CARE QUALITY COMMISSION
The Care Quality Commission (CQC) regulates and inspects health and social care services in England. It has a range of enforcement powers that can be used to protect patients and service users from the risk of harm. However, the CQC does not investigate complaints for the purpose of resolving them (except for those regarding the Mental Health Act). The providers are legally responsible for investigating complaints about their service.
Complaints by the Public About NHS Services
The NHS complaints procedure covers complaints made by a person about any matter connected with the provision of NHS services by NHS organisations or primary care practitioners: general practitioners (GPs), dentists, opticians and pharmacists. The procedure also covers services provided overseas or by the private sector where the NHS has paid for them.
If the complainant is not satisfied with the response the matter can be taken to the Parliamentary and Health Service Ombudsman or the Local Government Ombudsman.
Pharmacy Contract Requirement
Under the provisions of the NHS (Pharmaceutical and Local Pharmaceutical Services) Regulations 20131 pharmacy contractors are required to have in place arrangements for dealing with complaints about any matter connected with its provision of pharmaceutical services.
According to paragraph 34 of Schedule 4 to the 2013 Regulations:
a pharmacist shall have in place arrangements which comply with the requirements of the Local Authority Social Services and National Health Service Complaints (England) Regulations 2009(c), for the handling and consideration of any complaints made on or after 1st April 2009.
There is a similar requirement in Schedule 2 to the NHS (Local Pharmaceutical Services (LPS) etc.) Regulations 2006.2
The regulations also impose a duty on the NHS Commissioning Board (CB) to ensure that pharmacy contractors have those arrangements in place.
There is a similar requirement for each of the NHS primary care professions.
Power to Make Regulations
Section 113 of the NHS (Community Health and Standards) Act 2003 now states:
(1) The Secretary of State may by regulations make provision about the handling and consideration of complaints made under the regulations about:
(a) the exercise of any of the functions of an English NHS body or a cross- border SHA;
(b) the provision of health care by or for such a body;
(c) the provision of services by such a body or any other person in pursuance of arrangements made by the body under section 75 of the National Health Service Act 2006 or section 33 of the National Health Service (Wales) Act 2006 in relation to the exercise of the health-related functions of a local authority.
(d) anything done by the National Health Service Commissioning Board or a clinical commissioning group in pursuance of arrangements made under section 7A of the National Health Service Act 2006.
The Complaints Regulations
The actual arrangements are set out in the Local Authority Social Services and NHS Complaints (England) Regulations 2009, SI No. 309 (the ‘Complaints Regulations’).3 They apply to England and Wales.
Regulation 3 of the Complaints Regulations requires ‘responsible bodies’
to make arrangements for the handling and consideration of complaints.
Definitions
‘Responsible bodies’ are defined (in Regulation 2) to mean local authorities, NHS bodies and certain other providers who provide services under arrange- ments with NHS bodies.
Pharmacies are included by the definitions in Regulation 2, which states:
“independent provider” means a person or body who:
(a) provides health care in England under arrangements made with an NHS body;
and
(b) is not an NHS body or primary care provider;
“responsible body” means a local authority, NHS body, primary care provider or independent provider;
“primary care provider” means a person or body who:
(f) provides pharmaceutical services in accordance with arrangements made under section 126 of the 2006 Act;
(g) provides additional pharmaceutical services in accordance with arrangements made under section 127 of the 2006 Act; or
(h) provides local pharmaceutical services in accordance with an LPS scheme established under paragraph 1 of Schedule 12 to the 2006 Act.
Purpose of the Arrangements The arrangements ensure:
● complaints are properly and efficiently dealt with
● complainants are treated with respect and courtesy
● complainants receive, so far as is reasonably practical:
● assistance in understanding the process
● advice on where they may obtain assistance
● a timely and appropriate response
● complainants are informed about the outcome and
● further action is taken if necessary. (Regulation 3 Complaints Regulations 2009)
Responsible Person
The pharmacy contractor is required to designate a responsible person, to be responsible for ensuring compliance with the arrangements and in particu- lar ensuring that action is taken, if necessary, in the light of the outcome of a complaint.
The responsible person is required to be the chief executive officer of the company, or, if the pharmacy contractor is a partnership firm, must be one of the partners. In the case of a pharmacy business operated by a sole proprietor, the responsible person must be that sole proprietor.
The functions of the responsible person may be performed by any per- son authorised by the pharmacy contractor to act on behalf of the responsible person – but ultimately, the responsibility for ensuring compliance remains with the chief executive, partner or sole proprietor as appropriate. (Regulation 4 Complaints Regulations 2009)
Complaints Manager
The pharmacy contractor is also required to designate a complaints manager, to be responsible for managing the procedures for handling and considering complaints in accordance with the arrangements.
The complaints manager need not be an employee. He could be the same person as the responsible person or could even be a complaints manager desig- nated by another pharmacy contractor.
The functions of the complaints manager may be performed by any person authorised by the responsible body to act on behalf of the complaints man- ager. (Regulation 4 Complaints Regulations 2009)
The complaints procedure is intended only to resolve complaints. It does not investigate disciplinary matters or apportion blame.
The arrangements for handling complaints must be in writing and a copy must be given, free of charge, to any person who makes a request for one.
The pharmacy contractor is responsible for compliance with the regulations and must designate a ‘complaints manager’, to manage the procedures for han- dling and considering complaints. A deputy complaints manager may also be authorised, to act in the absence of the complaints manager.
Who Can Make a Complaint A complaint may be made by:
(a) a person who receives or has received services from a responsible body; or (b) a person who is affected, or likely to be affected, by the action, omission
or decision of the pharmacy concerned.
A complaint can also be made by a representative of a person who:
● has died
● is a child under the age of 18 years
● is unable to make a complaint because of a physical incapacity or lack of mental capacity
● has requested the representative to act on their behalf.
Where the complaint is made on behalf of a child or a person lacking capac- ity, the pharmacy contractor must not consider the complaint unless satisfied that there are reasonable grounds for the complaint being made by the representative instead of the child or person lacking capacity.
The pharmacy contractor must also be satisfied that the representative is conducting the complaint in the best interests of the person affected.
If the pharmacy contractor does not believe there are reasonable grounds for the representative making the complaint, or that the complaint is in the best interests of the person, the pharmacy must notify the representative in writing, with reasons. (Regulation 5 Complaints Regulations 2009)
Duty to Handle Complaints
A pharmacy contractor has a duty to handle complaints under the regulations only about the pharmaceutical services provided under arrangements with an NHS body.
Complaints that Are Not Required to Be Dealt Formally
Some complaints are not required to be dealt with under the NHS arrangements:
● A complaint which is made orally and is resolved to the complainant’s sat- isfaction on the next working day.
● A complaint involving the same subject matter as that of a previously resolved oral complaint.
● A complaint by a ‘responsible body’ (e.g., another pharmacy contractor) although where the complaint has simply been forwarded by one of these bodies, the pharmacy contractor is under a duty to deal with the complaint.
● A complaint which has previously been investigated under the current regulations.
● A complaint which is being or has been investigated by a Health Service Commissioner under the Health Service Commissioners Act 1993.
● A complaint arising out of the alleged failure by the pharmacy contractor to comply with a request for information under the Freedom of Information Act 2000. (Regulation 8 Complaints Regulations 2009)
Time Limits for Making a Complaint
A complaint must be made no later than 12 months after the date on which the matter occurred, or if later, the date on which the matter came to the notice of the complainant.
A complaint may be made orally, in writing or electronically. The phar- macy contractor must make a written record of an oral complaint and provide a copy of this record to the complainant.
The pharmacy contractor must acknowledge the complaint not later than 3 working days after the date on which the complaint is received. The acknowl- edgement may be made orally or in writing.
Working days under these regulations means Mondays to Fridays which are not Christmas Day, Good Friday or a bank holiday. (Regulation 13 Complaints Regulations 2009)
At the time it acknowledges the complaint, the pharmacy must offer to dis- cuss with the complainant, at an agreed time:
(a) the manner in which the complaint is to be handled; and (b) the period (‘the response period’) within which:
(i) the investigation of the complaint is likely to be completed; and (ii) the response is likely to be sent to the complainant.
If the complainant does not accept the offer of a discussion, the responsible body must itself:
(a) determine the response period; and
(b) notify the complainant in writing of that period.
The pharmacy contractor has up to 6 months in which to make the response to the complainant.
Complaints Made to the NHS Commissioning Board
Complaints may be made to the Board about the provision of services by a primary care provider under arrangements made between it and the Board. (Regulation 7 Complaints Regulations 2009)
EXTRACT FROM COMPLAINTS REGULATIONS
Responsibility for Complaints Arrangements 4.—(1) Each responsible body must designate:
(a) a person, in these Regulations referred to as a responsible person, to be responsible for ensuring compliance with the arrangements made under these Regulations, and in particular ensuring that action is taken if necessary in the light of the outcome of a complaint; and
(b) a person, in these Regulations referred to as a complaints manager, to be responsible for managing the procedures for handling and considering complaints in accordance with the arrangements made under these Regulations.
(4) The responsible person is to be:
(a) in the case of a local authority or NHS body, the person who acts as the chief executive officer of the authority or body;
(b) in the case of any other responsible body, the person who acts as the chief executive officer of the body or, if none:
(i) the person who is the sole proprietor of the responsible body;
(ii) where the responsible body is a partnership, a partner; or (iii) in any other case, a director of the responsible body, or a person who is responsible for managing the responsible body.
(5) The complaints manager may be:
(a) a person who is not an employee of the responsible body;
(b) the same person as the responsible person;
(c) a complaints manager designated by another responsible body under paragraph (1)(b).
Persons who May Make Complaints 5.—(1) A complaint may be made by:
(a) a person who receives or has received services from a responsible body; or (b) a person who is affected, or likely to be affected, by the action, omission or decision of the responsible body which is the subject of the complaint.
(2) A complaint may be made by a person (in this regulation referred to as a representative) acting on behalf of a person mentioned in paragraph (1) who:
(a) has died;
(b) is a child;
(c) is unable to make the complaint themselves because of:
(i) physical incapacity; or
(ii) lack of capacity within the meaning of the Mental Capacity Act 2005(a); or
(d) has requested the representative to act on their behalf.
(3) Where a representative makes a complaint on behalf of a child, the responsible body to which the complaint is made:
(a) must not consider the complaint unless it is satisfied that there are reasonable grounds for the complaint being made by a representative instead of the child; and
(b) if it is not so satisfied, must notify the representative in writing, and state the reason for its decision.
(4) This paragraph applies where:
(a) a representative makes a complaint on behalf of:
(i) a child; or
(ii) a person who lacks capacity within the meaning of the Mental Capacity Act 2005; and
(b) the responsible body to which the complaint is made is satisfied that the representative is not conducting the complaint in the best interests of the person on whose behalf the complaint is made.
(5) Where paragraph (4) applies:
(a) the complaint must not be considered or further considered under these Regulations; and
(b) the responsible body must notify the representative in writing, and state the reason for its decision.
(6) In these Regulations any reference to a complainant includes a reference to a representative.
Duty to Handle Complaints
6.—(1) This regulation applies to a complaint made on or after 1st April 2009 in accordance with these Regulations to:
(b) an NHS body about:
(i) the exercise of its functions; or
(ii) the exercise of any function discharged or to be discharged by it under arrangements made between it and a local authority under section 75 of the 2006 Act in relation to the exercise of the health- related functions of a local authority;
(c) a primary care provider about the provision of services by it under arrangements with an NHS body; or
(d) an independent provider about the provision of services by it under arrangements with an NHS body.
(4) Where this regulation applies to a complaint, the responsible body to which the complaint is made must handle the complaint in accordance with these Regulations.
Complaints about the Provision of Health Services 7.—(1) This regulation applies to a complaint which is:
(a) made to the NHS CB in accordance with these Regulations on or after 1st April 2009;
(b) about the services provided by a provider under arrangements with the Board; and
(c) not specified in regulation 8(1).
(2) In this regulation, “provider” means an NHS body, primary care provider or independent provider.
(3) Where a Primary Care Trust receives a complaint to which this regulation applies:
(a) the Primary Care Trust must ask the complainant whether the complainant consents to details of the complaint being sent to the provider; and
(b) if the complainant so consents, the Primary Care Trust must as soon as reasonably practicable send details of the complaint to the provider.
(4) If the Primary Care Trust considers that it is appropriate for the Primary Care Trust to deal with the complaint:
(a) it must so notify the complainant and the provider; and
(b) it must continue to handle the complaint in accordance with these Regulations.
(5) If the Primary Care Trust considers that it is more appropriate for the complaint to be dealt with by the provider, and the complainant consents:
(a) the Primary Care Trust must so notify the complainant and the provider;
(b) when the provider receives the notification given to it under sub- paragraph (a):
(i) the provider must handle the complaint in accordance with these Regulations; and
(ii) the complainant is deemed to have made the complaint to the provider under these Regulations.
SANCTIONS FOR BREACH OF TERMS OF SERVICE
The 2013 Regulations set out various procedures which are available to the NHS CB should it find that a pharmacy contractor has breached the terms of service (TOS).
Regulation 70(1) Where an NHS chemist (C) breaches a term of service and the breach is capable of remedy, the NHS CB may by a notice (‘a remedial notice’) require C to remedy the breach.
The NHS CB may also make a withholding of remuneration.
Regulation 71(1) Where an NHS chemist (C) breaches a term of service and the breach is not capable of remedy, the Primary Care Trust (PCT1) with which C has the arrangements to provide the pharmaceutical services to which the breach relates may by a notice (‘a breach notice’) require C not to repeat the breach.
Again the NHS CB may make a withholding of remuneration.
Any withholding is subject to the following:
(a) the NHS CB is satisfied that the breach is, or was, without good cause;
(b) the amount withheld is justifiable and proportionate, having regard to the nature and seriousness of the breach and the reasons for it;
(c) the NHS CB includes in the notice its reasons for both the decision to withhold remuneration and the amounts.
Removal from the Pharmaceutical List
The NHS CB may remove a contractor from the pharmaceutical list if the contractor:
(a) fails to take the steps set out in a remedial notice and the Board is satisfied that it is necessary to remove the contractor from the pharmaceutical list, or remove the listing of particular listed chemist premises:
(i) to protect the safety of any persons to whom the contractor may pro- vide pharmaceutical services; or
(ii) to protect the NHS CB from material financial loss; or (b) has breached the TOS, and:
(i) the contractor has repeatedly been issued with remedial notices or breach notices;
(ii) previously been issued with a remedial notice or breach notice and the Board is satisfied that the contractor is likely to persist in breaching the TOS without good cause.
The NHS CB may only remove:
(a) particular chemist premises from the listing if the relevant breaches all relate to those particular chemist premises; or
(b) the contractor from its pharmaceutical list if the relevant breaches all relate to listed chemist premises which are that contractor’s only listed premises.
The NHS CB may only remove the contractor, or chemist premises listed in relation to that contractor, from its pharmaceutical list under paragraph (1) if:
(a) the removal is justifiable and proportionate, having regard to the nature and seriousness of the breaches (or likely breaches) and the reasons for the same; and
(b) The NHS CB, when it notifies the contractor of the decision, includes in the notice its duly justified reasons for the decision.
NHS Fitness to Practice Procedures
The Department of Health issued guidance to Primary Care Trusts (PCTs) on the Fitness to Practise procedures in July 2005. (Delivering quality in pri- mary care: PCT management of primary care practitioners’ lists – community
chemist contractors/bodies corporate.) This Guidance has not been updated since the 2012 Regulations came into law.
The Fitness to Practice provisions in the 2013 Regulations permit the NHS CB to defer or reject an application for inclusion in the pharmaceutical list and also provide the power to remove a pharmacy contractor from the pharmaceutical list.
Mandatory Refusal of Application for Contract
Regulation 33 of the 2013 Regulations sets out circumstances where the NHS CB must refuse to grant an application on fitness grounds.
These are:
(a) where the applicant, a director or a superintendent:
● has been convicted in the United Kingdom of murder
● has been sentenced to a term of imprisonment of over 6 months for an offence committed after 1 April 2005.
(b) where the applicant:
● is subject to national disqualification
● has not updated his application following an investigation or hearing set out in Regulation 26(4).
Discretionary Refusal
The NHS CB has discretion to refuse applications on grounds of suitability, fraud or efficiency.
The Board should take into account issues such as:
● nature of offence or incident
● timescale
● number of offences or incidents
● any action taken or penalties imposed
● relevance to provision of NHS pharmaceutical services
● whether any offence was a ‘sexual offence’
● decisions of other PCTs.
REMOVAL OR SUSPENSION OF PRACTITIONERS
The Board may and in some cases must suspend and remove practitioners from the relevant lists on the grounds of inefficiency, fraud or unsuitability.
They may also impose conditions on continued presence on the list.
The criteria are similar to those relevant to decisions on applications.
Where a director or superintendent of a limited company has been convicted of murder or has been sentenced to more than 6 months imprisonment, the lim- ited company has 28 days to remove that person from office or the entire limited company will be removed from the list.