Y GWASANAETH IECHYD GWLADOL, CYMRU Enwi, cychwyn, cymhwyso a dehongli 1 1 Enw'r Rheoliadau hyn yw Rheoliadau'r Gwasanaeth Iechyd Gwladol (Gwasanaethau Fferyllol) (Diwygio) (Cymru) 2011. 2 Mae'r Rheoliadau hyn yn dod i rym ar 31 Rhagfyr 2011. 3 Mae'r Rheoliadau hyn yn gymwys o ran Cymru. 4 Yn y Rheoliadau hyn, ystyr “y prif Reoliadau” (“ the principal Regulations ”) yw Rheoliadau'r Gwasanaeth Iechyd Gwladol (Gwasanaethau Fferyllol) 1992 . Diwygio paragraff 25 o Atodlen 2 i'r prif Reoliadau 2 1 Mae paragraff 25 (llywodraethu clinigol) o Atodlen 2 i'r prif Reoliadau wedi ei ddiwygio yn unol â darpariaethau canlynol y rheoliad hwn. 2 Ar ôl is-baragraff (1), mewnosoder yr is-baragraff canlynol— 1A A system of clinical governance is “acceptable” if it provides for— a compliance with the clinical governance components set out in sub-paragraph (2), and b submission of an annual self assessment of compliance (to an approved level) with those clinical governance components via approved data submission arrangements which allow the Local Health Board to access that assessment. . 3 Yn is-baragraff (2), yn lle'r geiriau “For these purposes” hyd at “the following components-” rhodder y canlynol— The clinical governance components comprise of the following— . 4 Ym mharagraff (a) o is-baragraff (2)— a ar ôl is-baragraff (ii), mewnosoder yr is-baragraff canlynol— iia a requirement that where the chemist publicises the NHS services that are available at or from the chemist’s pharmacy (whether the chemist is producing their own publicity material or advertising services in material published by another person), the chemist does so in a manner which makes clear that the services are funded as part of the health service, ; a b ar ddiwedd is-baragraff (iii), ar ôl y coma, mewnosoder y canlynol— including a requirement to publicise the results of the survey and any appropriate action the chemist intends to take, . 5 Ym mharagraff (c) o is-baragraff (2)— a ar ddiwedd is-baragraff (iii), ar ôl y coma, mewnosoder y canlynol— which comprises of— a patient safety incident log, a near-miss log, and the reporting of patient safety incidents to the National Patient Safety Agency, ; b ar ôl is-baragraff (iii), mewnosoder yr is-baragraff canlynol— iiia arrangements, including record keeping arrangements, for dealing appropriately and timeously with communications concerning patient safety from the Welsh Ministers, the Medicines and Healthcare products Regulatory Agency and the National Patient Safety Agency, ; ac c yn lle is-baragraff (vi) rhodder yr is-baragraff canlynol— vi a clinical governance lead person for each pharmacy, appointed as such by the chemist (or that is the chemist), who is knowledgeable about both the pharmacy procedures of that pharmacy and the other NHS services that are available in the locality of that pharmacy, . 6 Ym mharagraff (e) o is-baragraff (2)— a hepgorer “and” ar ddiwedd is-baragraff (iv); b yn lle'r hanner colon ar ddiwedd is-baragraff (v) rhodder “, and”; ac c ar ôl is-baragraff (v), mewnosoder yr is-baragraff canlynol— vi arrangements (which must include a written policy) for ensuring that all staff and locums who, arising out of their employment with the chemist— aa make what is a protected disclosure within the meaning given in section 43A of the Employment Rights Act 1996 (meaning of protected disclosure) have the rights afforded in respect of such disclosures by that Act, and bb provide information in good faith and not for purposes of personal gain to the General Pharmaceutical Council or to a Local Health Board which includes an allegation of a serious nature which they reasonably believe to be substantially true, but disclosure of it is not a protected disclosure within the meaning given in section 43A, have the right not to be subjected to any detriment or to dismissal as a consequence of that act; . 7 Yn lle paragraff (f) o is-baragraff (2) rhodder y paragraff canlynol— f an information governance programme, which provides for— i compliance with approved procedures for information management and security, and ii submission of an annual self assessment of compliance (to an approved level) with those procedures via approved data submission arrangements which allow the Local Health Board to access that assessment; and . 8 Ar ôl paragraff (f) o is-baragraff (2) mewnosoder y paragraff canlynol— g a premises standards programme, which includes— i a system for maintaining cleanliness at the pharmacy which is designed to ensure, in a proportionate manner, that the risk to people at the pharmacy of healthcare acquired infection is minimised, and ii arrangements for there to be a clear separation between the areas of a pharmacy which are an appropriate healthcare environment (where patients receive NHS services) and those areas that are a non-healthcare environment. . Trefniadau trosiannol 3 1 Dim ond mewn perthynas â'r ddarpariaeth o wasanaethau fferyllol, ar unrhyw adeg cyn diwedd y cyfnod trosiannol, gan fferyllydd yr oedd ei enw, yn union cyn i'r Rheoliadau hyn ddod i rym, eisoes ar restr fferyllol a gynhelir gan Fwrdd Iechyd Lleol o dan y prif Reoliadau, y mae gan y rheoliad hwn effaith. 2 Yn ddarostyngedig i baragraff (3), yn ystod y cyfnod trosiannol nid yw'r fferyllydd wedi ei rwymo gan y canlynol— a unrhyw ddiwygiad penodol i baragraff 25 o Atodlen 2 i'r prif Reoliadau a wneir gan reoliad 2(3), (4)(b), (5)(a) ac (c) a (7) os ydynt yn hytrach, wedi dewis cydymffurfio, a'u bod yn cydymffurfio, â'r ddarpariaeth a addaswyd neu a amnewidiwyd gan y diwygiad penodol hwnnw fel yr oedd yn cael effaith cyn y diwygiad penodol hwnnw; neu b y diwygiadau i baragraff 25 o Atodlen 2 i'r prif Reoliadau a wneir gan reoliad 2(2), (4)(a), (5)(b), (6)(a) i (c) ac (8). 3 Nid oes dim yn y rheoliad hwn yn effeithio ar ddyletswydd fferyllydd i wneud y canlynol— a cydymffurfio â pharagraff 25 o Atodlen 2 i'r prif Reoliadau cyn diwedd y cyfnod trosiannol, fel y mae'n cael effaith fel arall; a b cydymffurfio â pharagraff 25 o Atodlen 2 i'r prif Reoliadau fel y'i diwygiwyd gan y Rheoliadau hyn, ar ddiwedd y cyfnod trosiannol ac ar ôl hynny. 4 Yn y rheoliad hwn, ystyr “cyfnod trosiannol” (“ transitional period ”) yw'r cyfnod sy'n cychwyn ar y diwrnod y mae'r Rheoliadau hyn yn dod i rym ac yn dod i ben ar 31 Mawrth 2012. Lesley Griffiths Y Gweinidog Iechyd a Gwasanaethau Cymdeithasol, un o Weinidogion Cymru 4 Rhagfyr 2011