Rheoliadau'r Gwasanaeth Iechyd Gwladol (Gwasanaethau Fferyllol) (Diwygio) (Cymru) 2011

Diwygio paragraff 25 o Atodlen 2 i'r prif Reoliadau

2.—( 1) Mae paragraff 25 (llywodraethu clinigol) o Atodlen 2 i'r prif Reoliadau(1) 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—

  (aa)

  a patient safety incident log,

  (bb)

  a near-miss log, and

  (cc)

  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(2) (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.”.

(1)

Mewnosodwyd paragraff 25 i O.S. 1992/662 gan O.S. 2005/1013 (Cy.67) ac fe'i diwygiwyd gan O.S. 2010/868 (Cy.90).

(2)

1996 p.18; mewnosodwyd adran 43A gan adran 1 o Ddeddf Datgelu er Lles y Cyhoedd 1998 (p.23). Gweler hefyd adran 43K(1)(c) o Ddeddf Hawliau Cyflogaeth 1996 sydd yn estyn ystyr “worker” ar gyfer y Rhan honno o'r Ddeddf sy'n ymwneud â datgeliadau gwarchodedig fel ei fod yn cynnwys pob unigolyn sy'n darparu gwasanaethau fferyllol yn unol â threfniadau a wnaed gan Fwrdd Iechyd Lleol o dan adran 80 o Ddeddf y Gwasanaeth Iechyd Gwladol (Cymru) 2006.