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)

Current status of the certification system

As of: March, 31 2016

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

Structure of the certification system

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

(Some) results of the questionnaire:

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