ACB...The full audited accounts of the ACB are now completed and as in previous years are available in the Annual Report provided to members at the AGM and on the website. The ACB

In this issue

UnwarrantedVariations –Carter Suggests VeryFast ChangeProcess forPathology

Pre-analyticalQuality Requirementsof ISO 15189

ACB ScholarshipsReview

Focus Details

FRCPath Exam ChangesUpdate

Duty Biochemist Conundrumsin Brum

The Association for Clinical Biochemistry & Laboratory Medicine | Issue 635 | March 2016

ACBNews

About ACB NewsThe Editor is responsible for the finalcontent. Views expressed are not necessarily those of the ACB. EditorProfessor Jonathan BergDepartment of Clinical BiochemistryCity HospitalDudley RoadBirmingham B18 7QHTel: 07792-912163/0121-507-5353Fax: 0121-507-5290Email: [email protected]

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

Dr Gina Frederick Pathology Laboratory, Level 5Royal Derby HospitalUttoxeter RoadDerby DE22 3NEEmail: [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]

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 PresidentDr Gwyn McCreanorTel: 01536-492692Email: [email protected]: @ACBPresident

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

Printed by Swan Print Ltd, BedfordISSN 1461 0337© Association for Clinical Biochemistry &Laboratory Medicine 2016

ACBNews

General News page 4

Practice FRCPath Style Calculations page 10

Current Topics page 12

Focus News page 16

Quality Matters page 18

Training Matters page 20

ACB News Crossword page 22

Issue 635 • March 2016

The monthly magazine for clinical science

Issue 635 |March 2016 | ACB News

Front cover: Carter does wholehospital variation, see inside foranalysis of the pathologyrecommendations

http://www.focus-acb.org.uk/

4 | General News

ACB News | Issue 635 |March 2016

Sudoku This month’s puzzleLast month’ssolution

UK Newborn Screening LaboratoriesNetwork Annual General MeetingTuesday 12th April 2016Nowgen Centre, Manchester10:00-10:30 Registration and Coffee10:30-11:00 Screening of Tyrosinaemia Type 1, Dr Mick Henderson, Leeds/Manchester11:00-11:20 Screening of Lysosomal Storage Disorders, Ms Catherine Treslove, Manchester11:20-11:40 MSUD Audit, Teresa Wu/Caroline Griffith, Manchester/Leeds11:40-12:00 Bloodspot Quality, Roanna George, Cardiff12:00-12:30 Neonatal Screening of Severe Combined Immunodeficiency

Prof Bobby Gasper, UCL Institute of Child Health12:30-13:30 Lunch13:30-14.00 Maintaining Programme Quality, Prof Jim Bonham 14.00-14:20 Communication of Pre-screening Information and Results to Parents

Dr Fiona Ulph/Dr Nimarta Dhami, University of Manchester14:20-14:40 Communication of Sickle Cell Carrier Results Between Parents and Children

Dr Melissa Noke, University of Manchester 14:40-15:00 BPSU Study of Congenital Hypothyroidism

Dr Rachel Knowles, UCL Institute of Child Health15:15-16:15 Business meeting (members only)

The meeting includes refreshments and lunch and will be accredited for 5 CPD points.Cost of meeting: £25.

Please contact Teresa Wu for further details:Tel: 0161 701 2140/2137 or Email: [email protected]


6 | General News

The ACB Scientific Committee has revised theprocess for reviewing and awarding ScientificScholarships in an attempt to address twomain issues that have arisen.Firstly, we have been in the happy position

of receiving an increasing number ofapplications, which are of consistently highquality. We would like to thank all previousapplicants for giving us the pleasant problemof deciding who to support and with howmuch money. The main consequence is that wehave seen a diminishing financial award perproject because of the increase in numbers of high-quality applications.Secondly, we have also been delighted to

receive applications from colleagues in diverseclinical areas including highly specialisedbiochemistry, genomics, immunology andmicrobiology/virology. We have sometimesfound that the members of the ScientificCommittee lack specific knowledge and insight into some areas of practice.To resolve these issues, we have made two

major changes to the process for awardingscholarships. The first is a decision to makefewer awards, but to fund the highest qualityprojects in full up to an amount of £9,000each. The keys to obtaining an award will bethe likely benefit to patients and to theresearcher’s career development. The second change is to introduce a process ofpeer-review. This means in practice that wewill need your applications submitted a monthearlier, by July 1st 2016.If you are a senior member of the ACB with

specialist expertise in a particular area, youmay be approached to peer-review a projectand we hope you’ll receive this requestfavourably.As in previous years, the application process

will open in May, and applicants are requiredto submit a short application form outliningthe proposed project. This includes a brief

introduction of the particular area of researchand the indications for carrying out theproject, including how it will impact patientcare. In addition, there should be a clear planof how the investigation will be carried out,including any ethical requirements andlogistics of obtaining patients samples, as wellas a breakdown of how the funding would beused. The grant may be used for any essentialequipment, reagents or consumables neededto carry out the work, but cannot be used tocover staffing or travel expenses. Applicationswill close in July and will then be sent out forpeer-review with a 4 week turnaround time.Applicants will be informed as to whethertheir application is going to the committeestage or has been deemed unsuitable for anaward. Applications deemed by peer-reviewersto be of sufficient quality will be discussed inthe September meeting of the ACB ScientificCommittee. Candidates will be notified of thecommittee’s decision by the end of Septemberor early October, with funds available almostimmediately. Immunologists, Haematologistsand Microbiologists/Virologists . . . Don’t missthis opportunity!

Great OpportunityWe are not perfect, but we do seek to improveand that is the reason for these changes. We believe that the ACB Scientific ScholarshipAwards offer ACB Members a greatopportunity to fund high-quality researchprojects, which not only directly benefitpatient care and cement our position as anessential part of the clinical team, but will alsohave a beneficial impact on their own personalcareer development as a scientist. For more information on the application

process and to see examples of othersuccessful projects from previous applicationsrounds visit http://www.acb.org.uk/whatwedo/science/scientific_scholarships.aspx �

Review System for ACB ScientificScholarships; 2016 and BeyondChris Chaloner, Director of Scientific Affairs, Association for Clinical Biochemistry and Laboratory Medicine 2016

http://www.acb.org.uk/whatwedo/science/scientific_scholarships.aspx


General News | 7

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 has occurred,

in the conduct of the financial affairs of theunion may take steps with a view toinvestigating further, obtaining clarificationand, if necessary, securing regularisation ofthat conduct. The member may raise any suchconcern with one or more of the following as it seems appropriate to raise it with: the officials of the union, the trustees of theproperty of the union, the auditor or auditorsof the union, the Certification Officer (who isan independent officer appointed by theSecretary of State) and the police.Where a member believes that the financial

affairs 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 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 2015 as required bySection 32A of Trade Union and Labour Relations (Consolidation) Act 1992

8 | General News


For Someone Interested in the History of ACB PublicationsProfessor Peter Wilding, PhD, FRCPath, FACBI am very proud to be an Honorary Member ofthe ACB (1997) and for the past fifty-four yearsI have been privileged to gain from mymembership through education, being amember of various committees, a past memberof Council (1976-77) and a frequentparticipant in numerous Annual Meetings heldthroughout the UK over the past fifty years.Early in my career the ACB journal was a

vital component of my education and I soonwanted to have that commodity at my disposalat all times. The result was that I kept thejournals and had them bound annually so thatI could access the information conveniently.Now, I have retired and feel that I must cut

back on the books I keep, so I am offering myunblemished collection of leather bound ACB journals to anyone who is willing to paythe transport costs. Every copy is in very goodcondition. The journals are the Proceedings ofthe ACB, Vols. 1-5, 1960-1968 and Annals of

Clinical Biochemistry, Vols 6-38, 1969-2001.I will be attending the ACB Focus Meeting in

Warwick in June and would be pleased todiscuss the issue or send photos. I seek nocompensation for the journals, but I hope thatthey will go to someone who treasures thehistory of the ACB.I can be contacted at: Professor Peter

Wilding, Professor Emeritus, Dept of Pathology& Laboratory Medicine, University ofPennsylvania Medical Center, 7.103 FoundersPavilion, 3400 Spruce Street, Philadelphia, PA,USA 19104-4283. Phone (home): +1 610-240-0233. Fax: +1 610-240-0234

� Peter is Past Chair of the AACC HistoryDivision and has made three films related to clinical chemistry in the USA. As Historian for IFCC he produced acollection of condensed ‘Histories’ of nearlysixty associations around the world. �

FRCPath Exam UpdateChanges to FRCPath ExaminationsContinued uncertainty surrounds changes to the future structure of the FRCPath exams.Changes are underway to replace both the essays and the SAQ paper with a multiple choicepaper for part one. This will need to be ratified by the GMC, and the new format examinationwill then need to be piloted. It is anticipated that this may take 2 years, and so the currentexamination format will continue until at least the Autumn 2017 session.Much of this uncertainty is linked to the Shape of Training (SoT) review for medics and the

implications that this might have for Chemical Pathology training. It is therefore likely thatchanges to the part two will also materialise in time to reflect that training, which mayinclude specific clinical skills based modules for chemical pathology trainees. However, planscannot be confirmed until there is more clarity regarding SoT and the future structure forchemical pathology training.

Dr Andrew Hutchesson (ex-officio FRCPath Chair of Examiners for Chemical Pathology)Dr Bernie Croal (Chair, FRCPath Clinical Biochemistry, Specialist Advisory Committee)Emma Ashley (Chair, ACB Trainees Committee)

Association for Clinical Biochemistryand Laboratory Medicine (NI Region) Spring Scientific MeetingFriday 15th April 2016Wellington Park Hotel, Belfast09.30 Opening Remarks

Mrs Margaret McDonnell, Chair, ACB NI Region

Morning Session Chair: Professor Maurice O’Kane, Western HSCT 09.40 Pathology, Meeting the Challenge, Driving the Change in NI Healthcare

Dr Michael McBride, Chief Medical Officer for Northern Ireland10.15 Human Factors in Healthcare

Dr Richard Corry, Consultant Anaesthetist, SEHSCT 10:.50 Direct Patient Access to Results – the GPs Perspective

Dr Donagh McDonagh, Associate Medical Director GP Practice, Belfast HSCT 11.25-11.50 Neworking11.50 FIT - Opportunities and Challenges for Bowel Cancer Screening

Professor Stephen Halloran MBE FRCPath, Professor Emeritus, University of Surrey12.25 Newborn Screening: What Does the Future Offer?

Professor Jim Bonham, Sheffield Children’s Hospital13.00-14.00 Lunch

Afternoon Session Chair: Dr Kathryn Ryan, Belfast HSCT14.00 An Approach to the Male with Constitutional Delay of Growth and Puberty

Dr Philip Johnston, Consultant General Medicine, Belfast HSCT14.35 Use of Pathology Testing in Neuroblastoma Patients

Dr Robert Johnston, Consultant Paediatric Oncologist, Belfast HSCT15.10 Laboratory Work in a War Zone on Operational Deployments

Dr Tom Trinick OBE, Consultant Chemical Pathologist & General Physician, SEHSCT 15.45-16.05 Coffee Break 16.05 Experiences of Local Delivery of Clinical Sservices for Patients with Familial

Hypercholesterolaemia (FH) in the Southern HSCT – the Lipidologist’s Perspective Dr Peter Sharpe, Consultant Chemical Pathologist, Southern HSCT

16.30 Experiences of Local Delivery of Clinical Services for Patients with FH in theSouthern HSCT – the FH Specialist Nurse’s Perspective Julie McCullough, Specialist FH Nurse, Southern HSCT

16.50 Closing Remarks Mrs Margaret McDonnell, Chair ACB NI Region

For more information, including registration, please visit the Regional Meetings section of the ACB website (www.acb.org.uk)

General News | 9


10 | Practice FRCPath Style Calculations


One definition of Acute Kidney Injury stage 1 is an increase in serum creatinine of ≥26 µmol/Lwithin 48 hours. Assuming the within-individual biological variation of creatinine is 4.7%,calculate the maximal permissible analytical variation to allow ≥95% confidence that an increase in measured creatinine from 150 to 176 µmol/L is genuine. Table of z-distribution:

P (two sided) 0.10 0.05 0.02 0.01 0.002 0.001z 1.65 1.96 2.33 2.58 3.09 3.29

FRCPath, Spring 2015

Since it is only an increase in creatinine we wish to detect, a single sided z-score is needed.Therefore select a z-score of 1.65 which will exclude 10% of results with half of these (5%)having an increase significantly higher than 26 µmol/L i.e. an increase in creatinine greater than26 µmol/L will be detected with at least 95% certainty.

z = Change in creatinineSD of the change

1.65 = 176 - 150 SD of the difference

SD of the difference = 176 - 150 = 26 = 15.76 µmol/L1.65 1.65

Converting to CV (%) at a mean value of 163 µmol/L:

CV (%) = 15.76 x 100 = 9.67%163

This is the CV of the difference between the two results. We need to find the CV of theindividual measurements. When two values are subtracted (or added) the CV of the difference(or sum) is the square root of the sum of the squares of the individual measurements (CV1 andCV2):

CV of the difference = √(CV12 + CV22)

Assuming CV1 = CV2 (now becoming simply CV) this simplifies to:

CV of the difference = √(2 x CV2) = √2 x CV = 1.414 CV

Therefore: 9.67 = 1.414 CV

CV = 9.67 = 6.84%1.414

Deacon’s Challenge No 178 - Answer

Practice FRCPath Style Calculations | 11


This is the total CV of each individual measurement which will be made up of biological(CVBiological) and analytical (CVAnalytical) components:

CVTotal2 = CVBiological2 + CVAnalytical2

Substitute CVBiological = 4.7% and CVTotal = 6.84% and solve for CVAnalytical :

6.842 = 4.72 + CVAnalytical2

CVAnalytical2 = 6.842 - 4.72 = 46.79 - 22.09 = 24.7

CVAnalytical = √24.7 = 5.0% (2 sig figs)

Question 179Recent work suggests that the incidence of Familial Hypercholesterolaemia (FH) in North-West Europe is approximately 1 in 200 live births. Using current techniques, thedetection rate of disease-associated mutations in FH is approximately 50%.

Calculate (a) the incidence of homozygous FH, and (b) the probability that the child of aproband with genetically-confirmed FH has homozygous FH.

FRCPath, Spring 2015

An Initial Assessment ofLord Carter’s OperationalProductivity and Performance in English NHS Acute Hospitals: Unwarranted Variations

In a statement to the House of Commons on5th February 2016 Jeremy Hunt, Secretary ofState for Health, announced that he accepted and will act on all the fifteenrecommendations in Lord Carter’s latest healthreport. Lord Carter will be asked to reportback in Spring 2017 on the progress that hasbeen made. He is becoming directly involvedin implementation phase with a role as non-executive director of NHS Improvementfrom April 2016.This report is about tackling unwarranted

variation to make savings across the NHS.Pathology is just a small component of thereport, with just the fourth of fifteenrecommendations looking at diagnosticservices. The report suggests extremely tightdeadlines, which along with imaging is thesubject of the fourth recommendation. In particular it states that if departmentscannot achieve the “acute pathology modelhospital benchmark” by April 2017 that theyshould agree a plan of consolidation oroutsourcing to other providers by January2017. That is just nine months to makedecisions on possible major changeprogrammes which would certainly involvecomplex analysis at Pathology Directorate andTrust Board level.The report has a specific section on

diagnostic services with pathology on

pages 36-38 and estimates the total NHSspending on pathology to be between £2.5 to£3.0 billion/year. This includes direct access(GP), acute secondary care, tertiary specialistand screening programmes. Pathology costs inthe data analysis derived from 32 Trusts thathelped with the study ranged from <1.5% toover 3.0% of trust operating expenditure.

‘Single Version of the Truth’ Required

Data are presented from the 32 hospitalcohort used in the study whereby pathologycosts are assessed as a proportion of trustoperating expenditure. This can vary markedly,with some trusts spending 2.8 times more onpathology than the cheapest services. Thenumber of qualified staff per 100,000 bed dayswas also used to suggest that this can vary by afactor of 2.4. The depth of understanding ofthese variations is limited in the report, withno analysis on the differences in the types ofhospital or work profiles that might, in part,explain such variation.Work undertaken by Lord Carter’s team has

included developing a set of benchmarks andindicators as part of the ‘model hospital’. This will enable trusts to compare their serviceswith others in terms of both quality and cost.The earlier 2008 Lord Carter Pathology

Review proposed that consolidation ofpathology gives a way of providing a means ofquality and financial effectiveness. The currentreport suggests their new analysis nowprovides evidence that this is happening withnetworking projects in Surrey and Berkshire,the West Midlands and Lancashire being citedas showing quality improvement and areduced cost base.NHS Improvement is to become the body

that will host performance managementwhich will provide a single integrated

12 | Current Topics


Unwarranted Variations;Support Needed for TimelyActionJonathan Berg, Editor

performance management framework onwhich trusts can be compared. Jeremy Huntsuggests this will allow trusts to “set baselinesfor improvement and provide them with thetools to manage their resources daily, weekly,monthly, yearly”. Lord Carter will be activelyinvolved in the goal of achieving a suggested£200 million of savings in pathology and awider £5 billion target for the whole NHS ashe takes up his new role at NHS Improvement.

Acute Pathology Model Hospital andMore – Personal Comments

The clear and overlapping deadlines forpathology in the report require fast action onbehalf of pathology leaders locally if thesetargets in the report are driven forward

successfully. The report leaves many questionsto be answered for those on the ground tryingto run pathology. Key things that come tomind are:

� Where are the ‘acute pathology modelhospital benchmarks’ so that one can assesswhere we are currently with local servicesand look to audit against this. If NHSImprovement has not yet developed thesethen it is impractical to work to thetimescales in the report.

� Pathology Quality Assurance Dashboard –while most pathology departmentsprobably produce monthly KPIs we do nothave a uniform dashboard and there iscurrently no information on ‘NHSImprovement’ websites that ACB News

Current Topics | 13


NHS Improvement� This new organisation was formed in 2015 and becomes operational from April 2016. Itbrings together Monitor and the Trust Development Authority regulators. This new bodyhas a single chief executive with Jim Mackey CEO of Northumbria Healthcare, appointed tothe role in October 2015.

� The development of the ‘model hospital’ has a tight timeframe and includes theappointment of a Professional Lead for each component and to help with the integratedperformance framework and leadership in developing the ‘metrics and benchmarks’.

� NHS Improvement will have an analytical unit which will collect and output information,report on an ongoing basis and provide data which is suggested in the report to become‘a single version of the truth’.

Recommendation Date to Achieve Comment

1 Acute Pathology Model Benchmarks April 2017 Pathology Departments to agree plans to consolidate with, or outsource to, other pathology providers by January 2017

2 Pathology Quality Assurance July 2016 Suggested to be hosted byDashboard in place locally ‘NHS Improvement’

3 Definitive list of pathology tests October 2016 Health & Social Carepublished Information Centre (HSCIC)

to produce and explain how to count

4 Guidance notes for collaborative October 2016 NHS Improvement to publishjoint venture these

Key Recommendations

could find on this. To reconfigure our localpathology dashboards will requiresignificant work locally. To do this by Julythis year seems unrealistic unless there isclear guidance to be issued from NHSImprovement in the next few weeks. Youwould have thought that templates for the dashboard would be available on theinternet already, but certainly on this coldFebruary Sunday afternoon, as this article iswritten, nothing can be found.

� Consolidation or outsource decisions – to take forward such complex discussions,following an assessment that you have notmet the acute hospital benchmarks, with atimeframe of the rest of 2016 to do optionappraisals and get a plan in place iscertainly a huge pressure.

Emphasis on Local Action

If you or I had suggested such deadlines formajor transformation locally then you mighthave expected more than a few sidewayslooks. To get senior pathology leaders andprofessional groups on-board, realistic targetsshould be set and appropriate resourcesprovided to help take things forward. Thisreport publishes a timeline for progress inpathology, but presently there is little visiblesupport of further information and resourcesto work to such proposed tight deadlines. How much better the publication of thisreport would have been if it had come withsome practical toolkits to help us take thingsforward. At present one is left with a feelingthat the deadlines are unrealistic. With theslight delay in publication (the report was firstsuggested to be coming out in Autumn 2015)work on a national dashboard could havemoved forward to the extent that allpathology departments were sent templatesand implementation guidelines on reportpublication day. Even more useful would be a

copy of the ‘acute pathology model hospitalbenchmark’ data which is essential to assesslocally the work to do to comply with thefourth recommendation. If all this support iswaiting for NHS Improvement to go live thenreally the timescales appear unachievable atthe outset.Many Pathology Departments are grappling

with major cost reduction programmes atpresent and adding the pressure of these newtight deadlines will for some make for a veryuncomfortable 2016. The appointment of aprofessional lead for pathology to help withthis work at NHS Improvement is anothercrucial decision which will impact on the way things are driven forward. We will ‘watch this space’ to see who ends up in thispivotal role. �

14 | Current Topics


https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/499229/Operational_productivity_A.pdf

http://www.cityassays.org.uk/

16 | Focus News


Focus 2016 has four fantastic plenary sessions,featuring world renowned physicians andscientists giving talks on a wide range ofinteresting and relevant topics applicable tomembers of the ACB and beyond.

ACB Foundation Award LectureOn Tuesday morning, thefirst speaker, ProfessorNaveed Sattar, gives the ACBFoundation Award Lectureon the topic of ‘Using trialand cohort biochemistrydata to make novel insightsinto cardio-metabolic

diseases’. Naveed is Professor of MetabolicMedicine and has published extensively indiabetes, cardiovascular disease, obesity, andinflammatory conditions contributing toclinical trials, biomarker and epidemiologicalstudies, and national and internationalguidelines. He is known for his ability tochallenge dogma and to cross link betweendisease areas in novel and clinicallyinformative ways.

The Flynn LectureLater that day, Professor SirStephen Bloom will deliverThe Flynn Lecture on ‘Guthormones: from laboratorybench to the understandingand treatment of obesityand diabetes’. ProfessorBloom is Head of Division forDiabetes, Endocrinology and Metabolism,Chair of the Academic Section ofEndocrinology and Investigative Medicine atImperial College London and Lead Clinician for Clinical Chemistry at Imperial CollegeHealthcare NHS Trust. His research work overthe years falls into five related categories:endocrinology clinical research, physiology and

pathology of gut hormones, control of insulinrelease and insulin resistance, role ofneuropeptides in organ control and the role ofneuropeptides in CNS regulation of appetiteand related hypothalamic functions.

ACB/AACC Transatlantic Award LectureOn Wednesday lunchtimeProfessor Patricia Jones willgive the ACB/AACCTransatlantic Award Lectureon ‘Scientific developmentsin fatty acid oxidation andtheir clinical applications’.Professor Jones is Clinical

Director of the Chemistry and MetabolicDisease Laboratories at Children’s MedicalCentre, Dallas, TX, and Professor of Pathologyat Southwestern Medical Centre. She is currentPresident of the AACC and has a primaryresearch interest in the area of fatty acidoxidation.

ACB International LectureThursday lunchtime seesProfessor Sverre Sandbergfrom the University ofBergen deliver the ACBInternational Lecture askingthe question, ‘Shouldanalytical performancespecifications for POCT andHospital Laboratory Tests besimilar? Challenges and pitfalls’. ProfessorSandberg is Director of both the NorwegianQuality Improvement of Primary CareLaboratories and the Norwegian PorphyriaCentre. As Past President of ELFM and EQALM,he is sure to deliver a thought-provoking andhighly relevant lecture for all laboratoryprofessionals wishing to make sure both theirlaboratory and near patient testing havequality at heart. �

Focus Plenary SessionsAlexander Lawson, Focus Publicity, Local Organising Committee

Focus News | 17


Founded in 1965, the University of Warwick isa large Russell Group campus university, with an international reputation in medicine,business and innovation and around 23,600full-time students and 1,800 academic andresearch staff. Being a campus-based universitythere are a large number of amenities onsite including shops, bars and restaurants, a summary of which may be found by visitingwww.warwick.ac.ukThe programme for each day will be held in

the Warwick Arts Centre. The Arts Centre isone of the largest multi-art form venues in theUK, delivering a high quality, engaging,diverse programme of cinema, performing andvisual arts, presented in world-class venues andspaces at the heart of the University ofWarwick campus. Since opening in 1974, theArts Centre has been a distinctive and specialplace, an important resource for the arts andfor audiences in the region and a significantforce in national and international artsnetworks. A virtual tour of the Warwick ArtsCentre may be found on their websitewww.warwickartscentre.co.uk.

Shakespeare’s BirthdayRooms being used for the parallel sessionsinclude Butterworth Hall, The Woods-ScawenRoom and the Cinema, with the exhibitionheld upstairs in a large, open, light space, idealfor viewing posters, browsing exhibits andsocialising. It is a fitting venue given that it isthe 400th anniversary of Shakespeare’sbirthday on Saturday 23rd April. Warwick Arts Centre is easily accessible from

the M42, M6 and M40 and is within a 20minute drive of Birmingham, Stratford UponAvon and Warwick. Onsite parking forattendees is free with registration and sinceFocus 2016 is being held outside of term-time,spaces should be plentiful. For those who wish to use public transport, Coventry RailwayStation is just a 10 minute drive away,

with direct rail links to London, BirminghamInternational Airport and the rest of thecountry. We will have Focus 2016representatives on hand at the train station to aid delegates with their journeys.All accommodation and entertainment for

the conference is onsite. Rooms comecomplete with tea and coffee making facilities,hairdryer, towels/toiletries, an iron/ironingboard, high-speed internet access and arewithin walking distance of the Arts Centre. For those of you who wish to explore thesurrounding area, the University is near to thehistoric towns of Warwick, Coventry, Stratfordupon Avon and Leamington Spa, eachbringing their own highlights to this diversearea. These include the Royal ShakespeareTheatre, Warwick Castle, Leamington SpaPump rooms, Coventry Cathedral and CoventryTransport Museum.Focus 2016 are also laying on some

entertainment to help delegates unwind atthe end of a busy day at the conference.Tuesday will see a Focus first, Segway racing!Safe, fun and open to everyone Segway racingtargets everyone with a taste for adventure. It will take place after the last session of theday outside the Warwick Arts Centre, with theevent crew providing all the necessaryequipment and rider training to make sure allexperiences are safe and as fun as possible.This will be followed by a buffet in thePanorama Suite with performances from theFocus Fringe bands, bar and late licence. OnWednesday we have the Conference Dinner,once again situated in the Panorama Suite,with great food, drinks and dancing.

Early Bird Deadline Upon UsFinally, can we remind everyone that the earlybird deadline for registration is 18th March and to download the ACB Focus 2016 App if you haven’t alreadydone so. �

Entertainment and VenueAlexander Lawson, Focus Publicity, Local Organising Committee


18 | Quality Matters

Pre-analytical processes in a number of areasof the quality management system are centralto good practice and laboratory accreditation.ISO 15189: 2012 requires it, and the previous2003 iteration stated that: “Laboratory management shall implement

quality indicators for systematically monitoringand evaluating the laboratory’s contributionto patient care. When this program identifiesopportunities for improvement, laboratorymanagement shall address them regardless of where they occur. Laboratory managementshall ensure that the medical laboratoryparticipates in quality improvement activitiesthat deal with relevant areas and outcomes of patient care.”Two important points are made here.

The first is that all laboratories should developquality indicators to monitor their impact onpatient care, and the second is continuousquality improvement i.e. when opportunitiesfor improvement, or evidence of poor practiceare identified, the laboratory has aresponsibility to address them even if theyoccur outside of the laboratory's control. We must recognise that all diagnosticlaboratories hold a lot of data which canhighlight deficiencies in the patient pathwayoutside the laboratory and this uniqueresource is both important and under-utilised.As the sole keepers of this data, laboratoriesshould take responsibility to use thisinformation to facilitate improvements inpatient care and laboratory efficiency. Whole process control is a familiar laboratoryconcept, and a critical part of the wholepatient care pathway.

What Data Could we Collect?

ISO 15189:2012 defines the pre-analyticalphase as “steps starting in chronological order,from the clinician's request and including theexamination requisition, patient preparation,collection of the primary sample, and

transportation to and within the laboratory,and ending when the analytical examinationprocedure begins”. This definition recognisesthe need to evaluate, monitor and improve allthe procedures and processes in the initialphase of the total testing process, includingthe procedures performed in the so-called“pre-pre-analytical phase” i.e. the processesthat happen outside the laboratory.Clause 4.14.7 states that the laboratory shall

establish quality indicators (QIs) to monitorand evaluate performance throughout criticalaspects of pre-examination, examination andpost-examination processes, for example, thenumber of unacceptable samples, the numberof errors at registration, number of correctedreports etc. So ISO clearly requires laboratoriesto develop quality indicators that cover notonly the analytical, but also the processesleading up to and following the actual analysisi.e. the extra analytical processes.ISO 15189 clause 5.4.1 requires that the

laboratory shall have documented proceduresand information for pre-examination activitiesto ensure the validity of the results ofexaminations, going on to state that theprocess of monitoring quality indicators shallbe planned, which includes establishing theobjectives, methodology, interpretation, limits,action plan and duration. This means that astandard operating procedure (SOP) must bein place defining how you will collect the data,how often, what you are defining asacceptable levels and, perhaps mostimportantly, what you will do with the data if an indicator falls outside acceptable levels.As with all SOPs indicators should beperiodically reviewed, to ensure theircontinued appropriateness.

How Can We Collect This Data?

From the above brief review of the ISOrequirement to measure key performanceindicators outside the analytical phase we now

Pre-analytical QualityRequirements of ISO 15189Dr Mike Cornes, Wolverhampton

Quality Matters | 19


come to how to do this practically. The ACBWorking Group for the Pre-analytical Phase iscurrently working on a ‘best practice’document as a follow up to its survey ofcurrent practices in pre-analytical QImonitoring. This new document will outline avariety of approaches on how you mightcollect this data and provide an overview ofwhat data the group feels should be collected.In summary though there are four mainapproaches:

� Regular audit� Manual logging of errors� Incident reporting (e.g. DATIX)� Use of the LIMS system

The use of the LIMS system would be the goldstandard approach, and after initial set upwould be the least time consuming. It isperhaps something we, as a group, should putin as a requirement when tendering for futureLIMS systems.

Why Should We Collect This Data?

If the accreditation requirements were notsufficient, professional leadership and a desirefor better patient care should be. We have, aslaboratorians, driven down analytical errorsover time to very low levels. This has been due,

in a large part, to the use of IQC andparticipation in EQA schemes. In order to drivedown errors in the total testing process wemust first measure what we want to improvevia extra-analytical QIs. We should alsocompare ourselves to other users via EQAschemes. There are now several of theseschemes available across Europe and in the UK there is a pilot scheme (PREPQ) availablefrom UK NEQAS looking at a selection of extra analytical indicators. The fact that EQA providers are setting up

these schemes gives laboratories anopportunity to review their own quality acrossthe total testing process in comparison withother laboratories, which in turn will improvethe patient pathway and I would urgelaboratories, as does ISO 15189, to startcollecting extra analytical quality indicatorsand enrol in an EQA scheme. �

� Based on a presentation given at the 2015UK NEQAS(H) Participants’ Meeting, andthe 2015 WEQAS Annual Conferenceavailable via www.ukneqash.org/downloads/ or http://www.weqas.com/download/monitoring-pre-analytical-quality/


A Report of the ACB TrainingCourse 5, October 2015, Birmingham

It was August of my first year of the STP andmy rotations were finally drawing to a close. In one of my regular meetings with mysupervisor, he suggested that I should look atbooking on the ACB Training Course that wascoming up, and explained that even thoughit’s aimed at those working towards FRCPath, I would definitely benefit from it. My ACBRegional Tutor agreed, and so I went aheadand booked myself a place,One Monday lunchtime in early October,

I arrived at The Conference Park at theUniversity of Birmingham, ready for 48 hours

of lectures and workshops. Drs Rachel Websterand Karen Smith had organised a fulltimetable for us, starting with an entertainingafternoon of EQA with Finlay MacKenzie ofUK NEQAS, followed by an interesting sessionon Method Introduction and PerformanceMonitoring from Rachel, Karen, and CraigWebster. None of these were topics that I hadmuch experience with and I quickly realisedthat they would be extremely useful, especiallywith my MSc project coming up.

Static OSPE with Helpful FeedbackTuesday morning brought with it a practice‘static OSPE’, 18 questions in the style of thePractical Skills module (Paper 1) of the FRCPathPart 2 examination, followed by a helpfulfeedback session. The paper and my notes willbe a useful resource for the future, as the

20 | Training Matters

Duty BiochemistConundrums in BrumAlexandra Nance, Addenbrookes Hospital, Cambridge


feedback session enabled me to not only learnsome of the science that I hadn’t previouslycovered, but also to improve my examtechnique. This was followed by a Duty Biochemist

Conundrums workshop, in which small groupswere given different scenarios faced by a DBand asked to feedback their decisions to thewhole group. Scenarios ranged from the ethicsof disclosing results directly from the lab topatients, dealing with GPs asking for advice onprescribing, to working out whether anabnormal result was real or artefactual. Thiswas a really fascinating session, each situationwas based on a real life example and, assomeone just starting out, I enjoyed seeing thewide range of questions that I could one daybe faced with and learning how to deal withthem.A Toxicology workshop was led by Dr Steve

George later on Tuesday afternoon – again, a subject that I’ve not yet had chance to cover.I hadn’t previously considered the variety ofcontexts and situations involved in toxicology,and this session especially brought to light theimpact on patients, from therapeutic drugmonitoring to providing answers for victims ofcrime.

Excellent Opportunity Not to beMissed by Trainees

One of the subjects that frequently crops up atwork is accreditation. Wednesday morningdealt with this, with presentations from arepresentative of UKAS and from Deon

Coley-Grant of New Cross Hospital, whose labhad recently undergone assessment. As well asthe facts of how UKAS differs from CPA, it wasvery interesting to have perspectives fromboth sides of the inspection, and to hearplenty of useful advice.I drove home feeling tired out by such an

intense couple of days, but encouraged byhow much I’d enjoyed them. Each presenterwas really engaging, the topics were usefuland it was easy to see how they could bepractically applied to everyday working. Yes, some sections were very much targeted atpreparing for FRCPath examinations, but muchof it was useful for any level, and even as apre-registration Trainee I felt able to cope withthe information. I would really encourage STP Trainees to

attend the ACB Training Courses, and theirtraining officers to send them. While on theSTP, we have the time and the fundingavailable to attend – once we’re no longersupernumerary, our departments may besupportive of our training but the needs of the service do come first. The information welearn on the Training Courses can be used tosupport our competency evidence, and ishelpful preparation for the OSFAs, especially in areas that our own training labs may notspecialise in. It’s also a chance to network, over coffee or dinner. I count myself fortunatein having the support of my training officerand of my ACB Regional Tutor; without theirencouragement I would have missed out onthis excellent opportunity. �

Training Matters | 21

22 | Crossword


Last month’s solution

Across 1 Finale from Church of England

organ (5)4 Doctor ordered cure-all of

smallest independent chemical unit (9)

9 Behave like somecarbapenemases (3)

10 Note acceptable time to prepare raw fish (3)

11 Variable not matched (7)12 Secure share return (4)13 Mislay tool used for

measurement of particles insolution (10)

15 Alone, first person leavesunhappy milieu for a 10 region (5)

16 Laparoscope without chlorinetreatment results in a series of dramas (4,5)

17 Doctor, Welshman, finds nothing in new signs to form an opinion (9)

21 Conception or reproduction (5)23 Assembling logically endless

light meals (10)24 Slight cut (4)27 Incomplete success grasping

limits of ‘inert’ isotope (7)28 Odd twitch (3)29 Without Spanish signet,

get away (3)30 Hospital doctor treated girl with

arrest – no novice (9)31 Doctor hated curtains (5)

Down1 Replacement tissue work (5)2 Affirm mature medium (7)3 Withdraw action about

diagnostic insults (4)4 Visits doctor not against process

for division multiplication (7)5 Unusual clue: Oxford graduate

develops corneal scar (7)6 Employed after 31, their final

product is incombustible (10)7 Difficult clue – in point,

essential one of 14 (7)8 Communicate ethnic origin for

team contest (5,4)14 Organic compounds could treat

penniless dipsomaniacs (10)15 Triad icon might be a pointer (9)18 Associating any ill effect with

middle-age (7)19 Mr Miles appears somewhat less

corpulent (7)20 Statesman involved in treason (7)22 Condition means patient is

unable to recognise diagnosticianfailure, indict away (7)

25 Lab workplace with mark asreference point (5)

26 Cutting current identification (4)

ACB News CrosswordSet by RugosaMaking Time for Extras . . . Start at the TopIt is not easy to find time to do anything except survive in UK Pathology Departments at present. The financialsqueeze and recommendation 4 in the new Carter Report adds even more to the mix. Certainly this has been thecase with our project to make some educational videos about pathology. We have spent a couple of years nowdeveloping these skills but the amount of work required to actually get a project like this up an running, on topof the more mainstream areas of pathology life, is daunting. Sometimes you just have to pressurise yourself totake things forward and so . . . we have an afternoon booked with Dr Mike Thomas at the National School ofHealthcare Sciences. We will interview him for ACB News and also put some of it down to our first YouTubeoffering to help get ‘this show on the road’!

Documents

ACB...The full audited accounts of the ACB are now completed and as in previous years are available in the Annual Report provided to members at the AGM and on the website. The ACB