results in pure water loss. Therefore:

Initial total sodium = final total sodium

The result is increased plasma (and ECF) sodium and osmolality which will shift water from theICF to ECF. Therefore pure water loss is shared between all compartments. Sodium is the maindeterminant of ECF osmolality. Although sodium is mainly confined to the ECF, all compartmentsare in osmotic equilibrium so we can assume that plasma sodium reflects osmolality in allcompartments. Therefore as an approximation:

Initial plasma Na concn x Initial total body H2O = Final plasma Na concn x Final total body H2O

Initial plasma Na concn is unknown so assume a “normal” value of 140 mmol/L

Since the average female is 55% water:

Initial total body H2O = Body wt (Kg) x 55%

= 62 x 55/100 = 34.1 L

Final plasma Na is given as 156 mmol/L

Therefore:

140 x 34.1 = Final total body H2O x 156

Final total body H2O = 140 x 34.1 = 30.6 L156

H2O deficit = Initial total body H2O - Final total body H2O

= 34.1 - 30.6 = 3.5 L

Deacon’s Challenge No 156 - Answer

Question 157A 70 kg man is admitted following a reported overdose of 14 g of Priadel (lithiumcarbonate) two hours previously. The concentration at admission is 3.7 mmol/L. Twelvehours later, a repeat value is 3.0 mmol/L. Calculate the volume of distribution and theelimination constant. Atomic masses: Lithium 6.94 Da, Carbon 12.01 Da, Oxygen16.00 Da.

FRCPath, Spring 2013

Twenty-two years ago Clinical PathologyAccreditation (UK) Ltd was formed and startedto accredit laboratories to CPA Standards. In the UK we can be proud of the pioneeringwork done by the CPA and the assessorsinvolved, along with the laboratories whoparticipated on a voluntary basis. Now thatCPA has been bought by UKAS, laboratoriesare beginning to make the transition fromusing the CPA standards to the newly revisedInternational Standard, ISO 15189 which setsout the requirements for quality andcompetence for medical laboratories. At atime when laboratories are under all sorts ofpressure it is important that this transitionshould create the least disruption. Whilstlaboratories who have used the CPA standardsfor many years will find little in therequirements of ISO 15189 to cause concernthere will be sense of unfamiliarity in the wayin which the standard is structured. If it hadnot been for strong opposition fromaccreditation bodies this latter problem couldhave been resolved during the preparation ofthe third edition (ISO 15189:2012).

Think About the Assessors

Any laboratory starting to consider thetransition needs to think not only of the workit might need to undertake but also think ofhow it can assist the accreditation assessorswho are also having to adjust to the change.Many laboratories will be thinking of, or havedone, a gap analysis to identify what needs tobe done to comply with the new standard.Whilst such an analysis is a useful way tobecome familiar with ISO 15189 it is likely that it will not reveal too many gaps if thelaboratory is already well prepared. Rewriting a major part of your laboratory

documentation should not be necessary. In my view the first and major step is toidentify whatever document or system acts asthe index to the laboratories documentation.

In most laboratories this will be the QualityManual, the contents and headings of whichwill follow the order of the CPA Standards. In my latest book (A Practical Guide to ISO15189 in Laboratory Medicine) I provide anumber of alternative ‘contents’ pages; onethat follows my ‘Ideal Standard’ (Figure B2) a counsel of perfection, one that follows ISO15189 (Figure B7) and perpetuates the illogical arrangement of the ISO 15189 mainsub-clauses to the one which, although it is acompromise, I would recommend forlaboratories in transition where the ISO 15189clauses are reordered into five main headings(Figure B8) Organisation and managementresponsibilities, Quality management system,Resource management, Examinationprocedures and Evaluation and qualityimprovement. I have prepared a companion to my book for

laboratories implementing ISO 15189:2012 ormaking the transition from CPA Standards

16 | Quality Matters


ISO 15189 Assessments . . .Ideas for Gentle TransitionDavid Burnett

David with Julie Evans, Quality Manager at SWBH NHSTrust in the West Midlands

which has a series of tables that indicate in thefirst column which CPA Standards relate to themain sub-clauses of ISO 15189 and in a secondcolumn which figures in my book relate to therequirements of the main sub-clauses of ISO 15189. Using the data in the first column itis easy to create a contents page as shownalongside which is a modified version of FigureB8. A copy can be found on the ACB website(www.acb.org.uk) or obtained [email protected], putting‘Companion ISO15189’ in subject line. This contents page can then form a top level index and cross reference document,hopefully useful to both the laboratory and the assessors. To complete the preparation of a new

Quality Manual it will be a matter of cuttingthe appropriate material in the current Quality Manual that relates to a particular CPA Standard and pasting it into theappropriate section of the new QualityManual. When you have done this and been

accredited to ISO 15189 you will join theincreasing number of laboratories throughoutthe world who are accredited to ISO 15189,including the laboratories of the US Food andDrugs Administration and the Laboratories inChina which tested samples during the BeijingOlympics! �

Quality Matters | 17


David addresses staff at the opening of a new laboratory

18 | Quality Matters


Laboratories appear filled with trepidationabout the new assessments with UKAS.Quality Managers speak of doom and gloomand many colleagues just have not got a clueabout what is happening. The common viewis an expectation that we are in trouble! So, ACB News hunted down someone at UKASto help with some common questions andthey have kindly answered them here:

Have the new style assessments startedyet? If not when do they start?The assessments to ISO 15189:2012 startedin October 2013. It is planned that alllaboratories will have gone through thetransition by the end of 2017 and duringthe course of 2018 the CPA Standards willbe withdrawn altogether.

Are you continuing with unpaid assessorsas part of the process – if so do you needmore and how should people apply, what is the training like?The input from the peer assessor is pivotal to the effectiveness of theassessment and even more valuableduring this transition period. UKAS isalways looking for additional peerassessors. New peer assessors will need tobe trained in assessing against ISO15189:2012 and to UKAS requirements.Interested parties can apply to be a peerassessor regardless of whether they areretired or in either full or part time work.Applicants will need to be able todemonstrate up to date awareness andknowledge of their field and provide aneffective and in depth assessment to ISO15189:2012 in their specific discipline.Currently, retired assessors are paid andthose assessors in current employment areunpaid.

All peer assessors will be asked to attenda training course to deliver assessments toISO 15189:2012 and ISO/IEC 17043.Anyone interested in becoming a peerassessor will need to complete an assessorapplication form, submit a CV and sign acontract. On receipt of the application theapplicant will be contacted by UKAS if theapplication criteria are met and there isavailability for peer assessors. The peerassessor application form can bedownloaded from the UKAS website:http://www.ukas.com/services/CPA/Peer_Assessor_Recruitment.aspTraining consists of an initial three day

course followed by observation of anassessment visit and finally participatingin assessments under observation for aperiod of time dependent on the assessor.

Uncertainty PrincipleRedefined; What is Happeningwith UKAS Assessments?

John Murphy, Marketing Manager at UKAS, answersthe questions that ACB readers asked aboutaccreditation

Quality Matters | 19


Laboratories can now apply with thewhole Pathology Department having oneapplication number. How does this workin practice for example with regard toassessments not all being carried out atthe same time?CPA laboratories or new applicants canapply for UKAS accreditation as a wholepathology department or individualdisciplines. However the laboratorydecides to apply for accreditation theorganisation will still need to submit fourUKAS forms: application form, AC form,UKAS agreement and UKAS supplementto the agreement. If the whole pathologydepartment is applying for accreditationthis needs to be completed on the ACform which lists all the relevantdisciplines.

If the application is for a specificdiscipline, only that discipline needs to belisted on the AC form. What is listed onthe AC form is what will be assessed andform the scope of the accreditation.Generally, if a laboratory applies as a

combined pathology department, the aimwill be to assess it as such and the visit willtake place at the same time rather thanseparately. Dependent on the size of thelaboratory, the assessment may stretchover more than one week. Multi-siteorganisations may take significantlylonger but the assessment manager’s role is to discuss proposed approacheswith the laboratory so that it is suitablyprepared.

Use of the CPA accredited logo – manylaboratories use the log on their printedreports, websites, handbooks, letterheadsand so on. How does this work if onlypart of the labs repertoire is accredited?If a laboratory is successful in maintainingCPA accreditation then it can use the CPA

logo. Once it has gained UKASaccreditation to ISO 15189 it can then usethe UKAS symbol and must cease to usethe CPA logo. If a laboratory is onlyaccredited for part of their activities, thisneeds to made clear in line with UKASpublication LAB 1 and BIS publication URN13/1224. For instance, reports that containthe UKAS symbol must clearly identifywithin that report any tests that are notpart of the scope of accreditation (thismay simply be by using an asterisk and afootnote). A laboratory may choose not toreference accreditation on reports, inwhich case, the scope of accreditedactivity must be made clear in some other way.

How many laboratories is it estimated are not yet in the system?UKAS only has a record of pathologylaboratories that are CPA accredited. At present UKAS accredits approximately1000 pathology laboratories to CPAstandards, which are in the process oftransition to UKAS accreditation to ISO15189.

POCT CPA Accreditation – has anyoneactually got this? I sense that laboratorieshave found the stringency of the POCTassessment, having set the bar so high, is such that even people that have a veryhigh level approach to POCT have givenup the idea of being assessed. Ten organisations are already accredited as a POCT Provider under CPA Standards.As with medical laboratories, theseorganisations will need to go through atransition to ISO 22870 at their nextassessment. �

20 | Meeting Reports


The annual two-day WEQASConference was held at theHilton Hotel, Liverpool. Theconference covered a widerange of topics, from pre-analytical quality to high-street diagnostics

Starting proceedings was Dr Ian Barnes, who began by highlighting the remit of thePathology Quality Assurance Review. Its aim is‘to identify issues within quality assuranceframeworks and governance at a nationallevel in pathology services’. There is a demandfor transparency which could result in theavailability of EQA data to the public. Headvocated that quality should be embedded incareer plans and included in CPD activities. The recommendations of the review werereported in early 2014. The second talk by Jennifer Glaysher

summarised her findings from her FRCPathpart II project on pre-analytical errors. Eachpre-analytical error is estimated to cost £135;the ISO15189 guidelines emphasise minimisingthese errors, mainly by educating service users.Automated error logging in WinPath withreal-time of feedback of errors to phlebotomyresulted in a significant decrease in thenumbers of haemolysed, insufficient andincorrectly labelled samples received into thelaboratory at Aintree. Paul Newland provided a paediatric

perspective on laboratory quality. Heexpanded discussion on pre-analytical errors inrelation to newborn blood spots in thescreening lab at Alder Hey. He also highlightedtheir demand management practices includingsending reports of requesting activity toconsultants and auditing phlebotomy errors. The final talk of the morning by Annette

Thomas reviewed IQC tools and recommendedthe use of analyte specific multi-rules.

QC packages such as BioRad Unity can be usedfor complex rule-based algorithms incomparison to the standard 2SD QC rule whichis routinely used in many laboratories. Limitsare set using the biological CV of each assay,the bias of the method from EQA performanceand the total allowable error for that analyte.The Westgard website provides detailedinformation on how to implement theseprocesses.

IQC Practice in the UK

The afternoon session began with Teresa Teal’spresentation on the results of an ACB NationalAudit in March 2011, regarding IQC practicesin UK biochemistry labs. The results areavailable on the Westgard website, andinclude the finding that 90% of labs apply thesame Westgard rules for all tests, and for 55%of labs this is the single ‘2SD’ rule only. 90% oflabs do not yet use six sigma metrics to assessIQC. Dr David James then presented hisrecommendations on EQA practices, soon tobe published in J Clin Path. He advocatedmaking a proactive choice of EQA provider,considering the frequency of distributions andprovision of ‘challenge samples’. Chosenproviders should also be CPA accreditedwherever possible, with an independentmedical and scientific committee. They shouldtake part in IVD vigilance activities andprovide commutable samples, with educationand training of registered users also being amajor part of their remit. After a short break, the CPA transition

project manager Delia Geary detailed thechanging requirements for CPA accreditationunder the new ISO15189 aligned standards.There will be greater emphasis onvalidation/verification of lab methods,including checking linearity and specificity andusing an appropriate number of samples todetermine accuracy and bias. Methoduncertainty and traceability must be assessed,with readily available uncertainty estimatesand a clear documented understanding of the

WEQAS User Group MeetingEmma Ashley, Emma Tuddenham & Laura Tooth, South-West London

Meeting Reports | 21


impact of this uncertainty on the patientpathway. There will also be more emphasis oninformation management and whether theLIMS meets both lab and users’ needs. Finally,Bernie Croal (Vice-President, RCPath) discusseddevelopments in the college key performanceindicators (KPIs) in light of the newcommissioning structure, where results can beproduced by ‘any qualified provider’. The college has set up RCPath Consulting toadvise GP commissioners on what to look forin a pathology service. The final draft of theKPIs, with their focus on patient outcomes, hasnow been approved as part of this process. It is expected that the KPIs will beincorporated into the CPA assessment processin due course.

Therapeutic Drug Management

The second day kicked off with a detailedpresentation on developments in TherapeuticDrug Management (TDM) from Dr MikeHallworth. He discussed changes in TDM dueto different prescribing patterns, for examplethe use of phenytoin, which requires carefulmonitoring of drug levels, has largely beensuperseded by carbamazepine and sodiumvalproate, which are much safer. The currentfocus is on prescribing the correct drug dosefrom the start, and pharmacogenetics isplaying a major role here (e.g. TPMT forazathioprine therapy). Mike predicted anincreased demand for pharmacogenetics, but identified financial and ethical challengeshere. Next, Gareth Davies presented the results of

the pilot WEQAS TDM EQA scheme whichcovered a wide range of drug classes. Theinitial results showed variations betweenmethods for certain drugs, particularly at highconcentrations. The scheme will provide threesamples every two months, and will besubmitted for UKAS accreditation in February.

WEQAS then hope to expand the repertoire ofanalytes offered.Before the break Anna Milan from the Royal

Liverpool University Hospital described recentdevelopments in alkaptonuria; a disease oftyrosine metabolism leading to increasedconcentrations of homogentisic acid acid(HGA). Nitisinone (NTBC), a potent inhibitor ofthis metabolic pathway, is a drug licensed forhereditary tyrosinaemia type 1 which hasrecently been used off licence in alkaptonuria.Anna described how her laboratory developedmethods for tyrosine and HGA, to support anew clinical trial in Liverpool offering NTBC toalkaptonuria patients. Finally, before lunch thedelegates split into two parallel sessions forEQA cases; basic and advanced.

POCT Accreditation

In the afternoon Samantha Ekin, POCTcoordinator for Stockport NHS FoundationTrust, shared her experiences of CPAaccreditation for POCT. The talk provideduseful pointers and advice for avoiding non-conformances. There should be a clearPOCT structure in the trust, audits and usersurveys should be performed frequently andall IQC ranges should be validated. Samantha’sbiggest tip was to perform a full gap analysisof POCT against the CPA standards and usethis as evidence during the inspection for howeach non-conformance identified wasaddressed prior to the visit. Before the meeting closed Gilbert Wieringa

spoke about the use of high street diagnostics.This was a topic the audience felt stronglyabout and initiated an interesting debate overthe role of the laboratory in this area. Overall,the diverse range of topics presented at thistwo day meeting gave us plenty of ‘food forthought’ and we will certainly be keen toattend again next year, when the meetingmoves back to Cardiff. �

22 | Crossword


Last month’s solution

Across 1 Post bearing thanks for shared

organ (8)5 Central element of 15 (6)9 Silent nameless man concealing

complaints (8)10 Mass hysteria about ignoring

Sharia practice (6)12 Imply trainee emulate initial

method of treatment for acancer (8,7)

13 Hint from abnormal neutrophils:afflicted with a granulomatous infection (7)

14 Odd green tea cell structure (4)18 Wary about being wrong (4)19 Infuse? Reportedly hesitated after

being more inclined (7)

23 Did public attack end this short-lived tax? (9,6)

24 Some are unequivocal – it mustbe an indicator (6)

25 Stricture about street noises (8)26 Written intentionally: understand

Scottish disgust (6)27 The last 80% of complaints

involved surgical procedures (8)

Down1 Playmates injured but not yet

for blood volume expander (6)2 Gene variant in parallel

evolution (6)3 Inspect ship for makeup (8)4 Later distribution option possible

for this lab test (5,7)

6 Element of job centre coordinates information (6)

7 Perhaps phage not always aninfectious agent (8)

8 Behaves violently, impactscatching young servant boy (8)

11 Complex summits involvingenemy defence setup against foreign invaders (6,6)

15 Mathematical system suggests a cause of colic (8)

16 Redolent of getting married in Croatia (8)

17 Mid-evening hot meal involved alcohol (8)

20 Certain about first urinary tractstitch (6)

21 A fantastic singing temptress has got up (6)

22 Dispenses endless mixture forinfection (6)

ACB News CrosswordSet by RugosaMiami Beach in the March SunWell, to start our Spring Miami experience we are heading to the art deco Miami Beach for a coupleof days fun in the sun. Once through immigration and all the other “lines” at Miami Dade then head on the unmanned train to the 150 Airport Flyer bus. The 150 runs every 30 minutes and costsjust $2.65. This is much better than starting your car hire at the airport as parking is very difficultand expensive on Miami Beach. The 150 will wiz you to Miami Beach in about 20 minutes. It stopsenough at the beach that you should be able to walk to your chosen hotel – which you can selectaccording to budget on hotel booking sites. For quieter hotels try those between South Beach andNorth Beach. Jogging in the morning along the beach and board walk is fun and you will not bealone! Next month: Canoe to the 10,000 islands from Collier State Park.

Situations Vacant | 23


in this issue ukas answers your questions getting up to speed

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