Decree No. 98 / 2012 Coll.
Order on medical documentation
Valid
Effective from 01.04.2012
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98
DECLARATION
of 22 March 2012
on health documentation
The Ministry of Health provides, pursuant to Section 120 of Act No. 372 / 2011 Coll., on health services and the conditions for their provision (Health Services Act), for the implementation of Section 69 (a) to (d) of the Health Services Act:
(1) The medical documentation, taking into account the extent of the health services provided, contains information on the patient's health status and facts relating to the provision of health services to the patient,
(a) the provider's identification data which are:
1. the name of the provider, where applicable;
2. the address of the place of provision of health services in the case of a natural person;
3. the business firm or name of the provider, the address of the registered office or the address of the place of business in the case of a legal person;
4. the identification number of the person, if assigned,
5. the name of the department or similar part where the health establishment of the provider is so divided (hereinafter referred to as "the department of the medical establishment"),
(b) patient identification and contact details, which are:
1. name, names, patient's surname,
2. the date of birth, the birth number, if assigned, the number of the insured person of the public health insurance, if this number is not the patient's birth number, and the health insurance code,
3. the address of the place of permanent residence in the territory of the Czech Republic, if any, the place of registered residence in the territory of the Czech Republic, and, in the case of a person without permanent residence in the territory of the Czech Republic, the address of residence outside the territory of the Czech Republic,
4. a correspondence address, if not identical to the address referred to in point 3, and if communicated to the patient,
5. telephone number, e-mail address and, where applicable, other contact details if communicated to the patient,
6. the unique department identifier of the patient assigned to the patient by the Institute of Health Information and Statistics of the Czech Republic,
(c) the sex of the patient, if intended;
(d) the name and, where appropriate, the name, surname and signature of the health professional or other professional who made the entry in the health file; This does not apply to a provider that provides health services on its own behalf,
(e) the date of entry into the medical file, the date and time of the emergency medical treatment or the performance of the patient's visiting service;
(f) in the case of the provision of day-care or bed-care, the date and time of taking care of the patient and the date and time of the termination of the care of the patient, including information on how the patient should be informed of any further care of the patient, who, in view of his or her medical condition, will not be able to do so without the assistance of another person, or the date and time of the submission of the intended release of the patient to the competent municipal authority, the date and time of the transfer of the patient to another provider, or the transfer of the patient to another medical institution, or the date and time of death,
(g) information on the course and outcome of the health services provided and other relevant circumstances relating to the patient's health status and the procedure for providing health services, including the anamnistic data needed for the provision of health services;
(h) information as to whether the patient is a patient with limited professional capacity in such a way that he is unable to assess the provision of health services or, where appropriate, the consequences of providing them (hereinafter referred to as a patient with limited professional capacity);
(i) identification and contact details of the legal representative of the patient, the guardian of the patient or of any other person authorised to give consent for the patient;
(j) identification and contact details of the registrant in the field of general medical practice or in the field of practical medicine for children and adolescents, if known;
(k) in patients with disabilities, information on the necessary medical devices or, where appropriate, the specific equipment used by the patient, in patients with auditory impairment or combined auditory and visual impairment, as well as information on the forms of communication the patient prefers;
(l) for persons carrying out epidemiologically serious activities (1), a record of the type of activity carried out.
(2) The medical documentation further contains:
(a) working conclusions and final diagnosis;
(b) a proposal for further treatment and information on the course of the provision of health services if the patient's medical condition so requires;
(c) a record of the scope of the health services provided or requested;
(d) a record of the current state of health as assessed by the patient and a targeted objective finding;
(e) a record of:
1. prescription of medicinal products, food for special medical purposes, including dosage and number of prescribed packages, or medical devices; a copy or a copy of the prescription under the Law on Medicines or the voucher under the Law on Medical Devices shall be considered as such;
2. the administration of medicinal products or foodstuffs for special medical purposes, including the quantity administered; in the case of the administration of a transfusion product, the unique registration number of the transfusion product, including the code identifying the blood service facility, date, time and signature of the medical professional who submitted the transfusion product,
3. Equipment of the patient with medicinal products, food for special medical purposes, including quantities or medical devices,
(f) a record of the issuing of the transport order, including the type of means of transport; a copy or a copy of the transport order shall be considered as such,
(g) records of nursing care provided, including records of nutritional and rehabilitation care provided;
(h) the record of vaccination, including the date of vaccination, the name of the vaccine and the batch number, in the case of the provider who has carried out the vaccination;
(i) the written consent of the patient or his legal representative, guardian or other persons authorised to grant the provision of health services as a patient, where the obligation of the written form of consent is provided for by another legislation2), or where, taking into account the nature of the health performance, consent has been requested by the provider in writing;
(j) a record of refusal to provide health services;
(k) a record of the use of limiting agents (3) against a patient containing:
1. a record of the indication of the restriction, including a specification of the type, reason and purpose of the restriction and the determination of the intervals of checks and their scope; the reasons for this must also indicate why it was not sufficient to apply a more moderate procedure than the use of restrictive devices,
2. the time at which the device is to start and end,
3. records of the continuous assessment of the duration of the reasons for the use of the device;
4. records of the patient's ongoing health assessment during the restriction;
5. in the event of complications, their description and method of handling;
6. the name and, where applicable, the name of the medical professional who indicated the use of the restraint; in the event that the use of the device has not been indicated by the doctor, the name or, where applicable, the name and surname of the doctor who was subsequently informed of the use of the device;
7. If the use of the device has not been indicated by the doctor, the doctor's record of the assessment of the justification of the restriction, including the time at which it was confirmed,
8. Information that and when a legal representative of a patient, or other person who, under the Law on Health Services, is entitled to the rights and obligations of a legal representative, or the guardian of the patient, has been informed of the use of restrictive measures,
(l) copies of medical opinions;
(m) in the case of the provision of requested health services, also a request issued by another provider;
(n) a record of the inspection of the patient-led medical file, indicating when and to what extent the inspection took place, including a record of the receipt of a copy or extract from the medical file, if any;
(o) a record of the recognition or termination of temporary incapacity for work, of the assessment of the health status during its duration, of the arrangements for the temporary work of the incapacitated insured person and of changes thereto, of the start of the need for treatment and its duration; a record of the cessation of temporary incapacity shall be made by the provider who kept the patient in the register of temporary work for incapacitated citizens before the termination of the temporary incapacity; if the patient has been transferred to the register of another provider or taken from another provider during temporary incapacity, the medical file shall also include a record of the date on which he was transferred or taken over;
(p) the medical records of the sickness insurance authority related to health assessment, temporary incapacity for work and the need for care;
(q) records of other relevant circumstances relating to the patient's medical condition identified in connection with the provision of health services;
(r) a record of the suspicion of a doctor of malicious, abused and neglected syndrome, of the measures taken and of the fulfilment of the reporting obligation in accordance with the relevant legislation4).
(3) The medical documentation of the provider who has decided to manage the patient summary shall also contain data and records which are relevant to the management of the patient summary and are not listed in paragraph 1 or 2, to the extent set out in Annex 4 to this Decree.
(4) The health documentation also contains records, components and other facts provided for by the Health Services Act and the conditions for their provision, the Specific Health Services Act or other legislation5).
The patient's medical documentation includes:
(a) the results of the examinations in the form of written descriptions, graphic, audiovisual, digital or other similar records of such examinations, operational protocol, anaesthesiological record;
(b) written information on the findings of the patient's health status, the course and termination of the provision of health services or recommendations and proposals for the provision of other health services to be provided by providers in the context of ensuring the continuity of the patient's health services;
(c) in the case of bed care, a summary of the information (epicriosis) on the course of the examination and treatment and a plan for further treatment if the bed care lasts for more than 7 days; the summary of the information (epicriosis) and the plan for further treatment shall be recorded in the medical file at least every 7 days, in the case of long-term bed care or subsequent psychiatric bed care at least once a month,
(d) in the case of occupational medical services, data on the content and conditions of work for which the worker's health is monitored, including data on the inclusion of individual environmental factors in the relevant category6), the results of biological exposure tests, the dose of ionising radiation and other data relevant to the assessment of the impact of working conditions on the health of the worker, as well as written information on the current state of health or its development transmitted by the registered provider in the field of general practice;
(e) records of investigative, therapeutic or administrative performance carried out under other legislation7), including patient health records, and copies of reports, information and data transmitted under these other legislation;
(f) records of serious or unexpected adverse events associated with the provision of health services, the administration of a medicinal product, using a medical device, the administration of a medicinal product in clinical trials or the use of a medical device in clinical trials, and records of a category A or B radiological event in which tissue reactions caused by faulty irradiation may adversely affect the patient's health status or, because of a radiological event, changes in his therapeutic procedure are required, to the extent that other legislation14),
(g) records of the verification of new procedures using a method which has not yet been introduced in human clinical practice (8);
(h) a record of the reporting of infectious diseases, the suspicion of infectious diseases, the death of infectious diseases or the exclusion of infectious diseases agents to the local competent public health authority to fulfil the obligation under the Public Health Protection Act.
(1) Each health file sheet shall include the name, surname, surname and birth number of the patient, date of birth, if no birth number is assigned, the provider's identification details to the extent of the name and / or surname of the provider in the case of a natural person, a business firm or the provider's name in the case of a legal person, and, if assigned, the person's identification number, the unique department identifier of the patient allocated to the patient by the Institute of Health Information and Statistics of the Czech Republic, or the name of the department of the medical establishment. The results of the tests referred to in Article 2 (a), which are not paper-based, shall be marked at least by identifying the patient.
(2) The components of the medical documentation referred to in Annex 1 to this Regulation, which are separate parts thereof, shall contain the information set out in this Annex and the data and information referred to in Article 1 (1) (a), (b), (d) and (e), unless otherwise specified in Annex 1 to this Regulation.
(3) The completion of the entry in the medical file shall be ensured and signed by the health professional or any other professional who has provided the patient with a medical service.
(4) If it is clear from the way in which the medical file is entered that it has been carried out by one health professional, it may not sign each partial entry during the day or shift, but it is sufficient for that health professional to sign the last entry during the day or shift.
The medical documentation of the emergency care services includes:
(a) an audible recording of the reception of calls to the national emergency number 155 and of calls transmitted by the operational centre to another essential component of the integrated emergency system (hereinafter referred to as emergency call);
(b) the recording of the operator in digital form;
(c) a copy of the exit record;
(d) identification and sorting card,
(e) a record of patient mass redeployment.
(1) For the purpose of providing basic data on the patient's health status through the National Contact Point for Electronic Health ("National Contact Point"), the patient summary is kept electronically and structured to another provider in code systems that allow communication between the National Contact Point and the Provider that directs and transfers the patient summary to the National Contact Point. Code systems for patient summary management are publicly available on the Ministry of Health website. The content and structure of the patient summary is set out in Annex 4 to this Decree.
(2) A patient summary may be maintained for the purpose of transmitting to the National Contact Point, provided that the patient summary provider ensures its continued availability. The patient summary may be provided through the individual interface of the provider or a multi-provider exchange platform.
(3) The provider who decides on the management of the patient summary shall report to the administrator of the National Contact Point through a data message to the data box of the administrator for the purpose of establishing access to the National Contact Point, the management of the patient summary. The notification shall include:
(a) the provider's identification details to the extent of the trading firm or the name and identification number of the person, if assigned;
(b) the address of the information system interface of the provider for communication with the National Contact Point;
(c) the provider's encryption certificate intended for communication with the National Contact Point;
(d) the provision of the patient summary referred to in the second sentence of paragraph 2.
(4) The provider shall at the same time attach to the notification referred to in paragraph 3 a protocol demonstrating the conformity test of the interface of the information system operated in accordance with the operational documentation of the National Contact Point. The national contact point administrator shall ensure that the conformity test is carried out. The operational documentation of the National Contact Point is publicly available on the Ministry of Health website.
(1) The requirement for a patient summary submitted through the National Contact Point to the provider who has notified the National Contact Point of the management and provision of the patient summary shall include:
(a) patient identification according to § 1 (1) (b) (1) and (2); and
(b) the identification details of the provider of another European Union State requesting the patient summary and its healthcare professional.
(2) The patient summary requirement is transmitted via the interface of the provider's information system, which has been notified to the National Contact Point pursuant to § 4a (3) (b).
(1) The provider maintains and maintains the health documentation in accordance with the principles set out in Annex 2 to this Regulation; ensure an assessment of the need for health documentation for the further provision of health services (hereinafter referred to as the "need assessment ') for the purposes of its decommissioning and destruction or further preservation. This applies mutatis mutandis to the competent administrative authority which has taken over the medical documentation under the Health Services Act.
(2) The medical documentation shall be kept for a period of 5 years and shall be marked with the "S 'character unless otherwise specified in another legislation or in Annex 3 to this Decree.
(3) The retention period of a patient-related medical file by one provider begins to run on 1 January of the following calendar year after the date on which the last entry in the patient's medical file was made, unless otherwise specified in Annex 3 to this Regulation.
(4) Where a medical file, or parts thereof, carried out by a single provider on a patient by its inclusion or material content is subject to several periods for its preservation in accordance with Annex 3 to this Regulation, the retention period shall be determined, the event relevant for the counting of the duration of that period, and the exclusion mark shall be determined according to the longest retention period. If the components of the medical documentation are separate parts of the medical file, the storage period may be determined, the event shall decide for counting the running of that time and the elimination character for each separate part of the medical file separately.
(1) The transfer of medical documentation, or part thereof, which has been taken in paper form and which the provider himself has acquired or received, to a document in electronic form shall be carried out by the provider in accordance with a procedure guaranteeing the authenticity of the document's origin, the integrity of the contents, the legibility of the document and the security of the transfer process.
(2) The document established in accordance with paragraph 1 shall be accompanied by a clause. The document shall be signed by the person responsible for transferring it by qualified electronic signature or the provider shall seal the qualified electronic seal and shall affix the clause with a qualified electronic time stamp.
(3) A paper document which has been converted by the provider into an electronic document is entitled to be destroyed by the provider.
(1) Annexes 2 and 3 to this Decision apply to health dossiers which began to be kept before 1 April 2012. If the maintenance period specified in § 5 has expired for this medical file prior to the date of entry into force of this decree and the shredding procedure has not been carried out or initiated pursuant to Decree No. 385 / 2006 Coll., on medical documentation, as amended by 31 March 2012, its necessity may be assessed from 1 July 2013.
(2) If a shredder procedure has been initiated for a medical file carried out before 1 April 2012, the medical file, as amended by 31 March 2012, shall be completed in accordance with Decree No. 385 / 2006 Coll., on the medical file.
This Decree shall take effect on 1 April 2012, with the exception of the provisions of Paragraph 1 (1) (k), which shall take effect on 1 April 2013.
Minister:
Doc. MUDr. Heger, CSc., v. r.
Příloha č. 1
Annex No 1 to Decree No 98 / 2012 Coll.
MINIMUM STATEMENT OF OWN HEALTH DOCUMENTATION
1. HEALTH DOCUMENTATION
The extract from the medical file shall include:
(a) basic historical data, supplemented by the information necessary for the purpose for which the extract is issued;
(b) information on the patient's recent medical condition and breakdown of medicinal products used by him, special medical food and medical devices used;
(c) diagnostic summary,
(d) a brief assessment of the patient's state of health, including responses to treatment and dynamics of the development of the results of laboratory and other auxiliary examinations;
(e) other relevant information including information from the assessment.
2. REQUEST OF OTHER HEALTH SERVICES (REQUEST)
Requests for additional health services include:
(a) the health services required and their justification, including the urgency of providing them;
(b) details of the last established state of health, including those results of laboratory and other auxiliary examinations which are relevant to the provision of requested health services;
(c) data on treatment to date and patient response;
(d) a work diagnosis;
(e) a brief assessment of the history data if they are related to the required health services.
In the event of a request for expert examination consisting of a laboratory examination or the use of instrumentation, if technically sufficient, the request shall contain the information referred to in points (a) and (e).
In addition to the information on the medical condition found, the provider of occupational health services shall always provide information on the occurrence of risk factors and health performance and the conditions under which the activity under assessment is carried out.
3. REPORT ON PROVIDED HEALTH SERVICES
The report on health services provided shall include:
(a) data on the state of health established, including the results of laboratory and other tests;
(b) data on treatment to date and patient response;
(c) recommendations for the further provision of health services, including recommendations in assessment care.
In the case of one-off provision of health services, the report shall contain information on the state of health identified, including the results of laboratory and other examinations and recommendations for the further provision of health services.
In the case of requested expert examinations consisting of laboratory examinations or the use of instrumentation, in particular ecg, ultrasound, X-ray, the report on the health services provided shall contain the information referred to in point (a).
4. INFORMATION ON TERMINATION OF THE SINGLE OR SIMPLE HEALTH (PRESENTATION REPORT)
A. Release message contains:
1. a brief indication of the history and current illness,
2. Time and course of one-day or bed care to describe why the patient was hospitalized and what was the result of diagnostic efforts, treatment and treatment,
3. a summary of the diagnoses for which medical care was provided during hospitalisation,
4. a record of the current treatment and the results of the examinations carried out, which are essential for the provision of other health services,
5. an overview of the health performance performed during hospitalisation, which is relevant for the further provision of health services, including their results and information on the complications encountered,
6. recommendations for providing the necessary health services, including rehabilitation and nursing care, and recommendations for dietary treatment, medicinal products, food for special medical purposes and their dosage and recommendations for medical devices to be provided by the provider of other health services and recommendations for medical assessment.
B. Preliminary discharge report shall include:
1. basic data on the course of hospitalisation,
2. a summary of the diagnoses for which medical care was provided during hospitalization;
3. a brief record of current treatment, rehabilitation and nursing care, dietary treatment, including the indication of medicinal products, food for special medical purposes and medical devices to which the patient is equipped,
4. recommendations on the follow-up to the provision of health services.
5. DOCTOR ASSESSMENT
The medical evaluation shall always include:
(a) identification data
1. the persons under consideration, to the extent of the name or, where applicable, the name, surname, date of birth, address of the place of permanent residence of the person under consideration, or place of residence in the territory of the Czech Republic, if any, if it is a foreigner,
2. the provider who issued the medical opinion, the name or, where applicable, the name, surname of the provider in the case of a natural person, a business firm or the name of the provider in the case of a legal person, the address of the place where the health services were provided, the identification number of the person, if any,
3. the judging physician, the name and, where appropriate, the names, surname and signature of the doctor,
4. the serial number or other registration mark of the opinion,
(b) the purpose of the assessment;
(c) assessment conclusion,
(d) information on the possibility of submitting a review proposal and the possibility of waiving the right to review;
(e) the date of issue of the opinion;
(f) the date of expiry of the opinion where, on the basis of the medical condition or medical fitness established, it is necessary to restrict its validity or where other legislation so provides.
6. DOCUMENTATION OF THE HEALTH SAFETY PROVIDER
The documentation of the health rescue service provider shall consist of a set of documents and records relating to a specific patient or event, including audio recordings (records) of the medical operating centre with time data.
A. The operator's record shall include:
(a) the date, time and serial number of the emergency call;
(b) the personal data of the patient, to the extent that the name and, where appropriate, the name, surname and date of birth can be ascertained, and the data needed to determine the place of intervention;
(c) the telephone number or any other indication of the possibility of connection at the caller, if this information can be ascertained;
(d) personal data of the operator who received the distress call;
(e) the time at which the emergency call for departure to the medical emergency services group is transmitted;
(f) indication of exit.
The operator's record shall be kept in electronic form and shall be kept on the medium for a life of more than 5 years.
B. The exit record shall include:
In addition to the particulars in Part A,
(a) the place where the exit is made;
(b) date and time of departure of the exit group, type of exit group,
(c) the date and time of arrival of the exit group at the event site;
(d) a brief description of the clinical condition and anamnistic data, if known,
(e) a work diagnosis,
(f) a description of the pre-hospital emergency care provided;
(g) the time and place of transfer of the patient to the health care establishment, including the identification data of the recipient provider and the health care professional, or the time and place of exit, unless the patient has been transmitted to the provider;
(h) the name and / or surname of the health care professionals who provided emergency care for the hospital.
The exit record shall be transmitted to the target acute bed care provider, or to the patient, in paper form, if not evaluated for transmission in electronic form, a copy of the alert shall be kept in paper or electronic form by the health rescue service provider.
C. Identification and sorting card contains:
(a) the unique patient registration number (combination of the letter identifying the region and the serial number of the card);
(b) the degree of urgency of the patient's treatment;
(c) the patient's sorting time;
(d) a work diagnosis;
(e) the time at which the patient is transferred to the removal device;
(f) the time at which the patient is transferred to the provider of emergency bed care;
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Regulation Information
| Citation | Decree No. 98 / 2012 Coll., on Health Documentation |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.03.2012 |
|---|---|
| Effective from | 01.04.2012 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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