Summary
Regulation 16 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 does three things. It requires every complaint received to be investigated and proportionate action taken, it requires an accessible system for identifying, receiving, recording, handling and responding to complaints, and it gives the Commission the power to request a summary of those complaints, the responses and any further correspondence, to be provided no later than 28 days beginning the day after the request. The third is the one that decides whether a system is adequate, because a clinic whose complaints arrive by email, by phone, in a review and in a consultation has no single list to summarise.
Complaints are the one duty in the fundamental standards that comes with a deadline written into the regulation. Twenty eight days, from a request you cannot predict, for a summary of material that may be spread across four channels and two years.
The hard word in Regulation 16 is not responding. It is identifying, because a clinic does not get to choose which channel a complaint arrives on.
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See it in your clinicEvery channel landing in one place, so a complaint is a record with a clock on it rather than a message somebody remembers.
Request a demo| Requirement | What it means in practice | Where it breaks |
|---|---|---|
| Identifying complaints | A complaint is a complaint whether it arrives by email, by phone, in a review or in the consulting room | Only the ones that arrive on the official form are counted, so the list is a subset of the facts |
| Recording and handling | An accessible system, operated effectively, covering the whole life of the complaint | The complaint is in a mailbox, the investigation in a document and the outcome in somebody's memory |
| Investigating and acting | Necessary and proportionate action in response to any failure identified | Action was taken and nothing connects it to the complaint that prompted it |
| The 28 day summary | On request, a summary of complaints, responses and further correspondence, within 28 days | Assembled by hand from several systems, under a deadline, by whoever is available |
Identifying is the word that decides the system
Regulation 16(2) requires the registered person to establish and operate effectively an accessible system for identifying, receiving, recording, handling and responding to complaints by service users and other persons. Five verbs, and the first is the one a complaints product usually assumes has already happened.
A clinic with a complaints form has built a system for receiving. Identifying is the harder duty, because the patient who says in a follow up that nobody called them back has complained, and so has the one who left a review, and neither of them filled in anything. A system that counts only what arrived through the front door produces a complaints log that is accurate about itself and incomplete about the clinic.
The 28 day clock, and what it is asking for
Regulation 16(3) requires the registered person to provide the Commission, when requested, and no later than 28 days beginning on the day after receipt of the request, a summary of complaints made under the complaints system, the responses made to them and any further correspondence with complainants, plus any other relevant information the Commission requests.
Read that as a systems specification rather than as an administrative chore. It asks for a joined record of complaint, response and subsequent correspondence, retrievable on demand, for a period the request defines rather than one you chose in advance. A clinic holding complaints in a shared mailbox can produce the messages and will struggle to produce the join.
The complaint that never meets the record
The second structural weakness is that complaints and clinical records are usually separate estates. A complaint about a missed result is a clinical fact as well as an administrative one, and when the two are stored apart the clinical significance of a pattern is invisible.
This is where Regulation 16 and Regulation 17 meet. Good governance requires systems to assess, monitor and improve quality and to mitigate risk, and three complaints about the same step in a pathway is exactly the signal that duty is reaching for. Complaints filed as correspondence rather than as events in a clinic's own record will never aggregate into that signal.
Proportionate action, and showing it happened
Regulation 16(1) requires that any complaint received is investigated and that necessary and proportionate action is taken in response to any failure identified by the complaint or the investigation. The evidence for that is a link between a change and the complaint that caused it.
Most clinics act and few can show the link, because the action lands in a policy document, a rota change or a conversation while the complaint stays in its own file. The cheap control is that the complaint record carries the outcome and the change, so an improvement made in March can be traced to the complaint received in February without anybody reconstructing it.
What we are not claiming
This page describes what the regulation requires and what a system can evidence. It is not legal advice, it is not a complaints policy, and it does not substitute for your registered manager's judgement or for the guidance CQC publishes. Where a decision turns on detail, the legislation linked below governs rather than this summary of it.
wai is not CQC registered and makes no claim to be. CQC registers providers of regulated activities rather than software. The registration and the duty stay with the clinic.
Where wai sits
wai runs the clinic's inbound channels into one place, so a message that arrives by email, by phone or in a thread becomes a record with an owner and a clock rather than a message somebody is expected to remember. The same record holds what was done about it.
What that buys is that the summary Regulation 16(3) describes is a query rather than an archaeology project, and that a pattern across several complaints is visible while it is still a pattern. The wider map of which regulations a clinic's systems answer is in software and CQC, what is actually being assessed.
Run the test above on whatever you use now. Ask it for every complaint in the last two years with responses attached, and time it. Clinicians still decide what enters the record.
Ask your current system for a summary of every complaint in the last two years, with responses. Time how long it takes.
Request a demoFrequently asked questions
What does Regulation 16 require about complaints?
That any complaint received is investigated and proportionate action taken, that the provider establishes and operates effectively an accessible system for identifying, receiving, recording, handling and responding to complaints, and that a summary of complaints and responses is provided to CQC on request within 28 days.
How long does a clinic have to produce a complaints summary for CQC?
No later than 28 days beginning on the day after the day the request is received. The summary covers complaints made under the complaints system, the responses made to them, any further correspondence with complainants, and any other relevant information the Commission requests.
Does a review or a verbal remark count as a complaint?
Regulation 16(2) names identifying as part of the duty, which means the system cannot rely on a complaint arriving through a particular channel. A patient who says in a follow up that nobody called them back has raised one, and a log that counts only submitted forms is incomplete about the clinic.
Why do complaints need to connect to the clinical record?
Because a complaint about a missed result is a clinical fact as well as an administrative one, and Regulation 17 requires systems that assess and monitor quality and mitigate risk. Three complaints about the same step in a pathway is the signal that duty reaches for, and it only appears if complaints aggregate as events rather than as correspondence.
What evidence shows proportionate action was taken?
A link between a change and the complaint that caused it. Most clinics act and few can show the link, because the action lands in a policy or a rota while the complaint stays in its own file. The control is that the complaint record carries the outcome and the change.
What is the single best test of a complaints system?
Ask it for a summary of every complaint in the last two years with responses and subsequent correspondence attached, and time how long it takes. That is the request Regulation 16(3) permits, and a clinic that cannot answer it quickly will be answering it under a deadline instead.
Sources
Two years of complaints, in one query
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