SOP reference CCSD/SOP/COMPLAINTS Date approved February 2015

Author(s) Audrey Raymond/Betty Next review due February 2016

Lamport
Reviewed by SMT Owner CEO

Approved by Director of Resources Distribution HTA Staff and Members

Process for handling complaints about maladministration

Abstract

1. This Standard Operating Procedure (SOP) outlines the informal and formal
resolution processes for handling complaints made by individuals or
organisations about alleged maladministration and inappropriate conduct by
HTA staff or Members.

2. Complaints may be made by any external person or organisation and can be

received by any member of HTA staff or the Authority.

Purpose

3. The purpose of this SOP is to explain to HTA staff and Members the procedure
for logging and resolving complaints.

Outcome

4. We will use a consistent process for resolving complaints within prescribed

timeframes and improve our reporting and management review of the quantity
of complaints received, outcome of complaints and lessons learned.

Scope and definition of complaint

What is a complaint?

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5. An enquiry is a complaint if it is an allegation against the HTA rather than any

other organisation, about the way we have exercised, or failed to exercise, our
functions or provided a service. A complaint can include allegations about:

• unprofessional behaviour, negligence, or failure to carry out our statutory

functions

• provision of an inadequate level of service

• inappropriate behaviour or conduct, or incompetence of HTA staff or

Members

• failure to provide a service

• delay that could have been avoided

• failing to follow correct or appropriate procedures

• unfairness, bias or prejudice

• giving advice which is misleading or inadequate

• refusing to answer reasonable questions

• rudeness and not apologising for mistakes

• not putting things right when something has gone wrong.

6. A complaint must be received within six months of the issue giving rise to the
allegation, or the complainant becoming aware of the incident, if later.

7. A complaint can be made by any person or organisation directly affected or

concerned by the alleged maladministration or poor service. A complaint may
be made by a third party with the written authorisation of the person or
organisation affected. We will not investigate any complaint from an
anonymous source.

8. Complaints referred to the Complaints Officer should be made in writing;

exceptionally, if a complainant cannot do this, an HTA staff member may take
details on their behalf.

9. A complaint can be received by any member of HTA staff or the Authority.

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What is not a complaint?

10. This SOP does not consider the following examples as being complaints as
defined within the HTA Complaints policy:

• complaints about organisations within the HTA’s regulatory remit

• the HTA’s relationship between or with its employees

• contractual or commercial disputes involving the HTA

• matters that have become the subject of legal proceedings or are under
police investigation

• complaints which have been investigated or are under investigation by the

Ombudsman

• policy and other decisions made by the HTA under its statutory remit.
Examples include:

• setting licence fee levels

o we may receive complaints about the fees being too high, if this is
the case we would follow the procedure for enquiries; logging it in
CRM and assigning to a Regulation Manager in the first instance
who will check their activity data supplied.

• interpreting the Human Tissue Act

• granting or refusing a licence

• approving or refusing to approve the donation of an organ

• third party allegations (including whistle blowing) against organisations

within the HTA’s regulatory remit of non-compliance with the Human
Tissue Act 2004 (the Act) or the HTA’s regulatory standards.

Principles applied when handling complaints

11. The principles we will apply when investigating complaints about allegations of
maladministration or inappropriate conduct by the HTA staff or Members
include:

• defining a complaint as any expression of dissatisfaction with

administration or service

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• publishing clear and transparent instructions to staff for reporting

complaints

• trying to resolve complaints informally by responding appropriately on initial

receipt, including providing an apology where required

• where complaints cannot be resolved, referring the complainant to the

Complaints Officer who will arrange for an investigation at regular intervals

• informing complainants about the progress of the investigation at regular

intervals

• communicating the outcome of any investigation as quickly as possible

both to the complainant and to any individual against whom the complaint
was made

• handling complaints promptly and efficiently and in confidence

• if the complainant takes their complaint to the media, then the HTA
reserves the right to respond to any media enquiries

• process of investigation is open and transparent and details of the

concerns raised will be shared with any individual who is the subject of the
allegations wherever possible and appropriate

• complaints upheld provide an opportunity for the HTA to learn lessons and
improve services

• providing statistical and qualitative information to the Authority on the

receipt, and outcome of complaints and lessons learned.

Related documents

• HTA-POL-059 Policy for handling complaints about maladministration and

inappropriate conduct.

Details of procedure

12. The details of procedure are described in a series of events set out in the table
below.

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Event 1: HTA staff receives an enquiry that is a complaint

(Informal complaints process triggered as below:)

Task Decision Notes

Step 1 Obtain details of the complaint Go to Step 2

• Name and contact details of the complainant (and

the individual affected if the complainant is acting
on behalf of someone else)
• Facts of the incident that triggered the complaint
including, if relevant, location, date, time
• Who from the HTA is involved (staff or Member?)
• What would resolution look like for the
complainant?

Step 2 Is the complaint valid? Yes – go to Step 3

No – go to Step 4

Step 3 Apologise Go to Step 5

• apologise, acknowledge the failure, accept

responsibility for the HTA
• explain why the failure happened and express
regret
• where appropriate, take steps to put things
right for the complainant and others who have
been affected in a similar way
• provide an undertaking to improve procedures
or systems, if appropriate

Step 4 Explain the HTA’s position Go to Step 5

• explain why you think the complaint is not valid

• explain how you came to your decision

Step 5 Record the complaint in CRM as a case on the

first day it is received (which should include all
information gathered at Step 1 and the resolution
conveyed at Step 3 or 4) and notify the
Complaints Officer that a complaint has been
logged in CRM and resolved.

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Step 6 Complaints Officer then logs the complaint as End of process

resolved in the Complaints Log

Event 2: Complaints Officer receives a written enquiry that is a complaint

(Formal complaints process triggered)

Task Decision Notes

Step 7 Complaints Officer registers the complaint in Go to Step 8
the Complaints log (saved under Quality
Management in IMPACT) and creates a case for
it within CRM.

Step 8 Complaints Officer acknowledges the Go to Step 9

complaint in writing within 3 working days

Step 9 Complaints Officer assigns the complaint to Go to Step 10

the relevant team to investigate

• If the complaint is about:

• Chair – a Member nominated by CE to
investigate
• Member – Chair to investigate
• CE – Chair to investigate
• HTA staff – line manager to investigate

Event 3: Nominated individual is allocated complaint to investigate (allocation

of complaint to be carried out within CRM)

Task Decision Notes

Step 10 Nominated individual gathers information and
assesses the complaint

• Name and contact details of the complainant (and

the individual affected if the complainant is acting
on behalf of someone else)
• Facts of the incident that triggered the complaint
including, if relevant, location, date, time
• Who from the HTA is involved (staff or Member?)
• Do we know what resolution would look like for

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the complainant?
• Set out in a report how the complaint was
investigated, what the findings are and the
recommendations for action

Step 11 Is the complaint valid? Yes – go to Step

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No – go to Step 4

Step 12 Draft a letter to the complainant and forward it Go to Step 13

and the investigation report to the Complaints
Officer to approve and dispatch

• The letter should:

• apologise, acknowledge the failure, accept
responsibility for the HTA
• explain why the failure happened and express
regret
• where appropriate, take steps to put things
right for the complainant and others who have
been affected in a similar way
• provide an undertaking to improve procedures or
systems
• describe how the complainant can take the
complaint forward if they are not satisfied with the
HTA’s decision
“We consider your complaint is now resolved. However, if
you are not satisfied with our decision then you can write to
our Complaints Officer and seek a review. Our Complaints
Officer will acknowledge your complaint within 3 working
days and provide you with the outcome of the review within
20 working days of receipt of your request. You can send
your request for review to enquiries@hta.gov.uk.”

Step 13 Complaints Officer reviews, approves and Go to Step 14

sends the letter to the complainant and
copies it to the investigating person

Step 14 Complaints Officer enters the resolution in End of process

the Complaints log and ensures that the case
within CRM is updated (resolved and closed).

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Event 4: Complaints Officer receives a request for a review of a complaint

decision

Task Decision Notes

New case
Step 15 Complaints Officer registers the request for a Go to Step 16 can be
review in the Complaints log (saved under opened in
CRM
Quality Management in IMPACT) which can
be linked
to original
complaint
Step 16 Complaints Officer acknowledges the request Go to Step 17
for a review in writing within 3 working days

Step 17 Complaints Officer decides if the request Yes – go to Step

includes new information 18
No – go to Step 22

Step 18 Complaints Officer returns the complaint to Go to Step 19

the original investigator to review the
decision in light of the new information

Step 19 Original investigator reviews the complaint in Go to Step 20

light of the new information

Step 20 Is the decision the same as the initial Yes – go to Step

decision? 21
No – go to Step 10

Step 21 Draft a letter to the complainant explaining Go to Step 30

that you have reviewed your decision in light
of the new information, repeat the decision
that was reached at Step 11 or 12, include the
information below and forward it to the
Complaints Officer to approve and dispatch

“We consider your complaint is now resolved. If you are

not satisfied with our decision then you can write to our
Complaints Officer and seek a review. Our Complaints
Officer will acknowledge your complaint within 3 working
days and provide you with the outcome of the review within
20 working days of receipt of your request. You can send
your request for review to enquiries@hta.gov.uk.”

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Step 22 Is this the first time the complainant has Yes – go to Step
asked the HTA to review without providing 23
any new information? No – go to Step 29

Step 23 Complaints Officer assigns the complaint to Go to Step 24

the relevant team to review

• If the complaint is about:

• Chair – a different member nominated by CE to
review
• Member – CE to review
• CE – Member nominated by Chair to review
• HTA staff – relevant Director to review
• The reviewer cannot be the same person who
undertook the original investigation

Step 24 Reviewer reviews the complaint handling to Go to Step 25

ensure HTA’s policy and SOP was followed

Step 25 Was due process followed? Yes – go to Step

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No – go to Step 27

Step 26 Draft a letter to the complainant explaining we Go to Step 30

have reviewed the HTA’s handling of the
complaint to ensure that due process was
followed and believe it was, include the
information below and forward it to the
Complaints Officer to approve and dispatch

“If you are still not satisfied with our decision then you have
the right to write to the Parliamentary and Health Service
Ombudsman and request a review of our decision. The
Ombudsman carries out independent investigations into
complaints about alleged unfair or improper actions or poor
service by UK government departments and their agencies,
including the Human Tissue Authority. The instructions for

submitting a complaint to the Ombudsman are available on

their website www.ombudsman.org.uk.”

Step 27 Draft a letter to the complainant, explaining Go to Step 28

we have reviewed the HTA’s handling of the
complaint to ensure that due process was

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followed and believe it was not investigated

properly and their complaint will be
investigated again, and then forward the draft
letter to the Complaints Officer to approve
and dispatch

Step 28 Complaints Officer reviews, approves and Go to Step 9

sends the letter to the complainant and
assigns the complaint for re-investigation
taking into consideration Reviewer’s findings

Step 29 Draft a letter to the complainant, explain that Go to Step 30 (i)

the HTA has already reviewed its handling of
the complaint to ensure due process was
followed and state the following and forward
it to the Complaints Officer to approve and
dispatch

“We consider our investigation process is complete. As

stated in our previous correspondence, you have the right
to write to the Parliamentary and Health Service
Ombudsman and request a review of our decision. The
Ombudsman carries out independent investigations into
complaints about alleged unfair or improper actions or poor
service by UK government departments and their agencies,
including the Human Tissue Authority. The instructions for
submitting a complaint to the Ombudsman are available on
their website www.ombudsman.org.uk.”

Step 30 Complaints Officer reviews, approves and Go to Step 31

sends the letter to the complainant and
copies it to the Investigator or Reviewer

Step 31 Complaints Officer logs the resolution in the End of process

Complaints log and updates case in CRM
(resolve/close).

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Guidance and Explanatory notes

(i) Refer to paragraphs 20 to 24 of the Policy for handling complaints about

maladministration and inappropriate conduct for guidance about how to
handle “Persistent complainants”.

Monitoring and Reporting

13. All complaints information will be centrally managed by the Communication and
Corporate Support Directorate and complaints resolved informally and formally
will be recorded in CRM as cases and also captured in the Complaints log.
This knowledge will be used to ensure that maladministration or inappropriate
conduct is not repeated. It will also be used to improve the HTA’s services.

14. The Complaints log is saved in the Quality Management folder of IMPACT and
headings for the Complaints log are attached to this SOP as Annex 1.

15. Complaints about the HTA will be monitored regularly by the Senior
Management Team and a report submitted to the Authority on a six monthly
basis. The report will include information recorded in CRM and the Complaints
log. This may include: HTA’s speed of response to complaints, number of
complaints, number, upheld, list of the actions taken to ensure similar examples
of maladministration and inappropriate conduct do not reoccur.

Review

16. The SOP will be reviewed every 12 months.

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Annex 1 – HTA Complaints log headings

1. In chronological order the Complaints log heading will include:

• Date complaint received

• Complainant’s name
• Complainant’s contact details
• Complaint received by
• Informal/formal complaint
• Subject of complaint
• Date acknowledgement letter sent (within 3 working days of receipt)
• Was complaint upheld? (Yes/No)
• Actions recommended for HTA (if applicable)
• Date response sent to complainant (within 20 working days of receipt)
• Date request for review received
• Date acknowledgement letter sent (within 3 working days of receipt)
• Type of review (New information provided or was due process followed)
• Summary of decision from review
• Date response sent to complainant
• Lessons learnt and action to be taken by HTA

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