W E L S H S TAT U T O RYI N S T R U M E N T S

2008 No. 3239 (W.286)

DANGEROUS DRUGS, WALES

The Controlled Drugs (Supervisionof Management and Use) (Wales)

Regulations 2008

EXPLANATORY NOTE

(This note is not part of the Regulations)

These Regulations contain measures relating toarrangements underpinning the safe management anduse of controlled drugs in Wales.

Part 1 outlines preliminary matters.

Part 2 relates to accountable officers. A number ofhealth care bodies are prescribed as designated bodies(regulation 3), and these are required to appointaccountable officers (regulation 4). There arelimitations upon who may act as accountable officers(regulation 5) and a duty on designated bodies toestablish arrangements for their removal from office inspecified circumstances (regulation 6). Designatedbodies are required to ensure that their accountableofficers have sufficient resources available to them(regulation 7).

Accountable officers are given a number of functionsrelating to the safe management and use of controlleddrugs. Essentially, these require the establishment bythe accountable officer of a number of sets ofarrangements which relate to the safe management anduse of controlled drugs. As well as the basicarrangements (regulation 9), these include safedisposal arrangements (regulation 10) and auditingarrangements (regulation 11). As well as being givenfunctions in relation to their own designated bodies,accountable officers are given functions in relation tohealth care professionals and others whose workinvolves the management and use of controlled drugs,for which their designated body is responsible. Theseresponsibilities include maintaining records of and

O F F E RY N N A U S TAT U D O LC Y M R U

2008 Rhif 3239 (Cy.286)

CYFFURIAU PERYGLUS,CYMRU

Rheoliadau Cyffuriau a Reolir(Goruchwylio Rheolaeth aDefnydd) (Cymru) 2008

NODYN ESBONIADOL

(Nid yw'r nodyn hwn yn rhan o'r Rheoliadau)

Mae'r Rheoliadau hyn yn cynnwys mesurau ynghylchtrefniadau sy'n tanategu rheoli a defnyddio cyffuriau areolir yn ddiogel yng Nghymru.

Mae Rhan 1 yn amlinellu materion rhagarweiniol.

Mae Rhan 2 yn ymwneud â swyddogion atebol. Caiffnifer o gyrff gofal iechyd eu rhagnodi'n gyrffdynodedig (rheoliad 3), ac mae'n ofynnol iddyntbenodi swyddogion atebol (rheoliad 4). Maecyfyngiadau ar bwy a all fod yn swyddogion atebol(rheoliad 5) ac mae dyletswydd ar gyrff dynodedig isefydlu trefniadau i'w symud o'u swydd mewnamgylchiadau penodedig (rheoliad 6). Mae'n ofynnol igyrff dynodedig sicrhau bod gan eu swyddogionatebol adnoddau effeithiol ar gael iddynt (rheoliad 7).

Rhoddir nifer o swyddogaethau i swyddogion atebolynghylch rheoli a defnyddio cyffuriau a reolir ynddiogel. Mewn gwirionedd, mae'r rhain yn gofyn amsefydlu nifer o setiau o drefniadau gan y swyddogatebol sy'n ymwneud â rheoli a defnyddio cyffuriau areolir yn ddiogel. Yn ogystal â'r trefniadau sylfaenol(rheoliad 9), mae'r rhain yn cynnwys trefniadau arwaredu'n ddiogel (rheoliad 10) a threfniadau archwilio(rheoliad 11). Yn ogystal â chael swyddogaethau o raneu cyrff dynodedig hwy eu hunain, rhoddir iswyddogion atebol swyddogaethau o ranproffesiynolion gofal iechyd ac eraill y mae eu gwaithyn ymwneud â rheoli a defnyddio cyffuriau a reolir, ymae eu corff dynodedig hwy yn gyfrifol amdanynt.Mae'r cyfrifoldebau hyn yn cynnwys cadw cofnodion

1

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 ByrddauIechyd Lleol hefyd gyfrifoldebau penodol dros osodrhwydweithiau gwybodaeth lleol, sy'n ymwneud ârheoli a defnyddio cyffuriau a reolir, ar gyfer eu hardal(rheoliad 18).

Mae Rhan 3 yn cynnwys trefniadau o ran arolygiadaucyfnodol o fangreoedd a ddefnyddir ar gyfer rheoli adefnyddio cyffuriau a reolir, lle na fyddid yn ymdrin â'rmaterion hyn fel rhan o arolygiadau eraill ar iechyd agofal cymdeithasol, a mesurau eraill o ran pweraumynediad.

Mae Rhan 4 yn ymwneud â chydweithredu rhwng nifero gyrff gofal iechyd rhestredig a chyrff eraill (rheoliad22), ac yn benodol, mae'n cynnwys trefniadau manwl oran datgelu gwybodaeth rhwng y cyrff y mae'n ofynnoliddynt, drwy Reoliadau, gydweithredu â'i gilydd mewncysylltiad â chanfod achosion lle y gall fod angencymryd camau yn erbyn unigolion (rheoliadau 24 i 27).Mae gofynion ar gadw cofnodion (rheoliad 28), adyletswyddau o ran adroddiadau ar ddigwyddiadau,sy'n ddatganiadau chwarterol y mae'n rhaid iswyddogion atebol eu gwneud am fanylion pryderonsydd gan eu corff dynodedig (rheoliad 29). Mae ganswyddogion atebol ddyletswyddau i gymryd camau oran pryderon sydd ganddynt (rheoliad 30), acamddiffynnir personau sy'n gweithredu'n ddidwyll odan y trefniadau ar gyfer rhannu gwybodaeth o dan yRhan hon rhag hawliadau am iawndal (rheoliad 31).

investigating concerns (regulations 15 and 16), andtaking appropriate action where there are well-foundedconcerns (regulation 17). Accountable officers forLocal Health Boards also have particularresponsibilities for setting up local intelligencenetworks, relating to the management and use ofcontrolled drugs, for their area (regulation 18).

Part 3 contains arrangements in relation to periodicinspections of premises used for the management anduse of controlled drugs, where these issues would notbe dealt with as part of other health and social careinspections, and other measures in relation to powersof entry.

Part 4 deals with co-operation between a number oflisted health care bodies and other organisations(regulation 22), and in particular, contains detailedarrangements with regards to the disclosure ofinformation between the bodies that are required, bythe Regulations, to co-operate with each other inconnection with the identification of cases whereaction may need to be taken against individuals(regulations 24 to 27). There are record keepingrequirements (regulation 28), and duties with regard tooccurrence reports, which are quarterly statements thataccountable officers must make about details ofconcerns that their designated body has (regulation29). Accountable officers have duties to take actionwith regard to concerns that they have (regulation 30),and persons acting in good faith under thearrangements for sharing information under this Partare protected from damages claims (regulation 31).

2

O F F E RY N N A U S TAT U D O LC Y M R U

2008 Rhif 3239 (Cy.286)

CYFFURIAU PERYGLUS,CYMRU

Rheoliadau Cyffuriau a Reolir(Goruchwylio Rheolaeth aDefnydd) (Cymru) 2008

Gwnaed 16 Rhagfyr 2008

Gosodwyd gerbron Cynulliad Cenedlaethol Cymru 18 Rhagfyr 2008

Yn dod i rym 9 Ionawr 2009

CYNNWYS

RHAN 1

Rhagarweiniol

1. Enwi, cychwyn a chymhwyso

2. Dehongli

RHAN 1

Swyddogion Atebol

3. Cyrff dynodedig

4. Penodi swyddogion atebol a rhestraucenedlaethol

5. Personau y caniateir eu penodi'n swyddogionatebol

6. Symud swyddogion atebol o'u swyddi

7. Cyllid ac adnoddau eraill sydd ar gael iswyddogion atebol

8. Swyddogion atebol i roi sylw i arferion gorau

9. Swyddogion atebol i sicrhau rheolaeth adefnydd cyffuriau a reolir yn ddiogel

10. Swyddogion atebol i sicrhau trefniadau difa agwaredu digonol ar gyfer cyffuriau a reolir

11. Swyddogion atebol i sicrhau monitro acarchwilio rheolaeth a defnydd cyffuriau areolir gan gyrff dynodedig

12. Pwerau i wneud datganiadau a hunanasesiadauyn ofynnol, fel rhan o drefniadau monitro acarchwilio swyddogion atebol neu fel arall

W E L S H S TAT U T O RYI N S T R U M E N T S

2008 No. 3239 (W.286)

DANGEROUS DRUGS, WALES

The Controlled Drugs (Supervisionof Management and Use) (Wales)

Regulations 2008

Made 16 December 2008

Laid before the National Assembly for Wales 18 December 2008

Coming into force 9 January 2009

CONTENTS

PART 1

Preliminary

1. Title, commencement and application

2. Interpretation

PART 2

Accountable Officers

3. Designated bodies

4. Appointment of accountable officers andnational lists

5. Persons who may be appointed as accountableofficers

6. Removal of accountable officers

7. Funds and other resources available toaccountable officers

8. Accountable officers to have regard to bestpractice

9. Accountable officers to secure the safemanagement and use of controlled drugs

10. Accountable officers to ensure adequatedestruction and disposal arrangements forcontrolled drugs

11. Accountable officers to ensure monitoring andauditing of management and use of controlleddrugs by designated bodies

12. Powers to require declarations and self-assessments, as part of accountable officers'monitoring and auditing arrangements orotherwise

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13. Swyddogion atebol i sicrhau bod unigolionperthnasol yn cael hyfforddiant priodol etc.

14. Swyddogion atebol i fonitro ac archwiliorheolaeth a defnydd cyffuriau a reolir ganunigolion perthnasol, ac i fonitro ac asesu euperfformiad

15. Swyddogion atebol i gadw cofnodion obryderon ynghylch unigolion perthnasol

16. Swyddogion atebol i asesu pryderon acymchwilio iddynt

17. Swyddogion atebol i gymryd camau priodol osoes seiliau da i'r pryderon

18. Swyddogion atebol i sefydlu trefniadau argyfer rhannu gwybodaeth

RHAN 2

Mynd i mewn i fangreoedd, arolygiadau cyfnodoletc.

19. Swyddogion atebol i gynnal arolygiadaucyfnodol

20. Mangreoedd perthnasol

21. Arolygiadau anheddau preifat nad ydynt yngwneud presenoldeb cwnstabl yn ofynnol

RHAN 3

Cydweithredu rhwng cyrff iechyd a chyrff eraill

22. Cyrff cyfrifol at ddibenion y Rhan hon

23. Personau perthnasol

24. Dyletswydd gyffredinol ar gyrff cyfrifol igydweithredu â'i gilydd o ran personauperthnasol

25. Dyletswydd i gydweithredu drwy ddatgelugwybodaeth ynglyn â phersonau perthnasol

26. Cyrff cyfrifol yn gofyn am wybodaethychwanegol i gael ei datgelu am bersonauperthnasol

27. Cyfyngiadau ynghylch datgelu

28. Gofynion cadw cofnodion ynghylchrheoliadau 25 a 26

29. Adroddiadau ar ddigwyddiadau

30. Dyletswyddau gan swyddogion atebol iamddiffyn diogelwch cleifion a'r cyhoedd

31. Datgelu gwybodaeth yn ddidwyll

13. Accountable officers to ensure relevantindividuals receive appropriate training etc.

14. Accountable officers to monitor and audit themanagement and use of controlled drugs byrelevant individuals, and to monitor and assesstheir performance

15. Accountable officers to maintain a record ofconcerns regarding relevant individuals

16. Accountable officers to assess and investigateconcerns

17. Accountable officers to take appropriate actionif there are well-founded concerns

18. Accountable officers to establish arrangementsfor sharing information

PART 3

Entering premises, periodic inspections etc.

19. Accountable officers to carry out periodicinspections

20. Relevant premises

21. Inspections of private dwellings not requiringthe presence of a constable

PART 4

Co-operation between health bodies and otherorganisations

22. Responsible bodies for the purposes of thisPart

23. Relevant persons

24. General duty on responsible bodies to co-operate with each other as regards relevantpersons

25. Duty to co-operate by disclosing informationas regards relevant persons

26. Responsible bodies requesting additionalinformation to be disclosed about relevantpersons

27. Restrictions relating to disclosures

28. Record keeping requirements relating toregulations 25 and 26

29. Occurrence reports

30. Accountable officers' duties to protect thesafety of patients and the general public

31. Disclosure of information in good faith

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Mae Gweinidogion Cymru, drwy arfer y pwerau aroddwyd gan adrannau 17, 18, 20(3) a (7) a 79(3) oDdeddf Iechyd 2006(1), yn gwneud y Rheoliadau aganlyn:

RHAN 1

Rhagarweiniol

Enwi, cychwyn a chymhwyso

1.—(1) Enw'r Rheoliadau hyn yw RheoliadauCyffuriau a Reolir (Goruchwylio Rheolaeth aDefnydd) (Cymru) 2008

(2) Daw'r Rheoliadau hyn i rym ar 9 Ionawr 2009.

(3) Mae'r Rheoliadau hyn yn gymwys o ran Cymru.

Dehongli

2.—(1) Yn y Rheoliadau hyn—

ystyr "AGGCC" ("CSSIW") yw Arolygiaeth Gofala Gwasanaethau Cymdeithasol Cymru (2);

ystyr "AGIC" ("HIW") yw Arolygiaeth GofalIechyd Cymru(3);

mae "Atebion Iechyd Cymru" ("Health SolutionsWales") yn is-adran o YmddiriedolaethGwasanaeth Iechyd Gwladol Felindre y mae eichangen gwasanaethau rhagnodi'n darparugwasanaethau cofnodi data a gwasanaethau prisioynghylch presgripsiynau a weinyddir yngNghymru;

ystyr "Awdurdod Gwasanaethau Busnes y GIG"("NHS Business Services Authority") yw AwdurdodGwasanaethau Busnes y GIG a sefydlwyd ganOrchymyn Awdurdod Gwasanaethau Busnes yGIG (NHS Business Services Authority) (Sefydlu aChyfansoddiad) 2005(4);

ystyr "awdurdod lleol" ("local authority") yw un ogynghorau Cymru y cyfeirir ato yn adran 1 o

The Welsh Ministers, in exercise of the powersconferred by sections 17, 18, 20(3) and (7) and 79(3) ofthe Health Act 2006(1), make the followingRegulations:

PART 1

Preliminary

Title, commencement and application

1.—(1) The title of these Regulations is theControlled Drugs (Supervision of Management andUse) (Wales) Regulations 2008.

(2) These Regulations come into force on 9 January2009.

(3) These Regulations apply in relation to Wales.

Interpretation

2.—(1) In these Regulations—

"the 2000 Act" ("Deddf 2000") means the CareStandards Act 2000(2);

"the 2003 Act" ("Deddf 2003") means the Healthand Social Care (Community Health andStandards) Act 2003(3);

"the 2006 Act" ("Deddf 2006.") means the HealthAct 2006(4);

"accountable officer" ("swyddog atebol") means aperson nominated or appointed under regulation 4;

"CSSIW" ("AGGCC") means the Care and SocialServices Inspectorate for Wales(5);

"designated body" ("corff dynodedig") is to beconstrued in accordance with regulation 3;

"Health Solutions Wales" ("Atebion IechydCymru") is a division of the Velindre NationalHealth Service Trust whose prescribing servicesbranch provides data entry and pricing servicesrelating to prescriptions dispensed in Wales;

(1) 2006 c.28. The powers of the National Assembly for Wales undersections 17, 18, 20 and 79 of the Health Act 2006 were transferredto the Welsh Ministers in accordance with paragraph 30 of Schedule11 to the Government of Wales Act 2006 (c.32).

(2) 2000 c.14.

(3) 2003 c.43.

(4) 2006 c.28.

(5) The Care and Social Services Inspectorate Wales ("CSSIW") is anoperationally distinct division of the Department of Public Servicesand Performance within the Welsh Assembly Government.

5

(1) 2006 p.28. Trosglwyddwyd pwerau Cynulliad Cenedlaethol Cymruo dan adrannau 17, 18, 20 a 79 o Ddeddf Iechyd 2006 i WeinidogionCymru yn unol â paragraff 30 o Atodlen 11 i Ddeddf LlywodraethCymru 2006 (p.32).

(2) Mae Arolygiaeth Gofal a Gwasanaethau Cymdeithasol Cymru("AGGCC") yn is-adran weithredol ar wahân o'r AdranGwasanaethau Cyhoeddus a Pherfformiad yn LlywodraethCynulliad Cymru.

(3) Mae Arolygiaeth Gofal Iechyd Cymru ("AGIC") yn is-adranweithredol ar wahân o'r Adran Gwasanaethau Cyhoeddus aPherfformiad yn Llywodraeth Cynulliad Cymru.

(4) O.S. 2005/3361.

Ddeddf Gwasanaethau Cymdeithasol AwdurdodauLleol 1970(1) (awdurdodau lleol);

mae i "busnes manwerthu fferyllol" yr ystyr aroddir i "retail pharmacy business" gan adran 132 oDdeddf Meddyginiaethau 1968(2) (cofrestrumangre);

ystyr "Bwrdd Iechyd Lleol" ("Local HealthBoard") yw Bwrdd Iechyd Lleol a sefydlwyd drwyOrchymyn o dan adran 11(1) o Ddeddf yGwasanaeth Iechyd Gwladol (Cymru) 2006(3);

ystyr "cartref gofal yng Nghymru" ("Welsh carehome") yw corff sy'n rhedeg sefydliad yngNghymru sy'n gartref gofal at ddibenion Deddf2000 yn rhinwedd adran 3 o'r Ddeddf honno(cartrefi gofal);

mae "corff cyfrifol" ("responsible body"), onid yw'rcyd-destun yn mynnu fel arall, i'w ddehongli ynunol â rheoliad 22;

mae "corff dynodedig" ("designated body") i'wddehongli yn unol â rheoliad 3;

ystyr "corff rheoleiddiol" ("regulatory body") ywcorff y cyfeirir ato yn adran 25(3) o DdeddfDiwygio'r Gwasanaeth Iechyd Gwladol aPhroffesiynau Gofal Iechyd 2002 (y Cyngor drosReoleiddio Proffesiynolion Gofal Iechyd)(4);

ystyr "Deddf" 2000 ("the 2000 Act") yw DeddfSafonau Gofal 2000(5);

ystyr "Deddf 2003" ("the 2003 Act") yw DeddfIechyd a Gofal Cymdeithasol (Iechyd a SafonauCymunedol) 2003(6);

ystyr "Deddf 2006" ("the 2006 Act") yw DeddfIechyd Meddwl 2006(7);

ystyr "Deddf GIG (Cymru) 2006 ("NHS (Wales)Act 2006") yw Deddf Gwasanaeth Iechyd Gwladol(Cymru) 2006;

ystyr "deddfwriaeth am gamddefnyddio cyffuriau"("misuse of drugs legislation") yw DeddfCamddefnyddio Cyffuriau 1971(8) ac unrhyw is-ddeddfwriaeth a wneir o dan y Ddeddf honno;

"HIW" ("AGIC") means the HealthcareInspectorate for Wales(1);

"the health service" ("y gwasanaeth iechyd") meansthe health service established in pursuance of theNational Health Service Act 1946(2);

"local authority" ("awdurdod lleol") means aWelsh council referred to in section 1 of the LocalAuthority Social Services Act 1970(3) (localauthorities);

"local intelligence network" ("rhwydwaithgwybodaeth leol") is to be construed in accordancewith regulation 18(2);

"Local Health Board" ("Bwrdd Iechyd Lleol")means a Local Health Board established by anOrder under section 11(1) of the National HealthService (Wales) Act 2006(4);

"misuse of drugs legislation" ("deddfwriaeth amgamddefnyddio cyffuriau") means the Misuse ofDrugs Act 1971(5) and any subordinate legislationmade under that Act;

"NHS Business Services Authority" ("AwdurdodGwasanaethau Busnes y GIG") means the NHSBusiness Services Authority established by theNHS Business Services Authority (AwdurdodGwasanaethau Busnes y GIG) (Establishment andConstitution) Order 2005(6);

"NHS Trust" ("Ymddiriedolaeth GIG") means aNational Health Service Trust established by anOrder under section 18(1) of the NHS (Wales) Act2006;

"NHS (Wales) Act 2006 ("Deddf GIG (Cymru)2006") means the National Health Service (Wales)Act 2006;

"registered dentist" ("deintydd cofrestredig")means a person who is registered in the dentistsregister kept under section 14 of the Dentists Act1984(7) (the dentists register and registrar);

"registered pharmacist" ("fferyllydd cofrestredig")means a person registered in the register ofpharmacists maintained by the RoyalPharmaceutical Society of Great Britain;

(1) 1970 p.42; diwygiwyd gan Ddeddf Llywodraeth Leol 1972 (p.70),adran 195(3), a Deddf Llywodraeth Leol (Cymru) 1994 (p.19),Atodlen 10, paragraff 7.

(2) 1968 p.67. Mae diwygiadau i adran 132 nad ydynt yn berthnasol i'rdiffiniad o "busnes manwerthu fferyllol".

(3) 2006 p.42.

(4) 2002 p.17.

(5) 2000 p.14.

(6) 2003 p.43.

(7) 2006 p.28.

(8) 1971 p.38.

(1) The Healthcare Inspectorate Wales ("HIW") is an operationallydistinct division of the Department of Public Services andPerformance within the Welsh Assembly Government.

(2) 1946 c.81. This Act was repealed by the National Health ServiceAct 1977, which was in turn repealed in relation to Wales by theNational Health Service (Wales) Act 2006 (c.42) ("the NHS (Wales)Act 2006").

(3) 1970 c.42; amended by the Local Government Act 1972 (c.70),section 195(3), and the Local Government (Wales) Act 1994 (c.19),Schedule 10, paragraph 7.

(4) 2006 c.42.

(5) 1971 c.38.

(6) S.I. 2005/3361

(7) 1984 c.24.

6

ystyr "deintydd cofrestredig" ("registered dentist")yw person sydd wedi'i gofrestru yn y gofrestrddeintyddion a gedwir o dan adran 14 o DdeddfDeintyddion 1984(1) (cofrestr y deintyddion a'rcofrestrydd);

ystyr "fferyllfa gofrestredig" ("registeredpharmacy") yw busnes manwerthu fferyllol yngNghymru sydd am y tro wedi'i gofnodi yn ygofrestr a gedwir o dan adran 75 o DdeddfMeddyginiaethau 1968 (cofrestru mangreoedd);

ystyr "fferyllydd cofrestredig" ("registeredpharmacist") yw person sydd wedi'i gofrestru yn ygofrestr fferyllwyr a gedwir gan GymdeithasFferyllol Frenhinol Prydain Fawr;

ystyr "y gwasanaeth iechyd" ("the health service")yw'r gwasanaeth iechyd a sefydlwyd yn unol âDeddf y Gwasanaeth Iechyd Gwladol 1946(2);

mae "mangre berthnasol" ("relevant premises") i'wddehongli yn unol â rheoliad 20;

mae "rhwydwaith gwybodaeth leol" ("localintelligence network") i'w ddehongli yn unol ârheoliad 18(2);

ystyr "swyddog atebol" ("accountable officer") ywperson a enwebwyd neu a benodwyd o dan reoliad4;

ystyr "Ymddiriedolaeth GIG" ("NHS Trust") ywYmddiriedolaeth Gwasanaeth Iechyd Gwladol asefydlwyd drwy Orchymyn o dan adran 18(1) oDdeddf GIG (Cymru) 2006;

ystyr "Ymddiriedolaeth GIG GwasanaethauAmbiwlans Cymru ("Welsh Ambulance ServicesNHS Trust") yw Ymddiriedolaeth GIGGwasanaethau Ambiwlans Cymru(3);

ystyr "ysbyty annibynnol yng Nghymru" ("Welshindependent hospital") yw corff sy'n rhedeg ysbytyyng Nghymru nad yw'n ysbyty yn y gwasanaethiechyd (o fewn yr ystyr a roddir yn adran 206(1) oDdeddf GIG (Cymru) 2006 (dehongli)) ond —

(a) sy'n sefydliad, a'i brif ddiben yw darparu gofallliniarol neu driniaeth feddygol neu seciatrig argyfer salwch neu ar gyfer anhwylder meddwl(hynny yw, salwch meddwl, datblygiadmeddwl a ataliwyd neu sy'n anghyflawn,anhwylder seicopathig, neu unrhyw anhwylderneu anabledd meddwl arall); neu

(b) sy'n unrhyw sefydliad arall lle y darperirtriniaeth neu nyrsio (neu'r ddau) i bersonau

"retail pharmacy business" ("busnes manwerthufferyllol") has the meaning given in section 132 ofthe Medicines Act 1968(1) (registration ofpremises);

"registered pharmacy" ("fferyllfa gofrestredig.")means a retail pharmacy business in Wales that itfor the time being entered in the register kept undersection 75 of the Medicines Act 1968 (registrationof premises);

"regulatory body" ("corff rheoleiddiol") means abody referred to in section 25(3) of the NationalHealth Service Reform and Health CareProfessions Act 2002 (the Council for theRegulation of Health Care Professionals)(2);

"relevant premises" ("mangre berthnasol") is to beconstrued in accordance with regulation 20;

"responsible body" ("corff cyfrifol"), unless thecontext otherwise requires, is to be construed inaccordance with regulation 22;

"Welsh Ambulance Services NHS Trust("Ymddiriedolaeth GIG Gwasanaethau AmbiwlansCymru") means the Welsh Ambulance ServicesNational Health Service Trust(3);

"Welsh care home" ("cartref gofal yng Nghymru")means a body that runs an establishment in Waleswhich is a care home for the purposes of the 2000Act by virtue of section 3 of that Act (care homes);

"Welsh independent hospital" ("ysbyty annibynnolyng Nghymru") means a body that runs a hospital inWales which is not a health service hospital (withinthe meaning given in section 206(1) of the NHS(Wales) Act 2006 (interpretation and construction))but which is—

(a) an establishment, the main purpose of which isto provide palliative care or medical orpsychiatric treatment for illness or for mentaldisorder (that is, mental illness, arrested orincomplete development of mind,psychopathic disorder, or any other disorder ordisability of mind); or

(b) any other establishment in which treatment ornursing (or both) are provided for personsliable to be detained under the Mental HealthAct 1983(4).

(1) 1984 p.24.

(2) 1946 p.81. Diddymwyd y Ddeddf hon gan Ddeddf y GwasanaethIechyd Gwladol 1977, a ddiddymwyd yn ei thro o ran Cymru ganDdeddf y Gwasanaeth Iechyd Gwladol 2006 (p.42) ("Deddf y GIG(Cymru) 2006").

(3) Sefydlwyd gan O.S. 1998/678.

(1) 1968 c.67. There are amendments to section 132 which are notrelevant to the definition of "retail pharmacy business".

(2) 2002 c.17.

(3) Established by S.I. 1998/678.

(4) 1983 c.20.

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sy'n agored i gael eu cadw'n gaeth o danDdeddf Iechyd Meddwl 1983(1).

(2) Os, yn rhinwedd y Rheoliadau hyn, bydd ynofynnol i berson neu gorff sicrhau mater, mae'rgofyniad i'w ddehongli fel gofyniad i gymryd pob camrhesymol i sicrhau'r mater hwnnw.

(3) Os gwneir cyfeiriad yn y Rheoliadau hyn atdrefniadau i ddarparu gwasanaethau, mae'r cyfeiriadi'w ddehongli fel cyfeiriad at drefniadau i ddarparugwasanaethau sy'n ymwneud, neu a all ymwneud, ârheoli neu ddefnyddio cyffuriau a reolir.

(4) At ddibenion y Rheoliadau hyn, mae "deddfiad"("enactment") yn cynnwys, deddfiad sydd mewnMesur gan Gynulliad Cenedlaethol Cymru neu mewnofferyn sydd wedi'i wneud oddi tano.

RHAN 2

Swyddogion Atebol

Cyrff dynodedig

3. Rhagnodir y canlynol yn gyrff dynodedig atddibenion adran 17 o Ddeddf 2006—

(a) Bwrdd Iechyd Lleol;

(b) ymddiriedolaeth GIG;

(c) Ymddiriedolaeth GIG GwasanaethauAmbiwlans Cymru;

(ch) ysbyty annibynnol yng Nghymru.

Penodi swyddogion atebol a rhestrau cenedlaethol

4.—(1) Rhaid i gorff dynodedig enwebu neu benodi(neu o dan reoliad 5(2) neu (4) enwebu neu benodi ar ycyd gyda chorff arall neu gyrff eraill) berson cymwys aphriodol sydd â phrofiad addas yn swyddog atebol ar eigyfer.

(2) Rhaid i gorff dynodedig hysbysu Prif WeithredwrAGIC yn ysgrifenedig—

(a) unrhyw enwebiad neu benodiad ganddo o danbaragraff (1) cyn gynted ag y bo'n ymarferol; a

(b) iddo symud swyddog atebol o'i swydd (p'un aio dan reoliad 6 ai peidio cyn gynted ag y bo'nymarferol.

(3) Rhaid i AGIC gyhoeddi, o bryd i'w gilydd ac yny modd y gwêl orau, restr o swyddogion atebol cyrffdynodedig yng Nghymru.

(2) Where, by virtue of these Regulations, a personor body is required to ensure a matter, the requirementis to be construed as a requirement to take allreasonable steps to ensure that matter.

(3) Where the reference is made in these Regulationsto arrangements to provide services, the reference is tobe construed as a reference to arrangements to provideservices that involve, or may involve, the managementor use of controlled drugs.

(4) For the purposes of these Regulations,"enactment" ("deddfiad") includes, an enactmentcomprised in, or an instrument made under, a Measureof the National Assembly for Wales.

PART 2

Accountable Officers

Designated bodies

3. The following are prescribed as designated bodiesfor the purposes of section 17 of the 2006 Act—

(a) a Local Health Board;

(b) an NHS Trust;

(c) the Welsh Ambulance Services NHS Trust;

(d) a Welsh independent hospital.

Appointment of accountable officers and nationallists

4.—(1) A designated body must nominate or appoint(or under regulation 5(2) or (4) jointly nominate orappoint with one or more other bodies) a fit and propersuitably experienced person as its accountable officer.

(2) A designated body must notify the ChiefExecutive of HIW in writing—

(a) any nomination or appointment by it in underparagraph (1) as soon as practicable; and

(b) the removal of an accountable officer by it(whether or not under regulation 6) as soon aspracticable.

(3) HIW must publish, from time to time and in suchmanner as it sees fit, a list of accountable officers ofdesignated bodies in Wales.

(1) 1983 p.20.

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Personau y caniateir eu penodi'n swyddogionatebol

5.—(1) Caiff ysbyty annibynnol yng Nghymruenwebu neu benodi person yn swyddog atebol ar eigyfer ond dim ond—

(a) o ran y person—

(i) os y person hwnnw yw ei reolwrcofrestredig, neu

(ii) os yw'r person yn un o'i swyddogion sy'natebol i'w reolwr cofrestredig,

ac os y person yw ei reolwr cofrestredig, rhaid iddofod yn atebol i brif weithredwr, cadeirydd neu reolwrgyfarwyddwr yr ysbyty; a

(b) os nad yw'r person yn rheolaidd yn cyflenwi,gweinyddu neu'n gwaredu cyffuriau a reolir felrhan o'i ddyletswyddau.

(2) Caiff dau ysbyty annibynnol yng Nghymru neufwy ar y cyd enwebu neu benodi un rheolwrcofrestredig yn swyddog atebol ar gyfer y ddau ysbytyneu'r holl ysbytai os yw'r rheolwr cofrestredig—

(a) wedi'i gofrestru'n rheolwr o ran y ddau ysbytyneu'r holl ysbytai; a

(b) os nad yw'n rheolaidd yn cyflenwi, gweinydduneu'n gwaredu cyffuriau a reolir fel rhan o'iddyletswyddau.

(3) Yn ddarostyngedig i baragraff (4), caiff corffdynodedig a bennir yn rheoliad 3(a), (b) neu (c)enwebu neu benodi person yn swyddog atebol ar eigyfer ond dim ond—

(a) os yw'r person yn swyddog neu gyflogai i'rcorff dynodedig, a—

(i) mae'n aelod o fwrdd cyfarwyddwyr, neubwyllgor rheoli neu bwyllgor gweithredoly corff dynodedig,

(ii) mae'n aelod o'r corff (pa enw bynnag syddiddo) sy'n gyfrifol am reoli'r corffdynodedig, neu

(iii) mae'n atebol i'r person y cyfeirir ato ymmharagraff (i) neu (ii); a

(b) os nad yw'r person yn rheolaidd yn cyflenwi,gweinyddu neu'n gwaredu cyffuriau a reolir felrhan o'i ddyletswyddau.

(4) Caiff dau gorff dynodedig neu fwy a bennir ynrheoliad 3(a), (b) neu (c) ond sydd o'r un math ar y cydenwebu neu benodi un person yn swyddog atebol argyfer y ddau gorff neu'r holl gyrff—

(a) os yw'r person yn bodloni paragraff (3)(a) oran un o'r cyrff dynodedig;

(b) os yw pob un o'r cyrff dynodedig wedi'ifodloni bod y person yn gallu cyflawni eigyfrifoldebau mewn perthynas ag ef; ac

(c) os nad yw'r person yn rheolaidd yn cyflenwi,gweinyddu neu'n gwaredu cyffuriau a reolir fel

Persons who may be appointed as accountableofficers

5.—(1) A Welsh independent hospital may onlynominate or appoint a person as its accountable officerif—

(a) the person is—

(i) its registered manager, or

(ii) one of its officers or employees who isanswerable to its registered manager,

and if the person is its registered manager, he or shemust be answerable to the chief executive, chairman ormanaging director of the hospital; and

(b) the person does not routinely supply,administer or dispose of controlled drugs aspart of his or her duties.

(2) Two or more Welsh independent hospitals mayjointly nominate or appoint one registered manager tobe the accountable officer for both or all of thehospitals if the registered manager—

(a) is registered as manager in relation to both orall of the hospitals; and

(b) does not routinely supply, administer ordispose of controlled drugs as part of his or herduties.

(3) Subject to paragraph (4), a designated bodyspecified in regulation 3(a), (b) or (c) may onlynominate or appoint a person as its accountable officerif—

(a) the person is an officer or employee of thedesignated body, and—

(i) a member of the board of directors, or themanagement or executive committee of thedesignated body,

(ii) a member of the body (howsoever it maybe called) that has responsibility for themanagement of the designated body, or

(iii) is answerable to a person referred to inparagraph (i) or (ii); and

(b) the person does not routinely supply,administer or dispose of controlled drugs aspart of his or her duties.

(4) Two or more designated bodies specified inregulation 3(a), (b) or (c) but which are of the sametype may jointly nominate or appoint one person to bethe accountable officer for both or all of the bodies,if—

(a) the person satisfies paragraph (3)(a) in relationto one of the designated bodies;

(b) each designated body is satisfied that theperson can properly discharge his or herresponsibilities in relation to it; and

(c) the person does not routinely supply,administer or dispose of controlled drugs as

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rhan o'i ddyletswyddau.

(5) Yn y rheoliad hwn, ystyr "rheolwr cofrestredig"("registered manager"), o ran ysbyty annibynnol yngNghymru, yw person sydd wedi'i gofrestru o dan RanII o Ddeddf 2000 yn rheolwr yr ysbyty.

Symud swyddogion atebol o'u swyddi

6.—(1) Rhaid i gorff dynodedig, ar ôl iddo ystyriedy mater yn briodol, symud ei swyddog atebol o'iswydd—

(a) os nad yw'r swyddog atebol bellach ynbodloni'r amodau a osodir yn rheoliad 5; neu

(b) os nad yw'r swyddog atebol yn ffit i fod ynswyddog atebol.

(2) Rhaid i gorff dynodedig (neu, yn achos penodiadar y cyd, y cyrff dynodedig a wnaeth y penodiad ar ycyd gan weithredu ar y cyd) fabwysiadu gweithdrefn (aall fod yn rhan o weithdrefn ddisgyblu fewnol) i'whystyried, pan fydd wedi'i hysbysu bod ei swyddogatebol wedi torri ei ddyletswyddau o dan y Rheoliadauhyn, p'un a oes angen iddo symud ei swyddog atebol o'iswydd ai peidio o dan baragraff (1)(b).

(3) Rhagdybir bod person (oni phrofir i'rgwrthwyneb) yn anffit i fod yn swyddog atebol os byddyn fwriadol, yn esgeulus neu drwy ddiffygcymhwysedd yn torri ei ddyletswyddau fel swyddogatebol o dan y Rheoliadau hyn.

(4) Nid yw'r rheoliad hwn yn rhagfarnu unrhywdrefniadau eraill a all fod gan gorff dynodedig (neu, ynachos penodiad ar y cyd, y cyrff dynodedig a wnaeth ypenodiad ar y cyd gan weithredu ar y cyd) i symud eiswyddog atebol o'i swydd fel rhan o'r trefniadau ycyflogir ef neu y cymerir ef ymlaen oddi tanynt.

Cyllid ac adnoddau eraill sydd ar gael iswyddogion atebol

7.—(1) Rhaid i gorff dynodedig ddarparu cyllid acadnoddau eraill i'w swyddog atebol y mae eu hangen ialluogi'r swyddog atebol i gyflawni ei gyfrifoldebau felei swyddog atebol.

(2) Gall yr adnoddau eraill hynny gynnwysmynediad i systemau gwybodaeth, llety a staff a'rdefnydd ohonynt.

Swyddogion atebol i roi sylw i arferion gorau

8. Wrth iddo gyflawni ei gyfrifoldebau, rhaid iswyddog atebol roi sylw i arferion gorau o ran rheoli adefnyddio cyffuriau a reolir.

part of his or her duties.

(5) In this regulation "registered manager" ("rheolwrcofrestredig"), in relation to a Welsh independenthospital, means the person who is registered under PartII of the 2000 Act as the manager of the hospital.

Removal of accountable officers

6.—(1) A designated body must, having dulyconsidered the matter, remove its accountable officer ifthe accountable officer—

(a) no longer satisfies the conditions set out inregulation 5; or

(b) is unfit to be an accountable officer.

(2) A designated body (or, in the case of a jointappointment, the designated bodies that made the jointappointment, acting jointly) must adopt a procedure(which may be part of an internal disciplinaryprocedure) for consideration, where it is on notice thatits accountable officer has breached his or her dutiesunder these Regulations, of whether or not it needs toremove its accountable officer under paragraph (1)(b).

(3) A person will be presumed (unless the contrary isproved) to be unfit to be an accountable officer if he orshe wilfully, negligently or through lack of competencebreaches his or her duties as an accountable officerunder these Regulations.

(4) This regulation is without prejudice to any otherarrangements that a designated body (or, in the case ofa joint appointment, the designated bodies that madethe joint appointment, acting jointly) may have forremoval of its accountable officer from office as part ofthe arrangements under which he or she is employed orengaged.

Funds and other resources available toaccountable officers

7.—(1) A designated body must provide itsaccountable officer with the funds and other resourcesnecessary to enable the accountable officer to carry outhis or her responsibilities as its accountable officer.

(2) Those other resources may include access to anduse of information systems, accommodation and staff.

Accountable officers to have regard to bestpractice

8. In discharging his or her responsibilities, anaccountable officer must have regard to best practice inrelation to the management and use of controlleddrugs.

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Swyddogion atebol i sicrhau rheolaeth a defnyddcyffuriau a reolir yn ddiogel

9.—(1) Rhaid i swyddog atebol—

(a) gwneud y ddau beth a ganlyn—

(i) sefydlu a gweithredu, neu sicrhau bod eigorff dynodedig yn sefydlu a gweithredu,trefniadau priodol i sicrhau rheolaeth adefnydd o gyffuriau a reolir yn ddiogel gany corff dynodedig, a

(ii) sicrhau bod corff neu berson sy'ngweithredu ar ran ei gorff dynodedig, neu'ndarparu gwasanaethau o dan drefniadau awneir gydag ef, yn sefydlu ac yngweithredu trefniadau priodol i sicrhaurheolaeth a defnydd cyffuriau a reolir ynddiogel gan y corff hwnnw neu'r personhwnnw; a

(b) gwneud y ddau beth a ganlyn—

(i) adolygu, neu sicrhau bod ei gorffdynodedig yn adolygu, trefniadau asefydlwyd gan y swyddog atebol neu eigorff dynodedig,

(ii) sicrhau bod corff neu berson sy'ngweithredu ar ran ei gorff dynodedig, neu'ndarparu gwasanaethau o dan drefniadau awneir gydag ef, yn adolygu trefniadau asefydlwyd ganddo neu gan ei swyddogatebol yn unol ag is-baragraff (a)(ii).

(2) Yn benodol, rhaid i swyddog atebol, fel rhan o'rtrefniadau hyn—

(a) sefydlu neu sicrhau bod ei gorff dynodedig (acunrhyw gorff neu berson sy'n gweithredu arran ei gorff dynodedig, neu'n darparugwasanaethau o dan drefniadau a wneir gydagef) yn sefydlu trefniadau priodol igydymffurfio â deddfwriaeth amgamddefnyddio cyffuriau; a

(b) sicrhau bod gan ei gorff dynodedig (ac unrhywgorff neu berson sy'n gweithredu ar ran ei gorffdynodedig, neu'n darparu gwasanaethau o dandrefniadau a wneir gydag ef) weithdrefnaugweithredu safonol cyfoes ar gael o ran rheolia defnyddio cyffuriau a reolir.

(3) Rhaid i'r gweithdrefnau gweithredu safonol, ynbenodol, ymwneud â'r materion canlynol—

(a) pwy sydd â mynediad at y cyffuriau a reolir;

(b) ble mae'r cyffuriau a reolir yn cael eu storio;

(c) diogelwch o ran storio a chludo cyffuriau areolir fel sy'n ofynnol gan ddeddfwriaeth amgamddefnyddio cyffuriau;

(ch) gwaredu a difa cyffuriau a reolir;

(d) pwy sydd i gael gwybod os byddcymhlethdodau'n codi; a

Accountable officers to secure the safemanagement and use of controlled drugs

9.—(1) An accountable officer must—

(a) both—

(i) establish and operate, or ensure, that his orher designated body establishes andoperates, appropriate arrangements forsecuring the safe management and use ofcontrolled drugs by the designated body,and

(ii) ensure that a body or person acting onbehalf of, or providing services underarrangements made with, his or herdesignated body establishes and operatesappropriate arrangements for securing thesafe management and use of controlleddrugs by that body or person; and

(b) both—

(i) review, or ensure that his or her designatedbody reviews, arrangements established bythe accountable officer or his or herdesignated body,

(ii) ensure that a body or person acting onbehalf of, or providing services underarrangements made with, his or herdesignated body reviews arrangementsestablished by it or the accountable officerin accordance with sub-paragraph (a)(ii).

(2) In particular, an accountable officer must, as partof these arrangements—

(a) establish or ensure that his or her designatedbody (and any body or person acting on behalfof, or providing services under arrangementsmade with, his or her designated body)establishes appropriate arrangements tocomply with the misuse of drugs legislation;and

(b) ensure that his or her designated body (and anybody or person acting on behalf of, orproviding services under arrangements madewith, his or her designated body) has adequateand up-to-date standard operating proceduresin place in relation to the management and useof controlled drugs.

(3) The standard operating procedures must, inparticular, cover the following matters—

(a) who has access to the controlled drugs;

(b) where the controlled drugs are stored;

(c) security in relation to the storage andtransportation of controlled drugs as requiredby the misuse of drugs legislation;

(d) disposal and destruction of controlled drugs;

(e) who is to be alerted if complications arise; and

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(dd) cadw cofnodion, gan gynnwys—

(i) cadw cofrestrau rheoli cyffuriau perthnasolo dan y ddeddfwriaeth am gamddefnyddiocyffuriau, a

(ii) cynnal cofnodion o'r cyffuriau a reolir abennir yn Atodlen 2 i ReoliadauCamddefnyddio Cyffuriau 2001(1)(cyffuriau a reolir a bennwyd y maedarpariaethau penodol o'r Rheoliadau'ngymwys iddynt) a ddychwelwyd gangleifion.

Swyddogion atebol i sicrhau trefniadau difa agwaredu digonol ar gyfer cyffuriau a reolir

10. Rhaid i swyddog atebol—

(a) sefydlu a gweithredu, neu sicrhau, bod ei gorffdynodedig yn sefydlu a gweithredu, trefniadaupriodol i sicrhau difa a gwaredu cyffuriau areolir yn ddiogel gan ei gorff dynodedig, a

(b) sicrhau bod unrhyw gorff neu berson sy'ngweithredu ar ran ei gorff dynodedig, neu'ndarparu gwasanaethau o dan drefniadau awneir gydag ef, yn sefydlu ac yn gweithredutrefniadau priodol i sicrhau difa a gwareducyffuriau a reolir yn ddiogel gan y corffhwnnw neu'r person hwnnw.

Swyddogion atebol i sicrhau monitro ac archwiliorheolaeth a defnydd cyffuriau a reolir gan gyrffdynodedig etc.

11.—(1) Rhaid i swyddog atebol—

(a) sefydlu a gweithredu, neu sicrhau bod ei gorffdynodedig yn sefydlu a gweithredu, trefniadaupriodol i fonitro ac archwilio rheolaeth adefnydd y corff dynodedig o gyffuriau a reolir;a

(b) sicrhau bod corff neu berson sy'n gweithreduar ran ei gorff dynodedig, neu'n darparugwasanaethau o dan drefniadau a wneir gydagef, yn sefydlu ac yn gweithredu trefniadaupriodol i fonitro ac archwilio rheolaeth adefnydd y person neu'r corff dynodedig ogyffuriau a reolir (hynny yw, eu rheolaeth a'udefnydd o gyffuriau a reolir o dan eutrefniadau gyda'r corff dynodedig, ac nid o danunrhyw drefniadau eraill).

(2) Rhaid i'r trefniadau hynny, yn benodol, ddarparuar gyfer y canlynol—

(a) monitro a dadansoddi rhagnodi cyffuriau areolir gan y gwasanaeth iechyd ac yn breifatdrwy ddefnyddio data sy'n ymwneud ârhagnodi a gweinyddu presgripsiynau yngNghymru sydd ar gael gan Atebion IechydCymru.

(f) record keeping, including—

(i) maintaining relevant controlled drugsregisters under the misuse of drugslegislation, and

(ii) maintaining a record of the controlleddrugs specified in Schedule 2 to the Misuseof Drugs Regulations 2001(1) (specifiedcontrolled drugs to which certainprovisions of the Regulations apply) thathave been returned by patients.

Accountable officers to ensure adequatedestruction and disposal arrangements forcontrolled drugs

10. An accountable officer must—

(a) establish and operate, or ensure that his or herdesignated body establishes and operatesappropriate arrangements for securing the safedestruction and disposal of controlled drugs byhis or her designated body, and

(b) ensure that any body or person acting on behalfof, or providing services under arrangementsmade with, his or her designated bodyestablishes and operates appropriatearrangements for securing the safe destructionand disposal of controlled drugs by that bodyor person.

Accountable officers to ensure monitoring andauditing of the management and use of controlleddrugs by designated bodies etc.

11.—(1) An accountable officer must—-

(a) establish and operate, or ensure that his or herdesignated body establishes and operates,appropriate arrangements for monitoring andauditing the designated body's managementand use of controlled drugs; and

(b) ensure that a body or person acting on behalfof, or providing services under arrangementsmade with, his or designated body establishesand operates appropriate arrangements formonitoring and auditing the person or body'smanagement and use of controlled drugs (thatis, their management and use of controlleddrugs under their arrangements with thedesignated body, not under any otherarrangements).

(2) Those arrangements must, in particular, providefor the following—

(a) monitoring and analysing health service andprivate prescribing of controlled drugs throughthe use of data relating to the prescribing anddispensing of prescriptions in Wales availablefrom Health Solutions Wales.

(1) O.S. 2001/3998; yr offeryn diwygio perthnasol yw 2003/1432. (1) S.I. 2001/3998; the relevant amending instrument is 2003/1432.

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(b) sicrhau bod gan y corff dynodedig (ac unrhywgorff neu berson sy'n gweithredu ar ran y corffdynodedig, neu'n darparu gwasanaethau o dandrefniadau a wneir gydag ef) systemau arwaith i roi gwybod i'r swyddog atebol amunrhyw gwynion neu bryderon sy'n ymwneudâ rheoli neu ddefnyddio cyffuriau a reolir;

(c) sicrhau bod gan y corff dynodedig (ac unrhywgorff neu berson sy'n gweithredu ar ran y corffdynodedig, neu'n darparu gwasanaethau o dandrefniadau a wneir gydag ef) system adroddam ddigwyddiadau ar waith ar gyferdigwyddiadau anffafriol sy'n ymwneud ârheoli neu ddefnyddio cyffuriau a reolir; ac

(ch) sicrhau bod gan y corff dynodedig (ac unrhywgorff neu berson sy'n gweithredu ar ran y corffdynodedig, neu'n darparu gwasanaethau o dandrefniadau a wneir gydag ef) drefniadaupriodol ar waith ar gyfer dadansoddi ac ymatebi ddigwyddiadau anffafriol sy'n ymwneud ârheoli neu ddefnyddio cyffuriau a reolir;

Pwerau i wneud datganiadau a hunanasesiadau ynofynnol, fel rhan o drefniadau monitro acarchwilio swyddogion atebol neu fel arall

12.—(1) Caiff swyddog atebol, sy'n swyddog atebola enwebwyd neu a benodwyd gan Fwrdd Iechyd Lleol,ofyn am ddatganiad cyfnodol a hunanasesiad ganymarferydd meddygol cyffredinol sydd ar ei restr oberfformwyr meddygol, a rhaid iddynt ddatgan

(a) a ydyw'r ymarferydd yn defnyddio cyffuriau areolir yn unrhyw un o'r mangreoedd lle ymae'n darparu gwasanaethau meddygolsylfaenol fel rhan o'r gwasanaeth iechyd; a

(b) sut y mae'r ymarferydd yn rheoli a defnyddiocyffuriau a reolir yn y mangreoedd hynny.

(2) Caiff AGIC ofyn am ddatganiad cyfnodol priodola hunanasesiad priodol gan ymddiriedolaethau GIGneu gan berson sydd wedi'i gofrestru gyda hwy sy'ndarparu gofal iechyd.

(3) Caiff AGGCC ofyn am ddatganiad cyfnodolpriodol a hunanasesiad priodol gan gartref gofal yngNghymru.

(4) Caiff Cymdeithas Fferyllol Frenhinol PrydainFawr ofyn am ddatganiad cyfnodol priodol ahunanasesiad priodol gan fferyllfa gofrestredig.

(5) Yn y rheoliad hwn, ystyr "ymarferydd meddygolcyffredinol" ("general medical practitioner") ywymarferydd meddygol y mae ei enw yn y gofrestr agynhelir gan y Cyngor Meddygol Cyffredinol o danerthygl 10 o Orchymyn Ymarfer Cyffredinol acArbenigol (Addysg, Hyfforddiant a Chymwysterau)2003 (Cofrestr Ymarferwyr Cyffredinol(1)).

(b) ensuring that the designated body (and anybody or person acting on behalf of, orproviding services under arrangements madewith, the designated body) has systems inplace to alert the accountable officer of anycomplaints or concerns involving themanagement or use of controlled drugs;

(c) ensuring that the designated body (and anybody or person acting on behalf of, orproviding services under arrangements madewith, the designated body) has an incidentreporting system in place for untowardincidents involving the management or use ofcontrolled drugs; and

(d) ensuring that the designated body (and anybody or person acting on behalf of, orproviding services under arrangements madewith, the designated body) has appropriatearrangements in place for analysing andresponding to untoward incidents involvingthe management or use of controlled drugs.

Powers to require declarations and self-assessments, as part of accountable officers'monitoring and auditing arrangements orotherwise

12.—(1) An accountable officer, who is anaccountable officer nominated or appointed by a LocalHealth Board, may request a periodic declaration and aself-assessment from a general medical practitioner onits medical performers list, which must state

(a) whether the practitioner uses controlled drugsat any of the premises from which he or sheprovides primary medical services as part ofthe health service; and

(b) how the practitioner manages and usescontrolled drugs at those premises.

(2) HIW may request an appropriate periodicdeclaration and an appropriate self-assessment from anNHS trust or a person registered with them thatprovides health care.

(3) CSSIW may request an appropriate periodicdeclaration and an appropriate self-assessment from aWelsh care home.

(4) The Royal Pharmaceutical Society of GreatBritain may request an appropriate periodic declarationand an appropriate self-assessment from a registeredpharmacy.

(5) In this regulation, "general medical practitioner"("ymarferydd meddygol cyffredinol") means a medicalpractitioner whose name is included in the registermaintained by the General Medical Council underarticle 10 of the General and Specialist MedicalPractice (Education, Training and Qualifications)Order 2003 (the General Practitioner Register(1)).

(1) O.S. 2003/1250. (1) S.I. 2003/1250.

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Swyddogion atebol i sicrhau bod unigolionperthnasol yn cael hyfforddiant priodol, etc

13.—(1) Rhaid i swyddog atebol—

(a) sefydlu a gweithredu, neu sicrhau bod ei gorffdynodedig yn sefydlu a gweithredu; a

(b) sicrhau bod corff neu berson sy'n gweithreduar ran ei gorff dynodedig, neu'n darparugwasanaethau o dan drefniadau a wneir gydagef, yn sefydlu a gweithredu,

y trefniadau a grybwyllir ym mharagraff (2).

(2) Mae'r trefniadau hynny yn drefniadau priodol isicrhau bod personau sydd—

(a) o ran y corff dynodedig, yn unigolionperthnasol(1); a

(b) yn ymwneud â rhagnodi, cyflenwi, gweinydduneu waredu cyffuriau a reolir,

yn cael, o bryd i'w gilydd, hyfforddiant priodol igyflawni eu cyfrifoldebau.

(3) Rhaid i'r swyddog atebol gydgysylltu â'i gorffdynodedig i sicrhau bod trefniadau ar waith ar gyfer yrunigolion perthnasol y cyfeirir atynt ym mharagraff(2)—

(a) i dderbyn gwybodaeth a, phan fydd yn briodol,hyfforddiant ar weithdrefnau gweithredusafonol lleol ar gyfer cyffuriau a reolir panfyddant yn ymwneud gyntaf â rhagnodi,cyflenwi, gweinyddu neu waredu cyffuriau areolir; a

(b) i gael eu hysbysu pan fydd unrhywweithdrefnau gweithredu safonol lleol ar gyfercyffuriau a reolir ar ôl hynny'n cael euhadolygu neu eu diwygio.

Swyddogion atebol i fonitro ac archwilio rheolaetha defnydd cyffuriau a reolir gan unigolionperthnasol, ac i fonitro ac asesu eu perfformiad

14.—(1) Rhaid i swyddog atebol—

(a) sefydlu a gweithredu, neu sicrhau bod ei gorffdynodedig yn sefydlu a gweithredu; a

(b) sicrhau bod corff neu berson sy'n gweithreduar ran ei gorff dynodedig, neu'n darparugwasanaethau o dan drefniadau a wneir gydagef, yn sefydlu a gweithredu,

y trefniadau a grybwyllir ym mharagraff (2).

(2) Mae'r trefniadau hynny'n drefniadau priodol—

(a) ar gyfer monitro ac archwilio rheolaeth adefnydd cyffuriau a reolir gan berson sydd, oran y corff dynodedig, yn unigolyn perthnasol;a

Accountable officers to ensure relevant individualsreceive appropriate training etc.

13.—(1) An accountable officer must—

(a) establish and operate, or ensure that his or herdesignated body establishes and operates; and

(b) ensure that a body or person acting on behalfof, or providing services under arrangementsmade with, his or her designated bodyestablishes and operates,

the arrangements mentioned in paragraph (2).

(2) Those arrangements are appropriatearrangements to ensure that persons who are—

(a) as regards the designated body, relevantindividuals(1); and

(b) involved in prescribing, supplying,administering or disposing of controlled drugs,

receive, from time to time, appropriate training tocarry out their responsibilities.

(3) The accountable officer must liaise with his orher designated body to ensure that arrangements are inplace for the relevant individuals referred to inparagraph (2)—

(a) to receive information and, where appropriate,training on local standard operating proceduresfor controlled drugs when they first becomeinvolved in prescribing, supplying,administering or disposing of controlled drugs;and

(b) to be informed when any local standardoperating procedures for controlled drugs aresubsequently reviewed or amended.

Accountable officers to monitor and audit themanagement and use of controlled drugs byrelevant individuals, and to monitor and assesstheir performance

14.—(1) An accountable officer must—

(a) establish and operate, or ensure that his or herdesignated body establishes and operates; and

(b) ensure that a body or person acting on behalfof, or providing services under arrangementsmade with, his or her designated bodyestablishes and operates,

the arrangements mentioned in paragraph (2).

(2) Those arrangements are appropriatearrangements—

(a) for monitoring and auditing the managementand use of controlled drugs by a person who is,as regards the designated body, a relevantindividual; and

(1) Diffinnir yr ymadrodd "relevant individual" yn adran 17(8)(b) oDdeddf Iechyd 2006.

(1) The expression "relevant individual" is defined in section 17(8)(b)of the Health Act 2006

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(b) ar gyfer monitro ac asesu perfformiadpersonau sydd, o ran y corff dynodedig, ynunigolion perthnasol, mewn cysylltiad â rheolia defnyddio cyffuriau a reolir.

(3) Rhaid i'r trefniadau o dan baragraff (1), panfyddant yn briodol, ddarparu ar gyfer y canlynol—

(a) cofnodi, yn unol â rheoliad 15, unrhywbryderon a fynegwyd o ran rheoli neuddefnyddio cyffuriau a reolir gan unigolynperthnasol;

(b) asesu ac ymchwilio, yn unol â rheoliad 16,unrhyw bryderon a godwyd o ran rheoli neuddefnyddio cyffuriau a reolir gan unigolynperthnasol; ac

(c) penderfynu a oes yna bryderon o ran rheoli neuddefnyddio cyffuriau a reolir gan unigolynperthnasol y mae'r corff dynodedig ynrhesymol yn ystyried y dylid eu rhannu âchorff cyfrifol o dan reoliad 25.

Swyddogion atebol i gadw cofnodion o bryderonynghylch unigolion perthnasol

15.—(1) Rhaid i swyddog atebol—

(a) sefydlu a gweithredu, neu sicrhau bod ei gorffdynodedig yn sefydlu a gweithredu, trefniadaupriodol i gofnodi pryderon a fynegwydynghylch digwyddiadau a oedd yn ymwneud â,neu a allai fod wedi ymwneud â rheoli neuddefnyddio cyffuriau a reolir yn amhriodol ganberson sydd, o ran ei gorff dynodedig, ynunigolyn perthnasol; a

(b) sicrhau bod unrhyw gorff neu berson sy'ngweithredu ar ran ei gorff dynodedig, neu'ndarparu gwasanaethau o dan drefniadau awneir gydag ef, yn sefydlu ac yn gweithredutrefniadau priodol i gofnodi pryderon afynegwyd ynghylch digwyddiadau a oedd ynymwneud â, neu a allai fod wedi ymwneud ârheoli neu ddefnyddio cyffuriau a reolir ynamhriodol gan berson sydd, o ran ei gorffdynodedig, yn unigolyn perthnasol.

(2) Rhaid i'r swyddog atebol sicrhau, fel rhan o'rtrefniadau o dan baragraff (1), bod cofnodion digonolyn cael eu llunio, a rhaid iddynt gynnwys (ond heb gaeleu cyfyngu i hynny), fel y bo'n briodol—

(a) y dyddiad pan roddwyd gwybod am y pryderi'r swyddog atebol;

(b) unrhyw ddyddiadau pan ddigwyddodd ymaterion a arweiniodd ar y pryder hwnnw;

(c) manylion ynghylch natur y pryder;

(ch) manylion am yr unigolyn perthnasol ymynegwyd y pryder amdano;

(d) manylion am y person, neu'r corff, a roeswybod am y pryder;

(b) for monitoring and assessing the performanceof persons who are, as regards the designatedbody, relevant individuals, in connection withthe management and use of controlled drugs.

(3) The arrangements under paragraph (1) must,where appropriate, provide for the following—

(a) recording, in accordance with regulation 15,any concerns raised in relation to themanagement or use of controlled drugs by arelevant individual;

(b) assessing and investigating, in accordance withregulation 16, any concerns raised regardingthe management or use of controlled drugs bya relevant individual; and

(c) determining whether there are concerns inrelation to the management or use of controlleddrugs by a relevant individual which thedesignated body reasonably considers shouldbe shared with a responsible body underregulation 25.

Accountable officers to maintain a record ofconcerns regarding relevant individuals

15.—(1) An accountable officer must—

(a) establish and operate, or ensure that his or herdesignated body establishes and operates,appropriate arrangements for recordingconcerns expressed about incidents thatinvolved, or may have involved, impropermanagement or use of controlled drugs by aperson who is, as regards his or her designatedbody, a relevant individual; and

(b) ensure that any body or person acting on behalfof, or providing services under arrangementsmade with, his or her designated bodyestablishes and operates appropriatearrangements for recording concernsexpressed about incidents that involved, ormay have involved, improper management oruse of controlled drugs by a person who is, asregards his or her designated body, a relevantindividual.

(2) The accountable officer must ensure, as part ofthe arrangements under paragraph (1), that adequaterecords are compiled, which must include (but not belimited to), as appropriate—-

(a) the date on which the concern was madeknown to the accountable officer;

(b) any dates on which the matters that led to theconcern took place;

(c) details regarding the nature of the concern;

(d) details of the relevant individual in relation towhom the concern was expressed;

(e) details of the person who, or body which, madeknown the concern;

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(dd) manylion o unrhyw gamau a gymrwyd gan ycorff dynodedig (neu unrhyw gorff neu bersonsy'n gweithredu ar ran y corff dynodedig, neu'ndarparu gwasanaethau o dan drefniadau awneir gyda'r corff dynodedig) ynghylch ypryder;

(e) asesiad a ddylid datgelu gwybodaethynghylch y pryder i gorff cyfrifol arall o danreoliad 25 neu 26; a

(f) os yw gwybodaeth ynghylch y pryder yn caelei ddatgelu i gorff cyfrifol arall o dan reoliad25 neu 26, manylion unrhyw ddatgeliad o'rfath, gan gynnwys enw'r corff cyfrifol ygwnaed y datgeliad iddo a natur yr wybodaetha ddatgelwyd i'r corff.

(3) Ceir cadw unrhyw gofnod o bryder mewnfformat ar bapur neu'n electronig.

(4) Rhaid i'r trefniadau o dan baragraff (1) gynnwystrefniadau sy'n cyfyngu mynediad at y cofnodion—

(a) i'r swyddog atebol a'i staff; a

(b) i eraill y mae angen iddynt gael mynediad atddibenion sicrhau rheoli neu ddefnyddiocyffuriau a reolir yn ddiogel.

Swyddogion atebol i asesu pryderon ac ymchwilioiddynt

16.—(1) Rhaid i swyddog atebol sefydlu agweithredu, neu sicrhau bod ei gorff dynodedig ynsefydlu a gweithredu, trefniadau priodol ar gyfer—

(a) asesu pryderon a fynegwyd ynghylchdigwyddiadau a oedd yn ymwneud â, neu aallai fod wedi ymwneud â rheoli neuddefnyddio cyffuriau a reolir yn amhriodol ganberson sydd, o ran ei gorff dynodedig, ynunigolyn perthnasol; a

(b) ymchwilio i bryderon o'r fath.

(2) Os, ar ôl asesiad o bryder a fynegwyd, bydd yswyddog atebol yn penderfynu bod angen ymchwiliad,caiff y swyddog atebol—

(a) cyflawni'r ymchwiliad hwnnw'n bersonol;

(b) gwneud cais ysgrifenedig i swyddog neugyflogai arall yn ei gorff dynodedig gyflawni'rymchwiliad; neu

(c) os yw'n briodol, ac yn ddarostyngedig ibaragraffau (5) a (6)—

(i) gwneud cais ysgrifenedig i swyddog neugyflogai (gan gynnwys, yn achos corffdynodedig, swyddog atebol) o unrhyw raio'r cyrff cyfrifol a restrir ym mharagraff (3)i gyflawni'r ymchwiliad, neu

(f) details of any action taken by the designatedbody (or a body or person acting on behalf of,or providing services under arrangementsmade with, the designated body) in relation tothe concern;

(g) the assessment of whether information inrelation to the concern should be disclosed toanother responsible body under regulation 25or 26; and

(h) if information regarding the concern isdisclosed to another responsible body underregulation 25 or 26, the details of any suchdisclosure, including the name of theresponsible body to which the disclosure wasmade and the nature of the informationdisclosed to the body.

(3) Any record of a concern may be kept in paperor electronic format.

(4) The arrangements under paragraph (1) mustinclude arrangements that limit access to the recordsto—

(a) the accountable officer and his or her staff; and

(b) others who need to have access for thepurposes of ensuring the safe management oruse of controlled drugs.

Accountable officers to assess and investigateconcerns

16.—(1) An accountable officer must establish andoperate, or ensure that his or her designated bodyestablishes and operates, appropriate arrangementsfor—

(a) assessing concerns expressed about incidentsthat involved, or may have involved, theimproper management or use of controlleddrugs by a person who is, as regards his or herdesignated body, a relevant individual; and

(b) investigating such concerns.

(2) If, after an assessment of a concern expressed,the accountable officer decides that an investigation isneeded, the accountable officer may—

(a) carry out that investigation personally;

(b) make a written request for another officer oremployee of his or her designated body tocarry out the investigation; or

(c) if appropriate, and subject to paragraphs (5)and (6)—-

(i) make a written request for an officer oremployee (including, in the case of adesignated body, an accountable officer)from any of the responsible bodies listed inparagraph (3) to carry out the investigation,or

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(ii) gwneud cais ysgrifenedig i nifer oswyddogion neu gyflogeion o unrhyw raio'r cyrff cyfrifol a restrir ym mharagraff (3)i ffurfio tîm ymchwilioar y cyd er mwyncyflawni'r ymchwiliad.

(3) Mae'r canlynol yn gyrff cyfrifol at ddibenionadran 18 o Ddeddf 2006 a'r rheoliad hwn—

(a) corff dynodedig;

(b) AGIC;

(c) Yr Is-adran Gwasanaeth Gwrth-dwyll a RheoliDiogelwch Awdurdod Gwasanaethau Busnes yGIG;

(ch) AGGCC;

(d) heddlu;

(dd) corff rheoleiddiol.

(4) Caiff swyddog atebol ddefnyddio ei bwerau odan baragraff (2)(c) i ofyn am ymchwiliad (neuymchwiliad ar y cyd gyda chyrff cyfrifol eraill) gan yrIs-adran Gwasanaeth Gwrth-dwyll a Rheoli DiogelwchAwdurdod Gwasanaethau Busnes y GIG i unrhywdwyll posibl ynglyn â'r gwasanaeth iechyd.

(5) Rhaid i'r swyddog atebol gadw, neu sicrhau bodei gorff dynodedig yn cadw, cofnodion o—

(a) unrhyw gais a wnaed i swyddog atebol o gorffdynodedig arall, neu i gorff cyfrifol arall, o danbaragraff (2)(c) i ymchwilio i bryder a oedd ynymwneud â, neu a allai fod wedi ymwneud ârheoli neu ddefnyddio cyffuriau a reolir ynamhriodol;

(b) unrhyw asesiad neu ymchwiliad o bryder aoedd yn ymwneud â, neu a allai fod wediymwneud â rheoli neu ddefnyddio cyffuriau areolir yn amhriodol gan unigolyn perthnasol agyflawnwyd gan y swyddog atebol neu ei gorffdynodedig; ac

(c) unrhyw hysbysiad a roddwyd i gorff cyfrifolarall neu swyddog atebol arall o dan reoliad25(4).

Swyddogion atebol i gymryd camau priodol os oesseiliau da i'r pryderon

17.—(1) Rhaid i swyddog atebol sefydlu agweithredu, neu sicrhau bod ei gorff dynodedig ynsefydlu a gweithredu, trefniadau priodol i sicrhau bodcamau priodol yn cael eu cymryd at ddibenion diogelucleifion neu aelodau o'r cyhoedd mewn achosion lle yrymddengys bod seiliau da i'r pryderon o ran rheoli neuddefnyddio cyffuriau a reolir gan berson sydd, o ran ycorff dynodedig, yn unigolyn perthnasol.

(2) Os oes seiliau da i'r pryderon o ran rheoli neuddefnyddio cyffuriau a reolir gan unigolion perthnasol,neu bryderon ehangach o dwyll posibl ynglyn â'r

(ii) make a written request for a number ofofficers or employees from any of theresponsible bodies listed in paragraph (3)to form a joint investigation team to carryout the investigation.

(3) The following are responsible bodies for thepurposes of section 18 of the 2006 Act and thisregulation—

(a) a designated body;

(b) HIW;

(c) the Counter Fraud and Security ManagementService Division of the NHS BusinessServices Authority;

(d) CSSIW;

(e) a police force;

(f) a regulatory body.

(4) An accountable officer may use his or herpowers under paragraph (2)(c) to request aninvestigation (or a joint investigation with otherresponsible bodies) by the Counter Fraud and SecurityManagement Service Division of the NHS BusinessServices Authority into any possible fraud in relation tothe health service.

(5) The accountable officer must keep, or ensure thathis or her designated body keeps, a record of—-

(a) any request made to an accountable officerfrom another designated body, or to anotherresponsible body, under paragraph (2)(c) toinvestigate a concern that involved, or mayhave involved, the improper management oruse of controlled drugs;

(b) any assessment or investigation of a concernthat involved, or may have involved, impropermanagement or use of controlled drugs by arelevant individual that the accountable officeror his or her designated body carried out; and

(c) any notification given to another responsiblebody or accountable officer under regulation25(4).

Accountable officers to take appropriate action ifthere are well-founded concerns

17.—(1) An accountable officer must establish andoperate, or ensure that his or her designated bodyestablishes and operates, appropriate arrangements forensuring that appropriate action is taken for thepurposes of protecting patients or members of thepublic in cases where concerns in relation to themanagement or use of controlled drugs by a personwho is, as regards the designated body, a relevantindividual, appear to be well-founded.

(2) If there are well-founded concerns in relation tothe management or use of controlled drugs by relevantindividuals, or wider concerns of possible fraud in

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gwasanaeth iechyd, fel rhan o'r trefniadau a sefydlwydo dan baragraff (1), ond yn ddarostyngedig ibaragraffau (4) a (5), gall y camau y caniateir i'rswyddog atebol eu cymryd gynnwys (er nad oes angeneu cyfyngu i hynny) unrhyw rai o'r canlynol—

(a) gofyn am gyngor, cefnogaeth, mentora neuhyfforddiant ychwanegol gan berson priodol,gan gynnwys—

(i) cynghorydd sy'n rhagnodi,

(ii) arweinydd mewn llywodraethu clinigol,neu

(iii) yn achos cyflogai, rheolwr llinell o fewn ycorff dynodedig;

(b) rhoi ar waith weithdrefn digwyddiad anffafrioldifrifol;

(c) atgyfeirio'r pryderon i gorff rheoleiddiol;

(ch) atgyfeirio'r pryderon i'r heddlu;

(d) mewn achos o dwyll posibl ynglyn â'rgwasanaeth iechyd, atgyfeirio'r pryderon i'rIs-adran Gwasanaeth Gwrth-dwyll a RheoliDiogelwch Awdurdod Gwasanaethau Busnes yGIG;

(dd) rhannu gwybodaeth â chyrff cyfrifol eraill agofyn am wybodaeth ganddynt yn unol âchanllawiau rheoliad 25 neu 26; neu

(e) os yw'r swyddog atebol yn swyddog atebol aenwebwyd neu a benodwyd gan Fwrdd IechydLleol, cynnull panel digwyddiadau, a luniwydo swyddogion o unrhyw un o'r cyrff sy'n gyrffcyfrifol at ddibenion Rhan 4, i ymchwilio i'rpryder a gwneud argymhellion fel a grybwyllirym mharagraff (3).

(3) Caiff panel digwyddiadau a gafodd ei gynnull odan baragraff (2)(e) argymell bod y swyddog atebolneu'r corff dynodedig yn cymryd camau sy'n cynnwys(er nad oes angen eu cyfyngu i hynny) unrhyw rai o'rcanlynol—

(a) parhau i fonitro'r unigolyn perthnasol;

(b) atgyfeirio'r pryderon i swyddog atebol arall;

(c) atgyfeirio'r pryderon i gorff rheoleiddiol;

(ch) atgyfeirio'r pryderon i'r heddlu; neu

(d) rhoi ar waith weithdrefn digwyddiad anffafrioldifrifol.

Swyddogion atebol i sefydlu trefniadau ar gyferrhannu gwybodaeth

18.—(1) Rhaid i swyddog atebol sefydlu agweithredu, neu sicrhau bod ei gorff dynodedig ynsefydlu a gweithredu, trefniadau priodol ar gyfersicrhau bod gwybodaeth yn cael ei rhannu'n briodol, ynunol â rheoliad 25 neu 26, gan ei gorff dynodedig âchyrff cyfrifol eraill ynglyn â rheoli a defnyddiocyffuriau a reolir.

relation to the health service, as part of thearrangements established under paragraph (1), butsubject to paragraphs (4) and (5), the action that theaccountable officer may take may include (although itneed not be limited to) any of the following—

(a) requesting additional advice, support,mentoring or training from an appropriateperson, including—

(i) a prescribing advisor,

(ii) a clinical governance lead, or

(iii) in the case of an employee, a line managerwithin the designated body;

(b) implementation of a serious untoward incidentprocedure;

(c) referral of the concerns to a regulatory body;

(d) referral of the concerns to a police force;

(e) in a case of possible fraud in relation to thehealth service, referral of the concerns to theCounter Fraud and Security ManagementService Division of the NHS BusinessServices Authority;

(f) sharing information with, and requestinginformation from, other responsible bodies, inaccordance with regulation 25 or 26; or

(g) if the accountable officer is an accountableofficer nominated or appointed by a LocalHealth Board, convening an incident panel,made up of officers from any of the bodies thatare responsible bodies for the purposes of Part4, to investigate the concern and makerecommendations as mentioned in paragraph(3).

(3) An incident panel convened under paragraph(2)(g) may recommend that the accountable officer ordesignated body take action that includes (although itneed not be limited to) any of the following—

(a) ongoing monitoring of the relevant individual;

(b) referral of the concerns to another accountableofficer;

(c) referral of the concerns to a regulatory body;

(d) referral of the concerns to a police force; or

(e) implementation of a serious untoward incidentprocedure.

Accountable officers to establish arrangements forsharing information

18.—(1) An accountable officer must establish andoperate, or ensure that his or her designated bodyestablishes and operates, appropriate arrangements forensuring the proper sharing of information, inaccordance with regulation 25 or 26, by his or herdesignated body with other responsible bodiesregarding the management and use of controlled drugs.

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(2) Os yw'r swyddog atebol yn swyddog atebol aenwebwyd neu a benodwyd gan Fwrdd Iechyd Lleol,rhaid i'r trefniadau hynny gynnwys sefydlurhwydwaith ("rhwydwaith gwybodaeth leol") ar gyferrhannu gwybodaeth ynglyn â rheoli a defnyddiocyffuriau a reolir.

(3) Rhaid i'r rhwydwaith gynnwys (er nad oes angenei gyfyngu i hynny) y mathau canlynol o gyrff, fel ybo'n briodol—

(a) Bwrdd Iechyd Lleol;

(b) ymddiriedolaeth GIG;

(c) AGIC;

(ch) AGGCC;

(d) Is-adran Gwasanaeth Gwrth-dwyll a RheoliDiogelwch Awdurdod Gwasanaethau Busnes yGIG;

(dd) corff rheoleiddiol;

(e) heddlu; ac

(f) awdurdod lleol.

RHAN 3

Mynd i mewn i fangreoedd, arolygiadau cyfnodoletc.

Swyddogion atebol i gynnal arolygiadau cyfnodol

19.—(1) Rhaid i swyddog atebol, sy'n swyddogatebol a enwebwyd neu a benodwyd gan Fwrdd IechydLleol, sefydlu a gweithredu trefniadau priodol neusicrhau bod ei gorff dynodedig yn sefydlu ac yngweithredu trefniadau priodol i wneud, mewncysylltiad â pherfformio swyddogaethau o dan yRheoliadau hyn, arolygiadau cyfnodol (yn unol agadran 20 o Ddeddf 2006) o fangreoedd—

(a) a ddefnyddir mewn cysylltiad â rheoli neuddefnyddio cyffuriau a reolir; a

(b) nad ydynt yn ddarostyngedig i arolygiadgan—

(i) AGIC,

(ii) AGGCC, neu

(iii) Cymdeithas Fferyllol Frenhinol PrydainFawr.

(2) Os bydd corff dynodedig wedi awdurdodi personyn ysgrifenedig o dan adran 20(5)(c) o Ddeddf 2006 igyflawni arolygiadau o fangreoedd perthnasol (neu ofangreoedd perthnasol penodol), caiff y trefniadau odan baragraff (1) (pan fo'n briodol) ddarparu i'r personhwnnw gynnal arolygiadau cyfnodol o dan ytrefniadau.

(3) Nid yw'n ofynnol i'r swyddog atebol, neu'rperson y cyfeirir ato ym mharagraff (2), roi hysbysiad

(2) If the accountable officer is an accountableofficer nominated or appointed by Local Health Board,those arrangements must include establishing anetwork (a "local intelligence network") for sharinginformation regarding the management and use ofcontrolled drugs.

(3) The network must include (although it need notbe limited to) the following types of bodies, asappropriate—

(a) a Local Health Board;

(b) an NHS trust;

(c) HIW;

(d) CSSIW;

(e) the Counter Fraud and Security ManagementService Division of the NHS BusinessServices Authority;

(f) a regulatory body;

(g) a police force; and

(h) a local authority.

PART 3

Entering premises, periodic inspections etc.

Accountable officers to carry out periodicinspections

19.—(1) An accountable officer, who is anaccountable officer nominated or appointed by a LocalHealth Board, must establish and operate appropriatearrangements or ensure that his or her designated bodyestablishes and operates appropriate arrangements formaking, in connection with the performance offunctions under these Regulations, periodic inspections(in accordance with section 20 of the 2006 Act) ofpremises which are—

(a) used in connection with management or use ofcontrolled drugs; and

(b) not subject to inspection by—

(i) HIW,

(ii) CSSIW, or

(iii) the Royal Pharmaceutical Society of GreatBritain.

(2) Where a designated body has authorised inwriting under section 20(5)(c) of the 2006 Act a personto carry out inspections of relevant premises (or ofspecific relevant premises), the arrangements underparagraph (1) may (where appropriate) provide for thatperson to carry out periodic inspections under thearrangements.

(3) The accountable officer, or the person referred toin paragraph (2), is not required to give notice of the

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o arolygiad i berchennog neu feddiannydd y fangre.

(4) Rhaid i'r swyddog atebol, neu'r person y cyfeirirato ym mharagraff (2), gadw cofnod o bob arolygiadsy'n cael ei gynnal ganddo fel rhan o'r trefniadau awnaed o dan baragraff (1).

(5) Ceir cadw'r cofnod hwnnw o arolygiadau mewnfformat ar bapur neu'n electronig.

Mangreoedd perthnasol

20.—(1) At ddibenion adran 20 o Ddeddf 2006,rhagnodir y canlynol yn fangreoedd perthnasol y gellideu harolygu gan swyddog atebol sy'n swyddog atebol aenwebwyd neu a benodwyd gan Fwrdd Iechyd Lleolneu (pan fo'n briodol) gan aelod o staff y Bwrdd IechydLleol—

(a) mangreoedd y Bwrdd Iechyd Lleol y mae ef ynswyddog atebol ar ei gyfer neu (pan fo'nbriodol) y mae ef yn aelod o'i staff;

(b) mangreoedd corff neu berson sy'n gweithreduar ran, neu'n darparu gwasanaethau o dandrefniadau a wnaed â'r Bwrdd Iechyd Lleolhwnnw, onid yw'r trefniadau hynny gydagymddiriedolaeth GIG neu ysbyty annibynnolyng Nghymru; ac

(c) unrhyw fangre arall sy'n dod o dan drefniadaua sefydlwyd yn rhinwedd rheoliad 19(1) ondna chrybwyllir mohonynt yn is-baragraffau (a)neu (b).

(2) At ddibenion adran 20 o Ddeddf 2006, mae'rcanlynol wedi'u rhagnodi'n fangreoedd perthnasol ygellid eu harolygu gan swyddog atebol sy'n swyddogatebol a enwebwyd neu a benodwyd ganymddiriedolaeth GIG, neu (pan fo'n briodol) gan aelodo staff ymddiriedolaeth GIG—

(a) mangreoedd yr ymddiriedolaeth GIG y mae efyn swyddog atebol ar ei chyfer neu (pan fo'nbriodol) y mae ef yn aelod o'i staff; a

(b) mangreoedd corff neu berson sy'n gweithreduar ran, neu'n darparu gwasanaethau o dandrefniadau a wnaed â'r ymddiriedolaeth GIGhonno, onid yw'r trefniadau hynny gydaBwrdd Iechyd Lleol neu ysbyty annibynnolyng Nghymru.

(3) At ddibenion adran 20 o Ddeddf 2006, rhagnodiry canlynol yn fangreoedd perthnasol y gellid euharolygu gan swyddog atebol sy'n swyddog atebol aenwebwyd neu a benodwyd gan ysbyty annibynnolyng Nghymru neu (pan fo'n briodol) gan aelod o staffyr ysbyty annibynnol yng Nghymru—

(a) mangreoedd yr ysbyty annibynnol yngNghymru mae ef yn swyddog atebol ar eigyfer; a

(b) mangreoedd corff neu berson sy'n gweithredu

inspection to the owner or occupier of the premises.

(4) The accountable officer, or the person referred toin paragraph (2), must keep a record of all theinspections carried out by him or her as part of thearrangements made under paragraph (1).

(5) That record of inspections may be kept in paperor electronic format.

Relevant premises

20.—(1) For the purposes of section 20 of the 2006Act, the following are prescribed as relevant premiseswhich may be inspected by an accountable officer whois an accountable officer nominated or appointed by aLocal Health Board or (where appropriate) by amember of the staff of the Local Health Board—-

(a) the premises of the Local Health Board forwhich he or she is the accountable officer or(where appropriate) of which he or she is amember of staff;

(b) the premises of a body or person acting onbehalf of, or providing services underarrangements made with, that Local HealthBoard, unless those arrangements are with anNHS trust or a Welsh independent hospital;and

(c) any other premises which are covered byarrangements established by virtue ofregulation 19(1) but which are not mentionedin sub-paragraphs (a) or (b).

(2) For the purposes of section 20 of the 2006 Act,the following are prescribed as relevant premiseswhich may be inspected by an accountable officer whois an accountable officer nominated or appointed by anNHS trust or (where appropriate) by a member of thestaff of the NHS trust—

(a) the premises of the NHS trust for which he orshe is the accountable officer or (whereappropriate) of which he or she is a member ofstaff; and

(b) the premises of a body or person acting onbehalf of, or providing services underarrangements made with, that NHS trust,unless those arrangements are with a LocalHealth Board or a Welsh independent hospital.

(3) For the purposes of section 20 of the 2006 Act,the following are prescribed as relevant premiseswhich may be inspected by an accountable officer whois an accountable officer nominated or appointed by aWelsh independent hospital or (where appropriate) bya member of the staff of the independent hospital—-

(a) the premises of the independent hospital forwhich he or she is the accountable officer; and

(b) the premises of a body or person acting on

20

ar ran, neu'n darparu gwasanaethau o dandrefniadau a wnaed â'r ysbyty annibynnolhwnnw yng Nghymru, onid yw'r trefniadauhynny gyda Bwrdd Iechyd Lleol neuymddiriedolaeth GIG.

(4) Mae'r holl fangreoedd a grybwyllir ymmharagraff (1) i (3) hefyd wedi'u rhagnodi felmangreoedd perthnasol o ran cwnstabliaid a phersonaua awdurdodwyd gan yr awdurdodau perthnasol o danadran 20(5)(a) o Ddeddf 2006 (ac yn unol â hynny feallant arfer y pwerau o dan adran 20 o Ddeddf 2006ynglyn â'r mangreoedd hynny).

(5) Rhaid i awdurdodiad a roddir o dan adran20(5)(a) neu (c) o Ddeddf 2006 fod yn ysgrifenedig.

(6) Caiff swyddog atebol ("y swyddog atebolcyntaf") wneud cais ysgrifenedig bod swyddog atebolo gorff dynodedig arall o'r un math yn arolygu—

(a) mangreoedd corff dynodedig y swyddog atebolcyntaf; neu

(b) mangreoedd corff neu berson sy'n gweithreduar ran, neu'n darparu gwasanaethau o dandrefniadau a wnaed â chorff dynodedig yswyddog atebol cyntaf,

yn ddarostyngedig i'r ffaith bod awdurdodiad priodolyn cael ei roi.

Arolygiadau anheddau preifat nad ydynt yngwneud presenoldeb cwnstabl yn ofynnol

21. Nid yw adran 20(3) o Ddeddf 2006 yn gymwyso ran—

(a) aelod o staff AGGCC, neu berson aawdurdodwyd ganddo sy'n mynd i mewn igartref gofal yng Nghymru;

(b) swyddog o Gymdeithas Fferyllol FrenhinolPrydain Fawr sy'n mynd i mewn i fferyllfagofrestredig;

(c) aelod o staff corff dynodedig neu berson aawdurdodwyd gan gorff dynodedig, sy'n myndi mewn i fangre sy'n annedd breifatproffesiynolyn gofal iechyd neu fangre sy'nffurfio rhan ohoni—

(i) sy'n darparu gofal iechyd (sy'n cynnwysgwasanaethau fferyllydd) yn yr anneddbreifat, a

(ii) sy'n annedd breifat ar gofrestr statudolmangre gofal iechyd neu a ddynodwyd ynfangre practis o dan drefniadau gydaBwrdd Iechyd Lleol i ddarparugwasanaethau sylfaenol meddygol neuddeintyddol.

behalf of, or providing services underarrangements made with, that independenthospital, unless those arrangements are with aLocal Health Board or an NHS trust.

(4) All the premises mentioned in paragraphs (1) to(3) are also prescribed as relevant premises in relationto constables and persons authorised by the relevantauthority under section 20(5)(a) of the 2006 Act (andaccordingly they may exercise the powers undersection 20 of the 2006 Act as regards those premises).

(5) An authorisation given under section 20(5)(a) or(c) of the 2006 Act must be in writing.

(6) An accountable officer ("the first accountableofficer") may request in writing that an accountableofficer of another designated body of the same typeinspect—

(a) the premises of the designated body of the firstaccountable officer; or

(b) the premises of a body or person acting onbehalf of, or providing services underarrangements made with the designated bodyof the first accountable officer,

subject to an appropriate authorisation beinggranted.

Inspections of private dwellings not requiring thepresence of a constable

21. Section 20(3) of the 2006 Act does not apply asregards—

(a) a member of staff of, or person authorised by,CSSIW entering a Welsh care home;

(b) an officer of the Royal Pharmaceutical Societyof Great Britain entering a registeredpharmacy;

(c) a member of staff of, or a person authorised by,a designated body, entering premises which areor form part of a private dwelling of a healthcare professional—-

(i) who is providing health care (whichincludes the services of a pharmacist) at theprivate dwelling, and

(ii) the private dwelling is on a statutoryregister of health care premises or isdesignated as practice premises underarrangements with a Local Health Board toprovide primary medical or dental services.

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RHAN 4

Cydweithredu rhwng cyrff iechyd a chyrff eraill

Cyrff cyfrifol at ddibenion y Rhan hon

22.—(1) Mae'r canlynol yn gyrff cyfrifol atddibenion adran 18 o Ddeddf 2006 a'r Rhan hon—

(a) Bwrdd Iechyd Lleol;

(b) ymddiriedolaeth GIG;

(c) Ymddiriedolaeth GIG GwasanaethauAmbiwlans Cymru;

(ch) ysbyty annibynnol yng Nghymru;

(d) AGIC;

(dd) AGGCC;

(e) Awdurdod Gwasanaethau Busnes y GIG,ynglyn â pherfformio ei swyddogaethau ganIs-adran Gwasanaeth Gwrth-dwyll a RheoliDiogelwch;

(f) Atebion Iechyd Cymru

(ff) heddlu;

(g) awdurdod lleol; ac

(ng) corff rheoleiddiol.

Personau perthnasol

23. Yn unol ag adran 19(1)(a) o Ddeddf 2006, mae'rcanlynol wedi'u rhagnodi'n bersonau perthnasol (ac ynunol â hynny maent yn "bersonau perthnasol" atddibenion y Rhan hon yn ychwanegol at y personau agrybwyllir yn adran 19(1)(b) o Ddeddf 2006)—

(a) ymarferydd meddygol cofrestredig neuddeintydd cofrestredig sy'n darparugwasanaethau meddygol i gleifion preifat ynunig;

(b) person sy'n cymryd rhan mewn unrhywweithgaredd a gynhelir gan ymarferyddmeddygol cofrestredig neu ddeintyddcofrestredig y cyfeirir ato ym mharagraff (a)sy'n ymwneud â chyflenwi neu weinydducyffuriau a reolir neu a allai ymwneud âhynny;

(c) fferyllydd cofrestredig sy'n darparugwasanaethau ar ran, neu o dan drefniadau awnaed â fferyllfa gofrestredig, mewnamgylchiadau lle nad yw'r fferyllfagofrestredig honno'n darparu gwasanaethau felrhan o'r gwasanaeth iechyd (p'un ai o dandrefniadau a wnaed â chorff dynodedig neu arran person neu gorff â chanddo drefniadau o'rfath);

(ch) person, heblaw fferyllydd cofrestredig, sy'ncymryd rhan mewn unrhyw weithgaredd agynhelir gan fferyllydd cofrestredig y cyfeirirato ym mharagraff (c) sy'n ymwneud â

PART 4

Co-operation between health bodies and otherorganisations

Responsible bodies for the purposes of this Part

22.—(1) The following are responsible bodies forthe purposes of section 18 of the 2006 Act and thisPart—

(a) a Local Health Board;

(b) an NHS trust;

(c) the Welsh Ambulance Services NHS Trust;

(d) a Welsh independent hospital;

(e) HIW;

(f) CSSIW;

(g) the NHS Business Services Authority, inrelation to the performance of its functions bythe Counter Fraud and Security ManagementService Division;

(h) Health Solutions Wales

(i) a police force;

(j) a local authority; and

(k) a regulatory body.

Relevant persons

23. In accordance with section 19(1)(a) of the 2006Act, the following are prescribed as relevant persons(and accordingly are "relevant persons" for thepurposes of this Part in addition to those persons whoare mentioned in section 19(1)(b) of the 2006 Act)—

(a) a registered medical practitioner or registereddentist who is providing medical services toprivate patients only;

(b) a person engaged in any activity carried on bya registered medical practitioner or registereddentist referred to in paragraph (a) thatinvolves, or may involve, the supply oradministration of controlled drugs;

(c) a registered pharmacist who is providingservices on behalf of, or under arrangementsmade with, a registered pharmacy, incircumstances where that registered pharmacyis not providing services as part of the healthservice (whether under arrangements madewith a designated body or on behalf of a personor body that has such arrangements);

(d) a person, other than a registered pharmacist,engaged in any activity carried on or by aregistered pharmacist referred to in paragraph(c) that involves, or may involve the supply or

22

chyflenwi neu weinyddu cyffuriau a reolir neua allai ymwneud â hynny;

(d) bydwraig neu nyrs gofrestredig sy'n darparugwasanaethau bydwreigiaeth neu nyrsio igleifion preifat yn unig sy'n ymwneud âchyflenwi neu weinyddu cyffuriau a reolir neua allai ymwneud â hynny;

(dd) person sy'n cynnal neu sy'n cymryd rhanmewn unrhyw weithgaredd sy'n ymwneud âchyflenwi neu weinyddu cyffuriau a reolir neua allai ymwneud â hynny, ac sydd—

(i) yn berson sydd wedi'i gofrestru o dan RanII o Ddeddf 2000 yn rheolwr, neu'r personsy'n cynnal, cartref gofal (y cyfeirir ato yny paragraff hwn fel "person cofrestredig"),neu

(ii) person sy'n cymryd rhan mewn unrhywweithgaredd a gynhelir gan bersoncofrestredig.

Dyletswydd gyffredinol ar gyrff cyfrifol igydweithredu â'i gilydd o ran personau perthnasol

24. Rhaid i gyrff cyfrifol gydweithredu â'i gilyddmewn cysylltiad â—

(a) canfod achosion lle gall fod angen cymrydcamau ynghylch materion sy'n codi o ranrheoli neu ddefnyddio cyffuriau a reolir ganberson perthnasol;

(b) ystyried y prif ddadleuon ynghylch cymrydcamau ynglyn â materion o'r fath; ac

(c) cymryd camau ynglyn â materion o'r fath.

Dyletswydd i gydweithredu drwy ddatgelugwybodaeth ynglyn â phersonau perthnasol

25.—(1) Caiff corff cyfrifol ddatgelu i unrhyw gorffcyfrifol arall unrhyw wybodaeth sydd ganddo yn eifeddiant neu dan ei reolaeth y mae o'r farn resymol ydylid ei rhannu â'r corff hwnnw at ddibenion—

(a) canfod achosion lle gall fod angen cymrydcamau ynghylch materion sy'n codi o ranrheoli neu ddefnyddio cyffuriau a reolir ganberson perthnasol;

(b) ystyried y prif ddadleuon ynghylch cymrydcamau ynglyn â materion o'r fath;

(c) cymryd camau ynglyn â materion o'r fath.

(2) Os bydd y corff cyfrifol yn dymuno datgelugwybodaeth o dan y rheoliad hwn—

(a) sy'n cynnwys gwybodaeth gyfrinachol sy'nymwneud â chlaf ac yn gallu dynodi pwyydyw; a

(b) nad oes angen yr wybodaeth gyfrinacholhonno at ddibenion adnabod achosion y gallfod angen cymryd camau ynghylch materionsy'n codi o ran rheoli neu ddefnyddio cyffuriaua reolir gan berson perthnasol, neu ar gyfer

administration of controlled drugs;

(e) a registered midwife or nurse who is providingmidwifery or nursing services to privatepatients only that involve, or may involve, thesupply or administration of controlled drugs;

(f) a person who is carrying on or engaged in anyactivity that involves, or may involve, thesupply or administration of controlled drugs,and who is—-

(i) a person who is registered under Part II ofthe 2000 Act as the manager of, or theperson who is carrying on, a care home(referred to in this paragraph as "aregistered person"), or

(ii) a person engaged in any activity carried onby a registered person.

General duty on responsible bodies to co-operatewith each other as regards relevant persons

24. Responsible bodies must co-operate with eachother in connection with—

(a) the identification of cases in which action mayneed to be taken in respect of matters arising inrelation to the management or use of controlleddrugs by a relevant person;

(b) the consideration of issues relating to thetaking of action in respect of such matters; and

(c) the taking of action in respect of such matters.

Duty to co-operate by disclosing information asregards relevant persons

25.—(1) A responsible body may disclose to anyother responsible body any information in itspossession or control which it reasonably considers itshould share with that body for the purposes of—

(a) identifying cases in which action may need tobe taken in respect of matters arising inrelation to the management or use of controlleddrugs by a relevant person;

(b) the consideration of issues relating to thetaking of action in respect of such matters;

(c) the taking of action in respect of such matters.

(2) If the responsible body wishes to discloseinformation under this regulation which—

(a) contains confidential information whichrelates to and can identify a patient; and

(b) that confidential information is not requiredfor the purposes of identifying cases in whichaction may need to be taken in respect ofmatters arising in relation to the managementor use of controlled drugs by a relevant person,

23

ystyried neu gymryd camau mewn achos o'rfath,

rhaid i'r corff cyfrifol, i'r graddau y mae hynny'nymarferol, dynnu o'r wybodaeth yr wybodaethgyfrinachol sy'n ymwneud â chlaf ac sy'n gallu dynodipwy ydyw.

(3) O ran y corff cyfrifol—

(a) os nad yw'n gallu, o dan baragraff (2), dynnuymaith o unrhyw wybodaeth sydd i'w datgeluunrhyw wybodaeth gyfrinachol sy'n ymwneudâ chlaf ac yn gallu dynodi pwy ydyw; neu

(b) os yw'n ystyried ei bod yn angenrheidioldatgelu gwybodaeth sy'n cynnwys yrwybodaeth gyfrinachol sy'n ymwneud â chlafac yn gallu dynodi pwy ydyw,

rhaid i'r corff cyfrifol, pan fydd yn ymarferol,sicrhau cydsyniad y claf y mae'r wybodaeth ynymwneud ag ef.

(4) Os bydd y corff cyfrifol (neu ei swyddog atebol)-

(a) wedi cychwyn asesiad o fater o bryder neuymchwiliad iddo o ran rheoli neu ddefnyddiocyffuriau a reolir gan unigolyn perthnasol odan reoliad 16 (a'r unigolyn hwnnw'n bersonperthnasol at ddibenion y Rhan hon); neu

(b) wedi cwblhau asesiad o fater o bryder neuymchwiliad iddo o dan reoliad 16,

rhaid iddo hysbysu'r personau a'r cyrff a restrir ymmharagraff (5) o gychwyn neu gwblhau'r asesiad neu'rymchwiliad, yn ôl y digwydd, a darparu manylionpriodol ynghylch natur yr asesiad neu'r ymchwiliad.

(5) Dyma'r personau a'r cyrff—

(a) os oes gan y corff cyfrifol swyddog atebol acnad yw'n ymwybodol o'r camau a gymrwyd, yswyddog atebol hwnnw;

(b) y swyddog atebol a enwebwyd neu abenodwyd yn swyddog atebol ar gyfer unrhywFwrdd Iechyd Lleol y mae'r unigolynperthnasol yn byw yn ei ardal neu'n darparugofal iechyd neu wasanaethau ynglyn â gofaliechyd ynddi; ac

(c) unrhyw gorff cyfrifol arall y mae'n ystyried eibod yn briodol ei hysbysu.

(6) Nid yw'n ofynnol i gorff cyfrifol hysbysu unrhywberson neu gorff, na darparu unrhyw fanylion, o danbaragraff (4) lle y byddai gwneud hynny'n rhagfarnuneu'n debygol o ragfarnu—

(a) unrhyw ymchwiliad sy'n cael ei gynnal gan ycorff cyfrifol, neu gan unrhyw gorff cyfrifolarall o dan unrhyw ddeddfiad; neu

(b) unrhyw achosion sifil neu droseddol.

or for considering or taking action in such acase,

the responsible body must, so far as it is practical todo so, remove from the information the confidentialinformation which relates to and can identify thepatient.

(3) If the responsible body—

(a) is unable, under paragraph (2), to remove fromany information to be disclosed anyconfidential information which relates to andcan identify a patient; or

(b) considers it necessary to disclose informationwhich contains the confidential informationthat relates to and can identify the patient,

the responsible body must, where practicable, obtainthe consent of the patient to whom the informationrelates.

(4) If the responsible body (or its accountableofficer) has—

(a) commenced an assessment of or aninvestigation into a matter of concern inrelation to the management or use of controlleddrugs by a relevant individual under regulation16 (that individual being a relevant person forthe purposes of this Part); or

(b) completed an assessment of or an investigationinto a matter of concern under regulation 16,

it must notify the persons and bodies listed inparagraph (5) of the commencement or completion ofthe assessment or investigation, as the case may be,and provide appropriate details regarding the nature ofthe assessment or investigation.

(5) Those persons and bodies are—

(a) if the responsible body has an accountableofficer and he or she is unaware of the actiontaken, that accountable officer;

(b) the accountable officer nominated or appointedas accountable officer for any Local HealthBoard in whose area the relevant individuallives or provides health care or services relatedto health care; and

(c) any other responsible body that it considers itappropriate to notify.

(6) A responsible body is not required to notify anyperson or body, or to provide any details, underparagraph (4) where to do so would prejudice or wouldbe likely to prejudice—

(a) any investigation being conducted by theresponsible body, or any other responsiblebody, under any enactment; or

(b) any civil or criminal proceedings.

24

(7) Nid oes dim yn y rheoliad hwn yn gwneudunrhyw ddatgeliad o wybodaeth yn ofynnol neu'ncaniatáu hynny a bod y cyfryw'n cael ei wahardd ganneu o dan unrhyw ddeddfiad arall.

(8) Wrth benderfynu at ddibenion paragraff (7) a ywdatgeliad heb ei wahardd oherwydd ei fod ynddatgeliad o ddata personol sy'n esempt rhagdarpariaethau peidio â datgelu Deddf Diogelu Data1998 yn rhinwedd adran 35(1) o'r Ddeddf honno(datgeliad sy'n ofynnol gan y gyfraith neu wedi'iwneud mewn cysylltiad ag achosion cyfreithiol etc),mae i'w dybied bod y datgeliad yn ofynnol gan yrheoliad hwn.

Cyrff cyfrifol yn gofyn am wybodaeth ychwanegoli gael ei datgelu am bersonau perthnasol

26.—(1) Os oes gan gorff cyfrifol yn ei feddiant neudan ei reolaeth wybodaeth ynghylch rheoli neuddefnyddio cyffuriau a reolir gan berson perthnasol ymae'n ystyried ei bod yn bryder difrifol (a all fod ynwybodaeth am ffitrwydd i ymarfer nad yw'ngysylltiedig ag unrhyw enghraifft benodedig o reolineu ddefnyddio cyffur a reolir), caiff ofyn ynysgrifenedig am wybodaeth ychwanegol ynglyn â'rmater gan unrhyw gorff cyfrifol arall y mae'n ystyriedy gall fod gwybodaeth berthnasol ganddo.

(2) Os bydd corff cyfrifol wedi derbyn cais o danbaragraff (1)—

(a) rhaid iddo benderfynu cyn pen cyfnodrhesymol o amser p'un ai i gydymffurfio â'rcais ai peidio; a

(b) caiff ddatgelu unrhyw wybodaeth ynghylchrheoli neu ddefnyddio cyffuriau a reolir ganberson perthnasol y mae'n ystyried ei bod ynberthnasol i'r cais.

(3) Os bydd y corff cyfrifol yn dymuno datgelugwybodaeth o dan y rheoliad hwn sy'n cynnwysgwybodaeth gyfrinachol sy'n ymwneud â chlaf ac yngallu dynodi pwy ydyw, rhaid i'r corff cyfrifol, i'rgraddau y mae hynny'n ymarferol, dynnu ymaith o'rwybodaeth yr wybodaeth gyfrinachol sy'n ymwneudâ'r claf ac yn gallu dynodi pwy ydyw.

(4) O ran y corff cyfrifol—

(a) os nad yw'n gallu, o dan baragraff (3), tynnuymaith o unrhyw wybodaeth sydd i'w datgeluunrhyw wybodaeth gyfrinachol sy'n ymwneudâ chlaf ac yn gallu dynodi pwy ydyw; neu

(b) os yw'n ystyried bod angen datgelugwybodaeth sy'n cynnwys gwybodaethgyfrinachol sy'n ymwneud â chlaf ac yn galludynodi pwy ydyw,

rhaid i'r corff cyfrifol, pan fo'n ymarferol, gaelcydsyniad y claf y mae'r wybodaeth yn ymwneud ag ef.

(5) Nid yw'n ofynnol i gorff cyfrifol ddatgelu

(7) Nothing in this regulation requires or permits anydisclosure of information which is prohibited by orunder any other enactment.

(8) In determining for the purposes of paragraph (7)whether disclosure is not prohibited by reason of beinga disclosure of personal data which is exempt from thenon-disclosure provisions of the Data Protection Act1998 by virtue of section 35(1) of that Act (disclosurerequired by law or made in connection with legalproceedings etc), it is to be assumed that the disclosureis required by this regulation.

Responsible bodies requesting additionalinformation be disclosed about relevant persons

26.—(1) If a responsible body has in its possessionor control information relating to the management oruse of controlled drugs by a relevant person that itconsiders to be of serious concern (which may befitness to practise information that is unrelated to anyspecific instance of the management or use of acontrolled drug), it may request in writing additionalinformation in relation to the matter from any otherresponsible body which it considers may have relevantinformation.

(2) If a responsible body has received a requestunder paragraph (1)—

(a) it must determine within a reasonable period oftime whether or not to comply with therequest; and

(b) it may disclose any information relating to themanagement or use of controlled drugs by arelevant person which it reasonably considersto be relevant to the request.

(3) If the responsible body wishes to discloseinformation under this regulation which containsconfidential information which relates to and canidentify a patient, the responsible body must, so far asit is practical to do so, remove from the information theconfidential information which relates to and canidentify the patient.

(4) If the responsible body—

(a) is unable, under paragraph (3), to remove fromany information to be disclosed anyconfidential information which relates to andcan identify a patient; or

(b) considers it necessary to disclose informationwhich contains the confidential informationthat relates to and can identify the patient,

the responsible body must, where practicable, obtainthe consent of the patient to whom the informationrelates.

(5) A responsible body is not required to disclose

25

gwybodaeth o dan y rheoliad os byddai'r datgeliad—

(a) yn rhagfarnu, neu os byddai'n debygol oragfarnu, unrhyw ymchwiliad a gynhelir gan ycorff cyfrifol, neu gan unrhyw gorff cyfrifolarall, o dan unrhyw ddeddfiad;

(b) yn rhagfarnu, neu os byddai'n debygol oragfarnu, unrhyw achosion sifil neu droseddol;neu

(c) yn golygu cost anghymesur.

(6) Nid oes dim yn y rheoliad hwn yn gwneudunrhyw ddatgeliad o wybodaeth yn ofynnol neu'ncaniatáu hynny a bod y cyfryw'n cael ei wahardd ganneu o dan unrhyw ddeddfiad arall.

(7) Wrth benderfynu at ddibenion paragraff (6) a ywdatgeliad heb ei wahardd oherwydd ei fod ynddatgeliad o ddata personol sy'n esempt rhagdarpariaethau peidio â datgelu Deddf Diogelu Data1998 yn rhinwedd adran 35(1) o'r Ddeddf honno(datgeliad sy'n ofynnol gan y gyfraith neu wedi'iwneud mewn cysylltiad ag achosion cyfreithiol etc),mae i'w dybied bod y datgeliad yn ofynnol gan yrheoliad hwn.

Cyfyngiadau ynghylch datgelu

27.—(1) Os oes gan gorff cyfrifol sy'n datgelu neu ydatgelir iddo unrhyw wybodaeth o dan reoliad 25 neu26 swyddog atebol, rhaid i'r datgeliad gael ei wneudgan neu i'r swyddog atebol neu ei staff (ac nid gan neui unrhyw berson arall a all fod yn gweithredu ar ran ycorff cyfrifol).

(2) Os bydd corff cyfrifol wedi cael gwybodaeth odan reoliad 25 neu 26, rhaid iddo beidio â phrosesu'rwybodaeth honno'n fwy na'r hyn sy'n angenrheidiol atddibenion—

(a) canfod yr achosion y gall fod angen cymrydcamau ynghylch materion sy'n codi o ranrheoli neu ddefnyddio cyffuriau a reolir ganberson perthnasol;

(b) ystyried y prif ddadleuon ynghylch cymrydcamau ynglyn â materion o'r fath; neu

(c) cymryd camau ynghylch materion o'r fath.

(3) Yn benodol, rhaid i'r corff cyfrifol—

(a) peidio â chaniatáu mynediad i unrhyw bersoni'r wybodaeth honno onid yw'n berson sydd, ynrhinwedd ei gontract cyflogaeth neu fel arall,yn ymwybodol o'r dibenion y gall yrwybodaeth gael ei phrosesu ar ei chyfer; a

(b) sicrhau bod mesurau trefniadaeth briodol yncael eu cymryd i rwystro datgeliad heb eiawdurdodi neu brosesu'r wybodaeth.

Gofynion cadw cofnodion ynghylch rheoliadau 25a 26

28.—(1) Rhaid i gorff cyfrifol gadw cofnod o'rcanlynol—

information under this regulation if the disclosure—

(a) would prejudice, or would be likely toprejudice, any investigation being conductedby the responsible body, or by any otherresponsible body, under any enactment;

(b) would prejudice, or would be likely toprejudice, any civil or criminal proceedings; or

(c) would involve disproportionate cost.

(6) Nothing in this regulation requires or permits anydisclosure of information which is prohibited by orunder any other enactment.

(7) In determining for the purposes of paragraph(6) whether disclosure is not prohibited by reason ofbeing a disclosure of personal data which is exemptfrom the non-disclosure provisions of the DataProtection Act 1998 by virtue of section 35(1) of thatAct (disclosure required by law or made in connectionwith legal proceedings etc.), it is to be assumed that thedisclosure is required by this regulation.

Restrictions relating to disclosures

27.—(1) If a responsible body that is disclosing or towhich is being disclosed any information underregulation 25 or 26 has an accountable officer, thedisclosure must be made by or to the accountableofficer or his or her staff (and not by or to any otherperson who may act on behalf of the responsible body).

(2) If a responsible body has received informationunder regulation 25 or 26, it must not process thatinformation more than is necessary for the purposesof—

(a) identifying cases in which action may need tobe taken in respect of matters arising inrelation to the management or use of controlleddrugs by a relevant person;

(b) considering issues relating to the taking ofaction in respect of such matters; or

(c) taking action in respect of such matters.

(3) In particular, the responsible body must—

(a) not allow any person access to that informationunless he or she is a person who, by virtue ofhis or her contract of employment orotherwise, is aware of the purposes for whichthe information may be processed; and

(b) ensure that appropriate organisationalmeasures are taken to prevent unauthoriseddisclosure or processing of the information.

Record keeping requirements relating toregulations 25 and 26

28.—(1) A responsible body must keep a record of—

26

(a) penderfyniad i ddatgelu gwybodaeth o danreoliad 25;

(b) manylion o natur yr wybodaeth a ddatgelir;

(c) manylion am y corff cyfrifol y datgelwyd yrwybodaeth iddo; ac

(ch) unrhyw fanylion eraill y mae'r corff cyfrifol ynystyried eu bod yn berthnasol i'r datgeliad.

(2) Rhaid i gorff cyfrifol gadw cofnod o'r canlynol—

(a) unrhyw gais a geir gan gorff cyfrifol arall iddatgelu gwybodaeth o dan reoliad 26;

(b) manylion o natur unrhyw wybodaeth addatgelir;

(c) manylion am y corff cyfrifol y datgelwyd yrwybodaeth iddo; a

(ch) unrhyw fanylion eraill y mae'r corff cyfrifol ynystyried eu bod yn berthnasol i'r datgeliad.

(3) Ceir cadw'r cofnodion mewn fformat ar bapurneu'n electronig.

Adroddiadau ar ddigwyddiadau

29.—(1) Rhaid i swyddog atebol (heblaw amswyddog atebol a enwebwyd neu a benodwyd ynswyddog atebol ar gyfer Bwrdd Iechyd Lleol) roi, ynchwarterol, adroddiad ar ddigwyddiadau i'r swyddogatebol a enwebwyd neu a benodwyd yn swyddogatebol ar gyfer y Bwrdd Iechyd Lleol sy'n arwainunrhyw rwydwaith gwybodaeth leol y mae ef neu eigorff dynodedig yn aelod ohono.

(2) Caiff yr adroddiad am ddigwyddiadau gynnwysyr wybodaeth ganlynol—

(a) manylion unrhyw bryderon sydd gan ei gorffdynodedig ynghylch ei reolaeth neu eiddefnydd o gyffuriau a reolir; neu

(b) cadarnhad gan ei gorff dynodedig nad oesganddo bryderon i adrodd amdanynt ynghylchei reolaeth neu ei ddefnydd o gyffuriau a reolir.

(3) Nid oes dim yn y rheoliad hwn yn gwneudunrhyw ddatgeliad o wybodaeth yn ofynnol neu'ncaniatáu hynny a bod y cyfryw'n cael ei wahardd ganneu o dan unrhyw ddeddfiad arall.

(4) Wrth benderfynu at ddibenion paragraff (3) a ywdatgeliad heb ei wahardd oherwydd ei fod ynddatgeliad o ddata personol sy'n esempt rhagdarpariaethau peidio â datgelu Deddf Diogelu Data1998 yn rhinwedd adran 35(1) o'r Ddeddf honno(datgeliad sy'n ofynnol gan y gyfraith neu wedi'iwneud mewn cysylltiad ag achosion cyfreithiol etc),mae i'w dybied bod y datgeliad yn ofynnol gan yrheoliad hwn.

(a) a decision to disclose information underregulation 25;

(b) details of the nature of the informationdisclosed;

(c) details of the responsible body to whichinformation was disclosed; and

(d) any other details which the responsible bodyconsiders to be relevant to the disclosure.

(2) A responsible body must keep a record of-

(a) any request received from anotherresponsible body to disclose informationunder regulation 26;

(b) details of the nature of any informationdisclosed;

(c) details of the responsible body to whichthe information was disclosed; and

(d) any other details which the responsiblebody considers to be relevant to thedisclosure.

(3) The records may be kept in paper or electronicformat.

Occurrence reports

29.—(1) An accountable officer (other than anaccountable officer nominated or appointed asaccountable officer for a Local Health Board) mustgive, on a quarterly basis, an occurrence report to theaccountable officer nominated or appointed asaccountable officer for the Local Health Board that isleading any local intelligence network of which he orshe or his or her designated body is a member.

(2) The occurrence report may contain the followinginformation——

(a) details of any concerns that his or herdesignated body has regarding its managementor use of controlled drugs; or

(b) confirmation by his or her designated body thatit has no concerns to report regarding itsmanagement or use of controlled drugs.

(3) Nothing in this regulation requires or permits anydisclosure of information which is prohibited by orunder any other enactment.

(4) In determining for the purposes of paragraph (3)whether disclosure is not prohibited by reason of beinga disclosure of personal data which is exempt from thenon-disclosure provisions of the Data Protection Act1998 by virtue of section 35(1) of that Act (disclosurerequired by law or made in connection with legalproceedings etc), it is to be assumed that the disclosureis required by this regulation.

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Dyletswyddau gan swyddogion atebol i amddiffyndiogelwch cleifion a'r cyhoedd

30.—(1) Os yw'r wybodaeth a rennir gan gorffcyfrifol o dan reoliad 25 neu 26 yn dangos pryder amddefnydd amhriodol neu anniogel o gyffuriau a reolirgan berson perthnasol, caiff swyddog atebol unrhywgorff dynodedig sy'n gyfrifol am—

(a) gwneud unrhyw drefniadau gyda'r personperthnasol ; neu

(b) gwneud unrhyw drefniadau gydag unrhywberson neu gorff arall, y mae'r personperthnasol yn darparu gwasanaethau oddi tanoneu y gallai fod yn gwneud hynny,

ac y mae'r wybodaeth honno yn ei feddiant neu danei reolaeth, yna caiff wneud argymhellion i unrhywgorff cyfrifol (gan gynnwys, pan fo'n briodol, ei gorffdynodedig ei hunan) o ran unrhyw gamau y mae'rswyddog atebol yn ystyried y dylai'r corff cyfrifol eucymryd i amddiffyn diogelwch cleifion neu'r cyhoedd.

(2) Os yw'r pryder yn ymwneud â pherson perthnasolnad yw'n darparu gwasanaethau i gorff dynodedig, neuo dan drefniadau sydd gan berson neu gorff arall ag ef,rhaid i'r swyddog atebol sy'n arwain y rhwydwaithgwybodaeth leol ar gyfer unrhyw ardal lle y mae'rperson perthnasol yn byw ynddi neu'n darparugwasanaethau ynddi—

(a) mynd ati i gymryd camau rhesymol iamddiffyn diogelwch cleifion neu'r cyhoedd; a

(b) pan fo'n briodol, cyfeirio'r mater i gorffcyfrifol perthnasol (er enghraifft, corffrheoleiddiol neu heddlu).

Datgelu gwybodaeth yn ddidwyll

31. Ni ellir cynnal achosion sifil yn erbyn personynghylch colled, niwed neu anaf o unrhyw fath y maeperson arall yn ei ddioddef o ganlyniad i ddatgelugwybodaeth yn ddidwyll o dan reoliad 25, 26, 29 neu30.

Accountable officers' duties to protect the safety ofpatients and the general public

30.-(1) If the information shared by a responsiblebody under regulation 25 or 26 shows a concern aboutinappropriate or unsafe use of controlled drugs by arelevant person, the accountable officer of anydesignated body responsible for—

(a) entering into any arrangements with therelevant person; or

(b) entering into any arrangements with any otherperson or body, under which the relevantperson provides or may provide services,

that has possession or control of that informationmay make recommendations to any responsible body(including, where appropriate, his or her owndesignated body) as to any action which theaccountable officer considers that the responsible bodyshould take to protect the safety of patients or thegeneral public.

(2) If the concern relates to a relevant person who isnot providing services to, or under arrangements thatanother person or body has with, a designated body, theaccountable officer leading the local intelligencenetwork for any area in which the relevant person livesor provides services must—

(a) seek to take reasonable steps to protect thesafety of patients or the general public; and

(b) where appropriate, refer the matter to arelevant responsible body (for example, aregulatory body or a police force).

Disclosure of information in good faith

31. Civil proceedings do not lie against a person inrespect of loss, damage or injury of any kind sufferedby another person as a result of the disclosure ofinformation in good faith under regulation 25, 26, 29 or30.

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Y Gweinidog dros Iechyd a GwasanaethauCymdeithasol, un o Weinidogion Cymru.

16 Rhagfyr 2008

Minister for Health and Social Services, one of theWelsh Ministers

16 December 2008

29

Edwina Hart

© h Hawlfraint y Goron 2008

Argraffwyd a chyhoeddwyd yn y Deyrnas Unedig gan The Stationery

Office Limited o dan awdurdod ac arolygiaeth Carol Tullo, Rheolwr

Gwasg Ei Mawrhydi ac Argraffydd Deddfau Seneddol y Frenhines.

© Crown copyright 2008

Printed and Published in the UK by the Stationery Office Limited

under the authority and superintendence of Carol Tullo,

Controller of Her Majesty’s Stationery Office and Queen’s Printer of

Acts of Parliament.

W411/01/09 ON