establishing the criteria and procedure for evaluating applications for inclusion healthcare provider to the National List of Workplaces for rare diseases in the Slovak Republic

Annex No 7

METHODOLOGY Commission of MZ SR for rare diseases

METHODOLOGY
Commission of the Ministry of Health of the Slovak Republic rare diseases (Rare Diseases, RD) of 18 November 2015 establishing the criteria and procedure for evaluating applications inclusion of the healthcare provider in the National List of sites for rare diseases in the Slovak Republic

For the development of healthcare for rare patients diseases in the Slovak Republic has an important role in terms of effectiveness centralisation, hierarchy and support to workplaces for rare diseases.

Based on Recommendations on quality criteria for centres of expertise knowledge for rare diseases in the Member States of 24 October European Union Committee of Experts on Rare Diseases 2011 Union Committee of Experts on Rare Diseases, EUCERD) Commission Ministry of Health of the Slovak Republic for rare diseases (Rare) Diseases Þ RD) provides:

Art. 1

Criteria and procedure for evaluating requests for inclusion Health care in the National list of rare workplaces diseases in the Slovak Republic are listed in Annex 1.

Art. 2

This upgrade of the methodological procedure takes effect on 1 April 2018.

František Cisarik, v.r.
The PresidentAnnex 1
on the methodological approach

Criteria and procedure for evaluating applications for inclusion National list of rare diseases workplaces in Slovakia Republic

Table No 1
Criteria for evaluating applications for designation of a provider Health care in the National list of rare workplaces diseases in the Slovak Republic

Criteria for evaluating applications for inclusion Health care provider on the National List workplaces for rare diseases in the Slovak Republic Documented
(in fact)
1. Workplace for Rare Diseases (next) only the ZCH Management of care for patients with rare diseases defined catchment area, preferentially national. Workplace show sufficient capacity for expert advice on the Rare disease/group of rare diseases the disease is considered to be of no more prevalence as 1:2 000 people).
  • to date care detail about certain rare disease/group of rare diseases (numbers)
  • general catchment area of the workplace given expertise,
  • and region which the workplace manages for rare disease/group of rare diseases ev. share of slovakian care for these ZCH (digit)
  • material-technical equipment and personnel providing a workplace for quality activity in the field ZCH
  • carried out expert activity (numbers, documentation, scope).
2. The extent of healthcare is organised to cover all needs of patients with some rare disease/group of rare diseases Slovak Republic. The ZCH workplace provides a complete assortment services for a given rare disease/group of rare diseases, which can be done in the Slovak Republic soficiently Implement. Diagnostics and treatment must achieve European objectives professional standards. Cooperation with others required workplaces at national level and knowledge of European level quality of work.
  • request for inclusion in the National List range of services provided by the ZCH workplace
  • cooperation with workplaces in Slovakia (vertical/horizontal, hierarchical, ZCH system in SR, professional company confirmation)
  • declared work in accordance with the most respected international with a bagel care for certain a rare disease/group of rare diseases; or international recommendation (citation)
  • cooperation with foreign workplaces, possibly within a network for ZCH (menovite)
3. Workplace for rare diseases participate in drawing up recommendations for good practice, and applications in practice.
  • texts good practice procedures, which workplace ZCH developed for rare disease/group rare diseases (citation),
  • recommendations for nationwide practice or documents of similar focus applied in slovakia practice (citation)
  • level organizational provision of the right practice in Slovak Republic (evaluation level diagnostics, therapies, management, definition of necessary Organisational protection)
4. The workplace provides education and training for healthcare professionals in appropriate specialties, including paramedical specialists, or even paramedical specialists non-medical professionals (teachers, carers), necessary for comprehensive care provision to patients with rare disease/group of rare diseases.
  • educational activities for the last three years, focused on all types of education and training, by experts (lectures, publications, workshops, conferences, courses) etc.) on rare diseases/frequent group (number)
  • in the classification for education doctors
  • health workers
  • non-medical workers
5.The ZCH field participates in research; to improve knowledge of diseases and to optimise diagnosis, care and treatment, including clinical evaluating the long-term effects of new medicines.
  • research workplace activities in the area the ZCH/group of the ZCH in question (list)
  • clinical participation trials of medicinal products
  • involvement in international research.
6. Use of quality management to providing care, including national and European legislative measures, participation in internal and external schemes quality controls, if applicable.
  • workplace participation in internal control schemes quality
  • workplace participation in external schemes quality controls
  • use EU Directives on cross-border health care
7. High level of expertise and experience; documented e.g. by the annual number of expertise provided; and Council Regulation (EC) No 659/1999 of 22 March 1999 laying down detailed rules for the application of Article 93 of the EC Treaty (OJ L 83, 27.3.1999, p. 1). significant recognition of the expertise workplace.
  • regional distribution rare diseases (regional region),
  • number of allowances granted expertise extra own region
  • organisation of cooperation other workplaces, providing expertise
  • has an obligation on the workplace dispensation?
8. Workplace ZCH is responsible for collecting data, within the meaning of the applicable Slovak legislation the Republics are subject to the notification obligation of the diseases concerned. Objective is to create a national register of rare diseases and involvement international registers.
  • does the ZCH site have a registry of the ZCH/group?
  • reports ZCH workplace cases to the National Centre health information?
  • is somehow involved in NCZI statistics ?
  • is the site involved in international registers?
  • uses the workplace to classify diseases by Orphanet?
9. Workplace ZCH documents the scope multidisciplinary approach (integration, where necessary medical, rehabilitation, psychological and social This appropriation is intended to cover expenditure relating to:.
  • activities of individual medical disciplines and other specialties involved in a comprehensive solution the issues raised by the FCH/ FCH group
  • involvement of other workers in a comprehensive health and social care solutions
10. Organisation of security cooperation continuity of care during childhood, adolescents, adults and at all stages of the disease where necessary.
  • how the organisation of care is ensured childhood
  • how patients can be transferred to a professional adult care
  • how the patient registration system is ensured by age, etc.
11. Long-term sustainability of workplace activity CSOs within the healthcare organisation system Slovak Republic and its financing.
  • financing of the work of the ZCH, including grants; and external resources
  • equipment and needs for addition to the required european level in the light of expert recommendations
  • innovation needed in action
  • legislative anchoring of the workplace
12. Cooperation of ZCH workplace with existing rare diseases.
  • patient support for ZCH/ ZCH group organization?
  • if not created you have cooperation with any by the patient organisation?
  • you can document activity for example: participating in meetings of the patient organisation, cooperation on practice recommendations, magazine contributions, a website, social cooperation, etc
Appendix:
describe other relevant facts why the application should be assessed positively, describe also the current shortcomings in the system that prevent the full development of your workplace

Table No 2

Procedure for evaluating requests for inclusion of a provider Health care in the National list of rare workplaces Diseases, Upgrade in 2018

1. Request on the designation of the provider health care to the National List of Workplaces rare diseases in the Slovak Republic (hereinafter "National') list) can be submitted by the healthcare provider; providing healthcare in the field of rare diseases for at least 5 years. Rare diseases are for this purpose characterized as diseases with population prevalence less than 1:2000 and as a rule, appear on the list of Orphanet. Knowledge required Orphanete and his coding system.
2. Applications for inclusion of a health provider care in the National list of rare workplaces diseases in the Slovak Republic are evaluated on the basis of twelve block criteria, which are listed in Table No 1. Answer ev. workplace expression required factual on all questionnaire questions.
3. Commission of the Ministry of Health Republics for Rare Diseases (Rare Diseases, RD) (hereinafter: only -COMMISIA-) established by the Ministry of Health of the Slovak Republic The Republics shall ensure transparent evaluation of applications inclusion of the healthcare provider in the National List of workplaces for rare diseases in the Slovak Republic. The member of the commission shall not be the applicant or be interested in the relationship with the applicant. Neither a member of the Commission nor a close person may be a statutory authority or a member of a statutory authority the applicant or a member of a legal person which is the applicant. A member of the commission may not evaluate a request for inclusion Health care provider on the National List workplaces for rare diseases in the Slovak Republic, submitted by his employer, who is also the applicant.
4. The Commission, when assessing applications for inclusion of the healthcare provider in the National List of sites for rare diseases in the Slovak Republic independent, evaluates them according to criteria that are listed in Table 1 and the procedure set out in Table No. 2. Inclusion in the National List is not eligible by law.
5. The final evaluation by the Commission shall strengths and weaknesses health care provider care, taking into account the criteria as well as the total number the percentage criteria met. Commission proposes inclusion workplaces in the National list of rare diseases workplaces in the Slovak Republic to one of two degrees: a. Workplace for rare diseases or b. workplace for rare diseases. Proposal for inclusion a category results from a comprehensive evaluation; and take into account the scope and scope of work at the workplace rare disease areas.
6. For the referral for inclusion Health care provider on the National List workplaces for rare diseases in the Slovak Republic Total number of criteria met required at least 75% from the highest possible number .
7. If total number of criteria met lower as 75%, request for inclusion of a health provider care in the National list of rare workplaces diseases in the Slovak Republic is deleted. The applicant is it shall communicate that result.
8. Since it is about ensuring concentrated care in a highly and closely specialised area; approval of the application for inclusion of a healthcare provider care in the National list of rare workplaces diseases in the Slovak Republic not claimable.
9. Ministry of Health of the Slovak Republic Based on the direction of healthcare provision in rare disease areas and on the basis of preferences of interest in development of health care at all, absolutely o Include the healthcare provider in the National List of sites for rare diseases in the Slovak Republic Having regard to the evaluated criteria set out in the table below, No 1.
10. Decision on the inclusion of the healthcare provider care in the National list of rare workplaces diseases in the Slovak Republic is valid for a fixed period, normally for three years. After the expiry of this period, the activity rare workplace re-evaluated according to criteria that are listed in Table 1.
11. Ministry of Health of the Slovak Republic keep a list of health providers on its website care included in the National List of Workplaces for rare diseases in the Slovak Republic..