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Quality Assurance in OncologyThe Certification System of the German Cancer Society (DKG)
Dr. Simone Wesselmann MBA
Contents
1. What are certified centres?
2. Prerequisites for and implementation of the certification system
• National Cancer Plan
• Current status of the certification system
3. Structure of the certification system
4. What effects does certification have?
• From the point of view of quality assurance
• From the patients’ viewpoint
• From the point of view of health-care providers
• From the point of view of health-care policy partners
1. What are certified centres?
“Definition:
A network of qualified and jointly certified
interdisciplinary and transsectoral ... institutions that ... if
possible represent the entire chain of health care for
those affected ... ”
National Cancer Plan, Action Area 2
Certified centres:“interdisciplinary and transsectoral … institutions”
The breast cancer centre as an example:
Obligatory members of the centre:
Gynecology, radiotherapy, pathology, radiology, hematology/oncology, nursing,
physicians in private practice, genetic counseling, psycho-oncology, social
services, physiotherapy, genetics, palliative medicine, pain therapy,
rehabilitation, cancer registry and self-help group
= Cooperation between medical specialties (= interdisciplinarity),
professional groups (= inter-professionalism), and sectors
(=transsectorally)
Certified centres:“that ... if possible represent the entire chain of health care”
The breast cancer centre as an example:
Networking in oncology
Certified centres:“A network of qualified and jointly certified ... institutions”
Certificate:provides guidance and
serves as a decision-making aid for patients
2. Prerequisites for and implementation of the certification system
• National Cancer Plan
• Current status of the certification system
National Cancer Plan
2. Further development of health-care structures in
oncology and quality assurance
Goal 5: Standardization of certification and quality assurance in oncological
treatment institutions
Ziel 6: Leitlinien
Ziel 8: Klinische Krebsregister
Ziel 9: Psychoonkologische Versorgung
NCP goal 5: Standardization of certification and quality assurance in oncological treatment institutions
Three-level modelof oncological care
This should be reflected in a uniform approach using uniform terms for the
oncological care structures.
NCP goal 5: Standardization of certification and quality assurance in oncological treatment institutions
Three-level model of oncological care:
• An organ cancer centre is a centre
specializing in one organ or specialty
(breast, colorectal, lung, prostate, skin,
gynecological tumours)
• Certified by German Cancer Society
(DKG)
• An Oncology Centre extends to several
organs or specialties, particularly for rare
cancers
• Certified by German Cancer Society
(DKG)
• A Comprehensive Cancer Centre (CCC)
is a leading oncology centre with major
research aims. Specifically for rare
cancer diseases and special issues
• Certified by German Cancer Aid (DKH)
3. Structure of the certification system
In the framework of certification procedures, it must be ensured that
the interdisciplinary definition and compilation of a catalogue of
requirements for certification are already established before an
independent, institutionally separate evaluation is carried out on the
basis of the requirements.
Aims of the National Cancer Plan:
Structure of the certification system
Certification Commissions:
- Task: to compile a list of specialist requirements
(= catalogue of requirements)
- Basis for work: current guidelines
- Composition:
• Interdisciplinary, transsectoral & multi-
profession
• 20–30 experts, nominated by specialist
societies and professional associations, as
well as patient representatives
Catalogue of requirements:- Contains the requirements that are checked during the
certification procedure
- Includes indicator sheet = quality indicators from the guidelines & quality indicators for expert reports and interdisciplinary work
Structure of the certification system
Executive: Auditors = oncology specialists with specific further training for
conducting audits Auditors are not voting members of the Certification
Commission Guidance for Auditors, auditing procedures and evaluations via
OnkoZert = an accredited certification institute that is independent of the DKG both financially and with regard to personnel
Audit:— Carried out by the auditors— Tasks of the auditors:
• Before the audit: assessment/plausibility checking of the completed questionnaire
• Audit: local site visit – 0.75 – 2.5 days; per audit: 1–8 auditors
• After the audit: audit report with recommendation to award/not award a certificate
Current status of the certification system
Certificate award committee:— Consists of 3 auditors per procedure— Decides whether to award a certificate on the basis
of the audit report— Members are not voting members of the
Certification Commission and have no links to thecentre they are assessing
Certificate:— Valid for 3 years
4. What effects does certification have?
From the point of view of health-care providers
From the patients’ viewpoint
From the point of view of quality assurance
From the point of view of health-care policy partners
From the point of view of quality assurance
• The centres have to present their results annually on a key figures sheet
• There are separate key figures for each type of cancer (ca. 25)
• Key figures for:
1. Presentation of the certified networkKey figures: e.g., tumor conference, psycho-oncology, social work,
research
2. Presentation of main treatment partners’ expert reportsKey figures: e.g., results for operations/interventions, post-op./post-
intervention complications
3. Presentation of guideline-appropriate treatmentQuality indicators from evidence-based oncological guidelines
Collection of treatment quality data:
From the point of view of quality assurance
Collection of treatment quality data:
Quality assurance in data entry:
- Data can be entered via the hospital or cancer registry
- Excel entry template
- With plausibility limits for all key figures: if the plausibility limits are
exceeded, the centre has to explain the reasons in a free text field
- With automatic copying of figures into various cells, avoiding the risk of
incorrect entry
- Can only be sent to OnkoZert when all the fields have been filled in and
have had their plausibility checked
- Before the audit:
- Formal checking by OnkoZert
- Checking of content by the auditor, who can request comments if needed
- During the audit:
- Checking of details using actual patient files
- Discussion of results between centre and auditor, establishing any steps
that need to be taken if appropriate
From the point of view of quality assurance
The national key figure results are
presented annually as:
1. An anonymized annual analysis per
cancer type
2. An individual annual analysis for each
centre
Presentation of treatment quality:
From the point of view of quality assurance
Example: anonymized annual report for
certified colorectal cancer centres, 2016
— Contains the results for 261 certified
colorectal cancer locations in 2015
— Contains the aggregate data for around
115,000 patients with a first diagnosis of bowel
cancer
— Contains the results for 30 indicators
— Shows the development of the results for
2010–2014
From the point of view of quality assurance
Example: individual annual analysis for
an individual colorectal cancer centre in
2016
— Contains the results of the anonymized report
— Contains the results for the individual centre
over a period of time (2012–2014)
— Contains the results for the individual centre in
comparison with other centres
From the point of view of quality assurance
Analysis of treatment results and planned measures:
Example: anastomic insufficiency,
rectal carcinomaFor all key figures that exceed the plausibility
limits or reference ranges, the centres’
explanations, planned actions, and auditors’
comments are analyzed in the audit report
From the point of view of quality assurance
Audit + internal discussion:identifying measures
Key figures sheet:input
Zentrum
Analyses
Certified network
Certified network
Improving the quality of treatment:
Plan Do Check Act !
From the patients’ viewpoint
Questionnaire completed by patients in certified breast cancer centres:
Initial question:
• How is the care provided in a breast cancer centre evaluated from the patients’ viewpoint?
• Breast centre: 8226 patients from 128 centres participated, 7301 responses, response rate 88.76%, questionnaire period March–November 2010
Kowalski C, Wesselmann S, Kreienberg R, Schulte H, Pfaff H. The patients' view on accredited breast cancer centres: strengths and potential forimprovement. Geburtshilfe und Frauenheilkunde. 2012;72(2):137-43
From the patients’ viewpoint
(Some) results from the questionnaire:
When the results for the scales and items are examined in detail, thepatients’ confidence in the physicians and nursing staff must be emphasizedin particular.
…
From the patients’ viewpoint
With prostate cancer:
Lent, V., Schultheis, H.M., Strauß, L., Laaser, M.K., Buntrock, S. (2013) Belastungsinkontinenz nach Prostatektomie in der Versorgungswirklichkeit.
Der Urologe. 52, 8, 1104-1109.
Conclusion for practice
In the reality of health care at large
convalescent hospitals, only
approximately half of the hospitals
(but approximately 80% of certified
prostate centres) reach the target
of preserving continence in
approximately one-third of the
patients …
From the patients’ viewpoint
With breast cancer:
Heil, J., Gondos, A., Rauch, G., Marmé, F., Rom, J., Golatta, M., Junkermann, H., Sinn, P., Aulmann, S., Debus, J., Hof, H., Schütz, F., Brenner, H.,
Sohn, C., Schneeweiss, A. (2012) Outcome analysis of patients with primary breast cancer initially treated at a certified academic breast unit. The
Breast. 21, 3, 303-308.
From the patients’ viewpoint
With breast cancer:
Beckmann, M.W., Brucker, C., Hanf, V., Rauh, C., Bani, M.R., Knob, S., Petsch, S., Schick, S., Fasching, P.A., Hartmann, A., Lux, M.P., Häberle, L.
(2011) Qualitätsgesicherte Versorgung in zertifizierten Brustzentren und Optimierung der Behandlung von Patientinnen mit einem Mammakarzinom.
Onkologie. 34, 7, 362-367
Conclusions:
Independently of the
classic prognostic
factors, care in a
certified breast centre
is associated with an
improvement in the
prognosis for patients
with breast carcinoma.
From the patients’ viewpoint
With rectal carcinoma:
With kind permission from Dr. Klinkhammer-Schalke (ADT)
Analysis:
The proportion of R0
resections (= complete
tumor removal) in rectal
carcinoma
Results:
Clinical cancer registry:
83% of the 4267 patients
received R0 resections (in
certified + noncertified
institutions)
Certified centres:
95.2% of the 6859 patients
received R0 resections
From the patients’ viewpoint
With rectal carcinoma:
With kind permission from Dr. Klinkhammer-Schalke (ADT)
Analysis:
Proportion of patients who
received combined
chemoradiotherapy before
surgery
Results:
Clinical cancer registry:
69.8% of the 1706 patients
received neoadjuvant
chemoradiotherapy (in
certified + noncertified
institutions)
Certified centres:
77.3% of the 3151 patients
received neoadjuvant
chemoradiotherapy
From the patients’ viewpoint
With colon carcinoma:
With kind permission from Dr. Klinkhammer-Schalke (ADT)
Analysis:
Proportion of patients
receiving postoperative
chemotherapy for stage III
colon carcinoma
Results:
Clinical cancer registry:
59.2% of the 2442 patients
received chemotherapy (in
certified + noncertifeid
institutions)
Certified centres:
70.9% of the 3177 patients
received chemotherapy
From the patients’ viewpoint
With colorectal carcinoma:
Analysis:
Proportion of patients in
whom at least 12 lymph
nodes were removed
during surgery
Results:
Clinical cancer registry:
92% of the 11,700 patients
underwent surgery with
removal of at least 12 LNs
(in certified + noncertified
institutions)
Certified centres:
95.9% of the 16,080
patients underwent surgery
with removeal of at least 12
LNsWith kind permission from Dr. Klinkhammer-Schalke (ADT)
From the point of view of health-care providers
Questionnaires sent to management of breast cancer and colorectal cancer centres
Initial questions:
• What effects does certification have on everyday clinical work? • How much acceptance is there for the concept of certified centres from the point of
view of the centres’ management?
Colorectal cancer centres: 211 centres contacted, 161 responses, response rate 76.3%. Questionnaire period September–October 2011Breast cancer centres: 243 sites contacted, 149 responses, response rate 61.3%. Questionnaire period June–September 2011
Kowalski C, Wesselmann S, Ansmann L, Kreienberg R, Pfaff H. Key informants' perspectives on accredited breast cancer centres: results of a survey. Geburtshilfe und Frauenheilkunde. 2012;72(3):235-42Huthmann D, Seufferlein T, Post S, Benz S, Stinner B, Wesselmann S. Certified stomach cancer centres as seen by their directors: results of a questionaire to keypersonnel. Zeitschrift fur Gastroenterologie. 2012;50(8):753-9.
From the point of view of health-care providers
What is your assessment of the concept of
Breast cancer centres? Colorectal cancer centres ?
(Some) results of the questionnaire:
From the point of view of health-care providers
Quality loop in
oncology
The results of oncological care must be made transparent
and must be secured and improved.
For this purpose, it is indispensable to establish a balanced
interplay between high-quality treatment guidelines (if
possible S3 guidelines), to implement these guidelines in
the individual patient’s situation, and to create a valid
interdisciplinary, inter-sector, and meaningful
documentation system.
From the point of view of health-care providers
Collaboration on oncological guideline
program and Certification:
- Im Rahmen der Erstellung der
evidenzbasierten Leitlinien werden
Qualitätsinidikatoren (QI) aus den wichtigen
Empfehlungen abgeleitet.
- The QIs provide the basis for certification
- Now in use for 13 guidelines
From the point of view of health-care providers
Collaboration between registeries, guideline
groups and certification system
The results of the QI analyses are returned to:
— The centres
— The guideline groups
and represent an important basis for further
development of the guidelines and of the
certification system
Conclusion
A certified Centre is a network of qualified and jointly certifiedinterdisciplinary and transsectoral institutions that if possible represent theentire chain of health care for those affected
The certification of the oncological care structures follows the three-level-model of oncological care (national cancer plan) consisting out of organcancer centres, oncology centres and comprehensive cancer centres
The certification system is structured in an legislative, executive andjudicative part with a division of tasks
Conclusion
Certification has effects from the
• point of view of quality assurance: implementation of a PDCA-Cycle
• patients’ viewpoint: improvment of quality of care
• point of view of health-care providers: improvment of quality of care, tumourboards, communication etc
• point of view of health-care policy partners: cooperation between theGerman Guideline Programm in Oncology (GGPO), cancer registriesand certification system