Law on quality: there are details of the accreditation procedure

The solutions proposed in the submitted draft clarify and organize the accreditation process, in particular with regard to its course, deadlines and participants in the process.

It is also important to plan accreditation reviews on an ongoing basis, including by setting review dates after the formal evaluation of the accreditation application, in effect ensuring proper review planning and continuity of accreditation, and reducing the waiting time for accreditation reviews to the minimum necessary.

The optional external evaluation of quality in health care will be carried out by the Minister of Health in cooperation with the accreditation center - the Center for Monitoring Quality in Health Care.

The evaluation procedure involves, among other things, reviewing the health care provider for compliance with accreditation standards.

The accreditation review is conducted on the basis of the accreditation review plan. The review plan specifies the schedule of the accreditation review, the scope of the documentation of the accreditation applicant necessary for the accreditation review made available to the visitors for the purpose of the conducted review.

Visitors score the fulfillment of individual accreditation standards, as referred to in Article 34 (2) (7) of the Law on Quality.

The coordinator prepares a draft accreditation review report, which he submits to the other members of the visiting team for approval.

Among other things, the report includes a discussion of each accreditation standard, along with a proposal for scoring the fulfillment of each standard and a justification for this assessment.

The visiting team may record the course of activities carried out as part of the accreditation review by means of an image or sound recording device.

The image or sound recorded by the visiting team shall be archived for a period of 18 months from the date the recording was made. The material referred to earlier may be made available to the members of the visiting team who recorded the records kept by the requesting entity and the course of activities conducting the accreditation review, as well as to the person in charge of the center in connection with the need to consider objections raised by the requesting entity to the review report, in accordance with the provisions of Article 35 of the Law on Quality.

The archived material may also be made available to the Accreditation Council if the Council has doubts about the visiting team's assessment of the facts as presented in the accreditation review report.

In addition, the recorded image or sound shall be made available to the Minister of Health for the purpose of exercising the authority to o conduct a new one-time accreditation review at the requesting entity, in accordance with Article 37 (8) of the Law on Quality, as well as to consider objections and determine the facts in connection with the objection procedure.

The regulation also specifies the model of the accreditation certificate, which includes:

1) the name of the health care provider and the number of the registration book;

2) indication of accreditation standards for a specific type of therapeutic activity or scope of services, e.g. for primary health care;

3) indication of the address and designation of the medical establishment or establishments, or indication of the place where health services are provided, in accordance with the entry in the register of health care providers;

4) the validity period of the accreditation;

5) indication of the legal basis (notice) for the type of accreditation standards subjected to the evaluation procedure.

The amount of fees for the assessment procedure, allowing the costs of the procedure to be covered, was established on the basis of the principles of financing the procedure for accreditation in health care, as set forth in the Law of November 6, 2008 on Accreditation in Health Care (Journal of Laws of 2016, item 2135), repealed by the Law on Quality.

The application for accreditation referred to in Article 26 (1) of the Law on Quality shall be submitted electronically according to the model published on the website of the accreditation center.

Project: TU

Source: RCL