Update: Body Fluid Testing. Fernando San Gil

Transcription

1 Update: Body Fluid Testing Fernando San Gil

2 Background Notes - 1 Year Significant moments in IVD 2013 NATA and the TGA publish new validation and registration requirements for in-house IVDs and for in-house modifications of TGA-approved methods Changes come into effect for all NATA/RCPA-accredited laboratories Commercial methods that are being used outside the scope of the vendors specifications are targeted 10/5/18 2

3 Background Notes -2 Section 4.4 of the NPAAC standard states: The accuracy and imprecision of in-house IVDs must be determined by at least one of the following methods applicable to the relevant biological material: a) the use of certified reference material b) comparison with a definitive method or a reference method c) performance of recovery experiments d) use of validated in-house reference material e) performance in external proficiency-testing programs or Laboratory sample exchange programs 10/5/18 3

4 Victorian Quality Assurance Group A qualitative survey to characterise the status quo of Body Fluid in Australia. The data showed: A broad menu of tests was analysed on many different Body Fluid types. There was a generally non-uniform approach to test profiles analysed on body fluids. There was a lack of uniformity in reporting of results e.g. RI and interpretive comments. There was a clear lack of validation (in-house or manufacturerbased) of methods. 10/5/18 4

5 Victorian Quality Assurance Group A quantitative survey to identify how these initial findings translated into result reporting. The data showed: Most body fluids showed homogeneity of results achieved between laboratories, across methods used and across the fluid types. Some body fluids had unexpected heterogeneity. These constitute a basis for the validity of ongoing use in this manner. Good inter-laboratory agreement for many analytes, both within laboratories sharing the same platform and also between platforms. 10/5/18 5

6 Victorian Quality Assurance Group - 3 Communication with Ms Michelle McNiven (Director of IVD Reforms, TGA) late in 2017 gave rise to two potential options that may provide an exemption to the inhouse IVD requirements and allow continuation of testing: Access to unapproved IVDs as an Authorised Prescriber (AP) o A pathologist would take responsibility for supply of the device (test) in their laboratory. Access to unapproved IVDs for clinical trials/research o Approval from TGA to access unapproved IVDs for clinical trials or research. Requires endorsement of an ethics committee and other hurdles. 10/5/18 6

7 RCPA Body Fluids Working Party - 1 First meeting of the RCPA Body Fluids Working Group held via teleconference on 1 st February Royal Australasian College of Surgeons, Royal Australasian College of Physicians declined to attend. The following groups sent apologies for the meeting: National Pathology Accreditation Advisory Council (NPAAC) Medical Oncology Group of Australia Endocrine Society of Australia 10/5/18 7

8 RCPA Body Fluids Working Party - 2 Organisation Represented Representative Organisation Represented Representative RCPA Department of Health Therapeutic Goods Administration A/Prof Bruce Latham (Chair) Clin/Prof John Burnett A/Prof Graham Jones Dr Louise Prentice Dr Debra Graves Dr Simon Singer Ms Michelle McNiven AACB Public Pathology Australia (PPA) Mr John Calleja Dr Kay Weng Choy Dr Fernando San Gil Prof Hans Schneider Dr Fernando San Gil NATA Mr Andrew Griffin Pathology Australia Dr Lee Price RCPA Quality Assurance Programs Prof Tony Badrick 10/5/18 8

9 RCPA Body Fluids Working Party - 3 TGA representative advised that there is no provision for an exemption to complying with the requirements. The two options offered in prior discussions were not a practical solution. Access to unapproved IVDs as an Authorised Prescriber (AP) Access to unapproved IVDs for clinical trials/research All laboratories performing body fluid testing needed to comply with the NPAAC requirements. 10/5/18 9

10 RCPA Body Fluids Working Party - 4 There was concern that the NPAAC requirement as it pertained to body fluids did not provide enough guidance for compliance. Using a risk-based approach to the validation of body fluids. Sharing of data The scope for the use of external evidence is unclear, such as: Peer-reviewed validation data Guidelines from Professional Societies Validation studies done by other laboratories 10/5/18 10

11 RCPA Body Fluids Working Party - 5 With regard to sharing of data, TGA representative advised: There is some scope for information sharing across a group of laboratories that operate under a single quality management system. However, this would require that the laboratories in the network were using the same specimen types, exact same methodology and instrumentation etc. Individual laboratories within the network still need to perform a verification study to demonstrate acceptable performance in their own hands. 10/5/18 11

12 RCPA Body Fluids Working Party - 6 The meeting ended by addressing the changes needed for compliance: 1. What should laboratories do now? 2. Development and agreement on a framework for validation of non-standard body fluids. 3. Participation in a Body Fluid EQA. 10/5/18 12

13 Where to from here What should laboratories do now (cont d)? S1.3 If an in-house IVD cannot be fully validated, and there is no reasonable access to an alternative validated assay, and it is used in one or more of the circumstances described in C1.3(i), then the report issued with the test result must contain the following statement: The test used cannot be fully validated to the current NPAAC Requirements because [insert a brief reason] and the results should be interpreted accordingly. For further information please contact the Laboratory. 10/5/18 13

14 Where to from here What should laboratories do now (cont d)? C1.3(ii) The Laboratory must have a documented plan for validation. C1.3(iii) Where an in-house IVD has been used in the circumstances described in S1.3, there must be validation records available to the extent possible. C1.3(iii) Where an in-house IVD has been used in the circumstances described in S1.3(c), validation must be completed as soon as possible. 10/5/18 14

15 Where to from here Development and agreement on a framework for validation of non-standard fluids. A number of groups have developed their own protocols for validation of non-standard body fluids e.g.: Laboratory Group Syd Path NSW Health Pathology Mayo Clinical Laboratories Body Fluid Validation Document Method Validation - Body Fluid Testing - Draft Protocol for Real-time/Rapid Validation Validation of tests on non-standard body fluids ommunique/2013/03-bodyfluid-testing/index.html 10/5/18 15

16 Where to from here Development and agreement on a framework for validation of non-standard fluids (cont d). It was agreed that Working Group would write to NPAAC to discuss amending the current requirement so that: External data could be used where appropriate in validating inhouse IVDs. The requirement for laboratories to be under a single quality management system in order to share validation information be reviewed. 10/5/18 16

17 Where to from here Participation in an EQA. Participation in a EQA program such as this would be seen as a step toward meeting compliance. RCPA QAP released a pilot Body Fluids EQA Program in March The proposed analytes are: Sodium, Creatinine, Glucose, Osmolality, Protein, Albumin, Amylase, Lipase, LDH, Cholesterol, Triglyceride, ph, Lactate, CA19.9, CEA. 10/5/18 17

18 Where to from here - 6 Since the first meeting: On 13 March 2018 A/Prof Bruce Latham (Chair) wrote to A/Prof Beverley Rowbotham (Chair, NPAAC) summarising the points raised at the RCPA Working Party meeting. The request was to be considered at the NPAAC Document Review and Liaison Committee held on 16 April No further correspondence or meeting of the RCPA Working Party has taken place to date. 10/5/18 18

19 Use of NATA Logo Can body fluid results and the accompanying disclaimer be printed on the laboratory reports with the NATA logo? The Working Group is proposing to use this clause (S1.3 of the IVD Requirements) in accordance within the intent it was placed into the NPAAC document. Therefore, the use of the clause and the disclaimer does allow for use of the NATA logo on reports. The analytes in question must be included in the scope of accreditation for the laboratory. 10/5/18 19

20 Acknowledgements John Calleja Kay Weng Choy Graham Jones 10/5/18 20

21 RCPA QAP Workshop 10/5/18 21

22 Case Study -1 10/5/18 22

23 Case Study -2 C1.3(ii) The Laboratory must have a documented plan for validation. C1.3(iii) Where an in-house IVD has been used in the circumstances described in S1.3(c), validation must be completed as soon as possible. Validation of non-standard body fluids for commercial assays - Phase 1 completion target date 30/6/18 Fluid Class Most common tests ordered on each fluid class Roche c6000/c8000 Abbott Siemens Pleural Protein, Amylase, Lipase, Glucose, Total Bilirubin, Cholesterol, Triglyceride, LD Wollongong: All tests RNSH: all tests Westmead: all tests Peritoneal Protein, Albumin, Glucose, LD, Cholesterol, Triglyceride Randwick: All tests Gosford: All tests Nepean: all tests Drainage Protein, Albumin, Glucose, LD, Cholesterol, Triglyceride Kogarah: All tests JHH: All tests Nepean: all tests Joint Protein, Glucose, LD, Uric Acid Liverpool: All tests Westmead: all tests 10/5/18 23

24 Case Study -3 C1.3(iii) Where an in-house IVD has been used in the circumstances described in S1.3, there must be validation records available to the extent possible. 10/5/18 24