Statutory Instruments
National Health Service, England
Made
8th February 2010
Laid before Parliament
11th February 2010
Coming into force
1st April 2010
1.—(1) These Regulations may be cited as the National Health Service (Quality Accounts) Regulations 2010 and shall come into force on 1st April 2010.
(2) In these Regulations—
“the 2006 Act” means the National Health Service Act 2006;
“the 2009 Act” means the Health Act 2009;
“relevant document” means a document which must be published under section 8(1) or (3) of the 2009 Act.
(3) For the purposes of these Regulations—
(a)“NHS services”(3) does not include the services exempted by regulation 2;
(b)a body or person sub-contracts services where—
(i)in the case of a body listed in section 8(2) of the 2009 Act, they make arrangements for a person not listed in section 8(2) or (3) of that Act to provide those services; and
(ii)in the case of a person listed in section 8(3) of the 2009 Act, they make arrangements as mentioned in section 2(5)(a) of that Act for another person to provide those services; and
(c)references to NHS services provided by a body or person are a reference to—
(i)in the case of a body listed in section 8(2) of the 2009 Act, any NHS services provided by that body; and
(ii)in the case of a person listed in section 8(3) of the 2009 Act, any NHS services provided by that person as mentioned in section 2(4)(a) or (b) of the 2009 Act, or which that person assists in providing as mentioned in section 2(4)(b) of that Act.
2.—(1) Section 8(1) and (3) of the 2009 Act (duty of provider to publish information) does not apply to community health services and primary care services.
(2) For the purpose of this regulation—
“community health services” means any services which the Secretary of State may provide under section 3(1)(d) or (e) (Secretary of State’s duty as to provision of certain services) of, or paragraph 2 or 7A(4) of Schedule 1 (further provision about the Secretary of State and services etc.) to, the 2006 Act and any service which he has a duty to provide under paragraph 1 or 8 of that Schedule;
“primary care services” means NHS services—
provided under a contract, agreement or arrangement made under or by virtue of the following provisions of the 2006 Act—
section 83(2)(b) (arrangements made by PCTs for provision of primary medical services),
section 84(1) (general medical services contracts),
section 92 (other arrangements for the provision of primary medical services),
section 100(1) (general dental services contracts),
section 107(1) (other arrangements for the provision of primary dental services),
section 117(1) (general ophthalmic services contracts),
section 126(1) (pharmaceutical services),
section 127(1) (additional pharmaceutical services), or
Schedule 12 (local pharmaceutical services schemes); or
provided by a Primary Care Trust pursuant to section 83(2)(a) (primary medical services), 99(2) (primary dental services) or 115(4)(a) (primary ophthalmic services) of the 2006 Act.
3.—(1) Section 8(1) and (3) of the 2009 Act does not apply to a body or person in respect of a reporting period, where paragraph (2) applies.
(2) This paragraph applies to a body or person—
(a)which on the relevant date employed no more than fifty full time equivalent employees; and
(b)whose total income in relation to the reporting period under all contracts, agreements or arrangements with Primary Care Trusts and Strategic Health Authorities for the provision of NHS services, is not more than £130,000.
(3) The number of full time equivalent employees is calculated by dividing the total number of hours worked by all employees on the relevant date by the average standard contracted hours for the employing body or person for that period.
(4) For the purposes of this regulation, “the relevant date” in relation to a reporting period is—
(a)for any body or person not providing or subcontracting NHS services on 1st April, the first day in that period the body or person provides or sub-contracts NHS services; or
(b)in all other cases 1st April in that period.
4.—(1) A relevant document must consist of 4 parts as follows—
(a)Part 1, containing a statement summarising the provider’s(5) view of the quality of NHS services provided or sub-contracted by the provider during the reporting period and the statement referred to in regulation 6;
(b)Part 2, containing the information relevant to the quality of NHS services provided or sub-contracted by the provider during the reporting period which is prescribed for the purposes of section 8(1) or (3) of the 2009 Act by paragraph (2) and the information required by regulation 7;
(c)Part 3, containing other information relevant to the quality of NHS services provided or sub-contracted by the provider during the reporting period which is included in the document by the provider; and
(d)an annex containing the statements or copies of the statements referred to in regulation 5.
(2) The information prescribed for the purposes of section 8(1) or (3) of the 2009 Act is the information specified in column 1 of the table in the Schedule as presented in the form of the statements specified in column 2 of that table.
(3) The annex referred to in paragraph (1)(d) is not required in a draft relevant document supplied under regulations 8 to 10
5.—(1) The statements or copies of statements referred to in regulation 4(1)(d) are—
(a)a copy of any written statement provided under regulation 8(2)(b);
(b)a copy of any written statement relating to the content of the relevant document, which is no more than 500 words in length, provided prior to publication by an appropriate Local Involvement Network in response to the draft received pursuant to regulation 9;
(c)a copy of any written statement relating to the content of the relevant document, which is no more than 500 words in length, provided prior to publication in response to the draft received pursuant to regulation 10 by—
(i)the appropriate Overview and Scrutiny Committee, or
(ii)a joint overview and scrutiny committee carrying out the functions of that Overview and Scrutiny Committee under regulations under section 245 of the 2006 Act (joint overview and scrutiny committees etc.); and
(d)a statement by the provider setting out any changes made to the relevant document following receipt of such written statements.
(2) For the purpose of this regulation, “appropriate Local Involvement Network” and “appropriate Overview and Scrutiny Committee” have the same meaning as in regulations 9 and 10.
6.—(1) The relevant document must include a written statement, at the end of Part 1, signed by the responsible person for the provider that to the best of that person’s knowledge the information in the document is accurate.
(2) For the purpose of this regulation “the responsible person” means, where the provider is—
(a)a body corporate or partnership, the most senior employee;
(b)an unincorporated body of persons other than a partnership, a member of the provider’s governing body or the most senior employee of the provider; or
(c)an individual, that individual.
7.—(1) The relevant document must include, in Part 2, a description of the areas for improvement in the quality of NHS services that the provider intends to provide or sub-contract for the 12 months following the end of the reporting period.
(2) The description must include—
(a)at least three priorities for improvement;
(b)how progress to achieve the priorities identified in paragraph (a) will be monitored and measured by the provider; and
(c)how progress to achieve the priorities identified in paragraph (a) will be reported by the provider.
8.—(1) The provider must provide a copy of the draft relevant document to the commissioning Primary Care Trust or Strategic Health Authority within 30 days beginning with 1st April following the end of the reporting period.
(2) The commissioning Primary Care Trust or Strategic Health Authority must—
(a)take reasonable steps to check the accuracy of the information contained in the draft relevant document in relation to NHS services provided or sub-contracted by the provider under contracts, agreements or arrangements with that Primary Care Trust or Strategic Health Authority;
(b)provide a written statement, which is no longer than 500 words in length—
(i)confirming whether or not they consider the draft relevant document contains accurate information in relation to NHS services provided or sub-contracted by the provider under contracts, agreements or arrangements with that Primary Care Trust or Strategic Health Authority; and
(ii)containing any other information they consider relevant to the quality of NHS services provided or sub-contracted by the provider during the reporting period,
within 30 days beginning with the date the draft relevant document is received by the commissioning Primary Care Trust or Strategic Health Authority.
(3) For the purpose of this Regulation “commissioning Primary Care Trust or Strategic Health Authority” means—
(a)where the provider is a Primary Care Trust, the Strategic Health Authority for the area in which the Trust is established;
(b)where all the NHS services that the provider provides or sub-contracts are provided under contracts, agreements or arrangements with one Strategic Health Authority, but no Primary Care Trusts that Strategic Health Authority;
(c)where the provider provides or sub-contracts NHS services under contracts, agreements or arrangements with more than one Strategic Health Authority but no Primary Care Trusts, the Strategic Health Authority which is responsible for the largest number of patients to which the provider has provided NHS services during the reporting period;
(d)where all the NHS services that the provider provides or sub-contracts are provided under contracts, agreements or arrangements with one Primary Care Trust, that Primary Care Trust;
(e)where the provider provides or sub-contracts NHS services under contracts, agreements or arrangements with more than one Primary Care Trust and one or more of those Primary Care Trusts co-ordinates the commissioning of services by some or all of those Trusts (“a co-ordinating commissioning PCT”)—
(i)the co-ordinating commissioning Primary Care Trust, or
(ii)where there is more than one co-ordinating commissioning PCT—
(aa)the co-ordinating commissioning PCT in the Strategic Health Authority area in which the provider is located which is responsible for the largest number of patients to which the provider has provided or sub-contracted NHS services during the reporting period, or
(bb)if there is no co-ordinating commissioning PCT in the Strategic Health Authority area in which the provider is located the co-ordinating commissioning PCT which is responsible for the largest number of patients to which the provider has provided or sub-contracted NHS services during the reporting period; or
(f)where the provider provides or sub-contracts NHS services under contracts, agreements or arrangements to more than one Primary Care Trust and there is no co-ordinating commissioning PCT, the Primary Care Trust which is responsible for the largest number of patients to which the provider has provided NHS services during the reporting period.
(4) A Primary Care Trust is responsible for a patient if the Trust must secure the provision of services for the benefit of that patient by virtue of—
(a)directions given by the Secretary of State under section 7 of the 2006 Act; or
(b)arrangements by Primary Care Trusts for the exercise of functions under regulation 10 of the 2002 Regulations.
(5) A Strategic Health Authority is responsible for a patient if the authority must secure the provision of services for the benefit of that patient, by virtue of—
(a)directions given by the Secretary of State under section 7 of the 2006 Act; or
(b)arrangements by Strategic Health Authorities for the exercise of functions under regulation 9 of the 2002 Regulations.
(6) For the purpose of this Regulation “the 2002 Regulations” means the National Health Service (Functions of Strategic Health Authorities and Primary Care Trusts and Administration Arrangements) (England) Regulations 2002(6).
9.—(1) The provider must provide a copy of the draft relevant document to each appropriate Local Involvement Network within 30 days beginning with 1st April following the end of the reporting period.
(2) For the purpose of this Regulation—
“Local Involvement Network” means a person who in pursuance of arrangements under section 221 of the Local Government and Public Involvement in Health Act 2007(7) (health services and social services: local involvement networks) carries on activities specified in section 221(2) of that Act for a local authority area;
“appropriate Local Involvement Network” means a Local Involvement Network in the local authority area in which the provider has its registered or principal office located.
10.—(1) The provider must provide a copy of the draft relevant document to the appropriate Overview and Scrutiny Committee within 30 days beginning with 1st April following the end of the reporting period.
(2) For the purpose of this Regulation—
“Overview and Scrutiny Committee” means an overview and scrutiny committee of any local authority to which section 244 of the 2006 Act applies (functions of overview and scrutiny committees);
“the appropriate Overview and Scrutiny Committee” means the Overview and Scrutiny Committee of the local authority in whose area the provider has its registered or principal office located.
11. By 30th June following the end of the reporting period—
(a)the relevant document must be published by making the document electronically available on the NHS Choices website(8), or another website if that website is not available at the time of publication; and
(b)a copy of the relevant document must be sent to the Secretary of State.
Signed by authority of the Secretary of State for Health
Mike O’Brien
Minister of State
Department of Health
8th February 2010
Regulation 4
| Prescribed Information | Form of statement (words in italics indicate information which must be inserted by the provider) | |
|---|---|---|
| 1. | The number of different types of NHS services provided or sub-contracted by the provider during the reporting period, as determined in accordance with the categorisation of services— (a) specified under the contracts, agreements or arrangements under which those services are provided; or (b) in the case of an NHS body providing services other than under a contract, agreement or arrangements, adopted by the provider. | During [reporting period] the [name of provider] provided and/or sub-contracted [number] NHS services. |
| 1.1 | The number of NHS services identified under entry 1 in relation to which the provider has reviewed all data available to them on the quality of care provided during the reporting period. | The [name of provider] has reviewed all the data available to them on the quality of care in [number] of these NHS services. |
| 1.2 | The percentage the income generated by the NHS services reviewed by the provider, as identified under entry 1.1, represents of the total income for the provider for the reporting period under all contracts, agreements and arrangements held by the provider for the provision of, or sub-contracting of, NHS services. | The income generated by the NHS services reviewed in [reporting period] represents [number] per cent of the total income generated from the provision of NHS services by the [name of provider] for [reporting period]. |
| 2. | The number of national clinical audits(9) and national confidential enquiries(10) which collected data during the reporting period and which covered the NHS services that the provider provides or sub-contracts. | During [reporting period] [number] national clinical audits and [number] national confidential enquiries covered NHS services that [name of provider] provides. |
| 2.1. | The number, as a percentage, of national clinical audits and national confidential enquiries, identified under entry 2, that the provider participated in during the reporting period. | During that period [name of provider] participated in [number as a percentage] national clinical audits and [number as a percentage] national confidential enquiries of the national clinical audits and national confidential enquiries which it was eligible to participate in. |
| 2.2 | A list of the national clinical audits and national confidential enquires identified under entry 2 that the provider was eligible to participate in. | The national clinical audits and national confidential enquiries that [name of provider] was eligible to participate in during [reporting period] are as follows: [insert list]. |
| 2.3 | A list of the national clinical audits and national confidential enquiries, identified under entry 2.1, that the provider participated in. | The national clinical audits and national confidential enquiries that [name of provider] participated in during [reporting period] are as follows: [insert list]. |
| 2.4 | A list of each national clinical audit and national confidential enquiry that the provider participated in, and which data collection was completed for during the reporting period, alongside the number of cases submitted to each audit, as a percentage of the number required by the terms of the audit or enquiry. | The national clinical audits and national confidential enquires that [name of provider] participated in, and for which data collection was completed during [reporting period], are listed below alongside the number of cases submitted to each audit or enquiry as a percentage of the number of registered cases required by the terms of that audit or enquiry. [insert list and percentages] |
| 2.5 | The number of national clinical audit reports published during the reporting period that were reviewed by the provider during the reporting period. | The reports of [number] national clinical audits were reviewed by the provider in [reporting period] and [name of provider] intends to take the following actions to improve the quality of healthcare provided [description of actions]. The reports of [number] local clinical audits were reviewed by the provider in [reporting period] and [name of provider] intends to take the following actions to improve the quality of healthcare provided [description of actions]. |
| 2.6. | A description of the action the provider intends to take to improve the quality of healthcare following the review of reports identified under entry 2.5. | |
| 2.7. | The number of local clinical audit(11) reports that were reviewed by the provider during the reporting period. | |
| 2.8. | A description of the action the provider intends to take to improve the quality of healthcare following the review of reports identified under entry 2.7. | |
| 3. | The number of patients receiving NHS services provided or sub-contracted by the provider during the reporting period that were recruited during that period to participate in research approved by a research ethics committee within the National Research Ethics Service(12). | The number of patients receiving NHS services provided or sub-contracted by [name of provider] in [reporting period] that were recruited during that period to participate in research approved by a research ethics committee was [insert number]. |
| 4. | Whether or not a proportion of the provider’s income during the reporting period was conditional on achieving quality improvement and innovation goals under the Commissioning for Quality and Innovation payment framework(13) agreed between the provider and any person or body they have entered into a contract, agreement or arrangement with for the provision of NHS services. | Either: (a) A proportion of [name of provider] income in [reporting period] was conditional on achieving quality improvement and innovation goals agreed between [name of provider] and any person or body they entered into a contract, agreement or arrangement with for the provision of NHS services, through the Commissioning for Quality and Innovation payment framework. Further details of the agreed goals for [reporting period] and for the following 12 month period are available on request from [where further information can be obtained]. Or: (b) [name of provider] income in [reporting period] was not conditional on achieving quality improvement and innovation goals through the Commissioning for Quality and Innovation payment framework because [insert reason]. |
| 4.1 | If a proportion of the provider’s income during the reporting period was not conditional on achieving quality improvement and innovation goals through the Commissioning for Quality and Innovation payment framework the reason for this. | |
| 4.2. | If a proportion of the provider’s income during the reporting period was conditional on achieving quality improvement and innovation goals through the Commissioning for Quality and Innovation payment framework, where further details of the agreed goals for the reporting period and the following 12 month period can be obtained. | |
| 5. | Whether or not the provider is required to register with the Care Quality Commission (“CQC”) under section 10 of the Health and Social Care Act 2008(14). | Either: [name of provider] is required to register with the Care Quality Commission and its current registration status is [insert description]. [name of provider] has the following conditions on registration [insert conditions where applicable]. The Care Quality Commission (has/has not) taken enforcement action against [name of provider] during [reporting period]. Or: [name of provider] is not required to register with the Care Quality Commission. |
| 5.1. | If the provider is required to register with the CQC— (a) whether at end of the reporting period the provider is— (i) registered with the CQC with no conditions attached to registration, (ii) registered with the CQC with conditions attached to registration, or (iii) not registered with the CQC; (b) if the provider’s registration with the CQC is subject to conditions what those conditions are; and (c) whether the Care Quality Commission has taken enforcement action against the provider during the reporting period. | |
| 6. | Whether or not the provider is subject to periodic reviews by the CQC under section 46 of the Health and Social Care Act 2008. | Either: [name of provider] is subject to periodic reviews by the Care Quality Commission and the last review was on [date]. The CQC’s assessment of the [name of provider] following that review was [insert assessment]. [name of provider] intends to take the following action to address the points made in the CQC’s assessment [insert details of action]. [name of provider] has made the following progress by 31st March [insert year] in taking such action [insert description of progress] Or: [name of provider] is not subject to periodic reviews by the CQC. |
| 6.1. | If the provider is subject to periodic reviews by the CQC— (a) the date of the most recent review, (b) the assessment made by the CQC following the review(15), (c) the action the provider intends to take to address the points made in that assessment by the CQC, and (d) any progress the provider has made in taking the action identified under paragraph (c) prior to the end of the reporting period. | |
| 7. | Whether or not the provider has taken part in any special reviews or investigations by the CQC under section 48 of the Health and Social Care Act 2008 during the reporting period. | Either: [name of provider] has participated in special reviews or investigations by the Care Quality Commission relating to the following areas during [reporting period] [insert details of special reviews and/or investigations]. [name of provider] intends to take the following action to address the conclusions or requirements reported by the CQC [insert details of action]. [name of provider] has made the following progress by 31st March [insert year] in taking such action [insert description of progress]. Or: [name of provider] has not participated in any special reviews or investigations by the CQC during the reporting period. |
| 7.1. | If the provider has participated in a special review or investigation by the CQC— (a) the subject matter of any review or investigation, (b) the conclusions or requirements reported by the CQC following any review or investigation, (c) the action the provider intends to take to address the conclusions or requirements reported by the CQC, and (d) any progress the provider has made in taking the action identified under paragraph (c) prior to the end of the reporting period. | |
| 8. | Whether or not during the reporting period the provider submitted records to the Secondary Uses service(16) for inclusion in the Hospital Episode Statistics(17) which are included in the latest version of those Statistics published prior to publication of the relevant document by the provider. | Either: [name of provider] submitted records during [reporting period] to the Secondary Uses service for inclusion in the Hospital Episode Statistics which are included in the latest published data. The percentage of records in the published data:
|
| 8.1. | If the provider submitted records to the Secondary Uses service for inclusion in the Hospital Episodes Statistics which are included in the latest published data: (a) the percentage of records relating to admitted patient care which include the patient’s— (i) valid NHS number; and (ii) General Medical Practice Code; (b) the percentage of records relating to out patient care which included the patient’s— (i) valid NHS number; and (ii) General Medical Practice Code; (c) the percentage of records relating to accident and emergency care which included the patient’s— (i) valid NHS number; and (ii) General Medical Practice Code. | |
| 9. | The provider’s score for the reporting period, as a percentage, for Information Quality and Records Management, assessed using the Information Governance Toolkit published by the Audit Commission(18) | [name of provider] score for [reporting period] for Information Quality and Records Management, assessed using the Information Governance Toolkit was [percentage]. |
| 10. | Whether or not the provider was subject to the Payment by Results clinical coding audit at any time during the reporting period by the Audit Commission(19). | Either: [name of provider] was subject to the Payment by Results clinical coding audit during the reporting period by the Audit Commission and the error rates reported in the latest published audit for that period for diagnoses and treatment coding (clinical coding) were [percentages]. Or: [name of provider] was not subject to the Payment by Results clinical coding audit during [reporting period] by the Audit Commission. |
| 10.1 | If the provider was subject to the Payment by Results clinical coding audit by the Audit Commission at any time during the reporting period, the error rates, as percentages, for clinical diagnosis coding and clinical treatment coding reported by the Audit Commission in any audit published in relation to the provider for the reporting period prior to publication of the relevant document by the provider. | |
(This note is not part of the Order)
These Regulations make provision about quality accounts. Under section 8 of the Health Act 2009 individuals or bodies who provide, or make arrangements for others to provide, NHS services must publish a document each year which sets out information relation to the quality of those services (a “quality account”).
Regulation 2 makes exemptions from the requirement to produce quality accounts for community health services and primary care services. Regulation 3 also exempts providers with small numbers of staff and a relatively low level of income derived from the provision of NHS services.
Regulations 4 to 7 and the Schedule set out the prescribed information, general content and form of quality accounts. This includes provision requiring the accounts to be in four parts with Part 1 containing a general statement about the quality of NHS services, Part 2 containing prescribed information, Part 3 containing other information about the quality of NHS services provided and the fourth part comprising an annex containing statements of assurance under regulation 8. The Schedule sets out the detail of the prescribed information and the form the information should take. Regulation 6 ensures that a senior employee verifies the accuracy of the account. Regulation 7 requires information to be included about the provider’s priorities for improvement.
Regulation 8 makes provision for the draft accounts to be checked and commented on prior to publication by a Primary Care Trust (“PCT”) or Strategic Health Authority (“SHA”). Where the provider provides NHS services to a number of PCTs or SHAs provision is made to identify one body that the accounts must be sent to. Any statement provided by the PCT or SHA must be included in the published account (regulation 4(1)(d) and 5).
Regulations 9 and 10 require the accounts to be sent, prior to publication, to any Local Involvement Network (“LINK”) and Overview and Scrutiny Committee (“OSC”) in the local authority area where the provider is located. If any LINK or OSC provides a statement about the quality account which is less than 500 words provision is made to ensure that the statement is included in the published account (regulation 5).
Regulation 11 requires the quality account to be published by 30th June each year by making the document available on the NHS Choices website, or other website if this is not available. A copy of the account must also be sent to the Secretary of State.
A full impact assessment of the effect that this instrument will have on the costs of business, the voluntary sector and public sector is available from the Department of Health website (http://www.dh.gov.uk) and is annexed to the Explanatory Memorandum which is available alongside the instrument on the OPSI website.
2006 c. 41; the powers of the Secretary of State under this Act as exercised in these Regulations are exercisable only in relation to England, by virtue of section 271 of that Act. See section 275(1) for the definition of “regulations”.
“NHS services” otherwise has the meaning given in section 2(7) of the Health Act 2009; see section 8(6) of that Act.
Paragraph 7A was inserted by section 143 of the Health and Social Care Act 2008 (c. 14).
See section 9(1) of the Health Act 2009 for the meaning of “the provider”.
S.I. 2002/2375. Regulation 9 was amended by S.I. 2003/1497 and S.I.2004/865. Regulation 10 was amended by S.I. 2003/1497, S.I. 2004/865, S.I.2008/3166 and S.I. 2009/462.
See http://nww.connectingforhealth.nhs.uk/susreporting/dataquality/registration.