Key Benefits:
Decision of 13 November 2015 laying down detailed rules for the implementation of the Law on quality, complaints and disputes (Implementing Decision Wkkgz)
We Willem-Alexander, at the grace of God, King of the Netherlands, Prince of Orange-Nassau, etc. etc. etc.
On the nomination of Our Minister of Health, Welfare and Sports of 15 May 2015, attribute 755048-135567-WJZ;
Having regard to the Article 1, third paragraph , 4, second and third members , 5 , 8, third member , 9, fourth member , 13, fifth paragraph , and 25, 2nd paragraph, of the Law quality, complaints and disputes care , Article 7, second paragraph, of the Tobacco Act , Article 15, 1st paragraph, of the Act use civil service number in care and Article 3, 1st paragraph, of the Law on Medical Devices , and Article 6 of Directive 2002 /98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of blood and blood components of human origin and amending Directive 2001 /83/EC of the Council (PbEU L 33);
The Department for the Advisory Board of the State heard (opinion of 29 June 2015, no. W13.15.0150/III);
Having regard to the further report by Our Minister of Health, Welfare and Sport of 10 November 2015, attribute 804964-139584-WJZ,
Have found good and understand:
For the purposes of this Decision and the provisions based thereon, the following definitions shall apply:
- Other notification: Other notification other than in the Article 11 of the Act ;
- Incident: an unintended or unexpected event, which relates to the quality of care, and has led, could have resulted or could lead to damage to the client;
- Inspection: Health Care Health Inspecting of the State Supervision on Public Health;
- internal procedure reporting incidents: internal procedure as referred to in Article 9, second paragraph, of the Act ;
- the complaints scheme: arrangements for the reception and handling of complaints as referred to in Article 13, first paragraph, of the Act ;
- Medical technology: application of organized knowledge and skills in the form of devices, medicines, vaccines, procedures and systems developed to solve health problems and improve the quality of life;
- Milder: the person who has made the notification;
- discharge in connection with disfunctions: denunciation, decomposition or non-continuation of an agreement between a healthcare provider and a healthcare provider on the basis of the judgement of the healthcare provider that the healthcare provider has been seriously deficied in its functioning;
- Product: product or device that finds application in care, including a product within the meaning of the Blood supply law -a medicinal product within the meaning of the Pharmaceutical Act , a medical device within the meaning of the Law on medical devices , body material within the meaning of the Law Safety and Quality of Body Material and a means within the meaning of the Opium Law ;
- Explanation of behaviour: Explanation of behaviour as referred to in Article 28 of the Law and Criminal Justice Act ;
- mandatory notification: notification referred to in Article 11 of the Act ;
- Hospital blood bank: Hospital compartment containing blood and blood components, intended for use only in hospitals, including for transfusion activities in a hospital, stores and distributes, and may carry out compatibility tests on that.
The Law shall not apply to:
a. The use of an UAD medicine or an AV medicinal product as intended to be used Article 1, first paragraph, parts t and u, of the Medicines Act ;
b. Aid resources as defined in Article 2.9 of the Act of Health Insurance ;
c. transport as defined in the Article 2.5, first paragraph, points (e) and (f) , 2.14 and 2.15 of the Decision on health insurance .
1 The care provider who is an institution providing Wlz care is in possession of a statement of behavior for health care providers providing care to its clients and for persons other than health care professionals in charge with its clients. can be contacted not earlier than three months prior to the time when the person concerned worked for the healthcare provider.
2 The care provider who is a solistically employed healthcare provider providing Wlz care is in possession of a statement regarding the conduct, issued at a time when not longer than three years has elapsed.
3 The first paragraph shall apply mutatis mutandis to the healthcare provider which is an institution providing medical mental health care as intended in the Health insurance decision which accommodation of the client brings with him in an accommodation during the dinner.
1 The care provider shall ensure the safe application of medical technology to the care provided in accordance with the responsibility of health care providers, resulting from the professional standard, including the quality standard, intended in Article 1 (z) of the Zorginsurance Act And field standards.
2 The healthcare provider shall also ensure the written commitment of medical technology to:
a. tasks, powers, responsibilities and competence requirements for those involved;
b. The information showing compliance with the standard of competence is required.
3 By arrangement of Our Minister, if necessary to ensure the safe application of medical technology, further requirements may be made to certain categories of health care providers.
1 The personnel of a hospital blood bank directly involved in the storage, testing and distribution of blood and blood components of human origin, shall have the necessary qualifications to carry out those tasks and shall be given timely suitable training and regular retraining.
2 The health care provider performs a quality management system for a hospital blood bank and applies it based on the principles of good practice.
3 The health care provider that maintains the hospital blood bank reports to State Department officials on public health and to the Blood Supply Organization intended in the area. Blood supply law , serious adverse events related to the storage, testing and distribution of blood and blood components that may affect its quality and safety, as well as serious adverse reactions occurring during or after transfusion. have been identified and can be attributed to the quality and safety of the blood and blood components.
4 The care provider that maintains the hospital blood bank ensures that the data collected when storing, testing and distributing blood and blood components collected by third parties, including genetic material, can be used. information, have been anonymised so that the donor is no longer identifiable. To:
-take measures for the purpose of data security, and shall create guarantees against unauthorised addition, deletion or alteration of files from donors or exclusions and against the transfer of information;
-he shall establish procedures to eliminate discrepancies between data;
-prevents any unauthorised disclosure of such information, but the donations must remain traceable.
5 The care provider who maintains the hospital blood bank also takes up the rules laid down by our Minister for the implementation of decisions of the European Union and other decisions of international law when exercising his/her duties. organizations in eight.
1 The internal procedure reporting incidents shall in any case contain rules on how the organisation:
a. Incidents shall be identified and reported for the purpose of carrying out an analysis;
Incidents, involving the care provider, colleagues and other experts involved, are being investigated;
(c) a decision shall be taken as soon as possible on the measures to be taken on the basis of the examination of a notification to ensure the quality of care;
d. the health care provider concerned and the relevant organisation part shall be informed of the results and conclusions of the analysis.
2 In addition, the internal procedure shall contain:
(a) the designation of one or more of the officials to whom incidents are reported;
b. the allocation of responsibilities to the persons referred to in point (a) and to other staff;
(c) principles of independent judgement, expertise and continuing training of the staff members referred to in point (a);
d. ensure the protection of personal data, including in any case the occurrence of excessive data processing, anonymisation of data as soon as possible, and the security of the reporting system;
(e) ensuring that the reporter and the officers referred to in point (a) are subject to the effects of complying with the internal procedure.
The complaints scheme of a healthcare provider ensures that a person as intended in Article 15, first paragraph, of the Act :
a. is not involved in the matter to which the complaint relates;
b. In carrying out its work, it shall aim at reaching as satisfactory a solution as possible to the complaint;
c. has the freedom to carry out its activities according to the Law , the professional standards and terms of reference for him, and without interference by the care provider.
The complaints scheme shall ensure that pending complaints are made available to the care provider by one or more persons employed by the care provider or by one or more third parties appointed by the care provider, if the handling of the complaints is to be made to the care provider. health provider is brought, and that the care provider receives copy of the written notice, referred to in Article 17, first paragraph, of the Act .
1 The complaints scheme ensures that the treatment of a complaint relating to the action of another person is carefully transferred to the person concerned, on whose action the complaint relates, unless the complainant does not have to do so. has been given permission.
2 The complaints scheme ensures a combined handling of complaints where a complaint relates to care being provided in connection with care, support or assistance that another grants and the complainant has made known that he is also involved in that has lodged a complaint, unless the complainant has not authorised it.
3 The complaints scheme shall ensure that the handling of a complaint as referred to in the second paragraph is made by, or on behalf of, the healthcare provider concerned and the other concerned jointly or in a manner that does justice to the coherence between the care, support, or assistance they provide.
1 A compulsory notification shall be made by electronic means or in writing at the Inspection.
2 A mandatory notification shall contain:
a. the name and contact details of the healthcare provider doing the notification, the Article 9 (a) , and Article 11, first paragraph, point (a) of the Commercial Registry Act 2007 Unique numbers, as well as the name and function of the reporter;
b. the day drawing of the notification;
c. Where a notification involves a product, the name of the product and the name and contact details of the company involved in the product;
d. the indication of whether it is a calamity, violence in the care of care or dismissal related to disfunctioning;
e. the indication of whether it is a health care provider registered in a registry as intended in Article 3 of the Act on Professions in Individual Health Care ;
f. where applicable, the name, contact details and date of birth of the affected cliёnt.
The mandatory notification of a calamity shall also include:
a. A de facto description of the calamity and the date on which it has taken place;
b. a brief description of the actions that have been and will be taken by or on behalf of the healthcare provider concerned, and the period within which it will take place:
1 °. to investigate the calamity;
2 °. to limit or promote the recovery of the consequences of the calamity;
3 °. to inform the client, his legal representative or his next of kin of the calamity, the measures taken by the healthcare provider in response to the calamity, and about the care provider present in the care provider the complaint handling;
c. Whether the calamity in connection with a reasonable suspicion of committing a criminal offence has been or will be brought to the attention of the Public Prosecutor ' s Office.
The mandatory reporting of violence in the care relationship also includes:
a de facto description of the violence and the date on which the violence took place;
b. the name, contact details and function of the persons other than the client, to whom the violence was committed, who were involved in the violence;
a concise definition of the actions which have been and will be undertaken by, or on behalf of, the healthcare provider concerned, and the period within which any action will be taken:
1 °. to investigate the violence in the care of care;
2 °. to limit or promote the recovery of the effects of the violence;
3. to inform the client against whom the violence was committed or his legal representative about the violence, the measures taken by the healthcare provider, or will take it, and on the person present in the care provider. the complaint handling;
d. Whether the violence in connection with a reasonable suspicion of committing a criminal offence has been or will be brought to the knowledge of the public prosecutor ' s office.
The compulsory reporting of dismissal in connection with disfunction shall also include:
a de facto description of the serious misconduct of a health care professional who has led the care provider to resign as a result of the disfunctioning or has manifested the care provider not to continue the contract;
b. the name, contact details and function of the health care provider concerned, as well as, where appropriate, the number, intended Article 3, 2nd paragraph, of the Act on the professions in individual health care , including the person concerned, is entered in the register;
c. a brief description of the actions undertaken by, or on behalf of, the healthcare provider concerned in order to:
1 °. to discuss the functioning of the health care provider with these;
2 °. improve the functioning of the system;
3 °, where appropriate, the communication that a case has been or will be brought before the competent regional disciplinary college.
1 The Inspectorate shall confirm receipt of a mandatory notification in writing or by electronic means to the reporter as soon as possible, indicating the contact details of the Inspectorate.
2 The inspection shall, in the confirmation referred to in paragraph 1, or within four weeks from the date of acknowledgement of receipt, send to the reporter a summary of the actions the Inspectorate will undertake and shall do so (i) communication of the period within which it will take place.
3 If not fulfilled, the Articles 8.1 to 8.4 , the Inspectorate shall give written or electronic notification to the healthcare provider concerned, within a period of two weeks, to fill in the notification.
1 The healthcare provider concerned and the health care providers concerned shall, following a mandatory notification to the Inspectorate, provide all the information necessary for the examination of the notification.
2 Data referred to in paragraph 1 shall include personal data and, if requested by the Inspectorate, information on the health and other special personal data of the reported facts in the reported facts. or clients and the health care providers concerned.
1 With regard to mandatory reporting of a calamity or violence in the care relationship, the Inspectorate is amassing knowledge of the relevant facts and the off-to-road interests necessary to establish or arise from a situation that is common to the security of clients or care or otherwise for providing good care can be a threat and may give rise to the adoption of measures.
The Commission shall, for the purpose of the task referred to in paragraph 1, carry out an examination of the responsibility of the healthcare provider or the undertaking concerned with due regard for the requirements to be given by the Inspectorate within eight weeks of its own investigation. to the relevant facts, unless the nature of the notification or any other information about the healthcare provider concerned or the company concerned gives the Inspectorate a failure to do so. The Inspection may extend the period at the request of the healthcare provider concerned or of the holding concerned.
3 The requirements referred to in paragraph 2 shall, in any event, relate to the manner in which the client concerned, or his/her representative or his/her descendants are informed of the calamity or violence, is involved in the investigation and shall be informed of the results thereof.
1 The inspection shall itself carry out the necessary examination if it finds that the healthcare provider concerned or the undertaking concerned does not itself carry out the requested examination, or the investigation does not comply with the requirements set out in Article 8.7, second paragraph .
2 If the Inspectorate itself does the necessary research:
(a) notify the reporter, in writing or by electronic means, of the time within which the investigation will be carried out;
(b) hear the healthcare provider or company concerned, the client concerned, or his/her representative or his representative, and, unless this is not considered relevant to the investigation, if possible, other persons directly affected by the investigation; Involved in the facts covered by the notification;
(c) shall obtain the written or electronic advice of one or more experts if it considers that it is important for the investigation.
3 Of the hearing referred to in paragraph 2 (b), a report shall be drawn up. The report is presented to those with whom it has been spoken. They will have the opportunity to respond in writing or electronically within two weeks to any factual inaccuracies in the report. The corrections received shall be incorporated or justified in the report.
1 If the Inspection on the basis of Article 8.7, second paragraph , the investigation finds that the matter covered by the notification has been carefully examined and that sufficient measures have been taken by the provider of care or the undertaking concerned, concludes the investigation. as a result of the notification.
2 The inspection shall indicate the termination in writing or by electronic and reasoned communication to the reporter and to the healthcare provider or the undertaking concerned.
1 Upon termination of the investigation, other than with application of Article 8.9 , the Inspectorate shall record the relevant facts in a draft report.
2 A draft report shall be notified as soon as possible to the reporter, the healthcare provider or the undertaking concerned and natural persons who have been heard during the investigation.
3 Those to whom the draft report has been notified shall be given the opportunity of responding in writing or electronically within four weeks to factual inaccuracies in the draft report.
1 As soon as possible after receipt of the reactions, Article 8.10, third paragraph , but in any case within four weeks of the period specified in that paragraph, the Inspectorate shall issue a report on the examination of the notification. The report shall contain the relevant facts, the conclusions of the Inspectorate and the measures to be taken.
2 In adopting the report, the Inspectorate refers to the reactions referred to in the Article 8.10, third paragraph . If those to whom the draft report has been notified under Article 8.10, substantially differ with the Inspectorate on the relevant facts, as laid down in the draft report, and the Inspectorate does not or may not in writing or by electronic means, it shall inform the person concerned thereof and shall include the views of those concerned in the report to be adopted.
3 If the findings of the report include that a health care provider is, or has been, a situation as referred to in Article 25, first paragraph, of the Act , the adoption of the report, by way of derogation from the first paragraph, shall not take place than after the care provider concerned has been given the opportunity to comment on the report.
4 The inspection shall send the report in writing or by electronic means to the reporter, the healthcare provider or the undertaking concerned as soon as possible and the natural or legal persons involved in the investigation.
1 With regard to mandatory reporting of a disservice dismissal, the Inspectorate is collecting knowledge of the relevant facts and the off-to-balance interests necessary to establish if there is a situation that is common to the security of clients or care or otherwise for delivering good care can represent a threat and therefore may be a reason for taking action.
2 The Inspectorate shall carry out further investigations following a notification as referred to in paragraph 1 and shall, in any event, invite the care provider concerned to have a call within a reasonable period to be set by the Inspectorate. If the health care provider concerned is not registered in a register as referred to in Article 3 of the Act on Professions in Individual Health Care , the further investigation may be omitted unless, in the opinion of the Inspectorate, there are reasonable grounds to believe that a serious risk exists for the safety of clients or the care or otherwise supplying of the customer. Good care.
3 In the call, the Inspectorate investigates whether there are grounds for taking action, and relates what the state of affairs is and which are the intentions of the health care provider concerned in relation to:
(a) the continuation or resumption of its work;
b. the removal or improvement of the aspects of his operation which have led to the dismissal in connection with disfunction or which have manifested the healthcare provider not to continue with the contract.
1 Upon termination of the further investigation, specified in Article 8.12, second paragraph , the Inspectorate shall record the relevant facts in a draft report.
2 If the health care provider concerned shows sufficient willingness to take steps, focused on the in Article 8.12, third paragraph, point (b) The draft report, defined purpose, in each case contains the steps that the healthcare provider will take, the time limits within which these steps will be taken and the way in which he will keep the inspection of the progress in it.
3 A draft report shall be notified to the health care provider concerned as soon as possible.
4 The healthcare provider concerned will be given the opportunity to respond in writing or electronically within four weeks to factual inaccuracies in the draft report.
1 As soon as possible after receipt of the reactions, Article 8.13, third paragraph , but in any case within four weeks of the period specified in that paragraph, the Inspectorate shall issue a report on the examination of the notification. The report shall contain the relevant facts, the conclusions of the Inspectorate and the measures to be taken.
2 In adopting the report, the Inspectorate refers to the reaction in question: Article 8.13, fourth paragraph If the health care provider concerned is substantially different from the Inspection view on the relevant facts as laid down in the draft report, and the Inspectorate does not take over or take over a reaction, it shall inform it in writing or by electronic means. to the person concerned and shall take into account the views of those concerned in the report to be adopted.
3 If, to the conclusions of the report, it is a matter of concern to the care provider or has been of a situation as specified in Article 25, first paragraph, of the Act , the adoption of the report, by way of derogation from the first paragraph, shall not take place than after the care provider concerned has been given the opportunity to comment on the report.
4 The Inspection shall send the report to the health care provider concerned as soon as possible in writing or by electronic means.
1 Any other notification shall be made by electronic means or in writing at the Inspection.
2 Another notification shall contain:
a. The name and contact details of the reporter and the capacity in which he makes the notification;
b. the day drawing of the notification;
c. the name and, if possible, contact details of the healthcare provider to whom the notification relates;
d. where a notification involves a product, the name of the product and the name and contact details of the company involved in the product;
e. the situation to which the notification relates and the date on which this situation occurred.
3 Any other notification shall contain, where possible, the indication of whether the notification relates to:
a. the functioning of the care provider or the quality assurance of the healthcare provider;
b. the professional functioning of a health care provider;
c. a product or the action of a company involved in a product;
d. operations Chapter X of the Act on Professions in Individual Health Care is applicable;
e. a population survey within the meaning of the Population survey law or a scientific study in the sense of the Law Medical-Scientific Research with People ;
f. It is not or not entirely fulfilled by a healthcare provider to the Articles 13 , 15 , 18, first and fifth members , and 23 of the Act .
1 The Inspectorate shall confirm receipt of another notification in writing or by electronic means to the reporter as soon as possible, indicating the date on which the notification is under consideration and contact details of the Inspectorate.
2 If not satisfied, Article 8.15 , the Inspectorate shall inform the reporter in writing or by electronic means of the notification within a period of two weeks, unless the reporter is not known.
3 If the period referred to in the second paragraph has elapsed without the notification being supplemented or the reporter is not known to the Inspectorate and examination of the notification is not possible, the Inspectorate may refer the notification beyond any further treatment - The Inspection shall, if possible, inform the reporter.
If the reporter has indicated in another notification to remain anonymous to others involved in the handling of the notification, then the Inspectorate shall ensure that traceability to the reporter is not possible.
1 The Inspection shall, as soon as possible and at the latest within four weeks of the date on which the other notification is given, determine whether there is any further investigation. This period may be extended by two weeks.
2 The verification of its determination as referred to in the first paragraph shall be made in writing or by an electronic and reasoned communication to the reporter.
3 If the Inspectorate has found that there is no reason to investigate the other notification, the notice, referred to in the second paragraph, shall be accompanied by information on other possibilities of obtaining a judgment on the notified report. Situation.
4 If the Inspectorate has found that there is a need to investigate the other notification, the communication referred to in paragraph 2 shall be accompanied by a brief description of the actions which the Inspectorate will take and the time limit for the inspection of the information to be given. within which it will take place.
In the case referred to in paragraph 4, the Inspection of its finding shall also be communicated in writing or by electronic communication to the healthcare provider concerned or to the undertaking concerned or to the person who is the subject of the population study or the scientific If they are not the milder, carry out the tests.
1 The healthcare provider concerned and the health care providers concerned shall, at the request of the Inspectorate, provide all the information necessary for the examination of the other notification.
2 Data referred to in paragraph 1 shall include personal data of the cliёnt or clients involved in the reported facts and those concerned with the health care providers concerned.
1 The Inspectorate shall examine another report if it considers the Inspectorate:
a. indicates, or may indicate, a situation which means, or may represent, a serious threat to the safety of clients or care,
b. In order to ensure that the safety of the customers is otherwise reasonable, it is otherwise reasonable to require further investigation; or
c. relates to the failure or not to be wholly fulfilled by a healthcare provider to the Articles 13 , 15 , 18, first and fifth members , and 23 of the Act .
2 Any other notification shall not be further investigated if:
(a) other, statutory or international obligations laid down in international law must be used,
b. the notification has already been subject to examination by the Inspectorate; or
c. the notification refers to an event which occurred more than two years ago, unless the content of the notification of the inspection makes further investigation necessary.
1 If the Inspectorate has found that there is a need to investigate another notification, the Inspectorate shall, within a period of four months, which may be renewed for a period not exceeding four months, make further details of the information relating to: relevant facts and the relevant interests necessary to establish whether there is a situation that may be a threat to the safety of clients or the care, otherwise for delivering good care or the safety of clients. means whether or not a healthcare provider acted in violation of the Articles 13 , 15 , 18, first and fifth members , and 23 of the Act .
2 The task referred to in the first paragraph shall be the task referred to in the first paragraph by the care provider or the undertaking concerned or the person carrying out the population survey or scientific examination, taking into account the fact that the person concerned is responsible for carrying out the information and the conditions for its use. require by the Inspectorate to investigate the relevant facts within eight weeks of its own examination, unless the nature of the notification or other information on the healthcare provider concerned or the undertaking concerned, or the person in question, the population study or scientific investigation, the Inspectorate gives rise to not to do so. The Inspection may extend the time limit at the request of the healthcare provider concerned or the undertaking concerned, or the person carrying out the population or scientific research.
3 The requirements referred to in paragraph 2 shall, in any event, relate to the manner in which the reporter or the client concerned, if it is not the reporter, or his representative or his/her naexisting is involved in the investigation.
1 The Inspection shall itself carry out the necessary examination if it finds that the healthcare provider concerned or the undertaking concerned, or the person carrying out the population or the scientific investigation, does not itself carry out the requested examination, the investigation does not comply with the required requirements.
2 If the Inspectorate itself does the necessary research:
(a) notify the reporter, in writing or by electronic means, of the time within which the investigation will be carried out;
(b) shall hear the reporter, unless it has no price to do so;
c. does it hear the healthcare provider or company concerned, or the person carrying out the population survey or scientific research, and the client concerned, if it is not the reporter, or his representative or his representative or naexisting and, unless it considers that it is not relevant for the investigation, if possible, other persons directly involved in the facts covered by the notification;
(d) obtain the written or electronic advice of one or more experts if that opinion is relevant for the purposes of the investigation.
3 Of the hearing referred to in paragraph 2 (b) and (c), a report shall be drawn up. The report is presented to those with whom it has been discussed. They will have the opportunity to respond in writing or electronically within two weeks to any factual inaccuracies in the report. The corrections received shall be incorporated or justified in the report.
1 The Inspection terminates the examination of another notification if it finds, on the basis of its investigation, that no situation exists for the safety of clients or care, or otherwise for providing good care or the provision of care. security of clients may mean a threat or that the healthcare provider has not acted in violation of the 13 , 15 , 18, first and fifth members , and 23 of the Act .
2 The Inspection terminates the examination of another notification if it finds, on the basis of the investigation, by the healthcare provider or the undertaking concerned, or the person carrying out the population investigation or the scientific investigation, that the matter covered by the notification has been carefully examined in its judgment and that by the healthcare provider concerned or the undertaking concerned or the person carrying out the population investigation or the scientific investigation, adequate measures have been taken.
3 The termination of the termination shall be in writing or by electronic and reasoned communication to the reporter, the healthcare provider or the undertaking concerned, or the person carrying out the population survey or the scientific investigation.
1 Upon termination of the investigation, other than with application of Article 8.23 , the Inspectorate lays down the relevant facts in a draft report.
2 A draft report shall be notified as soon as possible to the reporter, the healthcare provider, or the undertaking concerned, or the person carrying out the population survey or scientific research, the client concerned, if not the melder, and the natural or legal persons who have been heard during the investigation.
3 Those who have been notified of the draft report shall be given the opportunity of responding in writing or electronically within a period of four weeks to factual errors in the draft report.
1 As soon as possible after receipt of the reactions, Article 8.24, third paragraph , but in any case within four weeks of the period specified in that paragraph, the Inspectorate shall issue a report on the examination of the notification. The report shall contain the relevant facts, the conclusions of the Inspectorate and the measures to be taken.
2 In adopting the report, the Inspectorate refers to the reactions referred to in the Article 8.24, third paragraph . If those to whom the draft report has been notified pursuant to Article 8.24, substantially differ with the Inspectorate on the relevant facts, as recorded in the draft report, and the Inspectorate does not or may not in writing or by electronic means, it shall inform the person concerned thereof and shall include the views of those concerned in the report to be adopted.
3 If the findings of the report include that a health care provider is, or has been, a situation as referred to in Article 25, first paragraph, of the Act , the adoption of the report, by way of derogation from the first paragraph, shall not take place than after the care provider concerned has been given the opportunity to comment on the report.
4 The inspection sends the report to the reporter, the healthcare provider, or the company concerned as soon as possible, or the person carrying out the population investigation or scientific investigation, the client concerned, if it is not the reporter; and the natural or legal persons who have been heard during the investigation.
1 This Decision shall continue to apply in respect of the copy of the decision of the regional disciplinary college or of the central disciplinary college which, as a result of the decision of the Court of Governors, is Article 72, first paragraph, point (c) , below 74, 2nd member, of the Act on the Occupation of Individual Health Care shall be sent to the State Supervision of Public Health.
2 The Articles 8.18, second and third paragraphs , 8.22, 2nd Member , 8.23, third member , 8.24, second paragraph , and 8.25, 4th Member , remain outside application in relation to the reporter if the public ministry or a regional review committee as intended Article 3 of the Law Review Act on termination of life upon request and assistance in case of self-extinguage is the milder.
3 If the Public Prosecutor ' s Office or a Regional Review Board as referred to in Article 3 of the Law Review Act on termination of life upon request and assistance in case of self-extinguage The Commission shall, after the report has been adopted, send to the Ministry of Public Prosecutor the Commission after the adoption of the report. Article 8.25 , a notice stating the reasons for the measures to be taken in the light of the investigation.
If the Inspectorate considers that it is necessary to take immediate action to ensure the safety of customers or care, the Inspectorate shall be competent to derogate from the Commission. Articles 8.1 to 8.25 .
1 The Inspect for the purposes of providing information as referred to in the Article 25, second paragraph, section c, of the Act to healthcare providers who are an institution, note that in relation to a health care provider in a report as intended in Article 8.11 , 8.14 or 8.25 It has been established that there is a situation as referred to in Article 25 (1) of the Act.
2 The note shall include, in addition to identifying information provided by the healthcare professional, only the date on which the report referred to in paragraph 1 has been established. The note is removed from the file if five years have passed since its adoption.
3 If a healthcare provider that is an institution, to the obligation, is intended to Article 4, first paragraph, of the Act requests to the Inspectorate to provide information as to a health care provider as intended in Article 25, second paragraph, section c, of the Act ' The Inspectorate shall, as soon as possible, inform him or the care provider of an endorsement referred to in paragraph 1, specifying, where appropriate, the date specified in that paragraph.
Article 3.1, first paragraph , does not apply to health care providers and other persons referred to in that paragraph who are employed by the healthcare provider at the time of entry into force of that member or for a legal person who provides care for the care provider.
The Decision quality requirements hospital blood banks shall be withdrawn.
The Mandatory Reporting Code of Domestic Violence and Child Abuse rests on Article 8, third paragraph, of the Law quality, complaints and disputes care .
This Decision shall enter into force on a date to be determined by the Royal Decree, which may be determined differently for the various articles.
This Decision is cited as: Implementing Decision Wkkgz.
Charges and orders that this Decision will be placed in the Official Journal by means of the note of explanatory note accompanying it.
Wassenaar, 13 November 2015
William-Alexander
The Minister for Health, Welfare and Sport,
E.I. Schippers
Published the first of December 2015The Minister for Security and Justice,
G.A. van der Steur
