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Regulation in Primary Care 
-Impact in N Ireland 
Dr Sloan Harper 
Director of Integrated Care 
Health & Social Care Board
Primary care providers NI 
GP Practices 351 
GP Out of Hours providers 5 
Community Pharmacies 530 
Dental practices 380 
Optometry practices 281
How do we improve primary care 
services? 
• Targets & performance? 
• Choice & competition? 
• Inspection & regulation?
General Medical Services Regulation 
The Health and Personal Social Services (General Medical 
Services Contracts) Regulations (NI) 2004 and amendments. 
• GP Contract – a clinical governance framework 
• Practices failing to meet the requirements can be issued a “remedial 
notice” requiring improvement within a defined period, followed by a 
“breach notice” and termination of contract
General Medical Services Regulation 
The Health and Personal Social Services (Primary Medical Services 
Performers Lists) Regulations (NI) 2004 and Amendments. 
• Individuals can be removed if they have not provided GMS services 
in last 24 months, on basis of GMC decisions, convictions for certain 
serious crimes. 
• Inclusion on the list can be deferred during investigations. 
• Regional Performance Panel with professional and lay members 
advises HSCB
Benefits and Challenges 
• Statutory basis provides definitive requirements and 
ways to address shortcomings 
• Clinical underperformance 
• Infrastructure 
• Workforce development & accreditation 
• Processes can be slow, including time for GMC 
investigations 
• Cultural issues 
• Motivation 
• Trust
Procedure for handling of concerns about FPS Practitioners 
Accountability Outcomes 
Concerns Raised 
Stage 1 
Allocated to Case Officer 
Stage 2 
Regional Professional Panel 
Stage 3 
Reference Committee 
Director of Integrated Care 
Director of Integrated Care 
through Assistant Directors 
GMS, Pharmaceutical, 
Dental, Optometry Services 
Director of Integrated 
Care through Chair of 
Panel 
HSCB Board through 
Reference Committee 
All cases managed, recorded, 
concluded 
Managed, recorded and 
reported to Regional 
Professional Panel or 
referred to RPP 
Advice on investigation and 
management including 
direct referral to Counter 
Fraud and Probity Services; 
onward referral to 
Reference Committee 
Adjudication on referral to 
disciplinary authorities eg 
national regulators, PSNI*, 
HPSS Tribunal. 
Adjudication on PMPL** 
actions for GPs 
* PSNI: Police Service of NI ** PMPL: Primary Medical Performers' List
Quality & Outcomes Framework (QoF) 2013/14 
N Ireland England Scotland Wales 
GP Practices 351 7,921 995 465 
Max points 
available 
912 900 923 969 
Average 
points 
achieved 
896.5 831.4 900.8 928.9 
% 
Achievement 
98.3% 92.4% 97.6% 95.9%
105% 
100% 
95% 
90% 
85% 
80% 
75% 
70% 
65% 
60% 
55% 
50% 
Hypertension5 (HYP002NI) - The percentage of patients with hypertension in whom the last blood pressure 
(measured in the previous 9 months) is 150/90 or less 
(maximum threshold - 70%) 
1 10 19 28 37 46 55 64 73 82 91 100109118127136145154163172181190199208217226235244253262271280289298307316325334343352 
% Outcomes 
HSC Board GMS Practices 
2009/2010 Practice Outcome 
2013/2014 PracticeOutcome
Pharmacy 
Regulated through: 
• Contractual – terms of service set out in 
Regulation 
• Professional – registration of premises, 
superintendent pharmacists and responsible 
pharmacists
Medicines 
• Human Medicines Regulations (subsumed 
Medicines Act) 
• Misuse of Drugs Act
Challenges 
• Medicines – regulation complexity 
• Pharmacists – patient facing role 
• Pharmacy support staff – regulation 
• Contractual – patient registration; pharmacist 
lists
Support for Good Medical Practice…
Dental Regulations 
Principal 
• General Dental 
Services Regulations 
(1993) 
• HPSS Quality 
Improvement 
Regulations (2003) 
• GDC Standards for the 
Dental Team (2013) 
Supporting 
• Disciplinary Regulations 
(2014) 
• Patient Charge 
Regulations (1989) 
• Ionising Radiation 
Regulations (2000)
Implementation/ Enforcement of Regulations 
GDS Regulations 
• Post-treatment record checks 
• Post-treatment patient 
examinations 
• Practice declarations 
HQI Regulations- 
• 15 published dental practice 
quality standards. 
• Compliance checked by 
annual RQIA practice 
inspections 
GDC Standards 
• Ethical responsibility to follow 
• Employers, commissioners 
and patients may refer. 
• Referrals have to pass 
through two screening stages 
before a full hearing
Dental 
Benefits 
• Clear rules, fairness 
to all 
• Clear lines of 
accountability 
• Public Confidence 
• Assurance of Quality 
Challenges 
• Tension b/n running a 
business and 
maintaining quality 
• Variation in standards 
• Stress among 
practitioners 
• Resources to monitor 
contacts
General Ophthalmic Services 
HPSS GOS Regulations (NI) 2007 
• Schedule 1: (Regulation 2) Terms of Service outlines 
requirements for premises and equipment, access hours, 
and clinical records etc. 
• Schedule 2: (Regulation 3) Constitution of Ophthalmic 
Committee 
These are backed up by HSC (Disciplinary Procedures) 
Regulations (NI) 2014 giving HSCB powers to investigate 
allegations that a practitioner has failed to comply with Terms of 
Service
General Ophthalmic Services (GOS) 
Approach taken to governance of ophthalmic service provision 
Governance 
REGULATIONS 
QUALITY 
ASSURANCE 
PATIENT 
FEEDBACK 
1. Current regulatory framework - General Ophthalmic Services 
Regulations (Northern Ireland) 2007 - Principal Regulations and Terms of 
Service applied to all contractors 
2. Directorate of Integrated Care – Manual for the investigation and processes 
for management of underperformance 
Head of Optometry 
Clinical 
Adviser Team 
(1 clinical adviser is 
Governance lead) 
DoIC 
Business 
Support 
(Governance 
ABSMs)
Benefits and Challenges 
• Listing of all 
contractors 
• Governance 
arrangements in 
place to ensure 
compliance with 
Regulations and 
drive up quality. 
• No powers of 
suspension 
• Internal audit has 
recommended that 
HSCB negotiate and 
agree a new GOS 
contract to better 
monitor & action 
performance.
How else could we seek to improve clinical 
services? 
• Collaboration and co-operation
Delivering integration 
What are Integrated Care Partnerships? 
Networks of providers - Working together to deliver the right care, in the right place at the right time. 
ICP Areas

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Regulation in Primary Care Improves Quality in Northern Ireland

  • 1. Regulation in Primary Care -Impact in N Ireland Dr Sloan Harper Director of Integrated Care Health & Social Care Board
  • 2. Primary care providers NI GP Practices 351 GP Out of Hours providers 5 Community Pharmacies 530 Dental practices 380 Optometry practices 281
  • 3. How do we improve primary care services? • Targets & performance? • Choice & competition? • Inspection & regulation?
  • 4. General Medical Services Regulation The Health and Personal Social Services (General Medical Services Contracts) Regulations (NI) 2004 and amendments. • GP Contract – a clinical governance framework • Practices failing to meet the requirements can be issued a “remedial notice” requiring improvement within a defined period, followed by a “breach notice” and termination of contract
  • 5. General Medical Services Regulation The Health and Personal Social Services (Primary Medical Services Performers Lists) Regulations (NI) 2004 and Amendments. • Individuals can be removed if they have not provided GMS services in last 24 months, on basis of GMC decisions, convictions for certain serious crimes. • Inclusion on the list can be deferred during investigations. • Regional Performance Panel with professional and lay members advises HSCB
  • 6. Benefits and Challenges • Statutory basis provides definitive requirements and ways to address shortcomings • Clinical underperformance • Infrastructure • Workforce development & accreditation • Processes can be slow, including time for GMC investigations • Cultural issues • Motivation • Trust
  • 7. Procedure for handling of concerns about FPS Practitioners Accountability Outcomes Concerns Raised Stage 1 Allocated to Case Officer Stage 2 Regional Professional Panel Stage 3 Reference Committee Director of Integrated Care Director of Integrated Care through Assistant Directors GMS, Pharmaceutical, Dental, Optometry Services Director of Integrated Care through Chair of Panel HSCB Board through Reference Committee All cases managed, recorded, concluded Managed, recorded and reported to Regional Professional Panel or referred to RPP Advice on investigation and management including direct referral to Counter Fraud and Probity Services; onward referral to Reference Committee Adjudication on referral to disciplinary authorities eg national regulators, PSNI*, HPSS Tribunal. Adjudication on PMPL** actions for GPs * PSNI: Police Service of NI ** PMPL: Primary Medical Performers' List
  • 8. Quality & Outcomes Framework (QoF) 2013/14 N Ireland England Scotland Wales GP Practices 351 7,921 995 465 Max points available 912 900 923 969 Average points achieved 896.5 831.4 900.8 928.9 % Achievement 98.3% 92.4% 97.6% 95.9%
  • 9. 105% 100% 95% 90% 85% 80% 75% 70% 65% 60% 55% 50% Hypertension5 (HYP002NI) - The percentage of patients with hypertension in whom the last blood pressure (measured in the previous 9 months) is 150/90 or less (maximum threshold - 70%) 1 10 19 28 37 46 55 64 73 82 91 100109118127136145154163172181190199208217226235244253262271280289298307316325334343352 % Outcomes HSC Board GMS Practices 2009/2010 Practice Outcome 2013/2014 PracticeOutcome
  • 10. Pharmacy Regulated through: • Contractual – terms of service set out in Regulation • Professional – registration of premises, superintendent pharmacists and responsible pharmacists
  • 11. Medicines • Human Medicines Regulations (subsumed Medicines Act) • Misuse of Drugs Act
  • 12. Challenges • Medicines – regulation complexity • Pharmacists – patient facing role • Pharmacy support staff – regulation • Contractual – patient registration; pharmacist lists
  • 13. Support for Good Medical Practice…
  • 14. Dental Regulations Principal • General Dental Services Regulations (1993) • HPSS Quality Improvement Regulations (2003) • GDC Standards for the Dental Team (2013) Supporting • Disciplinary Regulations (2014) • Patient Charge Regulations (1989) • Ionising Radiation Regulations (2000)
  • 15. Implementation/ Enforcement of Regulations GDS Regulations • Post-treatment record checks • Post-treatment patient examinations • Practice declarations HQI Regulations- • 15 published dental practice quality standards. • Compliance checked by annual RQIA practice inspections GDC Standards • Ethical responsibility to follow • Employers, commissioners and patients may refer. • Referrals have to pass through two screening stages before a full hearing
  • 16. Dental Benefits • Clear rules, fairness to all • Clear lines of accountability • Public Confidence • Assurance of Quality Challenges • Tension b/n running a business and maintaining quality • Variation in standards • Stress among practitioners • Resources to monitor contacts
  • 17. General Ophthalmic Services HPSS GOS Regulations (NI) 2007 • Schedule 1: (Regulation 2) Terms of Service outlines requirements for premises and equipment, access hours, and clinical records etc. • Schedule 2: (Regulation 3) Constitution of Ophthalmic Committee These are backed up by HSC (Disciplinary Procedures) Regulations (NI) 2014 giving HSCB powers to investigate allegations that a practitioner has failed to comply with Terms of Service
  • 18. General Ophthalmic Services (GOS) Approach taken to governance of ophthalmic service provision Governance REGULATIONS QUALITY ASSURANCE PATIENT FEEDBACK 1. Current regulatory framework - General Ophthalmic Services Regulations (Northern Ireland) 2007 - Principal Regulations and Terms of Service applied to all contractors 2. Directorate of Integrated Care – Manual for the investigation and processes for management of underperformance Head of Optometry Clinical Adviser Team (1 clinical adviser is Governance lead) DoIC Business Support (Governance ABSMs)
  • 19. Benefits and Challenges • Listing of all contractors • Governance arrangements in place to ensure compliance with Regulations and drive up quality. • No powers of suspension • Internal audit has recommended that HSCB negotiate and agree a new GOS contract to better monitor & action performance.
  • 20. How else could we seek to improve clinical services? • Collaboration and co-operation
  • 21. Delivering integration What are Integrated Care Partnerships? Networks of providers - Working together to deliver the right care, in the right place at the right time. ICP Areas

Notes de l'éditeur

  1. The pharmacy profession in Northern Ireland is highly regulated and recent evidence suggests a high level of public support for the quality of services already provided by pharmacists. Notwithstanding this, and in light of current government policy, there is a need for the profession, as with all healthcare professions, to ensure continuous quality improvement in the services it provides to the public. Clearly there are many elements to be addressed in order to assure quality in a pharmaceutical service which fall within the general aspirations of clinical and social care governance. Pharmacy is currently regulated at three levels through: the Legal Framework for management of medicines; the Professional Framework and the Contractual Framework. These three levels are not discrete but are interlinked. Wrt the contractual mechanism – HSCB maintains a list of all pharmacies that hold a contract with HSCB for provision of pharmaceutical services on the health service. There is a “control of entry” mechanism which means that pharmacies cannot simply open anywhere. HSCB and DHSSPS is currently engaged on a needs assessment process to map the needs for pharmaceutical services to the provision of service which will further inform where we place pharmacies. Once a pharmacy is established the contractor must comply with terms of service. If non-compliant, disciplinary processes which may lead to tribunal can be undertaken. We work very closely with the professional regulator – PSNI. They register all pharmacists and pharmacies (including those that are non-NHS). Pharmacists are required to maintain CPD (30 hours)and seven pharmacists were removed from the register this year because of non-completion of CPD. The regulator also provides professional standards for those pharmacists that act as superintendents (overall responsibility for pharmacy businesses) and responsible pharmacists (those pharmacists that have day to day responsibility for a pharmacy) The Medicines Inspectorate are DHSSPS based but inspect pharmacies from a professional registration and a medicines legislation perspective.
  2. When talking about pharmacy, we need also to speak about medicines. The two biggest pieces of legislation are the HMRs and MoDs Act As dispensing errors can be technically a criminal act, HSCB must work closely with various bodies to managed. HSCB follow up AIs and SAIs in pharmacies and should they breech a threshold, we link with the PSNI and the Medicines inspectorate under the Pharmacy Networking Group to follow up and bring cases forward. This can lead to prosecution under medicines legislation or professional sanction. Shipman was a multiple murderer and in the wake of Shipman there have been additional regulatory mechanisms put in place to protect the public. Therefore, the overall governance associated with controlled drugs management falls to designated bodies such that HSCB maintains a governance responsibility for the safe management of controlled drugs by doctors, dentists, nurses and pharmacists in primary care. This has led to much tighter controls and potentially safer practice. However this can be challenging both from the practitioner level and from the responsible bodies perspective
  3. Given patient safety concerns and the increased complexity of medical therapies, we are seeing more and more complexity in respect of medicines. Practitioners are anxious around their responsibilities in respect of prescribing dispensing and administering unlicenesed medicines, specialist medicines, controlled drugs etc. HSCB role is to commission but in commissioning it isn’t just saying what you want and walking away – it is supporting the effective delivery of care for patients. As we see more developed roles for pharmacists particularly with patients, we will need more regulation e.g. ACCESS NI checks are not a pre-requisite but should they be? And as pharmacists take on new roles, their dispensing support staff need to be regulated as already happens in GB Finally, from a contractual perspective, we recognise the need to put in place patient registration as ultimately, having an identified professional responsible for the pharmacuetical care of a patient will lead to improvements in safety and qualuity
  4. GDS Regulations set out the basic terms of service of the health service primary dental care contract. They include the rules on such things as emergency dental care, practice quality requirements and mixing health service and private care. Breaches of the GDS Regulations may be dealt with using the Disciplinary Regulations. The Health Quality Improvement Regulations cover the quality of private dental care provided, practice equipment, practice processes (eg decontamination) and practice policies (eg dealing with a needle stick injury).
  5. GDS Regulations-compliance is monitored through post-treatment record checks and post-treatment patient examination. Both quality and probity are covered. HQI Regulations- DHSSPS has published 15 dental practice quality standards (eg handling patient complaints). These apply equally to NHS & Private. Compliance checked by annual practice inspections GDC Standards- GDC have published standards for dental professionals. Employers, commissioners and patients may refer. Sanctions range from warning to erasure from register.
  6. Variation in standards by country eg NI decontamination standards more stringent than England
  7. A brief update on what ICPs are (DHSSPS Policy Implementation Framework) Networks of providers – separate from the commissioning role Fantastic opportunity to work together better for the benefit of patients Will take time to build relationships and achieve outcomes but we have made a positive start 17 in place with all sectors represented as well as service users and carers Vision Make it easier for people to access the health and social care system Provide an environment for new ideas and innovations with a stronger emphasis on prevention and early intervention Support quicker decision making and therefore start the most appropriate treatment faster Reduce the need to visit hospital for services which could more easily be delivered locally