THE PROCESS OF EVALUATION AND ACCREDITATION OF OUTPATIENT HEALTHCARE UNITS(.pdf)
Accreditation is the process of validating the conformity of the characteristics of the health services, performed by the health units, with the accreditation standards adopted by the National Health Quality Management Authority, after which the health units are classified according to the accreditation categories to give confidence in their technical-professional and organizational competence.
To create the legislative framework for carrying out the imperative provisions of art. 6 lit. c) of Law no. 185/2017, with the subsequent modifications, according to which the ANMCS elaborates the standards and the methodology of accreditation of the health units, with the consultation of the Ministry of Health and of the authorities, institutions and organizations that have representatives in the Board of Directors of ANMCS, the Standards of the National Authority for Quality Management in Health for the outpatient health services were developed for 10 categories of outpatient health services, as follows: Standards for paraclinic radiology and medical imaging, Palliative Care Standards, Hospital Emergency Standards, Home Health Care Standards, Personalized Medical Device Prescription Standards, Outpatient Specialty Standards, Paraclinical Laboratory Standards, Medical Standards physics and rehabilitation, Standards for primary health care – family medicine, Standards for dental medicine.
Thus, the ANMCS standards and the methodology of evaluation and accreditation of the outpatient health units comply with the following principles:
- a) ensuring a quality management system of the health services and of the patient’s safety, to continuously improve them;
- b) ensuring non-discriminatory access of the patient to the health services, according to his needs, the mission and the resources of the outpatient health unit;
- c) respect for human dignity, principles of ethics and medical deontology and care for the patient’s health;
- d) orienting the organizational management towards the support of the patient-centred activities;
- e) ensuring the health status of the population through prevention, integrated, inter- and multidisciplinary approaches;
- f) promoting the efficiency and efficiency of health services by optimizing the decision-making process and by developing the concept of professional practice evaluation through clinical audit;
- g) promoting the concept of quality of health services and patient safety, as part of the organizational culture;
- h) environmental protection;
- i) transparency and openness, by continuously and efficiently informing the beneficiaries about the accreditation process, in all its stages;
- j) independence, objectivity, confidentiality and impartiality of the evaluation, accreditation and monitoring process;
- k) the integrity and professionalism of the evaluators.
GENERAL OBJECTIVES OF ACCREDITATION STANDARDS:
- Increasing the effectiveness of primary and secondary prevention through:
- – To know the exposure to risk factors of the people in the care of the family doctor and to take preventive measures
- – Early detection of pathological changes, determined by exposure to risk factors
- – Ensuring integrated management, and interdisciplinary collaboration of the case by the harmonization between all levels health;
- Increasing access to health services through:
- – Improve communication between professionals
- – Ensuring the clinical path of the patient
- – Respect for the levels of professional competence
- – Identify the management-level disturbances generated REGULATIO health units in the country’s health system and develop recommendations to deal with them.
Monitoring
During this period the accredited sanitary units will have, for assistance, a zonal responsible for the monitoring. Monitoring consists of:
- – the transmission by the health unit at 6 months and 1 year of information established by the specialized departments of ANMCS and made available to the health unit accredited through the CaPeSaro computer application. Thus, the compliance with the requirements on which the accreditation was granted as well as the remediation, in dynamics, of the non-conformities found at the time of the evaluation is permanently evaluated.
- – the communication by the accredited sanitary units, through the computer application CaPeSaro of any changes in their structure. By analyzing this information, ANMCS assesses whether the changes made affect the level of compliance with the standards on which the accreditation was issued.
- – reporting by the health unit of the possible adverse events associated with the healthcare, which are collected by ANMCS anonymously, to learn from errors. From the analysis of these data, ANMCS periodically elaborates information that it makes available to the health unit through the institution’s website.
01. What are the types of health services provided on an ambulatory basis that have the obligation to accredit ANMCS?
Answer: As a result of the amendments brought to Law 185/2017 on quality assurance in the health system, by LAW no. 329 of December 21, 2018, published in the MONITORUL OFICIAL no. 1103 of December 27, 2018, accreditation is a mandatory condition for ambulatory health units that provide the following types of health services:
- – ambulatory health services – paraclinical radiology and medical imaging
- – ambulatory health services – palliative care
- – ambulatory health services – pre-hospital emergency
- – ambulatory health services – home medical care
- – ambulatory health services – personalized medical devices according to a medical prescription
Ambulatory health units that do not have the obligation of accreditation can voluntarily enroll in the accreditation process, going through the same stages of the enrollment process.
02. What is the difference between standard medical devices and personalized medical devices according to a medical prescription?
Answer:
Medical devices manufactured to order are devices specially manufactured according to the written prescriptions of a duly qualified medical practitioner, who establishes for him, at his own risk, specific design characteristics and which is intended to be used only by a certain patient. . The above prescription may also be issued by any other person authorized by virtue of his professional qualification. Serial devices are standard, non-personalized medical devices. Serial devices that must be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered custom devices.
03. Is the ambulatory clinic integrated in the structure of the sanitary units with beds accredited together with the sanitary unit with beds or separately?
Answer: The ambulatory clinic integrated in the structure of the sanitary units with beds is accredited together with the sanitary unit with beds.
04. Will the date of the expiration of the evaluation of the Health Insurance House be taken into account when scheduling the evaluation visit?
Answer: For scheduling the evaluation visit, the expiration date of the evaluation of the Health Insurance House will be taken into account, along with other criteria such as the territorial optimization of the evaluation visits, the optimization depending on the type of health care evaluated, etc.
05. Will the health units that provide palliative care services and have day hospitalization be evaluated according to the criteria of the health units with beds or according to the criteria of the ambulatory health units?
Answer: All health units that also have day hospitalization will be evaluated according to the criteria of the health units with beds.
06. Do the health units that provide radiology and dental medical imaging services (radiodiagnostics) have the obligation to accredit ANMCS?
Answer: Yes, given that they are ambulatory health services – paraclinical radiology and medical imaging.
07. Are the registration certificates in the ANMCS evaluation obtained before 01.12.2019 still valid for contracting with CNAS?
Answer: They are no longer valid. In order to obtain a new certificate, it is necessary to update the data in the REGISTRATION section of your account in the Capesaro application and to go through the REGISTRATION stage in the evaluation process. After completing these steps you will be able to download the certificate.
08. If the ambulatory health unit has several work points and provides more types of medical care, is it necessary to create more accounts in the Capesaro application?
Answer: No, only one account will be created. In the registration section, the data of the registered office and the structure of the health unit will be filled in, and in the sign up section, all the working points and all the categories of medical care that will be evaluated will be filled in.
09. Is it possible to evaluate only some categories of the categories of services provided by the ambulatory health unit?
Answer: Yes, in the sign up section will be filled only the categories of medical care that are not exempted from the accreditation obligation, as well as those that the health unit intends to evaluate even if they fall into the category of those exempted.
10. Are the radiology and medical imaging services within the structures of the sanitary units with beds accredited together with the sanitary unit with beds or separately?
Answer: The radiology and medical imaging services that are within the structure of the sanitary unit with beds are accredited together with it.
11. Is the medical analysis laboratory within the structures of the sanitary units with beds accredited together with the sanitary unit with beds or separately?
Answer: The medical analysis laboratory within the structure of the sanitary unit with beds is accredited together with the sanitary unit with beds.
12. Does the contact e-mail address have to be the legal representative’s, or can it be the contact address of the institution, accessed every day?
Answer: As the legality and correctness of the transmitted documents is assumed by the legal representative by accessing the account through automatically generated access data, the e-mail address provided should be that of the legal representative or the person designated to upload the documents.
13. Does ANMCS accreditation replace RENAR accreditation for laboratories?
Answer: The existence of Renar certification / accreditation is for laboratories a proof of concern for the quality of the services provided but is not equivalent to ANMCS accreditation and does not represent a mandatory condition for accreditation.
14. Does the registration in accreditation require the payment of a fee at the time of registration?
Answer: NO. This registration process does not involve costs from the health units. This process creates the communication infrastructure between the health units and ANMCS as well as an estimate of the volume of activity of the institution taking into account the annual and multi-annual planning of the evaluation of ambulatory health units in the first accreditation cycle. The accreditation fee will be customized for each health unit, depending on the complexity of the structure and the services offered.
15. As the accreditation of ANMCS is a lengthy procedure, are there special specifications for the situation in which new work points are opened after registration, the structure of a department is changed or the activity in a work point is restricted?
Answer: During the validity period of the accreditation, during the post-accreditation monitoring, the deployment of some structures will not influence the accreditation and the new established structures will have to be accredited, according to the law, in maximum 5 years from the establishment.
16. After completing the registration I did not receive an email with the login details (username and password). What to do?
Answer: If you did not receive the login information on the completed email address, check that the email sent by the application has not been filtered and distributed in the “Junk Email” or “Spam” folder or it is possible that the email address to be filled in incorrectly at the registration stage.
17. If I fill in the email address incorrectly, what should I do?
Answer: The registration process must be resumed.
18. Where can I find registration and registration information?
Answer: In the tutorial “REGISTRATION AND REGISTRATION IN EVALUATION” that you can view and download from the page ANMCS – ACCREDITATION AMBULATORY 2020 – REGISTRATION AND REGISTRATION IN THE ACCREDITATION PROCESS or registration ENTRY (ENTRY TUTORIAL):
https://anmcs.gov.ro/web/wp-content/uploads/2020/04/Tutorial-Capesaro.pdf
19. The health unit has an account in the Capesaro application created in 2017-2019. What to do?
Answer: It is necessary to update the data in the registration section of your account in the Capesaro application and go through the sign up stage in the evaluation process. After completing these steps you will be able to download the registration certificate.
