Mr Aga J Hussain

Profession: Biomedical scientist

Registration Number: BS37705

Hearing Type: Final Hearing

Date and Time of hearing: 10:00 06/04/2021 End: 17:00 13/04/2021

Location: Virtual via video conference

Panel: Conduct and Competence Committee
Outcome: Hearing has not yet been held

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Allegation

Whilst employed at Birmingham Women’s & Children’s Hospital, as a Biomedical Scientist:

1. You did not ensure adequate records were maintained in that:

a) you did not ensure that records of validation and/or verification for the Ready to Use (RTU) Antibodies which were in use for IHC tests in July 2017 had been created and/or appropriately stored; specifically for the following antibodies:

i) AE1/AE3

ii) CA19.9

iii) CA125

iv) CDX2

v) CD10

vi) CD117

vii) CD31

viii) CD34

ix) CD56

x) CD68

xi) CEA (Mono)

xii) Chromogranin

xiii) Calretinin

xiv) Cytokeratin 5

xv) CK7

xvi) CK20

xvii) Desmin

xviii) EMA

xix) GCDFP-15

xx) GFAP

xxi) HMB45

xxii) HCG

xxiii) Inhibin

xxiv) Ki67

xxv) LCA

xxvi) Melan A

xxvii) Myoglobin

xxviii) Neurofilament

xxix) P53

xxx) P63

xxxi) Progesterone

xxxii) SMA

xxxiii) S100

xxxiv) Synaptophysin

xxxv) TTF-1

xxxvi) Vimentin

xxxvii) NSE

xxxviii) NAPSIN

xxxix) PAX8

b) Between February 2016 and July 2017, you prepared and/or submitted a document which indicated that the following antibodies had been validated and/or verified and/or signed off for routine use by the Consultant Pathologist, when the appropriate records had not been completed/filed:

i) AE1/AE3

ii) AFP

iii) CA19.9

iv) CA125

v) CDX2

vi) CD10

vii) CD117

viii) CD31

ix) CD34

x) CD56

xi) CD68

xii) CEA (Mono)

xiii) Chromogranin

xiv) Calretinin

xv) Cytokeratin 5

xvi) CK7

xvii) CK20

xviii) Desmin

xix) EMA

xx) GCDFP-15

xxi) GFAP

xxii) HMB45

xxiii) HCG

xxiv) Inhibin

xxv) Ki67

xxvi) LCA

xxvii) Melan A

xxviii) Myoglobin

xxix) Neurofilament

xxx) P53

xxxi) P63

xxxii) Progesterone

xxxiii) SMA

xxxiv) S100

xxxv) Synaptophysin

xxxvi) TTF-1

xxxvii) Vimentin

xxxviii) NSE

xxxix) NAPSIN

xl) PAX8

c) Between June 2014 and July 2016 you did not ensure that Control Tissue Validation Records which you created and/or reviewed consistently contained:

i) the authorising signatures of the Senior Biomedical Scientist responsible for that section and/or Consultant Pathologist;

ii) the antibody references for the reagents used for the validation and/or verification of the control tissues;

iii) the Lot numbers and/or expiry dates for the reagents used in the validation process;

iv) a record of consent for use of the Post-Mortem (PM) tissue which was used as a Control on the following dates:

iv. 19 December 2015

v. 08 January 2016

vi. 10 January 2016; and

vii. 11 January 2016.

i) a record of which type of tissue used in the specimen

d) Between June 2014 and July 2016 you did not ensure that the Immunohistochemistry Reagent and Consumables Management Records which you completed and/or reviewed:

i) consistently contained a record of the date of the final use of batch;

ii) matched the inventory details from Leica Bond Autostainer for a number of UPI and/or Lot numbers, including but not limited to:

i. 6027307;

ii. DB152-03-11A.

e) Between March 2014 and July 2017, you did not ensure antibody validation records were completed and/or appropriately stored which matched the inventory details from Leica Bond Autostainer for a number of reagents, including but not limited to the following UPI’s:

i) 07721228

ii) 08564311

iii) 05430029

iv) 08331338

v) 06587156

vi) 05487157

vii) 06638942

f) Between December 2015 and April 2016, you did not ensure the batch number of next batch in use was recorded on the Immunohistochemistry Reagent and Consumables Management Record, for the following batch numbers:

i) 42149;

ii) 43824; and

iii) 44819.

g) Between June 2014 and July 2017 you did not ensure that the Immunohistochemistry Reagent and Consumables Management Record which you completed and/or reviewed consistently contained the authorising signatures of the Consultant Pathologist and/or Senior Biomedical Scientist responsible for that section.

2. You did not ensure that accurate records were maintained, in that:

a) Between February 2016 and July 2017, you:

i) created a document which stated that the Myoglobin Antibody worked when in fact this was not the case;

ii) entered the incorrect expiry date for the following antibodies on the Leica Bond machine:

i. CAM.52; and

ii. P16.

iii) did not ensure the correct validation reference format was used on the Control Tissue Validation Record you completed and/or reviewed on the following dates, in that it stated “IHC” instead of “stain”:

i. 05 November 2015;

ii. 25 November 2015;

iii. 11 January 2016;

iv. 12 January 2016; and

v. 13 January 2016.

b) Between 13 December 2015 and July 2016, you did not ensure that the Immunohistochemistry Reagent and Consumables Management Record which you completed and/or reviewed had correct original control block and/or slide reference numbers for the following batch numbers:

i) 42149;

ii) 43533

iii) 43824;

iv) 44465;

v) 44819;

vi) 45339; and

vii) 46156.

c) Between May 2016 and June 2016, you did not ensure the date of final use of batch was entered correctly on the Immunohistochemistry Reagent and Consumables Management Record, for the following batch numbers:

i) 45339; and

ii) 46156.

d) Between November 2015 and December 2016, you entered the Consultant’s signature on a number of Control Tissue Validation Records and/or Immunohistochemistry Reagent and Consumables Management Records;

3. Between February 2015 and September 2015, you allowed approximately 73 out of date antibodies to be placed and/or remain in the “In-Use” section of the immunohistochemistry fridge;

4. On or around 29 May 2016, you did not go through the details of the mortuary register when the midwife and/or parent(s) of a deceased baby made enquiries for his release;

5. Between February 2015 and July 2017, you did not ensure safe techniques were used, specifically in relation to:

a) Antibody CD34 that was used as a validated control, in that:

i) The tissue in validated slide did not match the tissue on the In-Use control slide;

ii) The In – use control slide was not labelled correctly with the validation reference number;

iii) There was no paperwork to support that this control had been validated;

iv) The Validation control slide was stained on 29 October 2015, and the In-use control slide was cut on 18 December 2016.

b) A perinatal post mortem tissue in that:

i) it was taken from the original cassettes and you did not ensure it was marked with case numbers and/or identifying information;

ii) you did not ensure the tissue could be linked to records to show where the tissue came from and/or whether the tissue was consented for use as a control.

c) Several slides which you allowed to be filed as validated and verified controls in 2017 when the slides had been stained in 2016;

d) Slides ref: IHC 15/002 which you allowed to be entered on the system as validated on 10 December 2015, however the date stained was 04 January 2016;

e) an out of date antibody, LCA, which you allowed to be re- validated on or around 20 July 2016.

6. Your action described in paragraphs 1(b), 2(a)(i), 2(a)(ii) and 2(d) was dishonest.

7. The matters set out in paragraphs 1 to 6 constitute misconduct and/or lack of competence.

8. By reason of your misconduct and/or lack of competence your fitness to practise is impaired.

Finding

No information currently available

Order

No information currently available

Notes

This is a Final Hearing, taking place via video conference on Tuesday 06 April 2021 - tuesday 13 April 2021 excluding the weekend. 

Hearing History

History of Hearings for Mr Aga J Hussain

Date Panel Hearing type Outcomes / Status
06/04/2021 Conduct and Competence Committee Final Hearing Hearing has not yet been held