Translate the text from English to Welsh.



 
Today, the Human Tissue Authority (HTA) has published their report relating to an inspection of mortuary facilities within the Cardiff and Vale University Health Board at University Hospital of Wales (UHW) which took place on 9 and 10 August 2017\.  

  

The report identifies significant shortfalls against a number of standards which include traceability, premises and governance. Cardiff and Vale University Health Board has been actively working, over the past few weeks, to address these. Whilst I have been unable to make a public statement prior to the HTA publication of the report, I have discussed this matter directly with the Chair; in addition, my officials have had a number of discussions with the chief executive and executive team.  

  

The HTA is a regulatory agency, which licences and inspects organisations that store and use human tissue for purposes such as research, patient treatment, post\-mortem examination, teaching and public exhibitions.  

  

As part of their regulatory function the HTA carries out inspections of licensed establishments. Under the Human Tissue Act 2004, the HTA has a statutory responsibility to make judgments about the suitability of the designated individual (DI); licence applicant (Holder); premises and practices in relation to the licensed activities.  

  

The HTA publishes 13 standards that licensed establishments must meet, inspect against these standards and check that appropriate procedures are being followed. They inspect establishments on a cyclical basis, usually every three to five years, according to the potential risk of establishments, focusing on those posing the higher risk, owing to the nature of activity and impact on patients and families if things were to go wrong.  

  

All licensed establishments must appoint a DI who has a legal duty to ensure that statutory and regulatory requirements are met. They are responsible for supervising licensed activities and ensuring suitable practices are taking place.


The HTA inspection reports are exception\-based: only those standards that have been assessed as not met are included. Where the HTA determines that a standard is not met, the level of the shortfall is classified as ‘Critical’, ‘Major’ or ‘Minor’. Where HTA standards are met, but the HTA has identified an area of practice that could be further improved, advice is given to the DI.  

  

The latest routine inspection of mortuary facilities at UHW highlighted deficiencies against a number of the standards tested, including traceability, premises and governance. It identified three critical, 14 major and nine minor shortfalls against the standards. The three critical shortfalls related to traceability, audit, and management of post mortem samples.  

  

The HTA set the health board a timeframe to undertake a number of actions to address the issues identified.  

  

Significant work has been undertaken by Cardiff and Vale University Health Board since the inspection and receipt of the draft inspection report on 6 September. An improvement action plan has been implemented and they have met all HTA deadlines so far. A longer term action plan is in place to address the remaining issues. Actions taken include replacing the DI, an audit of all post\-mortem material currently being held at the mortuary and work is ongoing to address the facilities issues.  

  

The HTA has already revisited the site to undertake a follow up inspection and are satisfied with the progress on actions being implemented to meet the shortfalls identified during the initial inspection.    

I am deeply disappointed in the failings identified and there is still further work required to ensure the site is fully compliant. All NHS Chief Executives have been reminded of health boards’ responsibilities in relation to compliance with the Human Tissue Act 2004, its associated regulations, codes of practice and standards. The Chief Medical Officer’s office will continue to monitor the corrective and preventative actions being implemented to provide the assurances about progress on the shortfalls identified during the inspection.  

  

A copy of the inspection report is available on the Human Tissue Authority website.







Translation:


 
Heddiw, cyhoeddodd yr Awdurdod Meinweoedd Dynol ei adroddiad ar arolygiad o gyfleusterau corffdy o fewn Bwrdd Iechyd Prifysgol Caerdydd a'r Fro yn Ysbyty Athrofaol Cymru, a gynhaliwyd ar 9 a 10 Awst 2017\.  

  

Mae'r adroddiad yn nodi diffygion sylweddol yn erbyn nifer o safonau, gan gynnwys diffygion sy'n ymwneud â'r gallu i olrhain, y safle, a’r trefniadau llywodraethu. Mae Bwrdd Iechyd Prifysgol Caerdydd a'r Fro wedi bod yn gweithio i wella'r diffygion hyn yn ystod yr wythnosau diwethaf. Er nad oedd modd i mi wneud datganiad cyhoeddus cyn i’r Awdurdod gyhoeddi’r adroddiad, rwyf wedi trafod y mater hwn yn uniongyrchol gyda'r Cadeirydd, a hefyd mae fy swyddogion wedi cynnal nifer o drafodaethau gyda'r prif weithredwr a'r tîm gweithredol.  

  

Mae'r Awdurdod Meinweoedd Dynol yn asiantaeth reoleiddio sy'n trwyddedu ac yn arolygu sefydliadau sy'n cadw ac yn defnyddio meinweoedd dynol at ddibenion megis ymchwil, trin cleifion, cynnal archwiliadau post\-mortem, addysgu, ac arddangosfeydd cyhoeddus.    

  

Fel rhan o'i swyddogaeth reoleiddio, mae'r Awdurdod Meinweoedd Dynol yn cynnal arolygiadau o sefydliadau trwyddedig. O dan Ddeddf Meinweoedd Dynol 2004, mae cyfrifoldeb statudol ar yr Awdurdod i ffurfio barn ynghylch addasrwydd yr unigolyn dynodedig; y sawl sy'n ymgeisio am drwydded (deiliad); y safle a’r arferion sy'n gysylltiedig â'r gweithgareddau trwyddedig.  

  

Mae’r Awdurdod yn cyhoeddi 13 o safonau y mae'n rhaid i sefydliadau trwyddedig eu bodloni, cynnal arolygiadau sy'n mesur yn erbyn y safonau hyn a sicrhau bod y prosesau priodol yn cael eu dilyn. Bydd sefydliadau'n cael eu harolygu'n rheolaidd, fel arfer bob tair blynedd i bum mlynedd yn ôl y risg bosib, gan ganolbwyntio ar y rhai risg uwch  oherwydd natur ei weithgarwch a'r effaith ar gleifion a theuluoedd, pe bai pethau'n mynd o chwith.  

  

Rhaid i bob sefydliad trwyddedig benodi unigolyn dynodedig y mae arno ddyletswydd gyfreithiol i sicrhau bod gofynion statudol a rheoleiddiol yn cael eu bodloni. Mae'n gyfrifol am oruchwylio gweithgareddau trwyddedig a sicrhau bod yr arferion priodol ar waith.  

  

Mae adroddiadau arolygu'r Awdurdod yn seiliedig ar y safonau nad ydynt wedi eu bodloni, a dim ond y safonau hyn sy'n cael eu cynnwys ynddynt. Os bydd yr Awdurdod yn barnu bod safon heb ei bodloni, bydd lefel y diffyg yn cael ei chategoreiddio fel difrifol iawn, sylweddol neu lai difrifol. Os bydd safonau'r Awdurdod wedi eu bodloni, ond bod yr Awdurdod wedi nodi y gellid gwella arferion, rhoddir cyngor ar hynny i'r unigolyn dynodedig.  

  

Yn yr arolygiad rheolaidd diweddaraf o gyfleusterau corffdy yn Ysbyty Athrofaol Cymru, nodwyd diffygion yn erbyn nifer o'r safonau a oedd dan sylw, gan gynnwys materion yn ymwneud â'r gallu i olrhain, y safle, a’r trefniadau llywodraethu. Nodwyd tri diffyg difrifol iawn, 14 diffyg sylweddol a 9 diffyg llai difrifol. Roedd y tri diffyg difrifol iawn yn ymwneud â'r gallu i olrhain samplau post\-mortem, y trefniadau cofnodi a’r trefniadau ar gyfer eu rheoli.  

  

Pennodd yr Awdurdod amserlen ar gyfer cymryd nifer o gamau i ddatrys y problemau a nodwyd.  

  

Mae Bwrdd Iechyd Prifysgol Caerdydd a'r Fro wedi cyflawni gwaith sylweddol ers i'r arolygiad gael ei gynnal ac ers iddo dderbyn yr adroddiad arolygu drafft ar 6 Medi. Mae cynllun gwella wedi ei roi ar waith, a hyd yn hyn mae wedi bodloni pob un o'r terfynau amser a bennwyd gan yr Awdurdod. Mae cynllun gweithredu mwy tymor hir ar waith er mwyn rhoi sylw i'r materion sy'n weddill. Roedd y camau a gymerwyd yn cynnwys penodi unigolyn dynodedig newydd a chynnal archwiliad o'r holl  gofnodion sy'n gysylltiedig â meinweoedd post\-mortem sy'n cael eu cadw yn y corffdy ar hyn o bryd. Mae'r gwaith o roi sylw i'r materion sy'n ymwneud â chyfleusterau yn parhau i fynd rhagddo.  

  

Mae’r Awdurdod eisoes wedi cynnal ymweliad arall â’r safle i gynnal arolygiad dilynol, ac mae’n fodlon ar y cynnydd a wnaed yn sgil cymryd camau i unioni’r diffygion a nodwyd yn ystod yr arolygiad cychwynnol.  

  

Rwy’n teimlo’n siomedig iawn ynghylch y diffygion a nodwyd, ac mae gwaith pellach i’w wneud o hyd i sicrhau bod y safle’n cydymffurfio’n llwyr. Mae holl Brif Weithredwyr y GIG wedi cael eu hatgoffa o gyfrifoldebau byrddau iechyd i gydymffurfio â Deddf Meinweoedd Dynol 2004, a'r rheoliadau, codau ymarfer a safonau cysylltiedig. Bydd swyddfa’r Prif Swyddog Meddygol yn parhau i fonitro’r camau unioni ac atal a gymerir er mwyn darparu sicrwydd o ran y cynnydd a wneir mewn perthynas â’r diffygion a nodwyd yn ystod yr arolygiad.


Mae copi o'r adroddiad arolygu ar gael ar wefan yr Awdurdod Meinweoedd Dynol.