Questions based on Laws 544 and 52 Romanian patient - fair laws and maximum transparency

OBJECTIVE: HEALTHCARE CARD - EASY ACCESS TO THE LIST OF COSTS

• Information requested at CNAS level:

1. What legislation governs the individual's access to information about the costs of the health system related to them?
2. How many insured people are there in Romania?
3. Is EHR (Electronic Health Record) attached to the health card?
4. Why is the patient asked for a certificate of insurance for medical leave at discharge, even though he has a Health Card?
5. As long as the Health Card records all the costs/patient in the public and private health system (if under contract with the CNAS), it means that the CNAS, on the basis of the personal identity card (or the Health Card), can see how much has been spent on each patient in his or her life as a patient. How can the patient access these costs? What are the steps? Does this possibility exist today?
6. If there is no possibility for the patient to have easy access to the list and the amounts spent on him, who should take the necessary steps to make it possible?
7. Is there any data, at CNAS level, on costs/patient? How can we access them?
8. What is the highest amount consumed/patient, in his/her lifetime/year?
9. What is the lowest amount consumed/patient in his/her lifetime/year?
10. What is the average amount consumed/patient over his/her lifetime/year?
11. For minors, can these amounts be found out (easily accessible to their legal guardians)?
12. What are the steps to be taken at this stage for a patient to be aware of the expenditure incurred by the State for the benefit of his/her health?
13. Have sanctions been imposed on medical service providers (with or without a contract with CNAS) for failing to comply with the legal requirements for the registration of medical data in the DES? (EHR) (electronic health record) In that case, how many sanctions have been imposed thus far?
14. How many health care providers and/or doctors are complying with their obligation to enter data in the EHR, out of the total number of doctors and health care providers in the country?
15. Do only providers under contract with the health insurance company register in the EHR
16. Would there be a possibility of enrolment in the EHR for private health services as well?
17. Today, the following practice is common in hospitals: The patient is checked into Hospital A. Parallel to the discharge form (which is given to the patient), the bill for expenses/patient is created, which includes all costs for each operation performed, including the hotel regime. All of the costs in the Settlement remain, but they are not recorded in the database of hospital A, to settle them at CNAS, to the patient, or in a database to which they have access. How can the patient gain access to the costs that concern him? If the patient is transferred to another hospital, B will accompany him with the discharge papers and that will be the end of it. Hospital B will not have access to the database pertaining to it.
18. There are reports that the Health Insurance Company does not have full access to all functions of the Healthcare Card application, because the company that developed the software solution and provides maintenance has kept certain data for management, precisely to keep the CNAS dependent on its services. What can you tell us about this subject?

1. Information requested from the Ministry of Health
2. Is EHR (Electronic Health Record) attached to the health card?
3. Why, on discharge, is the patient asked for a certificate that he is insured, for sick leave, even though he has a Health Card?
4. As long as the Health Card records all the costs/patient in the public and private health system (if under contract with the CNAS or other health insurance companies), it means that the CNAS, on the basis of the personal identity card (or the Health Card), can see what has been spent with each patient in his or her life as a patient. How can the patient access these costs? What are the steps? Does this possibility exist today?
5. As long as the Health Card records all the costs/patient in the public and private health system (if under contract with the CNAS or other health insurance companies), it means that the CNAS, on the basis of the personal identity card (or the Health Card), can see what has been spent with each patient in his or her life as a patient. How can the patient access these costs? What are the steps? Does this possibility exist today?
6. Is there any data, at CNAS level, on costs/patient? How can we access them?
   1. What is the highest amount consumed/patient, in his/her lifetime/year?
   1. What is the lowest amount consumed/patient in his/her lifetime/year?
   1. What is the average amount consumed/patient over his/her lifetime/year?
7. For minors, can these amounts be found out (easily accessible to their legal guardians)?
8. 10. What steps should a patient take right now in order to be aware of the expenses incurred by the state for the benefit of his health?
9. Do only providers under contract with the health insurance company register in the EHR
10. Would there be a possibility of enrolment in the EHR for private health services as well?

• Information requested at the level of the Health Committees in Parliament (possibly also at the level of the Information Technology Committee)

1. As long as the Healthcare Card records all the costs/patient in the public and private health system (if it is under contract with the CNAS), it means that the CNAS, on the basis of the personal identity card (or the Healthcare Card), can see how much has been spent on each patient in his or her life as a patient. How can the patient access these costs? Does this possibility exist today?
2. Are you considering the possibility of regulating the patient's access, on the basis of the personal identity card, to a database (read-only) in which he can see all the costs incurred by the health system (public and private) in relation to him?
3. Who/what institution would be in charge of implementing such a measure, which would be beneficial not only for patients, but also for the provision of data on which to base actionable and enforceable public health policies?

OBJECTIVE: VIDEO RECORDING SURGICAL INTERVENTIONS

• Information requested - European Commission level:
• To the European Commission

COMMISSIONER Stella Kyriakides to the European Commission, Committee on Health and Food Safety

• DIRECTOR: Marina Zanchi, European Executive Agency for Health and Digital Domain

1. Is there legislation in any European country requiring video recording of surgical interventions in operating rooms, given the benefits of such a practice?
2. Is there a plan to enact a European-level legal rule that allows and imposes the procedure (obviously in accordance with GDPR rules)?
3. The funds could be used to finance such programs for hospitals (currently, video recordings of interventions are made sporadically, in certain hospitals, at their initiative, only if the doctor wishes, and only on laparoscope equipment).
4. There are scientific studies throughout the world which show the advantages of such a practice: in terms of teaching/ patient information/ intervention in the event of surgical errors/ malpractice. Is the widespread practice of video-recording surgery being considered in the EU, possibly enforced by legal rules?
5. Is there data on the number of deaths caused by surgical errors? How can we access them?

• Information requested from the Ministry of Health

1. Given the benefits of video recording in operating rooms, are there any laws/legal regulations requiring video recording of surgical interventions in any European country?
2. Does the Ministry of Health have information on the number of operating rooms in all hospitals? What about a situation regarding the adoption of the practice of registering surgery? In how many wards is it practised? How many doctors? In how many hospitals are surgeries registered in Romania? If so, please provide us with access to such data. If not, are you considering the management of such information and its dissemination to the public?
3. Who would fund widespread adoption/investment? Romania could finance such programs for hospitals with the funds?
4. Are there statistics on the number of deaths caused by surgical errors? What about malpractice lawsuits on the subject? How can we access them?
5. Is there data on the number of deaths caused by surgical mistakes? What about malpractice suits in this case? How do we access them?

• Information was requested regarding the Parliamentary Health and Information and Communication Technology Committees (questions 6-8 refer only to the Health Committees):

1. Given the benefits of video recording in operating rooms, are there any laws/legal regulations requiring video recording of surgical interventions in any European country?
2. If such legal standards do not exist, there is a national plan in place.
3. In Romania, how many hospitals are recording surgical interventions?
4. What laws should be added or amended to allow for the widespread use of such a practice? Are decision-makers willing to identify practical solutions (in accordance with GDPR)?
5. Who would fund widespread adoption/investment? Romania could finance such programs for hospitals with the funds?

6. Are there statistics on the number of deaths caused by surgical errors? What about malpractice suits on the subject? How can we access them
7. Are there statistics on the number of deaths caused by surgical errors?
8. List of countries with legislation on surgical registration

OBJECTIVE: IMMEDIATE ACCESS TO THE ENTIRE MEDICAL FILE:

• Information requested from CNAS

1. How many electronic records are now registered?
2. In DES, can data prior to its opening be uploaded?
3. Why do hospitals still work without DES, still on the papers brought by patients, when medical history is needed?
4. Does any healthcare provider (private and public) send you data in the EHR system?
5. What conclusions are there, half a year after the relaunch of EHR, for Public Policy?
6. Do only providers under contract with the health insurance company register in the EHR
7. Would there be a possibility of enrolment in the EHR for private health services as well?
8. Despite the availability of DESI, the following practices are still observed in hospitals: The patient is checked into Hospital A and given an anamnesis upon admission. The hospital A staff can only see data from its database; they cannot see what the patient did in other hospitals (B,C,D...). The patient is asked to bring any paperwork from previous hospitalizations or doctors. At admission and discharge, but also along the road, medical workers spend roughly 30-40% of their time on paperwork and bureaucracy, rather than committing all of their time to patient care/treatment. The patient is given the Discharge Form upon discharge, which states: the patient presented himself at the hospital for...with the symptoms... He was given/performed....x, y, z operations/ Upon discharge, his condition is ... and recommendations are ... When do you expect DESI to be functional and beneficial for its intended purpose?
9. What are the steps to be taken at this stage for a patient to be aware of the expenditure incurred by the State for the benefit of his/her health?

10. Have sanctions been imposed on health care providers (with or without contracts with the CNAS) for failure to comply with the legal provisions concerning the recording of medical data in the EHR (electronic health record)? If so, how many sanctions have been imposed so far?
11. How many health care providers and/or doctors are complying with their obligation to enter data in the EHR, out of the total number of doctors and health care providers in the country?
12. Do only providers under contract with the health insurance company register in the EHR
13. Would there be a possibility of enrolment in the EHR for private health services as well?
14. What legislation regulates the individual's access to the medical record (please indicate the legal rules you are aware of)?

• What legislation regulates the individual's access to the medical record (please indicate the legal rules you are aware of)?

1.1.Although the Electronic Health Record on the CNAS website is active as an application. In practice, for various reasons, doctors do not activate our file: their software does not communicate / is not compatible with that of CNAS / they do not know that this EHR exists and what it does, although it concerns them directly, and us.

What do you know about this situation and how/when will it be resolved? What steps are being taken to ensure that the provisions of the law are also used (real time access to one's own medical file)?

What can we patients do to speed things up? When I requested activation of EHR, no answers were given with the above arguments.

2. There are patients and medical professionals who say, in relation to patient access to the Observation Sheet (the one in the hospital, during the hospital stay), that the patient has access to his or her Observation Sheet only by court decision, which they consider absurd).

There are patients and medical professionals who say, in relation to patient access to the Observation Sheet (the one in the hospital, during the hospital stay), that the patient has access to his or her Observation Sheet only by court decision, which they consider absurd).

What is the reality? Does the patient or the carer need a court order to have access to the Observation Sheet or not? Is there a possibility to have access to this Observation Sheet in real time (sometimes a second opinion may be needed and would help).

3. Today, the following practice is common in hospitals:

• Medical file:

The patient has been admitted to Hospital A. The patient's medical history is taken upon admission (investigations).

Hospital A's staff can only see data from their database; they cannot see what the patient did in other hospitals (B,C,D...).

The patient is asked to bring paperwork from previous hospitalizations or doctors.

At admission and discharge, but also along the way, medical personnel spend about 30-40% of their time on paperwork and bureaucratic procedures, rather than allocating all of their time to patient care/treatment.

The patient is given the Discharge Form upon discharge, which states: the patient presented himself at the hospital for...with the symptoms.... He was given/performed....x, y, z operations/Upon discharge, his condition is........ and they are recommended....

REIMBURSEMENTS - expenses/patient - patient has no access to it (FACIAS encountered only one exception, the other days, during the research)

• Observation record (opens on admission)

It is only accessible to doctors, medical personnel involved in the patient's medical care, and medical/doctors requested for interconsultations.

Except by court order, the patient does not have access to the Observation Record.

The statistical departments of the hospitals take the observation sheets and enter them, by codes, into the database

We don't know if it is a practice, but, we have met hospitals that do not have Statistics linked to the internet, in order to avoid the risk of viruses and to secure the information.

The observation records are also archived in the hospital for many years.

In the discharge form, the patient is listed all treatments, investigations, tests, interventions.

We don't know if it is a practice, but, we have met hospitals that do not have Statistics linked to the internet, in order to avoid the risk of viruses and to secure the information.

We would ask you to enlighten us, so that, in our turn, we can pass on useful, realistic information or advice to the patients who request our support. You have all the data and the experts who know exactly what is going on.

And also, please let us know whether or not this practice, on the two topics (access to medical records and Observation Sheet) is okay and what we have to do?

4. Why don't all hospitals issue the Discharge Report, but only the surgeries and clinics established under the law OG 124/1998?

Since 2006, the disclosure of expenses for ambulatory medical services provided by specialist doctors in medical offices created in accordance with Government Ordinance No. 124/1998 has been necessary (ORDER NO. 1.100/2015 of the Minister of Health).

OBJECTIVE: CONTINUOUS, TRANSPARENT MONITORING AND REDUCTION OF IN-HOSPITAL INFECTIONS

• Information requested from the Ministry of Health

1. What legislation governs the continuous, transparent monitoring and reduction of intra-hospital infections ?
2. Why hasn't the CNPLIAAM been set up yet? When will it be set up?
3. Do you have a situation of hospitals in Romania that have or do not have an epidemiologist?
4. How many hospitals in Romania do not have an epidemiologist?
5. What tools do hospitals without an epidemiologist have at their disposal to identify and report nosocomial infections?
6. Is there an annual statistic, a database with reports of nosocomial infections made by hospitals? How do we have access to it? If not, who is in charge of it?
7. Does the legislation make it compulsory to report nosocomial infections? What are the measures for those who do not report/do not report? Who imposes sanctions and what are they? Is there a centralised record of sanctions imposed?
8. Do you know the reasons why these reports are not made or are made superficially? Please provide us with these reasons if you know them.
9. Do you know the reasons why these reports are not made or are made superficially? Please provide us with these reasons if you know them.
10. How can I know/transparently know what nosocomial infections are in a hospital?
11. What are the steps to be taken by a patient in a situation of being infected with HAI? Are tests only done in the hospital or can they be done individually? To whom does this patient or their relatives turn (if, unfortunately, there is a death)?
12. How can cases of non-reporting or incomplete reporting of nosocomial infections be sanctioned, given that Law 3 stipulates that the sanctioning of such cases is to be carried out in accordance with the methodological rules for the application of this law, which have not yet been issued?
13. How many times in the last five years has the Romanian State been taken to court in cases of patients who have suffered nosocomial infections?
14. How many times in the last five years has the Romanian State been taken to court in cases of patients who have suffered nosocomial infections?
15. What is the total compensation paid by the Romanian state for people who suffered from intra-hospital infections in the last five years?
16. What prevention and containment measures has the National Institute for Public Health proposed to the Ministry of Health, in accordance with its legal obligations?
17. How has the Ministry of Health cooperated so far, in accordance with the law, with the ECDC and the WHO to ensure the transposition of European and global recommendations on nosocomial infections?

• Information requested from the Romanian Society of Epidemiology::

1. Do you have a situation of hospitals in Romania that have and that do not have an epidemiologist?
2. How many hospitals in Romania do not have an epidemiologist?

1. Information requested from the NATIONAL INSTITUTE OF PUBLIC HEALTH:
2. Are there annual statistics, a database with reports of nosocomial infections made by hospitals? What is the periodicity with which this is done? Who carries them out? How can we access them?
3. How many hospitals make these reports and how many do not?
4. Do you know the reasons why these reports are not made or are made superficially? Please provide us with these reasons if you know them.
5. Are there any statistics or situations showing the rate of deaths caused by intra-hospital infections in Romania? How can we have access to them?
6. How can I know/transparently know what nosocomial infections are in a hospital?
7. What are the steps to be taken by a patient in a situation of being infected with HAI? Are tests only done in the hospital or can they be done individually? To whom does this patient or their relatives turn (if, unfortunately, there is a death)?
8. How can cases of non-reporting or incomplete reporting of nosocomial infections be sanctioned, given that Law 3 stipulates that the sanctioning of such cases is to be carried out in accordance with the methodological rules for the application of this law, which have not yet been issued?
9. How many times in the last five years has the Romanian State been taken to court in cases of patients who have suffered nosocomial infections?
10. What prevention and containment measures has the National Institute for Public Health proposed to the Ministry of Health, in accordance with its legal obligations?

• Information requested from ANMCS-–

1. Is there an annual statistic, a database with reports of nosocomial infections made by hospitals?
2. How many hospitals make these reports and how many do not?
3. Do you know the reasons why these reports are not made or are made superficially? Please provide us with these reasons if you know them.
4. Are there any statistics or situations showing the rate of deaths caused by intra-hospital infections in Romania? What is the frequency with which they are carried out? Who carries them out? How can we have access to them?
5. How many hospitals in Romania do not have an epidemiologist?
6. Does the legislation make it compulsory to report nosocomial infections? What are the measures for those who do not report/do not report? Who applies sanctions and what are they? How many times has the Romanian state been taken to court in the last five years for cases of patients suffering from nosocomial infections?
7. How many times in the last five years has the Romanian State been taken to court in cases of patients who have suffered nosocomial infections?
8. What is the total compensation paid by the Romanian state for people who suffered from intra-hospital infections in the last five years?

OBJECTIVE: ALL LAWS CONCERNING PATIENTS HAVE METHODOLOGICAL RULES WITHIN THE TIME SPECIFIED IN THE LAW

• Information requested from the Legislative Council (at the moment this is the institution that might have the first answers -. ...

Information requested from the Romanian Legislative Council http://www.clr.ro/ ):

1. Can laws without methodological rules be applied? If so, what are the criteria?
2. What happens when a ministry (the institution in charge of drafting and publishing the methodological rules for the application of a law) does not draft the rules within the time limit set in the law (30 days) after the publication of the law?
3. What are the methods by which those interested in the application of the law for which the implementing rules have not been published can take steps to have the rules made?
4. What would be the solutions for the application of some laws, if they do not have methodological rules?
5. Who/what institution is empowered to manage/check compliance with deadlines for the production and publication of implementing rules for laws that provide for this?
6. Is there a monitoring mechanism for this purpose? If so, what is it? Who manages it?
7. What are the possibilities for a citizen who receives the following answer: "The law is in force, but we cannot apply it because we do not have the rules"? There are situations where we have laws without implementing rules that last for more than one or two years, even though the rule is 30 days.
8. Is there anywhere an up-to-date situation of all laws without implementing rules that have been worked on within the time limit laid down in the texts of the laws? If so, how can we access it?

• Information requested from the Ministry of Health

1. The Ministry of Health has a legal obligation to produce Methodological Norms for the health laws. How many (and which) laws concerning patients, health system (e.g. law ref diabetes) are without implementing rules, although they provide for this?
2. For which laws (for which it was foreseen to develop methodological implementing rules) has the deadline for developing the necessary methodological rules been exceeded?
3. Can you provide us with a list of the exact laws (those for which the Ministry of Health is responsible) for which the methodological rules have not yet been drawn up and a timetable for their implementation, especially for those for which the deadline has passed?
4. What opportunities are available to citizens who are affected by a law, but it has no implementing rules and they are told that it will apply when the rules are in place?