© The Strategic Projects Team Hosted by the Greater East Midlands Commissioning Support Unit National Pathology Programme Standardisation and Harmonisation.

Slides:



Advertisements
Similar presentations
Ninewells Hospital & Medical School
Advertisements

When Using DOPPS Slides. DOPPS Slide Use Guidelines.
Mike Keen, CEO, Kent LPC. Why is change needed? NHS England states that: Primary care services face increasingly unsustainable pressures Community pharmacy.
NORIP, Malmø 27/ NORIP concept Common Nordic Reference Intervals NFKK meeting 27/ Pål Rustad Fürst Medical Laboratory, Oslo
Linda Ward Clinical Review & Effectiveness Specialist, EMSCG Primary care treatment funding decisions: developing a resource to.
Topics Reference interval studies The importance of seeing Parametric, Non-parametric and other Estimating the error of a reference interval study Sample.
Laboratory Quality Control
© Imperial College LondonPage 1 Non-Clinical Hot Topics in General Practice Professor Azeem Majeed Department of Primary Care & Social Medicine.
Statistical Analysis SC504/HS927 Spring Term 2008 Week 17 (25th January 2008): Analysing data.
Quality Assurance.
Senior Lecturer in Pathology
Evaluation of the Modification of Diet in Renal Disease (MDRD) and Cockcroft-Gault (C-G) formulas in the Calvert equation for Carboplatin Dosing Whitney.
Promoting Excellence in Family Medicine Enabling Patients to Access Electronic Health Records Guidance for Health Professionals.
1 Thyroid Testing Strategies in the South-West and Wessex A survey conducted on behalf of the ACB SW&W Regional Committee by Roberta Goodall.
Serum Creatinine and eGFR Where Are We Now? Dr Mike Bosomworth Lead Clinician - Blood Sciences Leeds Teaching Hospitals 16 th April
Unit #7 - Basic Quality Control for the Clinical Laboratory
Creatinine and the eGFR Graham Jones Department of Chemical Pathology St Vincent’s Hospital, Sydney AACB-AIMS Annual Scientific meeting Hobart 2006.
Estimated GFR Based on Creatinine and Cystatin C
Quality Assurance.
Quality Assessment 2 Quality Control.
Chronic kidney disease Mr James Hollinshead Public Health Analyst East Midlands Public Health Observatory (EMPHO) UK Renal Registry 2011 Annual Audit Meeting.
Measurements for 8 Common Analytes in Native Sera Identify Inadequate Standardization among 6 Routine Laboratory Assays H.C.M. Stepman, U. Tiikkainen,
Acute Quality Standards Dan Beckett Acute Physician CMO Advisor for Acute & General Medicine.
A High Prevalence of Vitamin D Inadequacy in a Minimal Trauma Fracture Population A High Prevalence of Vitamin D Inadequacy in a Minimal Trauma Fracture.
Evaluation of Beckton-Dickinson PST II and SST II Blood Collection Tubes P Graham, B Martin, M Roser, G Jones Department of Chemical Pathology, St Vincent’s.
Creatinine methods and eGFR reporting in the SW and Wessex Region of the ACB Introduction The NSF for Renal Services recommends that for the NHS in England,
Governance of the Pathology Catalogue Gifford Batstone.
Prof. of Clinical Chemistry, Mansoura University.
Lecture 4 Basic Statistics Dr. A.K.M. Shafiqul Islam School of Bioprocess Engineering University Malaysia Perlis
Quality Control Lecture 5
Statistics Networking Day Question design Jacki Schirmer Senior Research Fellow Health Research Institute & Institute for Applied Ecology
Monitoring the Performance of Nucleic Acid Tests using Data Generated from EDCNet and DigitalPT Wayne Dimech, Darren Jardine, Thu-Anh Pham and the staff.
NORIP, Malmö 27/ Implementation phase of NORIP Gunnar Nordin, EQUALIS, Uppsala Common Nordic Reference Values, Session 15, NFKK 24 – 27 April 2004.
Crude Rates and Standardisation Standardisation: used widely when making comparisons of rates between population groups and over time (ie. Number of health.
Medical Statistics as a science
Evaluation of the Presage™ ST2 ELISA Jun Lu 1, David G. Grenache 1,2 1 ARUP Institute for Clinical and Experimental Pathology, Salt Lake City, UT 2 Department.
Statistics & graphics for the laboratory 25 Biological variation Introduction Estimation (ANOVA application) Index-of-individuality Comparison of a result.
United Nations Workshop on Revision 3 of Principles and Recommendations for Population and Housing Censuses and Evaluation of Census Data, Amman 19 – 23.
Use of Reference Materials in Medical Testing SLAB 10th Anniversary Celebrations Accreditation Conference 10 th November 2015 Dr Deepani Siriwardhana Senior.
Quality control & Statistics. Definition: it is the science of gathering, analyzing, interpreting and representing data. Example: introduction a new test.
Comparability of methods and analysers Nora Nikolac
Carboplatin and Creatinine Have we got it right?
Control Charts and Trend Analysis for ISO 17025
 Remember Chemistry panel Quality Control:-  In a medical laboratory, it is a statistical process used to monitor and evaluate the analytical process.
Hyperphosphataemia in chronic kidney disease Support for education and learning for children and young people’s renal services: slide set March 2013 NICE.
Confidence Intervals and Hypothesis Testing Mark Dancox Public Health Intelligence Course – Day 3.
Improving the experience of all Londoners with COPD and minimising the impact of the disease London Respiratory Team Medicines Management Workstream Dr.
Introduction The composition of plasma and Cerebrospinal fluid (CSF) are similar with the only major difference between the two being the greatly reduced.
Patient Safety Monitoring in International Laboratories (SMILE) Mark Swartz, MT(ASCP), SMILE QA/QC Coordinator Improving the Sensitivity of QC Monitoring:
Result Authorisation – Correct or Not? Julie RYAN FAACB Chair SRAC AACB Healthscope Pathology.
APHO’s Technical Work Paul Fryers Deputy Director – East Midlands PHO Technical Advisor – APHO.
Method comparisons - what do we learn from the Nordic Reference Interval Project 2000 (NORIP) Pål Rustad Fürst Medical Laboratory Labquality Days 12/
Diagnostic clinical chemistry
NHS West Kent Clinical Commissioning Group CCG Performance Reporting arrangements Patient Participation Group Chairs 31 st March 2015.
Analysing ethnicity data Tools and methods Martin Bardsley Assistant Director. Office for Information on Health Care Performance.
Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for the Adoption of a More Uniform Reference Interval L.M. Thienpont, K.
Harmonization of Thyroid Stimulating Hormone (TSH); an Alternative Approach   Author: Izza Abdulhafedh Laboratory Scientist, The Nairobi Hospital, Kenya.
Unit #6 - Basic Quality Control for the Clinical Laboratory
Pakistan Society Of Chemical Pathologists Zoom Series of Lectures ZT 24. Quality Managent 1 Brig Aamir Ijaz MCPS, FCPS, FRCP (Edin), MCPS-HPE HOD and.
Laboratory Quality Control
Uncertainty: the biochemistry perspective
Joel D. Kopple, Xiaofei Zhu, Nancy L. Lew, Edmund G. Lowrie 
EAST GRADE course 2019 Introduction to Meta-Analysis
Introduction To Medical Technology
Quality Control Lecture 3
Quality Assessment The goal of laboratory analysis is to provide the accurate, reliable and timeliness result Quality assurance The overall program that.
Exercise 1 Use Transform  Compute variable to calculate weight lost by each person Calculate the overall mean weight lost Calculate the means and standard.
A proposal for Derivation of Analytical Quality Goal for Precision
Consultant Clinical Biochemist
Reporting of critical potassium results reporting in hyperkalaemia: Audit and survey of practice in Scotland Neil Greig 24/04/17.
Presentation transcript:

© The Strategic Projects Team Hosted by the Greater East Midlands Commissioning Support Unit National Pathology Programme Standardisation and Harmonisation Gifford Batstone National Pathology Programme

© The Strategic Projects Team Hosted by the Greater East Midlands Commissioning Support Unit April TRUD Release Revised list of units of measurement PBCL and NLMC New entries – 294 Inclusion of sample type Corrections to names eg BNP Deletions – 299 Duplications Linked to corrections

© The Strategic Projects Team Hosted by the Greater East Midlands Commissioning Support Unit Supplementary File Guidance at present/mandatory in future Linking analytes (with analysed specimen type) to a single unit of measurement Addition of Data Combination Indicators 0 = test not used to trend 1 = OK to assume combination 2 = requires a factor 3 = don’t even think about it 4 = not yet agreed

Why? - PQAR ‘The continued development of the NLMC to ensure consistency of data and information across the NHS in England should remain a priority. The professional bodies, the IVD manufacturers and others should work towards minimising the differences between analytical processes, requesting and reporting.’ Recommendation 4.66 Pathology Quality Assurance Review

Why? - PQAR ‘Laboratory processes should be harmonised so that patients can be confident about the consistency of their test results, especially as they start to gain access to their personal health records that may contain reports from different pathology services’ Press Release, Pathology Quality Assurance Review

© The Strategic Projects Team Hosted by the Greater East Midlands Commissioning Support Unit Ref Range Variation Self reported reference intervals for TSH and fT4. Each bar represents a different laboratory Each colour represents a single analytical method Statistical analysis 750,000 TSH reports gives mU/L but ?variation - age, method Data Finlay MacKenzie UKNEQAS 09/2012

TSH values: Geometric Mean before (A) and after (B) mathematical recalibration 16 immunoassays from 9 different manufacturers analysing the same sample in triplicate. Report of the IFCC Working Group for Standardization of Thyroid Function Tests; Part 1: Thyroid-Stimulating Hormone Thienpont L et al; Clinical Chemistry 56:6 902–911 (2010)

© The Strategic Projects Team Hosted by the Greater East Midlands Commissioning Support Unit Age group albumin (g/L) male female Serum Albumin Variation – Age and Sex Gary Weaving et al

© The Strategic Projects Team Hosted by the Greater East Midlands Commissioning Support Unit age group malefemale Average Albumin by laboratory

© The Strategic Projects Team Hosted by the Greater East Midlands Commissioning Support Unit Effect of assay on dose Mike Bosomworth Female, 45y, 55kg Method Mean Creatinine (μmol/l) C&G (ml/min) Carboplatin (mg) Enzymatic Kinetic Jaffe Jaffe - Compensated O'Leary Endpoint Jaffe IDMS Value Variability34% 26%

Comparison of 5 PTH methods Mean values of NEQAS distributions of Synthetic PTH - Sanjay Khanna Reference Ranges

Taking PTH results from 1735 CKD 5 patients in Brighton; Data transformed from Roche to other analytical methods and UKRA ULN applied >9xULN (HTBD) 2-9xULN (optimal) <2xULN (LTBD)

Standardization Harmonization Traceability Categories from ISO Miller 2012

Standardisation of Reports The emphasis is on the reports More than one approach: Standardisation of analytical techniques Use of WHO and similar reference materials Mathematical alignment of methods – Mean values of different methods Where no international reference materials – To WHO reference based methods

Questions and Comments please

age group age group average total calciumaverage adjusted calcium Same labs Adj Calcium Females

male female male female calcium (mmol/L) calcium adjusted by lab calcium re-adjusted for age differences in albumin mean +/- 2sd Effect of adj to age related alb

Comparison of range of results produced with laboratory reference range Females age 20 – 30 yr reference range width

0 – 0.1 % 0.1 – 10 % 1 – 10 % > 10 % % results lower than reference range <1 % 1 – 10 % 10 – 20 % % < 40 % % results lower than reference range Spread of results vs mean of results spread mean F, age Adjusted Calcium acceptable?