Decree No. 137 / 2018 Coll.
Decree amending Decree No. 98 / 2012 Coll., on Health Documentation, as amended
Valid
Effective from 24.07.2018
137
DECLARATION
of 27 June 2018
amending Decree No. 98 / 2012 Coll., on Health Documentation, as amended
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:
Decree No. 98 / 2012 Coll., on Health Documentation, as amended by Decree No. 236 / 2013 Coll. and Decree No. 364 / 2015 Coll., is amended as follows:
1. in Article 1 (1) (b), the words "and contact" shall be inserted after the words "identification."
2. In Article 1 (1), the following point 4 is added at the end of point (b):
"4. telephone number, e-mail address and, where appropriate, other contact details, if communicated to the patient, '.
3. In Paragraph 1 (1), at the end of the text in point (c), the words "if intended 'shall be added.
4. in Article 1 (1), point (f) is deleted;
Points (g) to (j) shall be renumbered as points (f) to (i).
5. in § 1 (1) (f) to (h):
"(f) in the case of the provision of day-old or bedside care, the date and time of the patient's admission and the date and time of termination of care, including information on how the patient should be informed of a person who should provide additional care for 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 patient's intended release to the competent municipal authority, the date and time of transfer of the patient to another provider or, where appropriate, his or her transfer to another medical establishment department, 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 the consequences of such provision (hereinafter referred to as "a patient with limited professional capacity"). "
6. in Paragraph 1 (1), the following points (i) and (j) are added:
"(i) the identification and contact details of the legal representative of the patient, the guardian of the patient or of another person authorised to give his consent for the patient;
(j) 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; ';
Point (i) shall be renumbered as point (k).
7. in Paragraph 1 (2) (b), the word "treatment" is replaced by "the provision of health services."
8. in Paragraph 1 (2) (e), the words' shall be added at the end of the text of point 1; a copy or a copy of the prescription shall be regarded as such in accordance with the Law on Medicines or the voucher under the Law on Medical Devices';
9. In Article 1 (2), the words "a copy or a copy of the transport order shall be considered as such at the end of the text of point (f)."
10. in Paragraph 1 (2) (g), the word "carried out" is replaced by the word "provided."
11. in Article 1 (2) (h), the words "the dates of vaccination," shall be inserted after the words "including," and the words "in the case of the provider who carried out the vaccination" shall be added at the end of the text of the letter.
12. in Article 1 (2) (i), the words ", guardian or other persons entitled to grant as a patient" shall be inserted after the word "representative."
13. in Paragraph 1 (2) (k), the words "shall be added at the end of the text of point 1; for that reason it must also indicate why it was not sufficient to apply a more moderate procedure than the use of restrictive devices."
14. in Paragraph 1 (2) (k), at the end of the text of point 5, the words "and method of solution" shall be added.
15. in Paragraph 1 (2) (k) (8):
"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 the legal representative or the guardian of the patient has been informed of the use of means of limitation,"
16. in Article 2 (b), the words "his treatment" are replaced by the words "the provision of health services."
17. at the end of the text in point (c), the words "the summary of information (epicrithesis) 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 at least once a month."
18. in Paragraph 2 (f), "events" is replaced by "events";
19. at the end of the text in point (f), the words "and records of a Category A or B radiological event in which tissue reactions caused by faulty irradiation may adversely affect the patient's medical condition or, because of a radiological event, changes in his treatment procedure are necessary, to the extent required by another legislation14)."
footnote 14:
"14) Decree No. 422 / 2016 Coll., on Radiation Protection and Security of Radionuclide Source. '.
20. in Article 2 (h), the words "infectious diseases" shall be replaced by the words "infectious diseases," the words "diseases" shall be replaced by the words "diseases" and, at the end of the text of the letter, the words "to fulfil the obligation under the Act on Public Health Protection" shall be added.
21. In Article 3 (1), the words "to the extent of the name or the name, surname of the provider in the case of a natural person, a trading firm or the name of the provider in the case of a legal person and the identification number of the person, if assigned, shall be inserted after the word" provider. "
22. In Article 3, at the end of paragraph 1, the sentence "The results of the examination referred to in Article 2 (a), which are not in paper form, shall be added at least so that it is possible to determine which patient they relate to."
23. in Article 3 (2), "to (f)" is replaced by "and (e)";
24. in Article 3 (3), the words "for execution" shall be replaced by the words "Implementation" and the words "responsible" shall be replaced by the words "ensuring and confirming its correctness with its signature."
25. in Article 3, the following paragraph 4 is added:
"(4) Where it is clear from the way in which the health file is entered that it has been carried out by one health professional, it does not need to sign each partial entry during the day or shift, but it is sufficient for that health professional to sign the final entry during the day or shift. '
26. in Article 5 (2), the second sentence is deleted;
27th Paragraph 5 (4) reads:
"(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 which are separate parts of the medical documentation are available, the storage time 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. ';
28.
(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 authorised to be destroyed by the provider. "
footnote 9 is deleted.
29. In Annex 1, Part 2, point (b):
'(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,';
30. In Part 2 of Annex 1 to the Final Text, the words "in particular ecg, ultrasound, X-ray 'are replaced by the words" if this is technically sufficient'.
31. In Annex 1, Part 2, the final text is replaced by "occupational medical services'.
32. Point 3 of Part 4 of Annex No 1:
"3. a summary of the diagnoses for which medical care was provided during hospitalisation,"
33. In Annex No 1, Part 4, Section A, point 5:
"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, '.
34. In Annex 1, Part 4, Section B, point 2:
"2. a summary of the diagnoses for which medical care was provided during hospitalisation,"
35. In Annex 1, Parts 5 to 8 are deleted.
Parts 9 to 13 shall be renumbered as Parts 5 to 9.
36. in Annex No 1, Part 5 (a) (2), the words "on whose behalf the medical assessor issued the medical assessment," shall be replaced by the words "which issued the medical opinion, and, where appropriate, the name, surname of the provider in the case of a natural person, a business name or the name of the provider in the case of a legal person, the address of the place of supply of health services," and the words ", address of the place of business or place of business, stamp of the provider" shall be deleted.
37. in Annex No 1, Part 5 (a) (3), the words "the doctor who issued the opinion on behalf of the provider" shall be replaced by "the assessor."
38. In Annex No 1, Part 5, the words "and the possibility of waiving the right to review 'shall be added at the end of the text in point (d).
39. In Annex 1, Part 6, Section And in the final text, the word "archives" is replaced by the word "stores."
40. In Annex 1, Part 6, Section B, at the end of the text in point (d), the words "and anamnistic data, if known 'are added.
41. In Annex 1, Part 6, Section B (g), the words "and a health care professional 'shall be inserted after the word" provider'.
42. In Annex 1, Part 6, Section B, in the final text, a comma is added after the word "patient," the words "in paper form" shall be inserted after the words "in paper form," unless the word "archived," the words "stored."
43. In Annex 1, Part 7 is deleted.
Parts 8 and 9 shall become Parts 7 and 8.
44. In Annex 1, Part 8, Section A (a) (1), the word "dead 'is replaced by the word" deceased'.
45. In Annex 1, Part 8, Section A (a), the words "if known 'shall be added at the end of the text of point 3.
46. In Annex No 1, Part 8, Section And the final text is:
"The accompanying document shall be accompanied by the signature of the doctor who carried out the examination of the deceased's body. ';
47. in Annex No 1, Part 8, Section B, point (e) is deleted;
Point (f) shall be renumbered as point (e).
48. In Annex No 1, Part 8, Section C, the words "if known 'shall be added at the end of the text in point (b).
49. In Annex No 1, Part 8, Section D (e), the words "if detected 'shall be added at the end of the text in point 3.
50. In Annex 2, Article 1 (2), "3 years' is replaced by" 5 years';
51. In Annex 2, Article 1, paragraphs 4 and 5 are deleted.
52. In Annex 2, Article 3 (3), the words "marked with" V "shall be inserted after the words" the health file. "
53. In the first sentence of Article 4 (2) of Annex 2, the words "the head of the health care professional of the competent department of the health care establishment leading the medical documentation or designated by him" shall be deleted and the words "designated by the provider" shall be inserted after the word "the worker" and the words "the authorised person" shall be replaced by "the designated person."
54. In Article 5 (1) of Annex 2:
"(1) The designated health professional shall draw up a proposal for the decommissioning of the health file containing the provider's identification data and the designated health care professional's identification data which has been drawn up by the proposal. ';
55. In Annex No 2, Article 5 (3), the word "entrusted 'is replaced by" designated'.
56. In Annex 2, Article 5 (6), the words "and the list thus modified shall be transmitted together with the proposal for the disposal of the medical file and the Protocol on the selection of archives to the Commission referred to in Article 1 (4), if established, for assessment and confirmation '.
57. In Annex 2, Article 6 reads as follows:
(1) The medical documentation for disposal must be destroyed. Destruction of medical documentation means degradation in such a way as to prevent reconstruction and identification of its contents.
(2) The provider shall establish and maintain a written record containing an inventory of the destroyed medical file together with information on when, how and by whom the medical file has been destroyed; the inventory contains patient identification data. The written record shall be kept without a time limit. ';
58. In Annex 2, Article 7, the words "with a member of a commission appointed and withdrawn by the competent administrative authority being at least one doctor who also carries out the activities of an authorised health professional 'are replaced by the words" which is the Ministry of the Interior, the Ministry of Justice or the Ministry of Defence. Where the competent administrative authority is the Regional Authority, the health file taken over shall bear the "S' exclusion mark and the provisions of this Annex governing the storage, disposal and destruction of the medical file bearing the" S 'exclusion mark shall apply mutatis mutandis.';
59. In Annex 3, the following is inserted under the title of the Annex:
"Common provisions:
A. If a single type of medical file indicates a number of events relevant to the calculation of the duration of the storage period of the medical file, the event that occurs first shall be used for the beginning of that period if it is known to the provider.
B. In the event that the retention period is calculated from the date of death of the patient and the provider does not know the date of death of the patient, the day on which the patient reaches 100 years of age or 5 years has passed since the last entry in the medical file, whichever is the later. "
60. In Annex 3, point 1:
"1. Health care provided by the registering provider - S
(a) 10 years after the change of the registrant or 10 years after the death of the patient in the case of the registrant in the field of general medicine;
(b) 10 years after the change of the registrant or 10 years after the death of the patient or 10 years after the age of 19, in the case of a registrant in the field of practical medicine for children and adolescents,
(c) 5 years after the last provision of health services to the patient, in the case of a registered dental or gyno and obstetrics provider. "
61. In Annex 3, point 2, the letter "S 'is replaced by" V' and the words "patient examination 'are replaced by the words" provision of health services to the patient'.
62. In Annex 3 (3) (b) and (c):
'(b) 10 years after the death of a dialysis patient,
(c) 10 years after the death of a patient who, under another legislation, is a carrier of infectious diseases. "
63. In Annex 3, point 5, the word "termination 'is inserted after" 40 years after'.
64. In Annex 3, point 5, the current text becomes point (a) and a comma is added at the end of the point.
65. In Annex 3, point 5, the following point (b) is added:
"(b) 20 years after the end of the last hospitalisation of the patient or 10 years after the death of the patient in the event of subsequent and long-term bed care."
66. In Annex 3, point 6, "15 'is replaced by" 10'.
67. In Annex 3, point 7, "10 'is replaced by" 5'.
68. In Annex 3 (8) (a):
"(a) - S
10 years after the death of a patient with recognised occupational disease, unless otherwise specified, '.
69. Annex 3 (8) (f) reads as follows:
"(f) - S
in the case of a staff member of category A14, until the staff member has reached or would have reached the age of 75 but always at least 30 years from the end of the employment in category A, ';
70. In Annex 3, point 10 (a), the words "if no autopsy is decided 'and the words" ordered, 20 years' are replaced by the words "performed, 10 ';
71. In Annex 3, point 10 (b), "150 'is replaced by" 40'.
72. In Annex 3, point 10 (c), "10 'is replaced by" 5'.
73. In Annex 3, point 11 reads as follows:
"11. Imaging methods
(a) - V
graphic or audiovisual record or other visual record (for example, digital) 10 years after the last examination of a patient related to the provision of health services, or verification of conditions of occupational disease (occupational disease threat) under another legislation (8), for whose needs the alert has been made, unless it is a patient in a disability or other care for diseases monitored by the imaging method,
(b) - S
information on the course and outcome of the patient's examination by the imaging method 5 years after transmission of the information to the provider who requested the examination by the imaging method;
(c) - S
graphic or other visual recording (e.g. digital) 1 year after receipt of the alert in the case of the non-issuing provider but only received in order to ensure the continuity of health services,
(d) - V
graphic or other visual recording (for example digital) 30 years after the end of the last examination of a patient related to the provision of medical services in a patient in dispensary or similar care for diseases monitored by the imaging method, or 10 years after the patient died.
(e) - S
the quantities and parameters enabling the determination of the dose from the medical exposure 10 years after the medical exposure.
This point shall not apply to graphic or audiovisual records or other visual records issued or requested by an outpatient health service provider in the field of dental medicine. ';
74. In Annex 3, point 12 (b), "was' is replaced by" were '.
75. In Annex 3, point 14, the text "S 'is replaced by the text" V'.
76. In Annex 3, point 15 reads:
"15. Anchor - S
(a) two years after the examination; concerns the provider who provided the requested health service;
(b) 5 years after the examination for a neonatal screening card,
(c) 10 years after carrying out an examination using ionising radiation; it concerns a provider who has provided a requested health service. ';
77. in Annex 3, the following points 17 to 19 are inserted after point 16:
"17. Record of administration of the advanced therapy medicinal product, donation of tissues and cells for human use and use of tissues or cells in humans - V
30 years after administration of the advanced therapy medicinal product, from the collection of tissues and cells for human use and from the use of tissues or cells in humans or 10 years after the death of the patient.
18. Medical documentation taken over by the Regional Office - S
(a) 10 years after the receipt of the medical documentation taken from the registered provider in the field of general medical practice or in the field of practical medicine for children and adolescents;
(b) 5 years after receipt of the medical file in other cases.
19. Medical documentation of persons in custody, prison sentence or security detention led by the Czech Prison Service - S
100 years from the date of birth of the patient or 10 years from the death of the patient. '
Transitional provisions
1. Health documentation kept before the date of entry into force of this Order shall be subject to the retention periods in accordance with Annex 3 to Decree No. 98 / 2012 Coll., as effective from the date of entry into force of this Order. If the retention period for this health file has expired pursuant to Article 5 of Decree No. 98 / 2012 Coll., as effective before the date of entry into force of this Decree, and no procedures have been initiated before the date of entry into force of this Decree to assess its need under Annex No. 2 to Decree No. 98 / 2012 Coll., as effective before the date of entry into force of this Order, the need for medical documentation may be assessed under Decree No. 98 / 2012 Coll., as effective from the date of entry into force of the Decree.
2. If the medical documentation held before the date of entry into force of this Decree is initiated procedures to assess its necessity under Annex 2 to Decree No. 98 / 2012 Coll., as effective before the date of entry into force of this Order, shall be completed in accordance with Decree No. 98 / 2012 Coll., as effective before the date of entry into force of the Decree.
3. The medical documentation or part thereof in paper form produced pursuant to Decree No. 98 / 2012 Coll., as effective before the date of entry into force of this Order, or before 1 April 2012 may be converted into a document in electronic form pursuant to § 6 of Decree No. 98 / 2012 Coll., as effective from the date of entry into force of this Order.
Efficacy
This Decree shall take effect on the 15th day following its publication, with the exception of Article I (1), (2), (5), (6), (13) to (15), (19), (22), (23), (28), (32), (34), (36) to (38), (40) and (41), which shall take effect on the first day of the fourth calendar month following its publication.
Minister for Health:
Mgr. et Mgr. Vojtěch v. r.
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Regulation Information
| Citation | Decree No. 137 / 2018 Coll., amending Decree No. 98 / 2012 Coll., on Health Documentation, as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 09.07.2018 |
|---|---|
| Effective from | 24.07.2018 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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