techiaith/legislation-gov-uk_en-cy huggingface dataset:
identifying cases in which action may need to be taken in respect of matters arising in relation to the management or use of controlled drugs by a relevant person;
canfod achosion lle gall fod angen cymryd camau ynghylch materion sy'n codi o ran rheoli neu ddefnyddio cyffuriau a reolir gan berson perthnasol;
the consideration of issues relating to the taking of action in respect of such matters;
ystyried y prif ddadleuon ynghylch cymryd camau ynglŷn â materion o'r fath;
If the responsible body wishes to disclose information under this regulation which -
Os bydd y corff cyfrifol yn dymuno datgelu gwybodaeth o dan y rheoliad hwn -
contains confidential information which relates to and can identify a patient; and
sy'n cynnwys gwybodaeth gyfrinachol sy'n ymwneud â chlaf ac yn gallu dynodi pwy ydyw; a
that confidential information is not required for the purposes of identifying cases in which action may need to be taken in respect of matters arising in relation to the management or use of controlled drugs by a relevant person, or for considering or taking action in such a case,
nad oes angen yr wybodaeth gyfrinachol honno at ddibenion adnabod achosion y gall fod angen cymryd camau ynghylch materion sy'n codi o ran rheoli neu ddefnyddio cyffuriau a reolir gan berson perthnasol, neu ar gyfer ystyried neu gymryd camau mewn achos o'r fath,
the responsible body must, so far as it is practical to do so, remove from the information the confidential information which relates to and can identify the patient.
rhaid i'r corff cyfrifol, i'r graddau y mae hynny'n ymarferol, dynnu o'r wybodaeth yr wybodaeth gyfrinachol sy'n ymwneud â chlaf ac sy'n gallu dynodi pwy ydyw.
is unable, under paragraph (2), to remove from any information to be disclosed any confidential information which relates to and can identify a patient; or
os nad yw'n gallu, o dan baragraff (2), dynnu ymaith o unrhyw wybodaeth sydd i'w datgelu unrhyw wybodaeth gyfrinachol sy'n ymwneud â chlaf ac yn gallu dynodi pwy ydyw; neu
considers it necessary to disclose information which contains the confidential information that relates to and can identify the patient,
os yw'n ystyried ei bod yn angenrheidiol datgelu gwybodaeth sy'n cynnwys yr wybodaeth gyfrinachol sy'n ymwneud â chlaf ac yn gallu dynodi pwy ydyw,
the responsible body must, where practicable, obtain the consent of the patient to whom the information relates.
rhaid i'r corff cyfrifol, pan fydd yn ymarferol, sicrhau cydsyniad y claf y mae'r wybodaeth yn ymwneud ag ef.
If the responsible body (or its accountable officer) has -
Os bydd y corff cyfrifol (neu ei swyddog atebol) -
commenced an assessment of or an investigation into a matter of concern in relation to the management or use of controlled drugs by a relevant individual under regulation 16 (that individual being a relevant person for the purposes of this Part); or
wedi cychwyn asesiad o fater o bryder neu ymchwiliad iddo o ran rheoli neu ddefnyddio cyffuriau a reolir gan unigolyn perthnasol o dan reoliad 16 (a'r unigolyn hwnnw'n berson perthnasol at ddibenion y Rhan hon); neu
completed an assessment of or an investigation into a matter of concern under regulation 16,
wedi cwblhau asesiad o fater o bryder neu ymchwiliad iddo o dan reoliad 16,
it must notify the persons and bodies listed in paragraph (5) of the commencement or completion of the assessment or investigation, as the case may be, and provide appropriate details regarding the nature of the assessment or investigation.
rhaid iddo hysbysu'r personau a'r cyrff a restrir ym mharagraff (5) o gychwyn neu gwblhau'r asesiad neu'r ymchwiliad, yn ôl y digwydd, a darparu manylion priodol ynghylch natur yr asesiad neu'r ymchwiliad.
Those persons and bodies are -
Dyma'r personau a'r cyrff -
if the responsible body has an accountable officer and he or she is unaware of the action taken, that accountable officer;
os oes gan y corff cyfrifol swyddog atebol ac nad yw'n ymwybodol o'r camau a gymrwyd, y swyddog atebol hwnnw;
the accountable officer nominated or appointed as accountable officer for any Local Health Board in whose area the relevant individual lives or provides health care or services related to health care; and
y swyddog atebol a enwebwyd neu a benodwyd yn swyddog atebol ar gyfer unrhyw Fwrdd Iechyd Lleol y mae'r unigolyn perthnasol yn byw yn ei ardal neu'n darparu gofal iechyd neu wasanaethau ynglyn â gofal iechyd ynddi; ac
any other responsible body that it considers it appropriate to notify.
unrhyw gorff cyfrifol arall y mae'n ystyried ei bod yn briodol ei hysbysu.
A responsible body is not required to notify any person or body, or to provide any details, under paragraph (4) where to do so would prejudice or would be likely to prejudice -
Nid yw'n ofynnol i gorff cyfrifol hysbysu unrhyw berson neu gorff, na darparu unrhyw fanylion, o dan baragraff (4) lle y byddai gwneud hynny'n rhagfarnu neu'n debygol o ragfarnu -
any investigation being conducted by the responsible body, or any other responsible body, under any enactment; or
unrhyw ymchwiliad sy'n cael ei gynnal gan y corff cyfrifol, neu gan unrhyw gorff cyfrifol arall o dan unrhyw ddeddfiad; neu
any civil or criminal proceedings.
unrhyw achosion sifil neu droseddol.
In determining for the purposes of paragraph (7) whether disclosure is not prohibited by reason of being a disclosure of personal data which is exempt from the non-disclosure provisions of the Data Protection Act 1998 by virtue of section 35 (1) of that Act (disclosure required by law or made in connection with legal proceedings etc), it is to be assumed that the disclosure is required by this regulation.
Wrth benderfynu at ddibenion paragraff (7) a yw datgeliad heb ei wahardd oherwydd ei fod yn ddatgeliad o ddata personol sy'n esempt rhag darpariaethau peidio â datgelu Deddf Diogelu Data 1998 yn rhinwedd adran 35 (1) o'r Ddeddf honno (datgeliad sy'n ofynnol gan y gyfraith neu wedi'i wneud mewn cysylltiad ag achosion cyfreithiol etc), mae i'w dybied bod y datgeliad yn ofynnol gan y rheoliad hwn.
Responsible bodies requesting additional information be disclosed about relevant persons
Cyrff cyfrifol yn gofyn am wybodaeth ychwanegol i gael ei datgelu am bersonau perthnasol
26. - (1) If a responsible body has in its possession or control information relating to the management or use of controlled drugs by a relevant person that it considers to be of serious concern (which may be fitness to practise information that is unrelated to any specific instance of the management or use of a controlled drug), it may request in writing additional information in relation to the matter from any other responsible body which it considers may have relevant information.
26. - (1) Os oes gan gorff cyfrifol yn ei feddiant neu dan ei reolaeth wybodaeth ynghylch rheoli neu ddefnyddio cyffuriau a reolir gan berson perthnasol y mae'n ystyried ei bod yn bryder difrifol (a all fod yn wybodaeth am ffitrwydd i ymarfer nad yw'n gysylltiedig ag unrhyw enghraifft benodedig o reoli neu ddefnyddio cyffur a reolir), caiff ofyn yn ysgrifenedig am wybodaeth ychwanegol ynglyn â'r mater gan unrhyw gorff cyfrifol arall y mae'n ystyried y gall fod gwybodaeth berthnasol ganddo.
If a responsible body has received a request under paragraph (1) -
Os bydd corff cyfrifol wedi derbyn cais o dan baragraff (1) -
it must determine within a reasonable period of time whether or not to comply with the request; and
rhaid iddo benderfynu cyn pen cyfnod rhesymol o amser p'un ai i gydymffurfio â'r cais ai peidio; a
it may disclose any information relating to the management or use of controlled drugs by a relevant person which it reasonably considers to be relevant to the request.
caiff ddatgelu unrhyw wybodaeth ynghylch rheoli neu ddefnyddio cyffuriau a reolir gan berson perthnasol y mae'n ystyried ei bod yn berthnasol i'r cais.
If the responsible body wishes to disclose information under this regulation which contains confidential information which relates to and can identify a patient, the responsible body must, so far as it is practical to do so, remove from the information the confidential information which relates to and can identify the patient.
Os bydd y corff cyfrifol yn dymuno datgelu gwybodaeth o dan y rheoliad hwn sy'n cynnwys gwybodaeth gyfrinachol sy'n ymwneud â chlaf ac yn gallu dynodi pwy ydyw, rhaid i'r corff cyfrifol, i'r graddau y mae hynny'n ymarferol, dynnu ymaith o'r wybodaeth yr wybodaeth gyfrinachol sy'n ymwneud â'r claf ac yn gallu dynodi pwy ydyw.
is unable, under paragraph (3), to remove from any information to be disclosed any confidential information which relates to and can identify a patient; or
os nad yw'n gallu, o dan baragraff (3), tynnu ymaith o unrhyw wybodaeth sydd i'w datgelu unrhyw wybodaeth gyfrinachol sy'n ymwneud â chlaf ac yn gallu dynodi pwy ydyw; neu
considers it necessary to disclose information which contains the confidential information that relates to and can identify the patient,
os yw'n ystyried bod angen datgelu gwybodaeth sy'n cynnwys gwybodaeth gyfrinachol sy'n ymwneud â chlaf ac yn gallu dynodi pwy ydyw,
the responsible body must, where practicable, obtain the consent of the patient to whom the information relates.
rhaid i'r corff cyfrifol, pan fo'n ymarferol, gael cydsyniad y claf y mae'r wybodaeth yn ymwneud ag ef.
A responsible body is not required to disclose information under this regulation if the disclosure -
Nid yw'n ofynnol i gorff cyfrifol ddatgelu gwybodaeth o dan y rheoliad os byddai'r datgeliad -
would prejudice, or would be likely to prejudice, any investigation being conducted by the responsible body, or by any other responsible body, under any enactment;
yn rhagfarnu, neu os byddai'n debygol o ragfarnu, unrhyw ymchwiliad a gynhelir gan y corff cyfrifol, neu gan unrhyw gorff cyfrifol arall, o dan unrhyw ddeddfiad;
would prejudice, or would be likely to prejudice, any civil or criminal proceedings; or
yn rhagfarnu, neu os byddai'n debygol o ragfarnu, unrhyw achosion sifil neu droseddol; neu
would involve disproportionate cost.
yn golygu cost anghymesur.
In determining for the purposes of paragraph (6) whether disclosure is not prohibited by reason of being a disclosure of personal data which is exempt from the non-disclosure provisions of the Data Protection Act 1998 by virtue of section 35 (1) of that Act (disclosure required by law or made in connection with legal proceedings etc.), it is to be assumed that the disclosure is required by this regulation.
Wrth benderfynu at ddibenion paragraff (6) a yw datgeliad heb ei wahardd oherwydd ei fod yn ddatgeliad o ddata personol sy'n esempt rhag darpariaethau peidio â datgelu Deddf Diogelu Data 1998 yn rhinwedd adran 35 (1) o'r Ddeddf honno (datgeliad sy'n ofynnol gan y gyfraith neu wedi'i wneud mewn cysylltiad ag achosion cyfreithiol etc), mae i'w dybied bod y datgeliad yn ofynnol gan y rheoliad hwn.
Restrictions relating to disclosures
Cyfyngiadau ynghylch datgelu
27. - (1) If a responsible body that is disclosing or to which is being disclosed any information under regulation 25 or 26 has an accountable officer, the disclosure must be made by or to the accountable officer or his or her staff (and not by or to any other person who may act on behalf of the responsible body).
27. - (1) Os oes gan gorff cyfrifol sy'n datgelu neu y datgelir iddo unrhyw wybodaeth o dan reoliad 25 neu 26 swyddog atebol, rhaid i'r datgeliad gael ei wneud gan neu i'r swyddog atebol neu ei staff (ac nid gan neu i unrhyw berson arall a all fod yn gweithredu ar ran y corff cyfrifol).
If a responsible body has received information under regulation 25 or 26, it must not process that information more than is necessary for the purposes of -
Os bydd corff cyfrifol wedi cael gwybodaeth o dan reoliad 25 neu 26, rhaid iddo beidio â phrosesu'r wybodaeth honno'n fwy na'r hyn sy'n angenrheidiol at ddibenion -
identifying cases in which action may need to be taken in respect of matters arising in relation to the management or use of controlled drugs by a relevant person;
canfod yr achosion y gall fod angen cymryd camau ynghylch materion sy'n codi o ran rheoli neu ddefnyddio cyffuriau a reolir gan berson perthnasol;
considering issues relating to the taking of action in respect of such matters; or
ystyried y prif ddadleuon ynghylch cymryd camau ynglyn â materion o'r fath; neu
taking action in respect of such matters.
cymryd camau ynghylch materion o'r fath.
In particular, the responsible body must -
Yn benodol, rhaid i'r corff cyfrifol -
not allow any person access to that information unless he or she is a person who, by virtue of his or her contract of employment or otherwise, is aware of the purposes for which the information may be processed; and
peidio â chaniatáu mynediad i unrhyw berson i'r wybodaeth honno onid yw'n berson sydd, yn rhinwedd ei gontract cyflogaeth neu fel arall, yn ymwybodol o'r dibenion y gall yr wybodaeth gael ei phrosesu ar ei chyfer; a
ensure that appropriate organisational measures are taken to prevent unauthorised disclosure or processing of the information.
sicrhau bod mesurau trefniadaeth briodol yn cael eu cymryd i rwystro datgeliad heb ei awdurdodi neu brosesu'r wybodaeth.
Record keeping requirements relating to regulations 25 and 26
Gofynion cadw cofnodion ynghylch rheoliadau 25 a 26
28. - (1) A responsible body must keep a record of -
28. - (1) Rhaid i gorff cyfrifol gadw cofnod o'r canlynol -
a decision to disclose information under regulation 25;
penderfyniad i ddatgelu gwybodaeth o dan reoliad 25;
details of the nature of the information disclosed;
manylion o natur yr wybodaeth a ddatgelir;
details of the responsible body to which information was disclosed; and
manylion am y corff cyfrifol y datgelwyd yr wybodaeth iddo; ac
A responsible body must keep a record of -
Rhaid i gorff cyfrifol gadw cofnod o'r canlynol -
any request received from another responsible body to disclose information under regulation 26;
unrhyw gais a geir gan gorff cyfrifol arall i ddatgelu gwybodaeth o dan reoliad 26;
details of the nature of any information disclosed;
manylion o natur unrhyw wybodaeth a ddatgelir;
details of the responsible body to which the information was disclosed; and
manylion am y corff cyfrifol y datgelwyd yr wybodaeth iddo; a
The records may be kept in paper or electronic format.
Ceir cadw'r cofnodion mewn fformat ar bapur neu'n electronig.
Occurrence reports
Adroddiadau ar ddigwyddiadau
29. - (1) An accountable officer (other than an accountable officer nominated or appointed as accountable officer for a Local Health Board) must give, on a quarterly basis, an occurrence report to the accountable officer nominated or appointed as accountable officer for the Local Health Board that is leading any local intelligence network of which he or she or his or her designated body is a member.
29. - (1) Rhaid i swyddog atebol (heblaw am swyddog atebol a enwebwyd neu a benodwyd yn swyddog atebol ar gyfer Bwrdd Iechyd Lleol) roi, yn chwarterol, adroddiad ar ddigwyddiadau i'r swyddog atebol a enwebwyd neu a benodwyd yn swyddog atebol ar gyfer y Bwrdd Iechyd Lleol sy'n arwain unrhyw rwydwaith gwybodaeth leol y mae ef neu ei gorff dynodedig yn aelod ohono.
The occurrence report may contain the following information - -
Caiff yr adroddiad am ddigwyddiadau gynnwys yr wybodaeth ganlynol -
details of any concerns that his or her designated body has regarding its management or use of controlled drugs; or
manylion unrhyw bryderon sydd gan ei gorff dynodedig ynghylch ei reolaeth neu ei ddefnydd o gyffuriau a reolir; neu
confirmation by his or her designated body that it has no concerns to report regarding its management or use of controlled drugs.
cadarnhad gan ei gorff dynodedig nad oes ganddo bryderon i adrodd amdanynt ynghylch ei reolaeth neu ei ddefnydd o gyffuriau a reolir.
In determining for the purposes of paragraph (3) whether disclosure is not prohibited by reason of being a disclosure of personal data which is exempt from the non-disclosure provisions of the Data Protection Act 1998 by virtue of section 35 (1) of that Act (disclosure required by law or made in connection with legal proceedings etc), it is to be assumed that the disclosure is required by this regulation.
Wrth benderfynu at ddibenion paragraff (3) a yw datgeliad heb ei wahardd oherwydd ei fod yn ddatgeliad o ddata personol sy'n esempt rhag darpariaethau peidio â datgelu Deddf Diogelu Data 1998 yn rhinwedd adran 35 (1) o'r Ddeddf honno (datgeliad sy'n ofynnol gan y gyfraith neu wedi'i wneud mewn cysylltiad ag achosion cyfreithiol etc), mae i'w dybied bod y datgeliad yn ofynnol gan y rheoliad hwn.
Accountable officers' duties to protect the safety of patients and the general public
Dyletswyddau gan swyddogion atebol i amddiffyn diogelwch cleifion a'r cyhoedd
30. - (1) If the information shared by a responsible body under regulation 25 or 26 shows a concern about inappropriate or unsafe use of controlled drugs by a relevant person, the accountable officer of any designated body responsible for -
30. - (1) Os yw'r wybodaeth a rennir gan gorff cyfrifol o dan reoliad 25 neu 26 yn dangos pryder am ddefnydd amhriodol neu anniogel o gyffuriau a reolir gan berson perthnasol, caiff swyddog atebol unrhyw gorff dynodedig sy'n gyfrifol am -
entering into any arrangements with the relevant person; or
gwneud unrhyw drefniadau gyda'r person perthnasol; neu
entering into any arrangements with any other person or body, under which the relevant person provides or may provide services,
gwneud unrhyw drefniadau gydag unrhyw berson neu gorff arall, y mae'r person perthnasol yn darparu gwasanaethau oddi tano neu y gallai fod yn gwneud hynny,
that has possession or control of that information may make recommendations to any responsible body (including, where appropriate, his or her own designated body) as to any action which the accountable officer considers that the responsible body should take to protect the safety of patients or the general public.
ac y mae'r wybodaeth honno yn ei feddiant neu dan ei reolaeth, yna caiff wneud argymhellion i unrhyw gorff cyfrifol (gan gynnwys, pan fo'n briodol, ei gorff dynodedig ei hunan) o ran unrhyw gamau y mae'r swyddog atebol yn ystyried y dylai'r corff cyfrifol eu cymryd i amddiffyn diogelwch cleifion neu'r cyhoedd.
If the concern relates to a relevant person who is not providing services to, or under arrangements that another person or body has with, a designated body, the accountable officer leading the local intelligence network for any area in which the relevant person lives or provides services must -
Os yw'r pryder yn ymwneud â pherson perthnasol nad yw'n darparu gwasanaethau i gorff dynodedig, neu o dan drefniadau sydd gan berson neu gorff arall ag ef, rhaid i'r swyddog atebol sy'n arwain y rhwydwaith gwybodaeth leol ar gyfer unrhyw ardal lle y mae'r person perthnasol yn byw ynddi neu'n darparu gwasanaethau ynddi -
seek to take reasonable steps to protect the safety of patients or the general public; and
mynd ati i gymryd camau rhesymol i amddiffyn diogelwch cleifion neu'r cyhoedd; a
where appropriate, refer the matter to a relevant responsible body (for example, a regulatory body or a police force).
pan fo'n briodol, cyfeirio'r mater i gorff cyfrifol perthnasol (er enghraifft, corff rheoleiddiol neu heddlu).
Disclosure of information in good faith
Datgelu gwybodaeth yn ddidwyll
31. Civil proceedings do not lie against a person in respect of loss, damage or injury of any kind suffered by another person as a result of the disclosure of information in good faith under regulation 25, 26, 29 or 30.
31. Ni ellir cynnal achosion sifil yn erbyn person ynghylch colled, niwed neu anaf o unrhyw fath y mae person arall yn ei ddioddef o ganlyniad i ddatgelu gwybodaeth yn ddidwyll o dan reoliad 25, 26, 29 neu 30.
Minister for Health and Social Services, one of the Welsh Ministers
Y Gweinidog dros Iechyd a Gwasanaethau Cymdeithasol, un o Weinidogion Cymru.
These Regulations contain measures relating to arrangements underpinning the safe management and use of controlled drugs in Wales.
Mae'r Rheoliadau hyn yn cynnwys mesurau ynghylch trefniadau sy'n tanategu rheoli a defnyddio cyffuriau a reolir yn ddiogel yng Nghymru.
Part 1 outlines preliminary matters.
Mae Rhan 1 yn amlinellu materion rhagarweiniol.
Part 2 relates to accountable officers. A number of health care bodies are prescribed as designated bodies (regulation 3), and these are required to appoint accountable officers (regulation 4). There are limitations upon who may act as accountable officers (regulation 5) and a duty on designated bodies to establish arrangements for their removal from office in specified circumstances (regulation 6). Designated bodies are required to ensure that their accountable officers have sufficient resources available to them (regulation 7).
Mae Rhan 2 yn ymwneud â swyddogion atebol. Caiff nifer o gyrff gofal iechyd eu rhagnodi'n gyrff dynodedig (rheoliad 3), ac mae'n ofynnol iddynt benodi swyddogion atebol (rheoliad 4). Mae cyfyngiadau ar bwy a all fod yn swyddogion atebol (rheoliad 5) ac mae dyletswydd ar gyrff dynodedig i sefydlu trefniadau i'w symud o'u swydd mewn amgylchiadau penodedig (rheoliad 6). Mae'n ofynnol i gyrff dynodedig sicrhau bod gan eu swyddogion atebol adnoddau effeithiol ar gael iddynt (rheoliad 7).
Accountable officers are given a number of functions relating to the safe management and use of controlled drugs. Essentially, these require the establishment by the accountable officer of a number of sets of arrangements which relate to the safe management and use of controlled drugs. As well as the basic arrangements (regulation 9), these include safe disposal arrangements (regulation 10) and auditing arrangements (regulation 11). As well as being given functions in relation to their own designated bodies, accountable officers are given functions in relation to health care professionals and others whose work involves the management and use of controlled drugs, for which their designated body is responsible. These responsibilities include maintaining records of and investigating concerns (regulations 15 and 16), and taking appropriate action where there are well-founded concerns (regulation 17). Accountable officers for Local Health Boards also have particular responsibilities for setting up local intelligence networks, relating to the management and use of controlled drugs, for their area (regulation 18).
Rhoddir nifer o swyddogaethau i swyddogion atebol ynghylch rheoli a defnyddio cyffuriau a reolir yn ddiogel. Mewn gwirionedd, mae'r rhain yn gofyn am sefydlu nifer o setiau o drefniadau gan y swyddog atebol sy'n ymwneud â rheoli a defnyddio cyffuriau a reolir yn ddiogel. Yn ogystal â'r trefniadau sylfaenol (rheoliad 9), mae'r rhain yn cynnwys trefniadau ar waredu'n ddiogel (rheoliad 10) a threfniadau archwilio (rheoliad 11). Yn ogystal â chael swyddogaethau o ran eu cyrff dynodedig hwy eu hunain, rhoddir i swyddogion atebol swyddogaethau o ran proffesiynolion gofal iechyd ac eraill y mae eu gwaith yn ymwneud â rheoli a defnyddio cyffuriau a reolir, y mae eu corff dynodedig hwy yn gyfrifol amdanynt. Mae'r cyfrifoldebau hyn yn cynnwys cadw cofnodion am bryderon ac ymchwilio iddynt (rheoliadau 15 a 16) a chymryd camau priodol os oes seiliau da i'r pryderon (rheoliad 17). Mae gan swyddogion atebol y Byrddau Iechyd Lleol hefyd gyfrifoldebau penodol dros osod rhwydweithiau gwybodaeth lleol, sy'n ymwneud â rheoli a defnyddio cyffuriau a reolir, ar gyfer eu hardal (rheoliad 18).
Part 3 contains arrangements in relation to periodic inspections of premises used for the management and use of controlled drugs, where these issues would not be dealt with as part of other health and social care inspections, and other measures in relation to powers of entry.
Mae Rhan 3 yn cynnwys trefniadau o ran arolygiadau cyfnodol o fangreoedd a ddefnyddir ar gyfer rheoli a defnyddio cyffuriau a reolir, lle na fyddid yn ymdrin â'r materion hyn fel rhan o arolygiadau eraill ar iechyd a gofal cymdeithasol, a mesurau eraill o ran pwerau mynediad.