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METHODOLOGY Commission of MZ SR for rare diseases

METHODOLOGY
Commission of the Ministry of Health of the Slovak Republic for Rare Diseases
(Rare Diseases - RD) of 18 November 2015 laying down the criteria and procedure
to evaluate applications for inclusion of a healthcare provider
to the network of national specialised expertise centres for rare diseases
correspondent in the Slovak Republic

Centralisation, hierarchy and support of national specialised expertise centres for rare diseases are important for the development of healthcare for patients with rare diseases in Slovakia.

Based on European Union Committee of Experts on Rare Diseases (EUCERD) The Commission of the Ministry of Health of the Slovak Republic for Rare Diseases (RD) provides:

Art. 1

The criteria and procedure for evaluating applications for inclusion of a healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic are set out in Annex No. 1.

Art. 2

This methodological procedure shall enter into force on 18 November 2015.

František Cisarik, v.r.
the president

Annex No 1
on the methodological approach

Criteria and procedure for evaluating applications for inclusion of a healthcare provider
care for the network of national specialised expertise centres for rare
diseases in the Slovak Republic

Table No 1
Criteria for evaluating applications for inclusion of a healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic

Criteria for evaluating applications for the inclusion of a healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic (hereinafter referred to as the "expert workplace') Documented
1. The expertise is intended to diagnose, treat and manage the care of patients with rare diseases in a defined catchment area, preferentially national. The expert workplace shows sufficient capacity for expert advice for a given rare disease/group of rare diseases (a rare disease is considered to have a prevalence of no more than 1:2 000 people).
  • current care for a rare disease/group of rare diseases,
  • the catchment area, which the expert workplace manages by covering the necessary health care in the Slovak Republic,
  • material-technical equipment and staffing of an expert workplace for trans-regional, nationwide activities,
  • the expertise performed.
2. The scope of healthcare is organised to cover all needs of patients with a certain rare disease/group of rare diseases in the Slovak Republic. The expert workplace provides a complete range of services for a given rare disease/group of rare diseases, which can be successfully implemented in the Slovak Republic. Diagnostics and treatment must achieve the objectives of European professional standards. Linking and cooperating with other expertise bodies at national, European and international level is required.
  • a request for inclusion in a network of expertise sites,
  • the list of healthcare providers who are included in the network of expertise centres is kept on the website of the Ministry of Health of the Slovak Republic,
  • international bagpipe care for a rare disease/group of rare diseases or international recommendations,
  • cooperation within the Slovak Republic and internationally.
3. The expert workplace is involved in making recommendations for good practice and their applications in practice.
  • the texts of good practices developed by the expert workplace for a rare disease/group of rare diseases,
  • recommendations on nationwide practice or documents of similar focus applied in slovak practice,
  • level of organizational provision of good practice in the Slovak Republic.
4. The expert workplace provides training and training for healthcare professionals in relevant specialties, including paramedical specialists, or also non-medical professionals (teachers, carers), needed for the complex provision of care to patients with rare diseases/a group of rare diseases.
  • educational activities in the last three years, focused on all types of education and training, carried out by experts in the field of expertise (studies, publications, workshops, conferences, courses, etc.) on rare diseases/group of rare diseases).
5. The expert workplace is involved in research to improve knowledge of diseases and optimise diagnosis, care and treatment, including clinical evaluation of the long-term effects of new medicines.
  • research activities of the expert workplace in the area of the rare disease/group of rare diseases concerned,
  • international involvement in research.
6. Use of quality management to provide care, including national and European legislative measures, participation in internal and external quality control schemes, if applicable.
  • participation of the expert body in internal and external quality control schemes.
7. High level of expertise and experience, documented e.g. by the annual number of expertise provided and the consecutive assessments, cited by publications, grants, significant recognitions of the expert workplace.
  • number of registered patients with rare disease,
  • regional distribution of patients with rare diseases,
  • proportion of patients registered in an expert workplace at the assumed slovak-wide incidence,
  • cooperation with other expertise departments.
8. The expert workplace is responsible for collecting data for clinical research, under the applicable legislation of the Slovak Republic subject to the reported obligation of the relevant diseases in order primarily to create a national register of rare diseases.
  • clinical database and assessment of the condition of managed patients in the professional workplace,
  • sending a report on patients from an expert site to the register of rare diseases or other registers held at the National Health Information Centre (this will create the conditions for the creation of a virtual register of rare diseases through which the Slovak Republic will participate in the European network of expert sites and in the European database of rare diseases).
9. The expert workplace demonstrates the scope of a multidisciplinary approach (including, where necessary, the integration of medical, rehabilitation, psychological and social needs).
  • the activities of individual medical disciplines and other specialties involved in a comprehensive solution to the problem of a rare disease/group of rare diseases (such as needs, such as being met).
10. Organisation of cooperation to ensure continuity of care during childhood, adolescence, adulthood and all stages of the disease where necessary.
  • expert guidance,
  • patient registration system by age, etc.
11. Long-term sustainability of the work of the expert workplace within the healthcare organisation system in the Slovak Republic and its financing.
  • information and statistics on the necessary content and scope of activities of the health care professional workplace in the Slovak Republic (data from the nearest populations are documented if these data are not accurate or available for Slovakia).
12. Cooperation of the expert workplace with existing patient organisations on rare diseases.
  • technical lectures at meetings and activities of patient organisations,
  • contributions in magazines issued by patient organisations or on the patient organisations' website.
FINAL EVALUATION:
(describe the strengths and weaknesses of the healthcare provider, taking into account the criteria as well as the total number of full criteria as a percentage)

Table No 2
Procedure for evaluating applications for inclusion of a healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic

1.An application for inclusion of a healthcare provider in a network of national specialised expertise centres for rare diseases in the Slovak Republic may be submitted by a healthcare provider providing healthcare in the field of rare diseases for at least three years.
2.Applications for inclusion of a healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic shall be evaluated on the basis of the twelve criteria set out in Table 1.
3.The Commission of the Ministry of Health of the Slovak Republic for Rare Diseases (Rare Diseases) (hereinafter referred to as "the Commission') established by the Ministry of Health of the Slovak Republic will ensure a transparent evaluation of the applications for the inclusion of the healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic. A member of the Commission shall not be applicant or interested in the applicant. Neither a member of the commission nor a close person shall be a statutory body or a member of the statutory body of the applicant nor a member of the legal person who is the applicant. A member of the commission must not evaluate the application for inclusion of a healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic, submitted by his employer, who is also an applicant.
4.When evaluating applications for inclusion of a healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic, the Commission is independent, evaluating them according to the criteria set out in Table 1 and the procedure set out in Table No. 2.
5.The final evaluation shall identify the strengths and weaknesses of the healthcare provider, taking into account the criteria as well as the overall number of percentage criteria met.
6.The recommended opinion for the inclusion of the healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic requires a total number of met criteria of 75% or more of the highest possible number of 100%.
7.If the total number of criteria met is less than 75%, the application for inclusion of the healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic shall be discarded.
8.As it concerns the provision of concentrated care in a highly and closely specialised area, approval of the application for inclusion of the healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic is not valid.
9.The Ministry of Health of the Slovak Republic, on the basis of the direction of the provision of healthcare in the field of rare diseases, decides to include the healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic, taking into account the evaluated criteria, which are listed in Table 1.
10.The decision to include the healthcare provider in the network of national specialised expertise centres for rare diseases in the Slovak Republic is valid for a limited period, as a rule for three years. After the expiry of this period, the activities of the National Specialised Expertise Centre for Rare Diseases in the Slovak Republic will be reviewed according to the criteria set out in Table 1.
11.The Ministry of Health of the Slovak Republic maintains on its website a list of healthcare providers who are included in the network of national specialised expertise centres for rare diseases in the Slovak Republic.
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