QA & Governance
Welcome to the QA & Governance section which addresses the accreditation of Pelvic Floor units, standards of practice and peer review. It also contains guidelines and commissioning doccumentation pertinent to the Pelvic Floor.
Chair: Mark Mercer-Jones, Gateshead
Accreditation of Units
Definition of Pelvic Floor Unit
Definition and accreditation of a pelvic floor multidisciplinary team
KPIs for unit accreditation
Tertiary referral centres for dealing with mesh complications
Accreditation of Units
The Pelvic Floor Society has an obligation to ensure high quality care is provided to patients with pelvic floor disorders. As such the society has strived to identify the components that make up the optimal pelvic floor service in terms of resource and process. These criteria have been assembled and their importance stratified by consensus to identify a benchmark of quality care which can be formally assessed to as part of an accreditation process .
We wish to invite all units to submit data to this accreditation process. A peer review carried out by at least 4 peers who are ordinary members of The Society will allow feedback as to whether these standards are met or where components of unit performance may be improved. It is hoped that, if carried out correctly, such a process will benefit its members in terms of recognition if standards are met and providing leverage for more resource if standards are not met. More importantly the patient will benefit from confidence that quality assurance is guaranteed as far as possible.
The proposed criteria (KPIs) and their weighting are detailed below. Some are regarded as mandatory (i.e. they require a score of greater than zero). A total score of greater than 75 indicates achievement of the necessary standards.
The process is not meant to be dictatorial, merely to provide peer review. It is proposed that those that meet current standards will be registered as ‘accredited by The Pelvic Floor Society’ for a period of 4 years. Those that do not meet all the criteria will be directed to areas that may be improved and invited to resubmit at any time. Wherever possible, support will be provided with the aim that all units that apply will eventually meet these criteria and be accredited.
A number of units have now been formally accredited. We are in a position to accredit further units and encourage all of those units who wish to undergo the process to contact Mark Mercer Jones and provide the information detailed below.
If you would like to be an assessor for this process could you send your details to Mark Mercer-Jones. If you have feedback regarding this process please also feel free to contact us.
IN 2014 ACPGBI UNDERTOOK A CENSUS OF CURRENT COLORECTAL SURGICAL PRACTICE ACROSS THE UK. ANDY WILLIAMS ANALYSED THE CENSUS DATA REGARDING PF PRACTICE AT THAT TIME.
Definition of Pelvic Floor Unit
- Dedicated PF Clinic or equivalent per week including secondary and tertiary referrals as part of a multidisciplinary service.
- Evidence of training in an accredited unit, which provides the full range of investigations and treatments required for training.
- Regular anorectal physiology & urodynamic sessions either personally or in a supervisory capacity.
- Provide three clinical sessions in PF per week.
- A regular & programmed PF MDT meeting a minimum of once/month
- One major procedure associated with pelvic floor dysfunction i.e. incontinence and prolapse per working week per year.
- Full clinical Audit e.g. TPFS or BSUG surgical audit
- Appropriate CME review in PF
Definition & accreditation of a pelvic floor multidisciplinary team
In the early 1990s it was recognised that treatment of cancer required a dedicated and formal MDT if cancer treatment was to be delivered by specialists rather than generalists with the additional aims of: avoiding missing factors relevant to the decision making process about treatment, allow a robust audit processes to be developed as well as improving communication with patients. There is a widespread perception that MDT working has brought benefits to patients and that the decision making process has been improved. Pelvic floor management is in many ways more complex that cancer management.
- The pelvic floor consists of multiple compartments traditionally managed by completely different specialties who may have different views about therapy. And yet pathology of the pelvic floor often affects multiple pelvic compartments.
- The complex nature of disease often requires multiple specialists involved in investigation and treatment. And yet many staff work in isolation with surgeons, physicians, radiologists, specialist nurses and physiologists having little direct discussion.
- The evidence base for therapy is poor. There is a desperate need for robust research and audit, which is not possible unless there is a method streaming patients and collating data.
- With such a complex management pathway there is a paramount need for uniform and clear communication with the patient as well as primary, secondary and even tertiary care.
The argument for a pelvic floor MDT appears strong. It would bring together staff with the necessary knowledge, skills and experience to ensure high quality diagnosis treatment and care. However, other than following the blueprint of cancer MDTs there is very little data to guide the definition and constitution of such an MDT and how to assure such teams will deliver consistent high quality care. Recognising this need The Pelvic Floor Society has prioritised the development of this guidance.
AIMS:
- To categorise the characteristics of a pelvic floor MDT
- To document its role
- To detail the process of accreditation
Sources of information:
There is no direct guidance about the definition, role or accreditation of a pelvic floor MDT.
Indirect guidance is taken from:
- The National Cancer Action Team
Characteristics of an effective multidisciplinary team are detailed in a document produced by the Department of Health. This gives details of what constitutes and effective MDT for cancer treatment. Many aspects of design can be extrapolated to the pelvic floor scenario. - NICE guidance CG49
NICE guidance exists for the treatment of faecal incontinence. This document recommends that ‘people who report or are reported to have faecal incontinence should be offered care to be managed by healthcare professionals who have the relevant skills,training and experience and who work within an integrated continence service’. The document suggests who should be involved in care. - British Society of Urogynaecology. Standards for Service Provision.
This document proposes methods for accreditation of services in a specialty closely associated with colorectal pelvic floor. - Expert opinion
Healthcare professionals recognised amongst their peers to have the relevant skills, training and experience to manage patients with pelvic floor conditions were questioned as to their views and opinions.
The focus of an MDT:
An effective pelvic floor MDT should result in:
- Individualised treatment and care assessed by professional healthcare workers with specialist knowledge and skills relevant to the pelvic floor
- Patients being offered the opportunity to be involved in clinical trials, regardless of age.
- Patients being given comprehensive information and tailored support needed to cope with a pelvic floor condition
- Continuity of care even when this care involves different healthcare professionals
- Good communication between primary, secondary and tertiary care
- Good data collection, both for the benefit of the patient and for robust high quality audit and research.
- Improved outcomes as a result of better understanding of the patient’s issues primarily and also their condition
- Adherence to local and national guidelines
- Promotion of effective working relationships
- Opportunities for education and training
- Optimisation of resources by more efficient working and standardisation of outcome measures.
Categorisation of MDT characteristics:
The Team: Members will be considered as core or essential to the running of a pelvic floor service. These core members will include at least one colorectal surgeon who specialises in performing the spectrum of operations that may be needed to treat the conditions. A pelvic floor physiologist and/or a specialist nurse who undertake diagnostic evaluation of pelvic floor abnormalities and introduce and optimize conservative management at an early stage and a urogynaecologist. It will also iclude a radiologist with an interest in pelvic floor disorders who is able to offer a high quality dynamic defaecography service and interpretation of endoanal ultrasound as well a a member of administrative staff to ensure documentation is accurate and effectively recorded.
Members that can be considered as valuable contributors but not essential (extended members) include:
- A medical gastroenterologists with an interest in dysmotility
- A pain management specialist interested in chronic pelvic pain
- A psychologist and psychiatrist
- A functional urologist
- Alternative therapist specializing in acupuncture/homeopathy.
Attendance:
- MDT members (core and extended) should have dedicated time in their job plan to prepare for and attend MDT meetings. The frequency and amount of time dedicated to such meetings should be negotiated locally to reflect the local workload, but should be no less that monthly.
- Core members should be present for discussion of all cases where their input is required- it is for the chair to decide (in consultation with others) whether there is adequate representation at a single meeting to make safe recommendations about any/all patients
- The chair is responsible for raising concerns about non-attendance and escalating these concerns if necessary. Frequent non-attendance should be addressed in the appraisal and job-planning review.
- Extended members and non -members attend for the cases that are relevant to them.
- There should be a register maintained of those attending and minutes recorded.
Chair: There should be a chair who is responsible for the organisation and smooth running of the MDT meetings. The responsibilities of the chair include:
- Preparing an agenda
- Ensuring meeting is quorate taking action if not
- Ensuring all relevant cases are discussed
- Ensuring all relevant team members are included
- Ensuring discussions are focused and relevant
- Ensures good communication
- Promotes evidence-based and patient centred recommendations and ensures that eligibility for relevant trial recruitment is considered
- Ensures all discussion points and treatment plans are complete before the next patient discussion starts
- Ensures all data is recorded and the recommendations summarized and fed back to the patient. GP and clinical team and patient within a locally agreed time frame
- Ensures it is clear who is going to action any interventions and that this is recorded.
Team working and culture:
It is essential that each MDT member has mutual respect and trust of each other and has an equal voice with different opinions valued. Best practice should be shared with an opportunity for learning from each other.
Infrastructure
- There should be a dedicated room with a layout to allow all members to sit and hear each other and view all presented data.
- There should be equipment for projecting and viewing radiological images
- There should be access to radiological investigations and other investigation results
Research:
Ideally, each meeting should be combined with a small presentation or journal review on a topical issue, which may involve any aspect of colorectal, urological or gynaecological pelvic floor topic. In particular for specialist centres, this will allow for research performed locally to be effectively disseminated amongst collaborative groups.
Meeting organization and logistics:
- MDT meetings should take place regularly as case volume dictates and at times so as not to clash with related clinical commitments such as pelvic floor clinics.
- Cases for discussion should be identified by each core member and included for submission to the chair.
- There is a locally agreed cut off time for inclusion of a case on the MDT. Flexibility for urgent cases should be allowed.
- The patient list is circulated to all members prior to the meeting, which includes a locally agreed minimal dataset.
- Each case is discussed by the member relevant to the case
- There is access to all relevant information at the meeting including patient notes, test results, images and appointment dates.
Post-MDT:
Ensuring processes are in place for communicating MDT recommendations to patients, GPs and clinical teams within locally agreed time frames. Ensuring the agreed actions are implemented or the MDT is notified of significant changes made to their recommendations.
Who to discuss?
- There should be local mechanisms in place to identify all patients where discussion at MDT is needed
- There should be local criteria in place so it is clear when to send a case to the MDT for consideration ie clarity on:which patients should be discussed & the clinical question?
Patient centred care
- Patients should be aware of the MDT purpose and structure
- There views should be represented by someone who has met the patient whenever possible. However, referrals to a designated lead within specialties is encouraged.
Clinical decision making process
- A locally agreed minimum dataset of information is provided at the meeting, including nationally recognised scoring systems where possible
- All clinically appropriate treatment options should be considered even if they cannot be offered locally.
- There should be access to a list of all current and relevant clinical trials and suitability should be considered for each patient.
- Standard treatment protocols should be in place and used when appropriate.
- Patient views, preferences and needs inform the decision making process
- MDT recommendations should always be:
- Evidence-based & patient- centred
- In line with standard treatment protocols. Deviations should have good reason and the reason documented
- If data is missing or incomplete it should be possible to bring the patient back for further discussion when the data becomes available.
- It should be clear who will communicate the MDT recommendation to the patient, GP and clinical team. This should be documented and filed in the patient’s notes (the responisibility of the admin staff).
Governance
Organisational support:
There are costs associated with running an MDT. There is therefore the need for organisational (employer support) for MDT meetings demonstrated via recognition that MDTs are the accepted model to deliver safe and high quality care. There is a need to fund the resources/ time/ equipment and facilities for MDT meetings to operate effectively
Data collection, analysis and audit:
- Data collection resource should be available to the MDT
- Key information that directly affects treatment decisions should be collected
- National datasets should be developed and populated allowing refinement of treatment
- Data collected is analysed and fed back to the MDT for the purpose of learning
- There should be internal and external audits of process and outcome. This should include an annual general meeting for discussion of outcomes and an accreditation process for pelvic floor processes of units.
Clinical governance
The purpose of the MDT and its expected outputs are clearly defined locally. There should be agreed guidelines as to
- How the MDT operates
- Who the core and extended members are
- The roles of the members
- How the members should work together
- How changes to clinical practice should be managed
- Communications post meeting
- Regular audits of standardised outcomes reporting to the core MDT group as evidenced by minutes at governance meetings.
There should be mechanisms in place to
- Record recommendations of the MDT versus the actual treatment given and reasons if there is variation
- Record serious or adverse events
- Monitor the proportion of patients discussed
- Monitoring of outcomes
Accreditation of units
The process whereby units will be accredited as nationally recognised pelvic floor units has yet to be developed. It will have to include definitions of what constitutes a colorectal pelvic floor specialist and what resources are available to them. However, it is clear that one important aspect of such a centre is whether an MDT exists and whether it meets the categories outlined in this document.
KPIs for Unit accreditation
Criteria updated July 2021. New areas highlighted in red.
Domain |
KPI |
Minimal Standard |
Aspirational Standard |
Score |
Comments for markers |
Process |
Information giving
Information gathering |
Patient information sheets for all major procedures -SNS -LVMR -Sphincter repair -STARR -Posterior repair as well as conservative management eg -Diet -biofeedback -irrigation
Unit protocol algorithm for 1. Constipation management 2. Incontinence management 3. Pelvic pain management
History and examination proforma
Quality of life assessment for all patients undergoing intervention |
Website based information
Evidence of follow up QoL assessment |
5
5
5
5 |
4 marks for core 1 for aspirational
2 for constipation 2 for incontinence 1 for pain
4 marks for assessment of all new 1 for follow up |
|
MDT Representation (SEE website for guidance)
Frequency
Selection
Administration
Regional/multi Trust MDM |
Colorectal Surgeon (>1) Urogynaecologist Radiologist Clinical Scientist and/or nurse specialist Trainees
Some membership of TPFS
Monthly
Discussion of ALL - Patients considering surgery, including SNS (and other continence procedures), rectal prolapse (IRP&ERP), defunctioning stomas, colectomy, STARR.
Evidence of conversion rate to surgery [from annual nos of new patients seen in OPD for 1) Constipation/ODS 2) Continence]
Register of attendees
2 or more Trust MDM’s |
Additionally: Physiotherapist Gastroenterologist Psychologist Pain specialist Research fellow/nurses
All enrolled in TPFS
More frequently
annual AGM (review of process)
Regional |
10
5
5
15
10
5
10 |
8 marks for core 2 for others
2 marks for 1 member. 5 for all
4 for monthly 1 for more frequently
Fail if not provided
Fail if not provided
4 for evidence of register 1 mark for AGM
8 for multi-trust 2 for regional |
Personnel |
Lead
Other consultants with interest
Allied health professional support (eg, continence nurse, GI physiologist, physiotherapist) |
-CV to include training, CPD etc -Job plan to include at least 1 PA per week - Evidence of an average of at least 1 major pelvic floor op per week (SNS, rectopexy, sphincter repair, etc) - Evidence of referrals from colleagues
-CV to include training, CPD etc -Job plan - Evidence of pelvic floor work - Evidence of referrals from general colleagues
Summary of numbers |
-National or international involvement in pelvic floor topics (leadership, quality improvement etc)
National or international involvement in pelvic floor issues (leadership, quality improvement etc)
Details of CPD
|
10
5
5 |
4 marks for >1PA 2 mark for op evidence 1 mark for CPD 1 mark for national involvement 2 marks for training
2 marks for >1PA 1 mark for op evidence 1 mark for CPD 1 mark for national
1 mark for evidence CPD 4 marks for evidence of AHP attendance |
Procedures
Research
PF Training |
Unit throughput data
Auditable Outcomes
Engagement in R&D
Evidence of training core trainees/AHCP’s |
12 month data kept for: - New OPD referrals - Biofeedback - Surgical activity
Morbidity recording and monitoring for 12 months, including reporting any mesh related complications to MHRA
Evidence of use of TPFS audit database for LVMR (if done)
Recurrence data for external rectal prolapse (12 month period)
Local audit
For surgical trainees, logbook evidence. AHCP’s annual appraisal evidence of training |
- Physiology investigation - Physiotherapy
Patient reported outcome measures - Severity scores - QofL scores
Recurrence data for >12 months
Recruitment to national portfolio study
PF fellow |
5
15
5
5
5
15 |
1 mark for each of these
10 marks for M&M 5 for aspirational (PROM’s) Fail if mesh related complications not reported
Fail if no evidence (if LVMR done)
Up to 3 for local audit, full 5 if national recruitment
10 for minimum standard, 5 for PF fellow |
Total mark achievable 150 (previously 90)
Pass mark is still 65%
Notes to accompany the new PF accreditation submission document for submitting units and markers
Changes and new KPI’s are indicated in red in the new submission document.
Patient selection:
Proof that ALL patients having surgery are recorded at the MDM (12 months data). The relevant elective surgery lists for all consultant surgeons for that period are to be provided and cross referenced with the corresponding MDM minutes.
For calculation of the conversion rate to surgery following failed conservative management, the numbers of new OPD referrals for constipation/ODS and faecal incontinence are to be provided for the index 12 months. The elective surgery numbers for these conditions will be available on the submitted elective surgery lists. It is the responsibility of the submitting unit to calculate and provide this evidence.
Auditable outcomes:
Morbidity and mortality reporting, depends upon the trust and integrity of the unit and it is expected that these are reported in the MDM minutes. Any mesh/implant related complications should be visible in the MDM minutes and cross-referenced with evidence (or not) of reporting to the MHRA
Notes for units that are applying for re-accreditation
Renewal is required every 4 years. Six months prior to the date for renewal the PFS Accreditation Chair will contact the unit to remind them. Any unit that does not comply with the timely submission of data required will be removed from the published list of accredited units (unless there are extenuating circumstances).
Data required:
- New requirements as per the newly published KPI’s for accreditation
- Any change in MDT representatives, job plans etc
- Any change in personnel
- Unit throughput data, including 12 months auditable outcomes, conversion rates, M&M, use of TPFS database, recurrence data for ERP
- R&D
- PF training